News Alert

Kymera Therapeutics this week announced that the company has entered into a multi-program strategic collaboration with Sanofi to develop and commercialize first-in-class protein degrader therapies targeting IRAK4 in patients with immune-inflammatory diseases. Under terms of the collaboration, Sanofi will make an upfront payment of $150 million in cash to Kymera for global rights to develop its small molecule IRAK4 protein degraders in inflammation and immunology indications, and a second earlier stage undisclosed program. IRAK4 is believed to play a key role in multiple immune-inflammatory diseases, including hidradenitis suppurativa, atopic dermatitis and rheumatoid arthritis. Learn More

As the race to develop a vaccine for the coronavirus speeds up, the biopharma industry is being careful to not set any dangerous precedent that may weaken their future intellectual property rights, a senior executive at IHS Markit said this week. "With vaccine development for Covid-19, pharmaceutical companies are certainly being very careful," Milena Izmirlieva, director of life sciences research at IHS Markit, said on CNBC's "Squawk Box Asia." She explained there have been calls for future Covid-19 vaccines to be treated as a public good, which would mean that they would be provided to everyone, without profit. Learn More

Kodiak Sciences has embarked on a major expansion with a lease of large office buildings in Palo Alto's choice Stanford Research Park, regulatory documents show. The company has leased about 155,000 square feet from an affiliate of Sand Hill Property Co., documents filed with the Securities and Exchange Commission and state government officials show. The buildings are part of a Sand Hill Property project that has launched a dramatic redevelopment of an old office complex at the corner of Page Mill Road and Hanover Street in Palo Alto. "The company expects to use the buildings as its new corporate headquarters for research laboratories and office space," Kodiak Sciences said in SEC documents that were filed on June 25, 2020. Learn More

This week Genentech and Amgen jointly filed stipulations in the U.S. District Court for the District of Delaware dismissing their BPCIA litigations concerning Amgen's biosimilars of Genentech's HERCEPTIN (trastuzumab) and AVASTIN (bevacizumab) oncology products. According to each court submission, the parties entered into a settlement agreement and mutually agreed to voluntarily dismiss all asserted claims and counterclaims with prejudice. The settlements come on the heels of two recent appellate decisions in these litigations from the U.S. Court of Appeals for the Federal Circuit in favor of Amgen. The settlements effectively end years of litigation between the two biotech giants. Learn More

AbbVie's Allergan and its Korean partner Medytox have won the first round of a U.S. trade dispute in which they are trying to block imports of Evolus's Jeuveau, a rival to the Botox wrinkle treatment. A U.S. trade judge investigating claims that Jeuveau was developed using stolen trade secrets found against Evolus and its partner, Daewoong Pharmaceutical Co., and has recommended a 10-year ban on Jeuveau imports, the companies said in statements. The judge's decision will now be reviewed by the U.S. Trade Commission which has the power to block imports of products that violate U.S. intellectual property rights. A final ruling is expected by the end of the year. Learn More

The University of Maryland (UMD) has made public it's decision to close the highly respected Biotechnology Research and Education Program (BREP) program. As of July 1, 2020, BREP's research equipment has fallen silent and its doors have been shut. Since its inception in 1985, BREP produced over 130 graduates from their 'work-study' program, which gave about 12 students each year cGMP-like industry experience on the most relevant technologies and processes. Another 80 or so UMD students each year enrolled in a biopharma course that provided industry-relevant education and training through the BREP program resources. The final undergraduate courses offered will be completed by the end of this month. Learn More

The Trump administration has awarded a contract worth $1.6 billion to Novavax for the development of a coronavirus vaccine, the largest bet yet by the federal government on an individual vaccine to combat the pandemic. The deal will pay for late-stage clinical trials and secure 100 million doses of the vaccine to be used by the United States, the company said. Novavax already has an ambitious manufacturing plan underway and said it expects to have 100 million doses ready for distribution in late 2020 and early 2021, if clinical trial data shows the vaccine is safe and effective. Learn More

The U.S. government has signed a $450 million contract with Regeneron for its potential COVID-19 antibody cocktail. The agreement comes under the government's "Operation Warp Speed" program that is aimed at faster distribution of vaccines and treatments to fight the new coronavirus when trials are successful. Under the contract with Regeneron, signed with the HHS' Biomedical Advanced Research and Development Authority and the Department of Defense, the doses manufactured under the project will be owned by the federal government. Regeneron's cocktail, REGN-COV2, contains an antibody made by the company and another isolated from recovered COVID-19 patients. Learn More

The U.S. FDA has placed a clinical hold on one of Cellectis's off-the-shelf CAR-T trials after one patient died of cardiac arrest, a worrying development for a technology thought to be safer than the approved alternative. Cellectis's treatment, UCARTCS1A, is derived from T cells provided by healthy donors, more practical and potentially less dangerous than traditional CAR-T therapies made from patients' own immune cells. But the patient death, which emerged in a multiple myeloma study, suggests off-the-shelf CAR-T could carry risks of its own. Learn More

In a forthcoming paper, "It is Time to Address Airborne Transmission of COVID-19," 239 scientists from more than 30 countries are pushing the WHO to pay more attention to the possible airborne spread of SARS-CoV-2, the novel coronavirus that causes COVID-19. At this time, the WHO and other public health organizations' guidelines refer to primary spread of the virus on droplets expelled when people with the disease sneeze, cough, or potentially speak loudly or sing. These are on "large respiratory droplets," and once they are expelled, they quickly fall to the ground. However, the researchers believe that airborne transmission via aerosolized particles, much smaller particles that can hang in the air, is more common than originally believed. Learn More

Emergent BioSolutions has announced a five-year manufacturing services agreement with Janssen Pharmaceuticals for large-scale drug substance manufacturing of J&J's investigational SARS-CoV-2 vaccine. Emergent will provide contract development and manufacturing (CDMO) services to produce drug substance at large scale over five years, valued at approximately $480 million for the first two years. Under the agreement, Emergent will begin providing large-scale drug substance manufacturing for Johnson & Johnson's adenovirus-based COVID-19 vaccine in 2021, upon successful completion of the activities under the previously executed Technology Transfer Agreement. Learn More

MilliporeSigma has enhanced its advanced bioprocess portfolio through the acquisition of RESOLUTION Spectra Systems. The company offers Raman spectroscopy analysis through its GMP-ready instrumentation and software. Financial details of the acquisition were not disclosed. This acquisition supports MilliporeSigma's recently launched Bio4C™ Software Suite, the latest component of Merck's expanding BioContinuum™ Platform, which allows for the convergence of intensified process and digital technologies to advance process speed, quality and flexibility, while reducing cost. Learn More

Tesla CEO Elon Musk has announced that the automaker has become the manufacturing partner for biotech firm CureVac who is working on a COVID-19 vaccine based on their RNA technology. The announcement comes as CureVac has secured a $300 million investment from the German government and Tesla looks to leverage its experience in automotive manufacturing into a significant presence in biotech, specifically RNA. For some this does not come as a surprise since Grohmann Engineering was doing things like that before it was acquired by Tesla and dropped all other clients to focus on the automaker. Learn More

A 30,000-patient trial of Moderna's coronavirus vaccine candidate, expected to start next week, has been delayed, a potential hurdle in the company's ambitious effort to deliver key data by Thanksgiving. Moderna is making changes to the trial plan, called a protocol, which has pushed back the expected start date of the Phase 3 study, according to investigators. The investigators, who spoke on condition of anonymity, emphasized that protocol changes are common but said it's not clear how long the start will be delayed. "My understanding was that they wanted to get the first vaccines given in July, and they say they're still committed to do that," one investigator said. "As best I can tell, they're close to being on target for that." Learn More

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The hub integrates Boehringer Ingelheim's external-facing functions, including its Research Beyond Borders (RBB), Business Development & Licensing (BD&L) and the Boehringer Ingelheim Venture Fund (BIVF) under one roof. The initiative aims to embed life science innovation in China into Boehringer Ingelheim's global drug discovery and development chain by seeking collaboration and investment opportunities ranging from early to mature stages. Learn More

An early trial of an experimental coronavirus vaccine from Pfizer and BioNtech showed it's safe and prompted patients to produce antibodies against the new virus, keeping it in the lead pack for a pandemic shot. The messenger RNA product was tested on 45 healthy adults divided in several groups: 24 of them got two injections with two different doses of the experimental vaccine, 12 of them received a single shot with a very high dose and nine patients got two dummy injections. The two-shot groups produced the highest level of antibodies. If the vaccine is successful, the companies expect to manufacture up to 100 million doses by the end of this year and potentially more than 1.2 billion doses by the end of 2021. Learn More

In a move raising concerns abroad, the US has announced the purchase of more than 500,000 doses of Gilead's drug remdesivir. The enormous purchase represents all of the drugs production for July and 90% of the production planned for August and September and comes as remdesivir remains one of only two drugs proven to work against Covid-19. This has raised alarms in the UK, Europe and elsewhere as experts note that the purchase effectively leaves none of the drug available for most of the rest of the world. All of this comes as the first 140,000 doses supplied to drug trials the world over have been used up. Learn More

Amgen won an appeals court ruling this week that will block the sale of Erlelzi from Novartis and all other biosimilar versions of Enbrel until 2029 at the earliest. This comes after Novartis had appealed an earlier lower court ruling in favor of Amgen regarding patent protection for the blockbuster drug. Alert readers will likely recall that Enbrel was first approved by the US FDA back in 1998 and was manufactured by Immunex based on patents purchased from Roche. Four years later, in 2002, Amgen would negotiate the acquisition of Immunex for $16 billion with 15% paid in cash and 85% with Amgen stock. An acquisition that has paid of handsomely for the biotech leader. Learn More

The U.S. Justice Department this week charged generic drug giant Glenmark Pharmaceuticals with manipulating the prices of drugs sold in the U.S., as part of a broad federal probe of price-fixing in the generics industry. The company was charged with one count of conspiracy in restraint of trade in a filing in the Eastern District of Pennsylvania. The complaint alleges that Glenmark and other companies raked in $200 million from the illegal scheme. It could face hundreds of millions of dollars in fines, according to a press release from DOJ announcing the charges. A Glenmark spokesperson said the allegations are false. Learn More

A new strain of the H1N1 swine flu virus is spreading silently in workers on pig farms in China and should be "urgently" controlled to avoid another pandemic, a team of scientists says in a new study. H1N1 is highly transmissible and spread around the world in 2009, killing about 285,000 people and morphing into seasonal flu. The newer strain, known as G4 EA H1N1, has been common on China's pig farms since 2016 and replicates efficiently in human airways, according to the study published this week. So far, it has infected some people without causing disease, but health experts fear that could change without warning. Learn More

Repligen has entered into an agreement to acquire Albany, NY-based Engineered Molding Technology (EMT), a manufacturer of single-use silicone assemblies and components used in the manufacturing of biologic drugs. EMT's standard and custom molded and over-molded connectors and silicone tubing products are key components in single-use filtration and chromatography systems. "The acquisition of EMT expands our line of single-use ProConnex flow paths, streamlines our supply chain for ATF, and gives us more flexibility as we scale and expand our single-use and systems portfolios," said Tony Hunt, president and chief executive officer, Repligen. Financial details of the deal have not been made public. Learn More

Two persons died and four were injured in a gas leak at API manufacturer Sainor Life Sciences this week. According to investigators, a reactor in the pharma unit began leaking benzene vapors which resulted in six people who were working in the unit becoming ill and being taken to the hospital. On the way, two of the six injured workers died with a third currently in the hospital on a ventilator in serious condition. The remaining three workers are understood to still be hospitalized and under observation. The pharma unit has been closed as the cause of the reactor gas leak is investigated. Learn More

Amid escalating concerns over antibiotic resistance, several big drug makers are creating a new $1 billion for-profit venture to acquire or invest in small antibiotic companies and their nascent products, according to two people familiar with the plans. The effort will be announced on July 9th by the chief executive officers at Pfizer, Merck, Eli Lilly, Novo Nordisk, Boehringer Ingelheim, Bayer Pharmaceuticals, and Merck KGaA, among others. Also on hand will be government officials from Germany, Sweden, the U.K., and France, as well as representatives from Wellcome Trust and Pew Charitable Trusts. Learn More

The maker of a drug shown to shorten recovery time for severely ill COVID-19 patients says it will charge $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries. Gilead Sciences announced the price this week for remdesivir, and said the price would be $3,120 for patients with private insurance. The amount that patients pay out of pocket depends on insurance, income and other factors. However, the price was swiftly criticized; a consumer group called it "an outrage" because of the amount taxpayers invested toward the drug's development. Learn More

Vaccines have gotten all the attention in the race to fight Covid-19, but there is a major push in the U.S. to develop antibody therapies to treat coronavirus. So much so that some scientists think antibody treatments may be available this year, even before a vaccine. During the 1918 flu pandemic, doctors proved convalescent plasma -- antibody-filled blood plasma from patients who recovered from the disease -- could fight flu. Convalescent plasma has been used to treat severe flu, MERS and SARS and now some US doctors are starting to see some success treating Covid-19, too. Learn More

A form of CRISPR widely expected to be safer and possibly more effective that the original has aced its first substantive test. When CRISPR "base editing" was used to knock out two cholesterol-associated genes in monkeys, the animals' blood levels of heart-disease-causing LDL ("bad") cholesterol and triglycerides plunged as much as 60% and 65%, respectively, Sekar Kathiresan, co-founder and CEO of Verve Therapeutics, announced on Saturday at the (virtual) meeting of the International Society for Stem Cell Research. The results are the first published data showing successful CRISPR base editing in a non-human primate; there have been similar successes in mice. Learn More

OSIsoft, perhaps best known in our community for its industry standard PI platform on which so many rely to manage their bioprocess data and more, could be sold for upwards of $4B+ in the coming months according to people familiar with the matter. Those understood to be likely serious bidders for the company include traditional industrial market leaders such as Emerson, Schneider, Siemens and others. The next-round bids are due to be submitted in July with some speculating that future bidders may include representatives from amongst others the tech sector. Learn More

Sanofi is considering cutting hundreds of jobs and will discuss potential steps with staff representatives over the coming days, five sources said this week. Management has begun meeting with staff representatives to outline a restructuring plan, five sources familiar with the matter told Reuters. They declined to be identified as the plan is still confidential. The reorganization could involve several European countries and possibly others outside the region, as well as all the divisions of Sanofi except the vaccines and rare diseases unit Genzyme, the sources said. Three sources said around 1,000 jobs in France were at risk. Learn More

The NIH may own intellectual property that undergirds a leading coronavirus vaccine being developed by Moderna, according to documents obtained by Axios and an analysis from Public Citizen. Why it matters: Because the federal government has an actual stake in this vaccine, it could try to make the vaccine a free or low-cost public good with wide distribution, if the product turns out to be safe and effective. The big picture: The NIH rarely claims ownership stakes or pursues patent rights, but that appears to be different with this coronavirus vaccine. Earlier this year NIH Director Collins noted "We do have some particular stake in the intellectual property" behind Moderna's coronavirus vaccine. Learn More

UniQure has sold off the rights to its experimental gene therapy for hemophilia B, announcing this week that it is licensing the treatment to CSL Behring for $450 million in cash. The Dutch gene therapy developer could receive as much as $1.6 billion more in conditional payments if the gene therapy, currently in late-stage testing, progresses as expected. Per deal terms, CSL will also reimburse UniQure's remaining development costs, cover expenses related to regulatory submissions and give UniQure royalties on net sales. The deal gives the biotech enough cash to fund itself for another four years and develop its other experimental gene therapies. Learn More

Kymab has announced that the Supreme Court of the United Kingdom has held that all of the claims of two patents, often referred to as the 'Murphy patents', owned by Regeneron that were asserted against Kymab are invalid. The Court's decision upholds the February 2016 decision of the High Court trial judge to revoke the claims and reverses the Appeal Court's determination that they were valid. The Murphy patents sought to cover genetically modified mice containing chimeric human-mouse antibody genes and the human antibodies made using such mice. The patent remains in full force in the US. Learn More

The U.S. FDA has lifted a partial clinical hold that had been placed on the phase 2 TELLOMAK trial which is examining the safety and efficacy of lacutamab in patients with advanced T-cell lymphoma, according to an announcement from the drug's developer, Innate Pharma SA. The decision is based on a quality assessment of a new Good Manufacturing Practice (GMP)-certified batch that has been successfully manufactured for the clinical development program for the agent, which includes TELLOMAK. In light of this feedback, the commercial stage oncology-focused biotech company can now recommence moving forward. Learn More

More than 99.9% of seasonal coronaviruses present in airborne droplets were killed when exposed to a particular wavelength of ultraviolet light that is safe to use around humans, a new study at Columbia University Irving Medical Center has found. "Based on our results, continuous airborne disinfection with far-UVC light at the current regulatory limit could greatly reduce the level of airborne virus in indoor environments occupied by people," says the study's lead author David Brenner, PhD. The research was published this week in Scientific Reports. The researchers had previously shown that far-UVC light can safely kill airborne influenza viruses. Learn More

A trial in pigs of AstraZeneca's experimental COVID-19 vaccine has found that two doses of the shot produced a greater antibody response than a single dose. Research released by Britain's Pirbright Institute this week found that giving an initial prime dose followed by a booster dose of the vaccine elicited a stronger immune response than a single dose. This suggests a two-dose approach may be more effective in getting protection against COVID-19, the disease caused by the new coronavirus. The ChAdOx1 nCoV-19 vaccine, also known as AZD1222, was originally developed by Oxford University scientists, who are now working with AstraZeneca on development and production. Learn More

Sanofi and Translate Bio have agreed to expand their existing collaboration and license agreement to develop mRNA vaccines for infectious diseases. Under the expansion agreement, Translate Bio will receive a total upfront payment of $425 million, consisting of a $300 million cash payment and a private placement common stock investment of $125 million. Under the collaboration, Translate Bio is using its mRNA platform to discover, design and manufacture vaccine candidates and Sanofi Pasteur is providing its deep vaccine expertise to advance vaccine candidates into and through further development. Learn More

Gilead has announced that it has acquired a 49.9 percent equity interest in Pionyr Immunotherapeutics, a privately held company developing first-in-class cancer immunotherapies, and an exclusive option to purchase the remainder of Pionyr. Under the terms of the agreement, Pionyr's shareholders will receive $275 million upon closing. Gilead will receive 49.9 percent of the common stock of Pionyr and an exclusive option to purchase the remaining equity. Gilead may exercise its exclusive option for a $315 million option exercise fee and up to $1.15 billion in potential future milestone payments. In addition, Gilead will provide Pionyr with additional funding for ongoing research and development programs. Learn More

The AltHost Consortium, an MIT led collaboration that includes Biogen, Amgen, Pfizer, Genentech and the Bill & Melinda Gates Foundation, announced this week that it will work to advance the speed and productivity of alternative host cell research and manufacturing. By adjoining MIT's cutting-edge research and innovation with the resources and clinical understanding of the industry, "AltHost" will enable its members to work together in a common environment of knowledge, practices, and efficiencies. By sharing alternative host cell research, AltHost members are supporting efforts to explore innovative ways to produce biologics and vaccines for clinical usage in diseases from diabetes to cancer. Learn More

Gilead will this week begin human study of an inhaled version of its COVID-19 drug remdesivir, potentially opening up an avenue to making the antiviral therapy more widely available to patients infected with the new coronavirus. Currently, remdesivir is given intravenously once daily, making early or outpatient treatment more challenging. But results from a government-run study, as well as scientists' understanding of how antiviral drugs work, suggest that patients who are treated with remdesivir earlier on benefit the most. Gilead will first test its inhaled formulation in healthy volunteers, to be recruited into a Phase 1 study. Studies of COVID-19 patients could begin by August, said Gilead CEO Daniel O'Day. Learn More

The UK government has introduced legislation to protect businesses that are key to public health from foreign takeovers. The changes give the government the power to protect companies that could be critical in helping the country in future health emergencies, but which may be struggling to weather the coronavirus pandemic. The new powers cover firms such as pharmaceutical and technology companies. The government already has the power to investigate takeovers for reasons such as national security and on financial grounds, including the ability to block a takeover or seek assurances from a buyer about plans for a business. Learn More

UV-C light has been used as a disinfectant against viruses and bacteria for more than 40 years. Now, researchers at Boston University and Signify have confirmed that it also effectively eradicates the SARS-CoV-2 virus. Specifically, a 5mJ/cm2 dose of UV-C light eradicated 99% of the SARS-CoV-2 virus in 6 seconds, according to testing by Anthony Griffiths, Ph.D., associate professor of microbiology, in Boston University's National Emerging Infectious Diseases Laboratories. Based on the data, he and his team determined that a 22mJ/cm2 dose of UV-C light will result in a reduction of 99.9999% of the virus in 25 seconds. That translates, at a basic level, to needing a 13W UV-C light bulb to kill viruses in a 10 x 16 ft (15 square meter) room, for an undetermined period of time. Learn More

Empatica and the Biomedical Advanced Research and Development Authority are joining forces to bring wearables to COVID-19 detection. The two will work together to validate Aura, a system that will alert individuals when it detects a likely SARS-CoV-2 infection.  Aura will use Empatica's medical smartwatches, software, and artificial intelligence capabilities. In February 2019, Empatica and BARDA's Division of Research, Innovation, and Ventures began to develop a digital biomarker that predicts respiratory infections. Preliminary findings have been promising, showing a strong correlation between viral shedding and changes in a person's physiology. Learn More

A new guidance from the US FDA clarifies how manufacturers of drugs and biological products should address COVID-19 infection in their employees. Generally speaking, employees who are ill or infected with SARS-CoV-2, the novel coronavirus, must be excluded from drug manufacturing areas and not permitted to return until they have met home isolation criteria established by the US CDC. This guidance holds true for individuals who have a positive test for COVID-19, even if they do not have symptoms, and for individuals with COVID-19 symptoms, regardless of testing status. Learn More

A U.S. district court judge ruled this week in favor of generic drugmaker Mylan regarding the patent for Biogen's booming multiple sclerosis drug Tecfidera. The court in West Virginia determined that Mylan proved claims for Biogen's patent are invalid for "lack of written description." Tecfidera has powered much of Biogen's growth since its launch seven years ago. The drug produced sales of $4.43 billion last year, making up almost one-third of the company's revenue, Reuters reported. According to industry analysts, this victory for Mylan could lead it to start a generic as soon as the FDA approves its pending application. A move that some say could bite into Biogen's total revenue by upwards of 20%. Learn More

AbbVie will pay Alpine Immune Sciences $60 million for an option to license a drug the Seattle biotech is developing for a number of autoimmune diseases. AbbVie can trigger the option after seeing how Alpine's drug, dubbed ALPN-101, performs in a Phase 2 study in patients with lupus. If AbbVie buys in and the drug progresses, Alpine could receive up to another $805 million in conditional payments. The deal marks the most lucrative potential partnership thus far for Alpine, a company headed by Mitch Gold, the former CEO of cancer immunotherapy pioneer Dendreon. Alpine has inked smaller pacts with two cancer cell therapy developers, but one of those - a deal with Gilead subsidiary Kite Pharma - fizzled last year. Learn More

Dicerna Pharmaceuticals this week announced that the U.S. FDA has granted rare pediatric disease designation for nedosiran, an investigational RNAi therapy. Under the FDA's rare pediatric disease designation program, Dicerna has been granted a priority review voucher. The voucher can be redeemed to receive priority review for a subsequent marketing application for a different product candidate or could be sold or transferred. Alert readers will recall that this time last year GW Research sold its rare pediatric disease priority review voucher for a reported $105 million. Learn More

When Nikitha Das gets up to go to work at a Cambridge laboratory these days, she has a new task that comes before brushing her teeth or eating breakfast: gargling for 60 seconds. Das, a scientist at Tango Therapeutics, doesn't have a sore throat. Under her employer's new rules for returning to the lab, she gargles with a special salt solution at home in Billerica and brings what she spits out to work in a plastic tube. Tango scientists test her sample and those of co-workers for the virus that causes COVID-19, then e-mails them the results later that day. About 35 employees have provided samples multiple times a week since June 8 and all have tested negative. Learn More

Orca Bio raised $192 million from Lightspeed Venture Partners and an unnamed investor for its experimental cell therapy platform. The investment brings total capital raised to almost $300 million, the Menlo Park, California-based company said in a statement this week. Investors in a previous financing round valued the biotech firm at more than $1 billion, according to Chief Executive Officer Ivan Dimov. Orca's lead drug candidate, called TRGFT-201, is a blend of stem and immune cells. The off-the-shelf therapy is made from healthy donor cells and is currently being tested in blood cancer patients, where the need is great, said Dimov, one of Orca's three co-founders. Learn More

With a stroke of the president's Executive Order pen, the Trump administration awarded a $354 million, four-year contract to a new company called Phlow. Its charge is to manufacture pharmaceutical ingredients and generic medicines used in treating patients hospitalized for Covid-19, ingredients that for years have been produced by overseas supply chains. On its surface, the move seems to make sense: secure domestic production capabilities for these medications to prevent shortages or disruptions in the supply chain, which may be subject to geopolitical shifts in the wind. The problem is that it won't work and will only exacerbate America's bigger underlying problem - access to affordable prescription drugs today. Learn More

The Trump administration aims to narrow its financial support to about seven experimental coronavirus vaccines from the 14 it has been working with so far, the U.S. Department of Health and Human Services (HHS) said this week. A government official said it was still deliberating which companies would ultimately be among those it will support, based on the success of closely watched trials and manufacturing capability. The New York Times reported earlier this month that the White House had selected five companies: Moderna, AstraZeneca, Pfizer, J&J and Merck. Learn More

The US FDA has warned Takeda over good manufacturing practice (GMP) violations observed during an inspection of its Hikari, Yamaguchi facility last November. Specifically, the warning letter cites the firm for three violations relating to its procedures for aseptic manufacturing and investigations into unexplained discrepancies and equipment malfunctions. The FDA says the company allowed manufacturing operations to resume without performing media fills as required in its procedures and shipped multiple batches of affected products to the US. Learn More

Sanofi this week made public detailed plans on how the company will make significant investments in France to increase its vaccines research and production capacities and contribute in responding to future pandemic risks. Aligned with its corporate strategy presented last December, Sanofi will invest $687 million to create a new production site and research center in France with both dedicated to vaccines. The product site will be built in Neuville sur Saône at a cost of $552 million while the new R&D center will be built at the current Sanofi Pasteur site in Marcy-l'Etoile at a cost of $135 million. Learn More

A team led by Scripps Research has discovered antibodies in the blood of recovered COVID-19 patients that provide powerful protection against SARS-CoV-2, the coronavirus that causes the disease, when tested in animals and human cell cultures. The research, published this week in Science, offers a paradigm of swift reaction to an emergent and deadly viral pandemic, and sets the stage for clinical trials and additional tests of the antibodies, which are now being produced as potential treatments and preventives for COVID-19. Learn More

The German government plans to invest 300 million euros ($338.5 million) in a 23% holding in previously unlisted CureVac to aid the further development of the biotech company's vaccine against the disease caused by the novel coronavirus. The finance ministry said in a letter to parliament's budget committee dated June 15th that CureVac "currently has a big capital requirement and plans a flotation on the Nasdaq in New York in July 2020." Alert readers will recall that the U.S. government attempted to acquire CureVac back in March which caused a backlash in Germany and calls to keep the company German. Learn More

Boehringer Ingelheim is to make a bank of its molecules available to scientists in a bid to encourage open innovation during the COVID-19 pandemic, when many scientists are working from home.  The biopharma company has dubbed its new crowdsourcing platform opnMe and aims to set new standards of collaboration within the scientific community. By improving cooperation and collaboration, Boehringer aims to accelerate research projects and improve knowledge about diseases for which there are few available treatments. This will be driven by BI's bank of pre-clinical tool compounds designed by the company's scientists, which can be unlocked and used to validate scientific hypotheses and discover novel biology. Learn More

Regeneron has begun the first human trials of a medicine that's designed to treat, and possibly prevent, coronavirus infection. The biotech will test its treatment, a cocktail of two engineered antibodies, in two placebo-controlled studies of hospitalized and non-hospitalized COVID-19 patients. Should those studies show the treatment safe, Regeneron aims to start two additional trials later this month that would test the drug combination as a preventive therapy in healthy volunteers who are either at high risk of exposure, like healthcare workers and first responders, or have been exposed to the virus by someone close to them. Learn More

The Massachusetts Institute of Technology has ended negotiations over a new contract with the major journal publisher Elsevier, making it the latest high-profile academic institution to walk away from Elsevier amid an escalating fight that could shape the way that academic research gets read and paid for. The decision is the result of an ongoing dispute over open-access research, which is made freely available to the public online. MIT's move follows the giant University of California system, which last year decided not to renew its subscriptions to Elsevier-published journals after months of negotiations. Learn More

A study by a team of researchers led by a Texas A&M University professor has found that not wearing a face mask dramatically increases a person's chances of being infected by the COVID-19 virus. Renyi Zhang, Texas A&M Distinguished Professor of Atmospheric Sciences and the Harold J. Haynes Chair in the College of Geosciences, and colleagues from the University of Texas, the University of California-San Diego and the California Institute of Technology have had their work published in the current issue of PNAS (Proceedings of the National Academy of Sciences). Learn More

Fujifilm has made public plans to invest roughly $928 million in the Denmark site of FUJIFILM Diosynth Biotechnologies. The investment will expand production lines for bulk drug substance with the addition of a further six mammalian cell bioreactors, bringing the total to 12 x 20,000-liter bioreactors by fall 2023, making the Denmark facility one of the few major large-scale manufacturing facilities in the bio-CDMO industry. The development will also include the addition of the Denmark site's first fill/finish production line (added by summer 2023), featuring a fully-automated, cutting-edge system capable of producing up to approximately 35 million units per annum to cater to large-scale production. Learn More

Novo Nordisk has reached a $725 million deal to acquire Corvidia Therapeutics, a clinical-stage biotech developing treatments for disorders affecting the heart and the kidneys. The upfront payment due to Corvidia shareholders is in cash. According to the terms of the agreement, Novo Nordisk could be on the hook for about three times that much depending on regulatory and sales milestones achieved by the Corvidia drugs. Details of those milestones, which could eventually increase Corvidia's haul to as much as $2.1 billion, were not specified. Corvidia's lead drug candidate, ziltivekimab, is being developed as a therapy for reducing the risk of cardiovascular problems in chronic kidney disease patients. Learn More

AstraZeneca this week picked Emergent BioSolutions to help produce the 300 million doses of the British drugmaker's potential COVID-19 vaccine pledged to the United States. Under the terms of the agreement Emergent will provide AstraZeneca with development services, analytical testing and drug substance process valued at about $87 million. The company also says that it will reserve large-scale manufacturing capacity for the AstraZeneca vaccine through 2020 at its Baltimore Bayview facility, which can produce up to hundreds of millions of doses annually. Learn More

AbbVie and Genmab have announced a $4 billion pact that will see the companies develop and commercialize a series of Genmab's early-stage cancer treatments. In a joint statement, AbbVie said it will pay Genmab $750 million up front and an additional $3.15 billion in various milestone payments to develop Genmab's next-generation cancer-treating antibody program. Included in the potential milestones are up to $1.15 billion in payments related to clinical development and commercial success across three existing treatment programs, and $2 billion in option-exercise and success-based milestone payments for a fourth. Learn More

A federal grand jury has indicted former Harvard chemistry chair Charles M. Lieber on two counts for making false statements to federal investigators who were examining funding he received from the Chinese government. The charge of making false statements allows for a sentence of up to five years in prison, three years of supervised release, and a fine of $250,000, according to a DOJ press release. The first count alleges that Lieber purposely told federal investigators in 2018 that he was never asked to participate in the Thousand Talents Program when in fact he had signed a three-year contract as a One Thousand Talent "high level foreign expert" in 2012, according to charging documents. Learn More

Twenty-six drug manufacturers were sued this week by the attorneys general of most U.S. states and several territories, which accused them of conspiring to reduce competition and drive up generic drug prices. The lawsuit accused Novartis' Sandoz unit, Teva Pharmaceuticals' Actavis unit, Mylan, Pfizer and other drugmakers of conspiring to rig the market between 2009 and 2016 for more than 80 drugs. Attorneys general from 46 states, the District of Columbia and four U.S. territories said the defendants prioritized profit over the public interest, depriving millions of consumers of lower prices for needed medication. Ten executives, including many directors, are also defendants in the 543-page complaint filed in a federal court in Connecticut. Learn More

Corning has announced that it will receive $204 million from the U.S. government to boost the manufacturing capacity of its vials that will be used to store coronavirus vaccines and treatments. Alert readers will recall that companies developing coronavirus vaccines, such as AstraZeneca and Johnson & Johnson have flagged potential supply shortages of glass vials, which could pose a challenge to scaling up the production of a vaccine. Corning's funding comes a day after the U.S. government awarded $143 million to privately-held SiO2 Materials Science to boost the production of its vials and syringes. Learn More

In a new report, the US FDA's Office of Pharmaceutical Quality (OPQ) provides insights into the agency's quality oversight of drugs and biologics intended for the US market. Amongst the data shared in the report is that in FY2019, the FDA saw an 8.6% decrease in the number of drug manufacturing sites in its catalog, from 4,676 in FY2018 to 4,273, despite the addition of 382 new sites. Of the sites in FDA's catalog in FY2019, 1,793 (42%) were located in the US, 858 (20%) in the EU, 505 (12%) in India and 379 (8%) in China. The FDA says its investigators performed 1,258 drug quality surveillance inspections in FY2019, a drop from the 1,346 conducted in FY2018. Learn More

WuXi Biologics has announced that it has signed a 10-year lease for a clinical manufacturing facility (MFG18) in Cranbury, New Jersey. The new clinical manufacturing facility will feature a total of 6000 L of bioreactor capacity as well as Process Development (PD) suites, Quality Control (QC) labs, all of which accompanied by supporting functions. The 66,000-square-foot facility is expected to become operational in late 2020 and will bring in up to 100 jobs to the region. This is the third plant for WuXi Biologics in the U.S. joining a previously announced manufacturing site in Worcester, Massachusetts and a PD lab in King of Prussia, Pennsylvania. Learn More

A well written article published in Science this week seeks to answer the question of who is to blame for the Surgisphere research scandal. Alert readers will recall that the research scandal led to retractions last week by The Lancet and The New England Journal of Medicine (NEJM), and the withdrawal of an online preprint, after the trove of patient data they all relied on was challenged. In related news, published reports indicate that questions have arisen about earlier academic work by the founder of Surgisphere as well. These reports indicate that consultants who specialize in analyzing scientific papers for signs of data manipulation have spotted multiple inconsistencies. Learn More

Virus DNA left on a hospital bed rail was found in nearly half of all sites sampled across a ward within 10 hours and persisted for at least five days, according to a new study by UCL and Great Ormond Street Hospital (GOSH). The study, published as a letter in the Journal of Hospital Infection, aimed to safely simulate how SARS-CoV-2, the virus that causes Covid-19, may spread across surfaces in a hospital. Instead of using the SARS-CoV-2 virus, researchers artificially replicated a section of DNA from plant-infecting virus, which cannot infect humans, and added it to a millilitre of water at a similar concentration to SARS-CoV-2 copies found in infected patients' respiratory samples. Learn More

interest in combining with Gilead Sciences, a story first reported in Bloomberg. The biopharma giant is thought to have ruled out any deal because it would have distracted it from developing its own drugs pipeline, especially promising oncology drugs, and from attempts to produce a successful coronavirus vaccine. There was skepticism, too, that such a huge deal could be put together because of logistical problems posed by lockdowns. This comes amid a view by many that such a coupling would fail to provide much synergy and come at too great a cost. Learn More

AstraZeneca has made a preliminary approach to rival drugmaker Gilead Sciences about a potential merger, according to people familiar with the matter, in what would be the biggest health-care deal on record. The U.K.-based firm informally contacted Gilead last month to gauge its interest in a possible tie-up, the people said, asking not to be identified because the details are private. AstraZeneca didn't specify terms for any transaction, they said. While Gilead has discussed the idea with advisers, no decisions have been made on how to proceed and the companies aren't in formal talks, the people added. Learn More

Novavax has announced that the U.S. Department of Defense has awarded it a contract to supply a large quantity of its vaccine candidate NVX-CoV2373 to the military. The biotech is currently in the phase 1 stage of clinical trials evaluating the vaccine against SARS-CoV-2, the coronavirus that causes COVID-19.  The Department of Defense will provide Novavax up to $60 million to support the domestic manufacture of several components of the experimental COVID-19 vaccine. In return, Novavax will supply 10 million doses of NVX-CoV2373 to the DoD this year. Learn More

The University of Utah has "mutually agreed" to terminate the faculty appointment of Amit Patel, who was among the authors of two retracted papers on Covid-19 and who appears to have played a key role in involving a little-known company that has ignited a firestorm of controversy. "The terminated position was an unpaid adjunct appointment with the Department of Biomedical Engineering," a university spokesperson told STAT. Patel had listed the affiliation on both papers, published in the Lancet and the New England Journal of Medicine. The spokesperson declined to comment on whether the decision was related to the retractions. Learn More

As the race to develop a Covid-19 vaccine accelerates, Inovio Pharmaceuticals has filed a lawsuit claiming it is being held "hostage" by its long-standing contract manufacturer, which is refusing to provide crucial data needed to scale up vaccine production. In arguing its case, Inovio maintained that a supply agreement requires VGXI to transfer technology know-how to other contract manufacturers if it declines to make a vaccine for Inovio. And recently, VGXI told Inovio that it cannot manufacture further batches of its experimental Covid-19 vaccine this year because it lacks manufacturing capacity, according to the lawsuit, filed in a Pennsylvania state court. Learn More

Pliant Therapeutics this week raised $144 million through an initial public offering, becoming the 15th biotech to start trading shares on Wall Street this year. Pliant's IPO keeps biotech close to its 2019 pace, a telling statistic given the coronavirus pandemic has thrown public markets into turmoil since early March. IPO activity has shown signs of picking up, too, with multiple biotechs either recently filing offerings or closing in on pricing them. The IPO market is a critical bellwether for the health of the biotech industry. An "open window" for IPOs gives startup biotechs and their venture backers confidence they can win the support of broader groups of investors, and at least thus far, biotechs have proven that's possible in a turbulent 2020. Learn More

The rate of layoffs in the U.S. biopharma industry has slowed, with just 32 jobs cut in May compared to 360 last May, according to data from executive outplacement firm Challenger Gray & Christmas. The industry cut no jobs in April, though the total number of job cuts among all industries was the highest that month since January 2002. So far this year, the biopharma has cut 951 jobs, compared to 2,596 at this time last year. The slowing of layoffs is likely due to efforts by biopharma's to respond to the COVID-19 pandemic. In contrast, across all job industries, the pandemic was cited as the reason for 984,073 job cuts so far this year, more than 69.5 percent of the total announced job cuts. Learn More

The Trump administration has picked five COVID-19 vaccine candidates that it views as the most likely to be successful, according to an article published in The New York Times. The newspaper stated that four of the companies whose candidates made the list are U.S.-based: Moderna, Johnson & Johnson, Merck, and Pfizer. The other is U.K.-headquartered AstraZeneca, which is partnering with the University of Oxford. Pfizer is also partnering with Germany-based BioNTech. More than 100 organizations and companies are currently working on vaccines to prevent COVID-19. The selection of these finalists is part of the administration's Operation Warp Speed, an initiative to rapidly develop a vaccine COVID-19. Learn More

The U.S. FDA has extended the review period for Novartis AG's multiple sclerosis drug ofatumumab by three months, the company announced this week. The company did not disclose the reason for the delay and said the regulatory decision is now expected in September, compared with previous expectations for an approval decision by June. Novartis said it still expects regulatory approval of the drug in Europe in the second quarter of 2021. The company has been aiming to tap the multiple sclerosis market where rival Roche sells its $4 billion-per-year blockbuster Ocrevus. Learn More

Biotech firm GRAIL, headquartered in Menlo Park, California, has promised to invest at least $103 million to build a 200,000-square-foot "state-of-the art" laboratory in Durham. It will include an office and warehouse space in North Carolina's Research Triangle Park. GRAIL is a healthcare company whose mission is to detect cancer early. It is using the power of next-generation sequencing, population-scale clinical studies, and computer and data science to enhance the scientific understanding of cancer biology and develop a multi-cancer early detection blood test. Since early 2016, GRAIL has raised more than $1.9 billion in four rounds of equity financing. Learn More

A government watchdog blasted the FDA for fumbling its oversight of the safety of the U.S. drug supply chain, suggesting the agency is not adequately conducting drug safety inspections overseas. The criticisms came in a hearing this week before the Senate Finance Committee, at which a top official for the Government Accountability Office outlined a number of surprising deficiencies in the FDA's surveillance of foreign drug manufacturing. It highlighted, in particular, the agency's longstanding practice of alerting drug makers in advance that it plans to conduct an inspection. U.S.-based drug makers do not get a similar heads-up. Learn More

Pfizer said this week that it will invest up to $500 million into publicly traded drug developers to fund their treatment candidates and provide access to the U.S. drugmaker's scientific expertise. The biopharma giant said it will make non-controlling investments in the biotechs with small- to medium-sized market capitalizations but did not identify them. Pfizer said its Breakthrough Growth Initiative program, under which it was making the investment, allows partner companies to access its research, clinical development and manufacturing resources. Learn More

AGC Biologics has announced that it has acquired AstraZeneca's 300,000-square-foot facility in Boulder and will revive manufacturing operations there in April. The Japanese biopharma, which provides contract development and manufacturing services globally, said it will invest $100 million in and employ 280 workers at the facility, located at 5550 Airport Blvd. The Boulder plant houses two 20,000-liter stainless steel mammalian cell bioreactors, and the company noted it could fit up to four more on its 20 acres. Alert readers will recall that AstraZeneca acquired the facility from Amgen in 2015 which had shut it down in 2012. Learn More

The U.S. government this week entered into a $628 million contract with Emergent BioSolutions to boost manufacturing capacity for a potential COVID-19 vaccine. The HHS task order with Emergent falls under an existing contract with the Biomedical Advanced Research and Development Authority (BARDA), a U.S. federal agency that funds disease-fighting technology. As drugmakers race to develop vaccines, tests and therapies for the disease, the United States is looking to secure manufacturing capacity under its "Operation Warp Speed" program announced in May to accelerate vaccine development. Learn More

Regeneron and Intellia Therapeutics are expanding a gene editing collaboration agreed to four years ago, announcing this week that they have added projects to treat hemophilia to their joint development program. Intellia will receive $100 million, adding to the $125 million it was paid in the initial round of the collaboration in 2016. The agreement also gives Regeneron the right to use Intellia's technology to develop and commercialize therapies that re-engineer cells to help fight disease. The collaboration comes just a week after Regeneron's longtime collaborator Sanofi announced it will sell off its stake in the big biotech as the two companies continue to loosen ties. Learn More

Roche unit Genentech must face cancer treatment centers' suits alleging it shortchanged them on the breast cancer biologic drug Herceptin, after the Tenth Circuit Court in the U.S. said the claims aren't preempted by federal law governing drug labeling and manufacture. The Tulsa Cancer Institute and others contended Herceptin's labeling was misleading because it said each vial contains 440 mg of Herceptin at a concentration of 21 mg/mL, but not every vial contained that amount, forcing them to buy more than they needed for their patients. The active drug, which comes in solid form, is reconstituted before use. Learn More

The world will likely need billions of doses of any vaccine that's proven safe and effective against the new coronavirus. But there's not enough glass vials to hold all those doses, creating another supply headache for drugmakers to solve as they work feverishly to complete clinical testing in record time. "The challenge is not so much to make the vaccine itself, it's to fill vials," said Pascal Soriot, CEO of AstraZeneca, on a conference call hosted by an industry trade group. In an effort to conserve limited supplies, AstraZeneca, J&J and Pfizer are all exploring whether they could safely fit five or 10 doses of vaccine into one vial instead of the current practice of one dose per vial. Learn More

Horseshoe crabs' icy-blue blood will remain the drug industry's standard for safety tests after US Pharmacopeia ditched a plan to give equal status to a synthetic substitute pushed by Lonza and animal welfare groups. The crabs' copper-rich blood clots in the presence of bacterial endotoxins and has long been used in tests to detect contamination in shots and infusions. More recently, man-made versions called recombinant Factor C (rFC) from Lonza and others have emerged. An industry battle has been brewing, as another testing giant, Charles River Laboratories, has criticized the synthetic option on safety grounds. US Pharmacopeia (USP), whose influential publications guide the drug industry, had initially proposed adding rFC to the existing chapter governing international endotoxin testing standards. Learn More

A well written article recently published in the Harvard Business Review explains why big biopharma's are betting on blockchain to fix their supply chain vulnerabilities. With a blockchain - which can make it cheaper, easier, and faster to verify what is true when a business process spans organizations with competing interests - companies can safely work together in a shared, permanent ledger. They can do this without giving up control of or even revealing their data, as mathematical proof of data can stand in as a trustworthy proxy for actual data. Instead of being owned and managed by a single company that everyone must trust, the ledger is governed by all members of a network. Learn More

The heads of some of the world's largest drug makers expressed a mix of confusion and resistance to a WHO voluntary pool to collect patent rights, regulatory test data, and other information that could be shared for developing Covid-19 therapies, vaccines, and diagnostics. The WHO effort reflects mounting concern that some Covid-19 medical products may not be accessible for poorer populations. By establishing a voluntary mechanism, the goal is to establish a pathway that will attract numerous governments, as well as industry, universities and nonprofit organizations. But not every executive likes the idea. Learn More

U.S. regulators are contacting biopharma companies that make a popular diabetes medication after some of the pills were found to contain high levels of a chemical that can cause cancer. The U.S. FDA discovered N-Nitrosodimethylamine, or NDMA, beyond acceptable amounts in some extended-release versions of metformin, Sarah Peddicord, an agency spokeswoman, said in a statement to Bloomberg. Some metformin recalls are expected as soon as this weekend, though it wasn't clear which companies were planning to remove their products from pharmacy shelves, according to a person familiar with the matter. Metformin is manufactured for the U.S. market by numerous generic drugmakers worldwide. Learn More

Thermo Fisher Scientific and CSL have announced a strategic partnership to help meet the growing demand for biologic therapies while also accelerating CSL's broader manufacturing objectives. Thermo Fisher will support CSL's product portfolio by leveraging its pharma services network, including drug product development, biologics manufacturing, sterile fill-finish, packaging and clinical trials logistics. Through a long-term lease agreement with CSL, Thermo Fisher will operate a new state-of-the-art biologics manufacturing facility in Lengnau, Switzerland, when construction is completed in mid-2021. Learn More

Financial analysts whose focus is the biopharma market have begun speculating publicly as to just what Sanofi's plans might be for the $11.7 billion it will earn from the sale of a significant portion of its stake in Regeneron. According to published reports, Sanofi had roughly $10 billion on hand at the end of 2019 so this new cash infusion could double its cash on hand. This has led some to predict that the drug giant will look to make a deal in the neighborhood of $5 billion in the gene therapy space. At that price range the neighborhood includes several well-regarded firms including bluebird bio and Ultragenyx. Learn More

Novavax has announced that it is buying Czech Republic based Praha Vaccines for $167 million in cash. The deal will provide Novavax with a manufacturing facility capable of supporting its stated goal of producing 1 billion doses of its COVID-19 vaccine candidate next year. Praha Vaccines is a business unit of India's Cyrus Poonawalla Group, which also owns Serum Institute, the world's largest maker of vaccines by volume. Earlier this week Novavax enrolled its first participant in an early stage study testing the vaccine candidate in humans. It is one of 10 being tested on humans according to the WHO. Learn More

Ireland's ambassador in Washington is on a public relations offensive to reassure coronavirus-wary Americans that his country is a secure and dependable source of vital biopharma supplies. "One point that I wanted to make, and I will be making this endlessly over the next few years, is that whatever you do with your supply chain in the United States, you should regard Ireland as an entirely integral part, and one that carries no risk whatsoever," Daniel Mulhall declared in a recent conference call to an American audience. Learn More

Janet Woodcock, a fixture of leadership at the U.S. FDA, will temporarily step aside as the director of the agency's Center for Drug Evaluation and Research to work solely on a White House initiative meant to accelerate Covid-19 treatments, Commissioner Stephen Hahn announced Friday in an agency-wide email obtained by STAT. The news is monumental for the FDA: Woodcock has served as the permanent director of CDER for more than a decade, since 2008. She joined the FDA in 1986 and is widely considered the most experienced regulator at the agency. Her cache has often rivaled that of the FDA commissioner, who technically serves as her boss. Learn More

Merck & Co. made clear this week that it hopes to play a major role in developing medicines for COVID-19, announcing a slate of deals to gain access to two vaccine candidates and one antiviral drug for the disease caused by the new coronavirus. The two experimental vaccines come by way of Themis, an Austrian biotech Merck is acquiring, and the nonprofit IAVI, with which Merck will collaborate. Clinical trials of the two candidates will begin later this year, Merck said. The pharma also bought rights to an oral antiviral drug from privately held Ridgeback Biotherapeutics. Learn More

The National Science Foundation (NSF) would get a sweeping remake-including a new name, a huge infusion of cash, and responsibility for maintaining U.S. global leadership in innovation-under bipartisan bills that have just been introduced in both houses of Congress. Many scientific leaders are thrilled that the bills call for giving NSF an additional $100 billion over 5 years to carry out its new duties. But some worry the legislation, if enacted, could compromise NSF's historical mission to explore the frontiers of knowledge without regard to possible commercial applications. Learn More

Sanofi is selling a stake in Regeneron Pharmaceuticals valued at about $13 billion, giving the French drug giant more firepower to invest in fast-growing fields such as cancer. Regeneron has agreed to repurchase $5 billion of its stock from Paris-based Sanofi. Regeneron said that the French company also plans to sell approximately 12.8 million shares, a holding worth more than $7 billion based on Friday's closing price. That will mark the largest public equity offering in the health-care industry on record. Sanofi holds about 23.2 million shares of Regeneron's stock, or 20.6% of the U.S. pharmaceutical company. Sanofi, which first purchased shares of the Tarrytown, New York-based company in 2004, will continue to own about 400,000 shares. Learn More

South Korean contract drugs manufacturer Samsung Biologics has signed a deal worth more than $231 million with GSK to supply biopharmaceutical products over the next eight years. The biotech arm of Samsung Group will start with manufacturing drugs for autoimmune disease lupus for GSK with the aim to expand to making other drugs for the British drugmaker, an official at Samsung Biologics told Reuters. The deal will initially cover commercial production of lupus drug Benlysta and first supply is expected in 2022. Learn More

A quarter of Americans have little or no interest in taking a coronavirus vaccine, a Reuters/Ipsos poll found, with some voicing concern that the record pace at which vaccine candidates are being developed could compromise safety. Most respondents in the survey of 4,428 U.S. adults taken between May 13 and May 19 said they would be heavily influenced by guidance from the U.S. FDA or results of large-scale scientific studies showing that the vaccine was safe. Studies are underway, but experts estimate that at least 70% of Americans would need to be immune through a vaccine or prior infection to achieve what is known as "herd immunity," when enough people are resistant to an infectious disease to prevent its spread. Learn More

The United States has secured almost a third of the first 1 billion doses planned for AstraZeneca's experimental COVID-19 vaccine by pledging up to $1.2 billion, as world powers scramble for medicines to get their economies back to work. While not yet proven to be effective against the coronavirus, vaccines are seen by world leaders as the only real way to restart their stalled economies, and even to get an edge over global competitors. After President Donald Trump demanded a vaccine, the U.S. Department of Health and Human Services (HHS) agreed to provide up to $1.2 billion to accelerate British drugmaker AstraZeneca's vaccine development and secure 300 million doses for the United States. Learn More