News Alert

At least four groups have started to develop vaccines to protect against the 2019 Novel Coronavirus (2019-nCoV) that was first detected in Wuhan, China. Among the companies working on a vaccine, Moderna and NIH have announced a partnership that will explore both a vaccine and therapeutic approach. However, work will begin with an investigation of the efficacy of existing antivirals and mAbs. The NIH plans to initiate this process by testing to determine if mAbs against the SARS virus are effective against the Wuhan Virus. At the same, Moderna will be working closely with the NIH on an mRNA vaccine. Estimates place the availability of a vaccine on an emergency basis at 1-2 years. Learn More

Belgium's financial services and markets authority (FSMA) said this week that it had opened an investigation into suspected insider trading against the chief executive of Mithra Pharmaceuticals. Francois Fornieri is suspected of buying Mithra shares via a third party in order to avoid mandatory notifications to the regulator, FSMA said, adding it had been looking into the case since September. For his part, Fornieri was quoted in Belgian business daily L'Echo as saying the allegation was nonsense, asking why he would do such an elaborate move to buy 40,000 shares when he already owned almost 13 million. Learn More

China's centralized procurement program, which seeks the lowest prices for therapeutics, is being seen by many as seeking to force foreign firms to revalue their access to the Chinese market. While at the same time prompting local firms to create strategies for survival under a policy that aims to consolidate the industry. Roughly 77 biopharma companies won contracts with the Chinese government by slashing prices of drugs by 53% on average, according to Chinese state media. Twenty-four foreign biopharma companies also joined the bidding process. Those who won the bids cut the prices of their originator drugs by 82% on average, the state media reported. Learn More

Eli Lilly and Company has made public plans to build a $470 million dollar biopharma manufacturing plant, creating more than 460 high-paying jobs, in Durham, North Carolina. The decision to build in North Carolina comes after the company conducted a nationwide search for a location for the new plant. Indiana, Pennsylvania and North Carolina were the finalists. According to published reports the new facility will produce injectable products and delivery devices. Alert readers will recall that late last year Lilly announced plans to invest $400 million into its manufacturing facilities at the Lilly Technology Center in Indianapolis. Learn More

AstraZeneca has announced plans for a five-year, $500 million investment in France. The details of the investment includes $230 million to finance the expansion and modernization of the company's development and manufacturing site in Dunkirk. This will include the building of three assembly lines and two packaging lines at the site. With an additional $275 million slated for investment in research and development efforts at company sites across France. Finally, an amount of $15 million has been set aside for the creation of a European Innovation Hub in Paris. Learn More

BeiGene has announced that the pivotal Phase 3 trial evaluating its anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens for the first-line treatment of patients with squamous non-small cell lung cancer met the primary endpoint of improved progression-free survival (PFS) at the planned interim analysis, as assessed by an independent review committee (IRC). The company says it intends to discuss its plans for filing a supplemental new drug application (sNDA) for tislelizumab as a first-line treatment with the Center for Drug Evaluation (CDE) at the National Medical Products Administration (NMPA) in China. Learn More

The World Health Organization announced this week that it would convene an expert panel to determine whether a fast-developing outbreak caused by a new virus in China should be declared a global health emergency. The news came as China reported confirmed cases in Beijing and in Guangdong province, 14 cases in health care workers - a first - and a confirmed incident involving human-to-human spread of the new virus, known provisionally as 2019-nCoV. It is a coronavirus, from the same family as the viruses that caused the 2003 SARS outbreak, which sickened more than 8,000 people globally, killing nearly 800. Learn More

A Pennsylvania judge has slashed to $6.8 million from $8 billion a punitive damages award against Johnson & Johnson to a man who said it failed to warn that boys using its antipsychotic drug Risperdal could grow breasts. Judge Kenneth Powell of the Philadelphia Court of Common Pleas reduced the payout that a jury awarded October 8th to the plaintiff Nicholas Murray, a Maryland resident. No reason was given for the reduction, which was disclosed in court records. Lawyers for Murray have said the punitive damages award was the first in thousands of lawsuits against Johnson & Johnson's Janssen Pharmaceuticals unit over Risperdal. Learn More

The European Patent Office (EPO) will uphold an earlier ruling to retract a key CRISPR/Cas9 genome editing patent held by the Broad Institute. The EPO Board of Appeal reversed its earlier decision to refer the case to a higher panel, and stated that it would uphold the 2018 ruling of the EPO's Opposition Division to cancel the Broad Institute's patent for failing to prove novelty and a valid priority claim. The Broad has said that nine of their 21 CRISPR/Cas9 patents in Europe could be affected by the ruling which 'does not involve the actual scientific merits of the patent application, but the interpretation of rules that dictate what happens when the names of inventors differ across international applications.' Learn More

Leading South Korean biosimilar manufacturer Celltrion has made public plans to build a plant in China in a move to directly advance into the world's second-largest biopharmaceutical market, its chief said. "We are in the final stage of signing a contract with the Chinese government. We will soon announce details of the plant," Chairman Seo Jung-jin said during the annual J.P. Morgan Healthcare Conference. The company's business roadmap centers on building a plant with a production capacity of 120,000 liters in China to boost capacity amid rising demand. According to Celltrion, the planned production facility will be the largest of its kind in China. Learn More

Insys Therapeutics, the first drugmaker to go bankrupt after opioid litigation, won court approval for its bankruptcy plan on January 16th. Under the plan, Insys sold the rights to its flagship opioid drug, Subsys, a form of fentanyl. But the money it made from selling its assets wasn't enough to cover its debts, which total more than $1 billion. The drugmaker plans to pay people with personal injury claims resulting from use of Insys drugs by using product liability insurance, but its creditors will only get about 8 cents on the dollar, or less, from the bankruptcy agreement. Under the plan, suppliers and those with damage claims will receive at least 4 cents on the dollar of what they're owed. Learn More

Lupin has received five observations from the U.S. FDA after inspection of its Visakhapatnam plant in Andhra Pradesh. The inspection of the company's Visakhapatnam API manufacturing facility by the U.S. FDA has been completed, Lupin said in a filing to the BSE over the weekend. The inspection was carried out between January 13th and 17th, 2020. "We are fully committed to adherence to CGMP regulations and uphold high-quality standards across all our manufacturing sites. We are confident of addressing the observations to the U.S. FDA's satisfaction," Nilesh Gupta, managing director at Lupin, said in the regulatory filing. Learn More

WuXi Biologics and Bayer have jointly announced an acquisition agreement that WuXi Biologics Germany GmbH will take over the operations of one of Bayer's final drug product manufacturing plants in Leverkusen, Germany, and purchase the associated equipment, in combination with a long-term lease contract for the building. Based on a manufacturing agreement to be negotiated, the plant would be operated by WuXi Biologics and serve as a back-up site for the final product manufacturing of Kovaltry™, an antihemophilic factor (recombinant). The transaction is expected to be concluded in the coming months subject to the satisfaction of customary closing conditions. Financial details were not disclosed. Learn More

This story first appeared without the correct text, it has since been corrected to reflect the headline. Our apologies for any confusion.

The Federal Circuit Court of the United States has affirmed the invalidation of Genentech's claims to methods for reducing Protein A leaching in affinity column chromatography in purifying monoclonal antibodies. This ruling comes after Genentech had appealed an earlier ruling by the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office invalidating its Patent No. 7,807,799. All of which stems from an earlier request by Hospira for an inter partes review of the patent in question arguing anticipation and obviousness. Legal analysts are citing the ruling as yet another example of the higher courts deference to the U.S. Patent and Trademark Office. Learn More

Just - Evotec Biologics has initiated construction of a 130,000 sq. ft. late-stage clinical and commercial manufacturing facility for biologics in Redmond, Washington. Construction on the greenfield site, located in Redmond Ridge Business Park, is expected to be completed by late 2020 and operational in the first quarter of 2021. The facility will contain manufacturing pods for implementing intensified fed-batch or continuous processing up to 1,000 L scale, with the capability of manufacturing metric tons of drug substance. Also included are supporting quality labs and process development labs. Learn More

The US FDA has gotten faster at approving new prescription drugs over the past four decades, but the evidence it relies on in making those decisions is getting weaker, according to new research published this week. As a result, there are more cures and treatments on the market but less proof that they are safe and effective. Almost half of recent new drug approvals were based on only one pivotal clinical trial instead of the two or more that used to be the norm, according to the study published in JAMA. And the reliance on surrogate measures has increased. In the case of cancer drugs, a surrogate measure could be shrinkage of tumors instead of improvements in survival after treatment. Learn More

Nektar Therapeutics has announced that it is withdrawing the application for its opioid painkiller for adults with chronic low back pain, after an FDA panel unanimously voted against the drug's approval. Independent advisers to the U.S. FDA voted 27-0 against the approval of the oral pill, NKTR-181, on concerns over the chances of its misuse or abuse as well as the lack of data to determine the possible abuse when snorted or injected and its potential for liver toxicity. By reducing the rate at which the drug enters the brain, Nektar had aimed to relieve pain without triggering the euphoric effect of opioids that could lead to abuse and addiction. Learn More

Four employees of a biopharma were arrested this week by law enforcement officers in Hyderabad for allegedly stealing the company's IP and using it to launch their own drug manufacturing business. To accomplish this the group allegedly arranged for two of them to collect proprietary data including batch production control records, STP and raw data on the drugs themselves. While a third member of the group would store the collected data in an electronic form for its move offsite. The fourth member of the group would then use the collected data to manufacture the drugs at a site they co-owned. Learn More

A former executive at Insys Therapeutics was sentenced this week to 33 months in federal prison in a bribery and kickbacks scheme that Massachusetts prosecutors say helped fuel the national opioid epidemic. Michael Gurry, a former vice president at Insys Therapeutics, was also sentenced to three months of probation and ordered to forfeit about $3.6 million and pay restitution, which will be determined later. Prosecutors say Insys Therapeutics employees paid millions of dollars in bribes to doctors nationwide to overprescribe Subsys, a powerful, addictive fentanyl-based painkiller for cancer patients. Learn More

GlaxoSmithKline has made innovation its top priority as the drugmaker seeks to land federal approval of six drugs within the next 12 months, CEO Emma Walmsley told CNBC this week. Performance and trust round out the balance of GSK's main priorities in 2020 as the British company labors to make advancements in treatments for a number of diseases, Walmsley said in a "Mad Money" interview from J.P. Morgan's annual health-care conference in San Francisco. Walmsley, however, stopped short of saying how much GSK would spend on the research and development. She said the company is "accelerating investment," but one of its "biggest cultural transformations" is in taking a more disciplined approach. Learn More

Kite Pharma, a subsidiary of Gilead Sciences, has made public plans to push back by roughly one year the planned achievement of commercial production at its site in Urbana. Alert readers will recall that the company is constructing a new 279,000-square-foot plant in Urbana, Maryland after purchasing the 20 acre property on Bennett Creek Blvd in November 2018 for $7.5 million. The project delay is being attributed to building enhancements. It is understood that the new site will manufacture Kite's producers of chimeric antigen receptor T (CAR T) therapies, including Yescarta, which is Kite Pharma's commercially available CAR T therapy. Learn More

Incyte will pay $750 million to add an experimental lymphoma treatment to its research pipeline, announcing a licensing deal with MorphoSys that gives it partial U.S. and exclusive ex-U.S. rights to the German biotech's drug tafasitimab. Incyte will also invest $150 million in MorphoSys stock and agreed to extend another $1.1 billion in conditional payments should development of tafasitimab hit certain clinical, regulatory and sales milestones. The deal comes on the heels of a significant setback for Incyte's pipeline. Earlier this month, the biotech disclosed a surprising failure for a drug viewed as important to the company's future growth prospects. Learn More

AstraZeneca has made public plans to discontinue a late-stage trial for heart disease drug Epanova to treat patients with mixed dyslipidaemia and expects a $100 million writedown to hit its core profit in the fourth quarter. The biopharma says the decision, which followed recommendations from an independent data monitoring committee, was due to low likelihood of Epanova's benefit to patients with mixed dyslipidaemia. AstraZeneca added Epanova, which is already approved in the United States to reduce high levels of triglyceride, to its pipeline when it bought U.S.-based Omthera Pharmaceuticals in 2013 to build up its cardiovascular drug business. Learn More

Aduro Biotech has announced a restructuring plan to further extend the company's operating capital and align personnel towards executing its clinical development strategy. Following a detailed review of its operations and growth opportunities, Aduro intends to reduce its current workforce by roughly 59% across the organization, minimize its corporate facilities footprint and shut down the Aduro Biotech Europe headquarters in Oss, The Netherlands by the end of the third quarter of 2020. The reduction in ongoing operating expenses is expected to extend the Company's cash runway. Learn More

Eli Lilly and Dermira have announced a definitive agreement for Lilly to acquire Dermira for roughly $1.1 billion, in an all-cash transaction. Dermira is a biopharma dedicated to developing new therapies for chronic skin conditions. The acquisition will expand Lilly's immunology pipeline with the addition of lebrikizumab, a novel, investigational, monoclonal antibody designed to bind IL-13 with high affinity that is being evaluated in a Phase 3 clinical development program for the treatment of moderate-to-severe atopic dermatitis in adolescent and adult patients, ages 12 years and older. Lebrikizumab was granted Fast Track designation from the U.S. FDA in December 2019. Learn More

Janssen has announced a significant investment to expand its R&D presence and capabilities in the San Francisco Bay Area. This investment will support the leasing and construction of a state-of-the-art R&D facility in the global innovation center of South San Francisco, CA. Janssen executed the lease at The Shore at Sierra Point in Brisbane, CA. Janssen personnel at this new facility will focus on infectious and retinal diseases, data science and emerging modalities within discovery, product development and supply. The expanded facility is projected to more than double Janssen's presence in South San Francisco and is anticipated to be fully operational in 2022, upon completion of construction. Learn More

Biotech veteran Alexis Borisy thinks he can undersell the drug industry. Here's the idea: Borisy is starting a company to develop drugs that copy the drugs that biopharma companies are making and sell them for about a third of what the competitor drugs are going for. These won't be generic drugs. Instead, Borisy aims to make fast followers-unique medications, protected by their own patents, that copy a drug or class of drugs. Borisy's will hit the market just a few years after their competitors at a fraction of the price. The new company is called EQRx, and is being unveiled this week. Learn More

California would become the first state to sell its own brand of generic prescription drugs in an effort to drive down rising healthcare costs under a proposal Gov. Gavin Newsom is expected to unveil in his new state budget today. A broad overview of the ambitious but still conceptual plan provided by Newsom's office says the state could contract with one or more generic drugmakers to manufacture certain prescriptions under the state's own label. Those drugs would be available to all Californians for purchase, presumably at a lower cost. The governor's office said the proposal would increase competition in the generic drug market, which in turn would lower prices for everyone. Learn More

Boehringer Ingelheim announced this week that it has partnered with Enleofen Bio to develop the latter's preclinical drugs targeting IL-11. The deal enables Enleofen to receive more than $1 billion per product in upfront payments and milestones from the German drugmaker. Enleofen's lead product candidate is ENx108A, an antibody that targets IL-11 and has been shown preclinically to reverse organ dysfunction by targeting fibrosis and inflammation. IL-11 belongs to a class of proteins known as cytokines. Blocking it has been shown to inhibit diseases affecting several organs, including the liver, lungs, retina and heart, among others. Learn More

Schrödinger and Bayer have announced a five-year technology alliance to develop a comprehensive de novo design solution with the objective to accelerate the discovery of innovative high-quality drugs. The technology is expected to be capable of enumerating, screening, and scoring billions of synthetically feasible, virtual compounds supporting the identification and optimization of potential new therapeutic candidates. The de novo design software will integrate the power of Schrödinger's molecular design technology, which relies on physics-based modeling augmented by machine learning, with Bayer's proprietary in silico models. Learn More

Array BioPharma has dropped claims that an Eli Lilly subsidiary and a handful of its scientists stole trade secrets. Array dismissed its claims against Loxo Oncology on Dec. 27, six months after a Colorado judge denied Array a preliminary injunction that would have blocked the scientists from working at Loxo, and six weeks after the U.S. Court of Appeals for the Tenth Circuit sounded inclined to affirm him. The resolution concludes, at least for now, a chilly ending to a five-year collaboration between Loxo and Array for the development of targeted cancer drugs. Loxo opened its own lab in the same market as Array in 2017 and hired two of Array's scientists, then added seven more in 2018, just after the collaboration deal expired. Learn More

AbbVie this week said it will create a subsidiary to market Botox, Juvederm, Coolsculpting and other aesthetics products that it will acquire via its $63 billion buyout of Allergan. The new unit will be headquartered in Irvine, Calif., and be led by the senior vice president for Allergan's aesthetics business, Carrie Strom. The Allergan eye care and specialty business, which includes Restasis, Ubrelvy and Botox for therapeutic uses, will be absorbed into the main AbbVie pharmaceutical organization. The changes will take place following the close of the acquisition, which is expected sometime in the first quarter of the year. Learn More

The Westchester County Industrial Development Agency (IDA) has given final approval for a massive renovation and expansion by BioMed Realty of the firm's nearly 100,000 square foot Ardsley Park Life Sciences Campus in the Town of Greenburgh. The renovation includes two separate buildings, the 22,000 square-foot Building 440 and the 75,000 square-foot Building 430. The former will house office and lab space for up to four new life science companies, while the latter up to an additional six. The project is expected to create approximately 600 jobs, including up to 350 full-time positions, and have a budget of $38 million. Learn More

A Chinese scientist accused of aiding a conspiracy to steal trade secrets potentially worth more than $1 billion from GlaxoSmithKline has been extradited from Switzerland to stand trial in Philadelphia. Federal prosecutors say Gongda Xue, a 50-year-old biochemist, received valuable proprietary cancer research that his sister stole while she worked for the pharmaceutical giant's research facility in Upper Merion from 2006 to 2016. He is also accused of pilfering confidential documents from one of his former employers, a Swiss research institute backed by Novartis. Xue's handover to American authorities comes after an 18-month court battle in Switzerland. Learn More

Alexion blockbuster drug Soliris could soon face a competitor from Apellis Pharma. This comed amid word that results from a late-stage study which showed the Apellis drug beat out Alexion's Soliris. The head-to-head trial enrolled 80 adults with paroxysmal nocturnal hemoglobinuria, a rare and potentially life-threatening blood disorder, giving half Soliris and half Apellis Pharmaceuticals' pegcetacoplan. After four months of treatment, patients on Apellis' therapy experienced a 28% boost in levels of a critical oxygen-carrying protein while those on Soliris saw a 17% decline. Learn More

Takeda is teaming up with MIT to advance projects intended to enhance its understanding of how to best use artificial intelligence to solve some of the biopharma industry's biggest challenges. The Japanese biopharma will fund 6 to 10 projects per year for three years. The partnership is part of Takeda CEO Christophe Weber's wider imperative to improve the company's data analytics, says Anne Heatherington, senior vice president and head of Data Sciences Institute at Takeda. The program sits at MIT's School of Engineering, near Takeda's R&D center in Cambridge, MA. Learn More

At a time when germs are growing more resistant to common antibiotics, many companies that are developing new versions of the drugs are hemorrhaging money and going out of business, gravely undermining efforts to contain the spread of deadly, drug-resistant bacteria. Antibiotic start-ups like Achaogen and Aradigm have gone belly up in recent months, pharmaceutical behemoths like Novartis and Allergan have abandoned the sector and many of the remaining American antibiotic companies are teetering toward insolvency. One of the biggest developers of antibiotics, Melinta Therapeutics, recently warned regulators it was running out of cash. Learn More

GlaxoSmithKline has penned a deal worth up to $1 billion (€955m) with Bavarian Nordic, to offload its travel vaccines Rabipur and Encepur. Under the terms of the deal, GSK has received an upfront payment of $345 million (€308m) and is eligible to receive milestone payments of up to $1 billion (€955m). GSK said in a statement that the divestment of the two vaccines coincides with its "strategic intent to increase focus and reinvest in growth assets, innovation and a simplified supply chain in its vaccines business". The move follows a major ongoing strategy refocus at the British pharma, after CEO Emma Walmsley spearheaded plans to reinvest in the company's oncology business at the beginning of 2019. Learn More

Similar to 2017 and 2018, the US FDA in 2019 approved an increasing number of orphan drugs and biologics, as well as drugs targeted at specific cancers. Sponsors have continued to target the development of pricier orphan treatments and the Center for Drug Evaluation and Research (CDER) reported approving more than twice as many orphan drugs in the past eight years as in the previous eight years. In addition, more than one-third of CDER's novel drug approvals in 2019 were cancer treatments. Learn More

Getinge has announced the successful acquisition of 100% of the shares of Applikon Biotechnology for an undisclosed sum. Applikon is perhaps best known in the industry as a leading supplier of upstream solutions for bioprocessing with an emphasis on bioreactors and controllers. While Getinge is perhaps best known to the industry for its solutions related to decontamination, sterilization, isolation and aseptic transfer. The two companies expect to leverage one another's strengths to further accelerate growth. To that end, it is understood that the senior management of Applikon will remain in place to continue to provide their experience and leadership. Learn More

Roche wasted no time in getting back into the gene therapy game. After the Federal Trade Commission cleared the way for it to acquire Spark Therapeutics and its portfolio of treatments for genetically driven diseases, Roche followed up with a massive $1.2 billion collaboration with Sarepta Therapeutics for the biotech's experimental Duchenne muscular dystrophy gene therapy. The deal, $750 million in cash and a $400 million share purchase, gives Roche rights to the therapy, called SRP-9001, in markets outside the United States. The collaboration will also include cost sharing for global development, and up to $1.7 billion in regulatory and sales milestones. Learn More

Illumina, has thrown in the towel on its planned $1.2 billion acquisition of competitor Pacific Biosciences. The deal, announced more than a year ago, would have given Illumina a tool to dive deeper into complex DNA-related questions about health and life, giving the company a competitive edge in its field. But it was too competitive, regulators said. Both the Federal Trade Commission and the United Kingdom's antitrust group asserted the merger would tip Illumina into monopoly territory. As a result of the failed deal Illumina will have to pay a $98 million penalty to PacBio for the collapse, as the two companies had previously agreed on the termination fee should the acquisition fall through. Learn More

On behalf of all of us here at Aspen Brook, Happy Holidays! We will be closed now through Friday, January 3rd as we spend time with family and friends. The Alert will return on Monday, January 6th.

Ipsen this week announced that David Meek has resigned as the company's Chief Executive Officer and will step down from the Board of Directors, effective December 31, 2019, to pursue another professional opportunity as President and Chief Executive Officer of FerGene. The Board of Ipsen has decided to appoint Aymeric Le Chatelier, currently Chief Financial Officer as Interim CEO to replace David Meek as of January 1, 2020. The newly-created office of the CEO will work closely with the Interim CEO and the Board of Directors to ensure a smooth transition. Learn More

Boehringer Ingelheim this week announced the discontinuation of the development of BI 1467335 for the treatment of NASH. BI 1467335 was acquired from Australia's Pharmaxis in 2015. This involved an upfront payment of $30 million and a total potential deal value of over $555 million. As part of its ambitions in the NASH arena, Boehringer also signed collaborations with Yuhan, Dicerna and Mina. In a statement, Boehringer Ingelheim states that it continues to be fully committed to building a comprehensive next generation portfolio of first-in-class treatments with breakthrough potential to enable resolution of NASH across all stages of the disease. Learn More

Johns Hopkins University will close its graduate programs in Rockville, Maryland by the summer of 2020, dealing a blow to the county's ambitions of expanding higher education opportunities. The university plans to consolidate the Center for Biotechnology Education on Medical Center Drive with the program's main campus in Baltimore, said Leslie Ford Weber, the director of campus, government and community affairs for Johns Hopkins in Montgomery County. Johns Hopkins will begin consolidating the programs in May, when full-time students finish their coursework. Classes in Montgomery County will end for good at the end of the summer term in mid-August, according to Ford Weber. Learn More

Lawmakers quietly tucked a boost for the biopharma industry in the massive, end-of-year spending package they unveiled this week- a surprising turn for a Congress that has, at least rhetorically, pushed to rein in drug prices. The provision, just three lines and 17 words in a 1173-page bill, would effectively expand the definition of biologic drugs, a category that includes presumably more complicated medicines made from living cells. Biologics get 12 years of patent protection, while so-called small-molecule medicines get five years, and the expansion would mean more new drugs would fit into the more-protected category. Learn More

Alnylam Pharmaceuticals gene-silencing therapy for a rare kidney disorder met the main goal of a late-stage study this week, bringing the company a step closer to marketing the first approved treatment for the condition. The study tested Alnylam's experimental drug, lumasiran, against placebo in patients aged six and above with primary hyperoxyluria type 1 (PH1), a life-threatening condition that is estimated to affect one in 58,000 people globally. Alnylam plans to file for the drug's approval in the United States and Europe early next year and hopes to launch the drug before the end of 2020. Learn More

Only about one quarter (25.1%) of Americans understand that a new drug approved by the US FDA does not necessarily mean the drug will help most people who use it, according to the results of a survey published last week in Pharmacoepidemiology & Drug Safety. However, the FDA's survey of a nationally representative group of 1,744 US adults did find that more than half understood that FDA approves prescription drugs when the drug offers benefits that outweigh the risks, although 17.5% thought that an FDA-approved drug will cure the condition for which it's prescribed. Learn More

The Federal Trade Commission has cleared Roche's $4.8 billion buyout of Spark Therapeutics, bringing to a close a 10-month investigation that had spurred concerns acquisitions of other gene therapy biotechs would be similarly scrutinized. Roche won't be required to sell any assets and has now received all the antitrust approvals it needed to complete the deal. Earlier this week the U.K. Competition and Markets Authority gave Roche a go ahead after finishing its own investigation. FTC commissioners voted 5-0 to close the agency's review, judging that the evidence it gathered "did not indicate that Roche would have incentive to delay or terminate Spark's developmental effort for its hemophilia A gene therapy..." Learn More

Charles River Labs (CRL) has announced the acquisition of HemaCare for roughly $380 million in cash. The deal provides CRL with human-derived cellular products for the cell therapy market as well as cell processing services to support the discovery, development, and manufacture of cell therapies, including allogeneic and autologous programs. Combined with CRL's integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition of HemaCare is expected to provide CRL with a comprehensive solution set for the fast-growing market of cell therapy developers and manufacturers worldwide. Learn More

Novartis has made public its decision to abandone development of fevipiprant in asthma after another double phase 3 trial failure. According to published reports, Novartis had been hoping that fevipiprant would prove to be a game-changer in some forms of asthma and generate blockbuster-level revenues in the process. But it wasn't to be as clinical studies showed the drug was no better than placebo at reducing asthma exacerbations. The decision to axe fevipiprant was not a huge surprise as the drug was already considered to be on life support by analysts after failure of two other trials in October. Learn More

Bristol-Myers Squibb has announced that it has won a $752 million jury verdict against Gilead Sciences in a U.S. patent dispute relating to technology for treating cancer. A jury in Los Angeles awarded the damages after finding that Yescarta, a treatment sold by Gilead's Kite Pharma unit, infringed on a patent exclusively licensed by Bristol-Myers' Juno Therapeutics division. The patent at issue in the lawsuit, which Juno licenses from the Memorial Sloan Kettering Cancer Center in New York, relates to CAR T-cell immunotherapy for cancer. Gilead says it expects to seek to undo the verdict through post-trial motions and an appeal. Learn More

A late-stage clinical trial has shown therapy combining Roche's immunotherapy Tecentriq with two of its other drugs helped people with a form of advanced melanoma. The study met its primary aim of showing progression-free survival in patients with previously untreated BRAF V600 mutation-positive advanced melanoma, Roche said. Adding Tecentriq, a monoclonal antibody, to Cotellic and Zelboraf helped reduce the risk of disease worsening or death compared to administering a placebo plus Cotellic and Zelboraf. Roche has an extensive clinical trial development program for Tecentriq, with more than 50 studies underway for use in fighting a wide array of conditions. Learn More

Biotech stocks caught fire in late 2019, following a $195 billion biopharma acquisition spree among biopharma giants like Bristol-Myers Squibb and AbbVie during the first nine months of the year. The scorching pace of acquisitions kicked up another notch earlier this month, as Merck and Sanofi snapped up promising biotech names. According to industry analysts this M&A activity is unlikely to slow in 2020 as leading biopharma's look to continue to secure deals with gene therapy and oncology companies expected to be the most sought after. One analyst notes that "a lot of indications could be disrupted by gene therapy". Learn More

The US FDA this week approved Sarepta's Duchenne muscular dystrophy therapy Vyondys 53, four months after rejecting the drug over safety concerns. The decision comes as a major surprise, as Sarepta had given no prior hints that it had resubmitted an application to the agency. Reversing a rejection so quickly is highly unusual. Following the FDA's August rejection, Sarepta appealed the decision through a formal dispute resolution process. Peter Stein, the director of the agency's Office of New Drugs, resolved the issues raised in the Complete Response Letter issued to Sarepta, the company said, and granted the appeal. Sarepta then filed its application again, resulting in the unexpected approval. Learn More

The US House of Representatives this week voted 230-192 to send to the Senate legislation requiring biopharma companies directly negotiate the price of 50 drugs with the federal government. The bill is unlikely to get a vote in the Senate, where an alternative voted out of the Finance Committee mainly proposes mandated rebates to Medicare for drugs that have price increases at greater than the rate of inflation. President Donald Trump has backed that plan, but there are no signs it will be debated soon. The industry trade group PhRMA has fiercely opposed the legislation, claiming it would trigger "nuclear winter" for biotech innovation. Learn More

The full US Senate voted this week 72-18 to confirm Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next commissioner of the US FDA. The vote came just over a month since he was nominated, although in that time little information has come to light about how he plans to direct the FDA. Still, senators on both sides of the aisle seemed convinced that he'll be able to handle the job. Learn More

The US reliance on imported pharmaceuticals and ingredients is rising as foreign drug facility inspections decreased by about 10% from 2016 to 2018. Part of the reason for the decline: The US FDA said it's still struggling to hire new inspectors. Testifying under oath before the House Subcommittee on Oversight and Investigations of the Committee on Energy & Commerce this week, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, defended the FDA's approach and discussed some of the vulnerabilities of the agency's foreign inspection program. She said the FDA is looking to hire 50 new inspectors, but there are difficulties. Learn More

The new trade agreement between the US, Mexico and Canada (USMCA), signed this week in Mexico City, dealt a blow to the biopharma industry as the final deal no longer includes provisions that would have extended the exclusivity of biologics in Canada and Mexico. Under the initial deal, Canada was expected to go from eight years of exclusivity for biologics to 10 years, and Mexico would go from five years to 10. However, those provisions have been removed from the final agreement. In addition to a loss of exclusivity, the final deal saw the removal of provisions related to patent evergreening and new exclusivities for research. Learn More

Novartis has shipped CAR-T cell therapies to about 1,800 people with blood cancer, a noteworthy accomplishment for a personalized product made from patients' own immune cells. But some of those people have received treatments that, while safe and effective, don't meet commercial product specifications set out by the FDA when it approved the Swiss drugmaker's Kymriah for leukemia and lymphoma. And 10% of the time, Novartis hasn't been able to ship a product at all, either due to out-of-specification issues or from manufacturing failures. Novartis says it has made progress in addressing the issues, and is working with the FDA to put in place solutions. Learn More

A South Korean court this week jailed three executives of Samsung Electronics for their role in a plot that included burying computers under factory floors at its biotech affiliate, in an investigation of alleged accounting fraud. Prosecutors had accused the executives of ordering employees at the biopharmaceutical firm to destroy and conceal internal documents, as authorities investigated accusations of a violation of accounting rules there. The efforts included inserting nearly two dozen computers and notebooks as well as computer servers in spaces under the floors of Samsung Biologics factories near Seoul. Learn More

Large pharma companies oppose legislation being considered by Congress to lower the prices of prescription drugs saying that this will lead to a decline in drug innovation. If that argument is credible, there should be evidence to show that the large pharma companies are responsible for discovering innovative new drugs. However, a study by STAT finds that discoveries by third parties accounted for 86% of the revenue of one industry leader and 89% of the revenue of another. As for the source of these third-party discoveries, they include acquisitions, universities and academic centers. Learn More

Kevin Ness has made a career of building tools for biologists. Now, with the burgeoning field of synthetic biology booming, he's ramping up his latest venture, Inscripta, which wants to get a genome-engineering device into the hands of every scientist who wants one. Inscripta's Onyx device is small enough to sit on a desktop, allowing scientists to modify cells faster and cheaper than would previously have been possible. A select group of researchers has been working with Inscripta to date through an early-access program. The company now expects to get the Onyx, which costs nearly $350,000 for the hardware, plus additional fees for reagents and software, into the market in 2020. Learn More

The US biosimilar industry has lingered in the shadow of the European market since the US pathway for approvals was initiated in 2009. Ten years later, or less than five years since the first FDA approval of a biosimilar, and just 42% of FDA-approved biosimilars have launched. But in the next three months, a bunch of new biosimilars will hit the market, including new ones in oncology, hinting at a wave of uptake. In fact, if everything stays on schedule, more than 60% of the biosimilars approved in the US will have launched by early next year. The rising number of launches, combined with an increasing amount of quick uptake, may put biosimilar foes on their heels. Learn More

Sanofi has announced that it is acquiring the cancer drug startup Synthorx for $2.5 billion. The 5-year-old startup has been working in the field of synthetic biology, expanding the genetic code to give its researchers more building blocks to create novel drugs. Sanofi said the startup appears to be at the forefront of cancer drug innovation, making it worth the high price tag. While Merck has announced an agreement to acquire ArQule for roughly $2.7 billion. ArQule is a biopharma company focused on kinase inhibitor discovery and development for the treatment of patients with cancer and other diseases. Learn More about the Sanofi/Synthorx deal or Learn More about the Merck/ArQule deal.

BioMed Realty has inked a 240,000-square-foot lease with Amgen at its Gateway of Pacific campus in South San Francisco. The new long-term deal at the 1.3-million-square-foot life science campus that is currently under construction will house Amgen's Bay Area scientists and employees focused on cardiometabolic, inflammation and oncology research. BioMed also recently signed leases with leading innovation companies, including Zymergen for 304,000 square feet to relocate its headquarters to BioMed's Emeryville Center of Innovation in the Bay Area. Learn More

Privately held drug developer Enzyvant has announced that the U.S. FDA had declined to approve its regenerative tissue therapy for a rare immunodeficiency disorder and raised concerns about its manufacturing. The company was hoping to win its first approval for the therapy, RVT-802, aimed at treating congenital athymia, a disorder affecting babies born without a small gland called thymus, which produces T-cells needed to regulate the immune system. The health regulator in a letter to Enzyvant raised questions about the manufacturing process for the treatment as well other issues based on its inspection of the manufacturing site, the company said. Learn More

Alexion says it will not ask bigger companies to acquire it. Instead, company executives say they believe their strategy of switching patients from an older product to a newer one, as well as experimental drugs in development, will drive more value through sales growth than would an acquisition. The unusual declaration comes following a meeting with shareholder activist Elliott Advisors, which had pushed Alexion to add former Takeda and Novartis executive Deborah Dunsire to the board in early 2018, and was pushing for the launch of a proactive sale process, Over the past two years, Alexion has undergone a board of directors "refreshment" and hired a new management team. Learn More

U.S. FDA staffers reviewing Correvio Pharma's heart drug have said that they did not believe the benefits of the therapy outweighed its risks, sending the company's shares down nearly 38%. The drug, Brinavess, approved in Europe and other countries including Canada, aims to correct erratic heart rhythm in the upper heart chambers due to a condition known as atrial fibrillation or AFib. Although Correvio has provided evidence of benefits, Brinavess comes with "serious liabilities" including low blood pressure, irregular heartbeats in the lower heart chambers, and death according to FDA staffers. A panel of independent experts to the FDA is set to convene this week to vote on the drug's approval with a final decision expected later this month. Learn More

Eli Lilly is turning to executives from Loxo Oncology, the biotech it bought in January for $8 billion, to lead a major reorganization of its cancer research efforts. Josh Bilenker, formerly Loxo's CEO, as well as two members of the biotech's leadership team, Jacob Van Naarden and Nisha Nanda, will head up a merged group that combines Lilly's cancer laboratories with Loxo's. The new unit, dubbed Loxo Oncology at Lilly, will be tasked with recasting the pharma's research and development more in the mold of the nimbler biotech, known for its success with genetically targeted cancer drugs. Learn More

The Trump administration is prepared to scrap provisions in the new USMCA trade pact that would benefit US pharmaceutical and biotech companies selling medicine in Canada and Mexico, according to people briefed on the negotiations. In a move expected to win support for the deal from Democrats in Congress, the US Trade Representative has signaled it is willing to make concessions that on a provision that would allow developers of cutting-edge biologic drugs to benefit from 10 years, down from 12 in the US, of data protection before they were forced to contend with generic competition, the people said. Learn More

An experimental Sage Therapeutics drug intended to alleviate depression symptoms quickly failed to beat a placebo in a pivotal study reported this week. Sage has been testing its drug, SAGE-217, as a treatment for the symptoms of major depressive disorder. The main goal of the Phase 3 study was to show a reduction in symptoms after 15 days, as measured by a scale used to assess depression. However, patients showed an average reduction of 12.6 on the scale, which was not enough to distance itself from the 11.2 average reduction reported for the placebo group. Investors frowned on the results, and shares of Sage sank more than 60 percent in pre-market trading. Learn More

Amazon's cloud computing arm, Amazon Web Services has announced that it has teamed up with Novartis as part of a multi-year partnership that Amazon said would change the way medicines are manufactured and delivered. A significant part of the collaboration will involve "insight centers" that the company said will allow better forecasting and tracking of production lines, detection of manufacturing bottlenecks and making recommendations for adjustments to improve accuracy. AWS services will allow Novartis to collect inventory, quality and production data and then apply internet-of-things, analytics and machine learning technology to help drive efficiencies. Learn More

Mexico's government has announced that progress was being made toward revising a new North American trade pact that will sharply reduce protections for biologic drugs, in what will be a setback for U.S. biopharma companies. Mexico approved the United States-Mexico-Canada Agreement (USMCA) this year, but U.S. ratification has been held up by Democratic lawmakers pressing the Trump administration for changes including steps on the drug protections. According to Jesus Seade, Mexico's Deputy Foreign Minister, "very high protection" for biologic drugs would be "eased drastically" in changes being discussed for the USMCA. Learn More

Thermo Fisher Scientific has opened a $90 million, 50,000-square-foot viral vector manufacturing facility in Lexington, Massachusetts. The contract development and manufacturing organization expects to create more than 200 jobs at the site, which will support development, testing and manufacturing for viral vectors, the inactivated viruses used to deliver gene therapies. According to the company the new site will help address a "bottleneck" in manufacturing viral vectors. Alert readers will recall that Thermo Fisher paid $1.7 billion earlier this year for viral vector contract manufacturer Brammer Bio. Learn More

A thoroughly researched well written article published by Bloomberg this week delves into the cyberattack that crippled more than 30,000 laptop and desktop computer at industry leader Merck. The attack new no boundaries, effectively taking hostage the company's sales, manufacturing and research units for a couple of weeks. In the end, Merck would claim $1.3 billion in related losses and seek to recover the monies through its insurance. However, in a move that surprised the biopharma giant, no fewer than 30 of its insurers and reinsurers denied coverage. The reason they all gave, Merck's property policies specifically excluded coverage of an "act of war". Learn More

Astellas Pharma is buying Audentes Therapeutics for about $3 billion in cash, that amounts to roughly 110% of the closing price for Audentes shares earlier this week. The move is designed to make genetic drugs a fifth primary focus for Astellas, joining existing business lines in regenerative, immuno-oncology, immunotherapy, and neuro-muscular medicine according to published reports. The acquisition marks the second biggest on record for Astellas after its 2010 purchase of OSI Pharmaceuticals for$3.8 billion. Astellas expects the deal, which is subject to regulatory approval including U.S. antitrust clearance, to close in the first quarter of 2020. Learn More

Singapore has announced that its research and development hub Biopolis will be expanded to meet the needs of biotechnology start-ups. Phase 6 of Biopolis will add a further 376,000+ sq. ft. (35,000 sq m) of business park space for biomedical sciences research and supporting activities and 64,000+ sq. ft. (6,000 sq m) for office and retail use. This will include 21,000+ sq. ft. (2,000 sq m) of fitted-out laboratory spaces with lab benches, waste drainage and exhaust provisions. Biopolis currently houses nine A*Star research institutes and over 60 companies, with thousands of employees undertaking research, clinical trials and commercialization of new scientific discoveries. Learn More

Seattle-based Cyrus Biotechnology says it'll collaborate with the Broad Institute of MIT and Harvard on ways to optimize CRISPR gene-editing techniques for use in developing novel human therapeutics. Cyrus Biotech and the Broad Institute will work on ways to reduce the potential for the body to mount an immune response against CRISPR-based therapies. MIT biochemist Feng Zhang, one of the pioneers in the development of CRISPR, will be the principal investigator for the effort at the Broad Institute. The results of the collaboration will be published in peer-reviewed journals and made freely available to the academic and non-profit scientific community. Learn More

The U.S. FDA has denied Lexicon Pharmaceuticals appeal against the rejection of its add-on treatment for type 1 diabetes, marking the company's third major setback this year and sending its shares plunging. Lexicon says it intends to reappeal the decision against Zynquista's approval with the FDA's Center for Drug Evaluation and Research (CDER), effectively going over the head of the current FDA office with which it is dealing. Lexicon says it does not intend to run new analyses for review with CDER. The U.S. FDA in March declined to approve Zynquista, two months after a panel of independent advisers to the health regulator raised concerns of the risk of a complication called diabetic ketoacidosis (DKA). Learn More

A new draft guidance from the U.S. FDA has opened the door for the development of insulin biosimilars, potentially allowing for cheaper near-identical versions of these biologic drugs to be interchanged with the originator. This is bad news for companies like Sanofi and Novo Nordisk, who are already under pressure to cut prices of their branded insulins in the US amid wider scrutiny about prescription drug prices. It also brings the US in line with the European Medicines Agency, which introduced a biosimilar approval pathway first and has already approved biosimilar insulins. Learn More

Novartis has opened a new manufacturing facility for cell and gene therapies in Switzerland. In addition to manufacturing areas for novel CAR-T cell therapies, the new building also hosts the production of innovative, difficult-to-manufacture solid dosage forms such as tablets and capsules. In September 2019, the first clinical production of a cell and gene therapy batch was successfully completed. The $90 million facility is on track to begin commercial production of its cell therapy Kymriah for cancer in 2020. The Swiss facility, as well as a separate French site also being expanded, are central to Novartis's plans to transform Kymriah from a modest $250 million-per-year seller into a $1 billion blockbuster as European demand rises. Learn More

Share values in several biopharma's have dropped after the Wall Street Journal reported that federal prosecutors have launched a criminal probe into whether biopharma companies purposely allowed painkillers to spread through US communities, fueling the opioid crisis. Teva slumped 8%, Amneal dropped 10%, and Mallinckrodt, McKesson, and AmeriSourceBergen all fell by more than 3% after the drugmakers and distributors received grand-jury subpoenas from the US attorney's office in the Eastern District of New York, the Journal reported, citing regulatory filings. Other biopharma companies are likely to receive subpoenas in the coming months, the newspaper added. Learn More

Reforms to a US national security regulation are putting off foreign investors and driving down VC investment in the biotech space by as much as 20 percent, says BIO's David Thomas. In August 2018, Congress passed the Foreign Investment Risk Review Modernization Act (FIRRMA) as part of the Fiscal 2019 National Defense Authorization Act. Whether the ruling was intended to specifically curb investment from China, as many commentators at the time suggested, it has had an adverse impact on venture capital (VC) investment in biotech, according to the Biotechnology Innovation Organization (BIO). Learn More

A group of Massachusetts academic, healthcare, biotech and biopharmaceutical industry leaders have come together to establish a new center for advanced biological manufacturing and engineering. The $50 million Center for Advanced Biological Innovation and Manufacturing will be an independent, nonprofit organization located in the Greater Boston area. The expectation is that this will be an independent, separate nonprofit corporation. Leaders from Harvard University, Massachusetts Institute of Technology, Fujifilm Diosynth Biotechnologies, GE Healthcare Life Sciences, Alexandria Real Estate Equities, Inc., will comprise the center's board of directors. Learn More

Blackstone Group has announced that it will invest $400 million in a joint venture with Swiss drug company Ferring that is working on an experimental gene therapy for bladder cancer, the private equity giant's largest ever bet on drug development. Investing in yet-to-be-approved medicines is a lucrative but also risky proposition for buyout firms, and only few have had the stomach to place such bets. Blackstone made its foray in the sector last year, acquiring Clarus, an investment firm specializing in life sciences. For its part, Ferring will invest $170 million in the joint venture with Blackstone, dubbed FerGene, bringing its total funding to $570 million, the companies said in a statement. Learn More

The U.S. FDA will give Roche's experimental therapy for spinal muscular atrophy an expedited review and will decide on approval within six months, If approved, Roche's risdiplam would be the third SMA therapy to reach market in the U.S., following approvals for Biogen's Spinraza and Novartis' Zolgensma. Less than three years ago, there were no FDA-approved medicines for SMA, a rare disease that is the most common genetic cause of infant mortality. According to Roche, the regulatory agency is expected to make a decision by May 24, 2020. Learn More

Novartis will buy cholesterol drug developer The Medicines Company for $9.7 billion, the latest and largest in a string of deals under CEO Vas Narasimhan aimed at reshaping the Swiss pharmaceutical company around newer technologies and higher-margin prescription therapies. Acquiring Medicines Co. will give Novartis control of a near-to-market heart drug, called inclisiran, which faces uncertain commercial prospects as well as high-profile rivals. Its path to an FDA approval, though, looks clear following late-stage study results confirming treatment with inclisiran cut cholesterol levels in half among individuals already taking statins. Medicines Co. expects to submit the drug to U.S. regulators by the end of the year. Learn More

AstraZeneca has announced that the U.S. FDA has given its go ahead for the company's Calquence drug to treat chronic lymphocytic leukemia (CLL), one of the most common types of leukemia in adults. The drug was approved roughly two months after being granted a Breakthrough Therapy Designation by the U.S. FDA in collaboration with drug watchdogs in Canada and Australia. The decision to also approve Calquence for the treatment of small lymphocytic lymphoma, a similar disease, will pit the AstraZeneca drug against AbbVie and Johnson & Johnson's established CLL treatment Imbruvica. Learn More

Plans are moving forward for another Bay Area biotech campus. Alexandria Real Estate Equities is transforming a chunk of property in San Carlos, California into a 1.6 million-square-foot biotech campus. According to the San Francisco Business Times, the real estate development company submitted plans for its proposed biotech campus. Alexandria Real Estate Equities intends to turn the space into six new buildings, each about five to seven floors for biotech companies to use. In addition to the buildings, the site will also include an amenities structure, parking garages and a small park, according to the Business Times. Learn More

Biotech is famously skeptical of Silicon Valley pitches to fix all that ails drug discovery with a prescription for pairing big data and artificial intelligence. But one of the biopharma industry's top R&D chiefs anticipates the day is coming fast when advanced computing techniques like machine learning yield results for the sector. "I would predict that in the next two to three years we'll have examples of targets, maybe not reagents, but targets discovered through machine learning and 'in silico' methods that unravel biology that wasn't appreciated before," said Hal Barron, GlaxoSmithKline's head of R&D, speaking this week on a panel at the STAT Summit. Learn More

Sanofi is holding discussions over options for its consumer-health business that could be worth $30 billion as new Chief Executive Officer Paul Hudson seeks to rejuvenate the French drugmaker, people familiar with the matter said. While the biopharma giant has made no decisions, it has been talking to financial advisers to gauge shareholder feedback, according to the people, who asked not to be identified because the deliberations are private. Hudson, who has said he will take a critical look at all of Sanofi's operations, will give a strategy update on December 10th of this year. Learn More

Kendall Square in Cambridge, Massachusetts, is home to the greatest concentration of biotechnology companies in the world. Once a salt marsh on the Charles River, the now-bustling enclave surrounding the MIT campus has evolved from a desolate wasteland of empty parking lots and crumbling warehouses in the 1970s to a vibrant ecosystem of innovation: the beating heart of the nation's biotechnology industry today. "From Controversy to Cure: Inside the Cambridge Biotech Boom" is a new documentary film by MIT Video Productions premiering this week with showings at MIT. It tells the story of the long, largely unplanned, and often haphazard series of events in Cambridge and beyond that ignited a "bio boom" in the greater Boston region. Learn More

Business struggles, significant debt and legal liabilities put some industry players at particularly high risk of declaring bankruptcy in the near future, including large drugmakers like Teva Pharmaceutical and Bausch Health as well as small biotechs including Clovis Oncology and Puma Biotechnology. A BioPharma Dive analysis identified 31 troubled biopharma companies that are at highest risk of going bankrupt in the next 12 months. While rare in the drug industry, bankruptcy filings have ticked up in 2019, driven by growing legal, political and market pressures that could bring more companies to zero. Learn More

Eli Lilly and Co. will invest $400 million in its manufacturing facility in Indianapolis, an upgrade that will lead to an additional 100 highly skilled jobs at the Indianapolis-based drug manufacturer. The money will go to enhancing the existing facilities at the Lilly Technology Center campus, which manufactures insulin. It will also help Lilly increase its capacity to make other diabetes medicine, company officials said in a news release. In addition to insulin, Lilly makes 10 non-insulin diabetes drugs. Company officials said that the money announced this week would go to improving the company's syringe-filling, device assembly and packaging operations. Learn More

Daniel O'Day, in his eight months on the job as CEO of Gilead Sciences (GILD), has faced a single, persistent question: What are you going to buy? "People are worried about the cash in our pocket," O'Day said with a grin at the STAT Summit on Wednesday. And Gilead, which had about $25 billion in cash at the end of the last quarter, is "in an acquisitive mode," he said. But that doesn't mean O'Day is planning to pull the trigger on a megadeal to please Wall Street. For one, "there's a lot more going on inside Gilead than the outside world knows," he said. And then there's the fact that buying and consuming promising companies has a way of sapping promise. Learn More

Medicines Co., the developer of a promising cholesterol drug, has attracted takeover interest from suitors including Novartis AG, people familiar with the matter said. Novartis has been holding talks about a potential acquisition of Medicines Co., going so far as to be seen as conducting due diligence on the company, one of the people said, asking not to be identified because the information is private. Other potential acquirers have also expressed interest in a purchase of Medicines Co., and there's no certainty an agreement will be reached, the people said.  The current market value of the company is roughly $4.7 billion. Learn More

Novo Ventures has committed up to $25 million over a five-year period to fund seed-stage drug discovery projects at the Broad Institute of MIT and Harvard in a deal which it says will propel it into the Massachusetts biotech community. The new biotech accelerator, dubbed the Novo Broad Greenhouse, will support between five and 10 projects per year at the Broad's Center for the Development of Therapeutics (CDoT), an academic institution engaged in early-stage discovery projects. Novo Ventures initially proposed the idea of funding research at the CDoT as it was looking for ways in which the investor, and relative newcomer to Boston, could become a more active player in the local biotech community. Learn More

A game that allows frustrated biopharma industry pros to make the step up to the CEO role - virtually at least - is coming to a games console near you in time for Christmas. First launched as a PC game in 2015, Big Pharma will be available for all three major games consoles - Sony's PlayStation 4, Nintendo Switch, and Microsoft Xbox One - beginning next month, according to publisher Klabater. The game - developed by Twice Circled and Positech Games - has players start with an empty warehouse, and have to buy the equipment and technology to try to turn it into a profitable factory with multiple production lines, whilst also pumping cash into R&D and sending drug-hunting explorers around the world. Learn More