News Alert

Bayer this week made pubic plans to shutter its operations at its Robinson site in Pittsburgh, a site that employs about 600 workers and which for more than 50 years served as the German drug giant's North American headquarters. Bayer said the closure - which will occur over the next two years - is part of company-wide consolidations and job reductions following its $63 billion acquisition last year of Monsanto, based in St. Louis. Bayer's health care businesses are based in Whippany, N.J. Learn More

Boehringer Ingelheim announced this week that it has started to expand capabilities at its biologics facility in Shanghai. The expansion includes an additional bioreactor and the infrastructure to support two 2,000-liter single-use bioreactor production lines. Boehringer said the new operations should meet GMP standards. While the facility has yet to manufacture commercial supply for any products, that should change later this year as Boehringer expects to begin production on an undisclosed monoclonal antibody. Learn more

Meissner is set to be announced as the main tenant of the IDA's advanced technology building in Castlebar, this according to published reports in Ireland. Meissner will occupy the building that was opened last February. The state-of-the-art 30,000+ sq. ft. facility was built as part of the IDA's five-year investment program in regional properties. While no figure has been used on the number of jobs that Meissner will bring to the region, it is understood that the facility could house as many as 150 workers. Learn More

U.K. Prime Minister Theresa May was handed a historic defeat in the House of Commons this week as members of Parliament (MPs) rejected her Brexit withdrawal plan by a margin of 230 votes - the largest ever in the democratic era. That uncertainty is causing widespread concerns over the potential impact on public health and access to drugs in both the U.K. and Europe, spurring a European pharmaceutical trade group to call for special consideration for the industry's supply chain. Learn More

Five Prime Therapeutics is cutting its headcount by 41 employees, roughly 20 percent. This corporate restructuring will eliminate positions in research, pathology and manufacturing in an effort to reduce operating expenses by upwards of $10 million. These monies will be used to support clinical-stage programs expected to report key data later this year. Alert readers will recall that BMS paid $350M upfront to Five Prime in 2015 to partner on the oncology drug cabiralizumab. Learn More

Pfizer this week made public plans to halt the development of five preclinical biosimilar assets, though the company will continue to market three biosimilars and develop five other biosimilars in mid- to late-stage development. Joining a handful of other companies - from Boehringer Ingelheim to Momenta to Sandoz and more -- in exiting the US biosimilar space in some shape or form. Pfizer's exit reiterates the view by many that the need exists to raise questions about the viability of the US biosimilar market as a whole. Learn More

The past year proved to be a big one for the U.S. FDA and the approval of novel drugs. Over the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler's diarrhea, migraine headaches and more. Over the past 190 years, the FDA has averaged an approval of 33 novel drugs each year, with 2018 having the highest number. In 2017, the FDA approved 46 novel drugs, but only 22 in 2016. Learn More

Black Diamond Therapeutics has announced the completion of a Series B financing round valued at $85 million. Proceeds from the financing will be used to establish its new corporate headquarters in Cambridge, MA, advance two-to-three existing development candidates into the clinic in the next 24 months, and bolster its platform's ability to rapidly identify precision medicines for mutant cancers intractable to standard care. This latest funding round brings the total dollars raised by Black diamond to $105 million. Learn More

As UK Prime Minister Theresa May's Brexit deal is expected to be rejected today in a House of Commons vote, the EMA has said that after closely monitoring staffers' intentions to relocate to Amsterdam, it currently expects a staff loss of about 25%. The 25% figure might seem like a lot of staffers to lose, but that figure is on the low end of predictions from a survey in September 2017 that found EMA expected to lose at least 19% of its staffers no matter which city was selected. In addition to the staffing losses, the EMA says it will further temporarily reduce or suspend activities in the first half of 2019 as it moves into the final phase of its physical relocation. Learn More

Estimates vary, but most molecules selected to begin clinical development won't end up on pharmacy shelves or in doctor's offices. By some recent signs, drugmakers are finding it harder and harder to hit on a therapy-to-be. Return on R&D investment hit a nine-year low in 2018, numbers recently crunched by Deloitte show. At this year's J.P. Morgan Healthcare Conference, a number of drugmakers made the case that new technologies, such as cell and gene therapy or RNA-targeted therapeutics, could speed development times and lower costs. Learn More

The partial government shutdown has become the longest shutdown in history, and biotech firms that have submitted regulatory filings are facing greater uncertainty about their future plans. More than 40 percent of FDA workers and thousands at the SEC are furloughed, and FDA Commissioner Scott Gottlieb is resorting to Twitter to post updates about how his agency is using its fast-dwindling funds. Learn More

AstraZeneca has made public plans to close two manufacturing sites in Colorado, eliminating 200+positions as it looks to consolidate biologics operations. The sites affected are Boulder, which was previously owned by Amgen and acquired in 2015 for $14.6 million and Longmont, the 70-acre site acquired in 2016 for $64.6 million. Clif Harald, Executive Director of the Boulder Economic Council, lamented the cuts: "We're very concerned about the impact of this decision on the employees. We didn't see it coming. But all tech is volatile. It isn't a complete surprise, but it wasn't expected." Learn More

U.S. Senators Amy Klobuchar (D-Minn.) and Chuck Grassley (R-Iowa) reintroduced legislation this week to toughen laws against "pay-for-delay" deals, in which drug companies seek to block competition by paying their generic competitors. The bipartisan Preserve Access to Affordable Generics and Biosimilars Act, first introduced by Klobuchar and Grassley in December under the previous Congress, is in line with the Trump administration's initiatives to increase competition. The new bill would prohibit branded drug companies from compensating generic, interchangeable biologic or biosimilar companies to delay market entry of competing products. Learn More

The sooner, the better. That's Christophe Weber's time frame for shedding assets as Takeda tries to reduce a heavy debt load after completing its $62 billion takeover of Shire. The company has laid out a scenario of a potential $10 billion in divestments in an effort to deleverage. Weber needs to move fast. For one, debt is a huge issue, with net borrowings more than doubling as Takeda takes on about $30 billion in debt to acquire Shire. S&P Global Ratings downgraded Takeda this week, questioning how quickly it will be able to repair worsening financial ratios. Takeda says it's looking to divest overseas businesses where the company isn't an industry leader and doesn't have critical mass in the market. Learn More

Samsung Bioepis this week announced it has signed a licensing agreement with Chinese biotech company 3SBio to develop and commercialize biosimilar medicines in China, the company's first foray into the market.The deal comes as China develops ambitious plans for its drug sector, particularly in biologics, which are gaining ground on traditional chemically synthesized medicines. The 3SBio agreement also covers biosimilar candidates from Samsung Bioepis, including SB8, based on the innovative cancer medicine Avastin. Samsung Bioepis says it will receive upfront and milestone payments from 3SBio, as well as royalties from sales. Learn More

Akorn has announced the receipt of a warning letter from the U.S. FDA following an inspection of the company's Decatur, Illinois manufacturing plant. The warning letter lists violations related to the agency's current good manufacturing practice regulations, which include poor aseptic behavior, as well as those related to environmental and personnel monitoring. The Lake Forest, Illinois-based company also failed to follow "appropriate written procedures" to prevent microbiological contamination of the drugs being produced at the plant, the letter said. The regulator also noted that foreign fibers and other contaminants were found on gloves that were supposed to be sterile. Learn More

As the House preps to take action on individual appropriations bills this week, including one that will fund the U.S. FDA, Commissioner Scott Gottlieb has further clarified what the agency has left in user fee funds, what review activities will take place and how the agency is helping its employees conduct inspections. Due to the partial shutdown, the FDA cannot accept new 2019 user fees, which means the agency cannot accept new medical product applications unless they are user-fee-program related but don't require the payment of a user fee. "We have about one month of funding left," Gottlieb said. Learn More

Nearly every person who's run the U.S. FDA in recent history agrees the agency should break free from its political supervisors - a rare consensus from commissioners who served under Republican and Democratic administrations alike. In two papers published this week, all seven of the FDA's most recent commissioners wrote that the current setup - in which the agency is a mere subdivision of the Department of Health and Human Services - interferes with the ability of its scientists to protect the health of the public. They described a situation in which a tangled web of responsibilities, along with political overseers who aren't necessarily motivated by science, all make it harder for the FDA to keep people safe. Learn More

Eli Lilly is buying Connecticut based Loxo Oncology for $8 billion in cash, making it the biggest acquisition in the drugmaker's 143-year history. Loxo gained prominence in 2017, just three years after going public, with impressive clinical trial results showing its drug to be highly effective on cancers driven by a single gene mutation known as TRK fusion. It earned U.S. approval in November for the treatment under the brand name Vitrakvi, which is sold in partnership with Bayer. Lilly says it "very much" wants to continue the agreement with Bayer, which sells Vitrakvi outside the United States and shares U.S. commercial costs and profits with Loxo. Learn More

Sanofi and Regeneron have restructured and extended their immune-oncology discovery and development agreement, giving the French drugmaker rights to opt-in to development and marketing of two potential cancer drugs targeting diseases including multiple myeloma. The two companies signed the agreement in 2015, and it was due to end in mid-2020, but the revision allows for ongoing collaborative development of two clinical-stage bispecific antibodies. Under the restructured agreement, Sanofi will pay Regeneron $462 million, representing the balance of payments due under the original agreement. Learn More

Bristol-Myers Squibb's $74 billion planned purchase of Celgene puts it in line to lead the drug industry's hottest market, cancer, as early as next year. The combined company will probably overtake front-runner Roche in 2020 with about $29 billion in oncology sales. Roche has dominated the cancer market for more than 15 years, thanks to a trio of medicines that account for more than a third of its sales. Those products now face competition, both from cheaper copies and newer drugs. Generic competition is a little farther away for Celgene's best-selling cancer therapy, Revlimid: analysts expect the drug's sales won't crest until the early 2020s. Learn More

Selecta Biosciences has announced a restructuring that will see it cut its R&D workforce by 36% and rearrange priorities in its pipeline programs. The restructuring will result in the company deprioritizing its oncology pipeline and focus on its ImmTOR immune tolerance platform technology along with growing strategic partnerships. Alert readers will recall that Carsten Brunn, most recently in senior management at Bayer, joined Selecta as CEO just last month. These latest moves are expected to reduce the company's burn rate by roughly 19% going forward but that alone is not expected to be enough to address the cash flow challenges that have been reported. Learn More

CDMO Rentschler Biopharma has announced that it has completed the acquisition of a manufacturing facility from Shire. The 93,000 square foot site is located near Boston in Milford, MA. Under the terms of the agreement, Rentschler Biopharma will continue to manufacture for Shire at the site.In addition, Rentschler plans to further grow the site to be leveraged as a CDMO for the development and manufacturing of complex biopharmaceuticals. About 70 employees currently work at the Milford site, all of whom have been offered continued employment at the site. Learn More

The U.S. FDA and other parts of the federal government may be headed for a shutdown after President Donald Trump said he would not sign a Senate-passed continuing resolution (CR) to keep the government open. If a shutdown takes place, the FDA would, in addition to keeping essential public health-related employees working, continue specific activities within its user fee programs, including work on prescription drugs, generic drugs, biosimilars, medical devices, animal drugs and tobacco products, according to the Department of Health and Human Services' contingency plans. About 7,000 FDA staff, or 41%, would be furloughed if the shutdown occurs, while the remaining 10,344 would be retained, according to the plans. Learn More

Novartis has made an offer to acquire CellforCure, a French contract manufacturer that the Swiss pharma already works with on clinical production of its cancer cell therapy Kymriah. If the drugmaker's bid is accepted by LFB, the owner of CellforCure, the CDMO's manufacturing facility in Les Ulis, France would be folded into Novartis' global manufacturing network alongside cell and gene therapy plants in Morris Plains, New Jersey and Stein, Switzerland. The Swiss pharma has sought to expand its production capabilities for Kymriah, even as manufacturing difficulties have hampered rollout of the cell therapy. Its initial collaboration with CellforCure was followed by an agreement with Cellular Biomedicines in China to supply the CAR-T therapy there. Learn More

On behalf of all of us here at Aspen Brook, Happy Holidays! We will be closed now through Friday, January 4th as we spend time with family and friends. The Alert will return on Monday, January 7th.

Business Insider has published the first report on the unredacted antitrust lawsuit, brought by Attorneys General for most U.S. states, against nearly 20 generic drugmakers. The suit alleges frequent, close communications and collaborations between employees of rival companies designed to bring about increased drug prices. Common drugs had their prices doubled, tripled, or even increased 1,000% or more, costing taxpayers and patients and violating federal and state competition and consumer protection laws, the federal antitrust suit alleges. The suit has brought new scrutiny to generic drugs, which are often thought of as low-cost, and the business practices of generic drugmakers. Learn More

General Electric has filed confidentially for an initial public offering of its health-care unit, according to people familiar with the matter, moving ahead with plans to spin off its second most profitable business line. The industrial conglomerate is working with Goldman Sachs, Bank of America, Citigroup, JPMorgan Chase & Co. and Morgan Stanley on the planned listing, said the people, who asked not to be identified as the details aren't public. A public filing is likely next spring, they said. The spun-out company is expected to include the fast-growing life-sciences division, which accounts for about a quarter of GE Healthcare's sales. Learn More

GSK paved the way for a split into two companies, agreeing to create a consumer-health joint venture with Pfizer to be listed on the stock market, sending the U.K. company's shares to their biggest gains in a decade. Glaxo will have a 68 percent controlling stake in the new entity, with combined sales of $12.7 billion and led by Brian McNamara, the CEO of the U.K. pharmaceutical giant's consumer arm. The deal lets Pfizer exit a business after a yearlong sale process failed to find a buyer. The noncash transaction creates the world's biggest supplier of over-the-counter medicines with brands of painkillers such as Advil and Panadol. Learn More

Medical marijuana has stepped onto the global stage. In what appears to be a first for marijuana and a major biopharmaceutical company, a Novartis subsidiary and a Canadian producer of medical cannabis products have agreed to market them around the world. Tilray Canada announced the agreement this week with Sandoz, a unit of Swiss-based Novartis that manufactures generic and biosimilar drugs. Under the deal, whose financial terms were not disclosed, Tilray and Sandoz will work together to supply and distribute non-smokable medical cannabis products. The companies will also co-brand and develop other products together. Learn More

Sen. Elizabeth Warren (D-MA) and Rep. Jan Schakowsky (D-IL) introduced identical bills in the Senate and House this week that would create an Office of Drug Manufacturing within the Department of Health and Human Services (HHS). The office would be tasked with manufacturing generic drugs that are in shortage or where there is limited competition. Specifically, the bill would authorize the office to manufacture drugs when no company is manufacturing them, when only one or two companies are manufacturing them but the price has spiked or they are in shortage, and when there are drugs on the WHO's essential medicine list and the price is a barrier to access. Learn More

Astellas has taken an option to acquire U.S. biotech Potenza Therapeutics after the companies spent more than three years working together on cancer immunotherapies. The Japanese pharma said the acquisition marks the successful outcome of a collaboration that began in 2015 to build a portfolio of novel immuno-oncology therapies. Astellas paid $164.6 million upfront to acquire Potenza, and shareholders will be eligible for additional payments totalling up to $240.1 million, depending on how clinical development progresses. The drugs that will be added to Astellas' portfolio include phase 1 drugs SP 8374/PTZ-201, an anti-TIGIT antibody immune checkpoint inhibitor and ASP 1948/PTZ-329, an anti-NRP1 antibody inhibiting T-regulatory cells. Learn More

The Masco Group has acquired the High Purity division of MarCor, based in Burlington, Ontario, Canada. The new company, to be known as Stilmas Americas, will be the hub for selling, engineering, manufacturing and servicing Stilmas equipment in North America. The Masco Group has a presence in three continents. Its European headquarters is in Italy and it also has manufacturing and servicing operations in France and a commercial and service office in Russia. In Asia, it has an autonomous engineering and manufacturing facility in China, to serve the local market, while in North America an existing commercial and service office in Pennsylvania will be complemented by the newly acquired Canadian facility. Learn More

A MassBiologics building in Boston was evacuated as a precautionary measure late last week after two chemicals came in contact with each other, causing a hazmat situation, authorities said. Crews responding to the MassBiologics site, located at 460 Walk Hill St., around 11:30 a.m. on Friday evacuated the building as hazmat crews investigated inside according to statements by Boston fire to local news stations. As of this writing, there has been no word on the specifics of the two chemicals that came into contact and caused the incident. Thankfully there were no reported injuries. Learn More

In a recent regulatory filing Advaxis let it be known that Amgen had issued a written notice that it will withdraw from the development partnership between the two companies. Alert readers will recall that the partnership was formed back in 2016 when Amgen agreed to pay $40 million upfront and purchase $25 million worth of Advaxis stock. In recent years Amgen has paid roughly $14 million more to its partner as milestones were met. The deal had been touted as being worth upwards of $540 million when it was signed. Advaxis has seen its share price plummet in value on news of the termination of the development deal. No reason has been made public for the reason behind the move. Learn More

Mylan announced this week that the United States Patent and Trademark Office had rejected Sanofi's infringement claims relating to insulin drug Lantus. Sanofi is heavily reliant on Lantus, its leading product with sales of $5.26 billion in 2017, and Mylan's own insulin drug would be its second competitor after Eli Lilly launched its version in late 2016. Sanofi, which settled a similar case with Lilly in 2016, allowing it to launch Basaglar, sued Mylan in October 2017. Separately, Mylan's generic versions of Lantus and Lantus SoloSTAR, developed with India's Biocon, are being reviewed by the FDA. Learn More

AGTC lost nearly half its market cap this week after Biogen exited a collaboration agreement on the heels of a big clinical failure. Interim six-month data on one of AGTC's investigational therapies showed it was generally safe but ineffective at treating a rare eye disorder known as X-linked retinoschisis (XLRS). The company plans to complete patient monitoring activities on the XLRS program but will not develop it further. Alert readers will recall that AGTC first linked up with Biogen in mid-2015, taking home $124 million upfront in exchange for licenses to programs targeting XLRS and X-linked retinitis pigmentosa (XLRP). Learn More

Eli Lilly and AC Immune have agreed to jointly develop the Swiss biotech's potential treatment for Alzheimer's disease. According to the terms of the partnership, AC Immune will conduct the early-stage development of the treatment, ACI-3024, while Lilly will fund and conduct further clinical development. AC Immune will receive an upfront payment of $80 million and $50 million in exchange for a note convertible to equity at a premium. AC Immune already has such partnerships with Johnson & Johnson and Roche Holding AG. Learn More

The U.S. FDA this week finalized its questions and answers guidance on complying with data integrity requirements under current good manufacturing practice (CGMP) for drugs and biologics. The guidance updates a draft version released in 2016 and has been revised to include additional information on the agency's current thinking on data integrity to help drugmakers identify lapses and implement best practices to shore up any gaps in their data integrity processes. The FDA says the guidance was developed in response to an increase in data integrity violations observed during inspections that have resulted in warning letters, import alerts and consent decrees in recent years. Learn More

The U.S. FDA this week released two new draft Q&A guidance documents on biosimilar development and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as well as two final guidance documents on the same topics and one proposed rule amending the definition of a biological product. The efforts are part of the FDA's decade-long work to begin, starting in March 2020, transitioning the approved marketing applications for a subset of biological products, such as insulin and human growth hormone - which were previously approved as drugs under section 505 of the FD&C Act - to be deemed to be biologics licenses. Learn More

Pfizer will add about 100 new jobs in oncology research and development at its La Jolla, California site, as its Cancer Immunology Discovery unit relocates out of South San Francisco and the company eliminates 100 roles there. A recent filing with the state of California disclosed the 100 expected layoffs in South San Francisco, set to take effect on February 18th, 2019. The shift will make the La Jolla campus one of the "largest pharmaceutical research centers" in the San Diego area, according to a Pfizer spokesperson. Learn More

Boehringer Ingelheim told unions this week that it plans to cut some 300 jobs in France as part of efforts to reorganize activities around its hub in Lyon following an asset swap with Sanofi. Boehringer Ingelheim's chairman for France, Jean Scheftsik de Szolnok, has said that the company was planning to cut up to 327 jobs out of a 2,800 workforce in France. However, it will also create 32 new positions. He said the plan was to offer voluntary departure packages to avoid forced exits, but added that it was too early to give a timeframe. Alert readers will recall that Boehringer agreed in January of last year to trade its consumer health division in exchange for France's Sanofi animal health arm Merial in a $20 billion transaction. Learn More

Gilead has announced that longtime Roche veteran Daniel O'Day will assume the role of Chairman and CEO at Gilead beginning on March 1st, 2019. This comes as current Gilead CEO, John Milligan and Chairman John Martin, leave the company at the end of this year. In related news, Roche has announced the appointment of Bill Anderson, currently head of its Genentech unit, to lead its Pharma division. These changes come at a critical time for both company's as they look to navigate a rapidly evolving biopharma market full of challenges and opportunities. Learn More

As data integrity violations continue to be found in Form 483s and warning letters, the Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S) released a 52-page draft guidance outlining how an inspector should inspect facilities that must adhere to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards. The guidance, which will be open for consultation until February 28th2019, was directed by the Australian and British-led PIC/S Working Group on Data Integrity. It is meant to facilitate a harmonized approach to inspections. Learn More

Novartis CEO Vas Narasimhan says he wants to 'un-boss' the biopharma giant while relaxing the firm's rules by allowing employees to wear jeans to work. The goal we set out to do is create an 'unboss culture'. He expanded on this point noting that "For many people, they love the idea of the culture change, everybody then wants to know why can't it happen right away." The biopharma chief's move comes as he seeks to increase the company's appeal to the millennial generation. Currently, half of Novartis 120,000 employees are millennials. Learn More

Moderna raised $604.3 million in a record biotech IPO this week, selling more than 26 million shares at $23 apiece. That figure could climb even higher: Underwriters, which include Morgan Stanley, J.P. Morgan, and others have an option to buy up to an additional 3,941,398 shares, according to Moderna's IPO announcement. The IPO gives Moderna a market capitalization of more than $8 billion, which blows away the previous record for a biotech offering and represents a huge valuation for a company without much proof yet that its technology works. Learn More

Mereo BioPharma and OncoMed have agreed to merge and the transaction has been unanimously approved by the Board of Directors of each company. Based upon an OncoMed net cash balance of $38 million at completion, current Mereo shareholders are expected to own approximately 75% while current OncoMed shareholders are expected to own the remaining 25%. This deal comes amid difficulties for OncoMed that saw the company experience a series of clinical trial stumbles and the dissolution of its drug development alliances in recent years. Learn More

Famed biotech venture capitalist G. Steven Burrill is headed to federal prison after pleading guilty to defrauding his investors and falsifying tax returns. Burrill, 74, faced up to 30 years in prison and $750,000 in fines, but he will serve just 30 months and pay $200 after signing a sealed plea agreement last year. Burrill will surrender to authorities on March 4, according to court documents. According to prosecutors, the Bay Area investor siphoned more than $18 million from his fund, Burrill & Company, between 2007 and 2013. Burrill then dodged more than $4.7 million in taxes by failing to report the income, prosecutors said. Learn More

Novo Nordisk, which employs almost 1,200 manufacturing workers, will invest $22 million at its Clayton facility, creating 22 full-time jobs. The move comes just ten months after the world's leading diabetes care company unveiled plans for a $65 million expansion there. Johnston County's Board of Commissioners voted earlier today to approve a seven-year package of financial incentives for Novo Nordisk's latest investment, the company's fourth in Johnston County since 2010. Novo Nordisk's Diabetes Finished Products (DFP) manufacturing facility in Clayton is responsible for the formulation, filling, inspection, assembly and packaging of diabetes and obesity medicines. Learn More

MiMedx this week announced it is cutting 240 jobs - about one-quarter of the embattled firm's workforce - as it struggles to survive. The Georgia based company, which sells injections used in orthopedics and wound coverings to treat burn victims, has been fighting to right itself as it copes with leadership upheaval and apparent problems with the accuracy of its financial disclosures. The company plans to cut costs to match revenues, according to a statement issued by David Coles, interim chief executive officer. Learn More

Located within the government-established Zhangjiang Hi-Tech Park, Pharma Valley is where one in three medicines approved by the China National Medical Products Administration (NMPA) has been developed. This is China's Kendall Square, the epicenter of the country's biotech industry, where scaffolding sprouts like weeds. It is home to more than 500 biotech companies that have flocked to the 10-square-kilometer cluster with roughly 30 companies opening in each of the last two years. Multinational companies such as Roche and Novartis are a minute's walk away from the glossy laboratories of contract research organizations and smaller, home-grown startups. Learn More

Clovis Oncology has announced that the European Patent Office upheld the IP claims of its European Patent 2534153 associated with the drug Rubraca. The ruling provides patent protection through at least 2031 for one aspect of the drug having to do with crystalization and European regulatory exclusivity until at least 2028 for another commercial aspect. Also, Clovis has filed for supplementary protection certificate extension on this patent in various European countries, which if approved, would serve to provide extension of protection until 2033 under this patent. Learn More

GSK has announced that it will buy Tesaro, the maker of the ovarian cancer drug Zejula, for $5.1 billion in cash. The deal fits into a framework outlined in July by Hal Barron, the widely respected pharma veteran who took over as GSK's head of R&D at the beginning of the year. He believes that genetics predict Zejula will prove more effective in a larger percentage of cancer patients than biotech observers expect. He also sees value in two experimental drugs Tesaro is testing that harness the immune system to attack cancer, an area that Barron has said will be of importance to GSK. Learn More

Johnson & Johnson is planning a new push into blood cancers that builds off a gene therapy it licensed from a Hong Kong-based company that has been awash in controversy. The largest U.S. drugmaker already has two blockbuster blood-cancer drugs, Darzalex and Imbruvica, but has lagged behind Novartis and Gilead in the burgeoning market for genetic approaches. J&J kick-started its move into the space by inking a deal with Nanjing Legend Biotech, a unit of China-based GenScript Biotech Corp., a year ago. Since then, results with the compound known as LCAR-B38M have been called into question. Learn More

In 2014, Christophe Weber left GSK to take over the reins of Takeda. Right from the outset, Weber vowed to cultivate a global identity and wanted Takeda to be viewed as a global leader. Against this backdrop, the Shire acquisition makes a lot of sense. Weber looks on the addition of Shire's R&D group as a "bolt on" acquisition since Shire complements, rather than duplicates, Takeda's ongoing efforts. He backed up his words when he discussed the anticipated budget for the new organization. Takeda will spend roughly $3.5 billion on R&D in 2018 with Shire's less than half of that. Post-merger, he anticipates the R&D budget to be somewhere between $4 - $5 billion. Learn More

Pfizer has announced that it has signed a licensing agreement with AbbVie, resolving all global intellectual property matters for Pfizer's proposed adalimumab biosimilar. Under the terms of the agreements, AbbVie grants Pfizer a non-exclusive patent license for the use and sale of Pfizer's proposed adalimumab biosimilar for many countries around the world. Pfizer may launch its adalimumab biosimilar upon approval by the European Medicines Agency in Europe. In the United States, the license period will begin on November 20, 2023. All litigation pending between the parties will be withdrawn. The financial details of the agreements are confidential. Learn More

Tosoh Bioscience has announced it has completed an equity investment in Semba Biosciences with the intention of acquiring full ownership. The transaction was approved by the Board of Directors of both companies and an Equity Participation Agreement has been executed. The two companies have been collaborating on various downstream biomanufacturing projects since 2007. According to Ali Soleymannezhad, Director of Sales and Marketing at Tosoh Bioscience, "by combining Semba Biosciences' advanced Simulated Moving Bed (SMB) technology with Tosoh Bioscience's best-in-class resins, we will be able to offer the most productive and the most efficient solution in bioprocess chromatography while maintaining the highest quality". Learn More

10X Genomics has made public plans to move from its current 40,000 sq. ft. site to a new 150,000+ sq. ft. site in early 2019. The new site, located in Pleasanton, CA, will enable to company to add as many as 200 employees over the next few months. Alert readers will recall that 10x has enjoyed massive growth with earnings having increased more than 2,000 percent in the last few years. The company is noting that this expansion of its presence in California will not have an adverse effect on its ongoing operation in Germany. Learn More

Bayer AG plans to cut 12,000 jobs and exit its animal health business in an effort to mollify Wall Street, which has punished the company over the tidal wave of lawsuits that came alongside the $63 billion takeover of Monsanto Co. The German company announced a rash of moves, including exiting the sun-care and foot-care segments, that it said would boost its core pharma and agricultural businesses. The cuts, including a significant number in Germany - where layoffs are politically sensitive - represent about 10 percent of the workforce. Learn More

Samsung BioLogics this week filed an administrative suit against South Korea's financial regulator over its ruling earlier this month that the company had violated accounting regulations by intentionally inflating its profits ahead of its market listing in 2016. The biopharmaceuticals manufacturer under Samsung Group said that it was also seeking a court injunction to nullify the penalties imposed by the Financial Services Commission, including recommendations to dismiss its chief executive and chief financial officer. Learn More

China's government has ordered a halt to work by a medical team that claimed to have helped make the world's first gene-edited babies, as a group of leading scientists declared that it's still too soon to try to make permanent changes to DNA that can be inherited by future generations. Chinese Vice Minister of Science and Technology Xu Nanping told state broadcaster CCTV that his ministry is strongly opposed to the efforts that reportedly produced twin girls born earlier this month. Xu called the team's actions illegal and unacceptable and said an investigation had been ordered, but made no mention of specific actions taken. Learn More

Novartis has announced that it is moving its HQ in the United Kingdom from Surrey to White City in West London. The new HQ, consisting of roughly 54,000 sq. ft of space on the second floor of the WestWorks building, is part of the White City Place development that was formerly the BBC Media Village. Around 600 Novartis staffers are expected to relocate to the new site y January 2020. Novartis joins fellow life sciences companies Autolus and Synthace at the site, which is close to the new Imperial College campus. Learn More

China is approving foreign drugs at a record pace, opening the door to its lucrative market for the world's leading pharmaceutical companies, while also extracting big discounts. Regulators have greenlighted dozens of outside drugs for use in China over the past 21 months, some within a few weeks. The approvals follow a series of policy moves by China to provide its 1.4 billion people access to new, lifesaving drugs, especially those that treat cancer. Learn More

In 2010, a Rice University graduate student named He Jiankui published a paper describing the nitty-gritty details of a then-arcane bacterial immune system called CRISPR. It was well before scientists unlocked the knowledge that CRISPR could be used to manipulate DNA with a precision and ease that other genome editors lacked. Now, just eight years later, and after returning to his native China, He has burst onto the global stage in the most spectacular way. Using YouTube rather than an academic journal, He claimed that with the aid of CRISPR, he had helped create the world's first babies - twin girls born a few weeks ago - whose genomes had been edited as embryos. Learn More

The U.S. FDA this week approved an advanced cancer treatment drug that combats solid tumors caused by a rare genetic mutation.The drug will be sold under the brand name Vitrakvi in a partnership between US-based pharmaceutical company Loxo Oncology and Germany's Bayer. According to the FDA, there had been no treatment for cancers with the TRK gene mutation until this week. The approval reflects a development in cancer treatment drugs away from body location-specific medicine to treatments based on genetic defects and mutations. Learn More

The U.S. FDA has approved Pfizer's Daurismo for patients with acute myeloid leukemia (AML) who are over 75 or who can't take intensive chemotherapy, a particularly hard-to-treat population. The approval of once-daily oral Daurismo with low-dose chemotherapy is based on the results of a Phase 2 trial. Data showed the Daurismo combination nearly doubled median overall survival, at 8.3 months, compared with chemotherapy alone, at 4.3 months. Approval for Daurismo adds another option for a cancer type that until recently had few treatment choices, and extends a streak of recent OK's Pfizer's secured for its cancer drug portfolio. Learn More

BASF has unveiled a company-wide reorganization that will involve moving its 11 business units into six divisions. The company will also simplify structures and processes, sharpen its portfolio, and better align its businesses to its customers. As part of its restructuring, the firm aims to enhance efficiencies in production, logistics, and R&D. This will include moving some of the firm's centralized R&D activities into business units. Other planned changes include the wider use of digitization and automation. The restructuring will impact about 20,000 of the firm's 115,000 employees, but BASF will not necessarily cut jobs, according to reports. Learn More

J&J suffered a serious setback in court last week when the U.S. Court of Appeals for the Federal Circuit declined the biopharma giants request for a temporary restraining order. The order was being sought in an effort to prevent Mylan and others from bringing to market a generic version of J&J's blockbuster prostate cancer drug Zytiga while it sought emergency relief from the U.S. Supreme Court. Alert readers will recall that the composition patent for Zytiga expired back in 2016. However, with sales of the drug topping $527 million in Q3 alone J&J is expected to examine every possible legal remedy to protect Zytiga from generic competition. Learn More

Rentschler Fill Solutions, a contract development and manufacturing organization (CDMO), has officially inaugurated its new state-of-the-art facility in Rankweil, Austria. In August, the company obtained the certificate of GMP compliance and the pharmaceutical manufacturing license for the European market from the Austrian Agency for Health and Food Safety. From the laying of the first stone of the foundation in July 2016 to completion of the GMP approval in August 2018, the new facility was completed in the record time of two years. Learn More

Sun Pharma has made public plans to combine its manufacturing operations currently located in the New Jersey cities of New Brunswick and Cranbury, potentially costing nearly 100 workers their jobs. According to a federal WARN notice, the consolidation will put 96 positions at risk of elimination at the Cranbury facility. Jobs slated for layoffs at various times in 2019 include operators, chemists, mechanics and others. "As part of this process, the operations at Cranbury, including inventory, products, manufacturing and lab equipment, are being transferred to New Brunswick" says a Sun Pharma spokesperson. Learn More

The Trump administration has accused the Chinese government of "unfairly" using venture capital to acquire cutting-edge technologies being developed in the United States, including biotechnology and artificial intelligence. In a report released this week, the U.S. trade representative said China had doubled down on its "unreasonable actions" since an investigation in March that alleged China is stealing American trade secrets and tilting the playing field in its favor with suspect licensing and investment practices. Learn More

The U.S. FDA has made official its concerns with Mylan's handling of operations at its largest manufacturing plant, issuing a sharply critical warning letter earlier this month that lays out a series of missteps and oversights at the Morgantown, West Virginia facility. The letter doesn't come as a surprise, however. Following an FDA inspection of the site in April 2018, Mylan began a major restructuring and corrective program that's so far cost more than $100 million. Still, the warning is notable, both in its findings and because it marks the first time the plant has fallen afoul of the FDA since Mylan established it in Morgantown 52 years ago. Learn More

A 99-year lease was supposed to be the key to creating a $1.2 billion biotech village here, bringing thousands of jobs and millions in tax revenue. It was never signed. Westchester County lawmakers approved a deal in April 2017 with Fareri Associates to develop county land called the "North 60" on the Grasslands Reservation, near Westchester Medical Center and New York Medical College. But the project faces an uncertain future after a shakeup in county government and a pitch by the developer to add rental apartments to the plans. Learn More

Cambrex has entered into an agreement to acquire Avista Pharma Solutions for $252 million. The East Rutherford-based maker of pharmaceutical ingredients said the deal will allow it to enter the early stage small molecule development and testing services market. Avista, a contract development, manufacturing and testing company, is a portfolio company of Ampersand Capital Partners, a health care-based private equity firm. It offers API and drug product development as well as CGMP manufacturing, microbiology testing and solid state sciences. The deal is expected to close in the fourth quarter of 2018. Learn More

The latest clinical results for Pfizer and Merck KGaA's cancer drug Bavencio won't help the companies make up ground in immuno-oncology, showing the checkpoint inhibitor failed to beat out chemotherapy in tough-to-treat forms of ovarian cancer. In the study, called JAVELIN Ovarian 200, Bavencio as a monotherapy and in combination with chemo was compared to chemo alone in patients with platinum-resistant or refractory disease. Topline results released by the companies, however, showed neither Bavencio regimen met the trial's overall survival or progression-free survival goals. Learn More

Seven African-American women who work at the Charles River Labs facility in Charleston, S.C., have filed a lawsuit in the U.S. District Court in South Carolina alleging that the CRO ignored "several discrimination, harassment and retaliation complaints" that had been made by the women over the course of three years. According to the complaint, a white male supervisor made racist comments about black people, denied the women promotions and transfers and also threw furniture. Additionally, the lawsuit alleges that Charles River Laboratories failed to keep the complaints confidential and that people who reported incidents of his behavior faced retaliation. Learn More

Vaccine maker Seqirus, a business unit of CSL, has broken ground on a $140 million expansion of its manufacturing site in Holly Springs, North Carolina. The Holly Springs plant, at 475 Green Oaks Parkway, has already jumped from producing 3 million doses of vaccine a few years ago to more than 20 million this year. The expansion will double that output to 40 million doses annually when it is completed in 2020. According to CSL CEO Paul Perreault, the company plans to make Holly Springs synonymous with flu vaccines. "We're really looking to expand the facility and really make it the place to supply influenza vaccines to the United States and to other spots around the globe," Perreault said. Learn More

CASI Pharmaceuticals has announced that it has entered into a framework agreements to build a state-of-the-art manufacturing site strategically located in the Wuxi Huishan Economic Development Zone in Jiangsu Province, China. The facility will be designed and constructed based on global cGMP requirements and is expected to have capacity for large-scale production. The facility will be a key asset supporting CASI's growth and commercialization plans with further agreements to be finalized and site construction to begin in mid-2019. Learn More

Roche's Genentech is to build on its existing partnership with T cell receptor (TCR) specialists Immunocore, and this time around the companies take aim at a certain protein type found in many solid tumors. That protein is known as MAGE-A4 and Immunocore's bispecific redirection candidate, IMC-C103C, specifically targets this. Under the terms of the deal, Immunocore will receive $100m in upfront and near-term milestone payments from Genentech. However, both companies will co-develop the candidate, but Immunocore will lead the first clinical trial, assessing safety and preliminary efficacy of IMC-C103C as both a monotherapy and in combination with Roche's Tecentriq. Learn More

The FDA approved a label expansion for Adcetris less than two weeks after Seattle Genetics submitted the sBLA. The agency said Adcetris is the first U.S.-approved treatment for newly diagnosed peripheral T-cell lymphoma (PTCL), and the second drug approved through FDA's Real-Time Oncology Review (RTOR) program. The RTOR pilot program allows the FDA to access key data and begin reviewing supplemental indications of approved cancer drugs before a sponsor's official submission. The agency's first approval via RTOR, a label expansion for Kisqali ribociclib from Novartis, took less than three weeks. In time, FDA intends to roll out the program to NDAs and BLAs. Learn More

Lilly is understood to be considering the sale of a portfolio of off-patent drugs in China as the leading biopharma seeks to raise cash amid a push into higher-growth products. According to reports, Lilly is working with advisers to gauge interest in a selection of older drugs for antibiotics and central nervous system diseases in China. The portfolio being discussed could be worth as much as $200 to $300 million to the right buyer. This comes amid ongoing efforts by the company to refocus its business on high growth areas such as oncology, moving away from markets seen as mature or lacking significant upside. Learn More

Sartorius Stedim and Lonza have announced that they have modified their current agreement for supply of cell culture media by mutual accord. The agreement, signed in 2012, gave Sartorius exclusive sales and marketing rights for certain cell culture media and buffers developed and manufactured by Lonza for use in biopharmaceutical manufacturing processes. Lonza retained sales for research-based products, among others. Under the modified agreement Sartorius will continue to offer current and future Lonza media and buffers on a non-exclusive basis and Lonza resumes sales and marketing of all its media products for both manufacturing and research. Learn More

United Therapeutics will pay up to $1.2 billion for exclusive, worldwide rights to a late-stage candidate for pulmonary arterial hypertension (PAH) from Arena Pharmaceuticals, the two companies announced this week. The deal doubles down on United's investment in PAH drugs. Terms hold that the company will pay $800 million upfront, as well as $250 million more if Arena's therapy, called ralinepag, receives a PAH approval in the U.S. and $150 million for any indication approval in Japan or a range of European countries. Arena will also receive royalties on future sales in the low double-digits. Learn More

Novartis is "completely committed" to its $10 billion-per-year Sandoz generics business, a spokesman said this week, after a newspaper reported Chief Executive Vas Narasimhan planned to split the unit off. "We're completely committed to the Sandoz business..." Novartis spokesman Sreejit Mohan told reporters. Earlier, Swiss newspaper Tages-Anzeiger reported the Basel-based drugmaker was preparing to split off Sandoz, citing an employee representative as well as participants in a Novartis investor event last week in London. According to the newspaper, Narasimhan outlined plans for the generics business to become an independent unit for which Novartis was reviewing "all strategic options". Learn More

Catalent Pharma Solutions has announced its plans to invest $2.5 million in a new, second clinical supply facility in Shanghai, China, due to open in early 2019. When completed, the facility is expected to employ 100 people and will double Catalent's total clinical storage capacity in China. The new 30,000 square-feet facility in Tangzhen, a district of Shanghai, will have three temperature-controlled rooms and will also offer returns and destruction services. Catalent will offer its FastChain® demand-led supply services from the new facility, as well as from the existing FTZ site. Learn More

Pfizer has announced the U.S. launch of its third biosimilar product, creating a new market threat to Amgen's Epogen and Johnson & Johnson's Procrit. Retacrit, a copycat of both Epogen and Procrit, gained U.S. FDA approval in May with initial shipments of the drug having went out to U.S. wholesalers earlier this week according to Pfizer. The leading biopharma has priced its drug at 57% lower than Procrit and 33% lower than Epogen. This is expected to result in a reduction in sell price for both branded biologics as they look to maintain market share that amounted to roughly $1B in sales each last year. Learn More

Allergan's patents on its blockbuster eye drug Restasis are invalid, a U.S. appeals court ruled this week. Without issuing a formal opinion, the U.S. Court of Appeals for the Federal Circuit in Washington affirmed a trial court decision that the patents are invalid, in a victory for Teva, Akorn and Mylan. The court ruling came a week after it heard arguments on the case. Allergan had been counting on the patents to block generic competition until 2024; all other patents on the drug have since expired. Restasis brought in $1.5 billion last year, or 9.2 percent of the company's revenue. It's the second-biggest money-maker behind the wrinkle treatment Botox. Learn More

South Korea's Financial Services Commission has ruled that Samsung Biologics "intentionally" violated accounting rules in 2015, a year ahead of its IPO. For its part, Samsung BioLogics has denied wrongdoing, citing an agreement with its U.S. partner as the reason for valuing its stake in Samsung Bioepis at fair market value rather than at book value. As a result of the ruling, trading of the company's stock has been suspended indefinitely while authorities decide whether to delist the firm. The regulator has also imposed a $7 million fine and advised the company to dismiss its current chief executive. However, Samsung has made clear that it intends to fight the ruling in court. Learn More

Samsung's long-term growth strategy will come under scrutiny today when South Korean regulators review allegations of accounting fraud at the group's biotech arm, its vehicle for expansion beyond the mobile and semiconductor sectors. Shares in Samsung BioLogics, the world's third-largest contract drugmaker by market share, have fallen 40% over the last month amid concerns that authorities could delist the company following an investigation into claims that it violated accounting rules three years ago. Learn More

General Electric CEO Larry Culp's latest comments to CNBC about GE Healthcare could indicate that an "outright sale" is among the options under consideration, according to a leading industry analyst. Culp called GE Healthcare a "tremendous" franchise, which has "flexibility" in terms of the planned spinoff. "We could preserve our tax-free spin status while selling up to 49.9 percent," Culp told CNBC's David Faber this week. This has led at least one leading analyst to speculate that Danaher would "love" to own the life science business of GE Healthcare. All of this speculation comes as GE Healthcare CEO Kieran Murphy has made public plans to have the business unit become independent by the end of 2019. Learn More

AstraZeneca has taken another step to refocus on priority drugs by selling U.S. rights to a treatment for infant lung infections to Sobi for an upfront fee of $1.5 billion, $1 billion in cash and $500 million in Sobi shares. Around 130 AstraZeneca staff will transfer to Sobi as the Swedish company takes over marketing of the treatment Synagis in the United States. The move is a significant commercial boost for rare diseases specialist Sobi, giving it a substantially increased U.S. footprint and expanding its business in immunology. Learn More

Samsung's long-term growth strategy will come under scrutiny today when South Korean regulators review allegations of accounting fraud at the group's biotech arm, its vehicle for expansion beyond the mobile and semiconductor sectors. Shares in Samsung BioLogics, the world's third-largest contract drugmaker by market share, have fallen 40% over the last month amid concerns that authorities could delist the company following an investigation into claims that it violated accounting rules three years ago. Learn More

General Electric CEO Larry Culp's latest comments to CNBC about GE Healthcare could indicate that an "outright sale" is among the options under consideration, according to a leading industry analyst. Culp called GE Healthcare a "tremendous" franchise, which has "flexibility" in terms of the planned spinoff. "We could preserve our tax-free spin status while selling up to 49.9 percent," Culp told CNBC's David Faber this week. This has led at least one leading analyst to speculate that Danaher would "love" to own the life science business of GE Healthcare. All of this speculation comes as GE Healthcare CEO Kieran Murphy has made public plans to have the business unit become independent by the end of 2019. Learn More

AstraZeneca has taken another step to refocus on priority drugs by selling U.S. rights to a treatment for infant lung infections to Sobi for an upfront fee of $1.5 billion, $1 billion in cash and $500 million in Sobi shares. Around 130 AstraZeneca staff will transfer to Sobi as the Swedish company takes over marketing of the treatment Synagis in the United States. The move is a significant commercial boost for rare diseases specialist Sobi, giving it a substantially increased U.S. footprint and expanding its business in immunology. Learn More

Incyte has won a lawsuit alleging that a high-ranking scientist stole company secrets and shared them with Silicon Valley startup Flexus, but will not receive any damages. A jury found that while Flexus Biosciences had in fact "misappropriated" an Incyte trade secret, it hadn't been "unjustly enriched" as a result. For its part Flexys noted in its defense that the trade secret in question was relatively simple to discover. Alert readers will recall that Flexus developed an immunotherapy cancer drug and was sold to Bristol Myers Squibb for $1.25 Billion. Incyte said in a statement that they will consider appealing. Learn More

Abzena CEO Dr. Jonathan Goldman has announced that the biotech has augmented its existing 500L scale biologics equipment with a $20 Million investment into two new manufacturing suites at 500 L and 2000 L scale in a new GMP facility in San Diego, which will be equipped with Sartorius single use bioreactors. Abzena's existing focus on cell line development is strengthened with a new ambr 15 automated high throughput bioreactor in Cambridge, UK, and existing synthetic chemistry capacity is increased with build out of a fully equipped multifume hood laboratory in Pennsylvania. Learn More

AMAL Therapeutics, a Swiss biotech developing peptide-based therapeutic cancer vaccines, has announced that it has received $32M in follow-on funding co-lead by Boehringer Ingelheim. The Company will use the funds to progress its lead vaccine (ATP128) toward clinical development and proof-of-concept in colorectal cancer. The clinical trial is expected to start in Summer of 2019. In addition, AMAL will further develop its proprietary technology KISIMA®, a unique self-adjuvanting protein-based immunisation platform capable of producing single therapeutic vaccines for immunotherapy and beyond. Learn More

EU antitrust regulators are set to approve Japanese drugmaker Takeda Pharmaceutical's $62 Billion offer for Shire on condition that Shire sells a drug it has in development. Last month, Takeda offered to divest Shire's pipeline compound SHP647 along with some associated rights after the European Commission voiced concerns about the overlap with its own drug for inflammatory bowel disease called Entyvio. Entyvio, a treatment for Crohn's disease and ulcerative colitis, is Takeda's biggest-selling drug. The deal is expected to be the biggest overseas acquisition by a Japanese company to date. Learn More

Last month, former Genentech employees were charged with conspiring to steal trade secrets to assist biosimilar developer JHL Biotech in developing its products. Last week, Genentech filed a motion in the United States district court for the Northern District of California, seeking an injunction to block JHL from making and selling potential biosimilars. Genentech says that the biosimilar company benefited from its proprietary information. A hearing is scheduled for December 13, 2018. The company will request that the court block JHL from "making, testing, using, promoting, offering to sell, marketing, commercializing, or selling biologics, therapeutics, drugs, and/or products of any kind that utilize, embody, or were developed, in whole or in part, with the benefit or use of any of Genentech's trade secret information." Learn More

Harvard University has announced that the Blavatnik Family Foundation has committed $200 million to Harvard Medical School. The commitment-the largest in the School's 236-year history-supports several key school priorities. These include deepening fundamental discovery; accelerating the development of new treatments; spurring applications of data science toward the comprehension, diagnosis, treatment and cure of disease; recruiting data scientists, computational biologists, bioengineers and other experts; and catalyzing collaborative discovery across the broader Harvard life sciences ecosystem. Learn More