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Court rejects attempt to block Bayer/Monsanto deal; Sanofi faces epilepsy suit

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Court rejects attempt to block Bayer/Monsanto deal; Sanofi faces epilepsy suit

* Bayer AG is a step closer to clinching a deal to buy Monsanto SA after a U.S. court threw out a Monsanto shareholders' lawsuit to block the acquisition, German paper Handelsblatt wrote. An investor alleged that Monsanto shares should be worth more than the $128 a share offer from Bayer and that Monsanto's board of directors breached its fiduciary responsibility to shareholders by accepting the offer.

Meanwhile, Bayer and Versant Ventures are jointly launching BlueRock Therapeutics, a regenerative medicine company that plans to develop induced pluripotent stem cell therapies for certain diseases. Bayer and Versant are investing $225 million in the biotech company.

* Alleged victims of Sanofi epilepsy drug Depakine have taken the first step in a class-action lawsuit against the French company, Le Figaro reported. The head of victims' group Apesac was quoted as saying that it had written to the company asking it to acknowledge its responsibility for the neurological problems allegedly suffered by the children of pregnant women who took the drug and to compensate them. France earlier this year set up a fund to meet compensation claims from victims of the medicine. Sanofi was quoted by Reuters as saying in October that it would accept any blame attributed by a court over the harmful effects of the treatment and had at that point made no financial provisions for compensating victims.

* The U.S. Supreme Court yesterday declined to hear an appeal from Canadian drugmaker Apotex Inc. in its legal battle against Amgen Inc. over whether all biosimilar manufacturers must wait 180 days after FDA approval before the companies can put their products on the U.S. market. Apotex was seeking approval to market a version of Amgen's Neulasta, a leukocyte growth factor used to treat the depletion of white blood cells caused by cancer.

* U.S. President-elect Donald Trump is considering appointing former FDA Deputy Commissioner Scott Gottlieb head of the agency, insiders told Reuters. Gottlieb is said to likely be favored over Jim O'Neill, an early Trump supporter who was also reportedly being considered for the role.

M&A and capital markets

* Zhejiang Hisoar Pharmaceutical Co. Ltd. struck a deal with Zhejiang Ruyi Industry to sell its entire stake in Jiangsu Haikuo Biopharmaceutical for 123 million Chinese yuan, according to China Securities Journal.

* Walvax Biotechnology Co. Ltd. reached a framework agreement with Shanghai Hengjiang Biotechnology to transfer its intellectual property of four independently developed typhoid fever and paratyphoid fever vaccines for at least 65 million yuan, China Securities Journal wrote.

Drug and product pipeline

* The U.S. FDA approved Eli Lilly & Co. and Boehringer Ingelheim's Synjardy XR for adults with type 2 diabetes.

* Achaogen Inc.'s plazomicin achieved U.S. FDA primary endpoints to treat complicated urinary tract infections and acute kidney infections. Plazomicin also performed well in the phase 3 trial in patients with serious infections due to carbapenem-resistant enterobacteriaceae, an antibiotic resistant bacteria.

* Takeda Pharmaceutical Co. Ltd. reported clinical benefits in using Entyvio for treating moderate to severely active Crohn's disease. Tests showed higher rates of response in patients with the inflammatory bowel disease who took Entyvio as a first-line biologic after failure of conventional therapy.

* BioMarin Pharmaceutical Inc. initiated a phase 3 study of vosoritide in children with achondroplasia, the most common form of dwarfism. BioMarin is also planning a separate phase 2 study evaluating the effect of vosoritide in infants and toddlers.

* Endo International PLC said Par Pharmaceutical started shipping ezetimibe tablets, the generic version of Merck & Co. Inc.'s Zetia, which is intended to lower cholesterol levels in patients with hyperlipidemia.

* Flexion Therapeutics submitted a new drug application to the U.S. FDA for Zilretta, which is being evaluated to treat patients with osteoarthritis of the knee. Zilretta has received fast track designation from the FDA.

* Health Canada approved Emergent BioSolutions Inc.'s new drug submission for botulism antitoxin heptavalent, or BAT.

* The U.S. FDA approved Shilpa Medicare Ltd.'s capecitabine tablets as a bioequivalent of Roche Holding's Xeloda tablets, which is indicated for the treatment of certain cancers.

* YiChang HEC ChangJiang Pharmaceutical Co. Ltd. said the China FDA approved the phase 2/3 clinical trial of yimitasvir phosphate, which is jointly developed with Sunshine Lake Pharma Co. Ltd. for the treatment of hepatitis C virus.

* Zealand Pharma A/S initiated the phase 2a trial of dasiglucagon for the potential treatment of type 1 diabetes.

* Japan Tobacco Inc. won manufacturing and marketing approval in Japan for anti-HIV drug Descovy, a fixed-dose combination containing tenofovir alafenamide, or TAF, and Emtriva. TAF was developed by Gilead Sciences Inc.

* Humanwell Healthcare (Group) Co. Ltd. secured approvals for clinical trials of WXFL 10040340 capsules, a poly adenosine diphosphate ribose polymerase inhibitor, from the China FDA, according to Shanghai Securities News. PARP inhibitor is used for the treatment of malignant solid tumors such as breast cancer and lung cancer.

* Jiangxi Boya Bio-Pharmaceutical Co. Ltd. secured approval from the China FDA for clinical trials of human prothrombin complex for the treatment of hemophilia B, Shanghai Securities News said. The company will launch the phase 3 clinical trials of the drug.

Operational activity

* CSPC Pharmaceutical Group Ltd. said unit CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co. Ltd. entered into an agreement with Casper Pharma Ltd. in relation to the product licensing and commercialization of a complex generic oncology drug in the U.S.

* MacroGenics Inc. and Synthon Biopharmaceuticals BV entered a license and collaboration agreement for the development of MGC018, an antibody-drug conjugate directed against certain solid tumors.

* Alexion Pharmaceuticals appointed David Brennan and David Anderson interim CEO and CFO, respectively. Brennan succeeds David Hallal, who left the company for personal reasons, while Anderson replaces Vikas Sinha, who resigned as CFO to pursue other opportunities.

* Cempra Inc. appointed board member David Zaccardelli acting CEO, following the retirement of CEO and President Prabhavathi Fernandes, effective Dec. 12.

* Alphatec Holdings Inc. named Terry Rich CEO, effective Dec. 10. Rich succeeds Leslie Cross, who has served as interim CEO since September 2016.

* Calithera BioSciences Inc. said William Waddill resigned as CFO and senior vice president, with effect on or about Dec. 31. Following Waddill's departure, Susan Molineaux will become the company's principal financial officer, while Stephanie Wong will become the company's principal accounting officer.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.