November 30, 2018
Bayer has announced staff reductions of approximately 10% of its global workforce, or 12,000 employees, across all of its business by the end of 2021. Approximately half of these cuts are in corporate functions, supporting functions, and business services, one-third in its crop-protection business, and about 10% in its pharmaceutical business. The restructuring follows the company’s $63-billion acquisition of Monsanto, an agrochemical and seed company, earlier this year.  Read More
Takeda Pharmaceutical Company has received clearance from the European Commission for its proposed $62-billion acquisition of Shire. Takeda and Shire received clearance from the US Federal Trade Commission for the proposed acquisition in July 2018. Takeda and Shire came to terms for a proposed acquisition of Shire by Takeda in May.  Read More
The FDA has approved Truxima (rituximab-abbs), a biosimilar of Roche’s Rituxan (rituximab), a drug to treat certain cancers and autoimmune diseases, from Teva Pharmaceutical Industries and Celltrion, an Incheon, South Korea-based pharmaceutical company. Rituxan had 2017 global sales of CHF 7.3 billion ($7.8 billion). Truxima is the first US-approved biosimilar to Rituxan. Read More
Mylan and Teva Pharmaceutical Industries have issued separate voluntary recalls to the consumer level of select lots of valsartan-containing products due to detected trace amounts of a probable human carcinogen, N-nitrosodiethylamine (NDEA), contained in the active pharmaceutical ingredient. Mylan announced its recall November 20 after NDEA was found in its valsartan manufactured at one of its plants in India. Teva announced its recall one week later when it detected NDEA in the valsartan supply it received from Mylan’s India plant.  Read More
Cambrex, a CMO of small-molecule active pharmaceutical ingredients and drug products, has agreed to acquire Avista Pharma Solutions, a contract testing, development, and manufacturing organization, for approximately $252 million. The acquisition positions Cambrex in the market for early-stage small-molecule development and testing services. Read More
The FDA has issued a Warning Letter to Mylan for its manufacturing plant in Morgantown, West Virginia for cGMP violations of finished pharmaceuticals. The company was cited for several quality-control issues, cleaning practices, investigations into out-of-specification results and variations, and change-management practices. Read More
Sun Pharmaceutical Industries, a Mumbai, India-headquartered pharmaceutical company, has agreed to acquire Pola Pharma, a Tokyo, Japan-based pharmaceutical company, for approximately $1 million. With the acquisition, Sun Pharma gains two manufacturing facilities and Pola’s drug portfolio, which consists primarily of dermatological drugs. Read More
In a move to advance digital health technologies, the FDA has issued a Federal Register notice to seek early input from the public on the agency’s proposed framework for prescription drug-use-related software, which is software disseminated by or on behalf of a sponsor that accompanies one or more of the sponsor’s prescription drugs or biologics. Read More
Fresenius Kabi, a specialty and generic pharmaceuticals company, is voluntarily recalling 163 lots of sodium chloride injection products to the consumer level due to natural rubber latex found in the vial stoppers. Read More
The FDA has approved a second cancer treatment based on a biomarker, rather than tumor location. Plus, a roundup of approvals of new molecular entities (NMEs) by the FDA from November 20 to November 28, featuring Pfizer, Astellas Pharma, Sobi, Novimmune, and Catalyst Pharma. Read More
A roundup of the latest news from suppliers, CDMOs and CMOs, featuring Lonza, CordenPharma, Catalent, WuXi Biologics, PCI Pharma Services, Kingchem, Rentschler, and Piramal. Read More
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Top Industry News is published and distributed by the Drug, Chemical & Associated Technologies Association (DCAT). The DCAT organization recognizes its members have minimal time to keep up with the continuous flow of news covering this dynamic industry. To help ensure our members never miss the most important stories impacting the global pharmaceutical manufacturing industry, we will deliver each Friday, the week's Top Industry News, as selected by DCAT Editorial Director Patricia Van Arnum. For more information, visit .