November 16, 2018
Takeda Pharmaceutical Company plans to hold a shareholder meeting on December 5 to vote on matters relating to its proposed $62-billion acquisition of Shire. Takeda and Shire came to terms for a proposed acquisition of Shire by Takeda in May 2018. The companies received US clearance in July and are awaiting European Union approval.  Read More
AstraZeneca has agreed to sell its US rights to Synagis (palivizumab), a drug for preventing lower respiratory tract infection caused by respiratory syncytial virus, for $1.5 billion to Swedish Orphan Biovitrum (Sobi), a Stockholm, Sweden-headquartered specialty healthcare company.   Read More
Allergan has decided not to pursue a $200-million expansion, first announced in 2016, at its manufacturing plant in Waco, Texas, which produces the company’s eye-care products, including Restasis (cyclosporine ophthalmic emulsion), a dry-eye drug with 2017 global sales of $1.47 billion. Allergan faces generic competition for the drug due to expected loss of exclusivity in 2018. As a result, the company has shifted its priority from expanding the Waco site to investing to improve efficiencies across its global manufacturing sites, including Waco. Read More
Moderna Therapeutics, a biotechnology company focusing on messenger RNA (mRNA) therapeutics, has filed a registration statement for an initial public offering (IPO) with the US Securities and Exchange Commission with a target of raising $500 million. mRNA therapeutics are a new class of medicines that directs the body’s cells to produce intracellular or secreted proteins that can have a therapeutic or preventive benefit.  Read More
Sandoz, the generics arm of Novartis, is voluntarily recalling in the US one lot of losartan potassium hydrochlorothiazide tablets, an anti-hypertension drug, to the consumer level. The product is being recalled due to a trace amount of an impurity found in the lorsartan active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceutical Co., a Linhai, China-based pharmaceutical company. The impurity, N-nitrosodiethylamine , has been classified as a probable human carcinogen. This is the third “sartan” API marketed in the US to be investigated for API impurities.  Read More
The FDA plans to take new steps to modernize its inspections program with a new way of assessing, recording, and reporting the data from surveillance and pre-approval inspections for sterile drug products.
A roundup of the latest news from suppliers, CDMOs and CMOs, featuring Catalent Pharma Solutions, MilliporeSigma, Metrics Contract Services, Samsung Biologics, PMI BioPharma Solutions, and Science Exchange. Read More
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