The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
GlaxoSmithKline (GSK) plans to acquire Tesaro, a Waltham, Massachusetts-based oncology-focused biopharmaceutical company, for approximately $5.1 billion to accelerate the build of GSK’s pipeline and commercial capability in oncology.
Tesaro is a...
The US Food and Drug Administration (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,...
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...
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 by the FDA from November 20 to November 28, 2018 featuring Teva Pharmaceutical Industries,...
Mylan and Teva Pharmaceutical Industries have issued a voluntary recall to the consumer level of select lots of valsartan-containing products due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA) contained in the active...
The US Food and Drug Administration (FDA) has issued a Warning Letter to Mylan for its manufacturing plant in Morgantown, West Virginia for cGMP violations for finished pharmaceuticals following an inspection from March 19, 2018, to April 12, 2018....
Fresenius Kabi, a specialty and generic pharmaceuticals company, is voluntarily recalling 163 lots of sodium chloride injection (USP, 0.9%, 10 mL) and sodium chloride injection (USP, 0.9%, 20 mL) to the consumer level due to natural rubber latex...
CASI Pharmaceuticals, a Rockville, Maryland-headquartered biopharmaceutical company, has entered into framework agreements to build a manufacturing site located in Jiangsu Province, China. The company has a wholly owned subsidiary and research and...
Seqirus, a subsidiary of CSL Limited and developer and manufacturer of influenza vaccines, is planning a $140-million expansion of its manufacturing facility in Holly Springs, North Carolina, as part of a plan to meet demand for Seqirus' cell-based...
Cambrex, a contract manufacturing organization of small-molecule active pharmaceutical ingredients (APIs) and drug products, has agreed to acquire Avista Pharma Solutions, a Durham, North Carolina-headquartered contract testing, development, and...
Sun Pharmaceutical Industries, a Mumbai, India-headquartered pharmaceutical company, has agreed to acquire Pola Pharma, a Tokyo, Japan-based pharmaceutical company focused on the research and development, manufacture, sale, and distribution of...
In a move to advance digital health technologies, the US Food and Drug Administration (FDA) has issued a Federal Register notice, “Prescription Drug-Use-Related Software” to seek early input from the public on the agency’s proposed framework for...
Takeda Pharmaceutical Company has received clearance from the European Commission (EC) 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...
Allergan has decided not to pursue a $200-million expansion, first announced in 2016, at its manufacturing plant in Waco, Texas. Allergan had announced in 2016 plans to expand the Waco facility, which produces the company’s eye-care products,...
Moderna Therapeutics, a Cambridge, Massachusetts-based biotechnology company focusing on messenger RNA (mRNA) therapeutics, has filed a registration statement for an initial public offering with the US Securities and Exchange Commission with a...
