The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
Lupin, a Mumbai, India-headquartered pharmaceutical company, has received 22 observations from the US Food and Drug Administration (FDA) across its three facilities in Mandideep, India, which Lupin says are “largely procedural in nature.” Lupin’s...
Janssen Pharmaceuticals, one of the pharmaceutical companies of Johnson & Johnson, and argenx, a clinical-stage biotechnology company developing differentiated antibody-based therapies for treating severe autoimmune diseases and cancer, have...
Following an announced $65-million investment in February (2018), Novo Nordisk plans to invest an additional $22 million in its finished-products manufacturing plant in Clayton, Johnston County, North Carolina. This is the company’s fourth...
Following December 5th shareholder meetings, Takeda Pharmaceutical and Shire announced that their respective shareholders have voted in favor of Takeda’s pending $62-billion acquisition of Shire. The deal is now subject to approval of a court in...
Following a previously announced strategic review, GlaxoSmithKline (GSK) has agreed to sell the Horlicks brand, its malted milk drink, and its other consumer healthcare nutrition brands to Unilever, a London, UK-based consumer goods company. As...
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...
