The latest developments from pharmaceutical and biopharmaceutical companies, both innovator and generic-drug companies, and leading regulatory news.
US Health and Human Services (HHS) Secretary Alex Azar has announced a final rule from the Centers for Medicare & Medicaid Services (CMS) that will require direct-to-consumer television advertisements for prescription pharmaceuticals covered by...
Takeda Pharmaceutical has opened a new 165,000-square-foot research facility in San Diego, California. The facility houses more 250 employees focused on specialized drug-discovery technologies and discovery research in gastroenterology and...
Merck & Co. plans to invest up to $1 billion in stages over the next three years to expand its manufacturing operation by adding 120,000 square feet to its existing 1.1-million-square-foot operation in Elkton, Virginia to increase production of...
In another industry recall of “sartan”-containing products, Teva Pharmaceuticals USA has initiated a voluntary recall of 35 lots of bulk losartan potassium USP tablets (six lots of 25-mg strength and 29 lots of 100-mg strength) in the US to...
Allergan, which is headquartered in Dublin, Ireland and operates four facilities in Ireland, has announced a EUR 65-million ($73-million) capital investment program for 2019 to facilitate the continued expansion of the company’s laboratories and...
The US Food and Drug Administration (FDA) has issued draft guidance, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, to specify new steps by the agency to strengthen the process of initiating voluntary recalls. The plan relates...
Merck & Co. has approved a new global restructuring program, at a cost of $800 million to $1.2 billion, as part of a global initiative focused primarily on further optimizing the company’s manufacturing and supply network as well as reducing...
In tracking approvals of new molecular entities, Johnson & Johnson's Janssen Pharmaceutical gains FDA approval for Balversa (erdafitinib) for treating metastatic bladder cancer and Amgen gets the FDA nod for Evenity (romosozumab-aqqg)...
In the latest industry recall of “sartan”-containing products, Torrent Pharmaceuticals, an Ahmedabad, India-based pharmaceutical company, is expanding its recall for losartan potassium tablets USP and losartan potassium/hydrochlorothiazide tablets,...
Eli Lilly and Company has entered into an agreement to sell the rights in China for two legacy Lilly antibiotic medicines, Ceclor (cefaclor) and Vancocin (vancomcycin), as well as a manufacturing facility in Suzhou, China that produces Ceclor, to...
Novartis has appointed Richard Saynor as Chief Executive Officer (CEO) of Sandoz, the company’s biosimilars and generics business, effective no later than August 1, 2019. He will be a member of the Executive Committee of Novartis and report to Vas...
GlaxoSmithKline (GSK) has announced $100 million of new investment in its manufacturing site in Hamilton, Montana to expand the production capacity of key components of the adjuvant system used in several of its vaccines, including Shingrix, a...
Kite, part of Gilead Sciences, has announced plans for a new facility in Frederick County, Maryland, which will produce cell therapies for treating cancer. The 20-acre site will expand Kite’s ability to manufacture a variety of chimeric antigen...
The Center for Process Innovation (CPI), the process manufacturing arm of the UK government’s network of Catapult centers that are designed to encourage innovation in specific areas, is partnering with GlaxoSmithKline and AstraZeneca to establish a...
Novo Nordisk plans to invest DKK 650 million ($98 million) in upgrading and expanding facilities at its production site in Kalundborg, Denmark.
The facilities targeted for investment manufacture a range of products for diabetes treatments and will...
