Mylan may be fending off an unsolicited $40 billion buyout offer from competitor Teva even as it is being rebuffed for making its own $31 billion bid for Perrigo, but it still has to take care of business as usual. Right now that includes having to recall 8 lots of injectable cancer drugs, most of it manufactured for Pfizer, after particulate was discovered in vials.
It has been a rough ride for the former Novartis, former Chiron vaccine plant in Vacaville, CA. Eli Lilly picked it up last year as part of its deal to buy Novartis' animal health assets but has decided it does not need the biologics API facility and so is putting it up for sale.
A new study of U.S. drug shortages has found that antibiotics, including those used to treat highly resistant infections, have often been in persistent short supply, putting patients' health at risk and leaving open the chance some would die before hospitals could get their hands on drugs.
When the Justice Department issued its 131-count indictment against the now-defunct New England Compounding Center, it accused the compounding pharmacy of working on the scale of a drug manufacturer rather than a compounding pharmacy which is required to fill individual prescriptions. Among the evidence that may surface if the case goes to trial is that NECC ignored that requirement, filling prescriptions with names on them that included Big Baby Jesus, Silver Surfer, Filet O'Fish and Coco Puff.
J&J's Janssen unit is recalling one lot of Ortho-Cept tablets because of the potential that the potency of the two active ingredients may not meet specifications, Health Canada reports.
Bayer had hoped to sell a veterinary med plant in Missouri that it picked up a few years ago from Teva. But no one has come forward, so the German drugmaker will close the plant and lay off 130 people.
More counterfeit Botox has made its way into the U.S. and, the FDA thinks, into physician offices. The agency is warning providers that they need to make sure they don't have any of it because it is believed to be unsafe.
The back labels of some bottles of Mucinex cold medicines may not show they contain acetaminophen and other active ingredients, leading U.K.-based Reckitt Benckiser to recall of 135 lots of the popular product in the U.S.
A federal lawsuit has put an over-the-counter drug packaging practice in the spotlight by trying to extract a penalty from Pfizer for using "nonfunctional slack-fill."
The FDA may be having difficulty getting inspectors stationed in China, but that has not stopped it from issuing warning letters to drug and ingredient makers there who have issues. The agency posted a second warning letter today for API maker Yunnan Hande Bio-Tech, which was previously cited in 2010.
Getting focused has been the catchphrase of the pharma industry for a couple of years, and its reach includes contract manufacturers no less than the Big Pharma players. French CMO Novasep said today that its "back to basics" strategy, which included some changes in its manufacturing network, has paid off with improved financials.
The $335 million Merck & Co. biologics plant in Ireland that went online last year is already getting another investment. Merck said last week that it would invest €11.5 million ($12.4 million) in the Carlow facility.
GlaxoSmithKline is recalling 1.7 million doses of its quadrivalent flu vaccine that were manufactured at a plant that ran into a series of manufacturing issues last year including an FDA warning letter. The company says there are questions about whether the vaccine is retaining its potency.
In a regulatory filing, Japan's Daiichi Sankyo said that its board has agreed to it selling some or all of its shares in Sun Pharmaceutical, which Reuters reports are now worth about $3.6 billion. No reason was given, the news service said, but its experience with Ranbaxy, which was recently acquired by Sun, has been nonstop issues.
Contract manufacturer Norwich Pharma Services, which last year said it would be laying off about a fourth of its workforce, will now invest about $26 million in new equipment at its facility in Norwich, NY.
Sanofi's highly anticipated dengue vaccine is being manufactured in a facility in France built specifically for the product. But expansion is also going on at Sanofi Pasteur's vaccine operation in Swiftwater, PA, in preparation for a launch of the vax which may happen later this year.
CDMO Catalent started nearly two years ago on an expansion that it said would cost about $35 million and add about 80,000 square feet to its operation in Winchester, KY. But with additional investments in fluid bed capacity, the project ended up running to $52 million for an expansion of about 90,000 square feet, nearly double its original footprint.
Bayer said it will boost its already big footprint in the Bay Area with a $100 million investment in its Berkeley, CA, facility that is focused on developing new treatments for hemophilia.
The GlaxoSmithKline plant in Dungarvan, Ireland, is making measurable headway in reducing its carbon footprint and appears to be on track to reach its goal of nipping two-thirds of its emissions over the next two years.
The FDA said it's stepping up its efforts to address the shortage of saline solution for humans and animals by increasing the importation of intravenous fluids from producers not previously approved by the regulatory agency.