The FDA has an ally in its effort to get hospitals to buy compounded drugs from only those companies that volunteer to be regulated under a new FDA program. It is one with substantial reach. While healthcare improvement company Premier is not generally one to look favorably on federal regulation that affects its 2,900 member hospitals, it is urging its clients to get on board with this one.
Former Fresenius employee Ronald Hillier has filed a state whistleblower lawsuit in Cook County in Chicago, alleging that when he pointed out issues that he believed could result in contaminated products, the company canned him.
Merck is recalling all of the lots of its cholesterol drug Lipruzet distributed since its approval in the U.S. last May, saying that packaging problems could affect its potency. It has warned the FDA that shortages are expected from the voluntary recall.
McKesson, the largest U.S. wholesale distributor of drugs, decided it needed an EU strategy after competitor AmerisourceBergen made its own deal there last year. So it made an $8.3 billion bid for German wholesaler Celesio. But with its failure Monday to close the Celesio deal, the San Francisco-based company finds itself again figuring out how to establish a beachhead on the continent.
India's Wockhardt, facing a raft of regulatory issues from the U.S. and Europe, is beefing up its quality oversight with a new leader for its regulatory and compliance division.
The Ohm Laboratories plant in New Jersey is currently Ranbaxy's only facility able to turn out product for the U.S. market. Now the FDA has raised questions about manufacturing practices at the active pharmaceutical plant that supplies about 70% of the raw ingredients for U.S. production, Ranbaxy's facility in Toansa.
A probe by Chinese authorities into alleged corruption in its pharma industry initially focused on drug manufacturers, and Western companies at that. But with the announcement that the former vice president of China's largest drug distributor has been detained, it has moved down the supply chain and firmly into its domestic industry. It also involves a company in a piece of the industry that is key to foreign drugmakers and one that has been tricky for them to navigate.
Sources tell The Economic Times that Aurobindo is talking with Actavis about buying active pharmaceutical ingredient plants in Western Europe that it could integrate into its sterile injectables operation. They said Actavis is looking to sell facilities in Italy, Spain, France, Germany and the Netherlands, and the Indian drugmaker is looking to scoop up a couple of them.
The new law that defines and broadens the FDA's oversight over drug compounders relies on the so-called outsourcers volunteering for oversight. So the big question was how many of the 3,000 or so firms would sign up. The answer as of Friday was 11.
Novartis is reportedly in talks with Merck & Co. to trade its vaccines and animal health businesses for Merck & Co.'s consumer health operations.
In November, Amgen received a California OSHA citation for an explosion at the biotech last May that injured a hazardous waste disposal employee. Wednesday another explosion was reported at the biotech, this one sending two workers to the hospital.
Private investment firm JLL Partners is orchestrating a $2.6 billion merger of its Canadian contract manufacturer Patheon ($PTI) with the Netherlands-based DSM Pharmaceutical Products on the bet that the combined company will grow in a growing niche of the industry.
A short production interruption at a drug manufacturing plant doesn't generally elicit a lot of publicity--unless it involves a drug treatment for children during the flu season. And so the FDA let it be known Wednesday that there may be spot shortages of Tamiflu liquid because of manufacturing issues at a Genentech plant.
Howard Sklamberg, who was instrumental in establishing the FDA's new Office of Pharmaceutical Quality within the Center for Drug Evaluation and Research, has been promoted for the second time in a year.
U.S.-based McKesson would just like to finalize its $8 billion-plus deal for German drug wholesaler Celesio so that it could try to catch up to competitor AmerisourceBergen in Europe. But Paul Singer, practiced in the art of taking advantage of takeovers, is not about to let that happen without getting something extra for his hedge fund, Elliott Management.
Baxter International issued a four-country recall two weeks ago of some of its injected products because particulate had been found in some of it. Now, in the U.S., it is recalling three lots of its Clinimix line of parenteral nutrition products for the same reason.
The European Medicines Agency is now making public its reports on companies that have failed plant inspections. The FDA has made warning letters and some Form 483 reports public for some years, but the EMA had not, according to Pharmafile, which went through the nearly 7 dozen reports in the data base that date back to 2007.
Chinese regulators last week cleared the manufacturers of hepatitis B vaccines of any connection to the deaths of nearly 20 children around the country, but that did not keep them from having their operations suspended for missing a Jan. 1 deadline to meet new manufacturing standards announced four years ago.
Many Western drugmakers are buying, building or partnering to establish manufacturing facilities in China. But Shenzhen Hepalink Pharmaceutical, one of China's largest raw heparin makers, has a deal to buy U.S. API maker Scientific Protein Laboratories.
Pall, which has been supplying drug manufacturers with filtration equipment for a long time, has decided to broaden its place in the biopharma manufacturing equipment industry, adding single-use bioreactors and supplies with a deal to buy a division of ATMI.