News

Premier supports the FDA's new compounder oversight plan

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 says he was fired for raising red flags

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 recalls all lots of Liptruzet shipped since its May debut

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 recalibrates its EU strategy after Celesio deal nosedives

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.

Wockhardt hires a new compliance exec in the face of FDA bans

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.

Ranbaxy manufacturing drama continues with FDA action on API plant

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.

China corruption probe takes a turn into domestic drug distribution business

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.

Aurobindo is looking to buy API plants from Actavis

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.

11 compounders tell the FDA to bring it on

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.

Rumored Novartis, Merck asset swap has interesting manufacturing implications

Novartis is reportedly in talks with Merck & Co. to trade its vaccines and animal health businesses for Merck & Co.'s consumer health operations. 

Amgen facility has its second explosion in 9 months

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.

Patheon's deal for DSM would transform it into the second largest CMO in the world

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.

UPDATED: Roche's Genentech tells the FDA to expect a brief Tamiflu shortage

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.

FDA names Sklamberg to oversee global regulatory issues

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.

UPDATED: McKesson's new offer appeases hedge fund on Celesio buyout

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 issues another recall after particulate found in products

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.

EMA makes inspection reports public

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.

China clears vaccine makers in deaths then shuts some down

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.

Chinese heparin maker Hepalink buying U.S.-based SPL

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 moves into single-use bioreactors with deal to buy ATMI LifeSciences

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.