News

Merck KGaA to power India plant with coconut and cashew shells

Next year, Merck KGaA plans to start a biomass heating plant in the U.S. but for now is starting on a project in India that will use cashew and coconut shells, recycling a local waste product into biomass fuel.

Some Aurobindo epilepsy capsules found empty, prompting recall

India's Aurobindo has recalled a lot of an epilepsy drug because some of the capsules contain no drug at all.

Merck manufacturing know-how brought to bear on NewLink Ebola vaccine

NewLink Genetics, the small Iowa company working on a promising Ebola vaccine, has been looking for manufacturing muscle, not to mention development experience and marketing know-how, to get its Ebola vaccine to market.

Baxter labeling issue could leave patients short on potassium chloride

For the second time in four months, Baxter International finds itself recalling highly concentrated potassium chloride. This time it's a labeling problem, one that the company says has the potential to be life-threatening.

AbbVie buys API plant in Singapore where it's already building one

When AbbVie announced its plans for a $320 million bulk manufacturing facility in Singapore in February, it said it would be its first in Asia when it was ready to roll near the end of the decade. But the drugmaker has now picked up a smaller API plant in Singapore and it will be up and running in 2016.

AstraZeneca joins Bristol-Myers, Amgen in biologics buildup

Bristol-Myers Squibb announced a new project in Ireland earlier this month, followed by Amgen's completion of a continuous processing facility in Singapore. Now AstraZeneca says it needs more biologics capacity and will spend in excess of $200 million to build out a facility in Maryland.

UPDATED: Hospira says shareholder suits tied to its plant problems are nearly wrapped up--again

In March, Hospira announced it had reached a $60 million agreement to settle a three-year-old lawsuit that said investors had been kept in the dark about the quality problems at its manufacturing operations. But another suit was filed last June, and now the Lake Forest, IL, company says it has been rolled into the settlement.

Ranbaxy can't stop the FDA from yanking drug approvals over plant problems

A U.S. federal judge has turned down Ranbaxy Laboratories' request for a temporary restraining order against the FDA after the agency revoked the Indian drugmaker's approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's antiviral Valcyte because of its manufacturing shortcomings.

Amgen opens $200M continuous purification plant in Singapore

Amgen CEO Robert Bradway hinted several years ago that the company was on the "cusp" of a new manufacturing process for making cell-based drugs that would upend the industry, being faster and cheaper. Today, Amgen said that time has arrived, with completion in Singapore of a $200 million plant that incorporates continuous processing.

Doc coughs up $2M for using unapproved Avastin on his cancer patients

A U.S. oncologist who thought he was getting a great deal on drugs that were almost the same thing as Avastin has found they will cost him an extra $2 million and a federal misdemeanor conviction.

Interpol: Organized crime, aware of weak points, targets counterfeit drugs

Organized crime has moved into selling counterfeit and compromised prescription drugs in Europe, exploiting the mishmash of customs laws and weak points in some border protection. Those weaknesses allowed the "Mafia" to get fake manifests, use suspect wholesalers, and sell counterfeits of Roche's Herceptin and other cancer drugs across Europe.

U.K. generics maker to build $31M plant in Alabama

A small generics maker from the U.K. has decided on Birmingham, AL, for its first manufacturing facility, enticed there by a hefty dose of incentives.

Ranbaxy fights FDA for killing its approval to make generic Nexium

This month, the FDA yanked the approvals it granted Ranbaxy to make generics of two blockbuster drugs, saying it was a mistake to grant the approval given that the plants where they were to be made were out of compliance. Ranbaxy has now filed a federal lawsuit against the FDA for canceling the approvals.

Apotex recalling blood pressure med made at banned plant in India

Canadian generics maker Apotex is recalling tens of thousands of bottles of a blood pressure medication manufactured at a plant in India which the FDA banned after discovering it had been faking test data for years.  

Recipharm picks up two more plants, this time in Portugal

Sweden's Recipharm is expanding its production footprint for the second time this year, with a €112.3 million ($140 million) cash and stock deal to buy Portuguese contract manufacturer and developer Lusomedicamenta Sociedade Técnica Farmacêutica.

Japan's largest CMO, Bushu, gets new private equity owner

In a deal valued at more than $660 million, Baring Private Equity Asia showed up Monday as the buyer of a Japanese CMO and Tokio Marine Capital as the seller.

Getting more FDA inspectors in China on Hamburg's agenda for trip to China

For nearly two years, efforts by the FDA to expand its oversight of Chinese pharmaceuticals manufactured for the U.S. market have been thwarted, an issue FDA Commissioner Margaret Hamburg hopes to resolve during a visit there this week to meet with Chinese and other global regulators.

Bristol-Myers to build $900M biologics plant in Ireland

Bristol-Myers Squibb, having already expanded its U.S. production to make more biologics with its facility in Devens, MA, will now erect its twin in Ireland, a 320,000-square-foot facility adjacent to a bulk manufacturing facility in Dublin.

Former top execs at Ranbaxy U.S. open consulting business

Ranbaxy's top U.S. execs were seen as pivotal in the company getting approval to move production of a generic of Novartis' blockbuster Diovan from a banned plant in India to Ranbaxy's New Jersey facility. But a handful of them resigned last month, and now they intend to use that experience helping other drugmakers make it through the FDA's tough maze of regulations, and to negotiate with payers.

Sun's deal to buy Ranbaxy faces delays

The owner and top executive of India's Sun Pharmaceutical Industries has pledged that the first thing he will do when his deal to buy Ranbaxy Laboratories closes is make the needed investments in Ranbaxy's manufacturing plants to bring them in line with the FDA's expectations. But those improvements will have to wait awhile yet.