News

Sanofi will produce generics of 6 drugs in Dubai

Sanofi, which bought controlling interest in Dubai's Globalpharma in June, will kick off production there with generics of 6 of its drugs. Sanofi is now managing the facility.

Turkish man sent to prison for smuggling fake Avastin into U.S.

A Turkish man who admitted to smuggling counterfeit cancer drugs to the U.S. labeled as gifts or documents has been sentenced to 27 months in federal prison.

Novo hiring 90 workers for its new plant in New Hampshire

Novo Nordisk in August bought a plant in New Hampshire that Japan's Olympus Biologics was giving up. Now it is looking for people to help operate it.

Lilly offers behind-the-scenes look at its decade-long tech transfer for TB drugs

Eli Lilly has published a how-to paper about its ambitious technology transfer program to help China, India, Russia and South Africa produce two drugs to treat multidrug-resistant tuberculosis. The bottom line is that the undertaking was harder than expected, and while it did not fully achieve all of its goals, it was worth doing.

More heat applied to Genentech CEO for supply-chain decision on cancer drugs

Genentech CEO Ian Clark is again being publicly chastised for his company's decision to move three of its best-selling cancer drugs to specialty distributors. Groups representing more than 5,000 hospitals say, besides higher costs, the move is as likely to encourage counterfeiting as to deter it.

Serum Institute of India to invest $160M in new plant

The vaccinemaker Serum Institute of India, which jumped into the biosimilars race in July, is expanding its manufacturing network both in India and the Netherlands. The company says it will invest about $163 million for a new facility in its home country.

Hikma gets FDA warning letter for plant in Portugal

Hikma Pharmaceuticals got a closeout notice in March for a warning letter that had been hanging over its West-Ward plant in New Jersey. But at nearly the same time, inspectors were looking over a Hikma facility in Portugal, and the Jordan-based company says the FDA has now issued a warning letter for its sterile injectables plant there.

Ranbaxy's New Jersey plant comes through for drugmaker

Despite FDA bans on four Ranbaxy Laboratories plants in India, the drugmaker managed to realize a profit in the last quarter as its plant in New Jersey was able to come through for it.

Australia's CSL gets three Novartis vaccine plants in $275M deal

For $275 million, Australia's CSL is buying from Novartis a network of vaccine manufacturing facilities, as well as a portfolio of products.

Fujifilm adding Texas-based vaccine specialist to its fold

Fujifilm said Monday that its Fujifilm Diosynth Biotechnologies subsidiary is buying a 49% interest in Kalon from its owners, which includes the Texas A&M University System where Kalon was founded in 2011. Terms of the deal, which is expected to close in the next few months, were not provided, but Fujifilm said it may buy the rest of Kalon, assuming certain milestones are hit.

Production issues for GSK, Sanofi delay flu vaccines in the U.S.

A Sanofi spokesperson told The Wall Street Journal that it has delayed some forms of its Fluzone because the flu strains used to produce the shot did not grow as fast as expected. A GSK spokesman said in an email Monday that it has cut its production targets to 26 million to 27 million doses for the U.S. from the 28 million to 33 million doses originally anticipated.

U.S. Attorney subpoenas Novo for info on Denmark plant

Denmark-based Novo Nordisk said on Friday that it had received a subpoena from a U.S. Attorney who wants some info about its manufacturing operations at a plant in Kalundborg. But the company said it really has no idea why.

Valeant recalls 205,000 bottles of blood pressure med

Trying hard to fight off a hostile takeover by Canada's Valeant, Botox maker Allergan has sent out press releases every time it stumbles onto something that appears to besmirch its pursuer. New fodder is in this week's FDA Enforcement Report. Valeant is recalling a couple hundred thousand bottles and tubes of products.

Roche, too, has big plans for improved HQ facilities

Swiss drugmaker Roche has plans for a big overhaul of its corporate headquarters. The drugmaker will spend about 3 billion Swiss francs ($3.2 billion) on a renovation that will add new labs and offices, and upgrade existing buildings on its Basel, Switzerland-based site.

Industry faces new effort to make it pay for drug disposal

The U.S. biopharma industry has been battling a drug take-back law in Alameda County, CA, for several years, concerned that if it is approved, other jurisdictions would start asking them to pay for drug disposal. That law was upheld by a federal court, and now San Francisco is looking to the industry to pay the full cost of its drug-disposal law.

GSK manufacturing will take hit in cost-cutting move

GlaxoSmithKline's manufacturing network will take a hit as the company cuts costs in the face of falling revenues. The U.K. drugmaker was shy on details but said in an earnings release Wednesday that it needed to "rescale" R&D and manufacturing, as well as other operations. It reported a 3% revenue decline for its third quarter.

Repackager mistakenly puts some ibuprofen bottles into naproxen boxes

According to an FDA Medwatch alert, drug repackager Contract Packaging Resources is voluntarily recalling 11,640 boxes of Assured brand naproxen sodium tablets in the 220-mg dose because some of the cartons actually contain bottles of 200-mg ibuprofen softgels instead.

Argos starts work on $57M plant in North Carolina

Argos Therapeutics, which has a personalized immunotherapy drug to treat renal cell carcinoma in trials, has kicked off work on a $57 million manufacturing facility in North Carolina. The biotech will get nearly $10 million in public support for the project.

Mylan recalls blood pressure med, following recalls of generic by two other drugmakers

Another drugmaker is having to recall metoprolol succinate extended release tablets, a generic for AstraZeneca hypertension drug Toprol XL. This time it is Mylan and the recall is for nearly 16,000 bottles of the beta blocker.

UPDATED: Janssen recalls 13,500 bottles of Xarelto because of contamination

Johnson & Johnson's Janssen unit is recalling 13,500 bottles of its top-selling anticoagulant Xarelto because of microbial contamination.