News

UPDATED: Merck KGaA negotiates huge production deal with Lupin

Merck is investing €80 million ($107.67 million) in a new plant in China to make treatments for diabetes and other conditions and to realize its aspirations there. But it appears it is looking to India as a way to cut production costs on some of its older products.

Gilead hands Sovaldi manufacturing tech to 7 generics makers

Gilead Sciences is presenting a huge gift to Mylan and half a dozen Indian generics makers. It is transferring the manufacturing technology for its biggest product and its blessing to go make cheap copies in 91 markets.

Hospira again reports a human hair discovered in a product

A loose hair has again tripped up Hospira, which is voluntarily recalling one lot of heparin as a result.

More counterfeits of Roche cancer drugs surface in Europe

Counterfeiters in Europe are displaying a fondness for mimicking high-priced Roche cancer drugs. For the second time in 5 months, authorities there have uncovered fakes, and the two cases appear not to be connected.

DOJ lawyer named director of FDA's Office of Compliance

The FDA has picked a successor to Howard Sklamberg to oversee the Office of Compliance (OC), Regulatory Focus reports.

Sources: FDA inspectors in Sun plant that has had recalls

Sun Pharmaceutical's U.S. subsidiary Caraco Pharmaceutical Laboratories has had a series of recalls this year of products that came out of a plant in Gujarat in India. Now the plant is being visited by FDA inspectors.

Apotex recalls Paxil tainted at GSK plant

Apotex, the Canadian generics maker that has had years of regulatory run-ins with the FDA, is recalling thousands of bottles of generic Paxil. This time regulators can't point fingers at Apotex. The drugs were manufactured by GlaxoSmithKline and are part of a larger recall for which the FDA spanked GSK.

Hospira will prep Indian workers at Vizag 'university'

When the sterile injectables plant Hospira is building in Vizag, India, opens, perhaps yet this year, the company expects the 1.1-million-square-foot manufacturing facility to add capacity at a lower operating cost. But a plant of that size requires a lot of workers, and so Hospira is also making plans to train the people it needs there.

FDA fight with compounder tests its patience and its limits

For nearly two years, the FDA and a Texas compounder have been sparring over whether its products are safe and whether it will bend to the pressure the agency is exerting. The FDA sent a warning on Tuesday saying that the company cannot affirm its products are safe and that providers were taking a chance by using them.

UPDATED: Merck again shipping BCG cancer treatment but Sanofi still is not

When a shortage of BCG vaccine used to treat tuberculosis and bladder cancer developed two years ago because of serious problems at a Sanofi Pasteur plant, the FDA asked Merck to pick up the slack. But Merck has had supply issues that interrupted production that it is only now resolving.

ProBioGen will double its Berlin staff to expand cell-based manufacturing

Contract manufacturer ProBioGen is joining a growing list of companies that are expanding their biologics manufacturing capabilities as more drugmakers need production expertise for cell-based drugs.

Germany's Aenova buys North Carolina packaging operation

Germany's Aenova has been in expansion mode. It pumped up production capacity with its acquisition last year of contract manufacturer Haupt Pharma and has now bought a U.S. company to help it boost its packaging capabilities. 

Perrigo recalls 367,000 tubes of nicotine lozenges

Smokers often turn to over-the-counter nicotine lozenges to cut their urges when they are trying to quit smoking. It turns out that products made by Perrigo and sold through a whole host of retailers like Wal-Mart and CVS might not work that well.

Cipla buys two Indian manufacturing facilities from partner Okasa

India's Cipla, which has recently been taking steps to expand its capacity outside of its home country, is now boosting its domestic operations. The drugmaker says it is buying two facilities from one of its contractors.

FDA, DOJ arrest NECC pharmacist about to leave the country

Federal authorities have arrested a pharmacist that worked for the now bankrupt New England Compounding Center. The compounder's manufacturing failures are believed to be responsible for a fungal meningitis outbreak in 2012 that killed 64 people and sickened 751. 

GSK's Canada vaccine plant runs into new problems

New problems have developed at GlaxoSmithKline's vaccine plant in Canada, interrupting production and affecting supply. The bottom line for Canada is that it will shave 2 million doses of its FluLaval trivalent vaccine off what GSK can deliver for the upcoming flu season. The impact on the U.S. is still being evaluated.

BARDA helping Mapp Biopharmaceutical scale production of Ebola drug

The U.S. Biomedical Advanced Research and Development Authority is making money available to help drugmakers test and manufacture drugs that might help turn the tide of the Ebola outbreak in Africa.

Theratechnologies returns HIV product Egrifta to U.S.

Canada's Theratechnologies says it is again shipping its 1-mg dose of its Egrifta to U.S. wholesalers. Manufacturing problems had led it to halt production earlier this year of the human growth hormone which is used by some HIV patients.

Wockhardt expects to resolve most FDA concerns within the year

Wockhardt has been in a world of hurt since the FDA last year banned two of the plants that made drugs for the U.S. market. But the Indian drugmaker has said that with the help of outside consultants it can get most of its problems with the FDA resolved within the year, and that has the M&A handicappers suggesting it is prime takeover target.

Xellia lays out $100M expansion plan for new U.S. facility

Xellia Pharmaceuticals has laid out expansion plans for its new U.S. facility only two months after establishing a foothold in the country by acquiring a manufacturing facility from Fresenius Kabi. In exchange, the city of Raleigh, NC will bless the the Denmark-based company with a tax break.