News

UPDATED: GSK, NewLink ramp up production of Ebola drugs, even as they conduct trials

In an effort to contain the Ebola outbreak in Africa that has already killed more than 1,500 people, companies around the world, including GlaxoSmithKline, are fast-tracking treatments and vaccines to try to get ahead of the disease spread. And in an effort to do that, companies are manufacturing doses, even as they are testing drugs, so that they will have product ready to go ASAP.

Grand River opens new finishing facility

Grand River Aseptic Manufacturing (GRAM), a small parenteral contract manufacturing company in Grand Rapids, MI, has opened a new 28,000-square-foot facility for its finishing operations, inspection services and storage, as well as housing a substantially larger lab, Contract Pharma reports.

Merck KGaA starts work on what will be its second-largest plant

Merck KGaA emphasized the importance of China as a market when it announced last year it would build a new plant there, and again last month when it announced it was getting ready to start construction on the facility. And this week, just in case anyone had missed it, the drugmaker said construction had begun on the plant which will make meds on China's essential drug list.

NAFTA says FDA was in its rights to ban Apotex plants

It's tough luck for Canada's Apotex in its international slug fest with the FDA. An arbitration panel has tossed its claim that the FDA violated the North American Free Trade Act when it banned products from its plants in Toronto and Quebec from 2009 to 2011.

Patheon gets U.S. biologics plants with Gallus deal

The big deal in contract manufacturing these days is biologics. Patheon is among those investing in facilities to capture more of that business. Patheon parent DPx has agreed to buy Gallus BioPharmaceuticals, presenting Patheon with its first biologics plants in the U.S.

Novo buys U.S. plant ditched by Olympus

Olympus Biologics' loss is Novo Nordisk's gain. This year, Japan-based Olympus gave up on producing regenerative products in the U.S. and put a "reduced" sale price on a plant in New Hampshire, which it said would close by August if it could not find a buyer. August rolled around and Sweden-based Novo swept in with a buy.

Teva recalls Parkinson's disease drug because it may be 'superpotent'

Teva Pharmaceutical Industries, whose manufacturing operation is being signifcantly pared down, is recalling one lot of its generic Parkinson's combo drug carbidopa/levodopa because it may have too much active pharmaceutical ingredient.

Lonza looks to biotech funders for entree to business

Swiss ingredient maker Lonza figures that if you can get in early with a winner, the rewards will be a lot greater. That is what happened when it became the supplier to manufacture Pharmacyclics' leukemia drug Imbruvica. And so instead of trying to strike a deal with each promising startup, it is turning to their source of funds, the venture capital crowd.

Alexion gets new Form 483 in follow-up inspection

Despite the best efforts of Alexion, the FDA has lingering concerns about manufacturing of the drugmaker's orphan drug Soliris at a plant in Rhode Island and presented it with a Form 483 with new observations following a follow-up inspection of the plant last week.

Lupin took hard look at troubled Wockhardt for possible bid

Nilesh Gupta, managing director of India's Lupin, told Bloomberg that his company gave Wockhardt a financial sizing up recently before deciding it didn't represent a good M&A target.

Sources: Ranbaxy's manufacturing problems lead to Texas

Ranbaxy Laboratories last year agreed to pay $500 million to settle litigation with federal authorities over the years that the drugmaker failed to follow good manufacturing practices and sold inferior drugs to the U.S. Now sources say it may ante up a much smaller payment to the state of Texas for many of the same issues.

PSC buys high-potency fill-finish facility from U.S. research group

Pomona, CA-based PSC Investments has bought a 37,000-square-foot high-potency sterile injectable fill-finish facility from the Morgridge Institute for Research.

FDA's 'Most Wanted Fugitives': The agency wants your help finding these bad players

You have heard about the FBI Top 10 Most Wanted list, and of the America's Most Wanted television show, but are you familiar with the FDA's list of Most Wanted Fugitives? Yes, the drug oversight agency has bad players who have fled that it would like to bring to justice. And it would like your help to do that.

Pfizer recalls nearly 94,000 vials of Depo-Medrol

Pfizer is recalling two lots of its 40 mg/ mL, 1 mL single-dose vials  of its anti inflammatory product Depo-Medrol.

Another drug company blames freezing during delivery for product problems

Bausch & Lomb recalled nearly 900,000 tubes of eye ointment last month, saying that freezing temperatures during delivery appeared to have caused the grit that some customers were complaining about. Now a Colorado biotech is also claiming to have fallen victim to that kind of supply chain issue, although its announcement raised eyebrows among observers.

Novo cutting emissions while building capacity at massive Denmark plant

About an hour and a half west of Copenhagen is a little coastal town, Kalundborg, with 16,000 inhabitants, a famous five-steepled church and a castle dating back to at least the 14th century. It also happens to be the home of the plant that produces half of the world's insulin, the key component to most diabetes treatments.

UPDATED: Hikma seizes on 'opportunities' for injectables growth

Jordan-based Hikma several years ago evaluated whether to sell off its sterile injectable business and decided it was too valuable to give up. Now that part of its business is underpinning it growth and it is expected to do so in the future after it bought out a bunch of drugs and a huge plant in the U.S. from Boehringer Ingelheim.

Lonza gets a break on the tax break it got for the U.S. plant it is closing

Swiss-based CMO Lonza is cutting its tax liability here through the blessing of local economic development. It is not being required to return any of the tax incentives it got for a plant expansion after deciding to abandon a Massachusetts manufacturing site.

DOJ investigates Dr. Reddy's for failing to protect children with packaging

The drugmaker says it disagrees with the U.S. Consumer Product Safety Commission's allegations and is talking things over with the CPSC. But the Department of Justice is also investigating a complaint related to the same matter under the Federal False Claims Act.

UPDATED: FDA warning letter says Marck plant plagued by faked records and dead frogs

The FDA in March issued an import alert against a Marck Biosciences sterile manufacturing plant in Kheda, India. A July warning letter posted today explains why. Employees recorded data for functions that were not performed. Records, if kept at all, were often put on "scratch paper." The bathroom was filled with mold and an exit loading dock was littered with dead and decaying frogs.