Workers at an Onyx Pharmaceuticals facility in South San Francisco filed out of the building and into a parking lot Wednesday afternoon after employees reported smelling gas.
The latest FDA visit to Hovione's plant in Loures, Portugal, for a preapproval inspection resulted in a Form 483 with three observations.
Drugmaker Pozen says its API supplier has done everything the FDA asked after noting issues in an April plant inspection and the company resubmitted its application in July. But the FDA's compliance division has been too busy to get back to the plant and see for itself, and so the agency has sent Pozen a second CRL with "identical wording."
A federal indictment alleges that the now-defunct New England Compounding Center reaped millions of dollars by cutting corners in the manufacture of what were supposed to be sterile drugs, falsifying records, using expired ingredients and lying to clients about their safety.
Just a week after saying it would close a plant in the U.S. and whack 180 jobs, AstraZeneca said that a facility in the U.K. will also close and 250 more jobs will be cut there.
The Cell Therapy Catapult is part of a government program created a couple of years ago to pump up the cell therapy industry in the U.K. The group plans to invest more than $85 million to build a large-scale cell manufacturing facility in Stevenage that companies can contract with for early-stage to commercial work.
Novartis' generic division, Sandoz, is having to recall one lot of its generic version of Novartis' blood pressure drug Atacand, but it is a copy that it does not manufacture itself. The drug is made in India by Mylan.
Indian pharmacies are reporting shortages of a number of drugs which are on the country's essential medications list and believe price caps are to blame.
Biocon intends to build a new facility in Vizag, India, for manufacturing insulin products. It is a turnabout for the Indian company, which went to Malaysia with its first insulin facility, in part, over concerns that India was falling behind in providing dependable infrastructure to the pharma industry.
Industry Voices: The future of pharma manufacturing--new disruptive technologies that can impact whole industry structures
The production model employed by the pharmaceutical manufacturing industry has remained rigid and inefficient--stalled on the cusp of a much-needed paradigm shift. But now, pressure is mounting from regulators and payers alike, and new methodologies and disruptive technologies are emerging.
Recalls for Baxter continue to pile up, with the drugmaker retrieving an injectable product this time because of particulate. The recall comes just weeks after it had to retrieve another injectable because of labeling problems.
Teva Pharmaceuticals has cut $650 million in costs this year but needs to more than double that over the next two as it faces generic competition to its workhorse multiple sclerosis drug Copaxone. A big part of that will be to continue revamping its production network, CEO Erez Vigodman says.
California-based Peregrine Pharmaceuticals says that contract manufacturing revenue was off in its last quarter but demand remains high for its Avid Bioservices unit, and so like a number of contract manufacturers that target biologics, it is adding capacity.
With the deadline for new track and trace requirements kicking in January 1 for drugmakers and wholesalers, the FDA has issued new guidance to help them understand what they are up against. According to Regulatory Focus, the agency has issued draft guidance on what information companies are supposed to exchange under the Drug Quality and Security Act (DQSA), which Congress passed last year.
AstraZeneca has been fighting a losing legal battle to protect the patent on its asthma drug Pulmicort Respules, and a plant in Massachusetts will pay part of the price. The U.K. drugmaker says it will close the plant next year, putting 180 workers out of jobs.
Indonesia is one of those emerging markets that has pressured outside companies to produce locally and companies like Pfizer, Merck and Fresenius Kabi have all built or expanded plants there in recent years. But the government, which controls some of the players, is taking steps to improve efficiency in the domestic market, pushing for a merger that ties the manufacturing expertise of one company to the supply chain strength of another.
Novartis continues the protracted drawdown at its Diovan plant in New York, telling the state nearly two dozen more jobs will be whacked starting at the end of March.
While Puerto Rico has had its share of announced plant closings this year, it has attracted Florida-based Romark Laboratories, which will make a $110 million investment there.
Indian drugmakers are in a dogfight with Indian regulators who have proposed banning the use of PET plastic bottles for some drug packaging. If they have to move to glass, it will add up to 30% to their transportation cost per bottle, they have complained.
The U.S. arm of India's Zydus Cadila has initiated its second recall in the U.S. in the last 7 months, this time because tablets of a drug for high blood pressure were found to have brown spots.