Sanofi supply-chain problems have again undermined the French drugmaker's earnings. This time around it is problems with being able to meet vaccine demand in a couple of emerging markets.
The FDA, trying to help face down a national shortage of saline in the U.S., is for the second time allowing a manufacturer to import product from a plant in Europe that is not approved for the U.S. market, permitting Baxter International to ship from a plant in Spain.
Takeda got approval in Japan a month ago for its cell-cultured influenza vaccine it developed with Baxter International. Now, the Japanese drugmaker says the government will pony up another $70 million so it can expand a manufacturing plant for which it has already received significant subsidies.
The FDA has been emphasizing quality to drugmakers in the last couple of years and made changes in the department to emphasize its importance. But as Regulatory Focus points out, it has lost some of its top talent in that arena. Mylan has hired away a second top FDA quality official, it reports.
India's federal regulator has ridden to the rescue of generic drugmaker Wockhardt, lifting a ban imposed just 4 days earlier by state authorities. The drugmaker reported to the markets Monday that it will resume manufacturing the pain product.
According to an inspection report obtained by Bloomberg, a Sun plant in Karkhadi displayed much of the same bad behavior as the Ranbaxy facilities the company says it can reform.
Faced with bans on some of its key drugmakers and intellectual property fights with Big Pharma, India has seen the worst pharma export numbers in a decade and a half.
The FDA says it wants to notify the public more quickly about drug recalls. And so it has started a pilot program in which it will send out notifications of recalls that have yet to be classified.
Chinese vaccinemaker Sinovac Biotech has won a grant from the Chinese government to build a production facility to manufacture its vaccine against hand, foot, and mouth disease. The awarding of the grant is a good omen that the government will approve the company's vaccine, which was submitted last year for approval.
Quality lapses can lead to regulatory action, which can mean closed plants and so drug shortages. But a new report says that the industry needs to move beyond its focus on what regulators want and dedicate itself to quality for its own rewards, to lower costs and build business.
Bristol-Myers Squibb hooked up with South Korea's Samsung last year when it wanted someone to handle manufacturing overseas for its hot-selling melanoma drug Yervoy. But with more promising biologics in its pipeline, the New York-based drugmaker has decided to deepen its commitment.
Some Indian regulators appear to have heeded FDA Commissioner Margaret Hamburg's call to set a higher bar for manufacturing quality. India's Wockhardt, already in deep trouble with the U.S. and Europe for slacking off on quality, says one of its products has been banned by a state regulator in Himachal Pradesh.
In addition to all of the other deals that Novartis announced today, an agreement to sell deal contract manufacturer LTS Lohmann is reportedly close, with private equity firm Nordic Capital expected to get it for about $1.7 billion, Bloomberg reported.
The full manufacturing implications of the complex three-way business swaps and sales that Novartis, GlaxoSmithKline and Eli Lilly announced today will take some time to sort out.
The FDA says the recent import alert imposed on 0.9% sodium chloride made at a Baxter International plant in Canada was issued because an "importer/consignee" tried to ship some into the U.S. The problem is, the saline made at that plant is not approved for sale in the U.S.
GlaxoSmithKline closed an aging active pharmaceutical plant in Thane, Maharashtra, India, a couple of years ago and let go of more than 300 people who worked there. Now, the British drugmaker would like to unload the property.
Cubist Pharmaceuticals has again been tripped up by one of its contractors, having to recall a single lot of its injectable antibiotic Cubicin because of particulate. The recall comes 8 months after a similar problem led it to recall four lots of the drug.
Sterile injectable drug maker Hospira last year ramped up production of the sedative and analgesic propofol, a drug CEO F. Michael Ball said he knew the market was anxious to see a bigger supply of. But the drugmaker is now recalling 7 lots of the drug because glass and metal particles have been found in some vial samples.
Attention deficit hyperactivity disorder drugs like Ritalin have been on the FDA shortage list for a variety of reasons. Now add to that packaging problems which have led Novartis to recall nearly 22,000 bottles.
NeoStem, the New York-based developer and manufacturer of cell therapies, will pick up another California plant with its all-stock acquisition of California Stem Cell, which it announced this week.