In March, Hospira announced it had reached a $60 million agreement to settle a three-year-old lawsuit that said investors had been kept in the dark about the quality problems at its manufacturing operations. But another suit was filed last June, and now the Lake Forest, IL, company says it has been rolled into the settlement.
A U.S. federal judge has turned down Ranbaxy Laboratories' request for a temporary restraining order against the FDA after the agency revoked the Indian drugmaker's approvals to make generics of AstraZeneca's blockbuster Nexium and Roche's antiviral Valcyte because of its manufacturing shortcomings.
Amgen CEO Robert Bradway hinted several years ago that the company was on the "cusp" of a new manufacturing process for making cell-based drugs that would upend the industry, being faster and cheaper. Today, Amgen said that time has arrived, with completion in Singapore of a $200 million plant that incorporates continuous processing.
A U.S. oncologist who thought he was getting a great deal on drugs that were almost the same thing as Avastin has found they will cost him an extra $2 million and a federal misdemeanor conviction.
Organized crime has moved into selling counterfeit and compromised prescription drugs in Europe, exploiting the mishmash of customs laws and weak points in some border protection. Those weaknesses allowed the "Mafia" to get fake manifests, use suspect wholesalers, and sell counterfeits of Roche's Herceptin and other cancer drugs across Europe.
A small generics maker from the U.K. has decided on Birmingham, AL, for its first manufacturing facility, enticed there by a hefty dose of incentives.
This month, the FDA yanked the approvals it granted Ranbaxy to make generics of two blockbuster drugs, saying it was a mistake to grant the approval given that the plants where they were to be made were out of compliance. Ranbaxy has now filed a federal lawsuit against the FDA for canceling the approvals.
Canadian generics maker Apotex is recalling tens of thousands of bottles of a blood pressure medication manufactured at a plant in India which the FDA banned after discovering it had been faking test data for years.
Sweden's Recipharm is expanding its production footprint for the second time this year, with a €112.3 million ($140 million) cash and stock deal to buy Portuguese contract manufacturer and developer Lusomedicamenta Sociedade Técnica Farmacêutica.
In a deal valued at more than $660 million, Baring Private Equity Asia showed up Monday as the buyer of a Japanese CMO and Tokio Marine Capital as the seller.
For nearly two years, efforts by the FDA to expand its oversight of Chinese pharmaceuticals manufactured for the U.S. market have been thwarted, an issue FDA Commissioner Margaret Hamburg hopes to resolve during a visit there this week to meet with Chinese and other global regulators.
Bristol-Myers Squibb, having already expanded its U.S. production to make more biologics with its facility in Devens, MA, will now erect its twin in Ireland, a 320,000-square-foot facility adjacent to a bulk manufacturing facility in Dublin.
Ranbaxy's top U.S. execs were seen as pivotal in the company getting approval to move production of a generic of Novartis' blockbuster Diovan from a banned plant in India to Ranbaxy's New Jersey facility. But a handful of them resigned last month, and now they intend to use that experience helping other drugmakers make it through the FDA's tough maze of regulations, and to negotiate with payers.
The owner and top executive of India's Sun Pharmaceutical Industries has pledged that the first thing he will do when his deal to buy Ranbaxy Laboratories closes is make the needed investments in Ranbaxy's manufacturing plants to bring them in line with the FDA's expectations. But those improvements will have to wait awhile yet.
The biotech arm of Spain's Grupo Chemo earlier this year bought a contract manufacturer in Spain specializing in monoclonal antibodies as part of its ambitions to produce biosimilars. Now its pharma division will get two manufacturing plants in Turkey and a portfolio of products with an acquisition there.
Neopharma, based in the United Arab Emirates, will build a plant in a new industrial city being developed in the south of the country. B.R. Shetty, who controls both Neopharma and New Medical Center Group of Companies, has pledged to spend 1 billion Saudi riyals ($266.5 million) to build both a drug manufacturing facility and a hospital in Jarzan City.
With its buyout of Aesica complete, the U.K's Consort is ready to fill more drug delivery devices, as well as an opportunity in the market. A specialist in developing inhalers, its Bespak device business will now be able to help companies take a drug from API manufacture, through joint development of the drug and device, and then onto the market.
In what is shaping into a major pharma supply chain scandal in Spain, investigators have accused one of the country's largest wholesalers of diverting millions of euros' worth of drugs subsidized by the government to the black market.
Aurobindo will pick up vitamin and supplement maker Natrol for $132.5 million, which it bid for the company in a Chapter 11 bankruptcy auction, the Wall Street Journal reports.
When India's Cadila Pharmaceuticals got complaints from customers about some of its APIs smelling bad, the drugmaker decided the odor stemmed from an impurity, so it tweaked the manufacturing process. The problem, according to the FDA, is that the plant never conducted an investigation to determine whether the impurity was in fact the cause, so the company never knew whether it had really resolved the cause of the stench.