Pfizer says it will support the trend toward making more data from clinical trials available by providing easy-to-understand summaries to patients who participate in the independent studies.
A Jubilant Life Sciences plant has joined a growing list of Indian drugmakers' facilities that have gotten crosswise with the FDA lately. But this time it is for a plant in the U.S., the second Jubilant plant in North America tagged by the agency this year.
Pfizer has always been proud of its design of Viagra, which has become known worldwide for its blue color and diamond shape. It thinks enough of it that it is fighting a pitched legal battle in Korea with drugmaker Hanmi Pharmaceutical over the shape of Hanmi's generic, which has grabbed nearly half the market there.
After settling much of the litigation tied to the health effects on newborns whose mothers took the antidepressant Paxil during pregnancy, maker GlaxoSmithKline has now won a wrongful death case brought by a woman who said she aborted after she was told her fetus had congenital heart defects.
Mylan's buyout of Agila Specialties from India's Strides Arcolab hit a hitch after the FDA issued a warning letter to one of Agila's plants. Mylan said it was holding back $250 million of the $1.75 billion payout until the regulatory issues get resolved.
Less than a month ago, Sanofi's multiple sclerosis treatment Lemtrada ran into problems with FDA staffers who were unconvinced of the drug's safety and efficacy. Now, it looks as if the U.K. may share some of those doubts. Its cost-effectiveness gatekeeper has asked the French pharma for more data, giving the company just over a month to submit the supplementary information.
U.K. Prime Minister David Cameron thinks GlaxoSmithKline is a "very decent and strong British business" and has been talking it up with Chinese officials during his trade visit there.
Pfizer is shedding 150 employees at its facility in Newbridge, Ireland. The company says the cuts are needed as generic competition continues to eat away at its revenues. The move comes just two weeks after the U.S. drugmaker targeted a plant in Puerto Rico for closure.
Teva Pharmaceutical Industries is searching for a new CEO while in the midst of a restructuring that will whack 5,000 jobs and counting the days until its top-selling drug falls off a patent cliff. But its interim leader says investors should not worry. The company has a plan.
Boehringer Ingelheim is in the midst of closing down its troubled Ben Venue generic sterile injectables facility in Ohio after deciding it was not worth pouring more money into its rehabilitation. But given that there is growth in generic and contract injectable manufacturing, the German company hopes someone might want to take it off its hands.
Dendreon's lead treatment, prostate cancer vaccine Provenge, continues to post sales losses, leaving many pessimistic that the struggling biotech will be able to right the ship. Now, however, it appears one of the company's doubters may have had an ulterior motive.
An award of $76 million may not sound like much in the big-dollar world of pharma, but for a branded drug company, it always feels good to win one against a generic drugmaker that has jumped the gun with a generic. That is how much a court says AstraZeneca should be paid by Apotex.
Lantus is the best-selling diabetes drug in the world right now and the top-selling drug for Sanofi. But the drug goes off patent in 2015, so the French drugmaker is coming on strong with its Lantus successor, known as U300.
This month, the FDA hammered a second Wockhardt plant in India, banning most of the products the generics drugmaker could ship to the U.S. A warning letter posted today shows that the plant was up to some of the same tricks that led the agency to its first ban earlier this year.
Hospira and its biosimilar partner Celltrion won European approval for the first biosimilar of a monoclonal antibody therapy in September when the EU signed off on their Inflectra, a biosimilar of Johnson & Johnson's Remicade. But despite the achievement, the partners still face a huge challenge: getting doctors to use the drug.
Novo Nordisk, the world leader in insulin products, took a big hit this year when the FDA denied approval of its newest long-lasting insulin drug, Tresiba. But CEO Lars Rebien Sørensen is taking every opportunity to let the markets know that Novo has lots of growth in its business.
Just weeks after selling its blood-transfusion business and announcing a new strategy focusing on pharmaceutical development, Novartis is reportedly opening the books on its animal-health business to potential buyers. Bayer may be the top suiter.
Pfizer likes the growth potential in the over-the-counter niche, and so it keeps piling new products onto the unit from around the world, ignoring investors who would like to it unload the business and share the wealth.
Japanese drugmaker Eisai is cutting its R&D operations, with plans to eliminate 130 positions from its facility in Andover, MA, as well as other research centers around the world.
Merck two months ago laid out plans for its fourth restructuring in 5 years, saying it would whack 8,500 jobs from its R&D and commercial operations and cut $2.5 billion in costs globally. And global the cuts have been, with 130 jobs being targeted at its women's healthcare production plant in Swords, Ireland in the next 6 months. The rest of the 570 jobs at the plant are to go by the end of 2017.