GlaxoSmithKline and Amgen are parting ways on Prolia, their comarketed osteoporosis med that's been among the fastest-growing products approved in the last few years. Amgen will take over the task in most areas under their agreement, leaving GSK freer to buckle down on some new launches of its own.
In the wake of the controversy over the FDA's decision to approve Zohydro, a pure hydrocodone drug that has no tamper-resistant technology tied to it, FDA Commissioner Margaret Hamburg Thursday used the approval of a new overdose treatment that anyone can carry to make her case that the FDA is just as concerned as everyone else about opioid drug abuse in the country.
Just four months after closing its $1.75 billion acquisition of Agila Specialities, generic drug maker Mylan is eyeing another takeover candidate--Sweden's Meda AB. Pennsylvania-based Mylan is talking with advisers about a takeover bid that could be made at a "significant premium" to Meda's $4.5 billion market value, according to sources quoted by the Financial Times.
The FDA has banned a handful of plants from some of India's biggest drugmakers in the last year, actions that have led to grumbling that the regulator is picking on Indian-owned operations. But now a plant in India owned by a Canadian firm has gotten the same treatment, an import alert that blocks products from being shipped to the U.S.
Alexion, like many of its pharma peers, has moved some operations to Ireland to enjoy the country's low tax rate. Now, it's beefing up those operations.
Nine months after GlaxoSmithKline's bribery scandal first ignited a corruption hunt among Big Pharma companies in China, drugmakers--GSK excepted--are returning to the strong emerging-markets growth they're accustomed to in the country.
Pharma's payments to doctors are diminishing on both sides of the Atlantic. A new report in Britain finds that drugmakers forked over £38.5 million ($63.9 million) to doctors last year. That's slightly less than the 2012 total of £40 million.
Novartis has cracked down on its Japanese management. The Swiss drugmaker pushed out its top three executives Thursday, after a scathing report from a panel investigating misconduct in a leukemia drug trial.
Just days after GlaxoSmithKline announced it would open a new R&D lab and invest more than $200 million in Africa, Sanofi CEO Chris Viehbacher is affirming his country's devotion to Africa, too.
Novartis' Japanese unit didn't fake clinical data in a head-to-head leukemia drug study, an investigatory panel found. But that doesn't mean the Swiss drugmaker's staff is off the hook in its latest Japanese scandal. According to the panel's report, employees not only broke the rules repeatedly--they also engaged in a cover-up.
GlaxoSmithKline has its second recall in as many weeks on its hands, this time affecting batches of the antidepressant Paxil that contain an ingredient manufactured at an Irish plant the FDA says isn't up to snuff.
Auxilium is marketing Vivus' new erectile dysfunction pill Stendra with a jazzy, suggestive promo video during March Madness, when millions of men are glued to the games.
It hasn't been easy being Amarin over the last several months. The Irish drugmaker slammed into one obstacle after another. Read more from FiercePharmaMarketing>>
Much has been made recently over the potential conflicts of interest that arise when doctors take speaking fees from pharma companies. But as a new report suggests, some companies are shelling out a whole lot more to keep medical school and hospital leaders on their boards--where conflicts-of-interest could be much further-reaching.
The FDA says it wants to level the playing field by having generic drugmakers independently update drug labels when there are known risks to the products. The industry feels as if it is being nudged off a cliff.
GlaxoSmithKline CEO Andrew Witty set a precedent back in 2009, when his company placed several patents in a public pool to help developing countries find cures for HIV and other diseases--and then challenged other companies to do the same.
Much has been made as of late of the manufacturing problems found at some of India's biggest drugmakers. But a warning letter sent in March to a GlaxoSmithKline active pharmaceutical ingredient plant in Cork, Ireland, illustrates that Big Pharma is not immune to quality issues.
Actavis has bagged its latest catch. Fresh off last month's deal to buy Forest Laboratories in a $25 billion deal, the generics maker forked over a much smaller amount--$100 million--to buy a small generics company in Thailand.
Eli Lilly just scored billions in additional sales. A federal judge decreed that an unusual patent on Lilly's cancer drug Alimta is valid. And that means the company keeps its Alimta exclusivity till 2022.
GlaxoSmithKline said Monday that after reviewing data from a Phase III trial, it has withdrawn its application to the European Medicines Agency seeking to expand approval of Votrient to include women with advanced ovarian cancer.