A flurry of regulatory decisions around the world delivered a big new European approval for Bayer's Xarelto, an FDA nod for Novartis' new antibiotic for cystic fibrosis patients, and a Japanese clearance for Roche's subcutaneous formulation of Actemra.
The logistics of getting drugs delivered in underdeveloped countries can be tricky. Many companies turn to partners with the expertise that can help them navigate the import laws and distribution obstacles that those countries present.
The fight over drug patents in India is quickly ratcheting up even as other countries are looking at new twists on the model for getting their hands on cheaper drugs.
Bayer and Merck have weighed in on the big pay-for-delay case. The two drugmakers filed briefs taking pharma's side in the case, which comes up for hearing at the Supreme Court later this month. And no wonder: It's the culmination of a years-long debate over patent settlements between generics companies and branded drugmakers.
Johnson & Johnson and Bayer AG are looking on the bright side of things when it comes to Xarelto. They are undertaking new trials they hope will lead to much wider use of the new kind of blood thinner. The announcement comes days after the FDA for the second time rebuffed their bid to get it a coveted approval for treatment of acute coronary syndrome (ACS).
Johnson & Johnson and Bayer tried again to persuade FDA on a new use for Xarelto, in patients with acute coronary syndrome. But once again, the attempt failed.
Bayer's new drugs are bringing home the bacon. The German drugmaker raised its 2015 forecast for 5 key products to €2.5 billion ($3.3 billion)--and confirmed previous promises that those drugs would surpass €5.5 billion by 2020.
Bayer's new cancer drug Stivarga has already added a notch to its belt. Cleared by the FDA last year to treat colorectal cancer, the drug is now approved as a treatment for a rare form of gastric cancer, gastrointestinal stromal tumors.
Embarrassed by the ads for erectile dysfunction drugs that pop up at the most inopportune moments? A new study found that the television commercials are indeed airing at family-viewing times--contrary to drugmakers' express promises to refrain.
In-licensed from Norway's Algeta, Alpharadin is one of the pharma company's top late-stage prospects, following a string of regulatory wins on the development front.