As the company points out, it's the only product cleared for patients whose chronic spontaneous urticaria haven't responded to antihistamines.
Merck KGaA's multiple sclerosis treatment Rebif is holding its own. Considering that the German drugmaker's flagship product faces some formidable new competitors--including Biogen Idec's brand-new powerhouse, Tecfidera--that's not too shabby.
After their antitrust-fighting colleagues levied $251 million in fines against Swiss drugmakers Roche and Novartis on allegations that they colluded to protect sales of their eye drug, Italian prosecutors are now investigating possible market manipulation and fraud, according to Reuters.
For Endo's testosterone therapy Aveed, the third time wasn't the charm with the FDA--but the fourth time was. After a trio of rejections, the FDA has given the thumbs up to the Low-T drug, and the Malvern, PA-based company expects to launch it this month. But amid the safety questions surrounding testosterone drugs, doing so may not be so easy.
Johnson & Johnson and AstraZeneca will just have to duke it out for share of the market for SGLT2 treatments for diabetes. A potential third competitor from Eli Lilly and Boehringer Ingelheim, empagliflozin, failed to win FDA approval, thanks to problems at a Boehringer manufacturing plant.
Sales of Sanofi's rare-disease treatment Kynamro, approved last January, got off to a slow start, but that situation shouldn't persist now that the French drugmaker's Genzyme unit has beefed up its sales force.
Eli Lilly is staring down the barrel of its Evista patent expiration. And Tuesday, Teva Pharmaceutical Industries won FDA approval to load the bullet. The company's generic version of Lilly's breast cancer and osteoporosis drug got the green light, and Teva says it will hit the U.S. market within a month.
Doctors have been prescribing Roche's cancer drug Avastin off-label to treat some of the same vision problems as its eye drug, Lucentis. Now, Italy's antitrust authority has fined Roche and marketing partner Novartis, accusing them of colluding to push doctors toward the pricier option--claims the pair denies.
Amarin's lawyers were just in court last week suing the FDA for limiting the exclusivity it granted the drugmaker's fish oil pill Vascepa. But the Irish drugmaker hustled them back to court Tuesday, this time to sue AzstraZeneca, which is awaiting FDA approval on its own product for treating super-high cholesterol.
How can Medicaid pay for the pricey new generation of hepatitis C drugs? Insurers want to know. And they're now asking state health agencies to pitch in, Reuters reports.
Teva Pharmaceutical Industries is trying to throw up yet another hurdle to a generic version of its blockbuster multiple sclerosis drug Copaxone from India's Natco Pharmaceuticals.
Roche's debt from its 2009 buyout of Genentech is winding down--and less money to pay means more money to play with, outgoing chairman Franz Humer says.
It's fairly routine for the U.K.'s cost-effectiveness watchdogs to ask companies for more data to support approval for use by the country's National Health Service. Clinical data, price modeling, the works. But asking for information on R&D costs? That's something different altogether.
Drugmakers aren't spending as much on speaking fees these days. Some companies--namely Pfizer and Eli Lilly--have slashed physician payments by more than half.
It turns out the corruption probe in China wasn't Sanofi's only recent bribery investigation. A German court convicted two former employees of bribery 10 months ago and slapped the French drugmaker with a €28 million ($39 million) fine--news that's just now coming to light thanks to a simplified German legal process that allows courts to try some crimes without a courtroom trial.
Japan's health ministry is one of the world's toughest when it comes to demanding truth in advertising. The newest target of its scrutiny is Takeda Pharmaceutical, which is now admitting it may have mis-marketed its hypertension drug Blopress. Takeda's CEO, Yasuchika Hasegawa, told reporters at a news conference on Monday that the company used "inappropriate expressions" to advertise the drug, according to The Wall Street Journal.
The German government has decided to extend a drug-pricing freeze through 2017.
Pfizer's once-gargantuan statin drug Lipitor has been cut down to size by generic competition. But if the drugmaker's plan to win over-the-counter status for the drug succeeds, Pfizer could add up to $1 billion back into its Lipitor franchise.
Drugmaker Questcor has run into questions--sometimes from regulators--about sales and marketing for its high-priced drug for autoimmune disorders, H.P. Acthar Gel. And every step of the way, short seller Citron Research has been there to trumpet those mishaps.