Jazz Pharmaceuticals secured the FDA's priority review for a long-delayed rare disease treatment, accelerating the path of a drug acquired in a $1 billion buyout.
2014 Fierce 15 member EarLens just obtained an FDA approval of its hearing aid via the rarely used de novo pathway for low- to moderate-risk devices that don't have a substantially equivalent predecessor on the market.
Amid growing backlash from state and local lawmakers over opioid marketing, New Hampshire in investigating several drugmakers for potential violations. The state says pain drug companies may have intentionally exaggerated their products' benefits while downplaying serious risks.
The FDA has promised a quick review for Clovis Oncology's new lung cancer treatment, bolstering the company's prospects as it races against a similar drug from AstraZeneca.
China's commerce ministry has lightly slapped a unit of Shanghai Fosun Pharmaceutical Group with a fine for acquiring a stake in a Suzhou-based company without government approval.
Médecins Sans Frontières warned in a high-profile campaign during the United Nations summit on development in in New York that the United States is pressuring Indian Prime Minister Narendra Modi to change the country's intellectual property policies for drugs, which could result in millions of people around the world being unable to access medicines.
Is the FDA overpromising and underdelivering? A recent study shows that when the agency uses terms such as "breakthrough" or "promising" in statements about a med, it could sway individuals' perceptions about how well the drug actually works.
A rope-a-dope strategy of sorts on biosimilars is in play for India's Dr. Reddy's as it shifts from a strategy of racing to the domestic market with products in favor of a coiled approach that will let it strike out in several markets in a burst.
UVLrx Therapeutics has secured a CE mark for its intravenous UV light therapeutic system across a wide variety of indications. The use of ultraviolet blood irradiation stretches back over a century, but fell out of favor with the rise of antibiotics in the 1950s. This system, dubbed UVLrx 1500, is designed to be used without removing the blood from the body.
How do you keep a 22-year-old injectable multiple sclerosis therapy competitive in the face of threats from high-flying oral contenders? Bayer has an idea. The company recently won FDA approval for Betaconnect, an automatic injector it thinks can help keep its standby treatment, Betaseron, in the game.