Topic:

Regulatory

Latest Headlines

Latest Headlines

Chinese regulators easing multi-region clinical trial hurdles

China's move to spur drug approvals is seen as a breakthrough on accepting multi-region clinical trial processes as part of an effort to clear nearly 20,000 medicine approval requests pending and allowing more innovative therapies to reach the market, according to a briefing by the country's State Council, or cabinet.

FDA clears NOWDiagnostics' drop-of-blood test for early detection of pregnancy

NOWDiagnostics just received FDA clearance for its AdexusDx point-of-care test, which uses a single blood to diagnose pregnancy earlier two to 8 earlier in the process than its urine-based cousins.

AbbVie hands United a record $350M payoff for a speedy FDA review voucher

The cost of a priority review voucher for the FDA keeps going up. AbbVie is forking over a record $350 million to acquire a voucher from United Therapeutics, giving them an option at shaving four months off the agency's standard 10-month review process.

Illumina, Mayo Clinic, LabCorp form cooperative venture to sell genetic insights to consumers

Genetic data has already proven its clinical benefits, but still has a ways to go when it comes to consumerization, as evidenced by the demise of 23andMe's saliva-based Personal Genome Test at the hands of the FDA.

FDA clears a controversial female libido drug despite 'modest' effects and dangerous risks

The FDA cleared Sprout Pharmaceuticals' much-scrutinized flibanserin, a first-of-its-kind pill designed to boost women's sexual desire, but not without sticking a black-box safety warning on the drug.

Seattle Genetics scores Adcetris expansion for 'high risk' lymphoma patients

Seattle Genetics just won a boost for its lymphoma drug Adcetris. The FDA added a new indication to the drug's toolbox, for patients with Hodgkin's lymphoma at high risk of relapse after a stem-cell transplant.

Hemispherx says plant upgrade will allow it to return its genital wart treatment to market

Hemispherx Biopharma has had a somewhat rocky relationship with both the FDA and the Street. But with a manufacturing upgrade complete and a distribution agreement in hand, it expects to return to the market its only approved product after a 7-year hiatus.

UPDATED: FDA castigates three Mylan sterile drug plants in warning letter

Mylan's recent recall of injected cancer drugs, was a hint that all was not well at some of the plants Mylan got two years ago in its $1.75 billion deal for Indian sterile injectables producer Agila Specialties. But just how deep those problems are came to light today when the FDA posted a warning letter for three of those Indian facilities, including one that was cited shortly before Mylan bought it.

Merck's Keytruda ready for quick FDA action on big melanoma expansion

Merck & Co.'s Keytruda has jumped on the FDA's priority review track for a new first-line use in melanoma. The PD-1 immunotherapy, already approved to treat relapsed melanoma and under FDA review in lung cancer, needs the broader melanoma approval to keep abreast of Bristol-Myers Squibb's rival drug Opdivo.

BioDelivery snags new FDA approval for Onsolis after ditching Meda partnership

BioDelivery Sciences' Onsolis, a cancer pain treatment that makes use of the company's buccal delivery platform, picked up a new FDA approval for a reformulation of the treatment, which is expected to return to the U.S. market in 2016. BioDelivery earlier this year pulled out of a commercialization partnership with Sweden's Meda, which decided to focus more on respiration, and BioDelivery is currently looking for a new partner.