Topic:

Regulatory

Latest Headlines

Latest Headlines

India's Sun Pharma recalls epilepsy treatment levetiracetam batch over failed dissolution tests

Sun Pharma issued a recall of 3,363 bottles of its levetiracetam extended-release drug for treating epilepsy in the United States after the tablets failed dissolution tests.

Novartis bags a surprise approval for the blood cancer-treating panobinostat

Going against the advice of its independent experts, the FDA approved Novartis' new blood cancer drug for patients with particularly deadly forms of multiple myeloma, looking past some serious safety issues and concerns about the drug's supporting data.

Celldex jumps after gaining an FDA 'breakthrough'

Shares of Celldex Therapeutics shot up 20% this morning after the biotech announced that the FDA had provided its breakthrough therapy designation for rindopepimut (Rintega), an experimental drug for patients with EGFRvIII-positive glioblastoma.

First adhesive varicose vein treatment wins FDA approval

With the FDA approval of Covidien's VenaSeal closure system, medical professionals can for the first time treat varicose veins in the legs by using an adhesive to cut off blood supply.

Lupin plant hit with Form 483 but continues to rack up approvals

The FDA has sent a Form 483 to Lupin listing 6 observations its inspectors made during a visit to one of the company's production plants in central India last month. However, the ticking off has done little to slow the rate of approvals for the facility, which has racked up two site transfer nods and one ANDA go-ahead since receiving the Form 483.

UPDATE: Gilead hauled up over ADR reporting in Japan

Japan's Ministry of Health, Labor and Welfare (MHLW) scolded Gilead Sciences Inc. for its failure to report overseas adverse drug reaction (ADR) cases involving three drugs within the required timeframe.

American Chamber survey finds companies less sanguine on China prospects

American businesses, including members of the pharmaceutical industry, appear to be less sanguine about their prospects of doing business or expanding it in China.

23andMe scores FDA OK to market genetic carrier test direct to consumers

23andMe nabbed FDA clearance to market its genetic carrier test directly to consumers, a big win for the company as it continues to get back in the agency's good graces and expand the reach for its genetic tests.

Ex-Merck analyst pleads guilty to insider trading

Former Merck analyst Zachary Zwerko pleaded guilty to federal insider-trading charges on Thursday for passing merger tips to a business school chum. The tips allowed the New York Mellon trader to make $700,000 in profits, Bloomberg reports.

23andMe nabs FDA marketing clearance for direct-to-consumer genetic carrier test

23andMe scored FDA clearance to market its direct-to-consumer genetic carrier test for Bloom syndrome, a crucial win for the company as it continues to make good with the agency and expand the reach for its genetic tests.