PHARMACY

Ranbaxy head steps down

BY Alaric DeArment

GURGAON, India The CEO of Ranbaxy Labs will step down next week, the Indian generic drug maker said Thursday.

Ranbaxy said Atul Sobti would leave the positions of CEO and managing director on Aug. 19, while president of the company’s global pharmaceutical business Arun Sawhney would serve as managing director beginning Aug. 20.

“We are extremely grateful for the significant contribution Mr. Sobti has made to Ranbaxy ever since he joined the company,” chairman Tsutomu Une said. “Under his leadership as CEO and managing director, Ranbaxy has realized various opportunities to repeat the strong operating performance while continuing to manage key challenges.”

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Curemark gets nod to start late-stage trial for ADHD drug

BY Alaric DeArment

RYE, N.Y. The Food and Drug Administration has approved a late-stage clinical trial of a drug for attention deficit hyperactivity disorder.

Curemark said the FDA cleared its application to run a phase 3 trial of CM-4612 in patients with ADHD. The company is currently conducting a phase 3 trial of CM-AT, a treatment for autism in children.

“We are very excited to have received [clearance] from the FDA so that we can move forward with clinical trials to study CM-4612,” Curemark CEO Joan Fallon said. “Curemark hopes to have the first physiologically based medication to address ADHD, in lieu of the current psychotropic and stimulant treatments.”

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FDA approves additional dosage for NovoSeven RT

BY Alaric DeArment

PRINCETON, N.J. The Food and Drug Administration has approved a new dose of a treatment for hemophilia from Novo Nordisk, the Danish drug maker said.

The FDA approved Novo Nordisk’s NovoSeven RT (coagulation factor VIIa [recombinant], room temperature stable) in 8-mg vials. The treatment, which comes in the form of a powder mixed for injection, was already available in 1, 2 and 5 mg vials. The FDA also approved an extension of shelf life for all vial sizes from 24 months to 36 months at or below 77 degrees.

NovoSeven RT is formulated for patients with hemophilia A or B with inhibitors. The new dosage will shorten the time it takes to prepare the injection, known as reconstitution, compared with current dosages.

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