PHARMACY

Under PEPFAR, Matrix gets tentative approval for generic Combivir

BY Alaric DeArment

PITTSBURGH — The Food and Drug Administration has given tentative approval to an antiretroviral treatment for children with HIV and AIDS under the President’s Emergency Plan for AIDS Relief program.

Mylan announced Thursday that its subsidiary, Matrix Labs, had received the tentative approval for lamivudine and zidovudine tablets in the 30-mg/60-mg strength. The drug is a generic version of Combivir, made by ViiV Healthcare, a company specializing in HIV and AIDS created as a partnership between Pfizer and GlaxoSmithKline.

“The approval of lamivudine and zidovudine is particularly important because it makes available an innovative [fixed-dose combination] treatment option for children who are living with HIV/AIDS in developing countries,” Mylan president Heather Bresch said.

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PHARMACY

MannKind receives complete response letter for Afrezza

BY Allison Cerra

VALENCIA, Calif. — It seems that MannKind has experienced a setback with a drug designed to control hyperglycemia in Type 1 and Type 2 diabetes patients.

The Food and Drug Administration on Thursday issued a complete response letter to the drug maker regarding Afrezza (insulin human [rDNA origin]) inhalation powder. The regulatory agency requested that the company conduct two clinical trials, one in patients with Type 1 diabetes and one in patients with Type 2 diabetes, with its next-generation inhaler, to assure it works as effectively as MedTone, its predecessor.

"While we are disappointed with the complete response letter, we are encouraged that the FDA is asking for clinical studies only to confirm the bridging and handling of the next-generation device in order to compare it to the device used in our extensive clinical program," said MannKind’s chairman and CEO Alfred Mann. "We remain committed to working with the FDA to make Afrezza available to people with diabetes."

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Report: Genzyme CEO calls acquisition by Sanofi-Aventis a long process

BY Alaric DeArment

BOSTON — Finalizing an acquisition of biotech company Genzyme by French drug maker Sanofi-Aventis “will take some time,” media reports quoted Genzyme’s chief executive as saying.

The Boston Globe quoted Genzyme CEO Henri Termeer as saying it would be a long process to understand the company’s full value, in particular because of an investigational multiple sclerosis drug, Campath (alemtuzumab), which could achieve blockbuster sales and thus raise the company’s value and acquisition price if it wins approval.

Sanofi voiced its intent to buy Genzyme last July for $18.5 billion, or about $69 per share. The Wall Street Journal and Bloomberg reported earlier this month that contingent value rights could raise the price to as much as $80 per share.

In other news, Genzyme announced it would build a $335 million plant in Geel, Belgium, for manufacturing Myozyme and Lumizyme (alglucosidase alfa), used to treat Pompe disease. The company expects to receive approval to market drugs manufactured in the plant in 2014.

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