PHARMACY

FDA approvals relatively flat in 2009

BY Allison Cerra

WASHINGTON The Food and Drug Administration approved 26 drugs in 2009, compared with 25 approvals in 2008.

According to research firm Washington Analysis, 2009 was the approval year of first-of-its-kind medicines, including such prescription medications as Novartis’ skin cancer drug Afinitor and Effient, a blood thinner made by Eli Lilly & Co. and Daiichi-Sankyo.

During this same period, the FDA also added “black box” warning labels to 31 drugs.

In May 2009, Margaret Hamburg was confirmed as the new FDA commissioner, promising “to prevent harm to the American people” through “swift, aggressive and effective” enforcement of FDA laws and regulations.

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PHARMACY

Report: Cipla in generic drug supply talks with GSK, Teva

BY Allison Cerra

NEW YORK An India drug maker is in generic drug supply talks with two companies, according to reports.

Cipla said it is in talks with GlaxoSmithKline and Teva to supply the companies with generic drugs.

“It may be specifically for one or two products — it is not a down-the-line drug deal,” Cipla chairman Yusuf Hamied told Reuters.

Cipla is one of the world’s biggest producers of low-cost antiretroviral drugs to fight HIV and AIDS. Last month, the company announced the launch of a generic H1N1 treatment.

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Taro elects directors in shareholders meeting; Sun disapproves

BY Allison Cerra

HAWTHORNE, N.Y. An Israeli drug maker said that its shareholders voted to elect all of the directors who were up for election, with the exception of the statutory external directors, at its annual shareholders meeting held Dec. 31.

The shareholders also approved the ratification of indemnification for non-executive directors and the appointment of the Taro’s independent auditors.

The company said that it stands behind its nominees for statutory external directors and their qualifications, and further stated that it would continue its efforts to elect statutory external directors as required by Israeli law, despite the efforts of Sun Pharmaceutical Industries to block their election. Sun has claimed that Barrie Levitt, Taro’s chairman, signed contractual obligation to sell Taro’s shares to Sun at a pre-defined price in June 2008. Sun said, however, that Levitt and the company “have prevented the close of this transaction through improper use of Taro resources.”

Sun has sought to acquire Taro for some time. In August 2008, Sun’s tender offer to acquire the company expired, but said that it would once again seek to acquire Taro. In late September, Taro sued Sun in the U.S. District Court for the Southern District of New York, alleging that Sun failed to disclose information to Taro shareholders, and misappropriating confidential information about Taro as part of its efforts to acquire the company – which it has sought to do since June 2008 – and illegally using it to undermine Taro’s relationships with customers and revenues.

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