Latest Headlines

Latest Headlines

ALSO NOTED: Par drops Advancis partnership; Diovan gets new indication; Pozen makes case for MT-100; and much more...

> Par Pharmaceutical has pulled out of its development partnership with Advancis, saving itself a scheduled $4.75 million payment. The news follows Advancis' announcement that it would slash its staff following the failure of Amoxicillin PULSYS in Phase III trials. Story > The FDA has approved a new indication for Novartis' bestselling Diovan, adding its use to improve survival after a heart attack. …

Idenix, Novartis hepatitis drug meets trial goal

Idenix Pharmaceuticals and Swiss drug maker Novartis said telbivudine, their experimental drug for hepatitis B, met its primary goal in a Phase III trial. The 1,350-patient study showed telbivudine was at least as effective as lamivudine, the standard Hepatitis B treatment, after one year of use. The companies said they plan to ask US regulators for approval by the end of 2005.- read this press release for more

Novartis, Schering cancer drug faces new setback

Novartis and Schering said their highly touted colorectal cancer drug, PTK/ZK, fell short in a second round of clinical trials by failing to show an overall survival benefit. The companies are now rethinking their plans to seek regulatory approval for the drug. The drug, one of a new class designed to starve tumors of the blood they need to grow, had been hailed as a potential rival to Roche and Genentech's Avastin, a big sales success, and Erbitux, a drug from ImClone and Merck that …

DEALS: Novartis expands OTC operations

Novartis wins big OTC deal.

Tokyo giant to acquire England's Arakis

Sosei will buy Cambridge, UK-based biopharma Arakis-- a 2005 Fierce 15 winner-- for £106.5 million, the companies announced. The buyout comes on the heels of Novartis' decision to develop one of Arakis' products into a treatment for smoker's cough. Arakis has three other products in clinical development, including a cancer pain drug that will enter Phase III trials later this year.- read this Business Weekly story for more

FDA wants to see more data on Chiron's Pulminiq

The FDA says Chiron's experimental therapy to prevent lung transplant rejection-- Pulminiq-- is "approvable," but needs new studies to prove its effectiveness to regulators. An FDA advisory panel said last June that the therapy seemed safe but questioned whether the trial included enough subjects to prove it was effective. Pulminiq is an inhaled version of cyclosporine, which is already approved for use in preventing the rejection of organ transplants. Chiron acquired Pulminiq from …

Novartis targets 'critical mass' in $660M OTC drug buyout

Novartis is acquiring a package of North American over-the-counter drugs-- including Excedrin, No-Doz and Comtrex-- from Bristol-Myers Squibb for $660 million. The news quickly sparked cheers from analysts, who saw the buyout as a good move for the Swiss drug giant. Novartis, already one of the largest OTC manufacturers in the world, said the move would give it greater "critical mass" in the North American market. Novartis announced on Thursday that its net profit in the first six …

Drug experts to review safety concerns for 3 asthma drugs

A panel of drug experts will review three asthma therapies today to determine if they should stay on the market after a small number of cases were reported by patients who said the drugs were associated with severe asthma exacerbations. The drugs are GlaxoSmithKline's Advair and Serevent and Novartis' Foradil. Two of the drugs contain the active ingredient salmeterol. Foradil contains formoterol. Advair and Serevent both feature warnings of a small increase in the number of deaths of …

ALSO NOTED: Impotence drug labels revised; Roche, GE to collaborate; Esprit buys rights to Sanctura; and much more...

> The FDA has approved revised labels for Levitra, Cialis and Viagra, warning users of a slight increase in the risk of sudden blindness. Story > Roche and GE Healthcare will collaborate on upcoming tests of Roche's experimental Alzheimer's treatment. Report > Esprit Pharma has acquired the US …

Biopharma companies funnel cash to defeat Calif. drug proposal

Drug companies have been funneling tens of millions of dollars into a war chest that will be used to campaign against a California initiative that would require manufacturers to extend discounts to low-income residents or face being kicked off the state's Medicaid formulary. Merck and GlaxoSmithKline have each anted up $8.54 million, with millions more coming from Amgen, Eli Lilly and Novartis. The money will also go to support an industry initiative that would create a voluntary discount …
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