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Amicus to delay filing for U.S. marketing rights for lead drug

* Amicus unlikely to file application this year * Had earlier expected to file application by Q4 * Drug aims to be first oral drug for Fabry disease * Company says European filing on track * Stock slumps as much as 59 pct (Adds details)   By Natalie Grover Oct 2 (Reuters) – Amicus Therapeutics […]

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Xenoport to seek partner to develop drug; CEO steps down

Xenoport Inc said it would stop developing on its own a drug that showed high rates of side effects in a study and instead focus on its treatment for restless leg syndrome. The company also said on Thursday that Ronald Barrett, its chief executive since 2001, has stepped down and will be succeeded by Chief […]

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FDA approves Bristol-Myers drug combination for skin cancer

The U.S. Food and Drug Administration approved Bristol-Myers Squibb Co’s immunotherapy drug combination to treat a form of skin cancer, setting the tone for other companies developing similar cocktails. This is the first time the FDA has approved a combination of two immuno-oncology drugs, Bristol-Myers said on Thursday, adding that the treatment will be available […]

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Call for Britain to over-ride patents on Roche cancer drug

A group of patients and campaigners has called on Britain’s health minister to over-ride patents protecting Roche’s expensive breast cancer drug Kadcyla to allow for the import or manufacture of cut-price copies.   The move shows the growing pricing pressure on drug companies on both sides of the Atlantic, especially in the field of cancer […]

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Troubled XOMA Nails Immuno-Oncology Pact Worth $530 Million+ With Novartis

BERKELEY, Calif. – Swiss-based Novartis AG (NVS) struck a deal worth more than $500 million with XOMA Corporation (XOMA) to acquire rights to the company’s anti-transforming growth factor-beta (TGFb) antibody program, Xoma announced this morning. Under terms of the deal, Xoma will receive $37 million in upfront payments, with the remaining $480 million in regulatory […]

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Germany’s Merck sells rights to Kuvan back to BioMarin Pharma

Germany’s Merck KGaA said it agreed to return to BioMarin Pharmaceutical Inc the rights to the Kuvan drug against rare genetic disorder PKU as it seeks to focus on cancer, immunology and neurology. Merck in 2005 acquired the rights to Kuvan and Peg-Pal, another PKU treatment, outside the United States and Japan. Under the agreement […]

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WHO ramps up HIV drug push with call for early treatment for all

Everyone with HIV should be given anti-retroviral drugs as soon as possible after diagnosis, meaning 37 million people worldwide should be on treatment, the World Health Organization (WHO) said on Wednesday.   Recent clinical trials have confirmed that early drug use extends the lives of those with the AIDS-causing virus and cuts the risk of […]

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Drug industry must address image problem over prices: Teva executive

Teva Pharmaceutical Industries Ltd’s research chief said on Tuesday the drug industry must act responsibly when it comes to pricing medications, given the mounting anger over the high cost of therapies in the United States.   Democratic presidential candidate Hillary Clinton brought new attention to the issue last week, proposing to cap patients’ treatment costs, […]

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New analysis says 2001 study of Paxil for teens misrepresented results

(Reuters Health) – According to a reanalysis of the original data from a 2001 study of paroxetine (Paxil) for teens with major depression, the drug was not effective and led to serious side effects, which is not how the results were presented 14 years ago. “There have been warnings about paroxetine for a long time,” […]

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Merck’s once-weekly diabetes drug approved in Japan

Merck & Co said its Type 2 diabetes drug had been approved in Japan, marking the first approval for the once-weekly drug. The drug, omarigliptin, belongs to the same class of drugs as Merck’s bestseller Januvia, which is to be taken once a day. Both drugs are aimed at lowering blood sugar levels. Januvia had […]

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