MAP Pharma shares dive after FDA rejects migraine treatment
Shares of MAP Pharmaceuticals Inc (MAPP.O) fell by a third in premarket trade on Tuesday, after health regulators rejected its orally inhaled treatment for migraine, but analysts remain optimistic of its potential to eventually win approval. The U.S. Food and Drug Administration, which raised issues related to the chemistry, manufacturing and controls (CMC) of the […]
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Ahead of the Bell: FDA outlines MAP drug issues
The Food and Drug Administration has asked drugmaker MAP Pharmaceuticals Inc. to address issues tied to chemistry, manufacturing and controls before it can decide whether to approve its potential migraine treatment Levadex. The company’s shares fell $4.04, or 23.6 percent, to $13.10 in premarket trading Tuesday. Regulators told the Mountain View, Calif., company in a […]
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FDA Launches Pilot to Allow Some Firms to Avoid Re-Inspections
The Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) are testing a Pilot Multi-Purpose Audit Program in 2012 and 2013 that will allow medical device companies under their jurisdiction to voluntarily submit certain audits and receive Agency inspection relief for one year. The policy was announced in […]
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CRO Files Chapter 11 After FDA Alert on Faulty Clinical Trials
Source: Pharmalot Eight months after the FDA alerted drugmakers to reevaluate clinical tests conducted by Cetero Research due to falsified data and manipulated samples, the contract research organization has filed for bankruptcy. Why? The FDA notice put a strain on its finances because lenders viewed this as a breach of “applicable health laws and regulations†[…]
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Mediocre Amgen CEO Nets $49 Million Golden Parachute
Source: Pharmalot As Kevin Sharer gets ready to retire as Amgen ceo in May and as chairman at year’s end, he has a lot to look forward to – some $49 million, in fact, according to the proxy filed with the Us Securities and Exchange Commission. The payout will follow a decade in which he […]
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Drug companies watching India’s drug patent case
India’s Supreme Court will hear final arguments starting this week in a case that could have life-or-death implications for millions of people with critical illnesses such as AIDS and cancer, not just in this country but across the developing world. The case pits the government of India against the Swiss pharmaceutical company Novartis and it […]
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Drugmaker Nephron could expand S.C. plant
Nephron Pharmaceutical’s new facility near Cayce, SC will be a major research and development center for new products the drugmaker wants to offer. The Orlando, Fla.-based company is looking to expand beyond generic respiratory medicine with anti-cancer and eye-care products among possibilities, company owners William and Lou Kennedy said Thursday at a celebration kicking off […]
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Other Than The Fact That We Have No Equipment For Drug Testing, Our Lab Is Great
Source: Pharmalot When it comes to manufacturing problems, some drugmakers experience lapses. Others have oversights. Then, there are those such as Laboratorios Jaloma, which lacks a few basics. Such as? Well, the drugmaker, which is based in Guadalajara, México, apparently did not have the equipment needed to actually test its products for release. This can […]
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‘Corrupt Lab Practices’ Charges by FDA Lead to Cetero Bankruptcy
Just eight months after the FDA issued a scathing report accusing employees at the contract research firm Cetero of faking research work for clients, the CRO has filed for bankruptcy protection and is angling to sell its assets to the highest bidder. Last July the FDA set off alarm bells for drug developers which had […]
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FDA Ok’d High Aricept Dose Despite Warning
Nearly two years ago, the FDA approved a higher dose of the Aricept treatment for Alzheimer’s, just a few months before the drug, which is sold by Pfizer and generated some $2 billion in annual revenue, was due to lose patent protection. At the time, Pfizer sold two versions of Aricept – a 5 mg […]
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