Browsing Category Press Releases

Autism Not Caused by Vaccines: Study

For years, countless parents have blamed the childhood vaccination schedule – and sometimes, specific vaccines – as a risk for developing autism. In fact, about one-third of parents continue to express concern about the cumulative effect of the number of vaccines (click here for a back story). And nearly one in 10 parents refuse or delay [...]

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Category : News &Press Releases

Alexion Hammered in FDA Inspection

One of the darlings of the biotech industry has suffered a blow following an FDA inspection of its Rhode Island facility. Alexion Pharmaceuticals disclosed this morning that the agency issued a so-called 483 inspection report, which refers to a failure to adhere to various good manufacturing practices. This plant is where Alexion manufactures Soliris, an orphan drug [...]

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Category : News &Press Releases

Impax Shares Plummet as FDA Finds Manufacturing Issues

Impax Laboratories Inc. (IPXL), the developer of the experimental drug Rytary for Parkinson’s disease, fell the most in almost three years after regulators found that manufacturing issues persist at a company plant. Impax declined 25 percent to $15.03 at 11:03 a.m. New York time, after falling to $14.88 in the biggest intraday drop since May [...]

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Category : News &Press Releases

FDA flags new concerns on Hospira’s Rocky Mount plant

Hospira Inc said U.S. health regulators raised fresh concerns about the injectable-drugs maker’s troubled Rocky Mount, North Carolina manufacturing plant – one of its largest production facilities. The much-awaited outcome of the FDA re-inspection of the plant did not provide significant additional clarity for the stock, Morgan Stanley analyst Marshall Urist wrote in a note. [...]

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Category : News &Press Releases

Pharma Manufacturing & Quality Management China 2012 is Upcoming

Pharma Manufacturing & Quality Management China 2012 is Upcoming – Effective Implementation of Quality Management System to Enhance New GMP Compliance By CPhI Conferences Published: Wednesday, Aug. 22, 2012 – 4:06 am SHANGHAI, Aug. 22, 2012 — /PRNewswire-Asia/ — Pharma Manufacturing & Quality Management China 2012, organized by CPhI Conferences, will be held on 6th [...]

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Category : Press Releases

Pharma IQ’s Drug Recalls Industry Outline

Pharma IQ’s Drug Recalls Industry Outline By Pharma IQ Published: Friday, Aug. 24, 2012 – 12:11 am LONDON, August 24, 2012 — /PRNewswire/ – Pharma IQ has just produced the Drug Recalls Industry Outline, where it analyses the challenges and implications of the late stage development failures. Pharma IQ had a quick look back over [...]

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Category : Press Releases

FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium

FDA issues new safety alert on Reumofan Plus and Reumofan Plus Premium The U.S. Food and Drug Administration today issued a new warning to consumers about the potential health risks of two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The products, Reumofan Plus and Reumofan [...]

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Category : Press Releases

Watson’s Generic Lidoderm(R) Receives FDA Approval

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for lidocaine topical patch 5%, the generic equivalent to Endo’s Lidoderm®. Watson plans to launch the product in September of 2013 pursuant [...]

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Category : Press Releases

Healthcare Review: Watson Pharmaceuticals, Pozen, Discovery Laboratories & Amarin Jump

U.S. stocks rose Friday, after a report that the European Central Bank is considering a new bond-buying program and Federal Reserve Chairman Ben Bernanke said the U.S. central bank had more tools, if needed, to stimulate the economy. Several healthcare stocks are making notable news at mid day on Friday: Watson Pharmaceuticals, Inc. (NYSE:WPI) stock [...]

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Category : Press Releases

Navamedic launches its third generic drug

Navamedic ASA (OSE: NAVA), the Norwegian pharmaceutical products company, today announced the successful launch of its third generic pharmaceutical product. The launch is an important step in becoming a significant Nordic generics provider. DonepezilR is a drug used by patients suffering from Alzheimers Disease and other dementia conditions. The product can replace Pfizer’s Aricept. The [...]

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Category : Press Releases

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