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Approvals

Osiris Stem Cell Therapy Approved in Canada

May 18 | News

NEW YORK (AP) — Osiris Therapeutics Inc. said Thursday that Canadian regulators approved its stem cell therapy Prochymal, which is intended to treat a deadly side effect of bone marrow transplants.  

Panel Backs First Rapid, Take Home HIV Test

May 16 | News

WASHINGTON (AP) — American consumers may soon be able to test themselves for the virus that causes AIDS in the privacy of their own homes, after a panel of experts on Tuesday recommended approval of the first rapid, over-the-counter HIV test.  

Achillion Gets FDA Incentives for Hepatitis C Drug

May 15 | News

NEW HAVEN, Conn. (AP) — Achillion Pharmaceuticals Inc. said Tuesday it will receive incentives from regulators as it studies a new experimental treatment for the hepatitis C virus.  

FDA Approves Protalix's Gaucher Drug Elelyso

May 1 | News

The Food and Drug Administration on Tuesday approved a new treatment for Gaucher disease, a rare genetic disorder that can cause liver and neurological problems.The new drug is called Elelyso. It was developed by Protalix BioTherapeutics Inc. and licensed to Pfizer Inc., which is the largest...

FDA Approves Vivus’ ED Drug Stendra

Apr 30 | News

The Food and Drug Administration on Friday approved a new impotence drug, Vivus Inc.'s Stendra.

FDA Approves Antibiotic to Treat, Prevent Plague

Apr 28 | News

U.S. regulators have approved use of a powerful Johnson & Johnson antibiotic to treat plague, an extremely rare, sometimes-deadly bacterial infection.

Novartis Drug Afinitor Approved by FDA

Apr 27 | News

Novartis Pharmaceuticals Corporation announced today that the FDA approved Afinitor (everolimus) tablets for the treatment of adult patients with kidney tumors known as renal angiomyolipomas and tuberous sclerosis complex (TSC), who do not require immediate surgery.

FDA Approves Votrient for Treatment of Patients with Certain Types of Advanced Soft Tissue Sarcoma

Apr 27 | News

GlaxoSmithKline plc announced today that the FDA has approved Votrient (pazopanib) for the treatment of patients with advanced soft tissue sarcoma who have received prior chemotherapy.

FDA Clears Codexis' New Enzyme-Making Process

Apr 25 | News

REDWOOD CITY, Calif. (AP) — Industrial enzyme developer Codexis Inc. said Tuesday that the Food and Drug Administration has approved the company's process for manufacturing the active pharmaceutical ingredient in Merck's diabetes drug Januvia.  

EU Committee Recommends Approval for Amag Drug

Apr 23 | News

LEXINGTON, Mass. (AP) — Amag Pharmaceuticals Inc. said Friday a European Union regulatory committee is recommending approval for its iron deficiency drug Feraheme.  

Blogs

The Tale of Two Deviations

The Tale of Two Deviations

Apr 23 | The QA Pharm

It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s).

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Can the Combination of Creative Destruction and “Steve Jobs’ Traits” Lead to a “Pharma QbD Spring”?

Apr 16 | Girish Malhotra, PE, President, EPCOT International

The answer is an unequivocal yes but we need some outsiders who can conspire with the insiders who will be the flag bearers within the companies. Outsiders can be the counsels/co-conspirators to the insiders for the coup d'etat.

Multimedia

Lung Cancer Drug Treats Rare Lymphoma Tumors

Lung Cancer Drug Treats Rare Lymphoma Tumors

May 17 | Video

A new study found Xalkori effective in treating anaplastic lymphoma among children, an encouraging development for gene-targeted therapy.

Merck - 2012 Facility of the Year Award - Facility Integration

Merck - 2012 Facility of the Year Award - Facility Integration

May 14 | Video

Brian Morrissey, Senior Project Engineer, Merck Manufacturing Division, talks to Pharmaceutical Processing's Editor In Chief Mike Auerbach during INTERPHEX 2012 about the company's Vaccine Bulk Manufacturing Facility Program of Projects. The facility has won the Facility Integration award in the 2012 Facility of the Year Award competition sponsored by ISPE, INTERPHEX and Pharmaceutical Processing magazine.

Medicine from a Vending Machine?

Medicine from a Vending Machine?

May 3 | Video

A Chinese company is pushing for acceptance of traditional Chinese medicine with a machine that can dispense herbs.

Taking Precautions to Prevent Contagion

Taking Precautions to Prevent Contagion

Apr 29 | Video

With the recent outbreak of viruses such as SARS, bird flu and swine flu, officials and travelers are being extra careful about preventing the illnesses from being transmitted.

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