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European Commission Investigates J&J and Novartis

February 1, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Commission claims that Johnson & Johnson and Novartis may have breached European antitrust rules.

Pfizer Reports Fourth-Quarter and Full-Year 2012 Financial Results

February 1, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

Pfizer has reported financial results for fourth-quarter and full-year 2012. Fourth-quarter 2012 revenues were $15.1 billion, a decrease of 7% compared with $16.1 billion in the year-ago quarter, which reflects an operational decline of $802 million, or 5%, and the unfavorable impact of foreign exchange of $271 million, or 2%.

US Pharmacopeial Convention Announces Revised Official Dates for Elemental Impurities Chapters

January 31, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.

Endo Pharmaceuticals and GVK Biosciences Form Research Collaboration

January 30, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

Endo Pharmaceuticals and GVK Biosciences (GVK BIO), a contract research organisation (CRO) based in India, have entered into an agreement to collaborate on the development of small molecules targeting an undisclosed protein. Using its discovery expertise, GVK BIO will deliver a clinical candidate and Endo will be responsible for the development and commercialisation of the product.

Ben Venue Laboratories Enters Consent Decree

January 29, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

Ben Venue Laboratories announced that it has voluntarily entered into a consent decree with FDA over violations of cGMP.

GSK in Joint Venture for Pediatric Vaccine

January 28, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

GlaxoSmithKline has formed a joint venture with Indian vaccines company Biological E to research and develop a six-in-one combination pediatric vaccine to help protect children in India and other developing countries from certain infectious diseases.

Actavis Unveils Long-Term Growth Strategy

January 25, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

Following its recent acquisition, Actavis (formerly Watson Pharmaceuticals) unveiled its long-term growth strategy during its investor meeting in New York.

FDA Approves New Influenza Vaccine Manufactured with Novel Technology

January 18, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has approved Protein Sciences's FluBlok, a seasonal influenza vaccine made with novel technology. FluBlok uses recombinant DNA and a modified baculovirus (a virus that infects insects) to produce a safe and effective human flu vaccine. FDA approved Flublok for people 18–49 years old.

Hameln Pharmaceuticals Receives FDA Warning Letter

January 16, 2013

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has issued a Warning Letter to Hameln Pharmaceuticals GmbH after observing "significant" cGMP violations for finished pharmaceuticals at the company?s facility in Hameln, Germany.

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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
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