Articles by Patricia Van Arnum - BioPharm International

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Articles by Patricia Van Arnum

Merck Announces Further Restructuring, Job Cuts

Aug 9, 2011

Last week, Merck & Co. unveiled plans to reduce its global workforce, as measured by year-end 2009 levels, by an additional 12–13% by 2015. The company described its plans in its report on second-quarter earnings, which the company issued on July 29, 2011.

SOCMA Offers Support for Free Trade Pacts with South Korea, Panama, and Colombia

Jul 19, 2011

The Society of Chemical Manufacturers and Affiliates (SOCMA) issued its support this week of the passage of pending free-trade agreements (FTA) with South Korea, Panama and Colombia by two Congressional committees. SOCMA is the US-based trade association representing custom and batch manufacturers, including contract manufacturers of fine chemicals, pharmaceutical intermediates, and active pharmaceutical ingredients.

IPEC Federation Issues Statement of Phthalate Use

Jul 5, 2011

The International Pharmaceutical Excipients Council (IPEC) Federation issued a statement on the use of phthalates in pharmaceutical products in response to reports of adulteration of certain nutritional supplements, vitamins, foods, and beverages imported from Taiwan. Two phthalates, di-ethyl hexyl phthlate (DEHP) and di-isononyl phthalate (DINP), which are commonly used as plasticizers for polyvinyl chloride (PVC)-based plastics, were found in certain adulterated products and subsequently recalled by Taiwan authorities. It is believed that the phthlates were added as a form of economically motivated adulteration as a low-cost replacement for palm oil.

Merck to Develop Biosimilar with Korean Chemical Manufacturer

Jun 21, 2011

Merck & Co. and the biobusiness of Hanwha Chemical, a Korean chemical manufacturer, have formed an exclusive global agreement to develop and a commercialize a biosimilar of Enbrel (etanercept), a drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and moderate to severe rheumatoid arthritis.

US Supreme Court Rules in Favor of Roche in University Patent-Rights Case

Jun 14, 2011

The US Supreme Court, in a decision concerning the patent rights of research universities, ruled in favor of Roche in a patent-dispute case between the pharmaceutical company and Stanford University. In a 7?2 vote, the Court upheld a lower court?s decision that Stanford did not have a claim to patents for technology to detect HIV blood levels using polymerase chain reaction (PCR) technology.

WHO Meets to Discuss Global Health Policy

Jun 7, 2011

During an eight-day series of meetings that concluded on May 24, 2011, the World Health Assembly, the decision-making body of the World Health Organization, passed 28 resolutions and adopted three decisions to guide the organization?s work and address global health issues. The sessions were held in Geneva during the annual meeting of the World Health Assembly. More than 2700 delegates attended, including government health ministers, senior health officials, nongovernment organizations, civil-society groups, and observers.

J&J to Recall Select Lots of Prezista Due to Possible TBA Contamination

May 24, 2011

Janssen-Cilag International, part of Johnson & Johnson (J&J) is working with regulatory authorities in five countries to address the trace amounts of 2,4,6-tribromoanisole (TBA) that were identified in five batches of the HIV?AIDS medicine Prezista (darunavir). The countries affected include the United Kingdom, Ireland, Germany, Austria, and Canada.

PhRMA Comments on USTR Report on Pharmaceutical Trade Practices

May 17, 2011

The Office of the United States Trade Representative (USTR) issued a report, 2011 Special 301 Report, as part of its annual review of the global state of intellectual-property rights (IPR) protection and enforcement. The report was issued earlier this month and addresses IPR protection and enforcement, and specific initiatives by the United States, its trading partners, and international bodies, including measures relating to drug anticounterfeiting and market access to medicines.

PhRMA Urges Congress to Reauthorize Legislation for Pediatric Drugs

May 10, 2011

The Pharmaceutical Research and Manufacturers of America (PhRMA) urged Congress to reauthorize two pieces of legislation relating to pediatric studies and exclusivity, the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). PhRMA made the comments in testimony in a public meeting before the Institute of Medicines (IOM), the health arm of the National Academy of Sciences.

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