Patricia Van Arnum

The manufacturing capacity-sharing model between Merck and MedImmune ushers in a new paradigm of "co-opetition."

Bristol-Myers Squibb has initiated a voluntary recall of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company, to the user level.

Eli Lilly has received $1.3 billion for payment of financial obligations from Amylin Pharmaceuticals following Bristol-Myers Squibb's acquisition of Amylin Pharmaceuticals earlier this month.

Myriad Genetics reported that a US federal appeals court has ruled that the company's composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible material under federal patent law. The court, however, denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences.

An internal investigation and voluntary disclosure by Pfizer led to a settlement with the US Department of Justice and Securities and Exchange Commission.

Bristol-Myers Squibb has agreed to acquire the biopharmaceutical company Amylin Pharmaceuticals for a purchase price of $5.3 billion and an additional $1.7 billion for assuming Amylin's net debt and a contractual payment obligation to Eli Lilly based on Amylin's recently terminated agreement with Eli Lilly over the diabetes drug exenatide.

Novartis, GlaxoSmithKline, and Lonza are among those participating in newly formed consortiums for developing and producing medical countermeasures.

The new guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.

GlaxoSmithKline tenders offer of $13.00 per share in an unsolicited bid despite an earlier rejection by Human Genome Sciences.

The company receives FDA and EMA approval for expansion of fill and finish operations for alglucosidase alfa.

In a move designed to increase its international presence, Watson Pharmaceuticals has agreed to acquire Actavis for EUR 4.25 billion ($5.62 billion).

A new report by FDA details the strategies, programs, and other activities the agency is using to address the rise of imported pharmaceutical products and APIs.

US spending on prescription drugs increased moderately in 2011 reflecting increased generic-drug incursion and lower spending on prescription drugs. Pfizer retained its number one position of the top company of US prescription drug sales, and the generic-drug company Teva Pharmaceutical moved into the top-five companies of US prescription drug sales.

Generic-drug incursion and reduced demand contribute to modest gains.

On Mar. 29, 2012, the Generic Pharmaceutical Association (GPhA) reiterated its call for Congress to move forward with user-fee proposals for generic drugs and biosimilar products.

GlaxoSmithKline (GSK) plans to invest more than £500 million ($798 million) in the United Kingdom across its manufacturing sites to increase production of key active ingredients for its pharmaceutical products and vaccines.

On Feb. 1, 2012, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to support the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. She also outlined a series of recommendations, sent to Congress in January 2012, to include in PDUFA V.

The US Department of Justice, on behalf of FDA, filed a consent decree of permanent injunction against the generic-drug manufacturer Ranbaxy in the US District Court of Maryland. The consent decree was filed against Ranbaxy Laboratories Ltd., an Indian corporation, and its subsidiary Ranbaxy Inc., headquartered in Princeton, New Jersey. The decree was filed on Jan. 25, 2012, and is subject to court approval.

Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011.

Samsung and Biogen Idec agreed to invest $300 million to establish a joint venture to develop, manufacture, and market biosimilars. The deal is Samsung?s latest effort to strengthen its position in biosimilars.

Merck & Co. highlighted the key developments in its late-stage pipeline and its near-term plans for regulatory filings. The company has 19 candidates in Phase III clinical trials and plans to submit eight new US regulatory filings in 2012?2013, including five new drug candidates.

AstraZeneca is investing $200 million in a new manufacturing site in China Medical City (CMC), Taizhou, Jiangsu province, China. The new site represents AstraZeneca?s largest investment in a single manufacturing facility globally.

Sanofi outlined its long-term financial objectives this week as the company discussed its strategy in mitigating generic-drug incursion and in generating growth in key therapeutic areas and emerging markets.

The second quarter of 2011 presented a mixed picture of financing for the life-science sector, which includes the biotechnology and medical-device industries. Although venture-capital funding for the sector as a whole showed strong improvement, biotechnology investing dropped in terms of overall dollars invested and number of deals.

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.

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.

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 & 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.

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.

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.