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.
Johnson & Johnson announced this week that Sheri S. McCoy, vice-chairman of the Executive Committee, has resigned from the company. She was considered to be in line for the CEO position, being filled by Alex Gorsky.
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.
The Management Board of the European Medicines Agency (EMA) has introduced a range of new measures to strengthen and extend its conflicts of interest (COI) policy for scientific-committee members and experts, as well as for members of the management board.
An initiative in the UK will invest £75 million ($120.2 million) into translational science, with the aim of transforming biological understanding into clinical impacts that will benefit patients and the UK economy.
The European Medicines Agency (EMA) has released guidance that outlines a European-wide approach for dealing with transparency and access to information included in marketing authorization applications.
A US court has denied AstraZeneca?s request for a preliminary injunction against FDA.
On Mar. 13, 2012, FDA issued a Warning Letter to Steven Victor, CEO of IntelliCell Biosciences for a violation of the Food, Drug, and Cosmetic Act (FD&C Act), and for violations of cGMP and Good Tissue Practice (GTP) in the manufacture of its adipose tissue-derived stem-cell product.
The National Institute for Bioprocessing Research and Training (NIBRT) in Ireland and Waters are partnering on training and research to increase large-molecule characterization capacity and knowledge, according to an NIBRT press release.
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.
GlaxoSmithKline (GSK) is launching a new program that will create apprenticeships in several areas including manufacturing and R&D at the company’s United Kingdom sites.
On Mar. 12, 2012, FDA released a draft guidance document for industry direct-to-consumer (DTC) television advertisements that describes FDA?s plans for implementing predissemination review.
The European Medicines Agency (EMA) has launched a pilot program for submitting centralized marketing authorization applications electronically.
On Mar. 7, 2012, GE Healthcare announced an agreement to acquire Xcellerex, a supplier of manufacturing technologies for the biopharmaceutical industry, for an undisclosed amount.
GlaxoSmithKline (GSK) and Daiichi Sankyo have formed a joint venture that they claim will create the biggest vaccines company in Japan.
Boehringer Ingelheim (BI) has announced in a press release the expansion of its biopharmaceutical manufacturing capabilities at its plants in Biberach, Germany and in Vienna, Austria.
Excellence United, an alliance of six specialty equipment companies, will make its first North American appearance at INTERPHEX 2012, held May 1–3 at the Javits Center in New York.
FDA has issued a list of planned draft and final guidance documents for release throughout 2012.
On Feb. 21, 2012, FDA announced steps the agency plans to take to increase the declining supply of certain cancer drugs. These steps came in response to President Obama?s Oct. 31, 2011 Executive Order.
Eli Lilly plans to invest EUR 330 million ($443.2 million) at its Kinsale location in Ireland to create a new biopharmaceutical commercialization and manufacturing facility. The investment will lead to 200 new jobs, as well as an additional 300 construction roles during the building process.
Merck KGaA announced measures intended to reduce costs and increase efficiency to ensure the long-term success of its business model. The measures are part of a comprehensive transformation program that will be implemented in two phases. In the first two years, Merck plans to implement a new leadership organization, implement efficiency measures, and develop a long-term growth strategy. In the second phase, the company will explore new areas for growth. Cost savings from the first-phase efficiency measures are expected to fuel second-phase growth.
The South African government is involved in talks with the Swiss biopharmaceutical company Lonza regarding a joint venture to construct the country's first plant to manufacture APIs for antiretroviral (ARV) medicines.
President Barack Obama released his budget proposal for fiscal year 2013. Included in the proposed budget is a $654-million increase in FDA funding, for a total FDA budget request of $4.49 billion
FDA has released a draft guidance for API manufacturers titled Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.
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.
GlaxoSmithKline (GSK) released its fourth quarter and full year 2011 earnings report on Feb. 7, 2012. In the report, the company tracks its R&D performance, and calculated the return on R&D to be 12%, up from 11% in 2010, and closing in on the company’s goal of a 14% return.
After months of anticipation, FDA issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.
The European Medicines Agency (EMA) has published an implementation plan for Europe?s new pharmacovigilance legislation, which comes into force in July with the aim of improving the safety and risk?benefit monitoring of drugs.
Pfizer, Sanofi, GlaxoSmithKline, and other major pharmaceutical companies have joined forces and pledged to defeat 10 neglected tropical diseases (NTDs) by 2020. The consortium comprises 13 pharmaceutical companies, the United States, United Kingdom and United Arab Emirates governments, the Bill & Melinda Gates Foundation, the World Health Organization (WHO), and several other global health entities.
