News

Representatives from the United Nations, governments, businesses, and nonprofit groups met in Cancún, Mexico, to move forward international efforts for meeting climate-change goals.

The Global Health Progress collaboration works to improve healthcare delivery in the developing world.

AstraZeneca and Abbott End Program; PhRMA Elects New Members; and More.

Dr. Reddy's Laboratories (Hyderabad, Andhra Pradesh, India) has entered into a technology transfer, manufacturing, and marketing agreement with R-Pharm (Moscow), a Russian pharmaceutical company.

After five years of discussions, the US Food and Drug Administration is joining the Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Cooperation Scheme (PIC Scheme), known together as PIC/S.

The European Medicines Agency outlined it work program and budget for 2011 and anticipates similar work loads for drug applications and practically no increases to its budget for that work program in 2011.

The European Medicines Agency launched on December 20, 2010, a public registry about small and medium-sized enterprises (SME) that includes information about SME-registered companies.

Novartis (Basel) signed a memorandum of understanding with the City of St. Petersburg, Russia, confirming its intent to build a new full-scale pharmaceutical manufacturing plant in St. Petersburg.

Pfizer Recalls One Lipitor Lot; Sanofi Aventis Names Head of R&D; and More.

ICH Unveils New Website and Logo

A US Food and Drug Administration inspection completed on Dec. 9, 2010 revealed persistent deficiencies at McNeil Consumer Healthcare's Fort Washington, Pennsylvania, facility.

Thermo Fisher to Acquire Dionex; Former SOCMA CEO Joe Acker Dies; and More.

Abbott Laboratories (Abbott Park, IL), B. Braun Medical (Bethlehem, PA), and Roxane Laboratories, a subsidiary of Boehringer Ingelheim (Ingelheim am Rhein, Germany), agreed to pay the United States $421 million to settle False Claims Act allegations.

Equipment and Processing Report talked to Jonathan Seville, dean of the School of Engineering at the University of Warwick, to find out how positron-emission particle tracking could help pharmaceutical manufacturers gain process understanding.

Pfizer (New York) appointed Ian C. Read, currently head of the company's global biopharmaceutical operations, as president, chief executive officer, and director. He succeeds Jeffrey B. Kindler, who retired from the company.

Company and People Notes: GlaxoSmithKline acquires Nanjing MeiRui Pharma; Cephalon's CEO to remain on medical leave; and more.

Tiered pricing is used throughout industry to help increase affordability and access to drugs in the developing world.

EMA Publishes New Transparency Policy, Releases Guideline for Biosimilar mAbs.

GlaxoSmithKline (GKS, London) outlined a plan to invest EUR 500 million ($649 million) in research and development (R&D) and related manufacturing in the United Kingdom conditioned on the successful implementation of a so-called "patent box" measure by the UK government.

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

Following new clinical data and a request from the FDA, Xanodyne Pharmaceuticals has agreed to withdraw its prescription pain products Darvon and Darvocet (propoxyphene) from the US market.

On Nov. 17, 2010, Novartis (Basel) disclosed its long-term business strategy, which emphasizes diversification in what the company described as high-growth healthcare segments.

Genzyme Sells Business Unit to Sekisui Chemical; Ablexis Names VP of Research; and More.

Bayer (Leverkusen, Germany) announced last week a restructuring program and a strategy to strengthen its focus in research, development, and marketing of new products in its healthcare and crop-sciences businesses as well an interest in expanding its activities in emerging markets.

FDA Issues Statement for Consumers about Antibiotic Use

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued on November 19 a summary of its latest meeting.

Building on their long-standing relationship, GlaxoSmithKline and Brazil's Oswald Cruz Foundation (Fiocruz) have announced a new collaboration to research and develop innovative medicines for neglected tropical diseases.

The International Conference on Harmonization (ICH) Steering Committee (SC) and its working groups met in Fukuoka, Japan Nov. 6-11, 2010.

European confidence and optimism in biotechnology is increasing, according to a survey conducted by the European Commission.

The European Medicines Agency and the Massachusetts Institute of Technology's (MIT's) Center for Biomedical Innovation (CBI) and Center for International Studies (CIS) are launching a collaborative research project with a focus on enhancing regulatory science in pharmaceuticals, according to an EMA press release.