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

IPEC extends its reach to Brazil and Argentina in an effort to harmonize excipient best practices.

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.

So 2010 is nearly over and what a year it's been for our industry.

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.

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.

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report.

Roche Details Restructuring Plan; Sigma-Aldrich Names Successors after CEO's Death; and More.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the November 2010 edition from BinMaster and Silverson Machines.

To find out about the regulatory, formulation, and manufacturing considerations involved in developing a new device to deliver a drug, Equipment and Processing Report talked to Paul Wotton, CEO of Antares Pharma.

Normal industrial practice is to control foot-borne contamination with adhesive peel-off disposable mats, but polymeric contamination-control flooring is becoming increasingly popular.

The biotechnology company Biogen Idec (Weston, MA) announced last week a major restructuring program that will refocus the company's research and development (R&D) programs, consolidate facilities, and reduce its workforce.

PQRI and FDA present Process Drift Workshop, and More.

The US Food and Drug Administration's Puerto Rico district office "may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island," according to Rep. Edolphus Towns (D-NY), chair of the US House of Representatives Committee on Oversight and Government Reform.

Eli Lilly Acquires Avid Radiopharmaceuticals; EMA Recruiting New Director; and More

The market for orally disintegrating and fast dissolving tablets could exceed revenues of $13 billion by 2015 based on upward global growth trends, according to a report from Technology Catalysts International, a technology transfer and business consulting firm based in Virginia.

Sanofi-aventis (Paris) has asked Genzyme to stand aside and let the shareholders decide on whether an acquisition should take place.

The European Medicines Agency published a draft list of questions and answers on postapproval change-management protocols last week.

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

The Global Reporting Initiative begins an effort to increase the level and strength of sustainability reporting among US-based corporations.