Week of Sept. 26, 2011: BMS collaborates with Ambryx; Merck & Co. opens new R&D center; Teva acquires joint venture interest; and More.

FDA has published a guidance on Marketed Unapproved Drugs-Compliance Policy Guide, which describes the agency's enforcement priorities with regard to products that lack regulatory approval or that are not marketed in accordance with the over-the-counter drug review.

FDA has issued a guidance titled User Fee Waivers, Reductions and Refunds for Drug and Biological Products that outlines FDA's policies for issuing waivers, refunds or reductions in prescription drug user fees.

GlaxoSmithKline (GSK) is looking to racecar technology as it seeks to improve its manufacturing, R&D, and consumer-healthcare areas. The company has formed a long-term partnership with the UK-based McLaren Group, which is best known for its expertise in the Formula 1 motor sport.

GE Healthcare, the health business of General Electric, will dedicate $1 billion of its total R&D budget during the next five years to its technologies for manufacturing biopharmaceuticals and for cancer research. Part of the money will go toward expanding the company's cancer-diagnostic and molecular-imaging capabilities, as well.

Bristol-Myers Squibb Completes Acquisition of Amira Pharmaceuticals; PPD Appoints Raymond H. Hill as CEO; and More.

President Obama released his plan for deficit reduction on Sept. 19, 2011, and included in the 80-page report are several provisions that would affect US drug makers if enacted.

Pfizer plans to invest EUR 145 million ($200 million) in its Grange Castle biotech-manufacturing site. Meanwhile, completion of the merger between Alkermes, Inc. and Elan Drug Technologies was announced in a press release on Sept. 16, 2011, following the approval by Alkermes, Inc. shareholders on Sept. 8, 2011.

Novartis presented an update on its long-term strategy, performance, and growth outlook last week, which revealed that the company is on track to deliver the strategic priorities it had set out in 2010.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2011 edition from Lechler and National Bulk Equipment.

Glass flaking or delamination can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. If glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.

In our manufacturing process, we are running into issues with our vial stoppers clumping in the feeder bowl. How can we ensure that the stoppers go through smoothly without clumping up?

FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement aimed at a stakeholder meeting being held at the US Department of Health and Human Services to address the growing issue of drug shortages in the United States.

Novo Nordisk announced the roll-out of its Changing Diabetes in Children program in India, making India the seventh country to participate.

AmerisourceBergen Completes the Acquisition of IntrinsiQ; Xcelience Expands its Manufacturing and Packaging Services; and More.

The European Commission has released a concept paper for public consultation that provides details about implementing pharmacovigilance measures, which will be necessary as part of the Commission's 2010 amended pharmacovigilance legislation.

The International Society for Pharmaceutical Engineering will soon publish an update for its guide to sterile-product manufacturing facilities. The new publication will replace the original guide and contain practical information about technological advances in sterile manufacturing.

The UK's Technology Strategy Board has partnered with the Engineering and Physical Sciences Research Council to invest up to £9 million ($14.2 million) in grant funding with the aim of driving proof-of-concept ideas to pilot technology demonstration for healthcare.

FDA Makes Organizational Changes Within CDER.

Deborah Autor testifies before US Senate HELP committee on requested authorities to improve pharma supply chain.

GSK, Anacor Expand R&D Collaboration; Xoma Announces Management Changes; and More.

USP Expands Presence in India.

FDA's Division of Drug Marketing, Advertising, and Communication issued a letter to Pfizer's vice-president of US Regulatory Affairs regarding its online resources page for Lipitor tablets.

Sweden's Medical Products Agency issues a report calling for strengthening environmental standards for pharmaceutical production within the European Union.

Representatives from FDA, the Generic Pharmaceutical Association, the European Fine Chemicals Group, and a task force from the Society of Chemical Manufacturers and Affiliates are nearing completion of draft legislation for the Generic Drug User Fee Act.

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.

Pfizer has completed its cash tender offer for the biopharm company Icagen after extending its initial deadline.

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