News

WHO Releases Draft Guideline For Production And Control Of Specified Starting Materials.

The European Medicines Agency's Management Board praised the European medicines regulatory network's handling of the 2009 H1N1 swine-flu pandemic.

In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, FDA issued a new final guidance for industry.

Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.

Pfizer Invests In Nodality; SOCMA Approves New Members; And More.

FDA issued a final rule to make cigarettes and smokeless tobacco products less attractive and less accessible to children and adolescents.

President Obama signed into law major healthcare reform following the passage of the bill by the House of Representatives.

Seventeen pharmaceutical markets are now ranked as "pharmerging," according to market-research firm IMS Health.

FDA issued a new guidance for industry to help new drug applicants write the dosage and administration section of their products' labels.

FDA Issues Safety Warning Regarding Zocor; And More.

Merck Ends Partnership With Dynavax; PhRMA Elects Officers; And More.

After months of increasingly rancorous debate, the House finally approved legislation on Mar. 21, 2010, that makes significant changes in the nation's healthcare system.

A report from Thomson Reuters claims the number of patent challenges in the US almost doubled between 2008 and 2009.

Abbott Agrees to Acquire Facet Biotech; FDA Issues Black-Box Warning For Plavix; and More.

FDA Issues Warning Letter To Paddock Laboratories; And More.

AstraZeneca signed a license and supply agreement with the drug company and manufacturer Torrent Pharmaceuticals.

Three companies joined the University of Pittsburgh Medical Center's 21st Century Biodefense initiative to establish a flexible vaccine development and production facility.

The European Generic Medicines Association is calling for a reform of the European patent system.

In the final phase of its transparency initiative, the US Food and Drug Administration seeks additional public comments about how it can increase its interactions with regulated industry.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the March 2010 edition from Munters and NETZSCH.

Recent developments demonstrate the importance of biologicals, which usually are delivered through injections, for the drug industry's future. To find out about the process of manufacturing prefilled syringes, and to learn about innovations in filling lines, Equipment and Processing Report talked to Thomas Otto, managing director of Vetter.

Continuous manufacturing could bring the pharmaceutical industry advantages such as improved product quality, easy scale-up, flexibility, and short cycle times. But how can a company switch from batch to continuous manufacturing?

Following a number of serious adverse events, including infections and fatalities, Roche and Biogen Idec have suspended the late-stage development of Ocrelizumab for the treatment of rheumatoid arthritis (RA).

The World Health Organization released new guidelines this week for the treatment of malaria and the first-ever guidelines on procuring safe and efficacious antimalarial drugs.

The Pharmaceutical Research and Manufacturers of America, along with eight other pharmaceutical, business, and trade organizations, are calling on Russian authorities to consider policy changes concerning clinical-trial regulation and intellectual property.

Exelixis And XenoPort Announce Job Cuts; GSK Dedicates India Facility; And More.

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

A UK consortium completed pilot runs of a pharmaceutical-safety program that uses electronic tracking and authentication to ensure the safety of drugs in the supply chain.

FDA Published The International Conference on Harmonization S9 Guideline; ISPE Released A New Good Practice Guide On Manufacturing Execution Systems.

The US Food and Drug Administration and the European Medicines Agency are implementing a streamlined process to help regulators better identify and share information regarding orphan-drug and biologic products.