News

This month's editor's comment.

Earlier this week, House Appropriations Committee Chairman Rep. David Obey (D-WI) introduced the FY 2009 Omnibus Appropriations Act (H.R. 1105).

Also, GPC Biotech AG and Agennix to merge; BASi appoints COO of scientific services; more...

The United States Trade Representative (USTR) is seeking documentation from chemical companies to identify possible non-tariff trade barriers, created by the European Union's Registration, Evaluation, Authorization and restriction of Chemicals (REACH) regulation, which would be inconsistent with the EU international trade obligations under World Trade Organization (WTO) rules, according to an informational release by the Synthetic Organic Chemical Manufacturers Association (SOCMA).

The US Food and Drug Administration stated its considerations in regards to the three draft annexes to the International Conference on Harmonization's Q4B document.

The US Food and Drug Administration has released a draft guidance for industry entitled Influenza: Developing Drugs for Treatment and/or Prophylaxis.

The US Food and Drug Administration posted the Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan on its website.

The US Food and Drug and Administration and the International Serious Adverse Event Consortium (SAEC) released last week the first data on certain types of genetic-based adverse drug events.

After two years of hearings, more than 5000 pages of expert testimonies, and 939 medical articles, a special federal court ruled that there was little, if any, evidence to support the claim that substances in the measles, mumps, and rubella vaccine (including the use of thimerosal) had led to the autism of three children.

Also, Sandoz received approval for its third biosimilar from the EU, WuXi PharmaTech's CFO Benson Tsang to leave at month's end; more...

Sanofi Aventis CEO Chris Viehbacher provided the company's growth strategy in light of changing conditions facing the pharmaceutical industry, which include patent expirations and declining research and development (R&D) productivity.

Congress and health policy groups have been pushing for and debating the merits of comparative effectiveness studies for years. Now, the freshly signed 2009 economic stimulus bill devotes $1.1 billion of the total $787 billion plan to this type of research.

Innovative containment solutions aim to minimize workers' exposure to cytotoxic compounds and ensure these compounds are not contaminated.

To implement QbD and reduce business risks, teams should begin QbD collaboration early during process development.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the February 2009 edition from Oystar USA and Schreiner MediPharm.

The US Food and Drug Administration sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS).

The US Food and Drug Administration withdrew this week its direct final rule on Reporting Information About Authorized Generic Drugs.

Taro Pharmaceuticals received a warning letter from the US Food and Drug Administration last week regarding its Brampton, Ontario, manufacturing facility.

The US Food and Drug Administration issued its first approval for a biological product produced by genetically engineered animals.

Congressman John D. Dingell (D-MI) introduced HR 759, known as the Food and Drug Globalization Act of 2009, which would amend the Food, Drug, and Cosmetic Act to address food, drug, and device safety, including registration of producers of drugs and applicable fees, documentation for admissibility of drug imports, country of origin labeling, and the inspection of producers of drugs and active pharmaceutical ingredients (API).

Also, PPD to acquire AbC.R.O.; Bilcare Global Clinical Supplies named Tony Moult general manager of Bilcare GCS Europe; more...

Senior Senate Judiciary Committee members Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced the Preserve Access to Affordable Generics Act to prohibit patent settlements under which manufacturers of branded pharmaceuticals pay generic-drug companies to delay the introduction of generic products to the market.

The United States Pharmacopeial (USP) Convention is pursuing greater collaboration with the US Department of Health and Human Services (HHS), and specifically, the US Food and Drug Administration.

GS1 UK, an independent organization that develops supply-chain standards, successfully completed the Pharma Traceability Pilot program and demonstrated the viability of a complete track-and-trace system for pharmaceutical products in a live, international supply-chain environment.

Also, recalls for two KV Pharmaceutical subsidiaries; Human Genome Sciences delivers anthrax drug to US Strategic National Stockpile; Akorn president and CEO leaves the company; more...

The Federal Trade Commission has filed a complaint in federal district court challenging agreements in which Solvay Pharmaceuticals (Marietta, GA) paid generic drug makers Watson Pharmaceuticals (Corona, CA) and Par Pharmaceutical Companies (Woodcliff Lake, NJ) to delay generic competition to Solvay's branded testosterone-replacement drug "AndroGel," a prescription pharmaceutical with annual sales of more than $400 million, according to an FTC press release.

The US Pharmacopeial (USP) Convention has announced new standards for heparin and glycerin.

Cambrex CEO Steve Klosk looks to higher valued-added segments such as high-potency actives, controlled substances, and drug-delivery technologies to drive growth.

Several contract manufacturers announced capacity and service expansions at InformEx, the exhibition of custom and batch manufacturers, held in San Francisco, last week.

The pending merger of Pfizer and Wyeth provides Pfizer with greater strategic diversification, particularly in biologics, but only minimally addresses its generics exposure in the near term.