News

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.

Former Senate Majority Leader Tom Daschle withdrew his name from consideration for US Secretary of Health and Human Services (HHS).

Without any GMP guidelines for excipients in Europe, change can't come soon enough for some industry groups.

GMP experts act fast to resolve some unusual and difficult problems.

To manage risk properly, industry must understand what it is and how to assess it

A new book inspires readers to seek ways to apply NMR spectroscopy to their own purposes.

FDA's role should not be overlooked as it has been in years past.

January was another very bleak month financially, but luckily it ended on a bit of a political high...

During the last 20 years, pharmaceutical R&D spending has increased 15-fold while new product approvals have increased only 0.70-fold.

The American Society for Quality (ASQ), a membership organization that focuses on quality training in several industries including pharmaceuticals and healthcare, has adopted a new certification for good manufacturing practice (GMP) professionals.

Also, UCB will divest certain business in emerging markets to GSK; the KineMatik Group named Michael G. Jarjour president and CEO; more...

Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) have introduced S. 301, known as the Physician Payments Sunshine Act of 2009 to the 111th Congress.

Pfizer will purchase Wyeth (Madison, NJ) under a definitive merger agreement approved by both companies' boards of directors.

Also, Elan explores strategic alternatives; NanoGuardian appoints John D. Glover to lead its Security Advisory Board; more...

Eli Lilly and Company has reached resolution regarding its previously reported government investigation into the company's US marketing and promotional practices for "Zyrexa" (olanzapine), an antipsychotic drug, thereby ending a government investigation started in 2004.

Last week, the US Food and Drug Administration issued a draft guidance for industry, Standards for Securing the Drug Supply Chain–Standardized Numerical Identification for Prescription Drug Packages, and launched a pilot program to help protect the pharmaceutical supply chain.

The US Department of Health and Human Services's Biomedical Advanced Research and Development Authority has awarded Novartis a contract valued up to $486 million over eight years to support the design, construction, validation, and licensing of a US cell-based influenza vaccine manufacturing facility in Holly Springs, North Carolina.