News

Almac Forms an Alliance with Exco InTouch; Michael Pearson Joins Valeant; and More.

US Pharmacopeia Seeks Scientists for its 2011-2012 Fellowship Program

The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.

FDA issued a draft guidance for industry on Mar. 11, 2011, titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants seeking such actions under the Federal Food, Drug, & Cosmetic Act (FD&C Act). A similar draft guidance was issued in July 1993. The new document clarifies the types of waivers, refunds, and reductions available under the user-fee provisions of the FD&C Act as well as the procedures for handling these requests, including how to appeal an FDA decision.

Last Tuesday, the US Senate approved the "America Invents Act," which is intended to reform the nation ’s patent system. If it becomes law, the bill will establish a first-to-file system by defining an invention ’s effective filing date as the actual filing date of the patent or patent application.

FDA and EMA Announce Joint Pilot Program

Epizyme signs drug-development deal with Eisai; Greg Plowman Joins Eli Lilly; and More.

Last Thursday, FDA filed a consent decree of permanent injunction against McNeil, a subsidiary of Johnson & Johnson, for failing to comply with current good manufacturing practice requirements. The action prevents McNeil from manufacturing and distributing drugs from its Fort Washington, Pennsylvania, facility until FDA determines that its operations comply with the law.

Many facilities buy compressed gas tanks or evaporate liquid nitrogen to supply processes with dry, high-purity nitrogen. An in-house nitrogen generator, however, provides several significant benefits.

Growing interest in continuous drug manufacturing has brought greater attention to in-line blending, a process that the petroleum and fine-chemicals industries have used for decades.

We are making an emulsion using a high-shear in-line mixer. It?s a 60-gal batch, and it?s taking nearly an hour to get the results we?re looking for. We have tried changing the in-line mixer?s workheads to a two-stage configuration, but it doesn?t affect the mixing time. Where are we going wrong?

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the February 2011 edition from Emerson Process Management and Spirax Sarco.

Japan has suspended the use of two pediatric vaccines made by Pfizer and sanofi following the deaths of four children in three days.

WuXi and BMS Form Collaboration; F. Michael Ball Leaves Allergan for Hospira; and More.

AstraZeneca announced this week that it will discontinue the production of Pulmicort (budesonide) 100 and 200 µg/dose HFA (hydrofluoroalkane) pressurized metered-dose inhaler (pMDI) due to manufacturing issues related to technical aspects of the device, which prevents the ongoing manufacture of the product.

FDA Posts PDUFA Meeting Minutes

At a conference on preserving national security at the University of Pittsburgh Medical Center last week, FDA Commissioner Margaret Hamburg stressed the importance of medical countermeasures for responding to natural and deliberate threats to public health.

The EMA has issued a statement addressing the withdrawal of the marketing authorization for Thelin, which was voluntarily withdrawn in 2010 because of a risk of serious liver injury.

In France, public confidence in health authorities and pharmaceutical industry has been shaken by a safety scandal over the drug Mediator (benfluorex hydrochloride).

FDA announced on Mar. 2, 2011, that it is taking action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products, according to an agency release.

Fujifilm and Merck & Co. have formed a definitive agreement by which Fujifilm will acquire the Merck BioManufacturing Network, a contract biopharmaceutical manufacturing and development business of Merck.

A number of European public health and transparency campaigners believe that conflict of interest rules may have been breached with the EMA's decision to allow its former Executive Director, Thomas Lönngren, to take up an advisory role within the private pharmaceutical sector.

The European Organization for Rare Diseases (EURORDIS), an alliance of patient organizations and individuals, celebrated its fourth Rare Disease Day on February 28.

FDA and Georgetown University Form Innovation Partnership

Pfizer Completes King Acquisition; ViiV Healthcare Names Chairman; and More.

Ongoing Free Trade Agreement (FTA) negotiations between the EU and India have hit a hurdle as some stakeholders urge the Indian government to fight against certain provisions in the FTA amid fears that access to generic drugs may be affected.

FDA recently sent sanofi-aventis two Warning Letters for its facilities in Frankfurt am Main, Germany, and Bridgewater, NJ.

What to do when your CMO changes the manufacturing equipment line.

A single, global tooling standard would offer many benefits, but one has been slow to emerge.

Social media tools have taken over many aspects of our lives, now including regulatory info.