News

The US Food and Drug Administration has updated its draft bioequivalence recommendations for several products, and added 66 new draft product-specific guidelines since October 2007.

The European Chemical Industry Council and five national chemical associations representing France, Germany, Italy, Spain, and the United Kingdom, have launched ReachLink. ReachLink is a company founded to help companies participate in the Substance Information Exchange Forum (SIEF), which is designed as an information-sharing vehicle to facilitate companies in meeting requirements under REACH

FDA has issued a Final Rule titled "Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals."

Also, Human Genome Sciences enters pact with Hospira, Zosano Pharma names Gail Schulze chair and CEO, more...

USP announced an interim revision to its monograph for levothyroxine sodium tablets, which will become official in USP 32-NF 27.

Boehringer Ingelheim and and Hisoar (Taizhou, China), a pharmaceutical production company, formed a strategic production alliance in China.

Companies launched 25 new active substances in 2007, a decline of 19% from the previous year, according to a new report from Parexel International.

Also, Novartis stops development on "Aurograb," Zealand Pharma appoints David H. Solomon as CEO, more...

The US Food and Drug Administration will hold a public meeting this month to gain public input on implementing the recommendations of the Nanotechnology Task Force report, taking another step closer to setting a regulatory framework for nanotechnology for pharmaceuticals and medical devices.

The pharmaceutical majors deploy green-chemistry strategies to improve the synthesis of active pharmaceutical ingredients and intermediates.

A recent book shows the links between synthesis, catalysis, and environmental protection.

Sterile manufacturing may be the next aspect of pharmaceutical manufacturing to consider in the continuous process paradigm.

Equipment qualification is a critical step in ensuring that a product or service is provided accurately and consistently with regards to manufacturing and testing. The time-saving attribute of adding prerequisites to a qualification program, along with the benefit of gaining the ability to track and trend problem areas, make the addition both worthwhile and cost-effective.

The selection of the chiral stationary phase is an important consideration in separating enantiomers when using high-performance liquid chromatography, supercritical fluid chromatography, and simulated moving bed chromatography.

Differential pricing is making more than just an appearance in Asia's pharma market these days.

Brief pharmaceutical news items for September 2008.

This year, the employment survey will acknowledge the industry's best employers.

With economics and politics in the way, can we defeat the malaria epidemic before it defeats us?

Operators are hit hard by breakage problems and strike out on FDA inspections.

Are hypersanitation trends a result of scaremongering or a lack of faith in medicine?

It's back to school. Another summer has flown past and here we all meet again, ready to return to work and face the winter with renewed energies. Welcome back!

The US Food and Drug Administration will hold a public hearing Oct. 2, 2008, to obtain input regarding over-the-counter (OTC) cough and cold drugs marketed for pediatric use.

The Healthcare Institute of New Jersey (HINJ) released a new research study showing that New Jersey's life-science industry experienced stable growth in 2007.

The deadline for nominations for the Innovations in Pharma Science Awards is here. Check out http://pharmtech.com/Innovations to nominate your company's work in one of five areas by next week

Also, Shire recalls "Daytrana" patch, Chromatide forms Scientific Advisory Board, more...

FDA has finalized a regulation regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval applicatin (PMA).

The specialty drug company King Pharmaceuticals is seeking to acquire the specialty pharmaceutical company Alpharma (Bridgewater, NJ) through an unsolicited bid of $33 per share or $1.4 billion in cash. Alpharma has rejected the bid.

The US Pharmacopeial Conventional added to its international sites with the official opening of its facility in Sao Paulo, Brazil.

The Synthetic Organic Chemical Manufacturers Association (SOCMA) is expressing trade concerns with the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulation, a new European Union policy on chemicals and their safe use.

Also, Tekmira will collaborate with Bristol-Myers Squibb, Helicos Biosciences appoints Steve Lombardi CEO, more...