Drug Development

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...

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

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...

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.

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.

The authors formulated and developed taste-masked RDFs of cetirizine hydrochloride for patients who experience difficulty in swallowing the tablet dosage form of the drug.

Brief pharmaceutical news items for February 2009.

The pharmaceutical majors forward projects in biocatalysis, solvent replacement, and other approaches in green chemistry.

A recent reader poll focused on predictions for the industry's future.

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

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

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

Also, Bristol-Myers Squibb forms collaboration with ZymoGenetics, Hana Biosciences appoints VP of regulatory affairs, more...

Also, Novozymes Biologicals settles pollution case with the US Department of Justice; EntreMed restructures management team; more...

Michigan State University researchers have discovered a technique for viewing whole cells to gain an understanding of protein inclusion bodies.

Outsourcing sterile manufacturing involves an integrated approach in product life-cycle management.

Catalysis for olefin metathesis and aldol reactions and synthetic routes to natural products are some recent gains.

The authors examine the challenges of integrating a large-scale chromatography and nanofiltration process for purification of a polyclonal antibody.

The incoming administration has renewed hope for stem cells, but less adequate copycats may follow.

After a year of increased attention on the pharmaceutical supply chain in Asia, what will be the region's short- and long-term role? This article contains bonus online-exclusive material.

A book explains the many pharmaceutical applications of polymers from natural sources.

Brief pharmaceutical news items for January 2009.

The authors describe a novel analytical approach that uses the shape-analysis capabilities of MFI to detect and enumerate silicone oil microdroplets in protein formulations that also contain aggregates of similar size and in a similar concentration.

Instead of hampering progress, cost pressures might inspire Big Pharma to get creative.

Readers give advice on their best approach to handling (batch) rejection

A new excipient for orally disintegrating tablets not only imparts superior tablet characteristics, but has the added advantage of allowing users to maintain full control over their formulations, manufacturing processes and intellectual property.