Formulation and Drug Delivery

Contract manufacturers of APIs and intermediates report gains, but express caution.

Michiel Ultee talks about the challenges involved in transferring technology to a CMO and why communication is so important.

The productivity of the pharma industry has been declining for several years. Could biotechnology reinvigorate drug development?

PAT guidance has been available from FDA for more than 4 years, but there have been no apparent breakthroughs in large-scale upstream production. Will companies consider using on?line chromatography to change this?

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

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...

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

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.

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.

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.

During the past years, there has been increasing demand for fast dissolving disintegrating tablets (FDDTs), such as orally disintegrating tablets (ODTs) and sublinguals.

A discussion of the basic principles of immunity and the nature of antibodies.

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...

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.

One relatively new dosage form is the orally dissolving strip, a thin film formulated with hydrophilic polymers that rapidly dissolves on the tongue.

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...

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

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.