Formulation and Drug Delivery

Also: Sanofi-aventis acquires BiPar Sciences; FDA issues Warning Letter to Chinese heparin manufacturer; Halo Pharmaceutical appoints chief scientific officer; more...

The United States Pharmacopeial (USP) Convention signed a memorandum of understanding (MOU) with the Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation (Roszdravnadzor) last week in Moscow.

Also, Sanofi-aventis acquires Medley and Laboratorios Kendrick; Eli Lilly's Cook to retire from board; more...

Also, Genzyme and Bayer HealthCare form agreement; FDA releases draft guidances; TransMolecular appointed Robert Radie president and CEO

Follow-on biologics or biosimilars offer a niche growth market for the pharmaceutical industry. As the process for establishing a regulatory pathway for biosimilars is debated, companies, including Big Pharma, are positioning themselves to gain this piece of the pharmaceutical pie.

Also, SOCMA changes name; two FDA approvals; Biogen Idec names chief operating officer; more...

Obama's cost-containment and science-innovation initiatives need to overlap.

A review of recent product innovations, policy developments, and growth prospects in the excipients market.

A Position Paper from the AAPS In Vitro Release and Dissolution Focus Group

The financial and economic downturn is likey to have long-term implications for outsourcing.

The number of biotechnology-based human therapeutic products in the late-stage pipeline along with the average cost to commercialize a biotech product has been steadily increasing with time. In addition, the biotech industry is facing unprecedented challenges of a sagging global economy and rising regulatory expectations. Companies have to continue to evolve their approaches to be more efficient with respect to time, resources and cost. This article describes some of the technologies that can help optimize time and cost of biopharmaecutical manufacturing.

The authors demonstrate how melt-extrusion and spray-drying methods can help to prepare solid dispersions of poorly soluble drugs using Eudragit polymers.

The authors examine common superdisintegrants (i.e., crospovidone Type A, crospovidone Type B, croscarmellose sodium, and sodium starch glycolate) with a set of poorly soluble drug actives and evaluate in vitro drug dissolution.

The authors examine the use of a novel highly functional pregelatinized starch as a controlled-release matrix excipient.

The authors studied the behavior of anhydrous lactose and the combination of anhydrous lactose and the combination of anhydrous lactose with microcrystalline cellulose on a pilot-scale roller compactor.

The authors examine the use of a hypromellose-based product as an excipient in a controlled release formulation using direct-compression tableting.

Also, Hospira to reduce workforce; WuXi AppTech makes senior appointments; more...

A bipartisan bill that would establish a regulatory pathway for the approval of biosimilars was introduced into the US House of Representatives last week.

Also, Genzyme receives warning letter; Mesa Laboratories appoints John J. Sullivan CEO and a member of the board of directors; more...

The spotlight on the biopharmaceutical industry is intensifying, as recently evidenced by Pfizer's (New York) ongoing acquisition of Wyeth (Madison, NJ), which was initiated partly to reduce the former's dependence on small-molecule drugs.

Also, Penn Pharma to expand; stem cell research funding ban lifted; Bristol-Myers Squibb made senior appointments; more...

Also, Schering-Plough's vaccine unit, Nobilon, formed an agreement with the World Health Organization; Ore Pharmaceuticals named president and CEO; more...

Scientists studying epilepsy have traditionally focused on the comings and goings of ions through molecular channels in nerve cells, and many current antiseizure therapies seek to modulate that dynamic.

USP's Stage 2 heparin monograph revisions address identification, potency, and impurities.

The authors investigate the effects of a polyethylene glycol plasticizer and water on cellulose acetate film properties.

Industry has changed, but its basic tenets have not. INTERPHEX's RJ Palermo discusses a 7-step process to keep pharma moving forward.

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?