News

The US Food and Drug Administration issued a final guidance, Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms, which provides recommendations that allow for greater flexibility when manufacturing biological products with spore-formers.

Early this month, Congress is expected to debate what some companies are calling the most significant changes to the United States patent system in 50 years.

A team of researchers from the University of Idaho and Seoul National University have designed a potential drug delivery system by coating silica nanowires with the protein fibronectin.

The US Food and Drug Administration issued a draft guidance, Pharmacogenomic Data Submissions Companion Guidance to be used as a companion to an earlier guidance, Pharmacogenomic Data Submissions, which was issued in March 2005.

Ranbaxy Laboratories has gained approvals from the US Food and Drug Administation to manufacture and market galantamine hydrobromide tablets and carvedilol tablets.

Company and People Notes: SAFC Expands in Wisconsin, Amgen Reduces Rhode Island Staff, More.

Boehringer Ingelheim decided to voluntarily withdraw its “Silomat” drug, which contains clobutinol hydrochloride, in all countries where it is available.

Purchase-order contracting is a commonly used approach to conducting commercial transactions, but it is a risky proposition when applied to pharmaceutical transactions, including the buying and selling of contract services and pharmaceutical ingredients. The authors examine the contract provisions covered in a commercial-supply agreement that are likely to be omitted under purchase-order contracting and the risk-reduction benefits that a commercial-supply agreement can offer in pharmaceutical procurement transactions.

Aptuit expands its drug-development capabilities with the formation of Aptuit Laurus to take advantage of the growing pharmaceutical outsourcing market in India.

FDA must increase inspections of foreign API manufacturing facilities as more production moves offshore.

Poor processing and misguided projections lead to trashed product.

In an age of "pre-existing conditions," can a new bill help patients get the treatment they need?

When it comes to research, the United States scientific community is still way ahead of the game, but we're not sharing our findings as often as we should. According to a new National Science Foundation (NSF) report, the number of science and engineering articles by US-based authors published in major peer-reviewed journals has plateaued.

US and China Crack Down on Regulation after SFDA Chief Executed; Xcellerex Receives US Grant for Biopharmaceutical Production; New FDA Guidance on Polymorphic Compounds in Generic Drugs; Comment Periods Open for ICH Q10 and Biologics Guidelines

Company and People Notes: GSK Hires Jacobs Engineering Group, Agilent Exec to Retire, More.

Last week, it was reported that the US Food and Drug Administration may start outsourcing jobs to private companies.

Catalent Pharma Solutions and Danish pharmaceutical company ALK-Abelló (Hørsholm, Denmark) will substantially increase Catalent’s “Zydis” oral-dissolving tablet production capacity dedicated to ALK-Abelló’s immunotherapy products.

Pfizer (New York) proceeded with two agreements this week: a drug-development deal with Bristol-Myers Squibb (New York) and a license agreement with Xoma (Berkeley, CA) for antibody technology.

The US Food and Drug Administration is seeking public comments on a study designed to investigate the impact of visual distraction and the interplay of different sensory modalities (e.g., verbal, visual) used to present risk and benefit information during a television prescription drug advertisement.

The biopharmaceutical company Biopartners recently published data that showed its biosimilar "Valtropin" (somatropin), a recombinant human-growth hormone product, demonstrated the same safety and efficacy as Eli Lilly’s "Humatrope" in children with growth hormone deficiency.

The US Food and Drug Administration approved updated labeling for “Coumadin,” a common blood-thinning drug, that explains that patients’ genetic composition may influence their response to the drug.

August 23, 2007 Notes: AstraZeneca selects Axway's supply-chain tracking technology, Biovex names vice-president of quality assurance, more.

The US Food and Drug Administration announced it will hold a public meeting to discuss the safety and efficacy of over-the-counter (OTC) pharmaceutical products developed for the treatment of cough and cold symptoms in children.

Amgen announced it would cut 2200–2600 jobs as part of a plan to increase operational efficiencies.

Asia–Pacific is strongly positioning itself in the global pharmaceutical market, according to a recent analysis by PricewaterhouseCoopers.

Icagen signed a worldwide collaboration and licensing agreement with Pfizer for the discovery, development, and commercialization of compounds that modulate three specific sodium ion channels and could provide treatments for pain and related disorders.

China will spend more than $1 billion to improve its food and drug safety by 2010 and give its State Food and Drug Administration more oversight powers.

Microbix Biosystems has established a team of experts to help manufacturers boost their production of influenza vaccine.

The US Food and Drug Administration announced the availability of a guidance document entitled “FDA Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996.”

Biomira Inc. and Merck KGaA update agreement, Tikvah names vice-president and CFO, more.