News

The scandal surrounding Servier's diabetes drug, Mediator, continues to unravel in France and could have implications for the whole pharmaceutical industry as the country scrutinises its regulatory systems.

2012 Facility of the Year Awards are Announced; Suzhou Pharma Services Names Oliver Mueller President; and More.

As the EU debates how best to spend billions of euros worth of research funding, the Humane Society International/Europe has issued a call to develop in vitro and computational techniques that can replace the use of animals in medical experiments.

According to a report from Frost & Sullivan, the European pharmaceutical contract manufacturing market could earn revenues of up to $20.75 billion in 2018, almost double that of 2011's revenue when the market earned $10.02 billion. Over the same period, the European market for biotechnology outsourcing is forecast to grow from $1.21 billion to $2.67 billion.

The EMA has released a concept paper for a guideline on pharmacogenomic methodologies in the evaluation of authorized medicines to address the fact that genetic differences can cause variability in drug therapy efficacy and safety.

Sanofi's subsidiary Genzyme has received FDA's approval for the production of Fabrazyme (agalsidase beta), used in the treatment of Fabry's disease, at its manufacturing facility in Framingham, Massachusetts. Shortages of Fabrazyme have been ongoing for the past two years.

Takeda has announced "strategic measures to achieve efficiencies for long-term growth", which includes cutting close to 3000 jobs, 2100 of which will come from Europe.

Constellation Pharmaceuticals announced that it has entered into a broad collaboration with Genentech, a member of the Roche group, to discover and develop innovative treatments based on epigenetics, which focuses on the identification of small molecule inhibitors of protein activity.

On Jan. 11, 2012, AstraZeneca and IMS Health announced a three-year collaboration to use real-world healthcare data from Europe to inform AstraZeneca's discovery and clinical development programs.

Takeda Restructures; Savient Pharmaceuticals Names David Veitch President of Savient Europe; and More.

On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act and programs for human generic drugs and biosimilar biological products.

The generic-drugs market is poised to experience strong growth as key blockbuster products go off patent, but companies looking to benefit from this will have to be careful about the product segments where they compete, according to a report from Frost & Sullivan.

Understanding equipment design and product-contact surfaces enables strong cleaning action.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the January 2012 edition from ACS Valves and Terra Universal.

The pharmaceutical industry has a history of developing innovative medicines and novel drug-delivery systems, but not all of its manufacturing processes use cutting-edge technologies. Demands to increase productivity in fill–finish lines are fueling the arguments of proponents of robotic automation to expedite manufacturing.

I work in a quality control laboratory and use a pH meter with a single-junction reference probe to test samples taken from various pharmaceutical (drug) production lines. The probe I use has a six-month warranty. It slowly stops working after just a couple weeks. I am replacing it once a month. We make sure to store it correctly according to the manufacturer's specifications and even use probe cleaner at the end of each shift to ensure that it stays clean. What can I do to increase the lifespan to at least cover the warranty period?

Sanofi will co-invest in start-up biotech company Warp Drive Bio by providing financial funding and access to its strains library and expertise in natural products.

The pharmaceutical majors advance vaccines for the developing world.

Xoma Restructures; AAIPharma Appoints Eric Evans as CFO; and More.

The US Pharmacopeia announced a draft standard containing best practices for ensuring that drugs can be traced to their original manufacturer, are not counterfeited or adulterated, and can be transported to their intended destination without compromising quality.

Novartis Consumer Health has announced a voluntary recall of all lots of select, bottle-packaged configurations of Excedrin, NoDoz, Bufferin and Gas-X Prevention. The recall follows consumer complaints of chipped or broken pills and inconsistent bottle packaging line clearance practices that could lead to stray tablets, capsules or caplets from other Novartis products.

Bristol-Myers Squibb (BMS) has signed an agreement to acquire the clinical-stage biotechnology company Inhibitex in a deal worth approximately $2.5 billion. The transaction will provide BMS with a potential candidate currently in Phase II development for the treatment of hepatitis C.

Ben Venue Laboratories is extending its voluntary suspension of manufacturing at its Bedford, Ohio, facility. The company had originally announced the suspension on Nov. 19, 2011, and announced the extension of the suspension on Dec. 23, 2011.

The National Institutes of Health has established the National Center for Advancing Translational Sciences, a center dedicated to the translation of scientific discoveries into new drugs, diagnostics, and devices.

Alexion Pharmaceuticals has signed an agreement to acquire all the capital stock of the biopharmaceutical company Enobia Pharma in a $610-million all-cash transaction.

USP Releases Guidelines on Ensuring the Integrity of the Pharmaceutical Supply Chain.

AMRI Restructures; ISPE Appoints Nancy S. Berg as CEO; and More.

The FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites.

On Dec. 29, 2011, FDA approved the TIRF REMS Access Program, which is intended to ease the burden on the healthcare system by allowing prescribers and pharmacies to enroll into one new single system instead of several different systems.

As part of the BRIC bloc with Russia, India, and China, Brazil is one of the world's leading emerging economies and is also considered by IMS Health to be one of seven pharmerging nations, which also include Mexico, Turkey, and South Korea.