News

Catalent Licenses NJIT Taste-Masking Technology; MicroConstants Completes FDA Inspection; and More.

EMA releases guideline on medicinal products for the treatment of schizophrenia.

Teva has invested $110 million in a new sterile plant in Hungary. The company hopes the plant will strengthen the company's role in Hungarian drug development.

New US Pharmacopeial Convention standards provide a universal approach to organizing labels for prescription containers dispensed by US pharmacists in an effort to improve patient understanding.

At this week's AAPS 2012 Annual Meeting in Chicago, graduate students across the country are being honored for their research and work in bio/pharmaceutical innovation. Pharmaceutical Technology had the chance to talk with a few of the recipients.

GlaxoSmithKline has outlined the measures it is taking as part of a new open innovation approach to R&D, including opening up its tuberculosis compound library, investing in its open laboratory in Spain, and sharing detailed clinical trial data with researchers.

Novasep announced that it will be investing EUR 30 million ($39 million) to build what will be the world's largest chromatography plant for the production of large volumes of commercial APIs.

Mayne Pharma to Acquire Metrics; Sanofi, Bristol-Myers Squibb Restructure Plavix Alliance; and More.

Merck has announced plans to close its headquarters in Whitehouse Station, New Jersey, and relocate to its existing facility in Summit, New Jersey, beginning in 2014.

A national fungal meningitis outbreak linked to contaminated vials of steroid injectables from a Massachusetts compounding operation has reignited the debate over the safety of compounded drugs and the need for stronger FDA regulation of these activities. Last week, the Centers for Disease Control and Prevention reported seven deaths and 91 ill.

FDA announced that it is working closely with the Centers for Disease Control (CDC) to identify the source of an outbreak of meningitis among patients who had received an epidural steroid injection.

Takeda's US subsidiary, Takeda America Holdings, has agreed to acquire the vaccine specialist company LigoCyte Pharmaceuticals for an upfront payment of $60 million in a move intended to bolster and expand the company's vaccine business.

Merck Returns Brinavess Rights to Cardiome; Sigma-Aldrich Expands in Scotland; and More.

Merck Serono's Asceneuron is the third company to be spun off from the company's Entrepreneur Partnership Program that was launched to mitigate the impact from recent restructuring at its Geneva site.

Several Big Pharma companies strengthen their manufacturing presence in Russia.

FDA launches BeSafeRx program and releases guidance for industry.

The European Medicines Agency has updated its guidance on biosimilar medicines, with the aim of helping companies to avoid unnecessary repetition of clinical trials.

The President's Council of Advisors on Science and Technology (PCAST) released a report containing recommendations for boosting innovation in drug discovery and development.

Sanofi is planning to shed approximately 900 jobs in France in the lead up to 2015 as it seeks to implement certain key strategic objectives.

Mallinckrodt Agrees to Acquire CNS Therapeutics; Sanofi Outlines R&D Restructuring; and More.

Although CPhI, ICSE, InnoPak and and P-Mec won’t begin until 9 October, you can start your CPhI experience a dary earlier on 8 October by attending the preshow Pre-Connect Conference.

The European Medicines Agency has abolished its Cell-based Product Working Party and Gene Therapy Working Party, with the aim of improving efficiencies and optimizing the use of available expertise.

Watson Laboratories has recalled two lots of hydrocodone bitartrate and acetaminophen tablets.

Novo Nordisk has invested $100 million in expanding its research centre in Beijing, China, to 12000 m2.

ISPE has published a new guidance titled ISPE Good Practice Guide: Quality Laboratory Facilities, which defines design guidelines for quality laboratories.

Pfizer Launches Joint Venture In China; Spectrum Sartorius Opens New Facility In Germany; And More.

Johnson & Johnson has announced plans to open four innovation centers in California, Boston, London, and China, with the aim of accelerating early innovation and facilitating collaboration and investment opportunities.

Teva announced an agreement in which Bayer HealthCare will acquire the US-based animal health business of Teva Pharmaceutical Industries for up to $145 million. The transaction is expected to close in 2013, subject to antitrust clearance and other conditions.

The European Generic Medicines Association (EGA) has raised concerns about the potential fees to be charged by the European Medicines Agency for pharmacovigilance activities

Delaying the onset of Alzheimer's disease by just five years could reduce the cost for care of Alzheimer's patients by $447 billion a year by 2050, according to a new PhRMA report.