News

GlaxoSmithKline (GSK) 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.

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. BioPharm International had the chance to talk with a few of the recipients.

Merck will close its headquarters in Whitehouse Station, NJ and relocate to its existing facility in Summit, NJ, beginning in 2014.

FDA announced that it is working closely with the Centers for Disease Control 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, is 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 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.

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.

The European Medicines Agency (EMA) has abolished its Cell-based Product Working Party (CPWP) and Gene Therapy Working Party (GTWP), with the aim of improving efficiencies and optimising the use of available expertise.

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

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.

Bayer expands animal health business with acquisition from Teva.

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

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

Pfizer and Mylan have agreed on terms by which Mylan may launch its generic version of Pfizer's Detrol LA (tolterodine tartrate) extended-release capsules, pending final approval by FDA.

Eli Lilly has received an FDA Warning Letter because of a "misleading" image of a multicoloured brain that appeared on the company’s website for the diagnostic PET tracer, Amyvid.

USP Hosts Symposium on Science and Standards

Merck KGaA has announced plans to eliminate 1100 jobs in Germany by the end of 2015—almost 10% of the company's 10,900 German positions.

Bristol-Myers Squibb has initiated a voluntary recall of 10 lots of BiCNU (carmustine for injection) previously manufactured by Ben Venue Laboratories, a former, third-party contract manufacturer for the company, to the user level.

The European Medicines Agency has launched a public consultation concerning its inventory of paediatric medicines with the aim of highlighting where further R&D efforts are required. The consultation is the first of its kind in this area.

The Johnson & Johnson subsidiary Janssen Pharmaceuticals has announced a settlement and consent decree with 36 states and the District of Columbia in regards to previously disclosed allegations related to the company's marketing and promotional practices relating to Risperdal (risperidone).

The European Medicines Agency has recommended that the anticancer medicine DepoCyte be recalled from EU countries following the discovery of manufacturing deficiencies at Pacira Pharmaceuticals' San Diego site.

The Observational Medical Outcomes Partnership (OMOP), which is managed by the Foundation, desires feedback on proposed research priorities and tasks.

Pfizer and Mylan have agreed to establish an exclusive long-term collaboration to develop, manufacture, distribute, and market generic drugs in Japan. The products included in the collaboration are expected to be sold under the Pfizer brand with joint labeling.

Eli Lilly has received $1.3 billion for payment of financial obligations from Amylin Pharmaceuticals following Bristol-Myers Squibb's acquisition of Amylin Pharmaceuticals earlier this month.

Myriad Genetics reported that a US federal appeals court has ruled that the company's composition of matter claims covering isolated DNA of the BRCA 1 and BRCA 2 genes are patent-eligible material under federal patent law. The court, however, denied the company's effort to patent methods of "comparing" or "analyzing" DNA sequences.

GlaxoSmithKline (GSK) is selling the majority of its 'classic brands' in Australia to Aspen Global for approximately £172 million ($271.1 million) in cash.

South Carolina-based Altec Medical pleaded guilty to one count of conspiring to defraud FDA and to commit federal offenses in connection with a drug-diversion scheme that lasted from 2007 to 2009.