News

More favourable conditions for the pharmaceutical industry, including a "golden era of renewed productivity and prosperity" have been forecast in a new report from analyst firm PricewaterhouseCoopers (PwC).

FDA announced the availability of the guidance, “Q11 Development and Manufacture of Drug Substances,†in the Nov. 20, 2011 edition of the Federal Register.

House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.

The launch of a global cross-pharmaceutical Investigator Databank follows the formation of TransCelerate BioPharma, another industry collaboration to address challenges in drug development.

The European Fine Chemicals Group has proposed that mandatory inspections be introduced for all global API manufacturers wishing to supply the European Union market.

The Italian Medicines Agency lifted a temporary hold on the use of Novartis seasonal influenza vaccines in Italy after affirming the vaccines' safety and efficacy.

An operation spanning 16 African countries and conducted by the World Customs Organization (WCO) in partnership with the Institute of Research against Counterfeit Medicines (IRACM) led to the seizure of more than 82 million doses of counterfeit medicines.

Watson Pharmaceuticals has completed its EUR 4.25 billion ($5.4 billion) acquisition of the Actavis Group. The combination creates the world's third largest generic-drug pharmaceutical company, with anticipated pro forma combined 2012 revenues in excess of $8 billion, according to Watson.

The European Commission (EC) has issued final approval for Europe’s first gene therapy; a treatment for a rare genetic disorder that currently has no other treatment options.

Boehringer Ingelheim agreed to pay $95 million to settle allegations that it improperly promoted four of its drugs.

AET BioTech and BioXpress Therapeutics have entered into an agreement to codevelop a biosimilar version of Abbott's tumor necrosis factor inhibitor monoclonal antibody adalimumab.

Pharmaceutical industry leaders Novartis and Merck—among others—released second-quarter 2012 results showing global sales down in third-quarter 2012, with growth in key pharmaceutical products helping to offset losses due to patent expirations.

NECC gets 483 after fungal meningitis outbreak.

Ben Venue Laboratories has resumed production on a limited number of manufacturing lines in the company's Bedford, Ohio, facilities.

Dr Reddy's is planning to acquire the specialty injectable company OctoPlus for approximately EUR27.4 million ($35.7 million) in cash to strengthen its technological capabilities in drug delivery.

Watson Pharmaceuticals has received clearance from the Federal Trade Commission (FTC) for its acquisition of generic drug manufacturer, Actavis.

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

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.

Novo Nordisk is investing $100 million to expand its R&D facilities in Beijing, China. The company estimates that the new 12,000-m2 (129,167 ft2) center will make it possible to increase the number of science employees from the current 130 to 200, with extra space available to accommodate additional future growth.

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