News

Vivalis and Intercell have agreed to the terms of a merger to create a new European biotechnology company called Valneva that will specialise in vaccines and antibodies.

FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.

Pfizer has agreed to pay $55 million plus interest to settle charges that Wyeth (acquired by Pfizer in October, 2009) improperly promoted the drug Protonix (pantoprazole).

The US Supreme Court accepted an appeal by the Federal Trade Commission of a decision that upheld an arrangement of payments by Solvay Pharmaceuticals to generic drug companies to postpone introduction of generic versions of its branded testosterone-replacement drug.

Biogen Idec and Isis Pharmaceuticals announced that they have entered into a global collaboration agreement under which the companies will discover and develop antisense drugs against three undisclosed targets to treat neurological or neuromuscular disorders.

The Court of Justice of the European Union has dismissed an appeal by AstraZeneca concerning a 2005 decision that found the company guilty of abusing its dominant position in the marketplace.

Myriad Genetics reports that the US Supreme Court has granted certiorari agreeing to hear the company's gene patentability case.

Eli Lilly released its annual report containing updates on progress and new initiatives in corporate responsibility.

The European Medicines Agency has published a plan to help Europe?s regulatory network prevent, mitigate and manage shortages of important medicines following manufacturing problems.

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

The European Commission (EC) is seeking to introduce a black symbol to identify medicines that are subject to additional monitoring.

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.

USP revises labeling requirements for Heparin.

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.