All News

Anthrax antitoxin is the first monoclonal antibody approved under FDA's Animal Efficacy Rule, and the first product from BARDA's Project Bioshield to receive FDA approval.

GlaxoSmithKline has formed a partnership with Vodafone to use mobile technology to help vaccinate more children against common infectious diseases in Africa.

The agency recommends to avoid the use of to dibutyl phthalate and di(2-ethylhexyl) phthalate in CDER-regulated drug and biologic products, including prescription and nonprescription products.

Amgen has agreed to pay a settlement of $762 million to resolve federal litigation accusing the company of inappropriately marketing the anemia treatment, Aranesp, for unapproved uses.

AIMM Therapeutics and Cosmo Pharmaceuticals have entered into a strategic partnership to develop oral diagnostic and therapeutic antibodies for gastrointestinal diseases including colon carcinoma.

Roche's MycoTOOL, which offers rapid detection of mycoplasms based on a polymerase chain reaction (PCR) test, has received FDA acceptance.

BASF has extended its offer period to acquire all of the issued and outstanding shares of Pronova BioPharma.

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FDA has issued a draft guidance to assist applicants in the submission of summary-level clinical-site data.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

GlaxoSmithKline announced its intent to increase ownership in its publicly-listed, consumer-healthcare subsidiary in India and in GlaxoSmithKline Consumer Nigeria as part of its emerging-markets investment strategy.

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.