News

AstraZeneca has paid approximately $3.2 billion to extend its diabetes alliance with Bristol-Myers Squibb (BMS), following BMS’s recently completed acquisition of Amylin Pharmaceuticals.

Elan Corporation announced plans to spin off its discovery unit and Neotope Biosciences division to create an independent entity focused on R&D.

The UK is to invest £8 million ($12.5 million) in a new center that will be dedicated to stem-cell biology and medicine, with the aim of developing new therapeutic approaches to illnesses that currently have no effective treatments.

The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.

An internal investigation and voluntary disclosure by Pfizer led to a settlement with the US Department of Justice and Securities and Exchange Commission.

Novartis has entered into a global collaboration with the University of Pennsylvania in the US to research, develop and commercialise targeted cancer therapies.

Gilead Sciences announced that it is entering into agreements with Indian generic drug manufacturers to enhance access in developing countries to its anti-HIV medicine, emtricitabine.

Pharmaceutical industry leaders Pfizer, Novartis, and Merck—among others—released second-quarter 2012 results, emphasizing growth of new products and strength in emerging markets.

First start-up funded by Merck Serono's Entrepreneur Partnership Program announced.

The UK's Medicines and Healthcare products Regulatory Agency has launched a public consultation regarding a scheme that could provide patients with access to unlicensed medicines in Phase II or III clinical trials.

Sandoz announced it has completed the acquisition of Fougera Pharmaceuticals, a maker of generic dermatology products, for $1.5 billion.

EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Glybera (alipogene tiparvovec, marking the first recommendation in Europe for a gene therapy medicine.

GlaxoSmithKline has announced that it will acquire Human Genome Sciences (HGS) for $14.25 per share in cash, or approximately $3.6 billion on an equity basis.

Par Pharmaceuticals, a maker of generic drugs, has entered into an agreement to be acquired by the private investment firm, TPG.

Global spending on medicines is estimated to reach nearly $1.2 trillion by 2016.

FDA approved a risk evaluation and mitigation strategy for extended-release and long-acting opioid medications.

Congress Passes Generic Drug Act

Guide helps companies meet CGMP requirements.

FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

GlaxoSmithKline has agreed to plead guilty and pay $3 billion to resolve criminal and civil liability resulting from unlawful promotion of certain drugs, failure to report safety data, and alleged false price reporting practices.

Bristol-Myers Squibb has agreed to acquire the biopharmaceutical company Amylin Pharmaceuticals for a purchase price of $5.3 billion and an additional $1.7 billion for assuming Amylin's net debt and a contractual payment obligation to Eli Lilly based on Amylin's recently terminated agreement with Eli Lilly over the diabetes drug exenatide.

In a 5–4 vote, the Supreme Court has ruled in favor of the Constitutionality of the Affordable Care Act.

In a 5-4 ruling, the US Supreme Court upheld the provision of the Affordable Care Act requiring all adults to purchase health insurance or pay a penalty-the so-called individual mandate.

The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.

The European Medicines Agency has published its first set of finalized guidelines concerning good pharmacovigilance practices.

Roche announced that it will be closing its R&D site in Nutley, NJ, eliminating approximately 1000 positions.

FDA Updates List of Warning Letters