News

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FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

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

US court ruled in favor of Teva in its patent-infringement lawsuit against Momenta and Mylan's generic versions of Teva's Copaxone.

Merck Serono has revealed its final “final efficiency program†for operations in Switzerland, which includes confirmation of the closure of sites in Geneva and Coinsins and their associated job cuts.

Novartis, GlaxoSmithKline, and Lonza are among those participating in newly formed consortiums for developing and producing medical countermeasures.

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

The European Federation of Pharmaceutical Industries and Associations has called for the German government to take "urgent action" regarding its pricing system, which is perceived as hindering the market entry of new, innovative medicines in the country.

Eli Lilly announced an increase in its manufacturing network in China through an expanded collaboration with Novast Laboratories, a generic and specialty pharmaceutical company based in Nantong, China.

The National Institutes of Health have gained the participation of Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, and Sanofi in their effort to advance new therapeutic research.

European and US associations call for continued vigilance against the threat of counterfeit medicines.

Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, have partnered to codevelop a portfolio of biosimilar compounds in oncology.

Takeda Pharmaceuticals announced that it has completed the acquisition of URL Pharma for an upfront payment of $800 million.

The new guide outlines potential product life-cycle approaches to the change-management system of a pharmaceutical quality system.

The United States Pharmacopeia has stated that references to General Chapter <911> "Viscosity" will be changed to General Chapter <911> "Viscosity-Capillary Viscometer Methods," <912> "Rotational Rheometer Methods," or <913> "Rolling Ball Viscometer Method."