Top News

 Teva announced that it has signed a definitive agreement to acquire the generic-drug business of Allergan in a transaction valued at $40.5 billion. The deal is expected to close in the first quarter of 2016.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive scientific opinion for GlaxoSmithKline’s (GSK’s) malaria candidate vaccine Mosquirix (RTS,S) for use outside of the European Union (EU) in children aged 6 weeks to 17 months.

Amoun, Egypt's largest drugmaker, will be sold to Valeant for $800 million.

Mylan issued a voluntary withdrawal of calcium chloride intravenous infusion 10% w/v 10mL prefilled syringe due to difficulties in administration.

The acquisition will bolster Celgene’s immunotherapy pipeline.

Two companies have been fined a total of GBP550,000 for faulty insulin syringes, which contained no drug and caused the death of a diabetic patient.

The 21st Century Cures Act took a giant step forward with a 344-77 approval in the House; the Senate debate is still ahead.

 The United States Treasury Department introduced policy in September 2014 to discourage companies from merging with foreign companies in another fiscal jurisdiction to escape tax responsibilities. The policy was enacted to make inversion more difficult and to curb a company’s acquisition of a related foreign company for the sole purpose of avoiding United States corporate tax rates.

The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Bristol-Myers Squibb builds R&D facilities in Massachusetts and San Francisco and discontinues discovery research in virology.

The divestment of Nimenrix and Mencevax was to satisfy regulatory clearances when GSK gained Novartis’ vaccines business in an asset swap in March 2015.

A new framework featured in the Journal of Clinical Oncology will help physicians compare clinical trial results-and costs-of popular cancer medications.

Kythera announces that it entered into a definitive agreement to be acquired by Allergan for $2.1 billion.

The Biotechnology Industry Organization announced a name change to the Biotechnology Innovation Organization, effective in early 2016.

An advisory panel deemed Amgen’s Repatha (evolocumab) to be safe overall.

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).

In a Citizen Petition to FDA, AbbVie calls the current biosimilar labeling practices “legally unsound.”

FDA cites 17 observations including air handling, quality control, and deficient microbial monitoring at NIH’s Clinical Center Pharmaceutical Development Section.

Baxter announces that it will partner with Mayo Clinic and Velocity Pharmaceutical to form Vitesse Biologics, a Baxalta-managed company focused on immunology, hematology, and oncology.

Prescription drug usage data on more than one million Marketplace enrollees suggest that costs for specialty drugs are 36% higher for people with Obamacare.

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.

The Irish company Endo International announced that it would acquire Par Pharmaceutical for $8.05 billion.

The US Court of Appeals granted Amgen’s request to block Novartis’ Neupogen biosimilar, Zarxio, from the US market until the court resolves litigation between the two companies.

Eleven of the leading US biosimilar developers have collaborated to form the Biosimilars Forum, a nonprofit organization formed to expand patient access to biosimilars.

Perrigo rejected Mylan’s second proposal for an acquisition valued at more than $34 billion, saying that the offer was too low to consider.

In a seething letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.