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  Sandoz announced on Sept. 3, 2015 that despite the barriers erected by competitor Amgen, Sandoz officially launched Zarxio (filgrastim-sndz), its biologic version of Amgen’s neutropenia medication Neupogen (filgrastim). To complement the drug launch, Sandoz is also launching Sandoz One Source, a patient services center providing support for and information on the medication.

The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.

The new company, Immatics US, will develop autologous and allogeneic adoptive cellular therapies for various types of tumors based on novel immunotherapy targets.

WuXi said its biologics manufacturing business will be one of the company’s key growth drivers over the next several years.

The company closed its Zebulon-based plant after routine testing of a cooling tower revealed the presence of the bacterium responsible for Legionnaire’s disease.

FDA determined the celebrity’s endorsement of Duchesnay’s morning-sickness medication Diclegis was misleading.

The new biotech company, Mereo, is based in the United Kingdom, and kicks off with three mid-stage assets from Novartis.

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

 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.