Top News

Pfizer closes the acquisition of Hospira, adding sterile injectables business to portfolio.

The platform, developed by Vectron Biosolutions, will be used for BI’s in-house pipeline and for its outsourcing clients.

Under the terms of the agreement, Sartorius Stedim Biotech will manufacture membrane adsorber technologies for GE, which will be marketed as part of GE’s ReadyToProcess product offerings.

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.

Mylan received a warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

GSK reports no employee injuries at the facility and is assessing damage.

The company is in discussions with Europe’s Adaptive Pathways Group on clinical trials that would evaluate its PLX cells for the treatment of specific diseases.

GlaxoSmithKline has temporarily shut down its manufacturing plant in Zebulon, North Carolina after Legionnella bacteria was found in a stand-alone cooling tower during routine inspection.

Following a divestiture of certain assets in Europe, the acquisition of Sigma-Aldrich by Merck KGaA will be complete.

The Biosimilars Forum, along with numerous House members, advocated for the use of unique J-codes for biosimilars in a recent letter to CMS.

World on the verge of an effective Ebola Vaccine according to WHO.

Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxalta declines to discuss the proposal.

Aprecia Pharmaceutical’s SPRITAM levetiracetam gains FDA approval for the treatment of epilepsy.

The purchase will strengthen Hikma’s position in the US generic drug market.

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

The deal to acquire Allergan’s generic-drug business is valued at $40.5 billion.

FDA approved the drug for a more narrow indication in the US than did EMA for Repatha, Praluent’s fiercest competitor.

A Federal circuit appeals court ruled that a biosimilar manufacturer will have to wait 6 months after FDA approval to commercially launch its medication.

Baxter has initiated a voluntary recall of two lots of IV solutions due to the potential presence of particulate matter.

A year-long process reauthorizing the Prescription Drug User Fee Act was launched July 15, 2015 with a public meeting, setting the stage for discussions with industry and FDA.

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

A large health system will use the biosimilar version of infliximab from Hospira after the company offered a discount of 45%.

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.

Enzyme replacement therapies for rare diseases and cancer treatments are recommended for approval.

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

The European Pharmacopoeia adopts six new texts and revises 31 monographs in its 152nd session.

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