Top News

Hikma Acquires Boehringer’s US Generic Drug Business for $2.65 Billion

July 29, 2015

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

FDA Issues Quality Metrics Draft Guidance Document for Comment

July 28, 2015

PTSM: Pharmaceutical Technology Sourcing and Management

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

Teva Withdraws Mylan Offer, Agrees to Acquire Allergan’s Generics Business

July 27, 2015

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

FDA Approves Praluent, the First PCSK9 Inhibitor in the US

July 27, 2015

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

Biosimilar Manufacturers Must Wait Six Months After Approval to Market Product

July 21, 2015

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

Insect in IV Solution Prompts Baxter Recall

July 20, 2015

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

FDA and Manufacturers Map Out PDUFA Reform Priorities

July 17, 2015

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.

House Approves Landmark “Cures” Legislation

July 10, 2015

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

French Hospital to Drop Remicade in Favor of a Biosimilar

July 07, 2015

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

21st Century Cures Act Gets a Revision

July 07, 2015

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