Topic:

Regulatory

Latest Headlines

Latest Headlines

Medicines Co. finally wins an FDA nod for the clot-busting cangrelor

A year after enduring a stinging FDA rejection, the Medicines Company convinced regulators to change their minds on the blood-thinning cangrelor, winning approval to treat a smaller group of patients after years of development.

Europe bans some APIs from Chinese drugmaker Zhuhai United

China's Zhuhai United Laboratories bills itself as the world's largest manufacturer of the API for the antibiotic amoxicillin. But the sterile manufacturing for some of its amoxicillin products has been called into question by inspectors in Europe, which is banning the sterile drugs for now, except in limited cases.

Siemens snags FDA approval for HIV combo test

Siemens scored FDA approval for its HIV combo test, a win for the company as it looks to its diagnostics unit to chart some growth amid lagging fortunes.

Australia's moves on biosimilar substitution draw flak from U.S. biologic medicines group

A move by Australia to be the first country to allow pharmacies in some cases to substitute biosimilars for originator drugs has drawn a rebuke by the U.S.-based Alliance for Safe Biologic Medicines, which includes members such as Amgen and the Biotechnology Industry Organization.

Natco eyes U.S. FDA green light for Copaxone generic sales

India's Natco Pharma said all it needs is the approval from the U.S. FDA to launch a generic version of Teva's Copaxone and put it on track to compete with versions from Sandoz, Momenta Pharmaceuticals and Mylan.

China's BeiGene gets U.S. FDA IND nod on oncology candidate BGB-3111

China's BeiGene has received U.S. FDA approval on an IND application for clinical development of BGB-3111, a proprietary Bruton tyrosine kinase inhibitor for the treatment of B-cell malignancies, putting a fresh round of funds to use as it works on three main oncology candidates.

Beijing-Washington eye investment pact as China's U.S. tech buys pay off

A steady march of investments in U.S. high-technology sectors by Chinese companies from telecom to biotech will come into focus this week in high-level talks in Washington, DC, that will cover a proposed bilateral investment treaty, Reuters reports.

FDA approves novel tongue sensor for the blind

The FDA approved a device that enables blind users to interpret the shape, size, location and motion of objects from patterns of electrical stimulation on the surface of their tongue.

FDA hints it will show 'additional flexibility' when it comes to approving device clinical trials

The FDA released an overview of its considerations and process for reviewing so-called investigational device exemptions, which give researchers permission to test developmental devices on humans.

Celgene hits speedbump for Otezla in U.K. with NICE rejection

Celgene has high hopes for its anti-inflammatory drug Otezla, shooting for blockbuster sales of the med with the help of new indications for psoriatic arthritis and psoriasis. But the company is off to a rough start with the drug in the U.K., as the country's cost gatekeeper decided not to recommend Otezla to treat psoriatic arthritis.