Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Sanofi-Aventis to see slew of Plavix generics join Japan NHI reimbursement list

Japan's National Health Insurance (NHI) has confirmed that a slew of generic versions of Sanofi's Plavix will join the reimbursement list after the latest review, a move tipped by the company in its first-quarter earnings call as well.

REMS website overhauled by FDA to simplify access to information

The FDA has overhauled its Risk Evaluation and Mitigation Strategies website to make it easier to find up-to-date information. The new version moves details of whether REMS apply to a drug, what components are in place and when they were last updated to the forefront, ending the need for users to dig through a database to find information.

UPDATED: WuXi files a 406 extension with U.S. SEC. What's the secret?

WuXi PharmaTech sought and has been approved for an extension under U.S. Securities and Exchange Commission Rule 406 to keep confidential treatment of information excluded from Form F-1 filed on July 24, 2007, as amended, according to an order filed June 17.