Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA approves pediatric version of Treximet to treat migraines

The FDA approved its first combination therapy to treat migraines in pediatric patients, giving its blessings to Pernix Therapeutics' Treximet for use in patients ages 12 to 17.

FDA blesses Baxter saline plant in Spain to produce for U.S.

A Baxter International plant in Spain which has been drafted to help alleviate a shortage of saline in the U.S. has gotten a new FDA designation that gives it more flexibility.

Hep C patient sues Blue Cross for blocking access to Harvoni

A patient denied the latest hepatitis C drugs has sued her insurance company. In this case, it's Anthem Blue Cross, and the California plaintiff says her plan blocked her from treatment because she's not sick enough to qualify under its rules.

FDA's SGLT2 warning bad news for AZ, J&J and Lilly--but could be a boon for Merck

Top companies are counting on the SGLT2 class of diabetes meds to ratchet up sales. But a new FDA warning could put a crimp on that plan.

A pair of Celgene partners gets on the FDA fast track

Celgene's expansive approach to partnering continues to bear fruit, as two of the Big Biotech's in-licensed treatments have been added to the FDA's fast-track program, promising a speedy regulatory review as each approaches Phase III.

China scraps 15% drug markup at 100 hospitals, to move nationwide by 2017

China's State Council plans to scrap a 15% markup on drug sales in major hospital nationwide, kicking into gear a pilot that aims to transform cost and quality issues over a two-year horizon.

Shanghai Pharma finds a partner for online drug sales in JD.com

Shanghai Pharmaceuticals has struck a deal with Chinese online retailer JD.com for OTC and other healthcare product sales as the space sees increased competition with rival Alibaba Group Holding, Reuters said, citing a Shanghai Stock Exchange announcement in Chinese by the drug company.

JHL says batch of oncology monoclonal antibody a 'milestone' in CMO efforts

JHL Biotech said it has successfully completed the GMP manufacture and lot release of its first 500-liter scale batch from its Taiwan facility for a privately held Chinese biotech company of its unspecified oncology monoclonal antibody product for use in Phase I clinical trials in Australia.

China, ASEAN to share infectious disease info to monitor for epidemics

China and the Association of Southeast Asian Nations (ASEAN) have agreed to share information about infectious diseases that cross the region's borders, according to the state news service, Xinhua.

Australia, pharmacy body near agreement on budget subsidies for medicines

Australia's government reportedly has reached an agreement with the nation's pharmacists, nearing an end to a long-fought battle over a budget to cover subsidized medicines.