Topic:

Regulatory

Latest Headlines

Latest Headlines

Early trends from India survey show TB drug resistance rates less than WHO estimates

Early trends from India's first survey on multidrug-resistant tuberculosis showed a lower rate of infections than World Health Organization estimates in findings that will help shape the government's treatment focus, the Indian Express newspaper reports.

Takeda hands in its Velcade successor with blockbuster ambitions

Japanese drugmaker Takeda is angling to win FDA approval for its lead cancer asset, an oral treatment for blood malignancies that is key to the company's future in oncology.

CFDA eyes new Shanghai evaluation center to speed drug approvals

Shanghai will build a China FDA medicine evaluation center to speed drug approvals,  CNTV  said on its website, as part of efforts to keep and attract drug and device firms to the region.

WuXi Healthcare Ventures plucks $50M from WuXi PharmaTech as anchor for second fund

U.S. and China focused WuXi Healthcare Ventures Fund picked up $50 million from affiliated WuXi PharmaTech, the sprawling China-based biopharma CRO, according to documents filed with the U.S. Securities and Exchange Commission. 

Japan's Takeda files NDA for ixazomib for relapsed multiple myeloma

Japan's Takeda Pharmaceutical has submitted a New Drug Application to the U.S. FDA for the use of ixazomib to treat patients with relapsed and/or refractory multiple myeloma, the company said in a press release, marking a milestone for its top oncology prospect.

India's biopharma woes grow with FDA Emcure plant ban

India's troubles with pharmaceutical manufacturing widened this week as the U.S. FDA issued an import alert for the Emcure Pharmaceuticals plant in Hinjawadi, citing deficiencies in good manufacturing practices at the site with no specifics immediately available.

Price controls fail to improve poor people's access to medicines in India, IMS report says

India's National Pharmaceutical Pricing Authority is busy on both the pharma and device fronts to bring down costs to consumers. But the efforts may do more harm than good, according to an industry-sponsored study by IMS Health in India.

Thoratec receives CE mark for new blood pump to assist patients during complex procedures

Thoratec received a CE mark for its HeartMate Percutaneous Heart Pump, following a 30-person clinical trial.

FDA slaps Emcure with import alert, adding to ban on Indian plants

The FDA has banned yet another Indian drug plant.

UPDATED: Consumer groups urge FTC to take Mylan's side in Teva deal fight

Mylan is dead set against a buyout bid from generics rival Teva Pharmaceutical Industries. But some U.S. consumer groups are spooked by the very talk of a deal, and they're lobbying the Federal Trade Commission against it.