Topic:

Regulatory

Latest Headlines

Latest Headlines

BMS scores positive EMA opinion for Opdivo in advanced melanoma patients

Bristol-Myers Squibb's immuno-oncology med Opdivo is racking up positive data and earning regulatory gold stars in record time. Now, the drug is poised to gain even more ground after the European Medicines Agency gave Opdivo its marketing thumbs-up as a first-line treatment for advanced melanoma--an approval it has yet to earn in the U.S.--and in previously treated patients.

Western firms form band of brothers, but welcome others, in Asian medical device association

Major Western device and medical technology firms launched Asia Pacific Medical Technology Association, or APACMed, pledging the association would unite a fragmented effort to work with regulators across a region that is both lucrative and frustrating on issues ranging from import rules to public tender guidelines.

India drug minister Kumar says don't worry, prices under control

India's drug minister said there was a misconception in the nation--including in its media--that prices of pharmaceuticals had skyrocketed recently. Ananth Kumar noted that 350 additional drugs had been brought under price controls in the past 10 months and other plans are already driving down costs.

China researchers confirm human embryo gene-editing work, but gave up, Nature says

China researchers have confirmed widespread rumors circulating in the scientific community that they had performed landmark work using a gene-editing technique on human embryos--usually an ethical no-no. Regardless of the debate surrounding the work, they concluded that what they were attempting was not feasible.

UPDATED: FDA gives Boehringer's Pradaxa antidote a boost with fast-track review

Boehringer Ingelheim already had the FDA's "breakthrough" designation on idarucizumab, an antidote to its blockbuster anticoagulant Pradaxa. Now, the reversal agent has stepped on the agency's fast track, which cuts review time by four months.

China proposes patent law changes to toughen IP protection

China officials have proposed changes in the country's patent laws intended to take its intellectual-property protections beyond the U.N. standards and to a higher level. The State Intellectual Property Office said the emphasis now is on patent commercialization as well as protection.

Biocon plans India listing for Syngene in R&D funding move

Biocon plans to list its Syngene International research subsidiary on the India stock market by launching a $160 million initial public offering. With money in Syngene's pockets, Biocon then plans to sell 10% of its holdings to raise about $95 million for its own research.

U.S.-based Threshold revives NZ cancer candidate for resistant lung cancer

New Zealand research on a promising cancer drug that was discarded by previous companies was revived by U.S.-based Threshold Pharmaceuticals, which announced a promising showing in Phase I and II trials for treating a type of resistant lung cancer.

St. Jude aims for Axium approval before year-end, with robust neuromodulation growth in 2016

St. Jude Medical took the opportunity on its April 22 earnings call to flesh out the logic and expectations behind its purchase of Spinal Modulation for a total of at least $215 million (plus undisclosed approval and revenue milestones) that was revealed earlier this week. Neuromodulation is one of its three pillars for achieving 4% to 5% revenue growth this year--and the company anticipates that in 2016 neuromodulation will be even stronger.

Vietnam-made vaccines WHO-cleared for export

Vietnam has become the 39th nation cleared for global exports of the vaccines it makes, joining an increasingly crowded field of local champions to multinational heavyweights. The World Health Organization gave that clearance recently for a country that expects to be a leading producer within the next 20 to 30 years.