Topic:

Regulatory

Latest Headlines

Latest Headlines

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.

Counterfeit Botox again found in the U.S.

More counterfeit Botox has made its way into the U.S. and, the FDA thinks, into physician offices. The agency is warning providers that they need to make sure they don't have any of it because it is believed to be unsafe.

FDA issues new guidelines on acceptance of data from overseas clinical trials

The FDA issued guidelines on its acceptance of medical device clinical data from overseas studies in a just-issued draft guidance, saying the "increasing globalization of clinical trials presents challenges to both US and foreign regulators."

FDA, industry scrambling to clarify or design new regs covering lab-developed tests

Science is rapidly shaping the landscape of the diagnostics industry, from the research into genetics and new materials like graphene, to the regulatory science practiced at the FDA.