Topic:

Regulatory

Latest Headlines

Latest Headlines

Novartis to pay record $12.6M to settle HHS price-reporting claims

Novartis has agreed to pay the largest-ever settlement over allegations of inaccurate or outdated drug-price reporting to the federal government, HHS officials say. That's not saying much, however: This record-breaking settlement amounts to $12.64 million.

U.S. sterile manufacturer racks up 13 observations in FDA visit

The FDA was not impressed with the aseptic filling operations at a California facility that it inspected earlier this year, laying out more than a dozen observations.

Doctor outreach at heart of Daiichi Sankyo's $39M settlement with DOJ

Two months after settlement of a $39 million Medicaid-related U.S. government suit was disclosed by Daiichi Sankyo, the details of the civil suit against the Japan-based drugmaker were laid out by the New York state's attorney general's office.

Japanese doctor testifies on inflating placebo counts in Diovan trials

A Japan physician testified in a case involving Novartis Pharma K.K. and its Diovan (valsartan) drug for high blood pressure that he falsified a report while participating in clinical trials marketing approval, sources said.

Japan's PMDA sets 12-month target on drug, device reviews with domestics favored

Japan's Pharmaceuticals and Medical Devices Agency (PMDA) aims to accelerate high-quality drug and medical device reviews to 12 months for at least 70% of new drugs filed for approval with domestic firms favored, according to its steering committee meeting on March 10.

India and China gear up for trade talks with a pharma focus

Beijing and New Delhi plan ministerial-level trade discussions to tackle pharmaceutical and four other major issues involving services and products that India can supply to China, according to an India official.

India plans adverse effects monitoring regime for medical devices

India's health ministry has plans to create the nation's first system for monitoring the adverse effects of medical devices. Up to now, health authorities have relied on data supplied by the world's developed countries.

Another strike against Merck's sugammadex as FDA nixes advisory panel confab

Merck & Co. says it's expecting yet another rejection from the FDA for its anesthesia drug sugammadex, as the agency scrapped an advisory panel's review of the drug slated for next week. The FDA told the company it plans additional site inspections before it hands the info over to an advisory committee.

Boston Sci's stroke-fighting Watchman overcomes years of regulatory roadblocks, wins FDA approval

Boston Scientific finally won FDA approval for its stroke-fighting Watchman device after setbacks or rejections in 2010 and 2014. The device was approved for patients with an appropriate rationale to seek a nonpharmacologic alternative to the blood thinner warfarin. The FDA's blessing follows a multiyear clinical trial of 2,400 patients.

India and U.S. scientists battle over virulence of swine flu strain in India

Scientists in India and the United States are doing battle over whether the H1N1 swine influenza virus has mutated into a strain more virulent than the one that has killed at least 1,700 people in India this year.