Archive for June 2018

Drug manufacturers in New York may soon be required to fund and operate take-back programs to dispose of unused drugs, as the state’s legislature voted unanimously last week to send legislation to the governor’s desk. Source: Drug Industry Daily

Illicit online sales of addictive substances are filling the gap created by successful efforts to reduce legal opioid prescriptions, FDA Commissioner Scott Gottlieb said Wednesday at an agency-hosted summit on reducing the availability of illicit opioids online. Source: Drug Industry Daily

Australia’s Therapeutic Goods Administration has updated its plan for mandatory drug shortage reporting based on public comments in response to an April request. Source: Drug Industry Daily

Novartis and BIO sent feedback to the FDA about its draft guidance on developing treatments for severely debilitating or life-threatening (SDLT) hematologic disorders, urging the agency to broaden its guidance. Source: Drug Industry Daily

Chinese API manufacturer Henan Lihua drew a warning from the FDA over serious testing violations, inaccurate records and drug quality failures at its facility in Anyang, Henan. Source: Drug Industry Daily

Democrats in Michigan’s state legislature have introduced a bill to repeal the Michigan Product Liability Act, a 1995 law that gives pharmaceutical companies immunity from legal action relating to sale or misleading advertising of dangerous products if the drugs in question are FDA-approved. Source: Drug Industry Daily

Remoxy ER, Pain Therapeutics’ new oxycodone pain relief candidate, failed to sway FDA advisory committee members this week. Source: Drug Industry Daily

The FDA hit Biologique Recherche with a warning letter after observing multiple violations at its Paris facility, noting inadequate testing methods, quality control concerns and a lack of validation for manufacturing processes, among other issues. Source: Drug Industry Daily

The Federal Trade Commission should examine the impact of “pay-for-delay” deals on the availability of cheaper biosimilars, two U.S. senators said in a letter Friday. Source: Drug Industry Daily

Two pharmacy benefit managers took in more than $223 million last year through their work with Ohio Medicaid plans, according to a new report commissioned by the state. Source: Drug Industry Daily