Two study coordinators at the Miami-based Tellus Clinical Research Inc. pleaded guilty July 20 in connection with a conspiracy to falsify data in trials evaluating treatments for medical conditions including opioid dependency, irritable bowel syndrome and diabetic nephropathy.
Continuing its evaluation of cancer drugs already on the U.S. market, the FDA will convene its Oncologic Drugs Advisory Committee (ODAC) Sept. 22 and 23 to consider two more approved drugs – Oncopeptides AB’s Pepaxto (melphalan flufenamide) and Secura Bio Inc.’s Copiktra (duvelisib).
The U.K.’s competition watchdog has found that a subsidiary of Pfizer Inc. and a generics firm jacked up the price of a life-saving epilepsy drug by up to 2,600%, fining them a total of £70 million (US$83.72 million). The Competition and Markets Authority’s decision is part of a long-running dispute against subsidiary Pfizer Ltd. and the generics firm Flynn Pharma Ltd.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Healthy.io, Nugen, Rapidai.
After political leaders across the globe made patents and other intellectual property (IP) safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
The effects of U.S. Supreme Court case law on patents are well demonstrated, but the latest victims of patent jurisprudence are directed toward a critical need for desperately ill patients. The Court of Appeals for the Federal Circuit ruled that several claims found in three patents licensed to Caredx Inc., of Brisbane, Calif., are ineligible due to a purported lack of inventiveness under Section 101 of the Patent Act, an outcome that sustains what some believe is a trend in case law that is hostile toward diagnostic patents in the U.S.
After political leaders across the globe made patents and other intellectual property safeguards the scapegoat for disparities in access to COVID-19 vaccines, the biopharma industry is sharing its vision for how to deal with the foundational issues of equitable access in pandemics to come – and it has nothing to do with IP waivers like the one World Trade Organization members adopted last month.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Apellis, Astrazeneca, Avadel, Daiichi, Destiny, Gilead, Incyte, Moderna, Viking.
Japan’s Ministry of Health, Labor and Welfare has cleared Japan Tissue Engineering Co. Ltd.’s (J-Tec) autologous cultured cartilage, called Jacc, after a seven-year re-examination period. Headquartered in Gamagori, in Japan’s Aichi prefecture, J-Tec was the first company in Japan to receive conditional clearance of regenerative medicine therapies under the new regenerative medicine pathway.
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