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.
Although it’s a latecomer to the COVID-19 pandemic in the U.S., there is a wedge of opportunity for Novavax Inc.’s adjuvanted protein-based vaccine among the 10% of the U.S. adult population that has yet to get a first jab.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Neuronetics.
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.
China’s NMPA gave the green light to Simcere Pharmaceutical Group Ltd. for Cosela (injectable trilaciclib hydrochloride) as a treatment to decrease the risk of chemotherapy-induced myelosuppression. It is intended for adult patients with extensive-stage small-cell lung cancer (ES-SCLC), before they undergo a platinum/etoposide-containing regimen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acer, Alzamend, Byondis, Calliditas, Entera, Eton, Relief, Rhythm, Stuart, Sumitomo.
The U.S. federal government’s crackdown on companies in the health care space shows no signs of slowing down as indicated by an announcement by the Department of Justice (DOJ) that it has achieved a settlement with Opko Health Inc. and Bioreference Health LLC regarding allegations of induced referrals.
Reliance Medical Systems LLC agreed to pay $1 million to address allegations of violation of the Anti-Kickback Statute (AKS), but the company has responded to that outcome with a blistering riposte.
A “clean” user fee bill with no congressionally added policy riders. It’s been a biopharma and med-tech dream for years. But now that U.S. Sen. Richard Burr (R-N.C.) has introduced such a bill, it could prove a nightmare, given competing legislation and the tight timetable for reauthorizing the user fee programs before the clock winds down on the current agreements Sept. 30 when fiscal 2022 ends.
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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