Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Invo Bioscience, Roche.
The U.K. National Institute for Health and Care Excellence (NICE) has undertaken a public consultation for a series of proposed changes to its procedures for evaluating medical devices and other medical technologies that could speed up these reviews. This new process would require a less time-consuming approach to evaluating lower-risk technologies that would not only turn around such evaluations more rapidly but would also leave more resources available for higher-risk products that would also enjoy a timelier review, thus potentially accelerating adoption of all these products in the National Health System.
With a new medical device policy, India is laying the groundwork for a spurt in domestic manufacturing and to emerge as an innovative and globally competitive in the space, which is currently heavily reliant on imports. The new National Medical Devices Policy 2023, approved by the government at the end of April and notified in May, aims to place the Indian medical devices sector on an accelerated growth path.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alx, Invivyd, Pharvaris.
In releasing a revised guidance June 30 detailing the requirements of the new Medicare Drug Price Negotiation Program, the U.S. Centers for Medicare & Medicaid Services addressed some of the issues raised in recent constitutional challenges to the guidance and the underlying negotiation provision in the Inflation Reduction Act.
The U.S. FDA is on a roll with new drug approvals for Pfizer Inc., clearing severe alopecia areata treatment Litfulo (ritlecitinib) just under a month after giving the go-ahead for the firm’s oral COVID-19 antiviral, Paxlovid (nirmatelvir/ritonavir).
The U.S. FTC picked up six allies in its unprecedented effort to stop Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc, as the attorneys general for California, Illinois, Minnesota, New York, Washington and Wisconsin joined the agency in signing onto an amended complaint filed under seal June 22 in the U.S. District Court for the Northern District of Illinois.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medical IP.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amylyx, Astrazeneca, Boehringer Ingelheim, Erasca, Gilead, Intercept, Janssen, Leo, Lianbio, Moderna, Molecure, Pfizer, Sarepta, Zealand.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Atyr, Cidara, GSK, Kite, Kymera, Mindset.
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