Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apyx Medical, Intuitive Surgical.
A heart-protective cardiac myosin inhibitor and two biologics – one for a type of non-Hodgkin lymphoma and another for an inflammatory skin condition – were among the therapies recommended for approval by the EMA’s Committee for Medicinal Products for Human Use this week.
The U.S. FDA’s Oncologic Drugs Advisory Committee has recommended by a wide majority that the PARP inhibitor Lynparza (olaparib) in a combination therapy for treating prostate cancer should be restricted to only patients whose tumors have a BRCA mutation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amicus, BMS, Editas, Eli Lilly, Gensight, GSK, Intelgenx, Novartis, Ocugen, Roche, Seres, Taiho, Takeda.
Regulatory harmonization is perhaps highest on the regulatory wish list of medical device manufacturers, but the FDA’s device center has tamped down expectations of a medical device single review program. Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) said the agency will release a strategic plan later this year for regulatory harmonization, but declined to offer any details other than to state that differences in risk classification schema are not as significant a source of drag on harmonization as may commonly be believed.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 3M, Innoblative, Ismart Developments.
The supply chain for Seres Therapeutics Inc.’s oral microbiome therapeutic Vowst, formerly known as SER-109, to prevent recurrent Clostridium difficile infection (rCDI) is “well-established,” said David Arkowitz, the firm’s chief financial officer and head of business development. “It’s the same supply chain that we used for phase III [trials], and we’ve been manufacturing product for launch for some time.” Arkowitz spoke during a conference call with investors April 27, regarding the previous day’s U.S. FDA go-ahead for Vowst, cleared for adults with rCDI, including first recurrence following antibacterial therapy.
The legislative pile-on continues as the U.S. Congress considers more ways to take down health care costs while defending innovation. The House Energy and Commerce Subcommittee on Health met April 26 to consider 17 draft discussion bills offered as bipartisan solutions to lower costs by increasing transparency and competition across the health care playing field.
The U.S. FDA’s Oncologic Drugs Advisory Committee meets April 28 to discuss the future of Astrazeneca plc and Merck & Co. Inc.’s supplemental NDA for Lynparza (olaparib) for an expanded label to treat prostate cancer. It has a few bones to pick. The FDA said it is concerned that the efficacy and safety have not been demonstrated outside of the small population of patients with tumor BRCA mutations and that the addition of olaparib to abiraterone may cause harm in patients who are definitively negative for tumor BRCA mutations.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akebia, Biogen, Cormedix, Direct, Inhibrx, Inovio.
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