While the U.S. continues to call out other countries for weak enforcement of intellectual property rights, trade secret theft and forced technology transfers in the life sciences sector, some companies in the sector claim similar things are happening in the U.S. In its 2023 Special 301 Report, released April 26, the Office of the U.S. Trade Representative (USTR) noted “the growing need for trading partners to provide effective protection and enforcement of trade secrets.”
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amolyt, Avadel, Boehringer Ingelheim, Elicera, Eloxx, Hyloris, Memo, Neurobo, Pharmather, Protara, Sirpant, Tenaya.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Directsync Surgical, Jogo Health, Kurin, Olympus.
In its first markup of the 118th Congress May 2, the Senate Health, Education, Labor and Pensions (HELP) Committee, under the new leadership of Sen. Bernie Sanders (I-Vt.), devolved into a brief mutiny of sorts as the committee members started to take up four bipartisan bills aimed at taming prescription drug prices.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aquavit, Arcutis, Ascendis, Atsena, Biomea, BMS, Cabaletta, Erasca, Kiromic, Medincell, Neurosense, Onquality, Sanofi, Teva.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Casana, Concept Medical, Medtronic, Nano-X Imaging, Tempus.
It’s not often that getting an NDA rejected by the U.S. FDA is cause for a company’s stock to rise. But in the case of Ascendis Pharma A/S, the agency’s anticipated complete response letter (CRL) for Transcon PTH (palopegteriparatide) offered some much-needed clarity and a potentially optimistic time frame for an NDA resubmission seeking approval of the once-daily hormone replacement therapy for hypoparathyroidism, news that sent the company’s shares (NASDAQ:ASND) up 24%, or $16.78, to close May 1 at $86.74.
The U.S. Centers for Medicare and Medicaid Services’ years-long musing over a streamlined coverage policy specifically for breakthrough medical devices is now taking a toll on breakthrough medications that could provide a cure or arrest the progression of debilitating diseases.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bristol Myers Squibb, H. Lundbeck, Moderna, Otsuka, Pfizer, Rnaimmune, Senhwa.
Cardiex Ltd. won U.S. FDA clearance for its Conneqt Pulse vascular biometric monitor. According to the digital health and wearables company, the device is the first in the world to provide measurements of both brachial blood pressure in the arm and central blood pressure in the heart and aorta, as well as arterial waveform analysis and other clinically relevant vascular biomarkers, outside the hospital, research institutions or clinical trial sites.
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