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BioWorld - Wednesday, February 8, 2023
Home » Topics » Regulatory

Regulatory
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CMS fixes needed to implement new US Part B inflation rebate

Feb. 8, 2023
By Mari Serebrov
No Comments
While the new inflation-based rebate on certain Part B drugs may generate billions of dollars in savings for Medicare, implementing the rebate could be more challenging than the U.S. Congress and the Biden administration expected when the Inflation Reduction Act was enacted last August.
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Regulatory actions for Feb. 8, 2023

Feb. 8, 2023
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Awakn, Astrazeneca, CSL Vifor, FSD, Kiora, Optimi, Pharmather, Rocket.
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World map with supply chain icons

FDA, industry team up in effort to improve product quality, supply chain resiliency

Feb. 7, 2023
By Mark McCarty
No Comments
The U.S. FDA and makers of medical devices have several collaborative programs, but the two sides have joined forces yet again in a new collaboration, this time to address both product quality issues and supply chain resiliency. 
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Chief product security officer a key in cybersecurity program maturity

Feb. 7, 2023
By Mark McCarty
No Comments
The Medical Device Innovation Consortium (MDIC) has played a key role in fostering a stronger industrial appreciation for the need for robust cybersecurity, but a recent MDIC report noted that many device makers are deficient in pushing cybersecurity considerations into the domain of design controls. However, the most critical element in cybersecurity may be whether a company has a chief product security officer (CPSO), the presence of absence of which seems to correlate strongly and uniformly with all aspects of cybersecurity in a manufacturer’s products.
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Renalguard therapy awarded breakthrough designation for cardiac surgery-associated AKI

Feb. 7, 2023
By David Godkin
No Comments
Cardiorenal Systems Inc. has scored a U.S. FDA breakthrough device designation for technology to prevent patients undergoing cardiac surgery from developing acute kidney injury (AKI). AKI is reported in up to 30% of approximately 780,000 cardiac surgeries performed each year in the U.S., Europe and the Middle East, complicating patient recovery, prolonging ICU hospitalization and contributing to patient mortality after surgery.
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Silhouette made of crumpled paper illustrating depression

Australia to allow psychiatrists to prescribe psilocybin and MDMA for depression, PTSD

Feb. 7, 2023
By Tamra Sami
No Comments
Beginning July 1, Australia’s Therapeutic Goods Administration will allow medicines containing the psychedelic substances psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for certain mental health conditions.
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WTO logo

Decision to expand WTO COVID-19 waiver drags on as pandemic wanes

Feb. 7, 2023
By Mari Serebrov
No Comments
Any decision on whether to expand a five-year World Trade Organization (WTO) waiver of intellectual property rights for COVID-19 vaccines to diagnostics and therapies likely will be delayed longer than proponents had hoped. WTO members originally were scheduled to vote on expanding the waiver in December, but the deadline was extended indefinitely when key members, including the U.S., pushed for a delay.
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Bcht Biotech gains China’s first approval for domestic zoster vaccine

Feb. 7, 2023
By Doris Yu
No Comments
Changchun Bcht Biotechnology Co. Ltd. has obtained marketing approval for its live attenuated zoster vaccine in China, making it the first approved shingles vaccine developed by a Chinese company. An injectable of 0.5 ml per dose, it is designed for adults ages 40 and older and will go up against GSK plc’s Shingrix vaccine.
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As geopolitical tensions mount, China increasingly views IP through national security lens

Feb. 7, 2023
By Tamra Sami
No Comments
The ruling Communist Party of China increasingly views intellectual property (IP) through a national security lens, and generally accepted concepts of IP as a private right and respect for the rule of law don’t always apply as China prioritizes its pursuit of global technology dominance.
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Regulatory actions for Feb. 7, 2023

Feb. 7, 2023
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dia Imaging Analysis, Northeast Scientific, Vero Biotech.
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