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Home » Topics » Regulatory

Regulatory
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New shortage threatens Rx supply chain

March 31, 2022
By Mari Serebrov
Throughout the COVID-19 pandemic, biopharma companies across the world have had to deal with shortages resulting from supply chain issues.
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Architectural pillars

US SEC proposal may retract SPAC space

March 31, 2022
By Mari Serebrov
The U.S. SEC is proposing rules that could close off the advantages of going public via a special purpose acquisition company, or SPAC.
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Regulatory actions for March 31, 2022

March 31, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Edwards.
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Regulatory actions for March 31, 2022

March 31, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abionyx, Antengene, ASC, Biogen, Guerbet, Hipra, Nurix, Realta, Receptor, Taiho, Viiv.
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Kidneys

Akebia draws CRL for vadadustat in CKD anemia

March 30, 2022
By Randy Osborne
Opinion on Wall Street said the matter could have gone either way, but in the end Akebia Therapeutics Inc.’s vadadustat, a HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease (CKD), garnered a complete response letter (CRL) instead of approval from the FDA. The news slammed Akebia shares (NASDAQ:AKBA), which closed at 82 cents, down $1.61, or 66%. Specifically, the agency said that the data in the NDA do not support a favorable benefit-risk assessment of vadadustat in dialysis-dependent (DD) and non-DDs patients.
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U.S. Capitol building, Washington D.C.

FDA’s Shuren says secrecy, speed trump transparency for user fee meeting minutes

March 30, 2022
By Mark McCarty
Negotiations between the U.S. FDA and industry over device user fees were a protracted struggle, but the agency was demonstrably loathe to post the minutes from meetings between the agency and industry representatives. Jeff Shuren, director of the FDA’s device center, said in a congressional hearing that those minutes were not posted because of a need to wrap up the negotiations rather than allow outsiders – including members of Congress – to see how difficult the negotiations had become.
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Regulatory actions for March 30, 2022

March 30, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aidoc, Cartiheal, Life Spine, Nanovibronix, Optellum, Shockwave Medical.
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ALS hope could be delayed following negative adcom vote for Amylyx

March 30, 2022
By Mari Serebrov
Unless the U.S. FDA once again overrides its Peripheral and Central Nervous System Drugs Advisory Committee, it looks like the ALS community will have a longer wait for an additional tool against the fatal, degenerative disease. After hearing from both Amylyx Pharmaceuticals Inc. and FDA reviewers, along with 26 people testifying during the open public hearing, the committee voted March 30 against approval of AMX-0035, a fixed-dose combination of sodium phenylbutyrate and taurursodiol, as a much-needed treatment for amyotrophic lateral sclerosis (ALS).
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Regulatory actions for March 30, 2022

March 30, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antares, Astrazeneca, BMS, Canbridge, CSL, Daewoong, Enanta, Immunogen, Mitsubishi Tanabe, Neurocrine, Novo Nordisk, Noxopharm, Reveragen, Santhera, Takeda, Urogen, Telix.
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New legislation tackles debate over remanufacturing of medical technology

March 29, 2022
By Mark McCarty
The ongoing tension between manufacturers of imaging systems and entities that perform extensive servicing activities has prompted activity on Capitol Hill in the form of H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act.
Read More
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