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Home » Topics » Regulatory

Regulatory
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Industry seeks clarity on EU’s joint clinical assessment plan

April 5, 2024
By Nuala Moran
With nine months to go before their introduction, the industry is flagging many uncertainties around the proposed guidelines for implementing joint clinical assessments.
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FDA sign

US FDA, Renovo at loggerheads over added sterilization inventory

April 5, 2024
By Mark McCarty
Some warning letters issued by the U.S. FDA are fairly simple matters, but that statement does not appear to apply to the Oct. 13, 2023, warning letter to Renovo Inc., of Bend, Ore. The warning letter provided a laundry list of sterilized reusable devices the agency said were not properly validated for sterilization, but the company rebutted these allegations in a vigorous defense of its reputation as a reprocessor.
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Amylyx pulling ALS drug Relyvrio from US, Canadian markets

April 4, 2024
By Jennifer Boggs
Less than a month after disclosing that its confirmatory phase III trial of Relyvrio (sodium phenylbutyrate plus taurursodiol) fell short of its endpoint, Amylyx Pharmaceuticals Inc. is withdrawing the amyotrophic lateral sclerosis (ALS) drug from the market.
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Staphylococcus aureus

US FDA approves antibiotic Zevtera, Basilea seeks US partner

April 4, 2024
By Karen Carey
In a long and winding regulatory road that began with two complete response letters 15 years ago, Allschwil, Switzerland-based Basilea Pharmaceutica Ltd. finally gained U.S. FDA approval of its intravenous cephalosporin antibiotic, Zevtera (ceftobiprole medocaril sodium), to treat Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia.
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Magnifying glass, FDA concept image

US FDA struggling to keep up with clinical research inspections

April 4, 2024
By Mari Serebrov
The lingering effects of the COVID-19 pandemic and ongoing recruitment/retention issues are making it difficult for the U.S. FDA’s bioresearch monitoring program to keep up with the on-site clinical research inspections that are a cornerstone of the preapproval process for new drugs, biological products and medical devices. The resulting delays could threaten the approval timelines for many products.
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Ahead of IPO, D&D Pharmatech wins US fast track for MASH drug

April 4, 2024
By Marian (YoonJee) Chu
Building D&D Pharmatech Inc. has been a rollercoaster ride, according to CEO Seulki Lee. The U.S. and Korea-based biotech is on another ascent, having scored U.S. FDA fast track designation for its metabolic dysfunction-associated steatohepatitis (MASH) drug, ahead of its third attempt at a public listing.
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Beckman Coulter, Agena hit with recent FDA warnings

April 4, 2024
By Mark McCarty
The U.S. FDA posted two device warning letters in the first week of April 2024, including one each to Beckman Coulter Inc., of Brea, Calif., and Agena Bioscience Inc. of San Diego, the former of which was directed toward the Chaska, Minn., facility that manufactures the Beckman Coulter Dxl 9000 analyzer.
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Australia’s anti-trust watchdog clears Cohlear-Oticon revised deal

April 4, 2024
By Tamra Sami
Australia’s Competition and Consumer Commission said it will not oppose Cochlear Ltd.’s proposed acquisition of the cochlear implants business of Denmark’s Oticon A/S after the bone conduction businesses was removed from the deal.
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Non-Hodgkin lymphoma cells in the blood flow
Immuno-oncology

Verismo submits IND application for Synkir-310 for relapsed or refractory B-cell NHL

April 4, 2024
Verismo Therapeutics Inc. has submitted an IND application to the FDA seeking to initiate a phase I trial this year of Synkir-310 for the treatment of relapsed or refractory B-cell non-Hodgkin lymphomas (B-cell NHL), including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and marginal zone lymphoma.
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Dollar sign dropper and test tube

US NIH under fresh scrutiny for questionable research funding

April 3, 2024
By Mari Serebrov
Does the NIH have the ability to screen for U.S. security issues in its award of research grants? That question is at the heart of an April 2 letter the Republican leadership of the House Energy and Commerce Committee sent to the Government Accountability Office in which it asked the government watchdog to examine the extent to which the NIH “adequately safeguards research funds from national security concerns related to the Chinese military or over the unethical use of human beings in research studies, especially from entities of concern in China.”
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