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BioWorld - Tuesday, June 24, 2025
Home » Topics » Regulatory

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LSX World Congress

European med-tech companies first looking to the US as EU MDR ‘not working’

May 10, 2023
By Shani Alexander
An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”
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Doctor examining child in wheelchair

Adcom briefing docs mixed; will FDA see Sarepta’s ‘grander vision’ in DMD gene therapy?

May 10, 2023
By Randy Osborne
How grave they might be remains unknown, but regulatory questions have surfaced in briefing documents related to the soon-to-happen panel meeting on Sarepta Therapeutics Inc.’s gene transfer therapy delandistrogene moxeparvovec in Duchenne muscular dystrophy (DMD). The U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee will meet May 12 to discuss the compound, also known as SRP-9001.
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Alpha-galactosidase enzyme

Protalix, Chiesi win US go-ahead for Elfabrio in Fabry disease

May 10, 2023
By Randy Osborne
On the heels of the marketing OK in Europe, Protalix Biotherapeutics Inc. and the Chiesi Group’s global rare diseases unit scored approval of Elfabrio (pegunigalsidase alfa-iwxj) from the U.S. FDA for adults with Fabry disease.
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Regulatory actions for May 10, 2023

May 10, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acrivon, Adaptive, Alphamab, Astrazeneca, Catalyst, Freya, Genentech, Radiopharm, Rocket, Salarius.
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Jury: Gilead not on the hook for $1B in PrEP royalties

May 9, 2023
By Mari Serebrov
The U.S. government’s attempts to enforce its ownership of biopharma intellectual property got a setback May 9 when a six-member federal jury in Delaware determined that Gilead Sciences Inc. did not infringe government patents claiming pre-exposure prophylaxis (PrEP) use of Gilead’s HIV drugs, Truvada and Descovy, both of which combine emtricitabine and tenofovir.
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Regulatory actions for May 9, 2023

May 9, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hubly Surgical, Omeq, Singlera Genomics, Sphingotec.
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Gavel and scales

UK, Australia responding to EU delays for regulatory deadlines

May 9, 2023
By Mark McCarty
The recent decision by the EU to delay the implementation dates for the Medical Device Regulation (MDR) initiative is having ripple effects across the globe as other regulatory jurisdictions amend their policies to keep pace. The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) and Australia’s Therapeutic Goods Administration (TGA) have both revised their strategies to align with the latest MDR delay, giving devices that will remain available in the EU a similar extension in the U.K. and Australia.
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Active Implants back to the drawing board after FDA hearing for Nusurface

May 9, 2023
By Mark McCarty
The regulatory record for successful replacements of the human meniscus is thin, but the latest attempt came up short as a U.S. FDA advisory committee voted 6-2 that the benefits of the Nusurface device by Active Implants LLC did not present an acceptable benefit-risk ratio. The device is commercially available in both the European Union and in Israel, however, suggesting that Memphis, Tenn.-based Active will not give up on the massive U.S. market, which offers a patient population that will undergo a tsunami of total knee replacements in the decades ahead unless a solution for the epidemic of cartilage degeneration can be found.
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World map made of pills
LSX World Congress

US Inflation Reduction Act to have global implications for biopharma

May 9, 2023
By Nuala Moran
The U.S. Inflation Reduction Act (IRA) may look like domestic affair, but the drug price controls it is bringing in are set to impact the biopharma sector across the globe.
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Japanese money and medicine

Biopharma CEOs urge Japan for open dialogue on innovation, pricing reforms ahead of G7 summit

May 9, 2023
By Tamra Sami
Ahead of the upcoming G7 summit to be hosted in Japan this month, a delegation of 24 CEOs from the Biopharmaceutical CEOs Roundtable met with Japanese Prime Minister Fumio Kishida to discuss global priorities and to flag concerns over drug pricing policies in Japan.
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