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BioWorld - Thursday, June 19, 2025
Home » Topics » Regulatory

Regulatory
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Regulatory, financial hurdles the gap between science and access

June 5, 2025
By Mari Serebrov
No Comments
Children with solid tumors who relapse are being treated with the same chemotherapy they would have been given 40 years ago, as “there have been no major approvals for pediatric solid tumors,” Catherine Bollard, senior vice president and chief research officer at Children’s National Hospital, said at a June 5 FDA roundtable on cell and gene therapies (CGTs). The problem isn’t the science. Bollard said many groups are working on curative CGTs “for these children who have lost all other hope for survival.” The real gap is that “big pharma doesn’t see the business model because it’s a rare disease,” she added.
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Pregnant woman

EMA: New clinical guideline includes pregnant, breastfeeding patients

June 5, 2025
By Nuala Moran
No Comments
The EMA has issued a new guideline on how to include and/or retain pregnant and breastfeeding women in clinical trials, in a move that it says “marks a change in the paradigm.” The aim is to ensure that trial sponsors generate robust clinical data in these populations.
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Eye wireframe illustration
Ocular

Chinese IND clearance for anti-IGF-1R antibody NTB-003 for thyroid eye disease

June 5, 2025
No Comments
Biocytogen Pharmaceuticals (Beijing) Co. Ltd. and Nanjing Chia Tai Tianqing Pharmaceutical Co. Ltd. have announced IND clearance by China’s National Medical Products Administration (NMPA) for NTB-003 (formerly BCG-009) for thyroid eye disease.
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Mesothelioma
Immuno-oncology

Oncovita’s Mvdeltac designated orphan drug for pleural mesothelioma

June 5, 2025
No Comments
Oncovita SAS’s lead oncolytic virus candidate, Mvdeltac, has been awarded orphan drug designation by the FDA.
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Telemedicine at the root of false claims conviction for more than $1B

June 4, 2025
By Mark McCarty
U.S. Medicare coverage of telehealth and telemedicine sometimes seems to lag inappropriately, but fears of fraud were borne out in a conviction obtained recently by the Department of Justice.
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Gavel and FTC logo

FTC active again in enforcement of contact lens rule

June 4, 2025
By Mark McCarty
The U.S. Federal Trade Commission said it sent letters to 37 contact lens prescribers reminding them a failure to automatically provide patients with a prescription can result in fines of more than $53,000 per violation.
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Sarepta’s gene therapy gets boost with FDA platform designation

June 4, 2025
By Mari Serebrov
No Comments
The U.S. FDA gave Sarepta Therapeutics Inc.’s rAAVrh74 viral vector, used in an investigational gene therapy for the treatment of limb-girdle muscular dystrophy, a step up, making it one of the first platforms to receive the agency’s platform technology designation.
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Flag of South Korea with skyscrapers in the background

Korea pharma exports rise to quarterly high of $2.5B in Q1

June 4, 2025
By Marian (YoonJee) Chu
No Comments
South Korea’s pharmaceutical exports rose nearly 18% year-on-year to reach $2.56 billion in the first quarter (Q1) this year, according to the Korea Health Industry Development Institute. Medical device exports, however, dropped about 5% in Q1 2025 to $1.39 billion, attributed to a drop in trade of implant products to both China and the U.S.
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US Fed Circuit rules in favor of Moderna in patent squabble

June 4, 2025
By Mari Serebrov
No Comments
Moderna Inc. once again emerged the winner in a court skirmish over claims that its COVID-19 vaccine infringed two Alnylam Pharmaceuticals Inc. patents. The U.S. Court of Appeals for the Federal Circuit issued a precedential opinion May 4, agreeing with a federal district court in Delaware that Moderna didn’t infringe the patents. For both courts, the decision was based on a single issue of claim construction.
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Pill with British pound sign

Pharma execs speak out: UK pricing rebates scare investors

June 4, 2025
By Nuala Moran
No Comments
The row between pharma companies and the U.K. government over rebates has intensified, with the Association of the British Pharmaceutical Industry calling up its members to speak on the record, as it ramps up the campaign against paying back over 23% on sales of branded drugs.
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