Mari Serebrov

Regulatory Editor at BioWorld

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Articles

Regulatory, financial hurdles the gap between science and access

2 days ago | bioworld.com | Mari Serebrov

Regulatory, financial hurdles the gap between science and accessChildren 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.
US Fed Circuit rules in favor of Moderna in patent squabble

3 days ago | bioworld.com | Mari Serebrov

US Fed Circuit rules in favor of Moderna in patent squabbleModerna 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.
Sarepta’s gene therapy gets boost with FDA platform designation

3 days ago | bioworld.com | Mari Serebrov

Sarepta’s gene therapy gets boost with FDA platform designationThe 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. BioWorld Regulatory Neurology/psychiatric Gene therapy U.S. FDA
US trade court blocks emergency tariffs, but threat remains

1 week ago | bioworld.com | Mari Serebrov

US trade court blocks emergency tariffs, but threat remainsA court decision blocking President Donald Trump’s reciprocal and trafficking tariffs was hardly a day old before the U.S. Court of Appeals for the Federal Circuit stepped in late May 29 to grant a temporary stay while it considers the administration’s appeal. The stay adds further uncertainty to the path ahead for drug and device companies. BioWorld BioWorld MedTech Regulatory U.S. Courts Policy Trade
Kennedy welcomes end of COVID-19 vaccines for healthy kids

1 week ago | bioworld.com | Mari Serebrov

Kennedy welcomes end of COVID-19 vaccines for healthy kids Without convening the U.S. CDC’s Advisory Committee on Immunization Practices, Health and Human Services Secretary Robert Kennedy decided to bring the government’s COVID-19 vaccine recommendations in line with the FDA’s new “evidence-based” approach to the shots. BioWorld Regulatory Coronavirus Vaccine U.S. FDA
Longtime life sciences director hit with insider trading

1 week ago | bioworld.com | Mari Serebrov

Longtime life sciences director hit with insider trading A former board member of Chinook Therapeutics Inc. and four others were charged May 22 in a 19-count indictment stemming from an alleged insider trading scheme that produced more than $600,000 in profits after the June 2023 announcement that Novartis AG was acquiring the Seattle-based Chinook in a $3.5 billion deal. BioWorld Regulatory U.S. Courts
In search of lower prices, FDA enhances Rx import program

2 weeks ago | bioworld.com | Mari Serebrov

In search of lower prices, FDA enhances Rx import programIt’s been nearly five years since the U.S. FDA, under the first Trump administration, issued a final rule and guidance on state importation plans (SIP) for importing less expensive prescription drugs from Canada. Yet only one state, Florida, has an approved SIP.
ODAC Starglo vote could impact universe of trials

2 weeks ago | bioworld.com | Mari Serebrov

ODAC Starglo vote could impact universe of trialsThe recent 8-1 adcom vote against the U.S. applicability of Genentech Inc.’s Starglo trial is being seen as a warning signal expanding beyond the confirmatory trial for Columvi (glofitamab) as a treatment for relapsed/refractory diffuse large B-cell lymphoma. BioWorld Regulatory Cancer Monoclonal antibody U.S. FDA
Split adcom vote not what Urogen envisioned

2 weeks ago | bioworld.com | Mari Serebrov

Split adcom vote not what Urogen envisionedMore telling than the U.S. FDA’s Oncologic Drugs Advisory Committee’s 4-5 vote May 21 on the overall benefit-risk of Urogen Pharma Inc.’s UGN-102 (mitomycin) is that the panel’s urology specialists and the patient representative all voted yes, saying the drug would be an important alternative to what is often a continuing cycle of surgery for patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.
US FDA rethinks COVID-19 boosters

2 weeks ago | bioworld.com | Mari Serebrov

With FDA vaccine nod, Novavax takes ACIP of new COVID-19 rulesFrets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s...