Dan Samorodnitsky

Minneapolis

Freelance Writer and Journalist at Freelance

i'm a science writer. i write about biology, genetics, the environment, stuff like that. my pronouns are he/him. cofounder @sequencermag

Articles

Nicole Verdun Exits FDA as CBER Director Vinay Prasad ‘Consolidates Power’

1 week ago | biospace.com | Dan Samorodnitsky

Nicole Verdun, the influential director of the FDA’s Office of Therapeutic Products, was placed on administrative leave Wednesday afternoon. Her deputy, Rachael Anatol, was also put on leave. Verdun had been with the agency since 2012 and was appointed director of the Office of Therapeutic Products (OTP), the agency’s cell and gene therapy division, in 2023 when it was established to deal with the deluge of cell and gene therapy (CGT) products that needed attention.
Gilead Wins Historic Approval for Twice-Yearly HIV Drug

1 week ago | biospace.com | Dan Samorodnitsky

The FDA approved Gilead’s landmark long-acting HIV treatment lenacapavir Wednesday afternoon. The drug will be marketed under the name Yeztugo. Lenacapavir had already been approved in 2022 and sold under a different name, Sunlenca. That approval only applied to patients with treatment-resistant HIV and had received prior treatment. Yeztuga is approved for all HIV patients as pre-exposure prophylaxis (PReP).
Scholar Rock Jumps on Weight Loss Data for Zepbound/Repurposed Antibody Combo

1 week ago | biospace.com | Dan Samorodnitsky

When combined with Eli Lilly’s blockbuster weight loss drug tirzepatide, Scholar Rock’s monoclonal antibody apitegromab—which faces an upcoming PDUFA for its use in spinal muscular atrophy— preserves 55% more lean muscle mass than tirzepatide alone, the biotech announced early Wednesday. That figure beats Scholar Rock’s own expectations. “The results are higher than initial management commentary of a 20-40% muscle preservation expectation,” analysts from Jefferies wrote in a note to investors.
Another Gene Therapy Death; Biopharma M&A Picks Up; a Vaccine Board of Vaccine Skeptics

1 week ago | biospace.com | Heather McKenzie |Jef Akst |Annalee Armstrong |Dan Samorodnitsky

> Listen on Spotify> Listen on Apple Products> Listen on Amazon Music> Listen on iHeartThis week, BioSpace is at 50% power as Heather McKenzie and Jef Akst are off attending this year’s BIO Conference in Boston. The half-team discusses this week’s biggest news: the death of another patient who took Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys.
Drilled goes deeper on fossil fuel industry misinformation and the legacy of Standing Rock

1 week ago | sequencermag.com | Dan Samorodnitsky

In 2016, a company called EnergyTransfer was getting ready to build a massive pipeline called the Dakota Access Pipeline pumping oil from the Bakken Region of North Dakota. This pipeline passed within a mile of the Standing Rock Sioux Reservation, underneath a lake near the reservation, as well as underneath the Missouri River, the tribes’ main drinking water source. There were concerns about culturally significant sacred sites, and concerns about climate change as well.
NextCure Joins China-ADC Gold Rush with $745M Simcere Deal

1 week ago | biospace.com | Dan Samorodnitsky

NextCure is joining the China biopharma gold rush, partnering with Simcere Pharmaceutical Group on development of a novel antibody-drug conjugate for treating solid tumors. Through the deal announced Monday, the Maryland-based company gets ex-China rights to SIM0505, an ADC developed by Simcere that targets CDH6 combined with a topoisomerase 1 inhibitor.
RFK Jr. Names New CDC Vaccine Advisors Days After ‘Clean Sweep’

2 weeks ago | biospace.com | Dan Samorodnitsky

Two days after “retiring” all 17 remaining members of the CDC’s Advisory Committee on Immunization Practices, Health Secretary Robert F. Kennedy Jr. has named their replacements. In a Wednesday afternoon post on X, Kennedy listed the eight new members of the ACIP, downsizing the committee significantly. “I’m now repopulating ACIP with the eight new members who will attend ACIP’s scheduled June 25 meeting,” Kennedy wrote in his post.
Genentech Lays Off 143 Employees in South San Francisco Reshuffle

2 weeks ago | biospace.com | Dan Samorodnitsky

After enduring multiple rounds of layoffs last year, Genentech’s employees are facing more uncertainty as the Roche unit lets go of 143 workers at its headquarters in South San Francisco, according to a Worker Adjustment and Retraining Notification. The layoffs, originally reported by the San Francisco Chronicle, will go into effect on July 14, as reported in the WARN notice. The company framed the downsizing as just business as usual.
As Gene Therapy Endures ‘Cold Winter,’ FDA Leaders Promise Support

2 weeks ago | biospace.com | Dan Samorodnitsky

Following comments from FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research Director Vinay Prasad signaling their support for rare diseases, the regulator hosted a roundtable last week to discuss the state of cell and gene therapies—still relatively young modalities often targeting rare indications. As the healthcare administors listened to feedback from the industry, they promised to help the technology reach its full potential.
SpliceBio Nabs $135 Million Series B To Advance Protein Splicing Medicines

2 weeks ago | biospace.com | Dan Samorodnitsky

Barcelona-based genetic medicines company SpliceBio has raised $135 million in a series B round to back its novel protein-splicing drug delivery system, the biotech announced Wednesday. The money will go toward development of the company’s lead gene therapy, which is being developed for Stargardt disease, an inherited type of macular degeneration.