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STAT1566 Endpoints1225 BioSpace565 Fierce Biotech562 BioPharma Dive467 raps192 onclive165 fda recalls

therapy area

all Oncology10451 Rare Disease2757 Immunology2463 Cardiology2287 Hematology1887 Pulmonology1875 Vaccines

Mother and daughter seek community for ultra-rare Nicolaides-Baraitser syndrome
In October 2020 a pediatric geneticist diagnosed an 11‑year‑old girl, Maya, with Nicolaides‑Baraitser syndrome, a condition documented in only 61 cases in the scientific literature. The doctor war…
STAT · 13d agoNeutral↗ source
Recon: FDA identifies four deaths in Newron schizophrenia drug trials; Dutch court blocks subcutaneous Keytruda in eight Europea...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
raps · 13d ago↗ source
Optogenetics therapy restores light sensitivity in half of retinitis pigmentosa patients in early trial

page 11 of 126

103

globenewswire health73

1646

Psychiatry & CNS1107

Ophthalmology871

Endocrinology & Metabolism691

A small clinical study examined an optogenetics‑based approach for treating retinitis pigmentosa, a genetic disorder that progressively destroys retinal light‑sensing cells and often leads to legal…

STAT · 14d agoPositive readoutPositive↗ source

Dutch court orders Merck to halt subcutaneous Keytruda sales in eight European countries

A Dutch court has issued an injunction that requires Merck to stop manufacturing and selling the injectable, subcutaneous formulation of its cancer immunotherapy Keytruda in eight European countrie…

Endpoints · 14d agoRegulatoryNegative↗ source

Zuckerberg’s Biohub secures $1.8 billion to expand AI-driven virtual cell platform with Meta and Google

Mark Zuckerberg and Priscilla Chan's nonprofit Biohub announced an expansion of its virtual cell initiative, now backed by $1.8 billion in funding. The new capital comes from a coalition that incl…

Endpoints · 14d agoPositive↗ source

2026 Nobel Chemistry Prize honors research on chiral molecules with implications for drug development

Henri B. Kagan, 95, and Kenso Soai, 76, received the 2026 Nobel Prize in chemistry for their work on asymmetric organic synthesis. Their research uncovered how certain reactions can act as their o…

STAT · 14d agoPositive↗ source

EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices

The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…

raps · 14d agoRegulatoryNeutral↗ source

Trump administration proposes $70,000 fee for OPT program, raising concerns for biotech talent pipeline

The Department of Homeland Security announced a proposal to charge $70,000 for the Optional Practical Training (OPT) program, which allows international students on F-1 visas to work in the United…

STAT · 14d agoRegulatoryNegative↗ source

PhRMA files lawsuit against Trump administration over GLOBE drug pricing demonstration program

PhRMA, the leading trade association for the pharmaceutical industry, has filed a lawsuit against the U.S. government challenging the Centers for Medicare & Medicaid Services' GLOBE drug pricing de…

Endpoints · 14d agoRegulatoryNegative↗ source

Ultragenyx sells priority review voucher for $210 million, retains another to monetize

Ultragenyx Pharmaceutical announced it has sold a priority review voucher to an undisclosed buyer for $210 million. The transaction is among the highest-priced voucher sales this year, providing a…

Endpoints · 14d agoDealPositive↗ source

WHO advises against GLP-1 obesity drugs for children under 10, limits use in teens

The World Health Organization issued guidance recommending that GLP-1 drugs not be used to treat obesity in children younger than ten years old. For adolescents aged 10 to 19, the WHO says these m…

Endpoints · 14d agoRegulatoryNegative↗ source

PhRMA sues Trump administration over Medicare GLOBE price pilot

PhRMA filed a lawsuit in the U.S. District Court for the District of Columbia challenging the Trump administration's GLOBE pilot that would tie Medicare Part B drug prices to those in peer nations.…

STAT · 14d agoRegulatoryNegative↗ source

Dutch court blocks Merck's subcutaneous Keytruda in several European markets

A Dutch court has ruled that Merck infringed a patent covering a subcutaneous formulation of its cancer drug Keytruda. The decision requires the company to stop manufacturing and marketing that ver…

STAT · 14d agoRegulatoryNegative↗ source

Novartis-partnered Matchpoint Therapeutics raises $150 million Series B to fund clinical entry

Matchpoint Therapeutics, a biotech company working with Novartis, announced the close of a new financing round. The round raised $150 million in Series B funding. The capital will be used to advan…

Endpoints · 14d agoDealPositive↗ source

Forbion secures $2.6 billion in its biggest European venture fund to date

Forbion, a leading European venture capital firm, announced it has closed a $2.6 billion fund, the largest it has raised and among the biggest recent funds in the region. The new capital will be d…

STAT · 14d agoDealPositive↗ source

DOJ expands fraud enforcement to include drug and device makers under FD&C Act

The Justice Department's National Fraud Enforcement Division released a new directive aimed at combating white-collar fraud, highlighting violations of the Federal Food, Drug, and Cosmetic Act. In…

STAT · 14d agoRegulatoryNegative↗ source

TCGX launches $600 million Asia-focused biotech fund to back life-science companies in China and the region

TCGX, a biotech investment firm led by Chen Yu and Dandan Dong, announced a new $600 million fund aimed at the Asian market. The fund will make direct investments in life-science companies located…

Endpoints · 14d agoDealPositive↗ source

CAR-T biotech Caribou Biosciences halts two programs and seeks exit after funding shortfall

Caribou Biosciences announced it is suspending two of its allogeneic CAR-T cell therapy projects. The company said it could not obtain the financing needed to keep the programs alive and is now lo…

Endpoints · 14d agoNegative↗ source

Experimental exon-skipping drug from Avidity Biosciences shows early improvement in a Duchenne patient

A recent story follows two teenage boys living with Duchenne muscular dystrophy, a rare and fatal muscle‑wasting condition. While one boy’s health continues to decline, the other, a 12‑year‑old nam…

STAT · 14d agoPositive↗ source

Caribou Biosciences shuts down after failing to fund late-stage CAR-T lymphoma trial

Caribou Biosciences, a biotech co-founded by Nobel laureate Jennifer Doudna, announced it is shutting down. The closure follows the company's inability to raise the funding required for a Phase 3…

STAT · 14d agoNegative↗ source

Bexorg receives $28 million ARPA-H grant to extend testing of revived human brain tissue

Bexorg, a biotech focused on brain research, was awarded $28 million by the U.S. Advanced Research Projects Agency for Health (ARPA-H). The funding will support longer-duration experiments on human…

Endpoints · 14d agoDealPositive↗ source

Nuvig Therapeutics halts Phase 2 trial of NVG-2089 in chronic inflammatory demyelinating polyneuropathy

Nuvig Therapeutics announced it is terminating one of its two ongoing clinical programs, a Phase 2 study of its candidate NVG-2089. The trial was designed to evaluate NVG-2089 in patients with chr…

Endpoints · 14d agoCRLNegative↗ source

Utah health AI pilots face regulatory uncertainty as FDA scrutiny looms

Utah has launched an AI sandbox that allows health-focused artificial-intelligence projects to be tested in real-world settings. The initiative aims to accelerate innovation while monitoring safety…

STAT · 14d agoRegulatoryNeutral↗ source

WHO issues first global guidelines on childhood and adolescent obesity

The World Health Organization has released its inaugural set of guidelines aimed at tackling the rapid increase in obesity among children and adolescents. The agency notes that in 2024, about 170 m…

STAT · 14d agoRegulatoryNeutral↗ source

MimiVax's glioblastoma vaccine falls short of Phase 2b primary endpoint

MimiVax reported that its investigational vaccine for glioblastoma did not achieve the primary efficacy goal in a Phase 2b trial. The study, more than a decade in development, compared the vaccine…

Endpoints · 14d agoNegative readoutNegative↗ source