FDA Clears Gilead's Hepatitis D Drug, Four Years After Prior Rejection
Gilead’s hepatitis D therapy Hepcludex (bulevirtide) has finally secured FDA approval after a prior rejection over manufacturing and distribution flaws. The drug becomes the first U.S.‑cleared treatment for chronic hepatitis D, a rare but aggressive liver infection affecting roughly 70,000 Americans. Phase 3 trials demonstrated robust viral suppression and liver‑function improvement, prompting the regulator to lift its hold. Gilead plans to launch Hepcludex later this year, with pricing yet to be disclosed.
AstraZeneca Wins EU Backing for Breast Cancer Drug, Splitting with FDA Panel
AstraZeneca’s breast‑cancer therapy, identified as [drug], received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, clearing the path for EU approval. In contrast, an FDA advisory committee voted against the drug last month,...
How Utah’s AI Prescribing Experiment Is Going so Far
Utah’s Department of Health released early results from its AI‑driven prescription renewal pilot, launched in mid‑December with health‑tech firm Doctronic. The system automatically processed roughly 12,000 chronic‑care renewals, achieving a 95% accuracy rate and cutting average turnaround from two days...
Tender Offer for Recordati; Sobi's Gout Drug Passes Phase 3 Test
CVC Capital Partners and Groupe Bruxelles Lambert have launched a cash voluntary tender offer for Recordati, valuing the Italian specialty‑pharma group at roughly €1.5 billion. Meanwhile, Swedish biotech firm Sobi announced that its investigational gout therapy met its primary endpoint in...
Novartis Says Avidity's Science Could Apply Beyond Muscular Dystrophies
Novartis announced that it will leverage its $12 billion acquisition of Avidity Biosciences to extend the latter’s RNA‑based platform beyond its current focus on muscular dystrophies. Avidity’s technology, which uses engineered messenger RNA to replace missing proteins, has shown promise in...
Biogen, Denali to Drop Drug in Non-Genetic Parkinson’s After Mid-Stage Study Flop
Biogen and Denali Therapeutics announced that their LRRK2 inhibitor BIIB122 failed to meet primary endpoints in a Phase 2b trial of early‑stage Parkinson’s disease. The mid‑stage study, which targeted patients without the LRRK2 genetic mutation, showed no statistically significant slowing...
#ASCO26: Merck Partner Kelun Outlines Phase 3 Lung Cancer Success in China Study
Merck’s Chinese partner Kelun‑Biotech reported that its Phase 3 trial of the antibody‑drug conjugate sac‑TMT met its primary endpoints in patients with advanced non‑small cell lung cancer. The study, conducted across multiple sites in China, showed a statistically significant improvement in...
#ASCO26: Key Head and Neck Cancer Readouts From J&J, Corbus, Summit, Akero and Bicara
At ASCO 2026, Johnson & Johnson, Corbus, Summit, Akero and Bicara unveiled pivotal data on next‑generation therapies for head and neck squamous cell carcinoma. J&J’s pembrolizumab‑plus‑chemotherapy regimen reduced the risk of death by roughly 20% in first‑line patients. Corbus reported...
#ASCO26: New Data Released for VEGF Bispecifics From BioNTech-BMS, Pfizer-3SBio
At ASCO 2026, BioNTech‑BMS and Pfizer‑3SBio unveiled new Phase 1/2 data on their VEGF‑targeting bispecific antibodies. BioNTech‑BMS reported a 45% overall response rate in heavily pre‑treated solid‑tumor patients, while Pfizer‑3SBio’s candidate achieved disease control in 78% of a similar cohort....
Parabilis Reveals IPO Plans the Day After Regeneron Deal as Listings Heat Up
Parabilis Medicines, the Harvard‑lab‑spun biotech targeting "undruggable" proteins, announced plans for a Nasdaq initial public offering just one day after unveiling a strategic partnership with Regeneron. The collaboration includes a $150 million upfront payment and co‑development of novel protein therapeutics. Backed...
TrumpRx Adds Hundreds of Generic Medicines to Site
The Trump administration’s direct‑to‑consumer pharmacy, TrumpRx, announced the addition of more than 600 generic medicines to its online catalog. The expansion more than doubles the platform’s drug inventory, positioning it as a broader alternative to traditional pharmacy benefit managers. TrumpRx...
Another Paragon Offshoot Chooses Reverse Merger, This Time for Migraine Drugs
Paragon Therapeutics’ latest spin‑off, InMed Pharmaceuticals, has merged with Mentari Therapeutics through a reverse merger, creating a publicly traded company focused on migraine prevention drugs. The deal, announced on Tuesday, combines InMed’s CGRP‑targeting pipeline with Mentari’s clinical assets and injects...
Acceleron Leaders and Westlake Jumpstart New IPF Biotech
Oorja Bio, founded by former Acceleron executives, announced its launch targeting idiopathic pulmonary fibrosis (IPF). The company closed a $30 million Series A round, with all capital coming from Westlake Capital. Leveraging the commercial success of the Winrevair lung drug, Oorja aims...
Wave Aims for Monthly Dosing with RNA Editing Treatment for AATD
Wave Life Sciences announced an updated read‑out from its early‑stage trial of an RNA‑editing therapy for alpha‑1 antitrypsin deficiency (AATD). The data indicate that the treatment can restore functional protein levels with a dosing schedule that could be moved to...
FDA's Unreleased Covid Vaccine Deaths Report Is Published by Lawmaker
A Republican lawmaker released an FDA-commissioned analysis examining alleged pediatric deaths linked to COVID‑19 vaccines, a report the agency failed to publish by its own deadline. The study, led by former FDA officials, concluded there is no statistically significant rise...