Gilead Sciences is paying $1.275 billion upfront for an oral IL-23 receptor drug with no efficacy data, staking a claim on an all-oral IBD franchise built around its own emvistegrast.
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Wound care is becoming one of big medtech's next frontiers, and Swedish wound-care leader Mölnlycke just announced a separation into an independent wound-care company. At the center of that landscape sits MediWound (NASDAQ: MDWD).
FDA expanded Anktiva's use to BCG-unresponsive, high-grade papillary-only bladder cancer without a dedicated trial, leaning on earlier carcinoma in situ data and scientific similarities. The move sets a precedent developers of rare indications will study closely.
Verastem's 900 mg KRAS G12D dose posted a 50% confirmed response rate in second-line pancreatic cancer, and the company will take a chemotherapy-free regimen into a first-line Phase 3. The rival comparison is overall survival.
In depth
PhRMA sued CMS on October 7 over the GLOBE most-favored-nation rule for Medicare Part B. The final rule covers as few as four manufacturers and $440 million in projected savings. The suit's real target is the CMMI test authority beneath it.
Read the storyMirum's brelovitug hit its Phase 3 endpoint in hepatitis delta, but Gilead's Hepcludex already holds the US approval and Vir's program is in flight. A strong readout no longer guarantees the market follows.
BigHat Biosciences raised $75 million as BHB810, a CDH17 VHH-Fc ADC, entered a Phase 1/2 gastric cancer trial. The round tests whether wet-lab data can fix AI drug discovery's translation problem.
The FDA granted accelerated approval to AstraZeneca’s camizestrant based on ctDNA resistance signals before radiographic progression, overruling a 6-3 advisory committee vote and betting on a new oncology paradigm.
Conjugating antisense oligonucleotides to transferrin receptor transport vehicles achieves fifty-fold deeper brain penetration, challenging the standard of invasive spinal punctures.
