RP1 got a second complete response letter on Friday. Replimune says development is no longer viable without accelerated approval. Biopharma raised $22.8B in Q1. Plus a full look at the week ahead.
Steve Ubl exits after a decade navigating drug pricing wars and the pandemic. The FDA wants an expedited IND pathway to speed Phase 1 trials. Plus: the week in review.
Lunsekimig met primary endpoints in asthma and nasal polyps but missed in atopic dermatitis. AbbVie's 86% Humira discount signals how pharma is responding to Section 232 tariffs. Foundayo rollout continues.
Gilead pays up to $5B for ADC specialist Tubulis. That's $15B in 3 deals since late February. Neurocrine enters rare metabolic disease with Soleno's Vykat XR. The M&A machine keeps running.
The FDA approved orforglipron on April 1 under the CNPV program. It's already shipping through LillyDirect at $149/month. Anthropic acquired a 10-person biotech AI startup. Takeda dumps Denali. The global pipeline contracts for the first time in 30 years.
The Section 232 order is the most significant trade action to hit pharma in decades. Generics and biosimilars are exempt. Companies with MFN pricing deals pay zero. A separate investigation into medical devices is active. Orforglipron in 4 days.
Biopharma spent nearly $47B on 19 deals in Q1. The XBI surged 7% on the last day of the quarter. Immunovant's batoclimab missed in both Phase 3 TED studies. Orforglipron in 7 days.
Novo's new pricing model signals where obesity is headed. 400 jobs gone at the ex-Catalent site. Medtronic's Stealth Axis cleared for cranial and ENT. Orforglipron in 8 days.
Lilly pays $7.8B for Centessa's narcolepsy pipeline. Biogen pays $5.6B for Apellis at a 140% premium. And orforglipron is 9 days away.
Largest AI drug deal ever. Takeda cuts 634 jobs. White House circulates drug pricing legislation.
Rocket clears FDA with Kresladi. Two NEJM trials shift PE and AFib treatment. Orforglipron decision in 11 days.
90%+ gene knockdown in FSHD validates the Arrowhead pivot. Plus: Maze’s data disconnect and Rocket’s PDUFA countdown.
Maze delivers first APOL1 proof, Rocket’s PDUFA hits Friday
Gilead pays $1.675B for Ouro Medicines. Sanofi pays $1.23B for Kali's trispecific. The autoimmune playbook just changed overnight.
A 73% efficacy result wasn't enough to hit the statistical bar. Zumilokibart challenges Dupixent on dosing. And ARIKAYCE expands its frontline case.
Wegovy HD, Imcivree, Icotyde, and Lynavoy all cleared. Novartis grabs a breast cancer asset. And retatrutide put the metabolic field on notice.
Imcivree lands its fourth indication, retatrutide delivers 36.6 lbs of weight loss in diabetes, and Lilly builds a metabolic monopoly.
First oral targeted psoriasis pill gets FDA nod, another PAH contender craters, and Imcivree's HO decision lands in less than 24 hours.
Rhythm's PDUFA lands Friday, Lilly's obesity pill decision looms, and GTC puts pharma AI under the microscope.
ACIP meets Wednesday, Rhythm’s PDUFA lands Friday, and China clears the first commercial BCI.
Sana validates the T1D cure thesis at 14 months, ACIP meets Wednesday, and Rhythm's PDUFA lands Friday.
A new tirzepatide-B12 impurity escalates the GLP-1 compounding war as Pfizer winds down its biotech incubator.
FORTIFY Phase 3 data positions BBP-418 as the first LGMD therapy while Evotec cuts 800 jobs and CAR-T competition intensifies.
Leucovorin approved using literature evidence alone as BioNTech shares drop and GLP-1 telehealth tensions ease.
Azetukalner posts the strongest pivotal epilepsy efficacy ever as Vertex advances its kidney disease filing.
