Archive snapshot · Biotech
Sat, Oct 3, 9:32 PM ET
Edwards Lifesciences wins FDA approval for first expandable pediatric heart valve
The device is designed to expand as children grow, potentially reducing the need for repeat open-heart surgeries in pediatric patients with congenital valve dis
Benzinga · +12 outlets
FDA approves Jaypirca (pirtobrutinib) for first-line CLL/SLL without 17p deletion
The expanded label moves Eli Lilly's BTK inhibitor into untreated chronic lymphocytic leukemia and small lymphocytic lymphoma patients, widening its earlier rel
AJMC · +14 outlets
Novo Nordisk bets up to $2.6B on Hengrui's weight-loss pill
The deal expands Novo's oral obesity pipeline beyond its own candidates amid intensifying competition with Eli Lilly in the GLP-1 market.
Drug Discovery News · +8 outlets
CMS finalizes mandatory GLOBE model tying Medicare Part B rebates to international prices
The mandatory model extends most-favored-nation style price benchmarking to physician-administered drugs, a significant shift in US drug pricing policy.
The Pharma Letter · +4 outlets
Pfizer to halt development of closely watched weight-loss drug
The decision removes one of the larger pharma entrants from the oral obesity race and reflects the difficulty of catching Lilly and Novo.
BusinessWorld Online · +13 outlets
Cullinan Therapeutics begins FDA NDA submission for zipalertinib combination in first-line EGFR exon 20 NSCLC
The filing follows Phase 3 REZILIENT3 results and targets an EGFR exon 20 insertion subset with limited first-line options.
quiverquant.com · +4 outlets
GRAIL shares rise 12.9% after positive FDA panel verdict on Galleri trial results
The advisory panel's favorable vote moves GRAIL's multi-cancer early detection blood test closer to US regulatory clearance.
Yahoo Finance · +2 outlets
Lilly details Foundayo heart benefit data in diabetes and obesity phase 3
Cardiovascular outcomes data could strengthen Foundayo's case as payers and regulators scrutinize GLP-1 class benefits beyond weight loss.
Fierce Pharma · +12 outlets
Eli Lilly to build $3.5B Pennsylvania weight-loss drug plant
The investment is part of Lilly's multi-billion-dollar manufacturing buildout to meet demand for its GLP-1 medicines.
polskieradio.pl · +14 outlets
Kailera and Hengrui's GLP-1/GIP candidate shows weight and menstrual benefits in women with PCOS
The mid-stage data points to a broader metabolic benefit beyond weight loss for the dual agonist, which is being developed for obesity-related conditions.
BioSpace · +2 outlets
Trump drug pricing rule may apply to only four drugmakers
The narrow scope of the rule limits its near-term revenue impact relative to earlier expectations for broad most-favored-nation pricing.
medwatch.com · +8 outlets
Boehringer's survodutide achieves up to 13.1% weight loss
The results add another contender to the crowded obesity drug field as Boehringer pushes its glucagon/GLP-1 dual agonist toward late-stage development.
The Pharma Letter · +12 outlets
Trump drug pricing deal projected to save $64.3B over 10 years
The savings estimate frames the administration's pricing agreement as a fiscal win while drugmakers navigate the new terms.
Medical Economics · +1 outlets
Fierce Pharma tracker: Lilly's Foundayo surges while Novo's Wegovy pill stalls
The tracker tracks the fast-moving oral GLP-1 race, where Lilly's oral candidate is gaining on Novo's rival pill in market momentum.
Fierce Pharma · +1 outlets
Trump delivers Oval Office announcement on weight loss drug costs
The event put GLP-1 pricing at the center of the administration's drug cost agenda, with implications for Medicare coverage of obesity medicines.
polskieradio.pl · +14 outlets
Eli Lilly revenue jumps 47.7% on obesity drug demand
The growth underscores how GLP-1 obesity medicines have become the primary revenue engine for large-cap pharma.
Pluang · +4 outlets
FDA extends Novo Nordisk's denecimig review over facility remediation
The delay ties a regulatory decision on the hemophilia candidate to manufacturing site fixes, a recurring issue for Novo's production network.
Mugglehead Investment Magazine · +1 outlets
Intellia's NTLA jumps premarket on positive late-stage gene-editing trial data
The readout is a key test for in vivo CRISPR editing as Intellia moves its lead program toward regulatory submission.
Stocktwits · +1 outlets

‹ back to this front page