Archive snapshot · Biotech
Mon, Oct 12, 9:31 PM ET
India government tells Supreme Court it will cap trade margins on cancer drugs at 30%
The move, prompted by Supreme Court pressure to widen price controls beyond oncology, could save an estimated Rs 2,500 crore annually.
LawBeat · +14 outlets
FDA approves first once-monthly subcutaneous olanzapine LAI for schizophrenia in adults
A long-acting injectable option reduces dosing frequency for schizophrenia patients and lifts Teva, the developer behind the approval.
Pharmacy Times · +14 outlets
Pfizer to halt development of closely watched weight-loss drug
The pullback removes one of the larger challengers to Lilly and Novo Nordisk in the obesity pill race.
Olhar Digital · +2 outlets
Travere Therapeutics wins FDA approval for drug in rare kidney disease
The much-awaited clearance gives Travere a new commercial asset in a rare kidney indication.
Stocktwits · +12 outlets
Lilly fights black market for its new obesity drug before launch as amylin combo raises the bar
Illicit supply and a potent amylin-based combo underscore the intensifying competition among obesity drugmakers.
Drug Discovery News · +14 outlets
Disc Medicine shares slump after FDA declines approval for inherited disorder drug on efficacy concerns
The rejection delays Disc Medicine's lead rare blood disorder candidate and weighs on its shares.
Stocktwits · +2 outlets
Canada authorizes first generic weight-loss drug, pressuring pharmaceutical stocks
Generic GLP-1 entry in Canada signals the start of price erosion for branded obesity medicines.
Olhar Digital · +6 outlets
Novo Nordisk files for Wegovy insurance coverage in South Korea as obesity price war intensifies
Reimbursement bids by Novo and local rivals including Hanmi signal a coming price fight in Korea's obesity market.
BigGo Finance · +10 outlets
Mirum Pharmaceuticals says LIVMARLI met Phase 3 EXPAND endpoint; RBC reiterates rating
Positive EXPAND data supports expanded labeling for LIVMARLI and keeps analyst sentiment bullish.
Mugglehead Investment Magazine · +2 outlets
Compass Therapeutics hits primary endpoint in Phase 3 treatment-resistant depression trial; shares jump 23%
A Phase 3 win in treatment-resistant depression would open a large, poorly served psychiatric market.
Stocktwits · +14 outlets
Capricor faces make-or-break FDA panel for Duchenne cell therapy
The advisory panel decision could determine the fate of Capricor's Duchenne muscular dystrophy therapy.
Stocktwits · +3 outlets
Replimune shares post best day on analyst view of higher melanoma approval odds after panel outcome
An overwhelmingly positive advisory panel outcome lifts expectations for Replimune's melanoma therapy.
Stocktwits · +6 outlets
ImmunityBio resubmits Anktiva application to FDA; UAE grants broadest approval yet
The dual FDA resubmission and expanded UAE clearance widen Anktiva's regulatory footprint.
Stocktwits · +2 outlets
Cytokinetics aficamten data show serious heart failure events in 4.7% versus 1.2% on placebo
The safety signal comes as Cytokinetics pursues approval for its cardiac myosin inhibitor.
Stock Titan · +4 outlets
HLB completes FDA resubmission for first-line liver cancer treatment
The resubmission restarts the US review clock for HLB's first-line liver cancer candidate.
아시아경제 · +5 outlets
MaaT Pharma says EMA rejected Xervyteg approval, shifts focus to US Phase 3 trial
The European setback pushes the microbiome company toward a US late-stage path.
scanx.trade · +1 outlets
Fate Therapeutics shares jump as FDA clears cell therapy for clinical trials
The IND clearance moves Fate's iPSC-derived cell therapy into human testing.
Stocktwits · +1 outlets
BridgeBio reports symptom gains in Phase 3 encaleret trial
Encaleret data support registration in a rare calcium disorder with few treatment options.
Mugglehead Investment Magazine

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