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Phase III Results Position Selecta/Sobi’s SEL-212 As Tough Competition For Krystexxa In Gout
Analysts pointed to SEL-212’s more favorable dosing and adverse event profile with fewer limitations that may harm compliance versus Krystexxa from Horizon, which is soon to be acquired by Amgen.
AbbVie Head-To-Head Data Show Skyrizi Tops IL-17 Competitors In Skin Clearanc
Skyrizi showed better skin-clearance results than Cosentyx or Taltz in a 52-week study of patients who had suboptimal results on the latter two drugs.
Long-Term Data Boost Novartis And Roche SMA Challenge To Biogen’s Spinraza
New long-term data from Novartis’s Zolgensma and Roche’s Erysdi will help close the gap on Biogen’s market leader Spinraza, but the three therapies look set to develop distinct or even complementary roles as the market matures.
Karuna Three-For-Three As Another KarXT Schizophrenia Trial Hits Primary Endpoint
The company is on track for a mid-2023 FDA filing, while executives suggested that they would likely pursue partnership for commercialization of the drug in Europe.
Takeda’s High-Dose TYK2 Data Could Set It Apart In Psoriasis
Safety and efficacy data show that as long as Takeda can execute effectively on a Phase III program for TAK-279, the company should be well positioned in the oral psoriasis market.
Affibody And UCB Eye Humira’s Weak Spot In Hidradenitis Suppurativa
The rival firms are advancing separate biologic candidates that target IL-17 in a bid to treat the more than 60% of hidradenitis suppurativa patients who remain uncontrolled on AbbVie’s Humira, with recent trial readouts showing promise.
Pipeline Watch: Eight Approvals And 12 Phase III Trial Updates
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
Phase III Results Could Boost Pfizer Revenue Ahead Of Xtandi’s Exclusivity Loss
Pfizer and Astellas announced positive topline Phase III results in non-metastatic prostate cancer for Xtandi, one of the top-selling drugs in Pfizer’s portfolio set to lose patent exclusivity this decade.
Obstacle Thrown In Sarepta’s Path To Market As Gene Therapy Will Face AdComm After All
The route to market for Sarepta’s gene therapy candidate SRP-9001 for Duchenne muscular dystrophy has just got more complex after a U-turn by the US FDA. Its accelerated approval will now be scrutinized by outside experts – but the company remains confident in its data.
Another Blow For Anti-TIGITs As Merck’s Vibostolimab/Keytruda Combo Misses In Phase II NSCLC Trial
Merck & Co’s combination treatment has disappointed in a challenging group of lung cancer patients, marking yet another setback for the increasingly precarious anti-TIGIT space even as some analysts say this is not the end of the road.
Scrip Asks…What Does 2023 Hold For Biopharma? Part 8: Therapeutic Area Advances
Neuroscience and oncology fuel high hopes for therapeutic R&D progress among 90-plus surveyed biopharma industry leaders.
NASDAQ Listing Done, Oculis Eyes Phase III Readouts
Having taken the special purpose acquisition corporation route to list in the US, Switzerland's Oculis is waiting for some vital late-stage data, notably on OCS-01 for diabetic macular edema.
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