Approvals & Launches
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AstraZeneca’s Lynparza Adds Narrow Prostate Cancer Indication
AstraZeneca had hoped data from Phase III PROpel would lead to an all-comers indication in first-line, metastatic castration-resistant prostate cancer, but new indication is limited to BRCA mutations.
Cosentyx Becomes First Biologic Approved For HS In Nearly A Decade
The Swiss major should have a considerable first-to-market advantage over other IL-17 biologics from the likes of UCB and Acelyrin that are also targeting the hidradenitis suppurativa space.
Lexicon’s Sotagliflozin Succeeds In Heart Failure Following Disappointment In Diabetes
Lexicon gets broad indication across heart failure for its dual SGLT1/2 inhibitor, which will be positioned against Lilly/BI’s Jardiance and AstraZeneca’s Farxiga.
UCB Holds Breath Amid Concerns Of Second FDA Rejection Of Bimzelx
The US Food and Drug Administration has published a report after an inspection of UCB’s Belgian facility where Bimzelx is manufactured and the findings suggest that a long-awaited approval for the psoriasis drug should not be taken for granted.
Pipeline Watch: 12 Approvals And 27 Phase III 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.
Ionis Finds Its Footing Ahead Of Its First Big Commercial Step
Ionis will launch its first commercial product through a co-commercialization agreement with AstraZeneca early next year, in preparation for its first wholly-owned drug launches soon to follow.
Blueprint Sees Blockbuster Potential For Ayvakit In Systemic Mastocytosis With ISM Nod
The US FDA gave the drug a broad label in adults with indolent SM, without restrictions for disease severity or prior treatment, and Blueprint sees a potential $1.5bn market opportunity.
Krystal Clears Path To Market For Topical Gene Therapy Vyjuvek
The company estimates there are about 9,000 reimbursable patients with dystrophic epidermolysis bullosa worldwide and anticipates a third-quarter launch following FDA approval.
Genmab Geared Up To Launch Epkinly With AbbVie
The Danish group, along with partner AbbVie, is all set for a commercial battle with Roche as Epkinly hits the US market for refractory diffuse large B-cell lymphoma a few weeks ahead of expected approval for the Swiss major’s same-in-class rival glofitamab.
Pipeline Watch: 10 Approvals And Six Phase III Readouts
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.
B+L/Novaliq Hope Miebo Can Stand Out In Crowded Dry Eye Field
The companies got US FDA approval for the drug, which they said is the only approved medicine that targets tear evaporation rather than tear production, though its mechanism is not fully understood.
Rinvoq Approved For Crohn’s Disease In Pivotal Year For AbbVie’s Immunology Business
US FDA approval in Crohn’s disease further boosts the revenue potential for Rinvoq as AbbVie navigates a period of declining sales overall due to the introduction of US biosimilars for Humira.
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