GSK’s Nucala Set For Dupixent Face-Off After FDA COPD Nod

 
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The UK major's asthma drug gets a key expanded approval.

Merus Bispecific Impresses In Head And Neck Cancer

 

Updated Phase II results from petosemtamab have impressed ahead of ASCO, outshining Keytruda monotherapy and its bispecific rival from Bicara.

Zydus To Continue Mirabegron Sales, Looks To World-First Dual Shigella-Typhoid Vaccine

 
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Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list

Boehringer’s CMO On How AI, Integrated Evidence Generation Underpin Its Ambitious Launch Plans

 

The German company has big plans for the next five years or so. Scrip speaks to its chief medical officer Lykke Hinsch Gylvin about how it is using AI and other innovative approaches to make good on its ambitions.


Sanofi Makes Alzheimer’s Bet With Vigil Buy

 
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The French drugmaker is expanding its neurology activities with the $470m deal.

New Vaccine Framework Avoided Worst-Case Scenario, Analysts Say

 
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The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

Merck KGaA Plans Phase III For Enpatoran After Mixed Phase II Lupus Data

 

The Phase II study testing the novel TLR7/8 inhibitor met the primary endpoint in a cohort of patients with cutaneous lupus erythematosus and systemic lupus erythematosus with rash, but did not in patients with SLE.

PureTech’s IPF Candidate Ready For Phase III After Efficacy Win

 

Coming one day after Boehringer’s underwhelming data, PureTech’s tweaked molecule, deupirfenidone, shows promise in slowing idiopathic pulmonary fibrosis.


End Is Nigh For 4SC After EMA’s No For Kinselby

 
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The German biotech has discontinued the oral HDAC inhibitor for cutaneous T-cell lymphoma.

In Brief: Tourmaline Reports Positive Topline Phase II Results for Pacibekitug In CKD

 

Based on first positive results for any quarterly IL-6 inhibitor, company plans to initiate Phase III cardiovascular outcomes trial.

Boehringer’s Next Generation IPF Drug Underwhelms

 

The company hoped its follow-up to blockbuster Ofev could clearly improve efficacy and safety benefits, but the full Phase III results from nerandomilast’s FIBRONEER-IPF fall short of a slam dunk.

Affimed’s ASCO ‘Hail Mary’ As Survival Chances Slim

 
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The German biotech has been forced into insolvency and NASDAQ suspension.


In Brief: Essence Raises Ionis Tryngolza Hypertriglyceridemia Filing Hopes

 

Tryngolza has met endpoints in a moderate hypertriglyceridemia trial. Positive results in severe disease in Q3 could allow for a filing for a broader patient population than its currently approved indication of familial chylomicronemia syndrome.

Apnimed’s AD109 Could Be A Wake-Up Call For Sleep Apnea Market

 
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The first of two Phase III trials in obstructive sleep apnea showed Apnimed’s combination pill can offer a therapeutic alternative to entrenched CPAP devices.

‘Unprecedented’ Data Lift AstraZeneca’s Ambitions For Airsupra

 
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The company hopes the drug will become the standard of care rescue treatment in asthma.

Pipeline Watch: Eight Approvals And Nineteen 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.


Merck KGaA Braces For Volatility But Does Not Expect Europe To Budge On Pricing

 

Shares are hit as German conglomerate lowers revenue forecast.

Leo Roars To A Profit In Q1 As Adbry Grows In US

 
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The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

Lundbeck Lifted By Leap In Migraine Therapy Sales

 
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Vyepti revenues rise by nearly 70% in the first quarter.

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.