Respiratory

Insmed’s PAH Data Indicate Potential To Surpass Established Therapies

 
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Insmed’s inhaled treprostinil exceeded goals for reducing pulmonary vascular resistance and improving six-minute walk test distance in Phase IIb data.

Sanofi Cements RSV Dominance As Merck & Co. Rival Awaits FDA D-Day

 
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The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.

Lyra Eyes US Filing For LYR-210 After Surprise ENLIGHTEN 2 Win

 

In a turn of fortunes, Lyra Therapeutics has reported positive Phase III results for LYR-210 in chronic rhinosinusitis, boosting hopes for US approval. The company plans to submit an NDA and pursue further trials, but its cash position is precarious.

Stock Watch: How GSK’s Nucala Info Drip Helped Share Price

 
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The information flow in the months before the approval of GSK’s Nucala in COPD provides an interesting case study, and brings to mind the cautionary tale of Alnylam’s Onpattro.


Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
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One Phase III trial hits but a second study misses by a mile.

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.

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.

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.


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.

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.

Insilico Fast-Tracks First AI-Designed TNIK Inhibitor For IPF

 

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.


AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
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The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

GSK Talks Up Nucala COPD Hospitalization Data In Challenge To Dupixent

 
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As the PDUFA date for the UK major’s IL-5 inhibitor draws close.

PureTech Weighs Up Pros And Cons Of Going Private

 
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The biotech has rejected a takeover bid from Nordic Capital but a sale to private equity could be a solution to the public market's continued reluctance to adequately value PureTech’s hub-and-spoke business model.

Paratek To Acquire Optinose, Expanding Portfolio Beyond Antibiotics

 
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Paratek agrees to acquire Optinose in a “take-private” deal valued at $330m, adding chronic rhinosinusitis product Xhance to its antibiotic Nuzyra.


Trevi Gets A Clap On The Back For Chronic Cough Data

 

A Phase IIa trial studying Haduvio for the treatment of refractory chronic cough showed a benefit for patients, opening the door to a broad market and impressing investors.

AstraZeneca And GSK Put Spotlight On Nasal Polyps Space

 
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Complete datasets on Tezspire and depemokimab caught the eye at the AAAAI/WAO meeting in San Diego and while the AstraZeneca/Amgen drug appears to be more efficacious, the GSK candidate offers greater convenience.

Scrip Asks... What Does 2025 Hold For Biopharma? Part 6: Therapeutic Area Advances

 

Over 140 biopharma leaders share their views on developments to watch for in key therapeutic areas this year. Advances in multiple scientific fields are opening up new avenues for treatment.

2025’s Biggest New Launches

 

Big pharma once again fails to dominate the top 20 expected best sellers from products due for launch this year. Small-to-medium pharma account for nearly half the list, while Vertex has two products in the top five.