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Pipeline Watch: Nine Approvals And Nine 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.

Alnylam Joins Competitive ATTR-CM Market With Amvuttra Approval

 

Amvuttra will target a substantially larger patient population with a new indication, but it is third to market behind Pfizer’s Vyndaqel and Bridge Bio’s Attruby and will cost more.

Pipeline Watch: Ten Approvals And Eighteen 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.

Roche Means Business With Biggest Ever Obesity Pact

 
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The Swiss giant has inked a deal potentially worth $5.30bn with Zealand to access the Danish biotech's long-acting amylin analog petrelintide.


Pipeline Watch: Nine Approvals And Fifteen 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.

Bayer Rolls Up Its Sleeves But Turnaround Will Take Time

 
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Pharma revenues are going to fall this year as a result of deeper generic competition for the German group’s top-selling drug, Xarelto, but it should return to growth from 2027 onwards.

BeiGene Scores Label Expansion For Tevimbra In Frontline Esophageal Cancer

 

The company sees a potential billion-dollar market opportunity in its approved indications and is launching the drug in what an exec called “a very targeted fashion” at a recent conference.

Wockhardt On Superbug Buster Zaynich, US Tariff Talk, Europe Manufacture

 
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In a video interview, Wockhardt chairman Habil Khorakiwala talks about global commercial and manufacturing plans for superbug-busting novel antibiotics and developments such as proposed US tariffs and the Windsor framework that could impact its markets.


Eisai/Biogen’s Alzheimer’s Drug Finally Closing In On EU Approval

 

Leqembi is finally on track for approval by the summer, though safety precautions mean fewer patients will be eligible for treatment than in the US, and its uptake is not expected to be strong.

Pipeline Watch: Eight Approvals And Five 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.

After Obesity, What Are Biopharma’s Big Growth Markets?

 

The five therapy areas forecast to achieve the highest growth between 2024 and 2030 include a mixture of the more obvious (MASH) and less high profile (glioma). In some cases, which companies will seize market share remains up for grabs.

Almirall Predicts Plenty More Growth In Psoriasis

 
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The Spanish group has upped its peak sales guidance for Ilumetri to €300m and believes the arrival of Stelara biosimilars will take a while to have much of an impact on the originator IL-23 class.


BridgeBio’s Attruby Off To A Strong Start – But Alnylam Awaits

 

Attruby is making fast inroads thanks to its edge over Pfizer’s established Vyndaqel, but will soon face competition from Alnylam.

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.

Bavarian Nordic Has Age Advantage For Chikungunya Vaccine, For Now

 

The FDA approved Vimkunya on 14 February as the first vaccine for preventing chikungunya in adolescents as well as adults.

Arcturus and CSL Take on Pfizer With Longer-Lasting COVID Vaccine

 
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Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.


GSK To Maintain Lead With Newly Approved Meningococcal Vaccine Penmenvy

 

Pfizer has been unable to take a big slice of the meningococcal vaccine market with Penbraya and now GSK looks set to consolidate its lead with its new 5-in-1 vaccine.

Egetis Eager To Launch Ultra Rare Disease Drug Emcitate

 
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The Swedish company is celebrating approval for the first treatment for rare congenital disorder MCT8 deficiency and plans a launch in the near future.

SpringWorks Gains New Approval Amid Merck KGaA Buyout Talks

 

After coming up blank with its in-house oncology efforts, the German conglomerate is mulling a deal to acquire the US specialist company which has just managed a new drug approval for mirdametinib.

New EU Rybrevant Approval Decisions Turn The Screw On Tagrisso

 

A manufacturing inspection issue may have put paid to J&J getting a rapid approval for its subcutaneous version of Rybrevant in the US, but a positive opinion from the CHMP plus an expanded EU approval for the IV version are two recent boosts to a franchise taking aim at Tagrisso’s crown.