Aldeyra Expects Mid-2025 Refiling Of Reproxalap After Second CRL

 
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Aldeyra’s dry eye candidate reproxalap received a second FDA complete response letter, but the firm expressed confidence about refiling quickly based on two ongoing studies.

Pipeline Watch: 13 Approvals And 13 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.

Roche’s Brain Shuttle Delivers In Alzheimer’s, Moves Ahead To Phase III

 

By allowing it to enter the brain more easily, trontinemab’s brain shuttle brings more patients to ‘amyloid zero’ levels faster, and with fewer brain swelling side effects.

Compass’ Bispecific BTC Contender Meets Phase II/III Endpoint

 
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Compass' bispecific antibody tovecimig hits primary efficacy endpoint in Phase II/III top-line data in advanced biliary tract cancer, and may have class side-effect advantages. But additional survival data may be needed to support US approval.


AZ’s Oncology R&D Head On China’s Scientific Promise And True Innovation

 

AstraZeneca remains committed to investing in R&D and alliances in China, where Susan Galbraith, the UK major’s head of oncology R&D, sees innovation eventually reaching parity with the US and Europe.

BeiGene Ends Anti-TIGIT Development In Lung Cancer

 
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BeiGene’s Phase III ociperlimab joins the list of failed TIGIT inhibitors, as candidates from Roche, Merck & Co. and others have failed late-stage studies.

Edgewise’s HCM Candidate May Provide Advantages Over BMS’s Camzyos

 
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With new Phase II data, Edgewise asserted that EDG-7500, a sarcomere modulator, could offer better efficacy and safety than cardiac myosin inhibitors in hypertrophic cardiomyopathy.

AbbVie On A STEAP Learning Curve In ADCs

 

Investing heavily in antibody-drug conjugates, AbbVie is pioneering a dual STEAP1xPSMA-targeting approach in prostate cancer, as other candidates advance.


Boehringer Still Sees Plenty Of Juice In Jardiance

 
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Strong sales growth for the German group’s SGLT2 inhibitor in 2024

Hengrui Renews Global Phase III Push As China Players Plan Pivotal Multinational Trials

 

After a more than three-year hiatus, China's Hengrui has signalled its return to multiregional Phase III trials as it looks to globalize its innovative pipeline. Meanwhile, a number of other Chinese players have announced plans to kick off Phase III trials this year and beyond.

Cerevance To Focus On Parkinson’s Adjunctive Therapy After Phase II Miss

 
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After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.

Baxdrostat, AstraZeneca’s Next Big CVRM Bet

 
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The firm has lofty ambitions for the aldosterone synthase inhibitor to treat hypertension and kidney disease.


Merck’s Winrevair Slashes Morbidity-Mortality Risk For PAH Patients

 

The ZENITH study is a landmark for Merck’s first-in-class activin signalling inhibitor and pulmonary arterial hypertension treatment.

Vertex Ends One Type 1 Diabetes Cell Therapy, Shifts Focus To Another

 
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Seeking cell therapy approaches to cure type 1 diabetes, Vertex abandons a candidate encapsulated to avoid immune system detection but hopes to file another candidate for approval in 2026.

Corcept’s Relacorilant Shows Benefit In Ovarian Cancer, Expanding Pipeline Opportunity

 

A Phase III trial testing the cortisol modulator showed a benefit on PFS and OS in patients with platinum-resistant ovarian cancer.

AstraZeneca Oral PCSK9 Prospects Pumped After Phase IIb Win

 
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The UK giant is forecasting peak sales of $5bn plus


Novo Scores Cardio Wins But Lilly Still Tipped To Take GLP-1 Crown

 

Novo’s semaglutide has shown its benefits as an injectable in patients with peripheral arterial disease and as an oral agent in cardiovascular outcomes, but stronger results are expected soon from Lilly’s tirzepatide.

Pipeline Watch: Seventeen Approvals And Ten 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.

Equillium Seeks Accelerated Approval For GVHD Drug Despite Primary Endpoint Miss

 

The biotech is banking on itolizumab’s longer-term efficacy as well as unmet need in frontline acute graft-versus-host disease as it prepares to meet with the FDA.

Almirall CEO Sounds Alarm Over Europe’s Reduced Competitiveness

 
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The head of the Spanish medical dermatology specialist told Scrip that maintaining the status quo will only result in the continent’s life sciences sector slipping further behind the US and China.