Clinical Trials

Revolution’s RAS Plans Move Ahead Despite Investors’ Safety Doubts

 

Tolerability problems with a high dose of its multi-RAS inhibitor in NSCLC patients knocked shares, but Revolution is pressing on in this setting and in pancreatic cancer. It also has eye-catching early results in colorectal cancer.

Stock Watch: AHA Conference Disappointments

 
• By 

Presenting data or announcing a licensing transaction at an appropriately themed conference would normally be expected to be viewed favorably by investors. This is not always the case, however.

Sweden’s Alligator Makes Cuts To Avoid Extinction

 
• By 

The company’s CD40 agonist mitazalimab has impressed in Phase II trials as a potential treatment for pancreatic cancer but with no partner in place yet and a lack of funds, Alligator has to cut 70% of its staff to keep going.

Simcere’s Sublingual Edaravone Nears International Phase III Trial After China Approval

 

China’s fresh approval of a sublingual form of Simcere's edaravone/dexborneol brain cytoprotective agent for acute ischemic stroke is paving the way for an international Phase III study in this indication.


Akeso: We’re The Leaders In Bispecific Cancer Immunotherapies

 

The Chinese company is building on its success with ivonescimab and believes it can stay ahead of its rivals and develop into a global company.

Abingworth Tight-Lipped On $1.5bn Clinical Trials Fund Reports

 
• By 

The Carlyle-backed venture capital group is said to be working on a new fund to help finance up to eight late-stage clinical studies through potential partnerships with big pharma for a share of royalties. The move would be in keeping with its recent investment activities.

Pipeline Watch: Nine 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.

Broad Benefits Of Immunic MS Drug Could Transform Treatment

 
• By 

While most drug development in the multiple sclerosis space has focused just on relapse prevention, Immunic’s dual-acting therapy vidofludimus calcium also offers a novel approach for neurodegeneration, its CEO Daniel Vitt tells Scrip.


Vabysmo Hopes To Ride New Coverage In China, Data To Expand In Asia

 

Roche's blockbuster ophthalmic drug set for China reimbursement list inclusion in three indications and shows positive interim results in PCV.

Outlook Holds Out Hope For Wet AMD Approval Despite Phase III Topline Miss

 

The company said the NORSE EIGHT trial of ONS-5010 did not meet the primary endpoint of showing noninferiority to ranibizumab, but it still plans to file for US FDA approval.

Lot Riding On IGI’s Promising Trispecific Antibody For Myeloma

 

Ahead of ASH 2024, Ichnos Glenmark Innovation’s CEO outlines to Scrip the promising profile of the alliance’s early stage trispecific versus existing bispecific antibodies in relapsed/refractory multiple myeloma, including a significant overall response rate.

Innovation Rewards, Regulatory Ecosystem Key To Korea Competitiveness - AZ Execs

 
• By 

AstraZeneca execs talk about the challenges South Korea faces in becoming a more attractive market for investment by global pharma firms and its significance as a site for clinical trials.


Amgen’s Phase II MariTide Data Lack Clarity Market Hoped For

 
• By 

Much anticipated Phase II results in obesity for Amgen’s GLP-1 agonist/GIP antagonist showed up to 20% weight loss, but without detailed data the drug’s competitiveness is hard to ascertain.

Alector Follows Cassava With An Alzheimer’s Miss

 

AL002 failed across the board in a mid-stage study, and Alector has trimmed its workforce as it refocuses on its other two assets.

Roche Softens TIGIT Blow With Poseida Buyout

 

The SKYSCRAPER-01 trial’s failure to generate an overall survival benefit is the biggest blow yet to the TIGIT inhibitor class, but Roche looking to move on with its buyout of the CAR-T therapy company.

Cassava’s Alzheimer’s Drug Fails In First Phase III, Second Pivotal Trial Stopped

 
• By 

After years of controversy, simufilam did not achieve statistical significance on any endpoints in ReThink-ALZ, so the company ended ReFocus-ALZ and its long-term extension study.


AstraZeneca’s Truqap Hits In Prostate Cancer

 

Analysts are hoping for a sizeable benefit on PFS when the full data emerge.

Two Hepatitis D Candidates Take A Step Towards The Market

 

Recent data put Vir and Bluejay ahead of the pack, but it is hard to know exactly how well their products work.

Pipeline Watch: Seven Approvals And 27 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.

Pfizer’s New Strategy Head Grapples With Some Blockbuster Problems

 

Recently recruited from his analyst post, Andrew Baum is now Pfizer’s head of strategy and is having to deal with some big decisions on R&D investment and long-term commercial bets.