GlycoMimetics’ Sickle Cell Candidate Nearly Ready For Hand-Over To Pfizer

Biotech focused on role of carbohydrates in biological processes completes Phase II program of lead candidate for sickle cell disease. Under a 2011 partnership, Pfizer takes over development of GMI-1070 in Phase III.

GlycoMimetics Inc. unveiled promising Phase II data for GMI-1070, its pan-selectin inhibitor for sickle cell disease, on April 15. Partnered since 2011 with Pfizer Inc., the compound offers the potential for the first drug therapy to treat vaso-occlusive crisis episodes in patients with sickle cell disease, a genetic disorder that affects more than 80,000 Americans.

In the double-blind, placebo-controlled Phase II study, the Gaithersburg, Md., biotech found that ‘1070 reduced duration of vaso-occlusive crisis (VOC),...

Welcome to Pink Sheet

Create an account to read this article

More from United States

Merck, AstraZeneca Downplay Impact of European Tariffs Despite Timing Uncertainties

 
• By 

Meanwhile, companies continue discussions with the Trump Administration over ways of increasing what European nations pay for drugs as an alternative to imposing a Most Favored Nation drug pricing policy in the US.

EU 15% Tariff Deal Still Leaves Questions For Pharma On Possible Grace Period, Generic Exemption

 

While the 15% rate is a substantial blow for pharmaceutical firms, the US-EU deal provides a framework for trade agreements with other countries that could see the industry avoiding higher tariffs elsewhere.

Medicare Part B ASP Proposal Sets ‘Guardrails’ Around Bona Fide Service Fee Reporting

 
• By 

Average sales prices, and Medicare spending on some drugs, would be expected to be lower, CMS says in the Physician Fee Schedule proposed rule.

A Record Year For US FDA Approvals? Commissioner Says It’s Possible

 

FDA Commissioner Martin Makary suggested 60 new molecular entities could be approved in 2025, which appears possible, but can the strained staff deliver?

More from North America

Real-Time Release Of CRLs Is US FDA’s Goal, Agency Leaders Affirm

 

The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.

No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
• By 

The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.

Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
• By 

New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.