Foghorn quieted by 2nd FDA hold

Today's Big News

Apr 24, 2023

Ionis, AstraZeneca's polyneuropathy med improved patients' quality of life in phase 3, teeing up battle with Alnylam


Foghorn muted again as FDA places partial clinical hold on second cancer drug trial


Applied Therapeutics fails phase 3 rare disease trial but plans to seek approval anyway


After 20-month hold, FDA drops resistance to fecal pooling, clears MaaT to run pivotal trial


Unity’s eye disease med passes extended phase 2 test, with Eylea battle on the horizon 

 

Featured

Ionis, AstraZeneca's polyneuropathy med improved patients' quality of life in phase 3, teeing up battle with Alnylam

Ionis and AstraZeneca are providing the first detailed look at phase 3 data of eplontersen, a treatment for ATTR polyneuropathy that's going toe-to-toe against Alnylam's franchise. AstraZeneca signed a collaboration deal worth up to $3.5 billion to co-develop and commercialize the drug.
 

Top Stories

Foghorn muted again as FDA places partial clinical hold on second cancer drug trial

As Foghorn Therapeutics battles to free a trial from an FDA clinical hold, the biotech is now facing a partial hold for another program—meaning the company's two clinical assets are now tied up in red tape.

Applied Therapeutics fails phase 3 rare disease trial but plans to seek approval anyway

Applied Therapeutics’ phase 3 pediatric rare disease clinical trial has failed. But the biotech, which buried that news more than 500 words into its press release, framed the study as positive and outlined plans to meet with the FDA to discuss a filing for approval.

After 20-month hold, FDA drops resistance to fecal pooling, clears MaaT to run pivotal trial

Twenty months after being rocked by a clinical hold, MaaT Pharma has finally received the green light from the FDA to run a phase 3 trial of its pooled fecal therapy in gastrointestinal acute graft-versus-host disease patients in the U.S.

Unity's eye disease med passes extended phase 2 test, with Eylea battle on the horizon

Unity's eye disease med has passed an extended phase 2 test, setting the state for a head-to-head battle with Regeneron's industry mainstay Eylea.

In heavyweight obesity fight, Eli Lilly launches Mounjaro head-to-head trial against Novo Nordisk's Wegovy

Eli Lilly quietly registered a new phase 3b trial pitting its Mounjaro against Novo Nordisk’s Wegovy in overweight or obese patients with with certain health conditions, teeing up an epic fight in a multibillion-dollar market.

Paragonix's organ transport hardware show gains in heart, lung transplants

Billed as complete upgrades over the simple, ice-packed coolers that have been relied upon to move donor tissue for decades, the company’s heart-focused SherpaPak and its LUNGguard system are both cleared by the FDA and CE marked for use in Europe.

Supreme Courts orders mifepristone to remain available pending lower court appeals

The top court voted 7-2 to stay the lower courts' decision, with Justices Alito and Thomas opposing.

Illumina sets deadline for proxy fight over its board of directors

Activist investor Carl Icahn lodged a public proxy fight against the DNA sequencing giant in early March—largely over the company’s $8 billion acquisition of Grail and its resulting legal quarrels with antitrust regulators.

See you later, Baqsimi: Lilly sells low blood sugar rescue treatment to Amphastar for $500M-plus

Eli Lilly is selling Baqsimi to California’s Amphastar for $500 million in cash upfront. Amphastar is on the hook for an additional $125 million upon the one-year anniversary of the deal’s close, expected in the third quarter. Further, Lilly is in line to receive sales-based milestones worth up to $450 million, the companies said Monday.

State Department cap on EB-3 visas limits international relief for nursing shortage

Limited slots for foreign-educated nurses introduce an international labor logjam even as hospitals clamor for clinicians.
 
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