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Home » Topics » Pharmaceuticals » Research and Development

Research and Development
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Uveitis Prompts Partial Clinical Hold on Nuvation Bio Cancer Drug

June 29, 2022
Uveitis — an inflammation of the middle layer of the eye — in treated patients has prompted FDA to halt enrollment in Nuvation Bio’s phase 1/2 dose-escalation study of NUV-422, a checkpoint inhibitor under investigation for a wide variety of solid tumors. Read More

Federal Judge Lets Stand $6.4 Billion Suit Claiming BMS Stalled New CAR T Cell Therapy

June 28, 2022
The FDA has approved Breyanzi for several large B-cell lymphoma indications in adults. Read More

GSK’s Hepatitis Drug Candidate Shows Promise

June 28, 2022
A phase 3 trial evaluating bepirovirsen as a monotherapy is slated to begin in the first half of 2023. Read More

Rexulti Shows Efficacy in Reducing Agitation in Alzheimer’s Patients

June 28, 2022
Otsuka and Lundbeck are planning a regulatory filing to the FDA later this year. Read More

Biogen Ends Post-Marketing Study of Aduhelm Due to Limited National Coverage Policy

June 27, 2022
Study investigators said it is “expected there will be limited [Aduhelm] prescription and usage in routine clinical practice making the study not feasible for enrollment.” Read More

Sanofi and GSK Present Promising Data for Bivalent COVID-19 Vaccine

June 27, 2022
Sanofi said the immunogenicity data support the use of the bivalent vaccine against variants including Omicron. Read More

FDA Places Clinical Hold on Sarepta’s Duchenne Drug Candidate

June 27, 2022
Sarepta Therapeutics has been hit with an FDA clinical hold on its trial of SRP-5051 (vesleteplirsen) for the treatment of Duchenne muscular dystrophy after a trial participant experienced a serious adverse event (SAE) that could have been life-threatening. Read More

Galderma’s Nemolizumab Drug Shows Promising Results in Prurigo Nodularis

June 23, 2022
The drug demonstrated a favorable benefit-risk balance, the company said. Read More

PTC Finally Gets Positive Results in a Study on Duchenne Drug Translarna

June 23, 2022
At long last, PTC Therapeutics has announced positive results from a study of Translarna (ataluren), the company’s drug for patients with nonsense mutation Duchenne muscular dystrophy. Read More

Sinopharm COVID-19 Shots Show Little Efficacy Against Omicron Subvariants

June 22, 2022
The vaccine produced a detectable neutralizing response against the spike protein mutation D614G in 84 percent of individuals. Read More

Clovis Abandons Previous FDA Approval of Rubraca Following Study Data

June 22, 2022
The company has also requested a withdrawal of the indication in Europe. Read More

Moderna Making Plans to Study COVID-19 Vaccine in Babies Three to Six Months Old

June 17, 2022
Enrollment is set to begin in September, with as many as 700 participants expected. Read More
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