BioSpace News Archive

Drug Development

Latest Data for Karuna’s Schizophrenia Drug Spark Investor Concern

Analysts point to a missed secondary endpoint and cardiovascular risks that may delay FDA approval as possible reasons for the unexpected drop in Karuna’s stock following the data reveal.

March 24, 2023
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4 min read
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Kate Goodwin
Policy

NICE Backs PTC’s Gene Therapy for Ultra-Rare Pediatric Disease

Upstaza is the first targeted therapy for aromatic L-amino acid decarboxylase (AADC) deficiency. PTC expects to submit a Biologics License Application to the FDA in the first half of 2023.

March 24, 2023
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2 min read
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Tristan Manalac
Drug Development

AbbVie Clinches Back-to-Back Clinical Wins in Ulcerative Colitis, Lupus

In a double data drop Thursday, AbbVie touted two clinical trial wins, for Skyrizi in ulcerative colitis and Rinvoq in systemic lupus erythematosus.

March 24, 2023
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2 min read
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Tristan Manalac
Drug Development

Relmada Looks to Rebound with New Protocol After Two Phase III Flops

Relmada Therapeutics announced it would make key changes to its clinical evaluation of REL-1017 as a possible add-on treatment for major depressive disorder.

March 24, 2023
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2 min read
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Ana Mulero
Policy

FDA Action Alert: Roche, Emergent and More

The FDA is expected to make decisions on Emergent BioSolutions’ sNDA for OTC Narcan and Roche’s Polivy in frontline DLBCL.

March 24, 2023
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3 min read
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Tristan Manalac
Philips convenes the Annual General Meeting of Shareholders 2023

Royal Philips announced it has convened the Annual General Meeting of Shareholders 2023 and published the agenda with explanatory notes.

March 24, 2023
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3 min read
Business

Oncorus Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates

Oncorus, Inc. today reported fourth quarter and full year 2022 financial results and provided an update on its business.

March 24, 2023
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8 min read
Business

atai Life Sciences Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical Pipeline Highlights

atai reported fourth quarter and full year 2022 financial results and provided clinical pipeline highlights.

March 24, 2023
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16 min read
Business

Stuart Peltz, Ph.D., Rare Disease Pioneer, to Retire as Chief Executive Officer of PTC Therapeutics

PTC Therapeutics, Inc. (NASDAQ: PTCT ). Stuart Peltz , Ph.D., founding Chief Executive Officer (CEO) of PTC Therapeutics announced today that he is stepping down after 25 years.

March 24, 2023
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6 min read
Genetown

Moderna to Host Fourth Annual Virtual Vaccines Day on April 11, 2023

Moderna, Inc. today announced that it will present its Vaccines Day for analysts and investors at 8:00 a.m. ET on Tuesday, April 11, 2023.

March 24, 2023
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1 min read