BioSpace News Archive

Policy

European Regulator Leaning Toward Rejecting Amylyx’s ALS Drug

Known as Relyvrio in the U.S., Amylyx’s AMX0035 may face a longer road to approval in Europe as the company reported that CHMP could reject its marketing authorization application.

May 30, 2023
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3 min read
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Heather McKenzie
Drug Development

AstraZeneca Touts Positive Phase III Endometrial Cancer Data for Imfinzi, Lynparza

DUO-E trial data show AstraZeneca’s Imfinzi, either alone or in combination with Lynparza, boosts progression-free survival in endometrial cancer.

May 30, 2023
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2 min read
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Tristan Manalac
Genetown

The Top Biotech Companies in Boston Hiring Now

Check out these hot Boston-based biotech companies hiring now.

May 30, 2023
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2 min read
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Rosemary Scott
Drug Development

Pfizer’s Weekly Injection Reduced Bleeding in Phase III Hemophilia Trial

Marstacimab decreased bleeding rates by 92% in patients with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors.

May 30, 2023
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2 min read
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Kate Goodwin
FDA

Lexicon Breaks Sotagliflozin Losing Streak with FDA Nod in Heart Failure

Following a series of stumbles in Type 1 diabetes, Lexicon’s dual SGLT inhibitor sotagliflozin finally won the FDA’s approval in heart failure and will be marketed as Inpefa.

May 30, 2023
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3 min read
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Tristan Manalac
Drug Development

FDA Gives Akebia Glimmer of Hope for Rejected CKD-Related Anemia Drug

Akebia announced it will submit a new NDA targeting CKD patients on dialysis, which will not involve additional trials.

May 30, 2023
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2 min read
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Rosemary Scott
Jazz Pharmaceuticals to Participate in the 2023 Goldman Sachs Global Healthcare Conference

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the Company will participate in the 2023 Goldman Sachs Global Healthcare Conference.

May 30, 2023
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1 min read
Biotech Bay

Dynavax to Present at Upcoming June 2023 Investor Conferences

Dynavax Technologies Corporation, a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, announced that the Company will present at the following upcoming investor conferences during the month of June.

May 30, 2023
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1 min read
Biotech Bay

Exelixis to Webcast Fireside Chats as Part of Investor Conferences in June 2023

Exelixis, Inc. announced that members of the company’s management team will participate in fireside chats at the following investor conferences in June.

May 30, 2023
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2 min read
Policy

FDA Roundup: May 30, 2023

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:.

May 30, 2023
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1 min read