BioSpace News Archive

FDA

Novartis Adds Hidradenitis Suppurativa to Cosentyx’s Label in Challenge to Humira

The Swiss pharma has set up its challenge to AbbVie’s blockbuster immunosuppressive drug Humira with a label expansion for Cosentyx in hidradenitis suppurativa, a painful long-term skin condition.

November 2, 2023
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2 min read
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Tristan Manalac
FDA

Amgen Contests J&J’s Stelara with FDA Approval for Interchangeable Biosimilar

Ahead of the Inflation Reduction Act’s drug price negotiations, the regulator has approved Amgen’s biosimilar challenge to Johnson & Johnson’s Stelara—with an interchangeable designation to boot.

November 2, 2023
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3 min read
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Tristan Manalac
Business

Novo Logs Over 700% Wegovy Sales Growth in Q3, Raises 2023 Outlook

Riding a wave of skyrocketing Wegovy and Ozempic sales, the company on Thursday raised its sales and operating profit outlook for the rest of the year as part of its third-quarter earnings announcement.

November 2, 2023
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2 min read
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Tristan Manalac
Business

Lilly’s Mounjaro Beats Q3 Expectations, But Company Cuts Full-Year Profit Guidance

Sales of type 2 diabetes treatment Mounjaro brought in $1.4 billion in the third quarter. However, the company cut its full-year profit guidance due to charges mainly related to recent acquisitions.

November 2, 2023
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1 min read
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Kate Goodwin
Business

Moderna Posts Q3 Loss, Takes $1.3B in Write-Downs on COVID-19 Shots

While Moderna’s total revenue for the third quarter beat analyst expectations, the company Thursday reported a loss as demand for its COVID vaccines declined.

November 2, 2023
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2 min read
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Tyler Patchen
FDA

Merck’s Keytruda Plus Chemo Secures FDA Approval for Biliary Tract Cancer

The company’s blockbuster cancer drug continues to snap up FDA approvals, this time in treating biliary tract cancer in combination with cisplatin and gemcitabine. It’s the sixth indication in gastrointestinal cancers.

November 2, 2023
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2 min read
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Tyler Patchen
Drug Development

Study Highlights Standout Clinical Success of Certain Cell and Gene Therapies

A recent report by Tufts Medical Center reveals impressive approval rates for durable cell and gene therapies, but experts urge caution over persistent safety and accessibility concerns.

November 2, 2023
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5 min read
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Aayushi Pratap
Business

Allogene Therapeutics Reports Third Quarter 2023 Financial Results and Business Update

Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer, today provided a corporate update and reported financial results for the quarter ended September 30, 2023.

November 2, 2023
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15 min read
Business

HOOKIPA Pharma to Report Third Quarter 2023 Financial Results and Recent Business Highlights on November 9, 2023

HOOKIPA Pharma Inc., a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, announced that it will release its third quarter 2023 financial results and business highlights on November 9, 2023.

November 2, 2023
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3 min read
Business

Xtant Medical to Issue Third Quarter 2023 Financial Results on November 9, 2023

Xtant Medical Holdings, Inc. (NYSE American: XTNT) today announced that it will release its financial results for the third quarter ended September 30, 2023, before the open of the financial markets on Thursday, November 9, 2023.

November 2, 2023
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1 min read