BioSpace News Archive

Business

GSK Makes $2B Play to Challenge Merck in Chronic Cough Market

The acquisition of Bellus Health will give GSK access to camlipixant, a potentially best-in-class P2X3 antagonist for chronic cough.

April 18, 2023

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3 min read

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Tristan Manalac

Pictured: Pneumonia patient on a ventilator/Courte

Drug Development

FDA Adcomm Backs Innoviva’s Pneumonia Antibiotic

A unanimous FDA committee vote supported the favorable risk-benefit profile of Innoviva’s sulbactam-durlobactam for hospital-acquired A. baumannii infections.

April 18, 2023

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2 min read

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Tristan Manalac

Pictured: Exterior view of the headquarters of the

FDA

Gamida’s Long Regulatory Road Ends in Approval of Blood Cancer Cell Therapy

Omisirge is approved for patients who receive cord blood transplantation following myeloablative therapy.

April 18, 2023

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2 min read

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Tristan Manalac

Drug Development

Merck’s Keytruda Scores Triple Hit at AACR

The checkpoint inhibitor improved patient outcomes in three cancer trials, according to results presented at the AACR meeting.

April 18, 2023

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4 min read

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Holly Barker

Policy

Basilea provides update on New Drug Application to the US Food and Drug Administration for antibiotic ceftobiprole

Basilea Pharmaceutica Ltd provided an updated timeline for its New Drug Application submission for its antibiotic ceftobiprole to the US Food and Drug Administration.

April 18, 2023

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4 min read

Sensorion to participate in Chardan’s Annual Genetic Medicines & Cell Therapy Manufacturing Summit and Kempen’s Life Sciences Conference

Sensorion a pioneering clinical-stage biotechnology company which specializes in gene therapies in the inner ear, is pleased to announce its participation in two investor conferences in April 2023.

April 18, 2023

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3 min read

Drug Development

Spexis announces closing of capital commitment of USD 4.5 million from SPRIM Global Investments (SGI) to enable initiation of ColiFin® Phase 3 study

Spexis AG announced that the company has finalized a capital commitment from SPRIM Global Investments totaling USD 4.5 million in the form of secured, interest-bearing debt with partial warrant coverage and subordinated debt mandatorily converting into equity.

April 18, 2023

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3 min read

New Data Showing that Transgene and NEC’s Individualized Cancer Vaccine TG4050 Induces Strong and Specific Immune Responses against Tumors Presented at AACR 2023

Transgene and NEC Corporation announced that new data will be presented on TG4050, an individualized neoantigen cancer vaccine, at the American Association for Cancer Research Annual Meeting in Orlando, Florida.

April 18, 2023

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11 min read

Pneumagen further strengthens IP protection for lead product Neumifil with granting of US composition of matter patent

Pneumagen announced that the US Patent and Trademark Office has issued a US Patent for HEX17, the active pharmaceutical ingredient in Neumifil.

April 18, 2023

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3 min read

Drug Development

Nordic Nanovector Publishes Data from the PARADIGME Phase 2 Clinical Trials with Betalutin® on European Clinical Trials Database

Nordic Nanovector ASA announces that full results from its Phase 2 clinical trials of Betalutin® in resistant/refractory indolent non-Hodgkin’s lymphoma have been published at EudraCT, the European Union Drug Regulating Authorities Clinical Trials Database of the European Union.

April 18, 2023

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7 min read