BioSpace News Archive

Policy

FDA Adcomm Votes 14-1 to Pull Covis’ Makena from the Market

The FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee voted nearly unanimously to withdraw the approval of Covis’ preterm birth drug Makena.

October 20, 2022
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2 min read
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Tristan Manalac
Business

Kyverna Files First IND to Leverage CAR-T Therapy for Lupus

Kyverna Therapeutics filed its first IND application this week to test the efficacy and tolerability of KYV-101, a CAR-T therapy for lupus nephritis.

October 20, 2022
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4 min read
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Mark Terry
Drug Development

BMS’ Opdivo Notches Phase III Win in Advanced Melanoma

BMS’s blockbuster checkpoint inhibitor Opdivo hit the primary endpoint in the Phase III CheckMate -76K trial for a particularly intractable form of melanoma.

October 20, 2022
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2 min read
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Mark Terry
Deals

AbbVie Gains Access to Pulmonary Fibrosis Antibody with $225M DJS Buy

AbbVie is buying DJS Antibodies for $225 million in cash to gain access to the British company’s potential fibrotic diseases drug and antibody discovery program.

October 20, 2022
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2 min read
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Mark Terry
Drug Development

Talaris Cleared to Continue Kidney Transplant Trial after Patient Death

After the Data Monitoring Committee reviewed the case based on protocol modifications implemented earlier this year, it was determined that enrollment in the trial and dosing may continue.

October 20, 2022
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3 min read
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Alex Keown
Business

Roche and Hookipa Tie Up in KRAS Inhibitor Deal Valued at Potential $950M (Updated)

Roche and Austria-based Hookipa Pharma tied up a licensing and research and development collaboration valued at more than $950 million focused on KRAS-mutated cancers.

October 20, 2022
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3 min read
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Alex Keown
Business

Pfizer and Erasca Target Pancreatic, Colorectal Cancer with “Synergistic” Pairing (Updated)

Erasca announced that it was expanding its existing partnership with Pfizer to assess its ERAS-007 in combination with the Big Pharma’s Ibrance.

October 20, 2022
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3 min read
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Tristan Manalac
Business

Biospace Movers & Shakers: Maravai, Predictive Oncology, Exagen and More Tap New Execs

With the appointment of new CEOs, CMOs and CSOs, biopharma and life sciences organizations shuffled their leadership positions as Q3 comes to a close.

October 20, 2022
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5 min read
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Alex Keown
Policy

Innate Pharma 2023 Financial Calendar

Innate Pharma SA released its 2023 financial calendar.

October 20, 2022
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3 min read
Business

Hansa Biopharma Interim report January-September 2022

Hansa Biopharma, the pioneer in immunomodulatory enzyme technology for rare IgG mediated diseases, announced its business update and interim report for January to September 2022.

October 20, 2022
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8 min read