European Commission approves Roche's Tecentriq SC, the EU's first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the European Commission has granted marketing authorisation for Tecentriq® SC (atezolizumab), the European Union (EU)'s first PD-(L)1 cancer immunotherapy for subcutaneous (under the skin) injection. Subcutaneous (SC) injection offers the potential for a faster, more convenient alternative to intravenous (IV) infusion and is preferred by cancer patients, nurses and physicians
Bayer's AskBio initiates Phase II GenePHIT trial in Congestive Heart Failure (CHF)
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- Category: Bayer
Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, have announced the initiation of GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known as NAN-101) for the treatment of congestive heart failure (CHF).
TIVDAK® supplemental Biologics License Application accepted for Priority Review by FDA for patients with recurrent or metastatic cervical cancer
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after first-line therapy.
AskBio Phase Ib trial of AB-1005 gene therapy in patients with Parkinson's disease meets primary endpoint
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- Category: Bayer
Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, announced today the completion of the 18-month data collection in the Phase Ib clinical trial for AB-1005 (AAV2-GDNF), an investigational gene therapy for treating patients with Parkinson's disease (PD).
FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies
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- Category: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with food allergy.
Pfizer declares first-quarter 2024 dividend
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- Category: Pfizer
Pfizer Inc. (NYSE: PFE) announced that its board of directors declared an increase in the quarterly cash dividend on the company's common stock to $0.42 for the first-quarter 2024 dividend, payable March 1, 2024, to holders of the Common Stock of record at the close of business on January 26, 2024.
FDA grants Priority Review to Amgen's tarlatamab application for advanced small cell lung cancer
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- Category: Amgen
Amgen (NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the Company's Biologics License Application (BLA) for tarlatamab.
Tarlatamab is a potential first-in-class, investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy for the treatment of adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
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