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Updated: 19 hours 38 min ago

FDA Approves CSL-uniQure's Hemophilia B Gene Therapy, the Most Expensive Medicine in the World

Wed, 11/23/2022 - 02:00
The FDA approved CSL Behring and uniQure’s Hemgenix, a one-time gene therapy developed for adults with Hemophilia B,the companies announced Tuesday afternoon.

FDA Grants Priority Review to Takeda's Dengue Vaccine

Wed, 11/23/2022 - 02:00
The FDA granted priority review to Takeda’s Biologics License Application for TAK-003, a dengue vaccine candidate. The vaccine to date is only approved for use in Indonesia.

Arvinas’ Experimental Breast Cancer Drug Fails to Impress Analysts

Wed, 11/23/2022 - 02:00
Late Monday, Arvinas Inc. was forced to divulge the contents of its upcoming breast cancer data presentation, slated for the 2022 San Antonio Breast Cancer Symposium (“SABCS”).

Novartis and MMV Move to Pivotal Study with New Class of Drug for Malaria

Wed, 11/23/2022 - 02:00
Novartis and Medicines for Malaria Venture are moving into Phase III for a combination treatment targeting the rise of artemisinin-resistant Malaria infection.

Breaking the Silos: How One Doctor is Working to Reshape Medicine

Wed, 11/23/2022 - 02:00
BioSpace spoke with Dr. Kiana Aran to discuss her life, her accomplishments and what it means to be a successful woman in science on a global scale.

GSK’s Blenrep Exits U.S. Market After Failing Confirmatory Trial

Tue, 11/22/2022 - 02:00
​​​​​​​Following a request from the FDA, GSK is withdrawing its multiple myeloma drug Blenrep from the U.S. market while continuing to push other combination trial programs.

Argenx Scores Priority Review for Generalized Myasthenia Gravis Therapeutic

Tue, 11/22/2022 - 02:00
The FDA granted argenx Priority Review status for the company’s BLA for SC efgartigimod for generalized myasthenia gravis.

Gratitude and Optimism: This Thanksgiving, BioSpace Celebrates Biopharma Wins

Tue, 11/22/2022 - 02:00
In a volatile year, marked with challenges, BioSpace is taking a pause to reflect on the many “wins” in biopharma.

FDA Greenlights Provention’s TZIELD as First Drug to Delay Advanced T1D

Fri, 11/18/2022 - 02:00
​​​​​​​The FDA has approved Provention’s BLA for intravenous antibody TZIELD to delay stage 3 type 1 diabetes, making it the first disease-modifying drug indicated to slow disease progression.

Iovance's BLA for Advanced Melanoma Therapeutic Delayed Until Q1 2023

Fri, 11/18/2022 - 02:00
Iovance Biotherapeutics announced the FDA's Biologics License Application for lifileucel will likely be completed in Q1 of 2023, a short delay after the agency requested additional data.

Pfizer-BioNTech, Moderna Tout New Data for Updated Omicron Boosters

Fri, 11/18/2022 - 02:00
Pfizer and BioNTech reported positive data Friday from their Omicron BA.4/BA.5-adapted bivalent booster. This followed a similar announcement by Moderna Monday.

Kidney Therapeutics to Halt CKD Progression Make Late-Stage Push Toward NDA

Fri, 11/18/2022 - 02:00
Therapeutics to halt the progression of chronic kidney disease are in Phase III trials, and others will enter that stage soon. NDAs could follow as early as 2024 with regulatory determinations in 2025.

Movers & Shakers: IPI, Lucy Therapeutics, Valneva and More Add New Leaders

Fri, 11/18/2022 - 02:00
With the Thanksgiving season upon us, there are many reasons for biopharma and life sciences companies to say thanks, including for new leaders.

5 Biopharma Jobs that Don't Require a Ph.D.

Fri, 11/18/2022 - 02:00
If you want to work in biopharma but only have a bachelor’s or master’s degree, there are still plenty of options available. To help, here are five job options in biopharma that don't require a Ph.D.

Sponsored: Are You Looking for a Long-Term Partnership for Your Next OEM Project? Trust Our Exper...

Fri, 11/18/2022 - 02:00
Discover how Eppendorf OEM worked with the market leader in laboratory automation to develop a win-win business model and 25-year partnership.

BioSpace Layoff Tracker 2022: Neoleukin, Tricida, Pear Therapeutics and More Cull Staff

Fri, 11/18/2022 - 02:00
The layoffs trend in the life sciences industry is continuing into the final months of 2022. See inside for details on which companies are reducing staff to increase cash flow.

Astellas Scores Late-Phase Win in CLDN18.2-Positive Gastric Cancer (Updated)

Thu, 11/17/2022 - 02:00
Astellas' Phase III SPOTLIGHT trial studying zolbetuximab in CLDN18.2-positive, HER2-negative gastric or gastroesophageal junction adenocarcinoma returned positive results.

Abandoned Bayer Drug Shows Preclinical Promise for Childhood Brain Tumors

Thu, 11/17/2022 - 02:00
New research out of McMaster University found a recently abandoned Bayer compound halted the growth of an aggressive form of pediatric medulloblastoma in mouse models.