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

Biospace news - 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

Biospace news - 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.

FDA approves first gene therapy to treat adults with Hemophilia B

World Pharma News - Tue, 11/22/2022 - 11:00
Today, the U.S. Food and Drug Administration approved Hemgenix (etranacogene dezaparvovec), an adeno-associated virus vector-based gene therapy for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.

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

Biospace news - 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

Biospace news - 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

Biospace news - 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.

Cryptic drug-binding sites discovered in the dance

World Pharma News - Mon, 11/21/2022 - 11:00
Some of the toughest challenges in treating disease are presented by “undruggable” proteins whose structures and roles in disease are known but are seemingly unable to be targeted by drugs that will bind to them. Researchers at King Abdullah University of Science and Technology (KAUST) have now shown that the molecular motion of many "undruggable" proteins can in fact expose sites at which drugs could bind.

Unusual type of antibody shows ultrapotent activity against Zika

World Pharma News - Fri, 11/18/2022 - 11:00
An unusual type of antibody that even at miniscule levels neutralizes the Zika virus and renders the virus infection undetectable in preclinical models has been identified by a team led by Weill Cornell Medicine, NewYork-Presbyterian and National Institutes of Health (NIH) investigators.

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

Biospace news - 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

Biospace news - 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

Biospace news - 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

Biospace news - 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

Biospace news - 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.

Biospace news - 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...

Biospace news - 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.

GSK announces positive Phase IIa study results for a new first-in-class candidate medicine for patients with tuberculosis

World Pharma News - Thu, 11/17/2022 - 11:00
GSK plc (LSE/NYSE: GSK) announced positive results from a Phase IIa study demonstrating that GSK3036656, a first-in-class investigational antitubercular agent, was well tolerated and showed early bactericidal activity with a low, once-daily oral dose after 14 days of treatment in participants with drug-susceptible pulmonary tuberculosis.

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

Biospace news - 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

Biospace news - 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.

Immatics Falls Victim to GSK's Receding Cell Therapy Pipeline

Biospace news - Thu, 11/17/2022 - 02:00
GSK has pulled out of its partnership focused on developing T-cell receptor therapeutics for solid tumors with Immatics, the German biotech revealed in its Q3 financial results published Thursday.