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FDA Grants Orphan Drug Designations to VBI, Hepion Cancer Drugs

Biospace news - Fri, 06/17/2022 - 02:00
VBI Vaccines and Hepion Pharmaceuticals have received Orphan Drug Designations from the U.S. Food and Drug Administration for their experimental cancer drugs.

FDA Authorizes Pfizer-BioNTech, Moderna COVID Vaccines for Children 6 Months to 4 Years

Biospace news - Fri, 06/17/2022 - 02:00
Friday morning, the FDA granted Emergency Use Authorization to both Moderna's and Pfizer-BioNTech's COVID-19 vaccines for use in children ages 6 months to 4 years old.

Addex Ends Trials Evaluating Parkinson's Treatment Due to Slow Recruitment

Biospace news - Fri, 06/17/2022 - 02:00
Addex Therapeutics announced it is canceling its Phase IIb/III study evaluating its drug dipraglurant due to patient recruiting, staffing and pandemic-related issues.

WTO Approves Patent Waivers to Increase Worldwide Access to COVID-19 Vaccines

Biospace news - Fri, 06/17/2022 - 02:00
The World Trade Organization approved vaccine patent waivers to increase the availability of COVID-19 vaccines to lower-income countries.

Bavarian Nordic Takes on Pfizer-BioNTech with COVID-19 Booster Candidate

Biospace news - Fri, 06/17/2022 - 02:00
​​​​​​​Bavarian Nordic announced that the upcoming Phase III trial for its COVID-19 booster candidate has been redesigned to compete against licensed mRNA-based vaccines.

AstraZeneca Rumored to Have Set Sights on Mereo BioPharma Buyout

Biospace news - Fri, 06/17/2022 - 02:00
AstraZeneca appears to have taken an interest in Mereo BioPharma and may be considering a buyout, according to speculations published by The Times UK.

Pilot Programs Prepare Decentralized Trials for Prime Time in EU and Japan

Biospace news - Fri, 06/17/2022 - 02:00
Speakers from Sanofi and CMIC discussed their respective experiences with DCT in Europe and Japan during Informa Connect’s Decentralized Clinical Trials hybrid meeting, held June 6-8.

FTC Unanimously Agrees to Keep Close Eye on PBMs, Higher Drug Costs

Biospace news - Fri, 06/17/2022 - 02:00
The vote came just over one week after the FTC announced it would probe claims regarding the role the middlemen play in determining retail prices of prescription drugs.

Atreca Taps Genentech's Stephen Gould to Serve as CSO

Biospace news - Fri, 06/17/2022 - 02:00
Atreca announced that Stephen Gould, Ph.D., will be the company's next chief scientific officer. Most recently, Gould was executive director, of Translational Oncology at Genentech.

Researchers Identify Molecule Produced During Exercise that Reduces Obesity

Biospace news - Fri, 06/17/2022 - 02:00
Researchers from the Baylor College of Medicine, part of the Stanford School of Medicine, discovered a molecule produced during exercise in mice that suppresses feeding and obesity.

Research Roundup: Science One Step Closer to Growing Organs in a Dish

Biospace news - Fri, 06/17/2022 - 02:00
Although it seems like science fiction, we may one day be able to grow replacement organs and tissues. For that and more reach news, continue reading.

BioSpace Movers & Shakers: ADC, Akari, Scorpion & More

Biospace news - Fri, 06/17/2022 - 02:00
This week's Movers & Shakers includes a number of chief business officers and business development leaders alongside those tapped for scientific roles.

Remote Workers More Productive in Short-Term Than Long-Term, Study Shows

Biospace news - Fri, 06/17/2022 - 02:00
Researchers surveyed 60,000 Microsoft employees and found that remote workers are more productive than their in-office counterparts in the short-term, but less productive long term.

Broadly neutralizing antibodies could provide immunity against SARS-CoV-2 variants

World Pharma News - Thu, 06/16/2022 - 10:00
Two broadly neutralizing antibodies show great promise to provide long-acting immunity against COVID-19 in immunocompromised populations according to a paper published June 15 in the Journal of Experimental Medicine (JEM). The antibodies were effective against all SARS-CoV-2 variants of concern tested and could be used alone or in an antibody cocktail to diminish the risk of infection.

Pfizer Makes Supportive Investment in Akero's NASH Drug

Biospace news - Thu, 06/16/2022 - 02:00
Shares of Akero Therapeutics are surging after the company announced pharma giant Pfizer made a $25 million equity investment to support the development of the company’s experimental liver drug.

Roche Therapy for Rare Form of Alzheimer's Falls Short in Phase III

Biospace news - Thu, 06/16/2022 - 02:00
The trial evaluated crenezumab’s ability to slow Alzheimer’s disease in cognitively unimpaired people with a specific gene mutation that causes early-onset Alzheimer’s disease.

Biogen Halts ALS Asset Agreement with Karyopharm

Biospace news - Thu, 06/16/2022 - 02:00
Biogen has terminated its asset purchase agreement with Karyopharm Therapeutics, putting a halt to the development of KPT-350 (BIIB100), which was being evaluated as a treatment for ALS.

FDA Sets Hearing Date for Covis' Beleaguered Preterm Birth Drug

Biospace news - Thu, 06/16/2022 - 02:00
Covis announced that the U.S. Food and Drug Administration has granted the company a hearing for its controversial drug Makena, which is intended to reduce preterm births.

"Holy Grail" Transplantation Technique Offers Hope to Patients with Rare Kidney Disease

Biospace news - Thu, 06/16/2022 - 02:00
In a study conducted by researchers at Stanford University, three pediatric patients with a rare genetic disease that often results in kidney failure received kidney transplants.