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Veru, Immunome Tout Positive Data for COVID-19 Therapeutics

Biospace news - Wed, 07/06/2022 - 02:00
Veru Inc. has announced the publication of positive Phase III results from its COVID-19 antiviral therapeutics that could lead to potential Emergency Use Authorization.

Otsuka-Partnered Mindset Wins Patent Allowance for Psychedelic CNS Assets

Biospace news - Wed, 07/06/2022 - 02:00
Mindset Pharma was granted allowance by the U.S. Patent and Trademark Office for its application for a psilocybin-based family of drugs to treat central nervous system disorders.

Applied Molecular Transport's UC Candidate Proves Effective in Early-Stage Intervention

Biospace news - Wed, 07/06/2022 - 02:00
In patients stricken with ulcerative colitis for less than five years, AMT-101 was nearly three times more effective in inducing clinical remission than the placebo after eight weeks.

Eisai, Biogen Score Priority Review on Another Alzheimer's Hopeful

Biospace news - Wed, 07/06/2022 - 02:00
Eisai and Biogen's BLA for lecanemab for Alzheimer's disease received FDA Priority Review with a target action date of January 6, 2023, while Roche's lymphoma drug scored the same designation.

Coherus, Junshi's Cancer Checkpoint Inhibitor Gets Second Chance with FDA

Biospace news - Wed, 07/06/2022 - 02:00
A cancer drug co-developed by Coherus BioSciences and Junshi Biosciences, toripalimab, is getting another opportunity before the U.S. Food and Drug Administration.

Researchers Explain Risks of COVID-19 Re-Infection

Biospace news - Wed, 07/06/2022 - 02:00
Findings from a study support the claim that the risk of developing a serious issue, such as respiratory or cardiac issues, is much more probable in the first 30 days following infection from COVID-19.

Study Suggests Time-Restricted Feeding Could Be Key to Combat Obesity

Biospace news - Wed, 07/06/2022 - 02:00
A new study on gut microbiome activity suggests that diet and eating schedules may affect the body's propensity to become obese and unhealthy.

Boehringer, Evotec and bioMérieux Recognize AMR Threat and More Deals

Biospace news - Wed, 07/06/2022 - 02:00
Boehringer, Evotec and bioMérieux found Aurobac to combat antimicrobial resistance, Turnstone and Moffitt Expand TIL Collab, Skyhawk to gain potential $2B from Sanofi RNA splicing deal.

Follow-Up Data on Bayer’s Larotrectinib Hints at Potentially Curative Impact

Biospace news - Wed, 07/06/2022 - 02:00
BioSpace connected with Theodore Laetsch, M.D., lead investigator of the pediatric larotrectinib trial (SCOUT), to gain more insight into the drug, the trial and how patients' lives are being affected.

Eliminating the Word "Fit" to Remove Unintentional Bias in Hiring

Biospace news - Wed, 07/06/2022 - 02:00
During the past two years, life sciences companies have made a commitment to DEI - but have they taken internal action that increases diversity and promotes inclusive measures?

eFFECTOR Takes Road Less Traveled to Maximize Cancer Treatment

Biospace news - Wed, 07/06/2022 - 02:00
eFFECTOR Therapeutics is pioneering the development of selective translation regulation inhibitors (STRIs), a class of therapies that block the production of disease-driving proteins in cancer.

Inhalable COVID-19 vaccine shows promise in rodent model

World Pharma News - Tue, 07/05/2022 - 10:00
Researchers have created an inhalable COVID-19 vaccine that is shelf stable at room temperature for up to three months, targets the lungs specifically and effectively, and allows for self-administration via an inhaler. The researchers also found that the delivery mechanism for this vaccine - a lung-derived exosome called LSC-Exo - is more effective at evading the lung's mucosal lining than the lipid-based nanoparticles currently in use, and can be used effectively with protein-based vaccines.

Seagen, ANeuroTech Start July with a Clinical Bang

Biospace news - Tue, 07/05/2022 - 02:00
Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug.

FDA Clears Vertex to Continue Dosing in Diabetes Cell Therapy Trial

Biospace news - Tue, 07/05/2022 - 02:00
The FDA lifted its clinical hold on Vertex Pharmaceuticals' Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID).

FDA Has Ways to Go to Keep Pace with 2020/21 Approvals

Biospace news - Tue, 07/05/2022 - 02:00
As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.

Dyne's Exon-51 Skipping DMD Therapy Moves Forward on FDA Go Sign

Biospace news - Tue, 07/05/2022 - 02:00
The FDA lifted the clinical hold on Dyne Therapeutics’ clinical study of DYNE-251 in Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. A Phase I/II trial is expected by mid-year.

Activists Call for Over-the-Counter Access to Abortion Meds

Biospace news - Tue, 07/05/2022 - 02:00
Following the Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the FDA to consider making abortion medication Mifeprex an over-the-counter option for patients.

Beyond Animal Testing: How AI is Increasing the Odds in Drug Development

Biospace news - Tue, 07/05/2022 - 02:00
Quris has developed an alternative to testing on animal models, and each one is smaller than the head of a pin. It holds the potential to increase the currently terrible odds in drug development.

Innate's Cancer Therapeutics are Reaching New Clinical Heights

Biospace news - Tue, 07/05/2022 - 02:00
Many of Innate Pharma’s cancer-fighting products are making clinical progress. BioSpace spoke with the company's head of product portfolio strategy and business development, Yannis Morel, Ph.D.

Researchers Stumble Upon Potential Key to Slow DMD

Biospace news - Tue, 07/05/2022 - 02:00
Research scientists have found that a colony-stimulating factor 1 receptor inhibitor may also be a potential treatment for Duchenne muscular dystrophy.