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Yale School of Public Health and Tevogen Bio partner to expand school's regulatory sciences program

The Yale School of Public Health is partnering with Tevogen Bio, a clinical stage biotechnology company, on a major expansion of the school's regulatory sciences program.

14 Jul 2021

FDA approves higher dose naloxone hydrochloride nasal spray product to combat opioid overdose

The U.S. Food and Drug Administration announced today the approval of a higher dose naloxone hydrochloride nasal spray product to treat opioid overdose. The newly approved product delivers 8 milligrams (mg) of naloxone into the nasal cavity. The FDA had previously approved 2 mg and 4 mg naloxone nasal spray products.

30 Apr 2021

FDA warns two companies for illegal marketing of unapproved CBD products

The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act).

22 Mar 2021

Progesterone therapy may improve clinical outcomes for male COVID-19 patients

COVID-19 disproportionately affects men compared with women, raising the possibility that a hormone like progesterone may improve clinical outcomes for certain hospitalized men with the disease.

18 Mar 2021

FDA-approved drug has limited treatment efficacy for hypoactive sexual desire disorder

An independent analysis of the medical trials which formed the final basis of approval by the US Food and Drug Administration (FDA) strongly suggests the drug bremelanotide has very limited effectiveness as a treatment for hypoactive sexual desire disorder (HSDD) in women, and that trial participants preferred a placebo.

8 Mar 2021

Intranasal COVID-19 vaccine candidate preclinically tested at UAB expected to start clinical trial

The Altimmune Inc. vaccine candidate that was tested preclinically at the University of Alabama at Birmingham last year is expected to start patient enrollment for its Phase 1 clinical trial next week.

20 Feb 2021

Researchers receive $5.1 million to expand clinical trial of drug to prevent ARDS in COVID-19 patients

Researchers evaluating whether an investigational oral drug, vadadustat, can help prevent acute respiratory distress s to expand the Phase II clinical trial at The University of Texas Health Science Center at HoustonQ.

13 Jan 2021

RedHill Biopharma: RHB-204 receives FDA Fast Track designation for treatment of NTM disease

RedHill Biopharma Ltd., a specialty biopharmaceutical company, today announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) - a rare disease for which there is no FDA-approved first-line therapy.

6 Jan 2021

FDA approves first generic glucagon for injection to treat severe hypoglycemia

Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus.

28 Dec 2020

BAT advances COVID-19 vaccine candidate into phase-I clinical trial

The COVID-19 vaccine candidate (KBP-COVID-19; NCT04473690) will become one of a number of potential vaccines to have progressed beyond pre-clinical testing.

16 Dec 2020

Eureka's InvisiMask human antibody nasal spray offers protection against SARS-CoV-2 in mice

Eureka Therapeutics, Inc. announced today successful preclinical results from its InvisiMask™ Human Antibody Nasal Spray in mice, which offers protection against SARS-CoV-2 S pseudotyped virus infection for up to 10 hours.

14 Dec 2020

UC Davis Health joins with Novavax to test a new experimental coronavirus vaccine

Despite the encouraging news of potentially successful COVID-19 vaccine trials, there is not yet an FDA-approved vaccine available. Research into other effective coronavirus vaccines continues, including at UC Davis Health.

8 Dec 2020

Study shows metformin can significantly reduce COVID-19 death risks in women

University of Minnesota Medical School and UnitedHealth Group researchers found that metformin was associated with significantly reduced COVID-19 death risks in women in one of the world's largest observational studies of COVID-19 patients.

3 Dec 2020

Researchers validate new radiolabeled molecule used in imaging tests to detect brain injury

Researchers have validated a new radiolabeled molecule that can be used with imaging tests to accurately detect and characterize brain injury.

22 Oct 2020

COVID-19 vaccine candidate shows potent immune response

A COVID-19 vaccine candidate that underwent extensive preclinical testing at the University of Alabama at Birmingham this spring and summer shows potent preclinical immune responses -; including several that distinguish it from other COVID-19 vaccine approaches -; according to a preprint deposited in the BioRxiv repository this week.

13 Oct 2020

Investigational antidepressant PT150 shows antiviral activity against SARS-CoV-2

In a recent bioRxiv study, an ad hoc multi-institutional research team from the US shows that a novel hormone receptor modulator PT150 has unique and possibly additive antiviral and immunomodulatory effects – highlighting its potential role in the treatment and prophylaxis of coronavirus disease (COVID-19).

14 Jul 2020

Researchers discover novel class of safer analgesics

Researchers at LSU Health New Orleans Neuroscience Center of Excellence and colleagues have discovered a new class of pipeline drugs to relieve pain and reduce fever without the danger of addiction or damage to the liver or kidneys.

6 Jul 2020

New vitamin K-based drug eliminates medication-resistant epileptic seizures in mice

In the cover article of the June 11 issue of the Journal of Medicinal Chemistry, a team of researchers at the Medical University of South Carolina, led by Sherine Chan, Ph.D., and James Chou, Ph.D., reports that a new vitamin K-based drug has proved effective in mouse models of medication-resistant seizures.

6 Jul 2020

Texas Heart Institute and 7 Hills Pharma receive $1.9 million to improve stem cell transplants

The Texas Heart Institute and 7 Hills Pharma received a $1.9 million, Phase II STTR (R42) grant from the National Heart Lung Blood Institute to advance further their lead product 7HP349, a novel integrin activator, to define the optimal dosing schedule for cord blood transplant along with a focus on development and production of a formulation that meets safety standards for filing an IND application with the FDA.

12 Jun 2020

Octapharma extends support for COVID-19 study following promising preliminary data

Following positive preliminary data, Octapharma USA is extending funding for an investigator-initiated study (IIS) focused on treating the most critical patients at the heart of the coronavirus pandemic, those experiencing hypoxia and who are at the highest risk of requiring mechanical ventilation.

3 Jun 2020