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Amgen to discuss application for LUMAKRAS® (sotorasib) for the treatment of KRAS G12C-positive NSCLC at FDA advisory committee meeting

Amgen today announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) will review data supporting the supplemental New Drug Application (sNDA) for the full approval of LUMAKRAS® (sotorasib) for adults with previously treated locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC) at a meeting on Oct. 5, 2023.

From AMGEN 1 Sep 2023

Universal approach could potentially expand CAR T cell therapy to all blood cancers

A broad new strategy could hold hope for treating virtually all blood cancers with CAR T cell therapy, which is currently approved for five subtypes of blood cancer.

31 Aug 2023

MaxCyte and Vittoria Biotherapeutics sign strategic platform license to advance next generation cellular therapies

MaxCyte, Inc., a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, and Vittoria Biotherapeutics (Vittoria), a leading edge, gene-edited cell therapeutics company with novel platform technologies poised to develop a pipeline of highly differentiated cellular therapies for both oncology and immunology indications, today announced the signing of a strategic platform license (SPL) of MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to Vittoria Biotherapeutics.

From MaxCyte, Inc. 10 Aug 2023

New selective targeted therapy for metastatic colorectal cancer prolongs overall survival

A new therapy is on the horizon for patients with metastatic colorectal cancer who have run out of treatment options.

16 Jun 2023

Eye drops to slow the progression of nearsightedness in kids could be on the horizon

The results of a new clinical trial suggest that the first drug therapy to slow the progression of nearsightedness in kids could be on the horizon.

1 Jun 2023

Valbenazine improves chorea associated with Huntington's disease

The drug valbenazine statistically improves chorea, a movement disorder commonly associated with Huntington's disease, when compared to a placebo, according to a recent international study led by UTHealth Houston researcher Erin Furr Stimming, MD, who served as principal investigator on behalf of the KINECT-HD Huntington Study Group.

19 May 2023

Small molecule inhibitor reverses malignant hyper-editing by an inflammation-induced protein isoform

Researchers at University of California San Diego School of Medicine, Sanford Stem Cell Institute and Moores Cancer Center report that a late-stage, pre-clinical small molecule inhibitor, called rebecsinib, reverses malignant hyper-editing by an inflammation-induced protein isoform, known as ADAR1 p150.

16 Feb 2023

Researchers seek to reduce Chikungunya virus-caused joint pain with new drug

Oregon Health & Science University researchers and partners are developing what could become the first-ever treatment against the debilitating joint pain that can last months or years after becoming infected with the emerging Chikungunya virus.

9 Dec 2022

NIAID awards more than $12 million for the development of antiviral therapies

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, recently awarded more than $12 million to three institutions for the development of antiviral therapies to treat diseases caused by viruses with pandemic potential.

21 Nov 2022

False positive monkeypox tests in low-risk patients with no exposures

Researchers reported three monkeypox diagnoses presenting atypical rashes.

13 Sep 2022

Sanders-Brown director receives $1.5 million grant to advance research on Alzheimer's treatment

Linda J. Van Eldik, Ph.D., director of the University of Kentucky Sanders-Brown Center on Aging, is part of a $1.5 million grant to help further research into a possible treatment for Alzheimer's disease.

19 Aug 2022

Modifi Bio comes up with a new technology to combat cancer cells with DNA modification

Modifi Biosciences announced today that the journal Science has published a critical study validating the company's novel oncology platform based on new classes of molecules that exploit tumor-associated DNA repair defects through direct cancer cell DNA modification.

29 Jul 2022

Scientists create a bioengineered 3D model that mimics the biology of two rare neuromuscular diseases

A scientific team supported by the National Institutes of Health has created a tiny, bioengineered 3-D model that mimics the biology of chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy, a pair of rare, devastating neuromuscular diseases.

19 Apr 2022

City of Hope's late-breaking clinical trial data to be presented at AACR

Researchers at City of Hope, one of the largest cancer research and treatment organizations in the United States, will present late-breaking and clinical trial findings at this year's American Association for Cancer Research Annual Meeting, which begins today.

8 Apr 2022

Tablet containing cannabidiol effectively reduces pain after shoulder surgery

An orally absorbed tablet containing cannabidiol (CBD) effectively reduces pain after shoulder surgery with no safety concerns, a new study finds.

25 Mar 2022

Noramco Announces Submission of Drug Master File for Lisdexamfetamine Dimesylate ─ Active Pharmaceutical Ingredient

Leading Producer of Controlled Substance APIs Now Supplying Lisdex API to Generic Drug Manufacturers Preparing for the 2023 Patent Expiry of Top-Selling Branded ADHD Therapy.

3 Dec 2021

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