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31

BMS, Synairgen regroup after trials miss primary endpoints

May 16, 2022 /in Blockbusters, Bristol Myers Squibb, Business, Clinical Trials, COVID-19 Therapeutic, COVID-19 therapeutic candidates, COVID-19 Therapeutics, COVID-19 Therapies, Metastatic Urothelial Carcinoma (mUC), R&D, R&D, Therapeutics

Bristol Myers Squibb shared the news that the company’s Phase III clinical trial investigating the safety and efficacy of Opdivo and Yervoy combination therapy (NCT03036098) in patients with metastatic urothelial carcinoma failed to meet the predetermined primary endpoint. A posthoc analysis was shared by Synairgen suggesting that, despite SNG001 failing to meet the primary endpoint of patient recovery and subsequent hospital discharge in a Phase III study for patients hospitalized with COVID-19 who required supplemental oxygen treatment, they may benefit from receiving the treatment.

32

N. Korea’s Kim orders military to stabilize supply of COVID drugs

May 16, 2022 /in Coronavirus Disease (COVID-19) Pandemic, Coronavirus Vaccines, COVID-19 Therapeutics, COVID-19 Vaccines, Medical Supplies, North Korea, Pandemics, Pyongyang, South Korea, Therapeutics, Vaccines

Leader Kim Jong Un ordered North Korea’s military to stabilize distribution of COVID-19 medicine in the capital, Pyongyang, in the battle against the country’s first confirmed outbreak of the disease, state media said.

33

FDA to address baby formula imports

May 16, 2022 /in Abbott, FDA, FDA Commissioner, Healthcare Companies, Infant Formulas, NBC, Therapeutics

The U.S. Food and Drug Administration will make an announcement regarding imported infant formula as soon as later on May 16, the agency’s chief told NBC News in an interview as regulators and lawmakers seek to address ongoing supply shortages.

34

Eli Lilly deals another blow to diabetes with latest FDA approval

May 16, 2022 /in Approvals, Chronic Diseases, Diabetes, Diabetes, Diabetes, Diabetes drugs, Eli Lilly, FDA, Glucagon, Glucagon-Like Peptide-1 (GLP-1) Analogs, Peptide Hormones, Therapeutics, Type 2 Diabetes

Eli Lilly scored another win against diabetes as the company’s once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist tirzepatide won approval under Priority Review from the U.S. Food and Drug Administration.

35

COVID-19 and Vaccine Safety Brings Pharmacovigilance Center Stage

May 13, 2022 /in Business, Coronavirus Disease (COVID-19) Pandemic, COVID-19 Vaccinations, Drug Development, Drug Safety, Messenger RNA (mRNA) Vaccines, Pharmacovigilance, R&D, Scientists, Surveys

Pharmacovigilance, the industry term for drug safety, was unfamiliar to most of the general public before March 2020. But as the coronavirus pandemic unfolded, its rapid spread thrust drug safety into the spotlight. The public is more aware of drug safety and health regulators’ role than ever — and as the demand for pharmacovigilance information rises, the industry has had to find ways to keep up — according to Beena Wood, VP of safety at ArisGlobal.

36

Editas, Neurocrine Snag Orphan Drug Designations as Congressional Debate Continues

May 13, 2022 /in Beta Thalassemia, Clinical Data, Congress, FDA, Gene Therapy, Huntington’s disease, Orphan Drug Designation, Pediatric Diseases, R&D, Sickle Cell Disease, Topline Data, World Orphan Drug Alliance (WODA)

As the fairness of orphan drug exclusivities is debated in Congress, the U.S. Food and Drug Administration granted Orphan Drug designations to Editas Medicine and Neurocrine Biosciences.

37

Universal Antivirals Could be the Future for Preventing Pandemics

May 13, 2022 /in Acute Respiratory Distress Syndrome (ARDS), Antivirals, BioSpace, Clinical Trials, Coronavirus Disease (COVID-19) Pandemic, Coronavirus Disease 2019 (COVID-19), Coronavirus Disease 2019 (COVID-19), Drug Supply Chain, Immune System, Influenza, Pandemics, Pneumonia, R&D, Respiratory Syncytial Virus (RSV) Infection, Vaccines, Viruses

Since the emergence of the COVID-19 pandemic, there has been increased interest in developing a universal antiviral that would stop a pandemic in its tracks.

38

Yale Researchers are Quantifying Genetic and Environmental Factors in Cancer

May 13, 2022 /in Advanced Non-Small Cell Lung Cancer, Bi-Specific Antibodies, Cancer, Clinical Trials, DNA, Environmental factors, FDA, Genetics, R&D, Solid Tumors, T-Cells, Yale University

Researchers at Yale University published research in Molecular Biology and Evolution describing a new molecular analysis approach to quantify DNA changes that contribute to cancer growth.

39

Elon Musk’s Neuralink Beaten to the Clinic by Synchron

May 13, 2022 /in Brain, Brain Implants, Business, Clinical Development, Computers, Elon Musk, Medical Devices, Paralysis, R&D

Elon Musk’s Neuralink was beaten to the clinic by a rival brain-computer interface company. Synchron enrolled the first patient in the COMMAND study that will assess the New York-based company’s implant in individuals with severe paralysis.

40

BridgeBio augments comeback week with sale of priority review voucher

May 13, 2022 /in Bristol Myers Squibb, Business, FDA, Layoffs, Molybdenum cofactor deficiency (MoCD) Type A, PDUFA, Priority Review, Priority Review Status, Priority Review Voucher, Rare Diseases, Rare Pediatric Disease Priority Review Voucher, Sales, Therapeutics

One day after BridgeBio Pharma struck a nearly $1 billion oncology pact with Bristol Myers Squibb, the California-based company announced plans to sell a priority review voucher received in February.

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