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11

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.

12

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.

13

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.

14

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.

15

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.

16

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.

17

UCB psoriasis drug will need to wait for US approval

May 13, 2022 /in Autoimmune Diseases, Biologics License Application (BLA), Complete Response Letter, FDA, Generalized Myasthenia Gravis (gMG), Humanized IgG1 monoclonal antibody, Immune-Mediated Diseases, Immunotherapeutics, Immunotherapies, Inflammatory Diseases, Lesions, Monoclonal Antibodies, Plaque Psoriasis, Plaque Psoriasis, Plaque Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis, Psoriasis Lesions, Scalp plaque psoriasis, Scalp Psoriasis, Skin Diseases, Therapeutics, UCB

The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.

18

Explainer: How North Korea’s COVID-19 outbreak could ignite a major health crisis

May 13, 2022 /in Coronavirus, Coronavirus Diagnostic Tests, Coronavirus Disease (COVID-19) Pandemic, Coronavirus Vaccines, COVAX Facility, COVID-19 Crisis, COVID-19 Deaths, COVID-19 Molecular Diagnostic Tests, COVID-19 self-testing kit, COVID-19 shots, COVID-19 Testing, Covid-19 Testing Guidance, COVID-19 Therapeutic, COVID-19 vaccination rates, COVID-19 Vaccinations, COVID-19 Vaccines, Diagnostic Tests, North Korea, Outbreaks, Pandemics, Politics, South Korea, Vaccinations, Vaccines, World Health Organization

North Korea’s admission that it is battling an “explosive” COVID-19 outbreak raised concerns that the virus could devastate a country with an under-resourced health system, limited testing capabilities, and no vaccine program.

19

North Korea reports first COVID-19 death as fever spreads ‘explosively’

May 13, 2022 /in Coronavirus, Coronavirus Disease (COVID-19) Pandemic, Coronavirus Vaccines, COVID-19 Deaths, COVID-19 Self Test, COVID-19 Testing, COVID-19 Vaccines, North Korea, Outbreaks, Pandemics, Politics, Pyongyang, South Korea, Therapeutics, Vaccines

At least one person confirmed to have COVID-19 has died in North Korea and hundreds of thousands have shown fever symptoms, state media said on May 13, offering hints at the potentially dire scale of the country’s first confirmed outbreak of the pandemic.

20

Scientists Rejuvenate Skin Cells by 30 Years, with Pioneering Potential

May 13, 2022 /in Babraham Institute, Biology, BioSpace, Embryonic stem cells, Induced Pluripotent Stem Cells (iPSC), R&D, Scientists, Skin cells, Studies, United Kingdom

As previously reported by BioSpace, a group of scientists from the Babraham Institute in the United Kingdom was able to successfully rejuvenate skin cells by a full 30 years.

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