In recent months, the biotech and biopharma industries have been struggling with layoffs and dropping stocks. However, some companies are still experiencing success. Sanofi, AstraZeneca, Avillion and Diadem recently announced positive clinical results, providing positive news for patients with multiple myeloma, asthma and Alzheimer’s disease.
Universal Antivirals Could be the Future for Preventing Pandemics
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, VirusesSince 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.
Spero Therapeutics is laying off approximately 75 percent of the company’s workforce as part of a restructuring operation in light of the U.S. Food and Drug Administration’s expected rejection of Spero’s New Drug Application (NDA) for bacterial diseases.
Respiratory Organizations Tackle the Challenge of Reducing Delays in Diagnosing Complex Lung Diseases
American College of Chest Physicians (CHEST), Chronic Fibrosing Interstitial Lung Diseases (ILD), Fibrosis, Idiopathic Pulmonary Fibrosis (IPF), Initiatives, Lung Disease, Nonprofit, R&D, RespiratoryThree Lakes Foundation and the American College of Chest Physicians (CHEST) recently announced their collaboration on a multiphase educational initiative aiming to reduce the time it takes to diagnose patients with Interstitial Lung Diseases (ILD).
Britain’s GSK halted enrollment and vaccination in three trials of the company’s experimental vaccine against the respiratory syncytial virus (RSV) in pregnant women, the latest setback in developing a vaccine for the microbe.
FDA’s ODAC Says Lilly & Innovent Must Run U.S. Trial
Business, Checkpoint Inhibitors, China, Clinical Trial Endpoints, Clinical Trials, Ethnicity, FDA/Regulatory, Lung Cancer, Oncologic Drugs Advisory Committee (ODAC), PD-1 Inhibitors, Primary Endpoints, Progression-Free Survival (PFS), R&D, Therapeutics, United StatesThe Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended that Eli Lilly and Co. and Innovent Biologics Inc. conduct a clinical trial applicable to the U.S. population for the lung cancer drug sintilimab. The U.S. FDA previously raised concerns over a clinical trial conducted entirely in China focused on a single ethnic group.
Regeneron, Sanofi Blockbuster Dupixent Scores Points in 5 More Indications
Asthma, Atopic Dermatitis (Eczema), Blockbusters, Chronic Idiopathic Urticaria, Chronic rhinosinusitis with nasal polyps (CRSwNP), Clinical Trials, ENT Diseases, Eosinophilic Esophagitis, Human Antibodies, Immunosuppressants, Prurigo nodularis, R&D, Regeneron Pharmaceuticals, Rhinosinusitis, Sanofi, TherapeuticsRegeneron Pharmaceuticals and Sanofi’s anti-inflammatory drug Dupixent (dupilumab) has shown to be effective against five types of type 2 inflammations, with more indications expected to surface soon.
BioSpace reviewed a busy January 5th for collaboration announcements in the life sciences world.
The U.S. Food and Drug Administration lifted the clinical hold made by the regulatory agency during February 2021 for Spero Therapeutics’ Phase IIa trial of SPR720, an oral antimicrobial agent being studied in patients with nontuberculous mycobacterial pulmonary disease (NTM-PD).
10 Biggest Novel Drug Approvals of 2021
Alzheimer's Disease, BNT162b2 (Pfizer and BioNTech), COVID-19 Vaccines, Cytomegalovirus Infections, Episodic Migraine, FDA, Lupus nephritis, New Drug Approvals, Non-Hodgkin Lymphoma, Non-Small Cell Lung Cancer (NSCLC), Pfizer, Sickle Cell Disease, Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD), Therapeutics, Weight managementBioSpace looks at the 10 biggest drug approvals of 2021, headlined by Biogen’s Aduhelm (aducanumab) for Alzheimer’s disease and Pfizer and BioNTech’s COVID-19 vaccine Comirnaty.