Fast Track Designation

Aptinyx Jumps Following Positive Phase II PTSD Study Results

Business, Clinical Data, Clinical Trials, Fast Track Designation, FDA, Post Traumatic Stress Disorder (PTSD), R&D, Shares

Aptinyx Jumps Following Positive Phase II PTSD Study Results Published: Oct. 20, 2020 By Alex Keown BioSpace Shares of Aptinyx skyrocketed more than 75% after the company reported its mid-stage experimental treatment for post-traumatic stress disorder demonstrated clinically meaningful and statistically significant results that will set up a pivotal study next year. This morning, […]

October 20, 2020/by Andrew Humphreys

Galapagos and Servier’s Arthritis Knee Repair Drug Fails Phase II

Business, Clinical Data, Clinical Trials, Fast Track Designation, FDA, Licensing, MRI, Primary Endpoints, R&D

Galapagos and Servier reported that their ROCELLA Phase II clinical trial of GLPG1972/S201086 failed to meet the study’s primary endpoint in osteoarthritis knee repair.

October 16, 2020/by Andrew Humphreys

FDA Grants Fast Track Designation to Pfizer’s DMD Gene Therapy

Boys, Business, Clinical Trial Endpoints, Clinical Trials, Duchenne Muscular Dystrophy (DMD), Fast Track Designation, FDA/Regulatory, Gene Therapy, Muscle strength, R&D

Pfizer snagged Fast Track designation from the U.S. Food and Drug Administration for the company’s Duchenne muscular dystrophy (DMD) gene therapy treatment, PF-06939926.

October 1, 2020/by Andrew Humphreys

ALX Oncology Pairs Lead Asset with Keytruda in HNSCC Study

Blockbusters, Business, CD47 Inhibitors, Checkpoint Inhibitors, Clinical Trials, Fast Track Designation, FDA, Head & Neck Squamous Cell Carcinoma (HNSCC), Partnerships, R&D, Therapeutics

ALX Oncology is partnering with pharma giant Merck to evaluate a combination of the CD47 inhibitor ALX148 with the blockbuster Keytruda as a potential treatment for patients with head and neck squamous cell carcinoma (HNSCC).

September 22, 2020/by Andrew Humphreys

Orphazyme’s Rare Lipid Disorder Drug Gets FDA Priority Review

Accepted NDA, Clinical Data, Clinical Trials, Fast Track Designation, FDA, FDA/Regulatory, Heat-Shock Proteins (HSPs), Lipid disorders, Niemann-Pick C Disease (NPC), Primary Endpoints, Priority Review Status, R&D, Rare Genetic Diseases, Secondary Endpoints

The U.S. Food and Drug Administration accepted Copenhagen, Denmark-based Orphazyme’s New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick disease Type C.

September 16, 2020/by Andrew Humphreys

FDA Action Alert: Bristol Myers Squibb and Trevena

ALK Mutations, EGFR Mutations, European Medicines Agency, Fast Track Designation, FDA, FDA/Regulatory, Non-Small Cell Lung Cancer, Pain, Supplemental Biologics License Application, Tumors

August is a busy month on the U.S. Food and Drug Administration)’s calendar, including a target action date for Bristol Myers Squibb’s supplemental Biologics License Application for Opdivo (nivolumab) plus Yervoy (ipilimumab), dosed concomitantly with a limited course of chemotherapy, for the first-line treatment of metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.

August 3, 2020/by BioSpace

FDA Approves Monjuvi for Treatment of DLBCL

Adults, Approvals, Breakthrough Therapy, Diffuse Large B-Cell Lymphoma (DLBCL), Fast Track Designation, FDA, FDA/Regulatory, Monoclonal Antibodies, Non-Hodgkin Lymphoma, Overall Response Rate (ORR), Priority Review Status, Stem Cell Transplant

The U.S. Food and Drug Administration approved MorphoSys and Incyte’s Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.

July 31, 2020/by Business Wire

Pfizer, BioNTech’s coronavirus vaccine candidates get FDA’s ‘fast track’ status

Business, Coronavirus Disease 2019 (COVID-19), Coronavirus Vaccines, Fast Track Designation, FDA, FDA/Regulatory, Shares

Pfizer Inc. and partner BioNTech SE said two of their experimental coronavirus vaccines received ‘fast track’ designation from the U.S. health agency, speeding up the regulatory review process.

July 13, 2020/by Reuters Health

CytoDyn’s Experimental Cancer and HIV Drug Shows Promise in Treating COVID-19

Cancer, Clinical Trials, Coronavirus Disease 2019 (COVID-19), Cytokines, Fast Track Designation, HIV, Immune Cells, Inflammation, Investigational New Drug (IND), R&D, Triple Negative Breast Cancer (TNBC)

Vancouver, Washington-based CytoDyn filed a second clinical trial protocol with the U.S. Food and Drug Administration to treat severely sick COVID-19 patients.

April 1, 2020/by BioSpace

Celgene Teams Up With Cambridge Biotech Nimbus To Tackle Autoimmune Diseases

Autoimmune Diseases, Biotech, Business, Computers, Cytokine Receptors, Fast Track Designation, FDA, Immunology, Inflammation, Partnerships, STING antagonists, Tyk2 (tyrosine kinase 2) Antagonists

Celgene entered into a partnership to take on autoimmune diseases with two of New Jersey-based Nimbus Therapeutics’ preclinical therapeutics.

October 3, 2017/by BioSpace