Pfizer announced the U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to the company’s New Drug Application (NDA) for abrocitinib (100mg and 200mg), an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor,...
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Lilly on the Verge of COVID-19 Monoclonal Antibody EUA Approval First for High Risk Patients with Recent Mild-to-Moderate COVID-19 Diagnosis
TrialSite shared that Eli Lilly’s (Lilly) monoclonal antibody program targeting COVID-19 appeared to be working, at least according to some trial site reports. Now Lilly is moving to secure an emergency use authorization for its monotherapy (LY-CoV555) to the U.S....
Regeneron Submits Request for FDA EUA for REGN-COV2 in Head to Head Competition with Eli Lilly
Regeneron reported that subsequent to the New York-based company’s discussions with regulatory authorities, they have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorization (EUA) for their investigational REGN-COV2...
Novavax Taps into the $1.6b in U.S. Fed Award to Fund Phase 3 Clinical Trial in the UK in Pursuit of Euro Filing
Novavax Inc. (Nasdaq: NVAX) has progressed their investigational vaccine product for COVID-19 called NVX-CoV2373 to Phase 3 to evaluate the efficacy, safety and immunogenicity of this candidate. Much of Novavax research occurs outside of the United States. For...
Novartis Moves to be on the ‘Right Side’ of History, Will Other Big Pharma Follow?
Novartis sells medicines for zero-profit
COVID-19 Vaccine INO-4800 Demonstrates Neutralizing Antibody and T-Cell Immune Responses in Preclinical Models
Inovio Pharmaceuticals (Nasdaq: INO) reported recent preclinical data summaries for their COVID-19 DNA vaccine called INO-4800 demonstrating promising information. Namely, the sponsor’s tests demonstrated robust neutralizing antibody and T cell immune responses...
Ansun Biopharma’s DAS181 Shows Promise in COVID-19 Patients with Respiratory Challenges
Recently, the Wall Street Journal introduced a small, 25-person San Diego-based biotech called Ansun Biophrma (Ansun) reporting on recent success of a drug that cleared COVID-19 symptoms in a small study involving four Chinese patients. With a strong background in...
‘Unprecedented Times call for Bold Moves’ as Competitive Plasma Firms Unite to Battle COVID-19
CSL Behring and Takeda Pharmaceutical Company have initiated an alliance bringing together the world’s leading plasma companies to focus on developing and delivering hyperimmune immunoglobulin to help fight the global war on COVID-19. Led by Australian and American...
Acceleration of First-Patient-First-Visit Study Milestone as Roche Study Investigating Tocilizumab in COVID-19 Pneumonia Patients Enrolls Patients in Spain
Roche recently announce the launch of a global study in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) plus standard of care in hospitalized adult...
Regeneron Leverages its Technology Platform, Process and People in the Hopes of Having A COVID-19 Therapy in Trials by Summer
Regeneron and its “VELOCISUITE®” platform was used to develop a treatment for Ebola (REGN-EB3), currently used by the Congolese government to fight that horrific virus. The New York State-based venture has, like many biopharma companies, dedicated a full force...
University of Laval Partner Medicago In Hot Pursuit COVID-19 Vaccine Candidate in Canada
Quebec-City-based Medicago, a subsidiary to Japan-based Mitsubishi Tanabe Pharma, reports a breakthrough in the fight against the coronavirus outbreak, making a claim that it has developed a COVID-19 vaccine candidate that could begin human testing as early as this...
Santen and TRACON Discontinue Development of DE-122 for Wet Age-Related Macular Degeneration
Santen and TRACON Pharmaceuticals announced the companies will discontinue the development of DE-122 for the treatment of wet age-related macular degeneration (wAMD) following the review of top-line data from the Phase 2a AVANTE clinical study. The study did not reach...
FDA Places Partial Clinical Hold on Unum Therapeutics Phase I Trial for non-Hodgkin Lymphoma Due to Safety Concern
In a filing with the U.S. Securities and Exchange Commission, Unum Therapeutics disclosed a verbal notification was received from the U.S. Food & Drug Administration (FDA) that it had placed a partial clinical hold on the Phase 1 trial (ATTCK-20-03) of Unum’s...
Opdivo Plus Yervoy Combination Granted Accelerated Approval by FDA for Hepatocellular Carcinoma
Bristol-Myers Squibb announced the U.S. FDA has granted accelerated approval to Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with...
FDA Approves Allergan’s Durysta Implant to Treat Glaucoma
Allergan announced the U.S. FDA has approved Durysta (bimatoprost implant) 10 mcg for intracameral administration. Durysta is the first intracameral, biodegradable sustained-release implant indicated to reduce intraocular pressure (IOP) in patients with open-angle...
Recordati and Novartis Announce FDA Approval of Isturisa for Cushing’s Disease
Recordati announced the U.S. FDA has approved Isturisa (osilodrostat) for the treatment of adults with Cushing’s disease for whom pituitary surgery is not an option or has not been curative. Recordati expects Istursia to...
Janssen Announces U.S. FDA Has Granted Breakthrough Therapy Designation to JNJ-6372 for Metastatic Non-Small Cell Lung Cancer
Janssen announced the U.S. Food and Drug Administration (FDA) granted JNJ-6372 Breakthrough Therapy Designation for metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations where the disease has progressed...
The World’s First NASH Drug Approved in India: Zydus Cadila’s Saroglitazar
A drug maker in India, Zydus Cadila, has become the first pharma company worldwide to secure a regulatory agency greenlight for a non-alcoholic steatohepatitis (NASH) therapy (Saroglitazar) as the Drug Controller General of India (DCGI) approved the drug. TrialSite...
EpicentRx Receives FDA Clearance of IND for Adenovirus Program AIM-001
EpicentRx announced that the U.S. FDA has cleared the investigational new drug (IND) application for AIM-001, an oncolytic adenovirus that is enhanced with a TGF-β (beta) trap transgene. EpicentRx plans to begin clinical trials with AIM-001 this year. Cancer cells...
Genentech’s Esbriet Granted Breakthrough Therapy Designation for Unclassifiable Interstitial Lung Disease
Genentech announced that the U.S. FDA has granted Breakthrough Therapy Designation to Esbriet (pirfenidone) for adults with unclassifiable interstitial lung disease (uILD). The designation is based on results from a Phase II trial, which suggested Esbriet slowed...