Despite having the global Covid-19 pandemic, the biopharma companies were involved in multiple M&A and licensing deals. The major focus of the year remains the production and distribution of vaccines to combat the COVID-19 globally All of the Biopharma companies on our list are on the front line to combat this global crisis. The top […]Read More
Pfizer and BioNTech Initiate COVID-19 Vaccine Trial in Children Under 12 Published: Mar 26, 2021 | Tags: Pfizer and BioNTech, Initiate, COVID-19 Vaccine Trial, Children, Under 12 Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases Published: Mar 26, 2021 | Tags: Tetra Bio-Pharma, Initiates, Additional Studies, ARDS-003, Neuroinflammation, Antiviral Diseases Immunai […]Read More
Shots: The P-IIIa STEP 4 trial involves assessing the safety and efficacy of Semaglutide (2.4 mg, SC, qw) vs PBO in adults with obesity for 68wks. The participants who reached the maintenance dose of semaglutide, during a 20wks. run-in period were randomized to either continue treatment with the therapy or switch to PBO for 48wks. […]Read More
Shots: The US FDA has issued refusal to file a letter covering the label expansion application for semaglutide (2.0mg/qw) for T2D, which was submitted on Jan 20, 2021 The US FDA has requested additional information including data relating to new manufacturing site Novo Nordisk plans to resubmit the application to FDA in Q2’21 Click here to […]Read More
Shots: The companies plan to initiate a P-IIb study assessing NovoNordisk’s semaglutide and FD combination of Gilead’s cilofexor + firsocostat vs PBO in ~440 patients with compensated cirrhosis (F4) due to NASH The trial will evaluate the therapeutic effect on liver fibrosis improvement and NASH resolution and expected to initiate recruitment in H2’21 The new […]Read More
Reistone Report Results for SHR0302 in P-II Study to Treat Ulcerative Colitis Published: Feb 5, 2020 | Tags: Reiston, Report, Result, SHR0302, P-II, Study, Treat, Ulcerative Colitis Enzene Receives Marketing Authorization for Teriparatide (biosimilar) in India Published: Feb 5, 2020 | Tags: Enzene, Receives, Marketing Authorization, Teriparatide (biosimilar), India Johnson & Johnson Reports EUA Submission […]Read More
Shots: The EMA’s CHMP accepted a positive opinion for the use of Sogroya (somapacitan), once-weekly recommending its approval for the treatment of adults with growth hormone deficiency (AGHD) The CHMP recommendation is based on P-III REAL 1 trial in 301 naïve adults and ongoing P-III REAL 4 trial investigating the efficacy and safety of somapacitan […]Read More
Shots: The approval is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification Result: 2.0 mg dose achieved significant and superior reduction in HbA1c, both doses are safe and well-tolerated profiles Ozempic is a glucagon-like peptide-1 (GLP-1) analogue and is currently approved […]Read More
Biopharma merger and acquisition activity in 2020 was mainly filled with late-stage, bolt-on acquisitions, which were orders of magnitude smaller than the mega M&A deals of prior years. AstraZeneca holds the top rank by acquiring Alexion Pharmaceuticals among the top 20 acquisitions with a total deal value of $39B at a 1-day premium of 45% […]Read More
Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, […]Read More
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