Tags : Prevent

Clinical Trials COVID-19

Regeneron Reports Results of REGEN-COV Antibody Cocktail Used as Passive

Shots: The ongoing P-III trial involves assessing REGEN-COV (casirivimab & imdevimab) in 2000+ participants used as a passive vaccine to prevent COVID-19. An exploratory analysis, conducted on the first ~400 individuals, randomized to receive passive vaccination with REGEN-COV (1200mg, SC) vs PBO Reduction in overall infections seen within 1st week with 100% prevention of symptomatic […]Read More

Biotech Regulatory

Sanofi’s Supemtek Receives CHMP’s Positive Opinion for Approval to Prevent

Shots: The CHMP’s recommendation is based on two P-III studies demonstrating the safety and efficacy of Supemtek (quadrivalent recombinant influenza vaccine) in 10,000+ patients aged ≥18yrs. The company expects EC’s decision in Q4’20 Supemtek is the first and only influenza vaccine to rely on recombinant manufacturing technology and is available in the US since 2017 […]Read More

Regulatory

Cipla Receives FDA’s ANDA Approval for its HFA Inhalation Aerosol

Shots: Cipla’s Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation is first device-based metered dose inhaler receives approval in the US which will further strengthen Cipla’s footprints in the US The first AB-rated generic version of Merck’s Proventil HFA Inhalation Aerosol is targeted to treat acute episodes of bronchospasm or prevention of asthmatic symptoms In end of […]Read More

COVID-19 Pharma

Sorrento Develops STI-4398 (COVIDTRAP Protein) to Prevent and Treat COVID-19

Shots: The company has created a preclinical batch of the STI-4398 (COVIDTRAP) protein to begin testing its neutralization and blocking activity in preventing the SARS-CoV-2 virus from infecting ACE2-expressing cells The in vitro cell studies for SARS-CoVID-2 virus infection and neutralization are anticipated to be conducted in the next few wks. in collaboration with world-leading […]Read More

Biotech Regulatory

Lundbeck’s Vyepti (eptinezumab-jjmr) Receives the US FDA’s Approval to Prevent

Shots: The approval is based on two P-IIItrials PROMISE-1 in episodic migraine and PROMISE-2 in chronic migraine  involves assessing of Vyepti (100mg or 300mg) vsPBO in 2076 patients with migraine PROMISE 1 study results: mean migraine frequency ~8.6 migraine days/month, mean change in MMD in 1-3mos. @100mg or 300mg  (-3.9 days, -4.3 days vs -3.2 […]Read More