Shots: WHO has granted EUL to AZ’s vaccine for active immunization to prevent COVID-19 in individuals aged ≥18yrs., including those over 65yrs. EUL granted AZ and SII enabling global access to the vaccine The WHO’s SAGE recommended a dosing interval of 8-12wks. and also recommended the use of the vaccine in countries where new variants, […]Read More
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
Shots: The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has also granted Provention’s request for Priority Review and assigned anticipated PDUFA date as Jul 02, 2021 The company is actively working with the FDA to support their review while planning […]Read More
Shots: Pfizer & BioNTech received the US FDA’s EUA for BNT162b2 for patients aged ≥16yrs with COVID-19. The companies are gathering additional data & prepared to file a planned BLA with the US FDA anticipating full approval in 2021 The EUA is based on P-III pivotal study demonstrating 95% efficacy in participants without prior SARS-CoV-2 […]Read More
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
Shots: Eli Lilly initiates P-III BLAZE-2 study assessing LY-CoV555 to prevent SARS-CoV-2 infection and COVID-19 in residents and staff at long-term care facilities in the US (skilled nursing facilities, commonly referred to as nursing homes, and assisted living facilities) The company will enroll up to ~2400 patients and test whether a single dose of LY-CoV555 […]Read More
Shots: The US FDA has approved an expanded indication for Gardasil 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58 The FDA has approved the therapy under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. The continued approval […]Read More
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
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
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
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