Shots: The FDA has approved Imfinzi for an additional dosing option (1500mg, FD, q4w) in the approved indications of unresectable stage III NSCLC after CRT and prior treated advanced bladder cancer The approval is based on multiple studies, including the P-III PACIFIC study which supported the 2wks., wt. based dosing in unresectable stage III NSCLC, […]Read More
Shots: EMA accepted the review of MAA for SB11 in Oct 2020. If approved, SB11 will add to the biosimilars portfolio developed by Samsung Bioepis and commercialized by Biogen, including three widely prescribed anti-TNF biosimilars in EU: BENEPALI, IMRALDI, and FLIXABI In Nov 2019, Samsung Bioepis entered into a new commercialization agreement with Biogen for […]Read More
Shots: Deep Genomics will receive an undisclosed upfront payment and is eligible to receive development milestones, BioMarin will receive an exclusive option to obtain Deep Genomics’ rights to each program for development & commercialization Deep Genomics will use its AI drug discovery platform (The AI workbench) to identify & validate target mechanisms, lead candidates & […]Read More
Shots: Pfizer launched a pilot program to support the state’s planning, deployment & administration of the COVID-19 vaccine candidate, to build on coordination with the relevant US agencies Pfizer has been working with US officials in OWS & the US CDC to help ensure that after potential authorization or approval, the Pfizer-bioNtech COVID-19 vaccine can […]Read More
Shots: The US FDA accepted for priority review the BLA of avalglucosidase alfa for long-term enzyme replacement therapy for the treatment of patients with Pompe disease. The target action date for the FDA decision is May 18, 2021 The BLA is based on positive data from two trials: P-III COMET study and P-II mini-COMET study […]Read More
Shots: This BT designation is based on P-IIb/III HPTN 083 study assessing cabotegravir (q8w) vs. FTC/TDF tablets (qd PO, 200/300 mg) in a study population of 4,566 for HIV prevention. The data were presented at the 23rd International AIDS Conference (AIDS 2020) Results: HPTN 083 study showed that cabotegravir was 66% more effective at preventing […]Read More
Shots: The P-III FIDELIO-DKD study in CKD and T2D enrolled over 13,000 patients with early kidney damage and more advanced stages of kidney disease. The data were presented at the ASN Kidney Week 2020 and published in the NEJM based on which Bayer submitted finerenone for marketing authorization in the US and the EU Results: […]Read More
Healthy animals contribute to the elimination of hunger and sustainable food production. The diseases that affect animal health also affect humans. Tackling them while they are present in animals not only safeguards our health, but it is also easier, more effective, and less expensive to address. Monitoring animal health and preventing animal disease outbreaks is […]Read More
Shots: Pfizer will continue to provide sales and marketing support and health system support for Cologuard through the end of 2022 and 2021, respectively. Exact Sciences will compensate Pfizer based on the amount of services provided, along with additional fixed and performance-related fees set forth in the agreement Cologuard was approved by US FDA in […]Read More
Shots: GSK will make equity investment to gain access to Vir’s technology of $250M, priced at $37.73 (a 10% premium to closing share price on March 27, 2020). The equity investment and collaboration will complete at the same time & are conditional upon customary conditions including regulatory review by appropriate regulatory agencies under Hart-Scott-Rodino Act […]Read More
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