In an interview with PharmaShot, Dr. Sophia Randolph, Chief Medical Officer of ALX Oncology shared her views on the ALX Oncology’s collaboration with Zymework for evaluating the combination with ALX148 and zanidatamab for patients with advanced HER2-expressing breast cancer and other HER2-expressing solid tumors. Shots: Zymeworks will conduct a P-Ib study to assess the safety […]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 US FDA approved Vocabria (30mg, tablet formulation) in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation Additionally, changes to the Edurant (rilpivirine) tablet label were revised to reflect the oral lead-in recommendations for use […]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
Shots: The FDA has issued a EUA for Simoa Semi-Quantitative SARS-CoV-2 IgG Ab test and can be operated on Simoa HD-X Analyzer The test checks for Abs that are directed against the spike protein. The test delivers a numerical result demonstrating Ab concentration ranging from 0.21-250mg/mL. The clinical studies demonstrated that the test had a […]Read More
Shots: Thank you for your overwhelming affection and support throughout the year. This year we achieved a massive increase in subscribers PharmaShots mobile app is ready and we planned to launch our PharmaShots mobile app in January 2021 May this holiday season fills your life with happiness and wealth. Wish you a Merry Christmas and […]Read More
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
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