Regeneron and Sanofi’s Libtayo (cemiplimab) Receive the EC’s Approval as 1L Treatment for Advanced Basal Cell Carcinoma Published: June 25, 2021 | Tags: Regeneron, Sanofi, Libtayo, cemiplimab, EC, Approval, Advanced Basal Cell Carcinoma Regeneron and Sanofi’s Libtayo (cemiplimab) Receive the EC’s Approval as 1L Treatment for Advanced NSCLC Published: June 25, 2021 | Tags: Regeneron, […]Read More
In an interview with PharmaShots, Dr. Kimberly Smith, Head of Global Research and Medical Strategy at ViiV Healthcare shares insights on the clinical data of GSK3640254 (GSK’254) at CROI 2021. She also highlights the key points of P-IIIb ATLAS-2M study that provide further evidence for both the once-monthly and every 2-months dosing regimens of long-acting […]Read More
In an interview with PharmaShots, Max Lataillade, Vice President, Head of Global Research Strategy, ViiV Healthcare shared his views on the development of Rukobia and the story of its development. He also shed light on what this approval means to the patients. Shots: MA for Rukobia marks a critical breakthrough for this select group of […]Read More
PhaseBio Signs a Supply Agreement with BioVectra to Support the Development and Commercialization of Bentracimab Published: Mar 12, 2021 | Tags: PhaseBio, Signs, Supply, Agreement, BioVectra, Support, Development, Commercialization, Bentracimab Takeda Reports NDA Submission of Lanadelumab to the MHLW as a Preventive Treatment for Hereditary Angioedema Attack in Japan Published: Mar 12, 2021 | Tags: […]Read More
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of 2012 The Breakthrough Designation is granted to the drug candidates as monotherapy or in combination with other drugs intended to treat serious or life-threatening diseases and has shown substantial improvement over available […]Read More
Shots: The P-IIa POC study involves assessing GSK3640254 (GSK’254, qd) in 34 treatment-naïve adults with HIV. The study is divided into 2 parts- in part 1, patients received GSK’254 (10/200mg) vs PBO for 10days and in part 2, patients got GSK’254 (40/80140 mg) vs PBO for 7days The study showed the antiviral activity b/w dose […]Read More
Shots: The P- IIIb ATLAS-2M study involves assessing long-acting cabotegravir and rilpivirine regimen for the treatment of HIV The ATLAS-2M 96wks. data reinforce the 1EPs @48wks. demonstrated the efficacy of every 2mos. dosing (q8w) was non-inferior to monthly dosing (q4w) dosing with (2.1% & 1.1%) participants having HIV-1 RNA ≥50 c/mL. The 2EPs @96 wks. […]Read More
In an interview with PharmaShots, Dr. Kimberly Smith, Head of Research & Development, ViiV Healthcare shed light on the FDA’s approval and the 3yrs. data of Dovato. Shots: Dovato (dolutegravir/lamivudine) is the first complete, once-daily, single-tablet, 2DR for the treatment of HIV-1 infection in both treatment-naïve and virologically suppressed adults In Aug 2020, the FDA […]Read More
Visby’s POC COVID-19 Test Receives the US FDA’s EUA for Use in CLIA Waived Settings Published: Feb 12, 2020 | Tags: Visby, POC, COVID-19, Test, Receives, US, FDA, EUA, Use, CLIA, Waived, Settings Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Published: Feb 12, 2020 | Tags: Takeda, Collaborates, Ensoma, Accelerate, Next-Generation, Vivo Gene […]Read More
Shots: The MAA is based on P-III BRIGHTE study assessing Rukobia (600mg, bid) + OBT vs PBO in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort In the randomized cohort, 60% achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count @96wks., HIV-1 […]Read More
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