Tags : ViiV Healthcare

Weekly Snapshot

PharmaShots Weekly Snapshots (June 21 – 25, 2021)

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

Weekly Snapshot

PharmaShots Weekly Snapshots (Mar 08 – 12, 2021)

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

Insights+

Insights+: Breakthrough Therapy Designation by the US FDA in 2020

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

Viewpoints

ViewPoints Interview: ViiV Healthcare’s Dr. Kimberly Smith Shares Insight on

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

Weekly Snapshot

PharmaShots Weekly Snapshots (Feb 08 – 12, 2021)

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

Regulatory

ViiV Healthcare’s Rukobia (fostemsavir) Receives Marketing Authorization for the Treatment

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