Tags : Gilead

Insights+

Insights+: The US FDA New Drug Approvals in June 2021

The US FDA has approved 6 NDAs and 2 BLAs in 2021, leading to treatments for patients and advances in the health care industry The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 37 novel products in 2021 Additionally, last year in 2020, the US FDA […]Read More

Insights+

PharmaShots’ Key Highlights of Second Quarter 2021

The second quarter of 2021 witnesses major acquisitions, approvals, and clinical data. There are major alliances in this quarter which include Merck signed ~$1.2B supply agreement with US Government for Molnupiravir to treat COVID-19 The big acquisition took place during the quarter including Microsoft acquired Nuance for ~$19.7B, MorphoSys acquired Constellation for ~$1.7B Our team […]Read More

Regulatory

Gilead Reports Submission of NDA to the US FDA for

Shots: The submission is based on P-II/III CAPELLA trial evaluating the safety & efficacy of lenacapavir (SC, every 6mos.) in combination with other antiretroviral agents vs PBO in 36 THE patients with multi-drug resistant HIV-1 infection The study demonstrated viral load reduction of ≥ 0.5 log10 copies/mL from baseline for 14days functional monothx. period (88% […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (June 14 – 18, 2021)

Lineage Signs an Exclusive Option Agreement with Amasa Therapeutics to Supply and Use of Clinical-Grade Hystem Published: June 18, 2021 | Tags: Lineage, Option Agreement, Amasa Therapeutics, Clinical-Grade Hystem BioNTech Reports First Patient Dosing in P-II Clinical Trial of BNT111 to Treat Advanced Melanoma Published: June 18, 2021 | Tags: BioNTech, P-II, Clinical Trial, BNT111, […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, Receive, EC, CHMP, Positive Opinion, MPM, AML Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan Published: Apr 23, 2021 | Tags: Gilead, Reports, NDA, Submission, […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshots (Apr 05 – 09, 2021)

Evotec and Exscientia Initiate Human Clinical Trials of their Novel Immuno-Oncology Drug Published: Apr 9, 2021 | Tags: Evotec and Exscientia, Initiate, Human Clinical Trials, Novel, Immuno-Oncology Drug PlantForm Signs Research and Development Agreement with Bio-Manguinhos/Fiocruz to Develop Biosimilar Pembrolizumab Published: Apr 9, 2021 | Tags: PlantForm, Signs, Research, Development Agreement, Bio-Manguinhos/Fiocruz, Develop, Biosimilar Pembrolizumab […]Read More