July, 2019 | PharmaShots

Pfizer Signs a License Agreement with Regenxbio for its NAV AAV9 Vector to Treat Friedreich’s Ataxia

July 31, 2019July 31, 2019Tuba Khan

Shots: Regenxbio to receive up front, development and commercial milestone and royalties on sales of products. Pfizer to get non-exclusive WW license with [Read More...]

Merck’s Keytruda (pembrolizumab) Receives FDA’s Approval as a Monotherapy for 1L+ Recurrent Locally Advanced or Metastatic Esophageal Cancer Expressing PD-L1 (CPS ≥10)

July 31, 2019July 31, 2019Tuba Khan

Shots: The approval is based on two studies, KEYNOTE-181 study results involve assessing of Keytruda (200mg, q3w) vs CT (paclitaxel/docetaxel) in 628 patients [Read More...]

Bayer’s Vitrakvi (larotrectinib) Receives Health Canada Approval for Advanced Solid Tumors Harboring NTRK Gene Fusion

July 31, 2019October 3, 2019Tuba Khan

Shots: Vitrakvi has received approval under Health Canada’s NOC/c policy based on the clinical study evaluating Vitrakvi in adults and children with solid [Read More...]

Gates Foundation Grants $13M to Lyndra Therapeutics for the Development of Once-Monthly Oral Contraceptive

July 31, 2019July 31, 2019Tuba Khan

Shots: The Gate Foundation has granted $13M to fund development program addressing the lack of global family planning options. The development of once-monthly [Read More...]

Biogen and Alkermes Report Results of Diroximel Fumarate in P-III EVOLVE-MS-2 Study for Multiple Sclerosis

July 31, 2019July 31, 2019Tuba Khan

Shots: The P-III EVOLVE-MS-2 study assessing the GI tolerability of Diroximel Fumarate (462mg, bid) vs Tecfidera (dimethyl fumarate, 240 mg, bid) in 506 [Read More...]

Bayer’s Nubeqa (darolutamide) Receives the US FDA’s Approval for Non-Metastatic Castration-Resistant Prostate Cancer in Men

July 31, 2019October 3, 2019Tuba Khan

Shots: The approval is based on P-III ARAMIS study results assessing Nubeqa (600mg, bid) + ADT vs PBO + ADT in 1,509 in [Read More...]

Merck’s Receives EU’s CHMP Positive Opinion for its Zerbaxa (ceftolozane and tazobactam) and Keytruda (pembrolizumab) + Inlyta (axitinib) Regimen

Merck Receives EU’s CHMP Positive Opinion for its Zerbaxa (ceftolozane and tazobactam) and Keytruda (pembrolizumab) + Inlyta (axitinib) Regimen

July 30, 2019July 30, 2019Tuba Khan

Shots: The positive CHMP opinion of Zerbaxa (3gm) is based on P-III ASPECT-NP study assessing Zerbaxa in patients with hospital-acquired pneumonia including ventilator-associated [Read More...]

Month
July 2019

Pfizer Signs a License Agreement with Regenxbio for its NAV AAV9 Vector to Treat Friedreich’s Ataxia

Merck’s Keytruda (pembrolizumab) Receives FDA’s Approval as a Monotherapy for 1L+ Recurrent Locally Advanced or Metastatic Esophageal Cancer Expressing PD-L1 (CPS ≥10)

Bayer’s Vitrakvi (larotrectinib) Receives Health Canada Approval for Advanced Solid Tumors Harboring NTRK Gene Fusion

Gates Foundation Grants $13M to Lyndra Therapeutics for the Development of Once-Monthly Oral Contraceptive

Biogen and Alkermes Report Results of Diroximel Fumarate in P-III EVOLVE-MS-2 Study for Multiple Sclerosis

Bayer’s Nubeqa (darolutamide) Receives the US FDA’s Approval for Non-Metastatic Castration-Resistant Prostate Cancer in Men

Merck Receives EU’s CHMP Positive Opinion for its Zerbaxa (ceftolozane and tazobactam) and Keytruda (pembrolizumab) + Inlyta (axitinib) Regimen

Novartis’ Lucentis Receive EU’s CHMP Positive Opinion for Retinopathy of Prematurity in Preterm Infants

Eli Lilly Reports Results of Verzenio (abemaciclib) in P-III MONARCH 2 for HR+ and HER2- Advanced Breast Cancer

Exact Sciences to Merge with Genomic Health Forming a New Cancer Diagnostics Company