PharmaShots

Insights+ Exclusive: The US FDA New Drug Approvals in December 2019 and January 2020

February 21, 2020February 21, 2020Shiwani Sharma

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products [Read More...]

Astellas and Seattle Genetics’ Padcev (enfortumab vedotin-ejfv) + Keytruda Receive FDA’s Breakthrough Therapy Designation as 1L Treatment for Advanced Bladder Cancer

February 20, 2020February 20, 2020Tuba Khan

Shots: The BT designation is based on P-Ib/II EV-103 study assessing Padcev + Keytruda (pembrolizumab) in patients with LA/ mUC who are unable [Read More...]

PharmaShots Weekly Snapshot (February 10-14, 2020)

February 17, 2020February 25, 2020Tuba Khan

1. Epizyme Reports the US FDA Acceptance of NDA for Tazverik (tazemetostat) to Treat Follicular Lymphoma Published: Feb 14, 2020 | Tags: Epizyme, Reports, [Read More...]

Astellas and Pfizer Report Results of Xtandi (enzalutamide) in P-III PROSPER Study for Non-Metastatic Castration-Resistant Prostate Cancer

February 12, 2020February 12, 2020Tuba Khan

Shots: The P-III PROSPER study involves assessing of Xtandi (160mg, QD) + ADT vs PBO + ADT in 1400 patients with nmCRPC across [Read More...]

PharmaShots Weekly Snapshot (January 27-31, 2020)

February 3, 2020February 10, 2020Tuba Khan

ProQR’s QR-421a Receives FDA’s Rare Pediatric Disease Designation for Retinitis Pigmentosa Published: Jan 30, 2020 | Tags: ProQR, QR-421a, Receives, FDA, Rare Pediatric Disease [Read More...]

Astellas Reports Submission of sNDA to MHLW for Evrenzo (roxadustat) to Treat Anemia Associated with Chronic Kidney Disease in Non-Dialysis Dependent Patients in Japan

January 30, 2020January 30, 2020Tuba Khan

Shots: The sNDA is based on three studies in 500+ patients with NDD-CKD. The first P-III study involve assessing Evrenzo vs darbepoetin alfa [Read More...]

Astellas to Establish a New Manufacturing Facility for API of Prograf in Toyama Technology Center

January 20, 2020January 20, 2020Tuba Khan

Shots: Astellas will construct the Third Fermentation Building as the manufacturing facility for API of Prograf (tacrolimus hydrate) in the Toyama Technology Center [Read More...]

PharmaShots Weekly Snapshot (January 13-17, 2020)

January 20, 2020January 27, 2020Tuba Khan

1. Arena’s APD418 Receives FDA’s Fast Track Designation to Treat Patients with Decompensated Heart Failure Published: Jan 17, 2020 | Tags: Arena, APD418, Receives, [Read More...]

Astellas’ Xospata (gilteritinib) Receives Health Canada Approval for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

January 15, 2020January 15, 2020Tuba Khan

Shots: The approval is based on P-III ADMIRAL study assessing Xospata (120mg) vs salvage CT in 371 patients in a ratio (2:1) with [Read More...]

Astellas and Adaptimmune Signs Co-Exclusive Agreement for Universal Donor Cell Platform and Stem-Cell Derived Allogeneic CAR-T and TCR T-Cell Therapies

January 14, 2020February 13, 2020Tuba Khan

Shots: Adaptimmune to receive $50M up front, ~73.75M development milestones/ target (if product co-developed & co-commercialized by both companies) and $147.5M as milestones/product [Read More...]

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