Archive


Category: BeyondSpring

  • BeyondSpring faces a tough winter as FDA rejects its lead drug

    BeyondSpring’s hopes of an early Christmas gift from the FDA were dashed today after the regulator said it was unable to approve the company’s lead drug plinabulin as a treatment for low white blood cell counts caused by cancer chemotherapy. In a complete response letter (CRL), the FDA said that it would need a second […]

  • PharmaShots’ Key Highlights of Third Quarter 2021

    The third quarter of 2021 highlights the approvals, clinical data & acquisitions. The new alliance observed in third quarter includes AzurRx signed a reverse triangular merger agreement to acquired First Wave Bio for ~$229M The key highlights of the big acquisition in this quarter includes Merck acquired Acceleron for ~$11.5B, Baxter acquired Hillrom for ~$10.5B, […]

  • PharmaShots Weekly Snapshots (August 23 – 27, 2021)

    Ascendis’ Skytrofa (lonapegsomatropin-tcgd) Receives the US FDA’s Approval for Pediatric Growth Hormone Deficiency Published: Aug 27, 2021 | Tags: Ascendis, Skytrofa, lonapegsomatropin-tcgd, US, FDA, Approval, Pediatric Growth Hormone Deficiency Amgen Presents Results of Repatha (evolocumab) in P-III HUYGENS Study for the Treatment of Acute Coronary Syndrome at ESC 2021 Published: Aug 27, 2021 | Tags: […]

  • PharmaShots Weekly Snapshots (Aug 02 – 06, 2021)

    Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to Develop Allogeneic Cell Therapies for the Treatment of Cancer Published: Aug 6, 2021 | Tags: Kite, Appia, Allogeneic Cell Therapies, Cancer Polpharma & Bioeq Report BLA Submission to the US […]

  • ViewPoints Interview: BeyondSpring’s Dr. Ramon Mohanlal Shares Insights on the Data of Triple Combo Plinabulin Presented at ASCO 2021

    In an interview with PharmaShots, Ramon Mohanlal, M.D., Ph.D., MBA, Chief Medical Officer and Executive Vice President of Research and Development at BeyondSpring share his views on the data of triple combination regimen presented at ASCO and also shed light on the impact of plinabulin on SCLC. Shots: Plinabulin in combination with nivolumab and ipilimumab […]

  • 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 […]

  • PharmaShots Weekly Snapshots (Mar 29 – Apr 02, 2021)

    Pfizer and BioNTech Report Results of BNT162b2 to Prevent COVID-19 Published: Apr 2, 2021 | Tags: Pfizer and BioNTech, Report, Results, BNT162b2, Prevent, COVID-19 Acceleron Presents Results of Sotatercept in P-II PULSAR Trial for the Treatment of Pulmonary Arterial Hypertension, Published in NEJM Published: Apr 2, 2021 | Tags: Acceleron, Presents, Results, Sotatercept, P-II PULSAR […]

  • 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 […]