2020 Treatment Trials 
Eye on FDA
JANUARY 6, 2021
During 2020, FDA was able to approve 53 – not surpassing the 2018 all time record of 59, but certainly an admirable second place. Notably, the 2020 NME approvals included 22 related to oncology, with 2 new GIST treatments, 3 in breast cancer and 2 approvals in prostate cancer. That, however, was not really the case.
Drug Target Review
JULY 4, 2023
These therapies have broadened treatment options for patients to expand beyond the more traditional small molecule drug alternatives. ADCs have the potential to redress the poor balance between safety and efficacy seen with traditional cancer treatment options. 3D rendering of Antibody Drug Conjugate Molecules.
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Drug Target Review
OCTOBER 5, 2023
This innovative approach involves the extraction of a patient’s own stem cells from either their bone marrow or blood , followed by a course of chemotherapy and antibody treatment. This study sought to shed light on the safety and effectiveness of aHSCT in routine healthcare settings, moving beyond the confines of clinical trials.
The Pharma Data
OCTOBER 12, 2021
Trial met primary endpoint. The trial met the primary endpoint, with a cure of 600 mg of AZD7442 given by intramuscular (IM) injection reducing the threat of developing severe COVID-19 or death (from any cause) by 50 compared to placebo in rehabilitants who had been characteristic for seven days or lower.
FDA Law Blog: Drug Discovery
DECEMBER 7, 2022
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
The Pharma Data
JANUARY 17, 2021
The treatment could be administered in primary care centers to people who test positive for COVID-19, avoiding hospitalization due to the progression of the disease and complementing the vaccine in the early phase after vaccination. In October 2020 , Grifols, together with other companies and various U.S.
The Pharma Data
APRIL 17, 2021
Biogen’s expansion in China now includes treatment options approved for relapsing MS and spinal muscular atrophy. today announced that China’s National Medical Products Administration (NMPA) has approved TECFIDERA ® (dimethyl fumarate) for the treatment of relapsing multiple sclerosis (MS).
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