First

AstraZeneca and MSD’s Selumetinib Receive EU’s CHMP Positive Opinion as the First Therapy for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas

Shots: EMA’s CHMP has recommended conditional marketing authorization of Selumetinib in the EU. The recommendation is based on the results from the P-I/II SPRINT Stratum 1 trial evaluating selumetinib as a monothx (PO, bid) in pediatric patients aged ≥3yrs. with NF1 and symptomatic, inoperable PNs The trial showed 66% ORR which is defined as the …

AstraZeneca and MSD’s Selumetinib Receive EU’s CHMP Positive Opinion as the First Therapy for Pediatric Patients with Neurofibromatosis Type 1 Plexiform Neurofibromas Read More »

Daiichi Sankyo Reports First patient Dosing in P- I/II Trial of DS-1594 to Treat Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia

Shots: MD Anderson will sponsor and lead P-I/II study to assess DS-1594 as monothx. and in combination regimens for patients with r/r AML and ALL The 1EPs of the P-I part of the study is to determine the maximum tolerated dose and RP2D of DS-1594 in ~54 patients with AML or ALL regardless of mutation …

Daiichi Sankyo Reports First patient Dosing in P- I/II Trial of DS-1594 to Treat Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia Read More »

uniQure Reports Completion of Enrollment in First Cohort of P- I/II Trial for AMT-130 to Treat Huntington’s Disease

Shots: The company has completed the enrollment in the first cohort of P- I/II trial involves assessing AMT-130 in 10 patients, out of which six patients received treatment with AMT-130 and four patients received imitation surgery for early manifest HD The company plans to initiate a second clinical study of AMT-130 in the EU in …

uniQure Reports Completion of Enrollment in First Cohort of P- I/II Trial for AMT-130 to Treat Huntington’s Disease Read More »

Janssen and SpringWorks Reports Dosing of First Patient in P-Ib trial for Nirogacestat + Teclistamab to Treat Relapsed or Refractory Multiple Myeloma

Shots: The first patient has been dosed in P-Ib trial evaluating SpringWorks’ Nirogacestat (GSI) + Janssen’s Teclistamab (Ab targeting BCMA and CD3) in patients with r/r MM. Janssen assumes all costs of study & other expenses related to the supply of nirogacestat In preclinical models, Nirogacestat increased the cell surface density of BCMA, reduced the …

Janssen and SpringWorks Reports Dosing of First Patient in P-Ib trial for Nirogacestat + Teclistamab to Treat Relapsed or Refractory Multiple Myeloma Read More »

G1 Therapeutics and Boehringer Ingelheim Launch Cosela (trilaciclib) in the US

Shots: On Feb 12, 2021, the US FDA has approved Cosela to decrease the incidence of CT induced myelosuppression in adult patients when administered before a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC The launch is supported by the “One Patient Support Program” which is designed to provide access and affordability solutions to eligible patients …

G1 Therapeutics and Boehringer Ingelheim Launch Cosela (trilaciclib) in the US Read More »

Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies

Shots: Ensoma to receive $100M in up front & preclinical research payment, $10M in equity investment, and is eligible to receive $1.25B as development and commercialization milestones along with royalties on sales of each product Takeda to get an exclusive WW rights Ensoma’s Engenious vectors for up to five rare disease indications. Ensoma to conduct …

Takeda Collaborates with Ensoma to Accelerate Next-Generation In Vivo Gene Therapies Read More »

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD

Shots: The first patient has been dosed in P-III CIFFREO study assessing PF-06939926 vs PBO in 99 ambulatory male patients aged 4-7yrs. with DMD across 55 sites in 15 countries. The first patient was dosed at a site in Barcelona, Spain on Dec 29, 2020. The 1EPs of the study is the change in NSAA …

Pfizer Reports the First Patients Dosing of PF-06939926 in P-III CIFFREO Study for DMD Read More »

Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US

Shots: Following the US FDA’s approval granted in early 2020, the first Carpediem (Cardio-Renal Pediatric Dialysis Emergency Machine) were installed & use at Cincinnati Children’s HMC in the US Carpediem system is indicated for acute kidney injury or fluid overloaded patients requiring hemodialysis or hemofiltration therapy The system is intended to provide CRRT to patients …

Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US Read More »

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Shots: Amgen, UCB, and Takeda reported that the first patient has been enrolled in the COMMUNITY trial. The study will test whether Amgen’s Otezla, Takeda’s lanadelumab, and UCB’s zilucoplan can reduce the severity of COVID-19 in hospitalized patients by moderating the immune system’s response to the disease The focus of the trial is to identify …

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study Read More »

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Shots: Egle has achieved the first milestone in its research agreement with Takeda, signed in June’2020. Egle will validate novel tumor-infiltrating regulatory T-cell targets while Takeda will develop the potential therapies Egle has leveraged its unique bioinformatic & translational capabilities to identify targets Following the achievement of the target identification, Egle will receive an R&D …

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda Read More »

Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home

Shots: The Lucira’s COVID-19 all-in-one test kit test has been authorized for home use with self-collected nasal swab samples in individuals aged≥ 14yrs. who are suspected of COVID-19 by their HCPs It is also authorized for use in POC settings for all ages, but samples must be collected by an HCP when the test is …

Lucira’s All-In-One Test Kit Receives the US FDA’s EUA as the First COVID-19 Test for Self-Testing at Home Read More »

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Shots: The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3 FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with …

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan Read More »

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Shots: The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the …

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola Read More »

ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy

Shots: The first healthy volunteer has been dosed in a P-I study of GRAd-COV2 against COVID-19 which is conducted by the Lazzaro Spallanzani National Institute for Infectious Diseases under the sponsorship of ReiThera The P-I study will evaluate the safety & immunogenicity of GRAd-COV2 in 90 healthy volunteers divided equally into two age cohorts: 18-55yrs. …

ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy Read More »

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis

Shots: The approval is based on P-III ASCLEPIOS I & II studies assessing Kesimpta (20mg, monthly, SC) vs teriflunomide (14mg, qd) in 1,882 patients aged 18-55yrs. with RMS with an EDSS b/w 0 and 5.5 across 37 countries. Additionally, P-II APLIOS study determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and …

Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis Read More »

Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

Shots: On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC’s approval under the brand name Zercepac Henlius followed the NMPA and EMA’s biosimilar guidelines and has taken multiple head-to-head comparisons b/w HLX02 and the reference, …

Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China Read More »

The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Shots: The FDA has approved Guardant360 CDx as a liquid biopsy companion diagnostic that uses NGS to identify EGFR mutations in patients with metastatic NSCLC The assay utilizes two technologies- i) liquid biopsy that uses a blood sample to provide HCPs with genetic information about the patient’s tumor and ii) NGS that uses large-panel genetic …

The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer Read More »

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL

Shots: The accelerated approval follows FDA’s PR and BT designation and is based on ZUMA-2 study assessing Tecartus (formerly KTE-X19) in 74 patients with r/r MCL prior treated with  anthracycline/ bendamustine-containing CT, an anti-CD20 Ab therapy and a BTK inhibitor (ibrutinib or acalabrutinib) Results: 87% patients responded to Tecartus (single infusion), including 62 % patients …

Kite’s Tecartus (brexucabtagene autoleucel) Receives the US FDA’s Approval as the First Cell-Based Gene Therapy for Relapsed or Refractory MCL Read More »

Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19

Shots: The US FDA has authorized Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to 4 individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples Quest Diagnostic expects to deploy the technique at its laboratories in Chantilly, VA …

Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19 Read More »

Clover Reports First Patient Dosing in P-III Trial with SCB-808 (biosimilar, etanercept) in China

Shots: The P-III study involves assessing of SCB-808 (SC) vs Enbrel (SC) in patients with ankylosing spondylitis (radiographic axial spondyloarthritis) to evaluate its safety, efficacy and PK The company utilizes its Trimer-Tag technology platform to develop novel therapies targeting trimerization-dependent pathways and is also leveraging its cGMP biomanufacturing capabilities to develop biosimilars SCB-808 is mAb …

Clover Reports First Patient Dosing in P-III Trial with SCB-808 (biosimilar, etanercept) in China Read More »