PharmaShots | Incisive News in 3 Shots

Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine
Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC
Regeneron Collaborates with BioNTech to Advance the Combination of FixVac and Libtayo (cemiplimab) in Melanoma
Immunic Reports Results of IMU-838 in P-II EMPhASIS Study in Patients with Relapsing-Remitting Multiple Sclerosis
MorphoSys’ Monjuvi (tafasitamab-cxix) + Lenalidomide Receives the US FDA’s Approval as 2L Treatment for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

PharmaShots Celebrates Successful Accomplishment of Two Years

Insights+

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

July 31, 2020July 31, 2020Shiwani Sharma

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 [Read More...]

PharmaShots Celebrates Successful Accomplishment of Two Years

July 28, 2020July 28, 2020

Insights+ Exclusive: The US FDA New Drug Approvals in June 2020

July 24, 2020July 24, 2020

Insights+ Interview: Paige’s CEO, Leo Grady Shares Insights on its Series B Funding and the FDA’s 510(k) Clearance for FullFocus Viewer

July 22, 2020July 22, 2020

Top 20 Prescription Drugs Based on 2019 Revenue

July 17, 2020July 17, 2020

Biosimilars

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

July 30, 2020July 30, 2020Shiwani Sharma

Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of [Read More...]

Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

July 27, 2020July 27, 2020

NCCN Collaborates with Pfizer to Explore Adoption of Biosimilars in Oncology

July 16, 2020July 16, 2020

Mylan and Fujifilm Kyowa Kirin Receive the US FDA’s Approval for its Hulio (biosimilar, adalimumab)

July 9, 2020July 9, 2020

Insights+ Key Biosimilars Events of April 2020

Insights+ Key Biosimilars Events of June 2020

July 3, 2020July 3, 2020

Pharma

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

August 3, 2020August 3, 2020Tuba Khan

Shots: The approval is based on integrated analysis including data from 74 people with LA/ m-NTRK fusion-positive solid tumors (14 tumor types) & [Read More...]

Regeneron Collaborates with BioNTech to Advance the Combination of FixVac and Libtayo (cemiplimab) in Melanoma

August 3, 2020August 3, 2020

Takeda’s Pevonedistat Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients with Higher-Risk Myelodysplastic Syndrome

July 31, 2020July 31, 2020

Sangamo Highlights its Genomic Medicine Pipeline at R&D Day 2019

Sangamo Signs a Worldwide License Agreement with Novartis to Develop Genomic Therapies for Three Neurodevelopmental Targets

July 30, 2020July 30, 2020

Eli Lilly Reports Results of Jardiance (empagliflozin) in P-III EMPEROR Trial for Heart Failure Patients with Reduced Ejection Fraction with and without Diabetes

July 30, 2020July 30, 2020

Biotech

Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

August 3, 2020August 3, 2020Tuba Khan

Shots: The US government will provide ~$2.1B to support the development of the vaccine, including clinical trials with some amount to be used [Read More...]

Immunic Reports Results of IMU-838 in P-II EMPhASIS Study in Patients with Relapsing-Remitting Multiple Sclerosis

August 3, 2020August 3, 2020

$MorphoSys’ Monjuvi (tafasitamab-cxix) + Lenalidomide Receives the US FDA’s Approval as 2L Treatment for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma$

MorphoSys’ Monjuvi (tafasitamab-cxix) + Lenalidomide Receives the US FDA’s Approval as 2L Treatment for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

August 3, 2020August 3, 2020

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S in the US and Belgium

Johnson & Johnson Initiates P-I/IIa Study of its Ad26.COV2.S Against COVID-19 in the US and Belgium

July 31, 2020July 31, 2020

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

July 31, 2020July 31, 2020

Digital Health

Baxter and Ayogo Expand their Partnership to Advance Digital Health Solution for Home Dialysis

July 29, 2020July 29, 2020Tuba Khan

Shots: The companies expanded the collaboration to support the needs of patients with kidney disease via digital health solutions. The agreement integrates Ayogo’s [Read More...]

Abbott’s IOS-Compatible App Receives the US FDA’s Approval for Patients with Neurological Disorder

July 24, 2020July 24, 2020

Chugai and Biofourmis Collaborate to Develop Solutions for Digitally Measuring Endometriosis Pain

July 23, 2020July 23, 2020

Biocon Collaborates with Voluntis on Digital Therapeutics for Insulins

July 22, 2020July 22, 2020

MedTech

Roche Receives the US FDA’s Approval for VENTANA HER2 Dual ISH Test as CDx to Identify Breast Cancer

July 31, 2020July 31, 2020Tuba Khan

Shots: The US FDA has approved the new VENTANA HER2 Dual ISH DNA Probe Cocktail assay to detect HER2 biomarker in BC and [Read More...]

Zebra Medical Receives the US FDA’s Approval for its HealthMammo Mammography Tool

July 28, 2020July 28, 2020

Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

July 22, 2020July 22, 2020

Paige Receives the US FDA’s 510(k) Clearance for its FullFocus Viewer to Use in Digital Pathology

July 21, 2020July 21, 2020

M&A

Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer

July 27, 2020July 27, 2020Tuba Khan

Shots: Sorrento enters into letter of intent to acquire SmartPharm and develops pipeline of gene-encoded therapeutic Ab, initiating with Sorrento’s STI-1499 or COVI-GUARD, [Read More...]

Gilead to Acquire Tizona’s Stake for $300M

Gilead to Acquire Tizona’s Stakes for $300M

July 22, 2020July 22, 2020

Thermo Fisher Scientific Amends its Agreement to Acquire QIAGEN

July 17, 2020July 17, 2020

Kronos Bio to Acquire Gilead’s SYK Inhibitor Portfolio

July 17, 2020July 17, 2020

Regulatory

Roche’s Tecentriq + Cotellic and Zelboraf Receives the US FDA’s Approval for Patients with Advanced Melanoma

July 31, 2020July 31, 2020Tuba Khan

Shots: The approval is based on P-III IMspire150 study assessing Tecentriq (atezolizumab) + Cotellic (cobimetinib) + Zelboraf (vemurafenib) vs PBO + Cotellic + [Read More...]

AstraZeneca Reports the US FDA Acceptance of sBLA and Granted Priority Review for Imfinzi (durvalumab) to Treat Patients with Extensive-Stage Small Cell Lung Cancer

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s BT Designation for the Adjuvant Treatment of Patients with Stage IB-IIIA EGFR-Mutated Lung Cancer

July 30, 2020July 30, 2020

Henlius and Accord Receive CHMP’s Positive Opinion for its HLX02 (biosimilar, trastuzumab)

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval for HER2-Positive Breast Cancer and Gastric Cancer

July 30, 2020July 30, 2020

UCB’s Cimzia (certolizumab pegol) Receives Health Canada Approval for Non-Radiographic Axial Spondyloarthritis

UCB Canada’s Brivlera (brivaracetam) Receives Health Canada Approval to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients

July 30, 2020July 30, 2020

Diagnostics

Eli Lilly’s P-tau217 Blood Test Demonstrate High Accuracy in Diagnosis of Alzheimer’s Disease

July 29, 2020July 29, 2020Tuba Khan

Shots: The study involved 1402 patients across 3 cohorts: a) 81 patients in Arizona (34 with AD and 47 without), b) 699 in [Read More...]

The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19

July 21, 2020July 21, 2020

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

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

July 20, 2020July 20, 2020

Thermo Fisher Scientific Amends its Agreement to Acquire QIAGEN

July 17, 2020July 17, 2020

Technology

MSD Signs a Two-Year Research Agreement with Almac to Discover DUB Therapeutic Targets for Neurodegenerative Diseases

April 30, 2020April 30, 2020Tuba Khan

Shots::stosohSthShots: Almac to receive upfront, research funding, development and commercial milestones along with the royalties on sales of products emerging from the collaboration. [Read More...]

Daiichi Sankyo Signs a Non-Exclusive License Agreement with Ultragenyx for Gene Therapy Manufacturing Technology

April 1, 2020

Insilico Collaborates with Pfizer to Explore Novel Data and AI System for Target Discovery

January 15, 2020January 15, 2020

Roche Signs a Technology License Agreement with Amunix Pharmaceutical to Develop Non-Oncology Therapies

January 13, 2020January 13, 2020

Events

Weekly Snapshot

PharmaShots Weekly Snapshot (Jul 27- 31, 2020)
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Immunic Reports Results of IMU-838 in P-II EMPhASIS Study in Patients with Relapsing-Remitting Multiple Sclerosis @ImmunicInc
https://pharmashots.com/37755/immunic-reports-results-of-imu-838-in-p-ii-emphasis-study-in-patients-with-relapsing-remitting-multiple-sclerosis/

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PharmaShots - Incisive news in 3 shots @Pharmashot·

MorphoSys’ Monjuvi (tafasitamab-cxix) + Lenalidomide Receives the US FDA’s Approval as 2L Treatment for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma @MorphoSys
https://pharmashots.com/37750/morphosys-monjuvi-tafasitamab-cxix-lenalidomide-receives-the-us-fdas-approval-as-2l-treatment-for-patients-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma/

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PharmaShots - Incisive news in 3 shots @Pharmashot·

Regeneron Collaborates with BioNTech to Advance the Combination of FixVac and Libtayo (cemiplimab) in Melanoma @Regeneron
https://pharmashots.com/37764/regeneron-collaborates-with-biontech-to-advance-the-combination-of-fixvac-and-libtayo-cemiplimab-in-melanoma/

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PharmaShots - Incisive news in 3 shots @Pharmashot·

10h

Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine @sanofi @sanofipasteur @GSK
https://pharmashots.com/37778/sanofi-and-gsk-receive-2-1b-from-the-us-government-to-supply-100m-doses-of-covid-19-vaccine/

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PharmaShots - Incisive news in 3 shots @Pharmashot·

12h

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC @Roche
https://pharmashots.com/37772/roches-rozlytrek-receives-ecs-conditional-marketing-authorization-for-ntrk-fusion-positive-solid-tumors-and-ros1-positive-advanced-nsclc/

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Sanofi and GSK Receive $2.1B from the US Government to Supply 100M Doses of COVID-19 Vaccine

Roche’s Rozlytrek Receives EC’s Conditional Marketing Authorization for NTRK Fusion-Positive Solid Tumors and ROS1-Positive Advanced NSCLC

Regeneron Collaborates with BioNTech to Advance the Combination of FixVac and Libtayo (cemiplimab) in Melanoma

Immunic Reports Results of IMU-838 in P-II EMPhASIS Study in Patients with Relapsing-Remitting Multiple Sclerosis

MorphoSys’ Monjuvi (tafasitamab-cxix) + Lenalidomide Receives the US FDA’s Approval as 2L Treatment for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma

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