PharmaShots Weekly Snapshots (Dec 7-11, 2020)

Roche Launches Elecsys SARS-CoV-2 Antigen Test to Support High-Volume COVID-19 Testing

Published: Dec 11, 2020 | Tags: Antigen, COVID-19, High, Laboratory, Launch, patients, Roche, SARS-CoV-2, Support, Suspected, Test, Testing, Volume

Chugai In-Licenses Roche’s Antibody Cocktail for COVID-19 in Japan

Published: Dec 10, 2020 | Tags: Casirivimab, Chugai, Commercialization, COVID-19, Development, Imdevimab, In-License Agreement, Japan, Roche, Sign

Roche Presents Results of Tecentriq (atezolizumab) in P-III IMvigor010 Study for MIUC at ESMO 2020

Published: Dec 10, 2020 | Tags: (atezolizumab), ESMO Virtual Congress 2020, IMvigor010 Study, Muscle-Invasive Urothelial Cancer (MIUC), P-III, reports, results, Roche, Tecentriq

Biogen Reports NDA Submission of Aducanumab (BIIB037) to the MHLW for Alzheimer’s Disease

Published: Dec 9, 2020 | Tags: (BIIB037) US FDA, aducanumab, Alzheimer Disease, Biogen, J-NDA Submission, reports

Gilead to Acquire MYR for ~$1.4B

Published: Dec 10, 2020 | Tags: ~$1.4B, Acquire, Gilead Sciences, MYR GmbH

Boehringer Ingelheim to Acquires NBE-Therapeutics ~ $1.5B

Published: Dec 10, 2020 | Tags: Acquires, Boehringer Ingelheim, NBE-Therapeutics

Pfizer and BioNTech ‘s BNT162b2 Receive Health Canada Authorization to Combat COVID-19

Published: Dec 9, 2020 | Tags: (BNT162b2), BioNTech, COVID-19, Health Canada Authorization, Interim Order, patients, Pfizer, receives

Google Launches Health Research App Focusing on Respiratory Illnesses

Published: Dec 9, 2020 | Tags: App, COVID-19, Flu, Google, Launches, Virtual Medical Research

Novartis Reports Results of Kisqali in P-III MONALEESA-7 Trial to Treat HR+/HER2- Metastatic Breast Cancer

Published: Dec 9, 2020 | Tags: HR+/HER2- Metastatic Breast Cancer, Kisqali, MONALEESA-7 Trial, Novartis, P-III, reports, results

Roche Collaborate with Moderna to include SARS-CoV-2 Ab Test in COVID-19 Vaccine Trials

Published: Dec 9, 2020 | Tags: Collaborates, COVID-19, Moderna, Roche, SARS-CoV-2 Ab Test, Vaccine Trials

Lilly Reports Results of Tirzepatide in P-lll SURPASS-1 Monotherapy Trial for Type-2 Diabetes

Published: Dec 9, 2020 | Tags: Lilly, Monotherapy Trial, P-lll, reports, results, SURPASS-1, Tirzepatide, Type-2 diabetes

Boehringer Ingelheim to Acquires Labor Dr. Merk & Kollegen for Boosting its Next Generation Cancer Immunology Program

Published: Dec 9, 2020 | Tags: Acquires, Boehringer, Cancer Immunology Program, Kollegen, Labor Dr. Merk, Next Generation, Strength

Elsevier Acquires Shadow Health

Published: Dec 9, 2020 | Tags: Acquires, Elsevier, Extensive Portfolio, Shadow Health

Roche Highlights its Bispecific Antibody Portfolio Across a Range of Blood Cancers at ASH 2020

Published: Dec 8, 2020 | Tags: 62, Across, ALL, Annual, antibody, ASH, Bispecific, Blood, cancers, Data, From, Meeting, Portfolio, Presents, Range, Roche, Virtual

Amgen’s Sotorasib Receives the US FDA’s Breakthrough Therapy Designation for Advanced or Metastatic NSCLC with KRAS G12C Mutation

Published: Dec 8, 2020 | Tags: Advanced or Metastatic Non-Small Cell Lung Cancer, Amgen, Breakthrough Therapy Designation, KRAS G12C, Mutation, receives, Sotorasib, US FDA’s

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

Published: Dec 8, 2020 | Tags: Acute, Carpediem, Dialysis, First, Launch, Machine, Medtronic, neonatal, Only, Pediatric, System, US

AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19

Published: Dec 8, 2020 | Tags: AstraZenca, AZD1222, Clinical Trials, COVID-19, Four, Interim Analysis, P-lll, reports, results

Novartis’ Asciminib (ABL001) Demonstrate Superiority Over Pfizer’s Bosulif in Chronic Myeloid Leukemia Trial

Published: Dec 8, 2020 | Tags: (ABL001), ASCEMBL Study, Asciminib, Chronic, Chronic Myeloid Leukemia, Novartis, P-lll, Philadelphia Chromosome, reports, results

RetinAI Collaborates with Novartis to Provide AI Solutions in Ophthalmology

Published: Dec 8, 2020 | Tags: Artificial Intelligence, Multi-Year Collaboration, Novartis, Ophthalmology, Provide, RetinAI, Signs, Solutions

Astellas Collaborates with KaliVir to Develop and Commercialize VET2-L2

Published: Dec 7, 2020 | Tags: Agreement, Astellas, Commercialization, Development, KaliVir Immunotherapeutics, Novel, Oncolytic, Signs, VET2-L2, Virus

Qiagen Launches QuantiFERON SARS-CoV-2 RUO Solution for COVID-19

Published: Dec 7, 2020 | Tags: COVID-19, Launches, Qiagen, QuantiFERON, SARS-CoV-2 RUO, Solution

Bayer Signs an Exclusive Worldwide License Agreement with Atara for Mesothelin-Targeted CAR T-cell Therapies to Treat Solid Tumors

Published: Dec 6, 2020 | Tags: Agreement, Atara, Bayer, Exclusive, License, Mesothelin-Targeted CAR T-cell Therapies, Signs, Solid Tumors, Worldwide

Nektar Therapeutics Presents Preclinical Data of NKTR-255 in P-Ib/II Study at ASH 2020

Published: Dec 7, 2020 | Tags: 2020, 62nd, Annual, ASH, Meeting, Nektar Therapeutics, NKTR-255, P-Ib/II, preclinical, Presents, results, study

AbbVie Reports Results of Imbruvica (ibrutinib) in Two P-III Studies as 1L Treatment for Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, AbbVie, CLL, ILLUMINATE Study, Imbruvica, Integrated Analysis, Long-Term, P-lll, reports, RESONATE-2

Roche Reports of Polivy + Bendamustine and MabThera / Rituxan in P-lb/ll GO29365 Study for R/R Diffuse Large B-Cell Lymphoma

Published: Dec 7, 2020 | Tags: (polatuzumab vedotin), (R/R) Diffuse Large B-Cell Lymphoma, Bendamustine, GO29365 Study, MabThera / Rituxan (rituximab), P-lb/ll, Polivy, reports, Result, Roche

Roche Presents Results of Hemlibra Reinforcing the Long-Term Benefits for Hemophilia A at ASH 2020

Published: Dec 7, 2020 | Tags: 62nd, Annual, ASH, Haemophilia A, HAVEN, Hemlibra, I-IV, Meeting, P-III, People, Presents, results, Roche, Studies, Virtual

AstraZeneca Reports Long-Term Efficacy and Tolerability of Calquence (acalabrutinib) in P-ll ACE-LY-004 Study for MCL

Published: Dec 7, 2020 | Tags: (acalabrutinib) in P-ll ACE-LY-004 Study for Relapsed or Refractory Mantle Cell Lymphoma, AstraZenca, Calquence, Long-Term Efficacy, reports, Tolerability

Roche Reports Long-Term Benefits of Venclexta/Venclyxto Based Combination for R/R Chronic Lymphocytic Leukemia

Published: Dec 5, 2020 | Tags: Based, CLL14, combination, MURANO, P-III, People, R/R CLL, reports, results, Roche, Studies, Venclexta, Venclyxto

Kite Reports Results of Yescarta in P-II ZUMA-5 Study for Adult Patients with R/R Indolent Non-Hodgkin Lymphoma

Published: Dec 5, 2020 | Tags: Adult, iNHL, Kite, P-II, patients, Refractory, Relapsed, reports, results, study, Yescarta, ZUMA-5

Janssen Reports Long-Term Benefits of Imbruvica (ibrutinib) as 1L Treatment for High-Risk Chronic Lymphocytic Leukemia

Published: Dec 6, 2020 | Tags: (ibrutinib), 1L treatment, High-Risk Chronic Lymphocytic Leukaemia, ILLUMINATE Study, Imbruvica, Janssen, P-lll, reports, RESONATE-2, results

Related Post: PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

The post PharmaShots Weekly Snapshots (Dec 7-11, 2020) first appeared on PharmaShots.

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 weighing 2.5 to 10kg

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: BioWorld

The post Medtronic Launches Carpediem as the First Pediatric and Neonatal Acute Dialysis Machine in the US first appeared on PharmaShots.

ViewPoints Interview: Medtronic’s Julie Foster Shares Insight on InPen Integrated with Guardian Connect CGM

In a recent interview with PharmaShots, Julie Foster, Vice President, Global Customer Experience of the Diabetes business at Medtronic, shares information about recent and upcoming announcements for the company.

Shots:

  • The integration of real-time CGM data into the smart insulin pen app follows the acquisition of Companion Medical’s InPen to the Medtronic portfolio, as of Sept’2020
  • The integrated system provides real-time glucose readings alongside insulin dose information giving users everything they need to manage their diabetes through a single smartphone app
  • InPen is the first and only FDA-cleared smart2 insulin pen on the market for people on MDI. The InPen app will continue to display information from other compatible CGM systems on a three-hour delay

Tuba: Medtronic has been taking some big steps to grow its diabetes portfolio with the purchase of Klue, Nutrino, and Companion Medical. What new capabilities does this give the company?

Julie: We are working to ‘close the loop for MDI’ patients. By combining smartpen with smart CGM technologies, we aim to deliver proactive dosing advice personalized to each individual. We acquired Nutrino and Klue to enable the future of diabetes therapy through artificial intelligence: Nutrino helps us improve our predictive analytic capabilities around mealtimes, and with the identification of what’s being consumed with greater accuracy. Klue’s gesture technology helps identify when that food is being consumed. Our goal is to combine AI technology and our extensive CareLink database of real-life data to develop technologies that we can leverage across all of our insulin delivery platforms — both pen and pump.

Tuba: Medtronic recently announced the launch of InPen integrated with real-time Guardian Connect CGM data. Can you explain the benefits of this integrated system?

Julie: Every person’s journey with diabetes is different, and we want to provide options for each individual that meet their needs. An example is this integrated system, which now provides real-time glucose readings alongside insulin dose information, giving users everything they need to manage their diabetes in one view as a complete picture, rather than switching between apps to understand their in-the-moment dosing needs. We want to help make life easier for people living with diabetes, and by building on the success of InPen with added real-time glucose data, we hope we’ve done just that.

https://pharmashots.com/36893/kiniksas-rilonacept-receives-the-us-fdas-orphan-drug-designation-treat-pericarditis/

Tuba: Can you share some details about Medtronic’s newest insulin pump system; the MiniMed 770G hybrid closed loop system? How is it different?

Julie: The MiniMed 770G system builds on the successful MiniMed 670G systems as it adds smartphone connectivity and an expanded age indication to children as young as two. Having a young child diagnosed with diabetes can be scary for parents, so we hope the use of this system will provide some peace of mind by enabling them to monitor their child’s sugars and pump details at any time on their phone.

Tuba: What is Medtronic’s philosophy for working together with customers? What role does customer feedback play in innovation?

Julie: Our customer experience philosophy boils down to, “Diabetes Takes No Breaks. Neither Do We. Always By Your Side.” Those living with type 1 diabetes never get to take a break from managing the disease – it is an around-the-clock job, so learning from patient experiences is the most critical way to drive our future products. For example, listening to the struggles parents face when their young child is diagnosed with type 1 helped us in the development and launch of the MiniMed 770G.  Based on continual feedback from our customers, we are deeply committed to continue advancing services and solutions for those working with Medtronic have the best experience possible. 

Tuba: Medtronic recently launched a CGM Access Discount program. Can you tell us more about the program, and how it differs or compliments the proposed updates from the Centers for Medicare & Medicaid Services to expand CGM coverage?

Julie: We are very encouraged by CMS’s proposed rule and commend the agency on taking action to help more people with diabetes. The proposal puts patients first and empowers them to choose what best meets their diabetes management needs. While the proposed CMS rule is under review, Medtronic is offering a CGM Access Discount program, which allows users without insurance coverage, or those who switched insurance and lost coverage, to access a discounted out-of-pocket cost for a Medtronic CGM. More information about that program can be found here.

Tuba: For diabetics, the dream of one day having a fully automated artificial pancreas is becoming more real with new technologies. How close do you think we are to this achievement?

Julie:  From the discovery of insulin, now almost at its centennial, to the evolution of insulin pumps beginning the 1960s, to advancements currently in development, the history of diabetes management is an amazing one. We were the first to put an automated insulin delivery system on the market, but we know we have much work to do and are committed to continual improvement and advancement of the technology, services, and solutions we offer.  

I can’t predict the future, yet one thing I can say with great confidence is that we will work tirelessly toward a world in which people with diabetes can live more freely without needing to think about managing their disease all the time. It is deeply aligned with our mission and our inspiration.

About Julie Foster:

Julie Foster is the Vice President, Global Customer Experience of the Diabetes business at Medtronic. Foster has been at Medtronic for over 30 years across multiple businesses, therapeutic areas, and regions, and holds degrees from the University of St. Thomas and the University of San Diego.

Related Post: ViewPoints Interview: Duke’s Andrea Taylor Shares Insight on Launch And Scale Speedometer

The post ViewPoints Interview: Medtronic’s Julie Foster Shares Insight on InPen Integrated with Guardian Connect CGM first appeared on PharmaShots.

ViewPoints Interview: Medtronic’s Julie Foster Shares Insight on InPen Integrated with Guardian Connect CGM

In a recent interview with PharmaShots, Julie Foster, Vice President, Global Customer Experience of the Diabetes business at Medtronic, shares information about recent and upcoming announcements for the company.

Shots:

  • The integration of real-time CGM data into the smart insulin pen app follows the acquisition of Companion Medical’s InPen to the Medtronic portfolio, as of Sept’2020
  • The integrated system provides real-time glucose readings alongside insulin dose information giving users everything they need to manage their diabetes through a single smartphone app
  • InPen is the first and only FDA-cleared smart2 insulin pen on the market for people on MDI. The InPen app will continue to display information from other compatible CGM systems on a three-hour delay

Tuba: Medtronic has been taking some big steps to grow its diabetes portfolio with the purchase of Klue, Nutrino, and Companion Medical. What new capabilities does this give the company?

Julie: We are working to ‘close the loop for MDI’ patients. By combining smartpen with smart CGM technologies, we aim to deliver proactive dosing advice personalized to each individual. We acquired Nutrino and Klue to enable the future of diabetes therapy through artificial intelligence: Nutrino helps us improve our predictive analytic capabilities around mealtimes, and with the identification of what’s being consumed with greater accuracy. Klue’s gesture technology helps identify when that food is being consumed. Our goal is to combine AI technology and our extensive CareLink database of real-life data to develop technologies that we can leverage across all of our insulin delivery platforms — both pen and pump.

Tuba: Medtronic recently announced the launch of InPen integrated with real-time Guardian Connect CGM data. Can you explain the benefits of this integrated system?

Julie: Every person’s journey with diabetes is different, and we want to provide options for each individual that meet their needs. An example is this integrated system, which now provides real-time glucose readings alongside insulin dose information, giving users everything they need to manage their diabetes in one view as a complete picture, rather than switching between apps to understand their in-the-moment dosing needs. We want to help make life easier for people living with diabetes, and by building on the success of InPen with added real-time glucose data, we hope we’ve done just that.

https://pharmashots.com/36893/kiniksas-rilonacept-receives-the-us-fdas-orphan-drug-designation-treat-pericarditis/

Tuba: Can you share some details about Medtronic’s newest insulin pump system; the MiniMed 770G hybrid closed loop system? How is it different?

Julie: The MiniMed 770G system builds on the successful MiniMed 670G systems as it adds smartphone connectivity and an expanded age indication to children as young as two. Having a young child diagnosed with diabetes can be scary for parents, so we hope the use of this system will provide some peace of mind by enabling them to monitor their child’s sugars and pump details at any time on their phone.

Tuba: What is Medtronic’s philosophy for working together with customers? What role does customer feedback play in innovation?

Julie: Our customer experience philosophy boils down to, “Diabetes Takes No Breaks. Neither Do We. Always By Your Side.” Those living with type 1 diabetes never get to take a break from managing the disease – it is an around-the-clock job, so learning from patient experiences is the most critical way to drive our future products. For example, listening to the struggles parents face when their young child is diagnosed with type 1 helped us in the development and launch of the MiniMed 770G.  Based on continual feedback from our customers, we are deeply committed to continue advancing services and solutions for those working with Medtronic have the best experience possible. 

Tuba: Medtronic recently launched a CGM Access Discount program. Can you tell us more about the program, and how it differs or compliments the proposed updates from the Centers for Medicare & Medicaid Services to expand CGM coverage?

Julie: We are very encouraged by CMS’s proposed rule and commend the agency on taking action to help more people with diabetes. The proposal puts patients first and empowers them to choose what best meets their diabetes management needs. While the proposed CMS rule is under review, Medtronic is offering a CGM Access Discount program, which allows users without insurance coverage, or those who switched insurance and lost coverage, to access a discounted out-of-pocket cost for a Medtronic CGM. More information about that program can be found here.

Tuba: For diabetics, the dream of one day having a fully automated artificial pancreas is becoming more real with new technologies. How close do you think we are to this achievement?

Julie:  From the discovery of insulin, now almost at its centennial, to the evolution of insulin pumps beginning the 1960s, to advancements currently in development, the history of diabetes management is an amazing one. We were the first to put an automated insulin delivery system on the market, but we know we have much work to do and are committed to continual improvement and advancement of the technology, services, and solutions we offer.  

I can’t predict the future, yet one thing I can say with great confidence is that we will work tirelessly toward a world in which people with diabetes can live more freely without needing to think about managing their disease all the time. It is deeply aligned with our mission and our inspiration.

About Julie Foster:

Julie Foster is the Vice President, Global Customer Experience of the Diabetes business at Medtronic. Foster has been at Medtronic for over 30 years across multiple businesses, therapeutic areas, and regions, and holds degrees from the University of St. Thomas and the University of San Diego.

Related Post: ViewPoints Interview: Duke’s Andrea Taylor Shares Insight on Launch And Scale Speedometer

The post ViewPoints Interview: Medtronic’s Julie Foster Shares Insight on InPen Integrated with Guardian Connect CGM first appeared on PharmaShots.

PharmaShots Weekly Snapshots (Nov 09-13, 2020)

Qiagen Launches Portable Digital SARS-CoV-2 Antigen Test in the US

Published: Nov 13,2020 | Tags: Antigen Test, Digital, Launches, Portable, Qiagen, SARS-CoV-2, US

GSK and Medicago Initiate P-II/III Study of its Plant-Derived COVID-19 Vaccine

Published: Nov 13,2020 | Tags: COVID-19, GSK, Initiate, Medicago, P-II/III, Plant- Derived study, vaccine

BD Acquires the Medical Business Assets of CUBEX

Published: Nov 13, 2020 | Tags: BD, Acquires, Medical Business, Assets, CUBEX

Health2Sync Divulges Benefits of Integrating Fitbit Wearable Devices into Diabetes Care in Taiwan

Published: Nov 13,2020 | Tags: Health2Sync, Divulges, Benefits, Integrating, Fitbit, Wearable Devices, Diabetes, Care, Taiwan

UCB Acquires Handl Therapeutics to Augment its Gene Therapy Portfolio

 Published: Nov 13,2020 | Tags: UCB, Acquires, Handl Therapeutics, Augment, Gene Therapy,  Portfolio

Medtronic Launches InPen Integrated with CGM Data for People with Diabetes on MDI

Published: Nov 13,2020 | Tags: CGM Data, Diabetes, InPen, Integrated, Launches, MDI, Medtronic

Qiagen Collaborate with TScan to Develop T Cell-Based COVID-19 Test

Published: Nov 12,2020 | Tags: COVID-19, Exclusive, License Agreement, Option, Qiagen, Research, Signs, TScan Therapeutics

AstraZenca’s Calquence (acalabrutinib) Fails to Meet its Primary Endpoint in P-II Studies for COVID-19

Published: Nov 12,2020 | Tags: acalabrutinib, AstraZenca, CALAVI, Calquence, COVID-19, P-ll Study, Report, Respiratory Complications, results

Pfizer and BioNTech to Supply EU with up to 200M Doses of BNT162B2 Against COVID-19

Published: Nov 12,2020 | Tags: Agreement, BioNTech, BNT162b2, EU, European Commission, m-RNA Vaccine, Pfizer, Signs, Supply

Pfizer Reports Results of Abrocitinib in Fifth P-lll JADE REGIMEN Across Different Dosing Regimens

Published: Nov 12,2020 | Tags: Abrocitinib, JADE REGIMEN Study, moderate to severe Atopic Dermatitis (AD), P-lll, Pfizer, Positive, Report, results

Moderna Report Results of mRNA-4157 + Keytruda in Interim P-l Study for HNSCC and MSS-CRC

Published: Nov 12,2020 | Tags: HNSCC, Interim, Moderna, mRNA-4157, P-l study, pembrolizumab, Report, results, SITC 2020

J&J Resumes all Clinical Trial of its COVID-19 Vaccine in the EU

Published: Nov 12,2020 | Tags: Clinical Trial, COVID-19, EU, J&J, Resumes, vaccine

CureVac Publishes Results of CVnCoV in Interim P-l Study for COVID-19

Published: Nov 11,2020 | Tags: COVID-19, CureVac, CVnCoV, Interim, P-l study, reports, results

Prestige Signs an Exclusive Agreement with Teva to Commercialize Tuznue (biosimilar, trastuzumab) in Israel

Published: Nov 11,2020 | Tags: Agreement, Biosimilar, Commercialize, Israel, Prestige, Signs, Teva, trastuzumab, Tuznue

NightWare Receives the US FDA’s Approval for the First Medical Device to Stop NightMAres Related to PTSD

Published: Nov 11,2020 | Tags: Designed, Marketing, New Device, Nightmare Disorder, Permit, PTSD, Reduce, Sleep, US FDA

Samsung Bioepis Initiates P-I Study of SB16 Proposed Biosimilar to Prolia (denosumab)

Published: Nov 11,2020 | Tags: (Denosumab), Initiates, P-I study, Prolia, Proposed Biosimilar, Samsung Bioepis, SB16

Abbott Launches IonicRF Generator for Patients with Chronic Pain in the US

Published: Nov 11,2020 | Tags: Abbott, Chronic, Generator, IonicRF, Launch, Pain, patients, US, Use

Henlius Reports First Patients Dosing in P-I Study of HLX14 (denosumab, biosimilar)

Published: Nov 11,2020 | Tags: Henlius, Reports, First, Patient Dosing, P-l Study, HLX14, denosumab, biosimilar

Novavax Receives the US FDA’s Fast Track Designation for NVX-CoV2373 to Treat COVID-19

Published: Nov 10, 2020 | Tags: COVID-19, Fast Track Designation, Novavax, NVX-CoV2373, receives, Treat, US FDA

AstraZeneca and Amgen Report Results of Tezepelumab in P-III NAVIGATOR for Asthma

Published: Nov 10,2020 | Tags: Amgen, Asthma, AstraZeneca, NAVIGATOR, P-III, patients, Positive, reports, results, Severe, Tezepelumab, Trial, Uncontrolled

Lilly’s Bamlanivimab (LY-CoV555) Receives the US FDA’s EUA for the Treatment of Recently Diagnosed COVID-19

Published: Nov 10,2020 | Tags: Bamlanivimab, COVID-19, Diagnosed, EUA, Lilly, LY-CoV555, receives, recently, Treatment, Us FDA

Pfizer and BioNTech’s BNT16`2b2 Demonstrates 90% Efficacy in Preventing COVID-19

Published: Nov 10,2020 | Tags: Against, BioNTech, BNT162b2, Clinical, Pfizer, reports, study

AstraZeneca’s Calquence (acalabrutinib) Receives EU’s Approval for Chronic Lymphocytic Leukaemia

Published: Nov 10,2020 | Tags: (acalabrutinib), AstraZeneca’s, Calquence, Chronic Lymphocytic Leukaemia (CLL), EU’s Approval, receives

Bayer Reports Regulatory Submission of Finerenone (BAY 94-8862) to the US and EU for CKD and T2D

Published: Nov 10,2020 | Tags: (BAY 94-8862), Bayer, EMA, Finerenone, Regulatory Applications, Submits, Treat Chronic Kidney Disease (CKD), Type 2 Diabetes (T2D), Us FDA

Alvotech and Cipla Collaborate to Ensure Access to Biosimilars in South Africa

Published: Nov 9,2020 | Tags: Access, Alvotech, Biosimilars, Cipla, Ensure, Exclusive Partnership, Expand, South Africa

Novartis’ Ilaris (canakinumab) Fails to Meet its Primary Endpoints in P-lll Study for COVID-19 Pneumonia and CRS

Published: Nov 9,2020 | Tags: (canakinumab), CAN-COVID Trial, Covid-19, Pneumonia, Cytokine Release Syndrome (CRS), Ilaris, Novartis, P-lll, Report, results

Eisai Reports Results of Lenvima (lenvatinib) + Everolimus in P-II 218 Study for Advanced Renal Cell Carcinoma

Published: Nov 9,2020 | Tags: 2020, 218, Advanced, Renal, Cell, Carcinoma, Eisai, Everolimus, IKCS, lenvatinib, Lenvima, P-II, Presents, results, study

Celltrion Reports Results of CT-P59 in P-I Study for COVID-19

Published: Nov 9, 2020 | Tags: 2020, Celltrion, Clinical, Conference, CT-P59, Fall, Korean Society of Infectious Diseases, P-I, Presents, results, Trial

The US FDA’s Advisory Panel Slams Biogen’s Aducanumab for Alzheimer’s Disease

Published: Nov 9, 2020 | Tags: aducanumab, Advisory, Biogen, Committee, EMERGE, ENGAGE, Meeting, P-III, reports, study, Updates, Us FDA

Merck and Transcenta Collaborate to Implement Continuous Manufacturing for Protein Therapeutics

Published: Nov 9, 2020 | Tags: Collaborate, Continuous Manufacturing, Implement, Merck, Protein Therapeutics, Transcenta

Related Post: PharmaShots Weekly Snapshot (Nov 02-06, 2020)

The post PharmaShots Weekly Snapshots (Nov 09-13, 2020) first appeared on PharmaShots.

Medtronic Launches InPen Integrated with CGM Data for People with Diabetes on MDI

Shots:

  • The integration of real-time CGM data into the smart insulin pen app follows the acquisition of Companion Medical’s InPen to the Medtronic portfolio, as of Sept’2020
  • The integrated system provides real-time glucose readings alongside insulin dose information giving users everything they need to manage their diabetes through a single smartphone app
  • InPen is the first and only FDA-cleared smart2 insulin pen on the market for people on MDI. The InPen app will continue to display information from other compatible CGM systems on a three-hour delay

Click here­ to­ read the full press release/ article | Ref: Medtronic | Image: Medical Product Outsourcing

The post Medtronic Launches InPen Integrated with CGM Data for People with Diabetes on MDI first appeared on PharmaShots.

Medtronic Launches Smart Insulin Pen Integrated with Real-Time CGM Data

Medtronic Launches Smart Insulin Pen Integrated with Real-Time CGM Data

What You Should Know:

Medtronic,
the global leader in medical technology, announced the launch of InPen
integrated with real-time Guardian
Connect Continuous Glucose Monitoring
(CGM) data.

– InPen is the first and only FDA-cleared smart insulin pen
on the market for people on multiple daily injections (MDI).

– The combined solution now provides real-time glucose
readings alongside insulin dose information giving users everything they need to
manage their diabetes in one view.

– The InPen app will continue to display information from
other currently compatible CGM systems on a three-hour delay.

– The integration of real-time CGM data into the smart
insulin pen app is a result of the addition of Companion Medical’s InPen to the
Medtronic portfolio, as of September 2020.

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke

Novo Nordisk to Acquire Emisphere Technologies for $1.8B

Published: Nov 6, 2020 | Tags: Novo Nordisk, Acquire, Emisphere Technologies, $1.8B

AstraZeneca’s Forxiga (dapagliflozin) Receives EC’s Approval for Heart Failure

Published: Nov 5, 2020 | Tags: AstraZeneca’s, Forxiga, (dapagliflozin), Receives, EU, Approval, Heart Failure

AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Published: Nov 5, 2020 | Tags: AstraZeneca, MSD, Lynparza, Olaparib, Receives, EU, Approved, HRD, Positive, Advanced, Ovarian, Cancer

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design

Published: Nov 5, 2020 | Tags: Iktos, Signs, Agreement, Merck, KGaA, AI, New, Drug, Design

Formycon Reports BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 5, 2020 | Tags: Formycon, Reports, BLA, Resubmission, Strategy, Lucentis, Biosimilar, FYB201

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Published: Nov 5, 2020 | Tags: Cosentyx, Novartis, P-IIIb, patients, Psoriatic Arthritis, reports, results, secukinumab, study, ULTIMATE

Merck to Acquire VelosBio for $2.75B

Published: Nov 5, 2020 | Tags: $2.75B, Acquire, Merck, Oncology Pipeline, VelosBio

Innovent and Lilly Report Results of Tyvyt (sintilimab) in Seven Clinical Studies to be Presented at the ESMO ASIA Congress 2020

Published: Nov 5, 2020 | Tags: 2020, 7, Asia, Clinical, Congress, ESMO, Injection, Innovent, Lilly, Presents, results, Sintilimab, Studies, Tyvyt

Coloplast Acquires Nine Continents Medical

Published: Nov 4, 2020 | Tags: Coloplast, Acquires, Nine Continents Medical

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Published: Nov 4, 2020 | Tags: Novavax, Collaborates, Commonwealth, Australia, Supply, 40M, Doses, NVX-coV2373, COVID-19

BioInvent Presents New Clinical and Preclinical Data of BI-1206 at ASH Annual Meeting

Published: Nov 5, 2020 | Tags: ASH Annual Meeting, BI-1206, BioInvent, Follicular Lymphoma Mantle Cell Lymphoma, Marginal Zone Lymphoma, P-l/lla Study, reports, results

Jounce Stops Enrollment in P-II EMERGE Study Evaluating Vopratelimab for Lung Cancer

Published: Nov 4,2020 | Tags: Jounce Therapeutics, P-II EMERGE trial, Program, reports, Update, Vopratelimab

Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Published: Nov 4, 2020 | Tags: Acceptance, Achondroplasia Regulatory, BioMarin, Children, FDA, NDA, reports, US, Vosoritide

CEPI to Invest ~$328M in Clover’s COVID-19 Vaccine Candidate

Published: Nov 3, 2020 | Tags: CEPI, Clover Biopharmaceuticals, Covid-19 Vaccine, Expand, Fund, Partnership

Abbott to Launch its Cardiac Mapping Platform in Europe and Australia

Published: Nov 2,2020 | Tags: Abbott, approval, CE Mark, EnSite X EP System, receives, TGA

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis

Published: Nov 4,2020 | Tags: BMS, BMS-986165, Deucravacitinib, Moderate, P-III, patients, Plaque, POETYK PSO-1, Positive, Psoriasis, reports, results, Severe, study

Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA 

Published: Nov 4,2020 | Tags: approval, Boston Scientific, DCB, patients, Peripheral Artery Disease, PPA, Range, receives, SFA, Treatment, Us FDA

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Published: Nov 3,2020 | Tags: Advanced, breast, Cancer, HR+/HER2, Kisqali, MONALEESA-7, Novartis, P-III, reports, results, ribociclib, study, Women

Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Published: Nov 3, 2020 | Tags: BPN14770, FXS, P-II, patients, Positive, reports, results, study, Tetra Therapeutics

Roche’s Tecentriq (atezolizumab) + Avastin (bevacizumab) Receive the EC’s Approval for Unresectable Hepatocellular Carcinoma

Published: Nov 3, 2020 | Tags: (atezolizumab), (bevacizumab), Aavastin, EU Approval Unresectable Hepatocellular Carcinoma (HCC), receives, Roche’s, Tecentriq

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Published: Nov 3, 2020 | Tags: 2020, ACR, Celltrion Healthcare, Convergence, CT-P17, P-III, Positive, Presents, RA, results, study, Treatment

Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia

Published: Nov 3, 2020 | Tags: (PP6M), Invega Sustenna, Invega Trinza, Janssen, NDA submission, reports, Us FDA

AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

Published: Nov 3, 2020 | Tags: AstraZeneca, Cancer, Collaborate, Combination Therapies, Commercialize, Develop, Fusion, Next-Generation Radiopharmaceuticals

Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

Published: Nov 2, 2020 | Tags: Aimovig, Episodic and Chronic Migraine (HER-MES), erenumab, Novartis, P-lV Study, positive results, Report

Sun Pharma Reports Five Year Results of Ilumya (tildrakizumab-asmn) in P-III Studies for Moderate-to-Severe Plaque Psoriasis

Published: Nov 2, 2020 | Tags: 5-year, Ilumya, Moderate, P-III, patients, reports, results, reSURFACE 1, reSURFACE 2, Severe, Studies, Sun Pharma, tildrakizumab-asmn

 Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Published: Nov 2, 2020 | Tags: Fibrodysplasia Ossificans Progressiva, Garetosmab, LUMINA-1 Trial, P-ll, patients, Regeneron, REGN2477, Report, results

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Published: Nov 2, 2020 | Tags: BE SURE, Bimekizumab, Moderate, P-III, patients, Psoriasis, reports, results, Severe, study, UCB

Sanofi to Acquire Kiadis for ~$358M

Published: Nov 2, 2020 | Tags: $358.76M, Acquire, Kiadis, Offers, Sanofi

Medtronic Expands ENT Portfolio with the Acquisition of Ai Biomed and the Approval of NIM Vital Nerve Monitoring System

Published: Nov 2, 2020 | Tags: Acquires, Ai Biomed Corp., ENT Portfolio, Medtronic’s, NIM Vital, Parathyroid Detection System, receives, US FDA’s Approval

Related Post: PharmaShots Weekly Snapshot (Oct 26 – 30, 2020)

The post PharmaShots Weekly Snapshot (Nov 02-06, 2020) first appeared on PharmaShots.

Medtronic’s Abre Venous Stent Receives the US FDA’s Approval to Treat Venous Outflow Obstruction

Shots:

  • The approval is based on ABRE clinical study assessing the Abre stent in 200 patients with iliofemoral venous outflow obstruction across the spectrum of deep venous obstruction including those with the post-thrombotic syndrome, NIVL & those who presented with an aDVT. The study also includes a challenging patient population, 44% of whom required stents that extended below the inguinal ligament into the CFV
  • The study resulted in meeting its 1EP of safety with a 2% rate of MAEs within 30 days and also met its 1EPs of efficacy with an overall primary patency rate of 88.0%, no stent fractures, and no stent migrations were reported in the study.
  • Abre venous self-expanding stent system is the device, indicated for use in the iliofemoral veins in patients with symptomatic iliofemoral venous outflow obstruction and has received CE Mark approval in April’2017

Click here ­to­ read full press release/ article | Ref: Medtronic | Image: elEconomista.es

The post Medtronic’s Abre Venous Stent Receives the US FDA’s Approval to Treat Venous Outflow Obstruction first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)

1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children

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

Published: Aug 07, 2020 | Tags: Guardant Health, Guardant360 CDx, Receives, US, FDA, Approval, First, Liquid Biopsy, NGS, Assay, Identify, EGFR, Mutations, Non-Small Cell Lung Cancer

 3. Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Published: Aug 10, 2020 | Tags: Roche, Report, Mixed Results, Etrolizumab, P-III, Studies, Patients, Moderately, Severely, Active, Ulcerative Colitis

4. Boehringer Ingelheim Acquires GST to Boost its Stem Cell Capabilities in Animal Health

Published: Aug 10, 2020 | Tags: Boehringer Ingelheim, Acquires, GST, Boost, Stem Cell Capabilities, Animal Health

5. Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Published: Aug 11, 2020 | Tags: Gilead, Reports, NDA, Submission, US, FDA, Veklury, Remdesivir, Treat, COVID-19

6. Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic HER2-Overexpressing Breast Cancer in Brazil

Published: Aug 11, 2020 | Tags: Samsung Bioepis, Launches, Ontruzant, trastuzumab, biosimilar, Early, Metastatic, HER2-Overexpressing, Breast Cancer, Brazil

7. Olympus to Acquire Arc Medical Design for Expanding its Product Portfolio

Published: Aug 10, 2020 | Tags: Olympus, Acquire, Arc Medical Design, Expand, Portfolio

8.  Bayer to Acquire KaNDy Therapeutics for Augmenting its Women’s Healthcare Portfolio

Published: Aug 11, 2020 | Tags: Bayer, Acquire, KaNDy Therapeutics, Augment, Women’s Healthcare, Portfolio

9.  Ligand to Acquire Pfenex for $516M

Published: Aug 11, 2020 | Tags: Ligand, Acquire, Pfenex, $516M

10. Medtronic to Acquire Companion Medical for Adding Smart Insulin Pen to its Diabetes Unit

Published: Aug 11, 2020 | Tags: Medtronic, Acquire, Companion Medical, Smart Insulin Pen, Diabetes Unit

11. BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Published: Aug 11, 2020 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, CT, Receive, Health Canada, Approval, Metastatic, Non-Small Cell Lung Cancer

12. Sarepta Therapeutics Collaborates with University of Florida to Accelerate the Development of Therapies for Rare Genetic Diseases

Published: Aug 12, 2020 | Tags: Sarepta Therapeutics, Collaborates, University of Florida, Accelerate, Development, Therapies, Rare Genetic Diseases

13.  Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Published: Aug 12, 2020 | Tags: Innovent, Eli Lilly, Report, sNDA, Acceptance, Tyvyt, sintilimab, Combination Regimen, 1L Therapy, in Squamous, Non-Small Cell Lung Cancer, China

14. Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

Published: Aug 12, 2020 | Tags: Roche, Collaborates, Celleron Therapeutics, Emactuzumab, Patients with Tenosynovial Giant Cell Tumor

15. Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Published: Aug 13, 2020 | Tags: Regeneron, Reports, US, FDA, Acceptance, Evinacumab, BLA, Priority Review, Treatment, Patients, HoFH

16Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Published: Aug 13, 2020 | Tags: Roche, Reports, US, FDA, Acceptance, sBLA,  Xolair, (omalizumab), Prefilled Syringe, Self-Administration, Across, All, Indications

17.   Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

Published: Aug 13, 2020 | Tags:  Zydus, Launches, Remdac, (remdesivir), $37.41, Vial, India

18.   Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B

Published: Aug 13, 2020 | Tags: Novo Nordisk, Resumes, P-III, Study, Concizumab, Patients, Hemophilia A and B

19.  Alphabet’s Verily Establishes CLIA-Certified Lab Focusing on COVID-19 Testing

Published: Aug 11, 2020 | Tags: Alphabet, Verily, Establishes, CLIA-Certified, Lab, Focusing, COVID-19, Testing

20.   Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

Published: Aug 13, 2020 | Tags: Strata Oncology, Collaborates, Mirati Therapeutics, Broaden, Enrollment, Clinical Trial, MRTX849, Patients,  Advanced Solid Tumors

21.  AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Published: Aug 13, 2020 | Tags:  AstraZeneca, Initiate, Production, COVID-19, Vaccine, Early, 2021

22. EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Published: Aug 13, 2020 | Tags: Johnson & Johnson, EC, Supply, 200M, Doses, COVID-19, Vaccine

23.  SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19 Vaccine

Published: Aug 14, 2020 | Tags: Novavax, SK bioscience, Collaborate, NVX-CoV2373, Treat, COVID-19

24. Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat COVID-19

Published: Aug 14, 2020 | Tags: Novavax, Collaborates, UK Government, Supply, 60M, Doses,  NVX-CoV2373, Combat, COVID-19

25. Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

Published: Aug 13, 2020 | Tags: Solasia, Signs, License Agreement, Isofol, Develop, Commercialize, Arfolitixorin, mCRC, Japan

Related Post: PharmaShots Weekly Snapshot (Aug 03- 07, 2020)

Medtronic to Acquire Companion Medical for Adding Smart Insulin Pen to its Diabetes Unit

Shots:

  • The acquisition will expand Medtronic’s capabilities to serve people using multiple daily injections (MDI) to manage diabetes with the addition of Companion Medical’s InPen to Medtronic’s portfolio. The acquisition is expected to be closed within 1-2mos.
  • Medtronic will advance the automation of insights and dosing capabilities to reduce the burden of diabetic patients. Additionally, Medtronic will expand the availability of InPen globally
  • InPen is the only US FDA-cleared smart insulin pen system paired with an integrated diabetes management app for providing support to diabetic patients regardless of how insulin is delivered

Click here ­to­ read full press release/ article | Ref: Medtronic  | Image: Diabetes Daily

Medtronic Acquires Smart Insulin Pen Company Companion Medical

Medtronic Acquires Smart Insulin Pen Company Companion Medical

What You Should Know:

– Today, Medtronic announced that it will
acquire Companion Medical, the manufacturer of InPen, a smart insulin pen
system paired with an integrated diabetes management app.

– The addition of Companion’s InPen system builds
upon Medtronic’s strategic acquisitions of Nutrino and Klue to further
improve overall automated decision-making capabilities and optimizes dosing
decisions using algorithms and AI for patients.


Medtronic,
today announced the planned acquisition
of privately-held Companion
Medical,
manufacturer of InPen — the only U.S. FDA-cleared smart insulin
pen system paired with an integrated diabetes management app on the market. The
addition of Companion Medical’s InPen to the Medtronic portfolio
expands the company’s ability to serve people where they are in their diabetes
journey and offer them a unique and expansive ecosystem of support — regardless
of how insulin is delivered.

FDA-Cleared Smart Pen System

The InPen dose calculator recommends a personalized dose
based on your blood glucose, the carbohydrates you’re eating, and your active
insulin. The calculator is customizable — choose between three different modes
depending on whether you count carbs or not.

InPen is the only smart pen system that tracks active
insulin. At any time, you can check the app and see how much insulin is still
active in your body from previous doses. InPen uses this information to let you
know if you need a correction dose and to help you avoid stacking.

Acquisition
Expands 
Medtronic Capabilities to Serve People Using Multiple Daily Injections (MDI)
to Manage Diabetes

The acquisition of Companion Medical builds upon prior Medtronic strategic
acquisitions, including Nutrino and Klue, that form the building blocks to
design powerful algorithms leveraging the company’s deep data science and AI
capabilities. With this latest acquisition, Medtronic will work to
further advance the automation of insights and dosing capabilities to help
alleviate burden regardless of the technology that’s preferred for insulin
delivery. In addition, Medtronic will look to expand the availability
of InPen globally.

“This acquisition is an ideal strategic fit for Medtronic as we further simplify diabetes management and improve outcomes by optimizing dosing decisions for the large number of people using multiple daily injection (MDI). We look forward to building upon the success of the InPen by combining it with our intelligent algorithms to deliver proactive dosing advice personalized to each individual. This smart CGM system can help people think less about diabetes and be able to live life with more freedom, on their own terms,” said Sean Salmon, executive vice president and president of the Diabetes Group at Medtronic. ”Our goal is to become a trusted partner that offers consistent support whether an individual wants to stay on MDI, transition to automated insulin delivery or take a break from their pump.”

Financial terms of the acquisition were not disclosed. The
acquisition is expected to close within one to two months – subject to the
satisfaction of certain customary closing conditions. The transaction is
expected to be neutral to Medtronic’s adjusted earnings per share in the
current fiscal year, and accretive thereafter.

“We are thrilled to be combining our strengths and differentiated product portfolios to work towards serving even more people around the world living with diabetes in the ways that matter most to them,” said Sean Saint, CEO and co-founder of Companion Medical. “Simplifying diabetes management to reduce burden and improve outcomes has always been our goal, and through a respected global leader like Medtronic, we’ll now be able to take InPen to this next phase of growth which is great news for people with diabetes who stand to benefit most.”

M&A Analysis: 3 Benefits of Siemens Healthineers’ $16.4B Acquisition of Varian Medical

M&A Analysis: 3 Benefits of Siemens Healthineers $16.4B Acquisition of Varian Medical

What You Should Know:

– Siemens Healthineers and Varian Medical announce a $16.4B deal in an all-cash transaction on 2nd August 2020.

– Deal expected to close in 1H 2021.

– Varian Medical will maintain its brand name and operate “independently”

– Siemens AG will drop holding in Siemens Healthineers from 85% to 72% as part of the transaction.


News of the deal between Siemens Healthineers and Varian Medical will have caught many industry onlookers off guard on Sunday evening. Flotation of the Healthineers business segment on the German stock market raised a few eyebrows back in 2017, but with Siemens AG retaining 85% of the stock, many observers postulated little change to the fortunes of the well-known business; an unwieldy technical hardware leader facing an uphill battle in an increasingly digital market.

However, the Varian deal has just made it very clear that Siemens Healthineers has emerged from the IPO with big ambitions and firepower to match. So, what does this mean for the future?

Win-win?

Three benefits of the deal are clear at first glance. Firstly, Siemens Healthineers will be adding an additional mature product set to its already strong modality hardware line-up. Radiation Therapy hardware (linear accelerators, or linac), is the lion’s share of Varian’s business, for which it is market leader holding over 55% of the global installed base in 2019. Combining this with Siemens’ extensive business in diagnostic imaging and diagnostics will create a product line-up that no major peer can today match. It also opens up opportunities for providing “end-to-end” oncology solutions (imaging, diagnostics, and therapy) under one vendor, a strong play in a market where health providers are increasingly looking to limit supply chain complexity and explore long-term managed service deals with fewer vendors.

Secondly, Varian is operating in a relatively exclusive market, with its only main competition coming from market peers Elekta and Accuray Inc. Demand for linacs has been consistently improving in recent years, with Varian suggesting only two-thirds of the Total Addressable Market (TAM) for Radiation Therapy has been catered for so far. The acquisition, therefore, opens a new growth market for Siemens Healthineers to offset the gradual slowing demand for its advanced imaging modality (MRI, CT) business, a more competitive and mature segment. The adoption of Radiation Therapy in emerging markets such as China and India is also well behind advanced imaging modalities, offering new greenfield opportunities near term, a rarity in most of Siemens Healthineers’ core markets.

Thirdly, Varian has grown to a size where progressing to the next level of growth will require substantial investment in operations and new market channels. Revenue growth over the last five years has been patchy, though gross margin remains strong for this sector. If Siemens can leverage its far larger operational and sales network and apply it to Varian’s product segments, none of Varian’s current main competitors will have the resources to compete, unless acquired by another major healthcare technology vendor.

The Digital Gem 

While the Radiation Therapy hardware business has gained the most attention for its potential impact on Siemens Healthineers’ business, Varian’s software business is arguably its most valuable jewel, hitting almost $600m and 18% YoY growth in FY19.

Many healthcare providers have become increasingly beleaguered by the challenges of digitalization today, especially in terms of complex integration of diagnostic and clinical applications across the healthcare system. This frustration is especially common in Oncology, which sits at the convergence of major departmental and enterprise IT systems, including the EMR, laboratory, radiology, and surgical segments.

Changing models of care provision towards multidisciplinary collaboration for diagnosis and care have only intensified focus on fixing this issue, with some preferring single-vendor offerings for major clinical or diagnostic departments. The Varian software suite is one of the few premium full-featured oncology IT portfolios available today, competing mostly against main rival Elekta, generalist oncology information system modules from EMR vendors (few of which have the same capability) and a host of smaller standalone specialist IT vendors.

For Siemens Healthineers, the Varian software asset is a great fit. Siemens has for some time been gradually changing direction in its digital strategy, away from large enterprise data management segments towards more targeted diagnostic and operational products. This process began with the sale of its EMR business to Cerner for $1.3B back in 2015, with notably reduced marketing focus and bidding or deal activity on big imaging management deals (PACS, VNA etc.) in North America in recent years.

Instead, Siemens Healthineers has channeled its digital efforts on three main areas where it has specialist capabilities: advanced visualization and access to artificial intelligence for image analysis; digitalization of advanced imaging hardware modalities, including driving efficiency for fleet management and radiology operations; and lab diagnostics automation. While still early in this transformation, this approach is tapping into the main challenges facing most healthcare providers today; improving clinical outcomes at a net neutral or reduced cost, better managing and reducing Total Cost of Ownership (TCO), and implementing autonomous technology to augment clinical and diagnostic practice.

Assuming integration with Siemens’ broader portfolio is not too bumpy, it is already clear how the different software assets of the Varian business sit well with Siemens’ digital strategy. The Aria Oncology Information System platform will provide an entry point for Siemens to build on clinical outcome improvement in Oncology (along with Noona/360 Oncology) while also integrating diagnostic content from the Siemens syngo imaging and AI-radiology applications. Further, with growing attention on operational software to support modality fleet services and radiology operations, Siemens could translate this business into RT linac fleet management, an area currently underserved.

With no competing vendor today able to match this capability in Oncology IT, the potential long-term benefits for Siemens’ digital strategy with Varian far outweigh the risks of integration.

From Morph Suits to Moon-shots

As alluded to in our introduction, perhaps most intriguing is the bullish signal Siemens Healthineers has made to its customers and the wider market about its future.

The Healthineers 2025 strategy identified three clear stages of transformation, with “reinforcing the core portfolio” the key aspect of the 2017-2019 post IPO. In the second phase “upgrading” the business focused on pushing up growth targets and earnings per share across all segments while adding capabilities in allied markets.

Picture9

Judged against the criteria for the “upgrading” phase, the Varian deal has ticked all the boxes, perhaps clarifying why Siemens was willing to pay a premium:

The scale of the deal has also reinforced that the gradual untethering of Siemens Healthineers from its corporate parent Siemens AG is bearing fruit, both in terms of flexibility to deal-make and the ability to use the financial firepower of its majority shareholder for competitive gain.

The deal, once completed in 1H 2021, also now puts Siemens Healthineers in an exclusive club of medical technology companies with annual revenues above $20B, with a potential position as the third-largest public firm globally (based on 2019 revenues, behind Medtronic and Johnson and Johnson).

It is therefore hard to argue that the Varian acquisition can be viewed as anything but positive for Siemens Healthineers. Given the current impact of the COVID-19 pandemic and expected challenging economic legacy, the growth potential of Varian will help to smooth the expected mid-term dip in some core business over the next few years.

Yet it is the intention and message that Siemens Healthineers is sending with the Varian acquisition that has is perhaps most impressive; despite the turmoil and challenges facing markets today, it fundamentally believes in its strategy to reinvent its healthcare business and target precision medicine long term.

Its major competitors should sit up and take note; Siemens Healthineers is fast re-establishing itself as a leading force within healthcare technology. The morph suits of the “Healthineers” brand launch was just one small step on this journey; the Varian acquisition is going to be one great leap.


About Steve Holloway 

Signify Research_Steve Holloway

Steve Holloway is the Director at Signify Research, an independent supplier of market intelligence and consultancy to the global healthcare technology industry. Steve has 9 years of experience in healthcare technology market intelligence, having served as Senior Analyst at InMedica (part of IMS Research) and Associate Director for IHS Inc.’s Healthcare Technology practice. Steve’s areas of expertise include healthcare IT and medical Imaging.

PharmaShots Weekly Snapshot (Jul 27- 31, 2020)

 1.  Oxford Biomedica Signs Three Year Clinical Supply Agreement with Axovant to Manufacture and Supply AXO-Lenti-PD for Parkinson’s Disease 

Published: Jul 31, 2020 | Tags: Oxford Biomedica, Signs, Three Year, Clinical Supply Agreement, Axovant, Manufacture, Supply, AXO-Lenti-PD, Parkinson’s Disease

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

Published: Jul 30, 2020 | Tags: Johnson & Johnson, Initiates, P-I/IIa, Study,  Ad26,  US, Belgium

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

Published: Jul 31, 2020 | Tags: Roche, Receives, US, FDA, Approval, VENTANA HER2 Dual ISH Test, CDx, Identify, Breast Cancer

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

Published: Jul 31, 2020 | Tags: Takeda, Pevonedistat, Receives, US, FDA, Breakthrough Therapy Designation, Patients, Higher-Risk Myelodysplastic Syndromes, HR-MDS

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

Published: Jul 31, 2020 | Tags: Roche, Tecentriq, Cotellic, Zelboraf, Receives, US, FDA, Approval, Patients, Advanced, Melanoma

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

Published: Jul 30, 2020 | Tags: Sangamo, Signs, Worldwide, License Agreement, Novartis, Develop, Genomic Therapies, Three, Neurodevelopmental Targets

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

Published: Jul 30, 2020 | Tags: Eli Lilly, Reports, Results, Jardiance, empagliflozin, P-III, EMPEROR Trial, Heart Failure, Patients, Reduced Ejection Fraction, with and without, Diabetes

8.  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

Published: Jul 29, 2020 | Tags: AstraZeneca, Tagrisso, Osimertinib, Receives, US, FDA, BT, Designation, Adjuvant Treatment, Patients, Stage IB-IIIA EGFR-Mutated, Lung Cancer

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

Published: Jul 30, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

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

Published: Jul 29, 2020 | Tags: UCB Canada, Brivlera, brivaracetam, Receives, Health Canada, Approval, Treat, Partial-Onset Seizures, Pediatric, Epilepsy Patients

11. BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Published: Jul 23, 2020 | Tags: BARDA, Signs, Multi-Year Agreement, Regeneron, REGN-EB3, National Preparedness

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

Published: Jul 29, 2020 | Tags: Baxter, Ayogo, Expand, Partnership, Advance, Digital, Health Solution, Home Dialysis

14.  Merck’s MK-6482 Receives the US FDA’s Breakthrough Therapy Designation to Treat Patients With Von Hippel-Lindau Disease-Associated Renal Cell Carcinoma

Published: Jul 29, 2020 | Tags: Merck, MK-6482, Receives, US, FDA, Breakthrough Therapy Designation, Treat, Patients, Von Hippel-Lindau Disease- Associated, Renal Cell Carcinoma

15AbbVie Report Results of Rinvoq (upadacitinib) in a P-III AD Up Study for Patients with Atopic Dermatitis

Published: Jul 28, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, P-III, AD Up, Study, Patients, Atopic Dermatitis

16.   Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Published: Jul 29, 2020 | Tags: Roche, Actemra/RoActemra, tocilizumab, Fails, Meet, Primary Endpoint, P-III, COVACTA Study, Patients, COVID-19, Associated Pneumonia

17.  Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Published: Jul 28, 2020 | Tags: Sanofi, GSK, Sign, Agreement, UK, Government, Supply, ~60M, Doses, COVID-19, Vaccine

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

Published: Jul 29, 2020 | Tags: Eli Lilly, P-tau217, Blood Test, Demonstrate, High Accuracy, Diagnosis, Alzheimer’s Disease

19.  Roche and UCB Collaborate to Develop UCB0107 for Alzheimer’s Disease

Published: Jul 28, 2020 | Tags: Roche, UCB, Collaborate, Develop, UCB0107,  Alzheimer’s Disease

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

Published: Jul 27, 2020 | Tags: Zebra Medical, Receives, US, FDA, Approval, HealthMammo, Mammography Tool, Oncology, Breast Cancer

21.   AstraZeneca Report Results of Farxiga in P-III DAPA-CKD Study for Patients with Chronic Kidney Disease

Published: Jul 27, 2020 | Tags: AstraZeneca, Reports, Results, Farxiga, P-III, DAPA-CKD, Study, Patients, Chronic Kidney Disease

22.  Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Published: Jul 28, 2020 | Tags: Eli Lilly, Amends, 2013, Agreement, Chi-Med, Commercialize, Elunate, Fruquintinib, China

23. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Emergent BioSolutions, Expand, Manufacturing, AZD1222, COVID-19

24.  Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Published: Jul 28, 2020 | Tags: Pfizer, BioNTech, Initiate, P-II/III, Global Study, Lead, mRNA, Vaccine, Candidate, Against, COVID-19

25.  Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India

Published: Jul 26, 2020 | Tags:  Three, Pharma, Companies, Launch, Favipiravir, COVID-19, India

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

Published: Jul 27, 2020 | Tags: Kite, Tecartus, brexucabtagene autoleucel, Receives, US, FDA, Approval, First, Cell-Based, Gene Therapy, Relapsed, Refractory, MCL

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

Published: Jul 26, 2020 | Tags: Centus Biotherapeutics, Equidacent, (bevacizumab, biosimilar, Receives, CHMP, Positive Opinion, Treatment, Multiple Cancer Indications

28.   AstraZeneca Signs an Agreement with Daichii Sankyo to Develop and Commercialize DS-1062 Worth Up to $6B

Published: Jul 27, 2020 | Tags: AstraZeneca, Signs, Agreement, Daichii Sankyo, Develop, Commercialize, DS-1062, Worth, Up to, $6B, Global, Oncology,

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

Published: Jul 27, 2020 | Tags: Sorrento, Acquire, SmartPharm, Develop, Pipeline, Gene-Encoded, Therapeutic Antibodies, Targeting, COVID-19, Cancer, Oncology, Global




PharmaShots Weekly Snapshot (Jul 20- 24, 2020)

 1.  Gilead and Galapagos’ Jyseleca (filgotinib) Receive the CHMP’s Positive Opinion for Moderate to Severe Rheumatoid Arthritis 

Published: Jul 24, 2020 | Tags: Gilead, Galapagos, Jyseleca, filgotinib, Receive, CHMP, Positive Opinion,  Moderate, Severe, Rheumatoid Arthritis

2.  Synaffix Expands its Existing Collaboration with ADC Therapeutics to Explore Two Additional Programs

Published: Jul 24, 2020 | Tags: Synaffix, Expands, Existing Collaboration, ADC, Explore, Two Additional Programs

 3. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)

Published: Jul 23, 2020 | Tags: Zydus, Initiate, Clinical Study, Desidustat, Patients, Chemotherapy Induced Anemia, CIA

4. AstraZeneca’s Breztri Aerosphere Receives the US FDA’s Approval for the Maintenance Treatment of COPD

Published: Jul 24, 2020 | Tags: AstraZeneca, Breztri Aerosphere, Receives, US, FDA, Approval, Maintenance Treatment, COPD

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

Published: Jul 17, 2020 | Tags: Abbott, IOS-Compatible App, Receives, US, FDA, Approval, Patients, Neurological Disorder

6. BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

Published: Jul 23, 2020 | Tags: BioMarin, Reports, Submission, MAA, EMA, Vosoritide, Treat, Children, Achondroplasia

7.  Ovid Therapeutics and University of Connecticut Collaborate to Accelerate the Development of OV101 (gaboxadol) for Angelman Syndrome

Published: Jul 22, 2020 | Tags: Ovid Therapeutics, University of Connecticut, Collaborate, Accelerate, Development, OV101, gaboxadol, Angelman Syndrome

8.  Genentech Reports Results of Port Delivery System with Ranibizumab in P-III Archway Study for Neovascular Age-Related Macular Degeneration

Published: Jul 22, 2020 | Tags: Genentech, Reports, Results, Port Delivery System, Ranibizumab, P-III, Archway Study, Neovascular Age-Related Macular Degeneration

9. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Published: Jul 22, 2020 | Tags: Glenmark, Report, Results, FabiFlu, favipiravir, P-III, Clinical Study, Patients, Mild, Moderate, COVID-19

10. Daiichi Sankyo Signs a Research Agreement Gustave Roussy for DS-1062 and Patritumab Deruxtecan to Treat Lung and Breast Cancer

Published: Jul 23, 2020 | Tags: Daiichi Sankyo, Signs, Research Agreement, Gustave Roussy, DS-1062, Patritumab Deruxtecan, Treat, Lung, Breast Cancer

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

Published: Jul 23, 2020 | Tags: Chugai, Biofourmis, Collaborate, Develop, Solutions, Digitally Measuring, Endometriosis Pain

13.  AbbVie Reports Results of Rinvoq (upadacitinib) as Monotherapy in a P-III Measure Up 2 Study for Atopic Dermatitis

Published: Jul 22, 2020 | Tags: AbbVie, Reports, Results, Rinvoq, upadacitinib, Monotherapy, P-III, Measure Up 2, Study, Atopic Dermatitis

14.  Evotec Collaborates with Quantro Therapeutics to Discover and Develop Novel Therapies for Cancer and Other Diseases

Published: Jul 22, 2020 | Tags: Evotec, Collaborates, Quantro Therapeutics, Discover, Develop, Novel, Therapies, Cancer, Other Diseases

15Boston Scientific Receives the US FDA’s Approval for Next-Generation WATCHMAN FLX Left Atrial Appendage Closure Device

Published: Jul 20, 2020 | Tags: Boston Scientific, Receives, US, FDA, Approval, Next-Generation, WATCHMAN FLX, Left Atrial, Appendage Closure Device

16.   Gilead to Acquire Tizona’s Stakes for $300M

Published: Jul 22, 2020 | Tags: Gilead, Acquire, Tizona, Stake, $300M, AbbVie, TTX-080, TTX-03

17.  Biocon Collaborates with Voluntis on Digital Therapeutics for Insulins

Published: Jul 21, 2020 | Tags: Biocon, Collaborates, Voluntis, Digital Therapeutics, Insulins

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

Published: Jul 22, 2020 | Tags: Paige, Receives, US, FDA, 510(k), Clearance, FullFocus Viewer, Use, Digital Pathology

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

Published: Jul 21, 2020 | Tags: The UK, Government, Launch, AbC-19, Lateral Flow, Free Finger-Prick Test, COVID-19

20.  Roche Collaborates with Jnana Therapeutics to Discover Novel Therapies to Treat Immune-Mediated and Neurological Diseases

Published: Jul 21, 2020 | Tags: Roche, Collaborates, Jnana Therapeutics, Discover, Novel Therapies, Treat, Immune-Mediated, Neurological Diseases

21.   Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India

Published: Jul 20, 2020 | Tags: Mylan, Launches, Remdesivir, Under, Brand Name, Desrem, COVID-19, India

22.  Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Published: Jul 21, 2020 | Tags: Pfizer, BioNTech, Elicits, Strong, T-cell, Response, P-I/II, Study, Against, COVID-19, Germany

23. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Published: Jul 20, 2020 | Tags: AstraZeneca, Oxford University, AZD1222, Delivers, Strong, Immune Response, P-II/III, COV001, Study, Against, COVID-19  

24.  Royalty Pharma Acquires PTC’s Royalty Interest in Risdiplam for $650M

Published: Jul 19, 2020 | Tags: Royalty Pharma, Acquires, PTC, Royalty Interest, Risdiplam,  $650M

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

Published: Jul 19, 2020 | Tags:  Quest Diagnostic, Receives, US, FDA, First, EUA, Sample Pooling, COVID-19

26. Roche Signs RWD Collaboration with PicnicHealth to Create Personalized Treatment for Patients with Multiple Sclerosis

Published: Jul 19, 2020 | Tags: Roche, Signs, RWD, Collaboration, PicnicHealth, Create, Personalized Treatment, Patients, Multiple Sclerosis

27.   Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Published: Jul 19, 2020 | Tags: Celltrion, Initiates, P-I, Study, COVID-19, Antibody Treatment, South Korea

28.   GSK to Acquire 10% stake in CureVac for $163M

Published: Jul 20, 2020 | Tags: GSK, Acquire, 10%, Stake, CureVac, $163M




PharmaShots Weekly Snapshot (Jul 13- 17, 2020)

 1.  Eli Lilly Reports Results of Mirikizumab in P-III OASIS-2 Study to Treat Moderate to Severe Plaque Psoriasis

Published: Jul 17, 2020 | Tags: Eli Lilly, Reports, Results, Mirikizumab, P-III, OASIS-2, Study, Treat, Moderate, Severe, Plaque Psoriasis

2.  Oncorus Initiates P-I Study of ONCR-177 in Patients with Advanced / Refractory Cutaneous Subcutaneous or Metastatic Nodal Solid Tumors

Published: Jul 16, 2020 | Tags: Oncorus, Initiates, P-I, ONCR-177, Patients, Advanced, Refractory, Cutaneous, Subcutaneous, Metastatic, Nodal Solid Tumors

 3. Thermo Fisher Scientific Amends its Agreement to Acquire QIAGEN

Published: Jul 16, 2020 | Tags: Thermo Fisher Scientific, Amends, Agreement, Acquire, QIAGEN

4.  Kiniksa’s Rilonacept Receives the US FDA’s Orphan Drug Designation to Treat Pericarditis

Published: Jul 16, 2020 | Tags: Kiniksa, Rilonacept, Receives, US, FDA, Orphan Drug Designation, Treat, Pericarditis

5. Merck KGaA Takes an Early Option in its Existing Immuno-Oncology Collaboration with F-star

Published: Jul 17, 2020 | Tags: Merck KGaA, Takes, Early Option, Existing, Immuno-Oncology, Collaboration, F-star

6. Kronos Bio to Acquire Gilead’s SYK Inhibitor Portfolio

Published: Jul 17, 2020 | Tags: Kronos Bio, Acquire, Gilead, SYK Inhibitor, Portfolio, Entospletinib, Lanraplenib

7.  Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

Published: Jul 16, 2020 | Tags: Merck, Bayer, Receive, US, FDA, Priority Review, Vericiguat, Reduce, Risk, CV Death, Patients, Symptomatic Chronic Heart Failure, HFrEF

8.  MSD Collaborates with Novocure to Evaluate Tumor Treating Fields Together with Keytruda (pembrolizumab) in Non-Small Cell Lung Cancer

Published: Jul 15, 2020 | Tags: MSD, Collaborates, Novocure, Evaluate, Tumor Treating Fields, Together, Keytruda, pembrolizumab, Non-Small Cell Lung Cancer

9. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India

Published: Jul 15, 2020 | Tags: Zydus, Initiates, Adaptive, P-I/II, Clinical Study, Evaluating, ZyCoV-D, Against, COVID-19, India

10.  NCCN Collaborates with Pfizer to Explore Adoption of Biosimilars in Oncology

Published: Jul 16, 2020 | Tags: NCCN, Collaborates, Pfizer, Explore, Adoption, Biosimilars, Oncology

11.  AstraZeneca Report Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Acute Ischemic Stroke or Transient Ischemic Attack

Published: Jul 16, 2020 | Tags: AstraZeneca, Report, Results, Brilinta, ticagrelor, P-III, THALES Study, Patients, Acute Ischemic Stroke, Transient Ischemic Attack

12.  Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Published: Jul 16, 2020 | Tags: Novartis, Launches, Zero Profit, Portfolio, Symptomatic Treatment, COVID-19

13.  Medtronic to Acquire Medicrea to Boost its Spine Offerings

Published: Jul 15, 2020 | Tags: Medtronic, Acquire, Medicrea, Boost, Spine Offerings

14.   AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Published: Jul 15, 2020 | Tags: AstraZeneca, University of Oxford, Share, Positive News, COVID-19 Vaccine, Imminently

15.   GSK’s Belantamab Mafodotin Receives the US FDA Advisory Committee’s Recommendation to Treat Relapsed/Refractory Multiple Myeloma

Published: Jul 14, 2020 | Tags: GSK, Belantamab Mafodotin, Receives, US, FDA, Advisory Committee, Recommendation, Treat, Relapsed/Refractory, Multiple Myeloma

16.  3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Published: Jul 14, 2020 | Tags: 3M, Collaborates, MIT, Develop, Paper-Based, Diagnostic Test, COVID-19

17.  Samsung Biologics Signs Multi-Product Development and Manufacturing Agreement with ImmuneOncia

Published: Jul 15, 2020 | Tags: Samsung Biologics, Signs, Multi-Product, Development, Manufacturing, Agreement, ImmuneOncia

18.  Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Published: Jul 14, 2020 | Tags: Moderna, Anticipate, Initiate, Late-stage, COVID-19, Vaccine, Trial, 27 July, 2020

19.   Sanofi and MD Anderson Sign a Five-Year Pact to Expedite Oncology Research and Development

Published: Jul 14, 2020 | Tags: Sanofi, MD Anderson, Sign, Five-Year, Pact, Expedite, Oncology, Research, Development

20.  Merck Signs an Exclusive Agreement with Dewpoint Therapeutics to Develop Curative Treatment for HIV

Published: Jul 13, 2020 | Tags: Merck, Signs, Exclusive Agreement, Dewpoint Therapeutics, Develop, Curative Treatment, HIV

21.  Roche’s Mosunetuzumab Receives the US FDA’s Breakthrough Therapy Designation to Treat Relapsed or Refractory Follicular Lymphoma

Published: Jul 14, 2020 | Tags: Roche, Mosunetuzumab, Receives, US, FDA, Breakthrough Therapy Designation, Treat, Relapsed, Refractory, Follicular Lymphoma

22.  Roche Expands its Collaboration with Immunomedics to Evaluate Tecentriq Based Combination Therapy in Urothelial and Non-Small Cell Lung Cancers

Published: Jul 13, 2020 | Tags: Roche, Expands, Collaboration, Immunomedics, Evaluate, Tecentriq, Based, Combination Therapy, Urothelial, Non-Small Cell Lung Cancers

23.  Roche Signs a ~$1B Agreement with Blueprint Medicines for its Precision Therapy to Treat Patients with RET-Altered Cancer Indications

Published: Jul 14, 2020 | Tags:  Roche, Signs, ~$1B, Agreement, Blueprint Medicines, Precision Therapy, Patients, RET-Altered, Cancer Indications

24. Paige Secures Funding from Goldman Sachs to Continue Innovation in Digital Pathology

Published: Jul 13, 2020 | Tags: Paige, Secures, Funding, Goldman Sachs, Continue, Innovation, Digital Pathology

25.   Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Published: Jul 10, 2020 | Tags: Gilead, Veklury, remdesivir, Receives, the TGA, Approval, Treat, Adults, Adolescent, Severe, COVID-19 Symptoms

26.   Pfizer with its Partner BioNTech Receives the US FDA’s Fast Track Designation for Two mRNA Based Therapies to Treat COVID-19

Published: Jul 13, 2020 | Tags: Pfizer, Partner, BioNTech,, Receives, the US FDA, Fast Track Designation, Two, mRNA, Based, Therapies, Treat, COVID-19

25. Samsung Biologics Expands its Development Partnership with STCube for STM418

Published: Jul 13, 2020 | Tags: Samsung Biologics, Expands, Development, Partnership, STCube, STM418

26.   Roche’s Reports Results of Tecentriq in P-III IMagyn050 Study for Women with 1L Newly Diagnosed Advanced Stage Ovarian Cancer

Published: Jul 13, 2020 | Tags: Roche, Reports, Results, Tecentriq, P-III, IMagyn050 Study, Women, 1L, Newly, Diagnosed, Advanced, Stage, Ovarian Cancer

27.  Biocon’s ALZUMAb (Itolizumab) Receives the DCGI’s Approval for Emergency Use to Treat Patients with Moderate to Severe COVID-19

Published: Jun 11, 2020 | Tags: Biocon, ALZUMAb, Itolizumab, Receives, the DCGI, Approval, Emergency, Use, Treat, Patients, Moderate, Severe, COVID-19