PharmaShots Weekly Snapshot (September 02 – 06, 2019)

1.Roche’s Tecentriq + Chemotherapy Receives EC’s Approval as 1L Treatment for Extensive Stage Small Cell Lung Cancer

Published: Sept 06, 2019 | Tags: Roche, Tecentriq, Chemotherapy, Receives, EC, Approval, Initial Treatment, Extensive Stage Small Cell Lung Cancer

2. OncoCyte to Acquire Razor Genomics for the Expansion of its Capabilities in Early-Stage Lung Cancer

Published: Sept 05, 2019 | Tags: Novartis, Signs, Option Agreement, Iconic Therapeutics, Ophthalmology Program

3. BMS Reports Results of Opdivo (nivolumab) in P-III CheckMate-548 Study for Patients Newly Diagnosed with MGMT-Methylated Glioblastoma Multiforme

Published: Sept 05, 2019 | Tags: BMS, Nivolumab, MGMT-Methylated Glioblastoma Multiforme, NewlyDiagnosed, Opdivo, P-III, Checkmate-548, Study, Patients, Reports, Results

4. SpeeDx’s ResistancePlus MG FleXible Receives CE-IVD Clearance for Detection of Sexually Transmitted Infection (STI)

Published: Sept 06, 2019 | Tags: Cantargia, Extends, Licensing Agreement, BioWa, POTELLIGENT Technology

5.AstraZeneca Signs a License Agreement with Theragnostics for its PARP Inhibitor

Published: Sept 06, 2019 | Tags: AstraZeneca, Signs, License Agreement, Theragnostics, PARP Inhibitor

6.Takeda Recalls Natpara (parathyroid hormone) Injection Formulation in the US

Published: Sept 06, 2019 | Tags: Takeda, Recalls, Natpara, parathyroid hormone, Injection, US

7.Roche’s Tecentriq Based Combination Therapy Receives EC’s Approval as 1L Treatment for Non-Squamous Non-Small Cell Lung Cancer

Published:  Sept 06, 2019 | Tags:  Roche, Tecentriq, EC, Approval, 1L, Treatment, Non-Squamous Non-Small Cell Lung Cancer

8.Novartis Signs an Exclusive Research and Option to Acquire Agreement with IFM Due to Develop Therapies Targeting cGAS/STING Pathway

Published: Sept 05, 2019 | Tags: Novartis, Enters, Exclusive, Option Agreement, IFM Therapeutics, Develop, Therapies, Targeting, cGAS/STING Pathway

9.AbbVie Signs a Research Agreement with Idera Pharmaceuticals to Evaluate Combination Therapy

Published: Sept 04, 2019 | Tags: AbbVie, Signs, Research Agreement, Idera Pharmaceuticals, Evaluate; Combination Therapy

10.Janssen’s Stelara (ustekinumab) Receives EC’s Approval for its Expanded Use to Treat Moderately to Severely Active Ulcerative Colitis

Published: Sept 04, 2019 | Tags: Janssen, Stelara, ustekinumab, Receives, European Commission, Approval, Expanded Use, Moderately to Severely Active Ulcerative Colitis

11. BioNTech Signs an Agreement with Gates Foundation to Develop Therapies for HIV and Tuberculosis

Published: Sept 04, 2019 | Tags: BioNTech, Signs, Agreement, Gates Foundation, Develop, HIV, Tuberculosis

12.Google Collaborates with Cochlear and GN Hearing to Support Direct Phone Streaming to Hearing Aids for Patients with Hearing Loss

Published: Sept 05, 2019 | Tags: Google, Collaborates, Cochlear, GN Hearing, Support, Direct Phone Streaming, Hearing Aids

13.AstraZeneca Collaborates with Schrödinger to Utilize its Molecule-Modeling Platform for Drug Discovery

Published: Sept 04, 2019 | Tags: AstraZeneca, Collaborates, Schrödinger, Molecule-Modeling Platform, Drug Discovery

14.BMS Signs an Agreement with BioMotiv to Develop Therapies for Patients with Serious Disorder

Published: Sept 04, 2019 | Tags: BMS, BioMotiv, Agreement, Serious Disorders, Develop, Therapies

15.Regenxbio Signs an Exclusive Worldwide Option and License Agreement with Clearside Biomedical to Evaluate its Delivery Platform for RGX-314

Published: Sept 04, 2019 | Tags: Regenxbio, Signs, Exclusive, Worldwide, Option and License Agreement, Clearside Biomedical, Evaluate, Delivery Platform, RGX-314

16.Janssen’s Investigational Prophylactic Vaccine Receives the US FDA’s Breakthrough Therapy Designation to Prevent Respiratory Syncytial Virus

Published: Sept 03, 2019 | Tags: Janssen, Investigational, Prophylactic Vaccine, Receives, US FDA, Breakthrough Therapy Designation, Respiratory Syncytial Virus

17.Karolinska Institutet Evaluates AsthmaTuner Self-monitoring Mobile App for Managing Uncontrolled Asthma

Published: Sept 03, 2019 | Tags: Vivus, Reports, Results, Qsymia, Pilot Clinical Study, Patients, Laparoscopic Sleeve Gastrectomy Surgery

18. Merck’s Keytruda (pembrolizumab) in Combination with Inlyta (axitinib) Receives European Commission’s Approval as a 1L Therapy for Advanced Renal Cell Carcinoma

Published: Sept 04, 2019 | Tags: Merck, Keytruda, pembrolizumab, Inlyta, axitinib, European Commission, Approval, 1L, Therapy, Advanced Renal Cell Carcinoma

19.Karolinska Institutet Evaluates AsthmaTuner Self-monitoring Mobile App for Managing Uncontrolled Asthma

Published: Sept 03, 2019 | Tags: Karolinska Institutet, Evaluates, AsthmaTuner, Self-monitoring, Mobile App, Uncontrolled Asthma

20.Boehringer Ingelheim Enters into a Licensing Agreement with Lupin to Expand its KRAS Cancer Program

Published: Sept 04, 2019 | Tags: Boehringer Ingelheim, Enters, Licensing Agreement, Lupin, Expand, KRAS Cancer Program

21.AstraZeneca’s Tagrisso (osimertinib) Receives NMPA’s Approval as a 1L Therapy for EGFR-Mutated Non-Small Cell Lung Cancer in China

Published: Sept 04, 2019 | Tags: AstraZenca, Tagrisso, osimertinib, Receives, NMPA, Approval, 1L, Therapy, EGFR Mutated Non-Small Cell Lung Cancer, China

22. Celltrion Enters into a Contract to Manufacture Agreement for its Remsima (biosimilar, infliximab) with Lonza

Published: Sept 03, 2019 | Tags: Celltrion, Enters, Contract to Manufacture, Agreement, Lonza, Biosimilar, Remsima

23.Vertex to Acquire Semma Therapeutics for Developing Curative Cell-Based Therapies to Treat Type 1 Diabetes

Published: Sept 03, 2019 | Tags: Vertex, Acquire, Semma Therapeutics, Developing, Curative Cell-Based Therapies, Type 1 Diabetes

24.Alytas Therapeutics Signs an Agreement with Velabs Therapeutics to Develop Novel Immune-Based Therapy for Obesity

Published: Sept 03, 2019 | Tags: Alytas Therapeutics, Signs, Agreement, Velabs Therapeutics, Develop, Novel, Immune-Based Therapy, Obesity

25. The European Society of Cardiology Recommends Bayer’s Xarelto (rivaroxaban) in Combination with Aspirin for the Management of Diabetes and Chronic Coronary Syndromes

Published: Sept 02, 2019 | Tags: The European Society of Cardiology, Recommends, Bayer, Xarelto, rivaroxaban, Aspirin, Diabetes, Chronic Coronary Syndromes

26.Polpharma Signs an Exclusive Worldwide Commercialization Agreement with Sandoz for Proposed Biosimilar Natalizumab to Treat Relapsing-Remitting Multiple Sclerosis

Published: Sept 03, 2019 | Tags: Polpharma, Signs, Exclusive, Worldwide, Commercialization, Agreement, Sandoz, Proposed Biosimilar, Natalizumab, Relapsing-Remitting Multiple Sclerosis

27.Helsinn Enters into an Exclusive Distribution and License Agreement with Blanver and Varifarma for Pracinostat in South America

Published: Sept 02, 2019 | Tags: Helsinn, Enters, Exclusive, Distribution, License, Agreement, Blanver, Varifarma, Pracinostat, South America

28. Boehringer Ingelheim and Zealand Pharma to Initiate P-II Study of BI 456906 for Obesity and Diabetes

Published: Sept 03, 2019 | Tags: Boehringer Ingelheim, Zealand Pharma, Initiate, P-II Study, BI 456906, Obesity, Diabetes

29.AstraZeneca Reports Detailed Results of Farxiga (dapagliflozin) in P-III DAPA-HF Study to Treat Patients with Heart Failure

Published: Sept 01, 2019 | Tags: AbbVie, Rinvoq, upadacitinib, Receives, US, FDA, Approval, Moderate, Severe, Rheumatoid Arthritis

30.Chugai Files an Application to MHLW for an Additional Indication of Kadcyla (trastuzumab emtansine) as an Adjuvant Therapy for HER2-Positive Early Breast Cancer in Japan

Published: Aug 30, 2019 | Tags: AbbVie, Rinvoq, upadacitinib, Receives, US, FDA, Approval, Moderate, Severe, Rheumatoid Arthritis

31.AstraZeneca Reports Results of Brilinta (ticagrelor) in P-III THEMIS Study for Coronary Artery Disease and Type-2 Diabetes

Published: Sept 01, 2019 | Tags: AbbVie, Rinvoq, upadacitinib, Receives, US, FDA, Approval, Moderate, Severe, Rheumatoid Arthritis

32.UniSA Evaluates Computer Vision Technology to Monitor Premature Babies in Neonatal Units

Published: Aug 30, 2019 | Tags: AbbVie, Rinvoq, upadacitinib, Receives, US, FDA, Approval, Moderate, Severe, Rheumatoid Arthritis

33.Novartis Reports Results of Entresto (sacubitril/valsartan) in Three P-III PARAGON-HF and P-IV PROVE-HF with EVALUATE-HF Studies for Patients with HFpEF and HFrEF

Published: Aug 06, 2019 | Tags: AbbVie, Rinvoq, upadacitinib, Receives, US, FDA, Approval, Moderate, Severe, Rheumatoid Arthritis

34.Roche Reports Positive Results of Xofluza (baloxavir marboxil) in Two P-III MINISTONE-2 and BLOCKSTONE Studies for Influenza Infection

Published: Sept 02, 2019 | Tags: AbbVie, Rinvoq, upadacitinib, Receives, US, FDA, Approval, Moderate, Severe, Rheumatoid Arthritis