PharmaShots Weekly Snapshot (October 07-11, 2019)

  1. OraSure Technologies’ Rapid Diagnostic OraQuick Ebola Rapid Antigen Test Receives the US FDA Marketing Approval for Detection of Ebola Virus Antigens

Published: Oct 10, 2019 | Tags: Diagnostic, Oraquick Ebola Rapid Antigen Test, Orasure Technologies, Rapid, Receives, The US FDA, Marketing, Approval, Detection, Ebola Virus Antigens

2. Alnylam Reports Submission of MAA to Brazilian Health Regulatory Agency for Onpattro (patisiran) to Treat Hereditary ATTR Amyloidosis with Polyneuropathy

Published: Oct 11, 2019 | Tags: Alnylam, Brazilian Health Regulatory Agency, Hereditary ATTR Amyloidosis, MAA, Onpattro, Patisiran, Polyneuropathy, Reports, Submission, Treat

3. Alexion Signs an Option to Co-Develop and Commercialize Agreement with Stealth for Elamipretide

Published: Oct 10, 2019 | Tags: Agreement, Alexion, Co-Develop, Commercialize, Option, Signs, Stealth

4. Biocon Biologics Signs an In-License Agreement with Just – Evotec Biologics

Published: Oct 10, 2019 | Tags: Agreement, Biocon Biologics, Biosimilar, Assets, In-License, Just – Evotec Biologics, Signs

5.Boehringer Ingelheim’s Ofev (nintedanib) Receives the US FDA’s Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype

Published: Oct 10, 2019 | Tags: Boehringer Ingelheim, Breakthrough Therapy, Chronic Fibrosing ILDs, Designation, Nintedanib, Ofev, Progressive Phenotype, Receives, The US FDA

6. Aclaris to Divest its Rhofade (oxymetazoline hydrochloride) with all IPR Rights to EPI Health

Published: Oct 11, 2019 | Tags: Aclaris, Divest, IPR Rights, Oxymetazoline Hydrochloride, Rhofade

7. Bayer’s G4A Digital Health Partnerships Program Signs an Agreement with Eleven Digital Health Startups Transforming Digital Health Solutions

Published: Oct 11, 2019 | Tags: Agreement, Bayer, Digital Health, Eleven, G4A Digital Health, Partnerships Program, Signs, Solutions, Startups, Transforming

8.Reata Regains Exclusive Worldwide Rights of its Nrf2 Activator Product Platform from AbbVie

Published:  Oct 10, 2019 | Tags: Abbvie, Reata, Regains, Exclusive, Worldwide, Rights, Nrf2 Activator Product, Platform

9.UCB to Acquire Ra Pharma to Improve Therapies for Patients with Myasthenia Gravis and Other Rare Diseases

Published: Oct 10, 2019 | Tags: UCB, Acquire, Ra Pharma, Improve, Therapies, Patients, Myasthenia Gravis, Other Rare Diseases

10.Bayer Launches a LifeHub UK for the Development of AI-Enabled Imaging Solutions Enhancing Data-Driven Drug Discovery and Disease Diagnosis

Published: Oct 10, 2019 | Tags: Bayer, Launches, LifeHub, UK, Development, AI-Enabled, Imaging Solutions, Enhancing, Data-Driven Drug Discovery, Disease Diagnosis

11.Sun Pharma Reports Four Years Result of Ilumya (tildrakizumab-asmn) in P-III reSURFACE 1 and 2 Trials in Patients with Moderate-to-Severe Plaque Psoriasis

Published: Oct 09, 2019 | Tags: Sun Pharma, Reports, Four Years, Result, Ilumya, tildrakizumab-asmn, P-III, reSURFACE 1 and 2, Trials, Patients, Moderate-to-Severe Plaque Psoriasis

12. Boehringer Ingelheim Reports Results of OFEV (nintedanib) in P-III INBUILD Trial for Patients with Chronic Fibrosing Interstitial Lung Disease with Progressive Phenotype (1)

Published: Oct 09, 2019 | Tags: Boehringer Ingelheim, Reports, Results, OFEV, nintedanib, P-III, INBUILD Trial, Patients, Chronic Fibrosing Interstitial Lung Disease, Progressive Phenotype (1)

13.Evotec Signs an Agreement with Celmatix to Develop Pre-Clinical Candidates for Women Health

Published: Oct 09, 2019 | Tags: Evotec, Signs, Agreement, Celmatix, Develop, Pre-Clinical, Candidates, Women Health

14.Mitsubishi Tanabe Signs a License Agreement with Viela Bio for its Inebilizumab

Published: Oct 09, 2019 | Tags: Mitsubishi Tanabe, Signs, License Agreement, Viela Bio, Inebilizumab

15.Bluebird Bio Signs a Three-Year Research Collaboration with Novo Nordisk to Develop In-Vivo Genome Editing Therapies for Hemophilia A

Published: Oct 09, 2019 | Tags: Bluebird Bio, Signs, Three-Year, Research Collaboration, Novo Nordisk, Develop, In-Vivo, Genome Editing Therapies, Hemophilia A

16.GE Healthcare Signs a Worldwide Development and Commercialization Agreement with Theragnostics for Late Stage PSMA Diagnostic for Prostate Cancer

Published: Oct 09, 2019 | Tags: GE Healthcare, Signs, Worldwide, Development, Commercialization, Agreement, Theragnostics, Late Stage, PSMA, Diagnostic, Prostate Cancer

17.Samsung Bioepis Reports Real-World Data of Benepali (biosimilar, etanercept) in Patients with Psoriasis at EADV 2019

Published: Oct 09, 2019 | Tags: Samsung Bioepis, Reports, Real-World Data, Benepali, biosimilar, etanercept, Patients, Psoriasis, EADV 2019

18.Amgen Canada’s EVENITY (romosozumab) Receives Health Canada Approval to Treat Osteoporosis in Postmenopausal Women at High Risk for Fracture

Published: Oct 08, 2019 | Tags: Amgen Canada, EVENITY, romosozumab, Receives, Health Canada, Approval, Treat, Osteoporosis, Postmenopausal Women, High Risk, Fracture

19.Prevail Signs an Agreement with Lonza to Develop and Manufacture AAV9 Gene Therapy Programs for Patients with Neurodegenerative Diseases

Published: Oct 08, 2019 | Tags: Prevail, Signs, Agreement, Lonza, Develop, Manufacture, AAV9 Gene Therapy, Programs, Patients, Neurodegenerative Diseases

20.AstraZeneca Canada’s Calquence (acalabrutinib) Receives Health Canada Approval for Patients Previously Treated with Mantle Cell Lymphoma (MCL)

Published: Oct 08, 2019 | Tags: AstraZeneca Canada, Calquence, acalabrutinib, Receives, Health Canada, Approval, Patients, Previously Treated, Mantle Cell Lymphoma, MCL

21. GSK Signs a Five Years Collaboration with Lyell to Develop Technologies Improving Cell Therapies for Cancer

Published: Oct 09, 2019 | Tags: GSK, Signs, Five Years, Collaboration, Lyell, Develop Technologies, Improving, Cell Therapies, Cancer

22. Gilead Reports Submission of NDA to MHLW for Filgotinib to Treat Rheumatoid Arthritis in Japan

Published: Oct 08, 2019 | Tags: Gilead, Reports, Submission, NDA, MHLW, Filgotinib, Treat, Rheumatoid Arthritis, Japan

23. Novartis’ Beovu (brolucizumab) Receives FDA’s Approval for the Treatment of Wet Age-Related Macular Degeneration

Published: Oct 08, 2019 | Tags:  Novartis, Beovu, brolucizumab, Receives, FDA, Approval, Treatment, Wet Age-Related Macular Degeneration

24. Medtronic Initiates Worldwide Pivotal Study to Evaluate its Extravascular Implantable Cardioverter Defibrillator System

Published: Oct 07, 2019 | Tags: Medtronic, Initiates, Worldwide, Pivotal Study, Evaluate, Extravascular Implantable Cardioverter Defibrillator System

25.MSD Signs a Research and Option to License Agreement with 4D Pharma to Develop Live Biotherapeutics for Vaccines

Published: Oct 08, 2019 | Tags: MSD, Signs, Research, Option to License Agreement, 4D Pharma, Develop, Live Biotherapeutics, Vaccines 

26. Allergan to Launch Three REFRESH RELIEVA Lubricant Eye Drops Expanding its REFRESH Portfolio

Published: Oct 07, 2019 | Tags: Allergan, Launch, Three, REFRESH RELIEVA Lubricant Eye Drops, Expanding, REFRESH Portfolio

27.Innovate Merging with RDD Pharma to Form New Gastroenterology Company Focusing on Specialty Rare and Orphan Diseases

Published: Oct 07, 2019 | Tags: Innovate, Merging, RDD Pharma, New Gastroenterology Company, Focusing, Specialty, Rare, Orphan Diseases

28.Biofourmis’ Biovitals Analytics Engine Receives FDA’s 510(k) Clearance for Ambulatory Physiologic Monitoring

Published: Oct 07, 2019 | Tags: Biofourmis, Biovitals Analytics Engine, Receives, FDA, 510(k), Clearance, Ambulatory Physiologic Monitoring

29.Pfizer Signs an Exclusive Worldwide License Agreement with Akcea for its AKCEA-ANGPTL3-L(Rx)

Published: Oct 07, 2019 | Tags: Pfizer, Signs, Exclusive, Worldwide, License Agreement, Akcea, AKCEA-ANGPTL3-L(Rx)

30.Alvogen and Pfenex’s PF708 (biosimilar, teriparatide) Receives FDA’s Approval for the Treatment of Osteoporosis

Published: Oct 07, 2019 | Tags: Alvogen, Pfenex, PF708, biosimilar, teriparatide, Receives, FDA, Approval, Treatment, Osteoporosis

31. Eli Lilly Report Results of Cyramza (ramucirumab) in P-III RELAY Study for 1L Treatment of EGFR-Mutated Non-Small Cell Lung Cancer

Published: Oct 07, 2019 | Tags: Eli Lilly, Report, Results, Cyramza, ramucirumab, P-III, RELAY Study, 1L, Treatment, EGFR-Mutated, Non-Small Cell Lung Cancer

32. Takeda Signs Multi-Target Strategic Collaboration with Prometheus to Develop Targeted Therapies for Inflammatory Bowel Disease

Published: Oct 03, 2019 | Tags: Takeda, Signs, Multi-Target Strategic Collaboration, Prometheus, Develop, Targeted, Therapies, Inflammatory Bowel Disease

33. AveXis Reports Results of AVXS-101 (Intrathecal) in P-I/II STRONG Study for Patients with SMA Type 2

Published: Oct 05, 2019 | Tags: AveXis, Reports, Results, AVXS-101, intrathecal, P-I/II, STRONG Study, SMA, Type 2 Patients