PharmaShots Weekly Snapshot (August 19 – 23, 2019)

1. OxThera’s Oxabact Receives EMA’s Positive Decision on Pediatric Investigational Plan to Treat Primary Hyperoxaluria

Published: Aug 23, 2019 | Tags: OxThera, Oxabact, Receives, EMA, Positive Decision, Pediatric Investigational Plan, Treat, Primary Hyperoxaluria

2.Novartis Signs an Option Agreement with Iconic Therapeutics for its Ophthalmology Program

Published: Aug 22, 2019 | Tags: Novartis, Signs, Option Agreement, Iconic Therapeutics, Ophthalmology Program

3.Roche’s Tecentriq (atezolizumab) Receives MHLW’s Approval as the First Immunotherapy for Extensive-Stage Small Cell Lung Cancer in Japan

Published: Aug 22, 2019 | Tags: Roche, Tecentriq, atezolizumab, Receives, MHLW, Approval, First, Immunotherapy, Extensive-Stage Small Cell Lung Cancer, Japan

4.Cantargia Extends its Licensing Agreement with BioWa for its POTELLIGENT Technology

Published: Aug 23, 2019 | Tags: Cantargia, Extends, Licensing Agreement, BioWa, POTELLIGENT Technology

5.Amgen and Allergan Report Results of ABP 798 (biosimilar, rituximab) in JASMINE Study for Non-Hodgkin’s Lymphoma

Published: Aug 23, 2019 | Tags: Amgen, Allergan, Report, Results, ABP 798, biosimilar, rituximab, JASMINE, Study, Non-Hodgkin’s Lymphoma

6.MSD Signs an Exclusive License and Research Agreement with Themis Bioscience to Develop Vaccine Therapies

Published: Aug 22, 2019 | Tags: MSD, Signs, Exclusive, License, Research, Agreement, Themis Bioscience, Develop, Vaccine Therapies

7.AstraZeneca Signs an Agreement with Sobi to Buy its Priority Review Voucher for $95M

Published:  Aug 22, 2019 | Tags:  AstraZeneca, Agreement, Sobi, Buy, Priority Review Voucher, $95M

8.Innovent Signs a License Agreement with Eli Lilly to Develop and Commercialize OXM3 in China

Published: Aug 22, 2019 | Tags: Innovent, Signs, License, Agreement, Eli Lilly, Develop, Commercialize, OXM3, China

9.AstraZeneca and FibroGen’s Roxadustat Receive NMPA’s Approval for the Treatment of Anemia in Non-Dialysis-Dependent Patients with Chronic Kidney Disease in China

Published: Aug 22, 2019 | Tags: AstraZeneca, FibroGen, Roxadustat, Receives, NMPA, Approval, Anemia, Non-Dialysis-Dependent, Chronic Kidney Disease, China

10.Biocon Receives EU’s GMP Certification for its Semglee (biosimilar, Insulin Glargine) Manufacturing Facility in Malaysia

Published: Aug 22, 2019 | Tags: Biocon, Semglee, biosimilar, Insulin Glargine, Manufacturing Facility, Receives, EU, GMP, Certification, Malaysia

11.Janssen’s Darzalex (daratumumab) Receives MHLW’s Approval for Transplant Ineligible Patients with Multiple Myeloma in Japan

Published: Aug 22, 2019 | Tags: Janssen, Darzalex, daratumumab, Receives, MHLW, Approval, Transplant Ineligible Patients, Multiple Myeloma, Japan

12.Pfizer to Invest $500M in State-of-the-Art Gene Therapy Facility in North Carolina

Published: Aug 21, 2019 | Tags: Pfizer, Invest, $500M, state-of-the-art Gene Therapy, Facility, North Carolina

13.Orexo Enters into an Agreement with GAIA to Develop and Commercialize Digital Therapy for Opioid Use Disorder

Published: Aug 20, 2019 | Tags: Orexo, Enters, Agreement, GAIA, Develop, Commercialize, Digital Therapy, Opioid Use Disorder

14.BioInvent to Initiate P-I/IIa Study with BI-1206 in Combination with Merck’s Keytruda (pembrolizumab) for Solid Tumors

Published: Aug 21, 2019 | Tags: BioInvent, Initiate, P-I/IIa, Study, BI-1206, Merck, Keytruda, pembrolizumab, Solid Tumors

15.GSK Reports Submission of NDA to MHLW for Daprodustat to Treat Patients with Renal Anaemia due to Chronic Kidney Disease in Japan

Published: Aug 21, 2019 | Tags: GSK, Reports, Submission, NDA, MHLW, Daprodustat, Renal Anaemia, Chronic Kidney Disease, Japan

16.AstraZeneca Reports Results of Imfinzi (durvalumab) + Tremelimumab in P-III NEPTUNE Study for Stage IV Non-Small Cell Lung Cancer

Published: Aug 21, 2019 | Tags: AstraZeneca, Reports, Results, Imfinzi, durvalumab, Tremelimumab, P-III, NEPTUNE, Study, Stage IV, Non-Small Cell Lung Cancer

17.Vivus Reports Results of Qsymia in Pilot Clinical Study for Patients with Laparoscopic Sleeve Gastrectomy Surgery

Published: Aug 20, 2019 | Tags: Vivus, Reports, Results, Qsymia, Pilot Clinical Study, Patients, Laparoscopic Sleeve Gastrectomy Surgery

18.Biotheus Enters into an Agreement with Alligator Bioscience to Develop Bispecific Molecules in Greater China

Published: Aug 20, 2019 | Tags: Biotheus, Enters, Antibody, Agreement, Alligator Bioscience, Greater China

19. Gedeon Richter Launches Terrosa (biosimilar, teriparatide) in Europe

Published: Aug 20, 2019 | Tags: Gedeon Richter, Launches, Terrosa, biosimilar, teriparatide, Europe

20.Elanco To Acquire Bayer’s Animal Health Business for $7.6B

Published: Aug 20, 2019 | Tags: Elanco, Acquire, Bayer, Animal Health Business, $7.6B

21.Nabriva’s Xenleta (lefamulin) Receives FDA’s Approval for the Treatment of Community-Acquired Bacterial Pneumonia in Adults

Published: Aug 19, 2019 | Tags: Nabriva, Xenleta, lefamulin, Receives, FDA, Approval, Treatment, Community Acquired Bacterial Pneumonia, Adults

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

Published: Aug 20, 2019 | Tags: AstraZeneca, Reports, Results, Farxiga, dapagliflozin, P-III, DAPA-HF, Study, Treat, Patients, Heart Failure

23.Boston Scientific’s ImageReady MRI For Vercise Gevia Deep Brain Stimulation System Receives FDA’s Approval for Parkinson’s Disease

Published: Aug 20, 2019 | Tags: Boston Scientific, ImageReady MRI, Vercise Gevia, Deep Brain Stimulation System, Receives, FDA, Approval, Parkinson’s Disease

24.Dr. Reddy’s Laboratories Launches Versavo (biosimilar, bevacizumab) for Multiple Cancer Indications in India

Published: Aug 19, 2019 | Tags: Dr. Reddy’s Laboratories, Launches, Versavo, biosimilar, bevacizumab, Cancers, India

25.Glenmark’s Combination Therapy of Remogliflozin Etabonate + Metformin Hydrochloride Receive Approval for Type 2 Diabetes in India

Published: Aug 19, 2019 | Tags: Glenmark, Combination Therapy, Remogliflozin Etabonate, Metformin Hydrochloride, Receive, Approval, Type 2 Diabetes, India

26.CVRx’s Barostim Neo Device Receives the US FDA’s Approval as World’s First Heart Failure Neuromodulation Device

Published: Aug 16, 2019 | Tags: CVRx, Barostim Neo, Device, Receives, US, FDA, Approval, World, First, Heart Failure Neuromodulation Device

27.Alcon to Launch PRECISION1 Daily Disposable Contact Lenses in the US

Published: Aug 19, 2019 | Tags: Alcon, Launch, PRECISION1, Daily, Disposable, Contact Lenses, US

28.Celgene’s Inrebic (fedratinib) Receives the US FDA’s Approval for Myelofibrosis

Published: Aug 16, 2019 | Tags: Celgene, Inrebic, fedratinib, Receives, US, FDA, Approval, Myelofibrosis

29.AbbVie’s Rinvoq (upadacitinib) Receives the US FDA’s Approval for Moderate to Severe Rheumatoid Arthritis

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