PharmaShots Weekly Snapshot (September 23– 27, 2019)


1. Incyte Reports Updated Results of Pemigatinib in P-II FIGHT-202 Trial for Patients with Previously Treated Advanced Cholangiocarcinoma

Published: Sept 27, 2019 | Tags: Incyte, Reports, Updated, Results, Pemigatinib, P-II, FIGHT-202 Trial, Patients, Previously, Treated, Advanced, Cholangiocarcinoma

2.Pfizer Reports Results of Abrocitinib in P-III JADE MONO-2 Study for Moderate to Severe Atopic Dermatitis

Published: Sept 27, 2019 | Tags: Pfizer, Reports, Results, Abrocitinib, P-III, JADE MONO-2 Study, Moderate, Severe, Atopic Dermatitis

3. Simcere Signs an Exclusive License Agreement with JW Pharmaceutical for an Anti-Gout Drug Candidate URC-102 in China

Published: Sept 27, 2019 | Tags: Simcere, Signs, Exclusive, License Agreement, JW Pharmaceutical, Anti-Gout Drug Candidate, URC-102, China

4. Ieso Launches Eight Billion Minds Digital Initiative Addressing Unmet Mental Health Needs

Published: Sept 26, 2019 | Tags: Ieso, Launches, Eight Billion Minds, Digital Initiative, Addressing, Unmet, Mental Health Needs

5.Medtronic Reports Results of Resolute Onyx DES in Onyx ONE Global Study for High-Bleeding Risk Patients with One-Month DAPT

Published: Sept 26, 2019 | Tags: Medtronic, Reports, Results, Resolute Onyx DES, Onyx ONE Global Study, High-Bleeding Risk, One-Month DAPT

6. Janssen’s Darzalex (daratumumab) Combination Therapy Receives FDA’s Approval for Frontline Multiple Myeloma

Published: Sept 26, 2019 | Tags: Janssen, Darzalex, daratumumab, Combination Therapy, Receives, FDA, Approval, Frontline Multiple Myeloma

7.AbbVie’s Mavyret (glecaprevir/pibrentasvir) Receives FDA’s Approval for its Expanded Indication in Treatment-Naïve Patients with Chronic Hepatitis C and Compensated Cirrhosis Across All Genotypes

Published: Sept 26, 2019 | Tags: AbbVie, Mavyret, glecaprevir, pibrentasvir, Receives, FDA, Approval, Expanded Indication, Treatment-Naïve Patients, Chronic Hepatitis C, Compensated Cirrhosis

8. Medtronic to Initiate Clinical Study Evaluating Infuse Bone Graft in TLIF Spine Procedures

Published:  Sept 26, 2019 | Tags: Medtronic, Initiate, Clinical Study, Evaluating, Infuse Bone Graft, TLIF Spine Procedures

9. AstraZeneca and Innate Pharma to Advance Monalizumab in a P-III Study for Head and Neck Cancer

Published: Sept 26, 2019 | Tags: AstraZeneca, Innate Pharma, Advance, Monalizumab, P-III, Study, Head and Neck Cancer

10.Jazz Reports Results of JZP-258 in a P-III Study to Treat Cataplexy and Excessive Daytime Sleepiness in Patients with Narcolepsy

Published: Sept 26, 2019 | Tags: Jazz, Reports, Results, JZP-258, P-III, Treat, Cataplexy, EDS, Narcolepsy

11. Thermo Fisher to Expand its Clinical Trials Capabilities and Collaborates with Frontier to Develop Therapy for HIV

Published: Sept 26, 2019 | Tags: Thermo Fisher, Reports, Expansion, Clinical Trials, Capabilities, Collaborates, Frontier, HIV

12.Abbott’sARCHITECT STAT High Sensitivity Troponin-I Blood Test Receives FDA Clearance to Detect Heart Attacks Faster and Accurately

Published: Sept 25, 2019 | Tags: Abbott, ARCHITECT STAT High Sensitivity Troponin-I Blood Test, Receives, FDA, Clearance, Heart Attacks, Faster, Accurately

13. Takeda Reports Results of Vedolizumab in its First Head-to-Head Biologic Study for Ulcerative Colitis

Published: Sept 25, 2019 | Tags: Takeda, Reports, Results, Vedolizumab, First, Head-to-Head, Biologic Study, Ulcerative Colitis

14.Ethicon Launches Echelon Circular as the First Powered Circular Stapler for Colorectal Gastric and Thoracic Surgery

Published: Sept 24, 2019 | Tags: Ethicon, Launches, Echelon Circular, Powered Circular Stapler, Colorectal, Gastric, Thoracic, Surgery

15. Achillion’s Danicopan (ACH-4471) Receives FDA’s Breakthrough Therapy Designation for Paroxysmal Nocturnal Hemoglobinuria

Published: Sept 25, 2019 | Tags: Achillion, Danicopan, ACH-4471, Receives, FDA, Breakthrough Therapy Designation, Paroxysmal Nocturnal Hemoglobinuria

16. Bavarian Nordic’s Jynneos Vaccine Receives FDA’s Approval to Prevent Smallpox and Monkeypox Disease in Adults

Published: Sept 24, 2019 | Tags: Bavarian Nordic, Jynneos Vaccine, Receives, FDA, Approval, Prevent, Smallpox, Monkeypox Disease, Adults

17.Amgen Reports Results of Blincyto (blinatumomab) in Two P-III Studies for Relapsed Acute Lymphoblastic Leukemia in Pediatric Patients

Published: Sept 24, 2019 | Tags: Amgen, Reports, Results, Blincyto, blinatumomab, Relapsed Acute Lymphoblastic Leukemia, Pediatric Patients

18. Pfizer Expands its Collaboration with Flatiron Health to Integrate the Use of Real-World Evidence in Oncology

Published: Sept 24, 2019 | Tags: Pfizer, Expands, Collaboration, Flatiron Health, Integrate, Real-World Evidence, Oncology

19.Biocon Biologics Acquires Pfizer’s Research Facility to Expand its Research and Development Footprint

Published: Sept 24, 2019 | Tags: Biocon Biologics, Acquires, Pfizer, Research Facility, Expand, R&D Footprints

20.Aldeyra’s ADX-2191 Receives FDA’s Fast Track Designation to Prevent Proliferative Vitreoretinopathy

Published: Sept 03, 2019 | Tags: Aldeyra, ADX-2191, Receives, FDA, Fast Track Designation, Prevent, Proliferative Vitreoretinopathy

21.BMS’ Opdivo (nivolumab) Receives CHMP Recommendation for Approval of its Four-Week Dosing Schedule

Published: Sept 24, 2019 | Tags: BMS, Opdivo, nivolumab, Receives, CHMP, Recommendation, Approval, Four-Week Dosing Schedule

22. Takeda Collaborates with Evotec to Discover Clinical Candidates for Multiple Therapeutic Areas

Published: Sept 24, 2019 | Tags: Takeda, Collaborates, Evotec, Discover, Clinical Candidates, Multiple Therapeutic Areas

23. Bayer Collaborate with Women’s Hospital and Massachusetts General Hospital to Launch Joint Lab Targeting Chronic Lung Diseases

Published: Sept 24, 2019 | Tags: Bayer, Collaborates, Women’s Hospital, Massachusetts General Hospital, Launch, Joint, Chronic Lung Diseases

24. Sandoz Voluntary Recalls Ranitidine Hydrochloride Capsules Due to Elevated Amount of N-Nitrosodimethylamine in the US

Published: Sept 23, 2019 | Tags: Sandoz, Voluntary, Recalls, Ranitidine Hydrochloride, N-Nitrosodimethylamine, US

25. Bayer’s Vitrakvi (larotrectinib) Receives EMA’s Approval as the First Tumor Agonist in Europe

Published: Sept 23, 2019 | Tags: Bayer, Vitrakvi, larotrectinib, Receives, EMA, Approval, First Tumor Agonist, Europe

26. MSD Collaborates with I-Mab to Evaluate Keytruda + TJC4 for Multiple Cancer Indications

Published: Sept 23, 2019 | Tags: MSD, I-Mab, Enters, Clinical Collaboration, Evaluate, Keytruda, TJC4, Cancer

27.Mallinckrodt Reports Results of StrataGraft Regenerative Tissue in P-III STRATA2016 Study for Deep Partial-thickness Thermal Burns

Published: Sept 23, 2019 | Tags: Mallinckrodt, Reports, Results, StrataGraft Regenerative Tissue, P-III, STRATA2016, Study, Deep Partial-thickness Thermal Burns

28. Celltrion’s CT-P13 (biosimilar, infliximab) Receives CHMP’s Positive Opinion for its SC Formulation to Treat Rheumatoid Arthritis

Published: Sept 23, 2019 | Tags: Celltrion, CT-P13, biosimilar, infliximab, Receives, CHMP Positive Opinion, SC Formulation, Rheumatoid Arthritis

29. Biogen’s Plegridy (peginterferon beta-1a) and Avonex (interferon beta-1a) Receive CHMP’s Positive Opinion to Use During Pregnancy and Breastfeeding

Published: Sept 23, 2019 | Tags: Biogen, Plegridy, peginterferon beta-1a, Avonex, interferon beta-1a, Receive, CHMP, Positive Opinion, Pregnancy, Breastfeeding

30.Clovis Oncology Signs a License Agreement with 3B Pharmaceuticals for FAP-Targeted Radiopharmaceutical Program

Published: Sept 23, 2019 | Tags: Clovis Oncology, Signs, License Agreement, 3B Pharmaceuticals, FAP-Targeted Radiopharmaceutical Program

31. Novo Nordisk’s Rybelsus (semaglutide) Receives FDA’s Approval as the First Oral GLP-1 analog for Type 2 Diabetes

Published: Sept 23, 2019 | Tags: Novo Nordisk, Rybelsus, semaglutide, Receives, FDA, Approval, GLP-1 Analog, Type 2 Diabetes