PharmaShots Weekly Snapshot (Jun 22- 26, 2020)

 1.  EMA’s CHMP Recommends the Approval of Two Biosimilar Referencing Lilly’s Forsteo (teriparatide) for the Treatment of Osteoporosis

Published: Jun 26, 2020 | Tags: EMA, CHMP, Recommend, Approval, Two, Biosimilar, Referencing, Lilly, Forsteo, teriparatide, Osteoporosis

2.  Medtronic Receives the US FDA’s Approval for its Percept PC Neurostimulator with BrainSense Technology

Published: Jun 25, 2020 | Tags: Medtronic, Receives, US, FDA, Approval, Percept PC Neurostimulator, BrainSense Technology

 3. Sandoz Launches the Biosimilars Generation Campaign in Canada

Published: Jun 25, 2020 | Tags: Sandoz, Launches, Biosimilars Generation Campaign, Canada

4.  Roche Launches uPath PD-L1 (SP263) Automated Digital Pathology Algorithm to Speed Up NSCLC Diagnosis

Published: Jun 26, 2020 | Tags: Roche, Launches, uPath PD-L1, SP263, Automated, Digital Pathology Algorithm, Speed Up, NSCLC Diagnosis

5. EMA Anticipates the EC’s Conditional Marketing Authorization for Gilead’s Remdesivir in Coming Week

Published: Jun 25, 2020 | Tags: EMA, Anticipates, EC, Conditional Marketing Authorization, Gilead, Remdesivir, Imminently

6.  Zogenix’s Fintepla (fenfluramine) Receives the US FDA’s Approval for the Treatment of Seizures Associated with Dravet Syndrome

Published: Jun 25, 2020 | Tags: Zogenix, Fintepla, fenfluramine, Receives, US, FDA, Approval, Treatment, Seizures, Associated, Dravet Syndrome

7.  AbbVie Signs an Exclusive Research and Option to License Agreement with Sosei Heptares Targeting Inflammatory and Autoimmune Diseases

Published: Jun 25, 2020 | Tags: AbbVie, Signs, Exclusive, Research, Option to License, Agreement, Sosei Heptares, Targeting, Inflammatory, Autoimmune Diseases

8.  Theravance Reports First Patient Dosing in a P-II Study of TD-0903 for Hospitalized Patients with Acute Lung Injury Associated with COVID-19

Published: Jun 25, 2020 | Tags: Theravance, Reports, First, Patients, Dosing, P-II Study, TD-0903, Hospitalized, Patients, Acute Lung Injury, Associated, COVID-19

9. Fulcrum Initiates P-III LOSVID Study Evaluating Losmapimod for Patients Hospitalized with COVID-19

Published: Jun 25, 2020 | Tags: Fulcrum, Initiates, P-III, LOSVID, Study, Evaluating, Losmapimod, Patients, Hospitalized, COVID-19

10.  Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Patients with Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma

Published: Jun 24, 2020 | Tags: Merck, Keytruda, pembrolizumab, Receives, US, FDA, Approval, Patients, Recurrent, Metastatic, Cutaneous Squamous Cell Carcinoma

11.  AstraZeneca Reports Results of Breztri Aerosphere in P-III ETHOS Study to Treat COPD

Published: Jun 24, 2020 | Tags: AstraZeneca, Reports, Results, Breztri Aerosphere, P-III, ETHOS Study, Treat, COPD

12.  Merck Collaborates with Yumanity to Accelerate the Development of Two Therapies Targeting Neurodegenerative Diseases

Published: Jun 24, 2020 | Tags: Merck, Collaborates, Yumanity, Accelerate, Development, Two, Therapies, Targeting, Neurodegenerative Diseases

13.  CSL Behring to Acquire uniQure’ Hemophilia B Candidate (AMT-061) for ~$2B

Published: Jun 24, 2020 | Tags: CSL Behring, Acquire, uniQure, Heamophilia B, Candidate, AMT-061, ~$2B

14.   FibroGen Report Enrollment of First Patient in P-II Study Evaluating Pamrevlumab in Patients Hospitalized with Acute COVID-19

Published: Jun 24, 2020 | Tags: FibroGen, Report, Enrollment, First Patient, P-II, Study, Evaluating, Pamrevlumab, Patients, Hospitalized, Acute, COVID-19

15.   The US FDA Launches Project Patient Voice to Share Patient-Reported Outcomes from Cancer Trials

Published: Jun 24, 2020 | Tags: US, FDA, Launches, Project Patient Voice, Share, Patient Reported Outcomes, Cancer Trials

16.   AstraZeneca Signs an Agreement with Symbiosis for Sterile Manufacturing of its AZD1222 Against COVID-19

Published: Jun 24, 2020 | Tags: AstraZeneca, Signs, Agreement, Symbiosis, Sterile Manufacturing, AZD1222, Against, COVID-19

17. Sarepta Signs a Two-Year Research and Option Agreement with Codiak for Up to Five Neuromuscular Targets

Published: Jun 24, 2020 | Tags: Sarepta, Signs, Two-Year, Research and Option, Agreement, Codiak, Up to, Five, Neuromuscular Targets

18. Gilead Holds an Exclusive Option to Acquire Pionyr Immunotherapeutics for ~$1.75B

Published: Jun 24, 2020 | Tags: Gilead, Holds, Exclusive, Option to Acquire, Pionyr Immunotherapeutics, ~$1.75B

19.  Sanofi Anticipates the Approval of its COVID-19 Vaccine by First Half of 2021

Published: Jun 23, 2020 | Tags: Sanofi, Anticipates, Approval, COVID-19, Vaccine, First Half, 2021

20.   Schrodinger Expands its Drug Discovery Efforts Against COVID-19 Deploying Parallel Computing on Google Cloud

Published: Jun 23, 2020 | Tags: Schrödinger, Expands, Drug Discovery, Efforts, Against, COVID-19, Deploying, Parallel Computing, Google Cloud

21. BioInvent Reports the Enrollment of First Patient in P-I/IIa Study of BI-1206 + Keytruda for Solid Tumors

Published: Jun 23, 2020 | Tags: BioInvent, Reports, Enrollment, P-I/IIa, Study, BI-1206, Keytruda, Solid Tumors

22.  ATAI Launches IntroSpect Digital Therapeutics to Foster Mental Health Care

Published: Jun 22, 2020 | Tags: ATAI, Launches, IntroSpect Digital Therapeutics, Foster, Mental Health Care

23. AbbVie Reports the US FDA’s Acceptance of BOTOX’s sBLA for Pediatric Patients with Neurogenic Detrusor Overactivity

Published: Jun 22, 2020 | Tags: AbbVie, Reports, US, FDA, Acceptance, BOTOX, sBLA, Pediatric Patients, Neurogenic Detrusor Overactivity

24.  Sanofi Expands its 2018 Collaboration with Translate Bio to Develop mRNA Vaccines Against Infectious Diseases

Published: Jun 22, 2020 | Tags:  Sanofi, Expands, 2018, Collaboration, Translate Bio, develop, mRNA, Vaccines, Against, Infectious Diseases

25.  Gilead to Initiate P-I Study Evaluating Inhaled Version of Remedesivir Against COVID-19 in August 2020

Published: Jun 22, 2020 | Tags: Gilead, Initiate, P-I, Study, Evaluating, Inhaled Version, Remedesivir, Against, COVID-19, August, 2020

26.  Merck’s Keytruda Receives the NMPA’s Approval as a 2L Treatment for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Published: Jun 21, 2020 | Tags: Foundation Medicine, Acquires, Lexent, Expand, Liquid Biopsy Platforms

27. Cipla Launches Cipremi (remdesivir lyophilized powder for injection 100 mg) to Treat Patients with Severe COVID-19

Published: Jun 20, 2020 | Tags: Cipla, Launches, Cipremi, Remdesivir, Patients, COVID-19

28. Novartis Halts Clinical Trial Evaluating Hydroxychloroquine Against COVID-19 Due to Slow Enrollment

Published: Jun 20, 2020 | Tags: Eli Lilly, Initiates, P-III, Study, Evaluating, Baricitinib, Hospitalized, Patients, COVID-19

29.  Merck KGaA and Pfizer Report EMA’s Validation for Bavencio (avelumab) as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Published: Jun 21, 2020 | Tags: Gilead, Signs, License Agreement, Zydus, Dr. Reddy’s, Remdesivir, Treat, COVID-19

30. Glenmark Launches FabiFlu (favipiravir) as the First Oral Medication to Treat Mild to Moderate COVID-19 in India

Published: Jun 21, 2020 | Tags: AstraZeneca, Supply, 400M, Doses, Vaccines, IVA, End, 2020