PharmaShots Weekly Snapshot (Aug 24 -28, 2020)

1. Taysha Gene Therapies’ TSHA-101 Receives the US FDA’s Orphan Drug Designation and Rare Pediatric Disease Designation for GM2 Gangliosidosis

Published: Aug 27, 2020 | Tags:  Taysha Gene Therapies, TSHA-101, Receives, US, FDA, Orphan Drug Designation, Rare Pediatric Disease Designation, GM2 Gangliosidosis

2. Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

Published: Aug 28, 2020 | Tags:  Bayer, Reports, NDA, Submission, NMPA, Chronic Heart Failure, China, Vericiguat

3. Galecto’s GB0139 Receives the US FDA’s and EMA’s Orphan Drug Designations for Idiopathic Pulmonary Fibrosis

Published: Aug 27, 2020 | Tags: Galecto, GB0139, Receives, US, FDA, EMA, Orphan Drug Designations, Idiopathic Pulmonary Fibrosis

4. Philips to Acquire Intact Vascular for $360M

Published: Aug 27, 2020 | Tags: Philips, Acquire, Intact Vascular, $360M

5. BioNTech and Fosun Pharma to Supply ~10M Doses of COVID-19 Vaccine to Hong Kong and Macao

Published: Aug 27, 2020 | Tags: BioNTech, Fosun Pharma,  Supply, ~10M, Doses, COVID-19 Vaccine, Hong Kong, Macao

6. Amazon Enters into Fitness Space with the Launch of Halo Band and App

Published: Aug 27, 2020 | Tags: Amazon, Enters, Fitness Space, Launch, Halo Band

7. BeiGene Signs an Exclusive License Agreement with Singlomics for Neutralizing COVID-19 Antibodies

Published: Aug 27, 2020 | Tags: BeiGene, Signs, Exclusive, License Agreement, Singlomics, Neutralizing, COVID-19, Antibodies

8. Abbott’s BinaxNOW COVID-19 Ag Card Receives the US FDA’s EUA to Detect COVID-19

Published: Aug 27, 2020 | Tags: Abbott, BinaxNOW COVID-19 Ag Card, Receives, US, FDA, EUA, Detect, COVID-19

9. FDC Launches Two Variants of Favipiravir for COVID-19 in India

Published: Aug 26, 2020 | Tags:  FDC, Launches, Two Variants, Favipiravir, COVID-19, India

10. Celltrion Initiates P-I Study of CT-P59 Against COVID-19 in Korea

Published: Aug 26, 2020 | Tags:  Celltrion, Initiates, P-I, Study, CT-P59, COVID-19, Korea

11. GSK’s Blenrep (belantamab mafodotin) Receives EC’s Approval for R/R Multiple Myeloma

Published: Aug 26, 2020 | Tags:  GSK, Blenrep, (belantamab mafodotin), Receives, EC’s, Approval, R/R, Multiple Myeloma

12. Lupin and Mylan Launch Nepexto (biosimilar, etanercept) in Germany

Published: Aug 26, 2020 | Tags: Fitbit, Report, Results, COVID-19, Study, Early, Detection, Diseases

13. Takeda Collaborates with Engitix to Target Fibrotic Liver Diseases

Published: Aug 26, 2020 | Tags: Takeda, Collaborates, Engitix, Target, Fibrotic Liver Diseases

14. Philips and B. Braun’s Onvision Needle Tip Tracking Technology Receive the US FDA’s 510 (k) Clearance for Regional Anesthesia

Published: Aug 25, 2020 | Tags: Philips, B. Braun, Onvision Needle Tip Tracking Technology, Receive, US, FDA, 510 (k) Clearance, Regional Anesthesia

15. Qiagen to Launch Digital Test for Detecting SARS-CoV-2 Antibodies in the US

Published: Aug 25, 2020 | Tags: Qiagen, Launch, Digital Test, Detecting, SARS-CoV-2, Antibodies, US

16. Novartis Reports Results of Asciminib (ABL001) in P-III ASCEMBL Study for Chronic Myeloid Leukemia

Published: Aug 26, 2020 | Tags: Novartis, Reports, Results, Asciminib, (ABL001), P-III, ASCEMBL Study, Chronic Myeloid Leukemia

17. Takeda and OVID Report Results of Soticlestat (TAK-935/OV935) in P-II ELEKTRA Study for Dravet Syndrome or Lennox-Gastaut Syndrome

Published: Aug 25, 2020 | Tags: Takeda, OVID, Report, Results, Soticlestat, TAK-935/OV935, P-II, ELEKTRA Study, Dravet Syndrome, Lennox-Gastaut Syndrome

18. ACADIA Acquires CerSci Therapeutics for $52.5M

Published: Aug 25, 2020 | Tags: ACADIA, Acquires, CerSci Therapeutics, $52.5M

19. AbbVie and Harvard University Collaborate to Develop Novel Therapies Against Emergent Viral Diseases

Published: Aug 25, 2020 | Tags: AbbVie, Harvard University, Collaborate, Develop, Novel Therapies, Against, Emergent Viral Diseases

20. AbbVie Exercises its Option to License Morphosys’ αvβ6 Integrin Inhibitor Program for Fibrotic Disease

Published: Aug 24, 2020 | Tags: AbbVie, Exercises, License, Option, Morphosys, αvβ6 Integrin, Inhibitor Program, Fibrotic Disease

21. BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

Published: Aug 24, 2020 | Tags: BeiGene, Signs, License, Supply, Agreement, Bio-Thera, BAT1706, biosimilar, bevacizumab, China

22. AstraZeneca Initiates P-I Study of AZD7442 Against COVID-19

Published: Aug 25, 2020 | Tags: AstraZeneca, Initiates, P-I, Study, AZD7442, Against, COVID-19

23. Merck’s Keytruda (pembrolizumab) Receives Two New PMDA’s Approvals in Japan

Published: Aug 24, 2020 | Tags: Merck, Keytruda, (pembrolizumab), Receives, PMDA, Approvals, Japan

24. Bionano Genomics Acquires Lineagen to Facilitate the Clinical Adoption of Saphyr for Digital Cytogenetics

Published: Aug 24, 2020 | Tags: Bionano, Genomics, Acquires, Lineagen, Facilitate, Clinical Adoption, Saphyr, Digital Cytogenetics

26. Bayer and One Drop Collaborate to Develop Digital Therapies Across Multiple Therapeutic Areas

Published: Aug 24, 2020 | Tags:  Bayer, One Drop, Collaborate, Develop, Digital Therapies, Across, Multiple, Therapeutic Areas

27. BMS to Acquire Forbius for its AVID200 to Expand its Footprints in Oncology and Fibrosis

Published: Aug 24, 2020 | Tags: BMS, Acquire, Forbius, Adding, TGF-beta Inhibitor, Portfolio

28.  Novartis’ Triple Regimen Fails to Meet the Primary Endpoint in P-III COMBI-i Study for Advanced Melanoma

Published: Aug 23, 2020 | Tags: Novartis, Triple Regimen, Fails, Meet, Primary Endpoint, P-III, COMBI-I, Study, Advanced Melanoma

29. ReiThera Reports First Patient Dosing with its COVID-19 Vaccine Candidate in Italy

Published: Aug 24, 2020 | Tags: ReiThera, Reports, First, Patient Dosing, COVID-19, Vaccine Candidate, Italy

30. Takeda to Divest its Consumer Health Unit to Blackstone for $2.3B in Japan

Published: Aug 24, 2020 | Tags:  Takeda, Divest, Consumer Health Unit, Blackstone,  $2.3B, Japan

31. Chugai’s Kadcyla (trastuzumab emtansine) Receives MHLW’s Approval for Adjuvant Therapy of HER2-Positive Early Breast Cancer

Published: Aug 23, 2020 | Tags: Chugai, Kadcyla, (trastuzumab emtansine), Receives, MHLW, Approval, Adjuvant Therapy, HER2-Positive, Early Breast Cancer

32. Vertex’s Kaftrio + Ivacaftor Receive the EC’s Approval to Treat Cystic Fibrosis in People Aged 12 Years and Older

Published: Aug 22, 2020 | Tags: Vertex, Kaftrio, Ivacaftor, Receive, EC, Approval, Cystic Fibrosis, Aged, 12 Years, Older

32. AstraZeneca Collaborates with RenalytixAI to Develop Precision Medicine for Chronic Diseases

Published: Aug 22, 2020 | Tags: AstraZeneca, Collaborates, RenalytixAI, Develop, Precision Medicine, Chronic Diseases

FDC Launches Two Variants of Favipiravir for COVID-19 in India

Shots:

  • FDC has launched two variants of Favipiravir under the brand names PiFLU and Favenza to treat mild to moderate COVID-19 in India. The products will be available across the country
  • Both the variant will be available at $0.74 (Rs. 55) /tablet. The DCGI had earlier approved the use of Favipiravir as an off-patent, oral antiviral drug that has shown clinical recovery in COVID-19 patients with mild to moderate symptoms
  • Additionally, FDC has increased the production of Enerzal and Electral, as according to ASPEN guidelines, 03 liters of fluid intake in a day (60-20ml in every 30 min) helps in speedy recovery of people who are home quarantined

Click here ­to­ read full press release/ article | Ref: FDC | Image:  Business Insider