The US FDA Issues Final Guidance on Interchangeable Biosimilars
Shots: The US FDA finalizes its guidance on interchangeability of a biosimilar with its reference biologic, which means it may be substituted without
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the US FDA
Breakthrough Therapy Designation by the US FDA in 2018
Breakthrough Therapy (BT) Designation is an expedited review program introduced in Section 902 of the Food and Drug Safety and Innovation Act of
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Medtronic to Recall its Dual Chamber Implantable Pulse Generators (IPGs) in the US
Shots: The Class I recall of IPGs with model names Adapta, Versa, Sensia, Relia, Attesta, Sphera, and Vitatron A, E, G, Q series,
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Zimber Biomet’s Rosa Knee System Receives the US FDA’s 510(k) Clearance for Robotically-Assisted Surgeries
Shots: Rose Knee System is a 3D tool designed for the improvement in performing knee replacement surgery to facilitate implant positioning of soft-tissues
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Dr. Reddy’s Tosymra (sumatriptan nasal spray) 10mg Receives the US FDA Approval for Acute Treatment of Migraine
Shots: The approval is based on the clinical trial assessing Tosymra in patients with a migraine and demonstrated well tolerated and safe results
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Beigene’s Zanubrutinib (BGB-3111) Receives the US FDA’s Breakthrough Therapy Designation for Mantle Cell Lymphoma (MCL)
Shots: The BT designation follows the P-II trial assessing Zanubrutinib in patients with 1L mantle cell lymphoma Beigene’s Zanubrutinib is being evaluated globally
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Merck’s Keytruda (pembrolizumab) Receives FDA’s Approval for LA or Metastatic Merkel cell carcinoma (MCC)
Shots: The approval is based on P-II CITN-09/KEYNOTE-017 study assessing Keytruda in 50 patients with recurrent LA or mMCC who had not received
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Albireo’s A4250 Receives EU Orphan Drug Designation (ODD) for Biliary Atresia
Shots: The designation is based on P-III clinical trial assessing A4250 in patients with progressive familial intrahepatic cholestasis (PFIC) Albireo to get 10 years of market exclusivity
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Loxo’s Vitrakvi (larotrectinib) Receives the US FDA Approval for the Treatment of Solid Tumors in Adults and Pediatric Patients
Shots: The approval is based on combined data from P-I adult trial, P-II NAVIGATE trial and P-I/II pediatric SCOUT trial assessing Vitrakvi in
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AstraZeneca Reports Results of Imfinzi (durvalumab) & Tremelimumab in Global P-III MYSTIC Trial for Stage IV Non-Small Cell Lung Cancer (NSCLC)
Shots: The P-III MYSTIC Trial involves assessing of Imfinzi (durvalumab) as a monothx or Imfinzi plus tremelimumab vs SoC Pt-based CT in patients
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