Though much of the attention in the biopharma industry focuses on FDA approvals
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Weekly Top Stories Tue, 27 Dec 2022
We have 30 articles this week. #Intercept Resubmits New Drug Application to U.S. FDA for #Obeticholic Acid in Patients with #Liver Fibrosis due to NASH.#Immuron Receives FDA Approval for Travelan IND Application. #Accord Healthcare Inc. Issues Nationwide Voluntary Recall of #Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 Due to Product Mix-up. #FDA Approves #Genentech’s Lunsumio, a First-in-Class Bispecific Antibody, to Treat People with #Relapsed or Refractory Follicular Lymphoma. #Libtayo® (cemiplimab) Approved in Japan for Advanced or Recurrent #Cervical Cancer. #Merck Expands ADC Footprint with $9.3B Kelun Licensing Deal.
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6. 
 Intercept Resubmits New Drug Application to U.S. FDA for Obeticholic Acid in Patients with Liver Fibrosis due to NASH
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 Immuron Receives FDA Approval for Travelan IND Application
8. 
 Accord Healthcare Inc. Issues Nationwide Voluntary Recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 Due to Product Mix-up
9. 
 FDA Approves Genentech’s Lunsumio, a First-in-Class Bispecific Antibody, to Treat People With Relapsed or Refractory Follicular Lymphoma
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 Elpiscience Announces CDE IND Clearance of ES014, a First in Class Anti-CD39xTGF-β Bispecific Antibody for Patients with Advanced Solid Tumors
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 Libtayo® (cemiplimab) Approved in Japan for Advanced or Recurrent Cervical Cancer
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 Merck Expands ADC Footprint with $9.3B Kelun Licensing Deal
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 Biomica Raises $20M to Advance its Pipeline of Microbiome-based Therapeutics
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 Mesoblast and Oaktree Extend Availability Period of Undrawn Tranches of Financing Facility
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 Outlook Therapeutics® Enters Definitive Agreement for $31.8 Million Unsecured Convertible Promissory Note
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 BioArctic’s partner Eisai initiates BLA submission of data for lecanemab in China
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 Johnson & Johnson Completes Acquisition of Abiomed
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 Vistagen to Acquire Pherin Pharmaceuticals
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 Berkeley Lights to Acquire IsoPlexis, Creating a Premier Functional Cell Biology Company
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Editor: Ed Francis

Ed has more than 25 years of management consulting experience and currently is the Global Managing Partner for Infosys Consulting Health and Life Sciences business guiding some of the industry's most prominent health and life sciences organizations through complex transformations.

If you need help with your complex transformation whether it be M&A, digital, or strategic cost reduction or need to bring more innovation into your business strategy Ed can be contacted at Edward.Francis@infosys.com and +1-847-910-6073

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