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Mark Zipkin

CARB-X Places $22 Million Bet on Affinivax Staph Vaccine
Less than two months after bacterial vaccine company Affinivax’s Series C financing, the company is getting a $22 million boost from infectious disease consortium CARB-X to push forward a vaccine for tough-to-treat preclinical Staphylococcus aureus
March 9, 2021
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2 min read
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Mark Zipkin
Drug Development
Seres to Discontinue Microbiome Cancer Clinical Program
Microbiome company Seres Therapeutics announced the discontinuation of its Phase Ib trial of SER-401, an orally delivered consortia of bacteria that was intended to boost the efficacy of checkpoint inhibitors in patients with metastatic melanoma.
March 8, 2021
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2 min read
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Mark Zipkin
Drug Development
Bharat’s Next-Gen COVID-19 Nasal Vaccine Moving Toward Human Testing
Days after vaccine-maker Bharat Biotech released interim Phase III efficacy data for a COVID-19 vaccine already in use in India, a pulmonary expert is expressing enthusiasm for the company’s next-generation intranasal vaccine on track to enter clinical testing this quarter.
March 5, 2021
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2 min read
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Mark Zipkin
TF-Images/Getty Images
Business
Merck KGaA to Consolidate Its Silicon Valley Innovation Sites
Merck KGaA is consolidating its Silicon Valley business/technology and materials innovations facilities under one 30,000-square-foot roof in San Jose, California, in an effort to boost their collaborative capacity for developing materials with biological applications.
March 4, 2021
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2 min read
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Mark Zipkin
Drug Development
Arena Reconsiders Strategy as CB2 Agonist Misses Primary Endpoint in Phase II
Gastrointestinal and autoimmune company Arena Pharmaceuticals announced mixed topline results for the Phase IIb trial of its oral cannabinoid receptor type 2 (CB2) agonist olorinab.
March 3, 2021
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2 min read
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Mark Zipkin
Drug Development
Lilly, Incyte Report Positive Data for JAK Inhibitor in Phase III Alopecia Trial
The topline data from the BRAVE-AA2 study in 546 adults showed both 2 mg and 4 mg doses of Olumiant regrew hair in adult patients with more than 50% scalp hair loss, compared with placebo.
March 3, 2021
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2 min read
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Mark Zipkin
Drug Development
FDA Accepts NDA for Oyster Point’s Dry Eye Therapy OC-01
Eye disease company Oyster Point announced the New Drug Application for its dry eye disease therapy OC-01, submitted in December, has been accepted for regulatory review on the back of positive Phase III data.
March 2, 2021
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2 min read
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Mark Zipkin
Photo courtesy of Athenex.
Drug Development
FDA Issues CRL Citing Safety, Data Issues for Athenex’s Oral Encequidar
Cancer therapy company Athenex suffered a regulatory setback with the receipt of a complete response letter from the U.S. Food and Drug Administration.
March 2, 2021
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2 min read
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Mark Zipkin
Business
Gene Replacement Therapy-Focused Jaguar and Its Subsidiary Launch with Deerfield-backed Series A
Deerfield Management-backed Jaguar Gene Therapy, and its ciliopathy-focused subsidiary Axovia Therapeutics, launched today with an undisclosed Series A.
February 25, 2021
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2 min read
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Mark Zipkin
Drug Development
FDA Puts bluebird bio’s LentiGlobin on Clinical Hold
The hold comes just after patient dosing began in HGB-210, the company’s Phase III single-arm open-label LentiGlobin trial for SCD patients between the ages of 2 and 50.
February 24, 2021
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2 min read
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Mark Zipkin
Drug Development
COVID-19 Vaccine Maker Clover Raises $230 Million in Series C Round
Chinese fusion protein company Clover Biopharmaceuticals raised a $230 million series C round co-led by GL Ventures and Temasek, which will push its COVID-19 vaccine into Phase II/III testing and production planning.
February 23, 2021
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2 min read
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Mark Zipkin
STR/NurPhoto via Getty Images
Drug Development
Tweaked COVID-19 Vaccine Starts Phase II for GSK, Sanofi
The retooled COVID-19 vaccine promised by GlaxoSmithKline and vaccine giant Sanofi is entering Phase IIb testing, with new antigen dosages it hopes will boost the lackluster immune response seen in adults 50 and over during its last Phase I/II trial.
February 22, 2021
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2 min read
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Mark Zipkin
AbbVie recently returned the rights of eye drug Ab
Policy
Immunocore’s TCR Bispecific Tebentafusp Earns Breakthrough Designation for Ocular Cancer
The tebentafusp has earned a breakthrough designation for ocular cancer. The company is planning regulatory filings in the U.S. later this year and in Europe thereafter.
February 19, 2021
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2 min read
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Mark Zipkin
Pictured: Red and white Lilly sign on building/Mic
Business
Lilly, Rigel to Partner on RIPK1 Inhibitors in Deal Worth Up to $960 Million
Eli Lilly is jumping into the RIPK1 chase, paying $125 million up front to partner with Rigel Pharmaceuticals to co-develop its lead RIPK1 inhibitor program across all indications.
February 18, 2021
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2 min read
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Mark Zipkin
ricochet64/Shutterstock
Policy
BMS, Sanofi on Hook for $834 Million Over Deceptive Plavix Labeling in Hawaii
The companies have announced their intent to appeal the decision.
February 16, 2021
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2 min read
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Mark Zipkin
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