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Mark Zipkin

Business
Former Merck Exec Joins Flagship to Helm AI Startup Generate Biomedicines
Michael T. Nally became the latest Merck executive to join Flagship Pioneering, taking the reins of its machine learning protein therapy company Generate Biomedicines.
March 31, 2021
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2 min read
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Mark Zipkin
Drug Development
Wave to Discontinue Lead Huntington’s Programs After Disappointing Clinical Data
Disappointing data from two Phase Ib/IIa trials for both lead Huntington’s disease antisense candidates have pushed Wave Life Sciences to shelve the assets and focus on its next generation of therapies.
March 30, 2021
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2 min read
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Mark Zipkin
Drug Development
NeuroRx Reports Positive RLF-100 Data for Critically Ill COVID-19 Patients
A new readout from a Phase IIb/III trial showed intravenous RLF-100 (aviptadil) met the primary endpoint of improving survival and recovery at 60 days post-treatment for respiratory failure in critically ill patients with COVID-19.
March 29, 2021
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2 min read
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Mark Zipkin
Policy
Report: Orphan Drug Act Boosted Rare Disease Therapies, But Access is Uneven
The Orphan Drug Act passed in 1983 and granted tax credits, subsidies and fee waivers for rare disease drug development in areas of unmet need. It also guaranteed seven years of market exclusivity following approval, longer than the five years typical for most new chemical entities.
March 26, 2021
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2 min read
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Mark Zipkin
Business
Krystal Biotech Launches Spinoff for Gene-Based Anti-Wrinkle Products
On the back of a $135 million public offering in February, rare disease gene therapy company Krystal Biotech has launched subsidiary Jeune Inc. to promote its gene therapies for aesthetic skin conditions.
March 25, 2021
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2 min read
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Mark Zipkin
Extracellular vesicle therapies are gaining moment
Leading Approaches to Extracellular Vesicles Therapies
Two financings – and a surprise stock bump – in three days for the some of the most advanced extracellular vesicle (EV) companies show investors are champing at the bit to see the technology unleashed.
March 25, 2021
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5 min read
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Mark Zipkin
Concussion Study in Rugby Players Could Lead to Point-of-Injury Diagnostics for Broader Population
Researchers at the University of Birmingham have identified 14 small non-coding RNAs in saliva that can diagnose a concussion with 96% accuracy, based on sample analysis from 1,028 professional rugby players.
March 24, 2021
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2 min read
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Mark Zipkin
Business
Asher Raises $55 Million Series A for Targeted Cancer Immunotherapies
Targeted immunotherapy company Asher Bio launched today with a $55 million Series A round led by Third Rock Ventures, aiming to move its lead engineered interleukin-2 (IL-2) therapy into human testing next year.
March 23, 2021
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2 min read
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Mark Zipkin
Courtesy of Merck & Co. Inc.
FDA
Merck Scores Latest Label Expansion for Keytruda in Esophageal Carcinomas
Keytruda (pembrolizumab) won another regulatory victory, making it the first checkpoint inhibitor approved by the U.S. FDA for first line treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinomas regardless of PD-L1 expression.
March 23, 2021
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2 min read
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Mark Zipkin
Biotech Bay
New Animal Model of Alzheimer’s Could Open the Door to New Therapies
A new nonhuman primate Alzheimer’s disease model developed by researchers from University of California, Davis and elsewhere could open the door to getting better therapies into human testing.
March 19, 2021
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2 min read
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Mark Zipkin
BioMidwest
New Study Shows Artificial Heart Valves Can Grow and Function in Lambs
A new report from University of Minnesota researchers shows that artificial heart valves implanted in lambs continued to grow and function for at least a year after surgery, a promising finding for pediatric patients in need of heart valve replacements.
March 18, 2021
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2 min read
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Mark Zipkin
Policy
FDA to Consider Allowing Trials for Algernon’s Psychedelic DMT
Algernon Pharmaceuticals has requested a pre-Investigational New Drug meeting with regulators in the hopes of launching a clinical trial in stroke patients for n,n-dimethyltryptamine, a naturally derived psychedelic compound.
March 17, 2021
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2 min read
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Mark Zipkin
Bicara CEO Claire Mazumdar, Courtesy of Bicara The
Business
Biocon Launches Bifunctional Antibody IO Subsidiary Bicara with $40 Million
Cambridge-based Bicara Therapeutics launched with a $40 million investment from its parent company, Biocon, to advance its bifunctional antibodies targeting both tumors and the immune system in cancer patients who are refractory to checkpoint inhibitors.
March 15, 2021
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2 min read
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Mark Zipkin
Preclinical Data Boosts Case for Cell Source’s CD8+ Veto Cells in BMT
Recently published data from a mouse model of sickle cell disease (SCD) is bolstering the case for the safety of Cell Source’s CD8+ veto cells, currently in Phase I/II testing to improve peripheral blood stem cell transplantation in patients with hematological malignancies.
March 12, 2021
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2 min read
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Mark Zipkin
Drug Development
COVID-19 Vaccine News: Moderna Variant Vaccine Begins Human Testing, AZ Put on Hold in Denmark
Patients in a Phase II trial have begun receiving Moderna’s vaccine against the SARS-CoV-2 variant first identified in South Africa, the company announced.
March 11, 2021
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2 min read
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Mark Zipkin
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