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Brandon May

Drug Development
V2ACT Therapeutics on Track to Launch Phase I/IIa Pancreatic Cancer Trial, Following FDA Nod
The U.S. Food and Drug Administration (FDA) has given the greenlight for V2ACT Therapeutics to proceed with a Phase I/IIa clinical trial of its investigational treatment for newly diagnosed surgically resectable pancreatic cancer.
December 11, 2020
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3 min read
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Brandon May
Business
Intercept’s COO Takes the Helm as CEO as Company Seeks to Expand Ocaliva Indication After FDA Rejection
Intercept Pharmaceuticals is currently undergoing a leadership transition, with the company’s Chief Operating officer Jerome Durso taking the helm of the company as its newest President and Chief Executive Officer.
December 10, 2020
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3 min read
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Brandon May
Pictured: Red and white Lilly sign on building/Mic
Drug Development
Late-Stage Trial Results Show Promise for Eli Lilly’s Tirzepatide as Treatment for Type 2 Diabetes
Topline results from the Phase III SURPASS-1 trial show that a 40-week treatment with Eli Lilly’s tirzepatide led to significant reductions in A1c and body weight in adults with type 2 diabetes.
December 9, 2020
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3 min read
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Brandon May
Courtesy of Repelsteeltje/Getty Images
Policy
Hope for Pneumococcal Pneumonia Patients as FDA Grants Priority Review of Pfizer’s Vaccine Candidate
Pfizer is one step closer to receiving approval for its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate after the Food and Drug Administration (FDA) on Wednesday granted priority review of a Biologics License Application (BLA) for the invasive disease and pneumonia vaccine.
December 9, 2020
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3 min read
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Brandon May
grandbrothers/Shutterstock
Policy
FDA Likely to Report Pfizer-BioNTech COVID-19 Vaccine is Safe and Effective, Push to EUA
The document prepared and released by FDA staff indicates scientists from the agency plan to tell the advisory committee on Thursday that the available clinical trial data are adequate to support its safe and effective use in public immunization programs.
December 8, 2020
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2 min read
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Brandon May
Evan El-Amin/Shutterstock
Policy
Pharma Organizations Sue Trump Administration Over Final Ruling to Lower Drug Prices
Pharmaceutical Research and Manufacturers of America (PhRMA), alongside other biotech industry trade organizations, filed a lawsuit Friday against the Trump administration’s new rules for lowering drug prices.
December 7, 2020
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3 min read
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Brandon May
Drug Development
AB Science’s Mastinib Plus Gemcitabine Improves Survival, Descreases Pain, in Early Pancreatic Cancer
A dual treatment approach consisting of gemcitabine combined with AB Science’s masitinib was associated with significant increases in survival among patients with pancreatic cancer and pain.
December 4, 2020
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3 min read
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Brandon May
Michael Vi/Shutterstock
Drug Development
Despite Failure to Meet Phase III Primary Endpoint, Jazz’s SCLC Drug Holds Promise
While promising, the study showed no difference between this combination regimen and physician’s choice of topotecan or cyclophosphamide/doxorubicin/vincristine (CAV) in terms of overall survival (OS).
December 3, 2020
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3 min read
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Brandon May
Pavel Kapysh/Shutterstock
Drug Development
Agios’ Mitapivat Trial Meets Primary Endpoint in Patients with Pyruvate Deficiency
Topline results from Agios Pharmaceuticals’ Phase III ACTIVATE trial show that treatment with mitapivat was associated with a significantly greater hemoglobin response compared with placebo in patients with pyruvate kinase deficiency.
December 1, 2020
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3 min read
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Brandon May
Business
Spotlight Therapeutics Closes $30 Million Series A to Advance CRISPR Technology
Venture capital investment firm GV, formerly Google Ventures, led the Series A financing round for the company. Other investors contributed to the round but have decided to remain anonymous.
November 30, 2020
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2 min read
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Brandon May
Deals
Selvita Expands Drug Discovery Services with Acquisition of Fidelta
Preclinical contract research organization (CRO) Selvita has entered into a deal with Galapagos to acquire its inflammation-, fibrosis- and anti-infectives-focused CRO Fidelta.
November 25, 2020
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3 min read
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Brandon May
Policy
Guardant Health and Foundation Medicine Face Off in Another Legal Battle
Guardant Health is taking Roche-owned Foundation Medicine to court over a patent dispute for their liquid biopsy technology, further heating up the rivalry between the two cancer detection companies.
November 25, 2020
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3 min read
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Brandon May
Courtesy of Michael Vi/Getty Images
FDA
FDA Approves Flu Treatment for Preventative Use After Exposure
Genentech’s influenza treatment Xofluza® (baloxavir marboxil) has been granted approval by the U.S. Food and Drug Administration for use in people 12 years and older, making it the first single-dose post-exposure prophylaxis strategy approved by the agency.
November 24, 2020
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3 min read
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Brandon May
Pictured: Gloved hand holding syringe in front of
BioCapital
Novavax’s COVID-19 Vaccine Shows Efficacy in Monkeys, but Does That Translate to Humans?
Maryland-based vaccine company Novavax said its COVID-19 vaccine candidate, NVX‑CoV2373, prevented SARS-CoV-2 infection in monkeys, hinting that the product could likewise prove effective in humans.
November 23, 2020
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2 min read
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Brandon May
Drug Development
After FDA Grants Priority Review, ADC Therapeutics Gets One Step Closer to Bringing B-Cell Lymphoma Drug to Market
The U.S. Food and Drug Administration has accepted ADC Therapeutics’ Biologics License Application (BLA) and granted priority review for the company’s relapsed/refractory diffuse large B-cell lymphoma (DLBCL) treatment, loncastuximab tesirine (Lonca).
November 20, 2020
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3 min read
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Brandon May
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