Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Rebukes Eli Lilly For 'Misleading' Instagram Post About Trulicity
Stat: FDA Scolds Lilly For Misleading Instagram Post About Diabetes Drug
Eli Lilly (LLY) was rebuked by the U.S. Food and Drug Administration for running a misleading Instagram post that omitted risk information about its best-selling Trulicity diabetes medicine, marking the second time in as many months the regulator scolded the company for failing to follow advertising rules. In the latest transgression, the FDA noted the Instagram post made an incorrect claim that the drug could lower blood sugar levels and displayed key information about risks and appropriate use in small, fast-moving type on the screen. Yet the benefits of the diabetes drug were prominently featured in “colorful, compelling, and attention-grabbing fast-paced visuals.” (Silverman, 1/25)
In other pharmaceutical news —
Stat: Sierra Oncology Drug Improves Anemia And Other Myelofibrosis Symptoms
Sierra Oncology said Tuesday that its experimental treatment for the blood cancer myelofibrosis achieved all the efficacy goals of a Phase 3 clinical trial, including an improvement in anemia that currently approved drugs don’t address. Based on the positive study results, Sierra intends to file a U.S. marketing application for its drug, called momelotinib, during the second quarter. If approved, the drug will enter a myelofibrosis treatment market that is dominated by Jakafi, the Incyte/Novartis drug with sales exceeding $2 billion annually. (Feuerstein, 1/25)
Laboratory Equipment: New Drug Delivery System Offers Hope For Treating Genetic Diseases
A team of researchers led by Harvard and Broad Institute scientists has developed a new drug delivery system using engineered DNA-free virus-like particles (eVLPs) to package and deliver therapeutic levels of gene-editing proteins to animal models of disease. The team utilized eVLPs to edit a gene in mice that is associated with high cholesterol levels and to partially restore vision in mice with a point mutation that causes genetic blindness. Because eVLPs enable safer in vivo delivery of gene-editing agents than some methods used in the clinic, with comparable or higher efficiencies, this new platform is a promising technology for the delivery of therapeutic macromolecules in living animals with minimized risk of off-target editing or DNA integration. (1/24)
The Bakersfield Californian: TScan Therapeutics Announces FDA Clearance Of Investigational New Drug Application For TSC-100
TScan Therapeutics, Inc., a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell therapies (TCR-T) for the treatment of patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate TSC-100 for the treatment of patients with hematologic malignancies who are undergoing allogeneic hematopoietic cell transplantation (HCT). The target of TSC-100 is the minor histocompatibility antigen HA-1, which is a lineage-specific antigen found on blood cells. The Company will now submit the clinical protocol to Institutional Review Boards (IRB) for the initial study sites and expects to begin dosing patients in the first half of 2022. (1/24)
Also —
AJMC: Despite New Launches, No Price Drops Seen Among Brand-Name NSCLC Drugs
Between 2015 and 2020, prices of brand-name medications for treatment of metastatic non–small cell lung cancer (NSCLC) increased without evidence of price competition, according to research published today in JAMA Network Open. The findings raise concern about the affordability of promising oncology drugs and suggest the need for drug pricing reform, authors wrote. Previous studies have shown that the introduction of new anticancer agents in the US market did not lower prices among same-class brand-name oncology drugs, contrary to what one might expect in a capitalist system. Oncology drug prices also function as a determinant of health disparities. (Melillo, 1/25)
The Boston Globe: Massachusetts Biopharma Firms Raised A Record $13.7 Billion In Venture Capital Last Year
Massachusetts drug makers continued to bring in huge amounts of venture capital last year, setting a record for money raised, according to the industry trade group. Local biopharma firms attracted $13.7 billion in 2021, up 70 percent from a year prior, the Massachusetts Biotechnology Council said in a report Wednesday. The group said “the power of biopharma companies to change the course of human health through vaccines and therapeutics” is continuing to attract money.“ Biotech companies are launching every day across Massachusetts and investors want to be involved from the start,” said MassBio chief executive Joe Broncore in a statement. “Not only for potentially good returns, but also for the chance of playing a role in the creation of a breakthrough medicine.” (Gardizy, 1/26)
FiercePharma: AstraZeneca Taps E! Host Nina Parker For Asthma Campaign As It Hopes New Drug Tezspire Can 'Break The Cycle’
AstraZeneca and Amgen got an early Christmas present from the FDA when the agency approved Tezspire on Dec. 17, and they swiftly launched an unbranded awareness and education campaign called “Break the Cycle.” The face of the campaign is E! host Nina Parker, who has asthma and talks about the “misinformation and stigma” around the condition. The idea behind breaking the cycle is to help patients understand that there's a way to break out of their uncontrolled asthma and not have to reshape their day or use so-called rescue inhalers. (Adams, 1/25)
