Senate investigates big pharma-telehealth partnerships
A Senate report on Big Pharma’s New Sales Scheme: Expanding Patient Access or a Virtual Pill Mill? has investigated Pfizer and Eli Lilly for partnering with telehealth companies to promote direct-to-consumer drug sales. Through platforms like PfizerForAll and LillyDirect, patients can obtain prescriptions without video visits or full medical evaluations, according to the report.
The investigation found high prescription rates (up to 100 percent with some providers), raising concerns about conflicts of interest, erosion of clinical judgment, and potential overprescribing. Democrat senators Richard Durbin, Elizabeth Warren, and Peter Welch, along with independent senator Bernie Sanders, suggest telehealth providers receive payments from the drug companies, and patients are often funneled toward specific drugs and clinicians, potentially undermining independent care and violating anti-kickback laws. The report warns that these partnerships may resemble “virtual pill mills,” prioritizing sales over patient safety. The report also urges further scrutiny of these practices, citing data sharing, targeted marketing, and cursory care that could inflate federal health spending and compromise patient care.
GSK’s Blenrep faces FDA rejection
The FDA’s Oncologic Drugs Advisory Committee recommended against approving GSK’s proposed dosages of Blenrep (belantamab mafodotin) in combination therapies for relapsed or refractory multiple myeloma. The committee cited serious ocular safety concerns, including corneal damage and visual side effects, as outweighing the benefits. Votes were 5-3 against Blenrep + bortezomib + dexamethasone, and 7-1 against Blenrep + pomalidomide + dexamethasone.
The FDA is expected to deliver its final verdict before the end of July. Blenrep remains approved in the UK, Japan, and Switzerland, with regulatory reviews ongoing in the EU and China. GSK says it is “confident in the benefit/risk profile” and will continue to cooperate further with regulators.
Roche astegolimab update
Roche has announced topline results from two key trials of astegolimab, an investigational antibody for chronic obstructive pulmonary disease (COPD) treatment. In the phase IIb ALIENTO study of 1,301 participants, astegolimab administered biweekly significantly reduced the annualized exacerbation rate by 15.4 percent at 52 weeks compared to placebo. However, the larger phase III ARNASA trial (1,375 participants) did not achieve a statistically significant reduction. Both trials enrolled a wide-ranging COPD population, including current and former smokers irrespective of eosinophil count. The safety profile of astegolimab remained consistent with previous findings, showing no new safety issues. Roche emphasized the disparity between the positive phase IIb and the neutral phase III results and confirmed ongoing evaluation of the data. The company noted that total exacerbation rates were generally lower than expected in both studies.
Sarepta pauses Elevidys shipments
Sarepta Therapeutics has now voluntarily paused Elevidys shipments in the US for non-ambulatory Duchenne muscular dystrophy (DMD) patients. This decision follows the FDA’s informal earlier request and reflects safety concerns, especially liver-related risks. The company initially halted dosing for non-ambulatory patients in June for an expert advisory committee to assess enhanced immunosuppressive protocols and to align with the FDA on label updates. CEO Doug Ingram said, “As a patient-centric organization, the decision to voluntarily and temporarily pause shipments of Elevidys was a painful one, as individuals with Duchenne are losing muscle daily and in need of disease-modifying options. It is important for the patients we serve that Sarepta maintains a productive and positive working relationship with FDA, and it became obvious that maintaining that productive working relationship required this temporary suspension while we address any questions that FDA may have and complete the Elevidys label supplement process.”
New analytical lab for West Pharmaceutical Services
West Pharmaceutical Services has opened a new analytical laboratory in Stolberg, Germany, near its existing manufacturing site. Officially opened on July 17, the facility houses approximately 80 team members and strengthens West’s capabilities in analytical chemistry and microbiological testing. The lab supports manufacturing through finished goods release testing, incoming inspections, and specialized projects like method validations and automation testing. It is also equipped to provide contract testing services to customers and designed for future expansion to meet rising industry demands and regulatory standards, including EU GMP Annex 1.
Research
Temozolomide plus radiation equals tumor shrinkage
Researchers at Niigata University, Japan, have successfully treated an adult patient with a brainstem glioma that harbored a rare IDH2 mutation – an uncommon genetic change in this tumor type. Initially misdiagnosed as a more aggressive H3K27M-mutant glioma, the patient’s gradual hearing loss and the tumor’s unusual location prompted magnetic resonance spectroscopy (MRS). This revealed elevated 2‑hydroxyglutarate, suggesting an IDH mutation, which was confirmed by a follow-up biopsy. Since such tumors often feature a methylated MGMT promoter, they are sensitive to temozolomide. The patient was treated with combined radiation and temozolomide, resulting in dramatic tumor shrinkage and restored hearing. After one year of maintenance therapy, the patient remains treatment‑free with no signs of relapse. Published in Frontiers in Oncology, this case highlights the critical role of MRS-guided genetic diagnostics in tailoring effective therapies for rare brain tumors.
CRISPR-based vitamin D boost for tumors
Scientists from the Hamad Bin Khalifa University, Doha, Qatar, have explored the role of the SDR42E1 gene in vitamin D metabolism and cancer pathways using CRISPR/Cas9-edited colorectal HCT116 cells. By introducing a nonsense mutation in SDR42E1, previously linked to vitamin D deficiency, the researchers observed widespread transcriptomic and proteomic changes. Key findings include altered expression of genes involved in sterol metabolism and cancer regulation. Knock-in of the defective SDR42E1 significantly reduced cell viability (by 53 percent), while overexpression reversed these effects, supporting SDR42E1’s role in cell survival and vitamin D absorption. Proteomic analyses confirmed downregulation of key metabolic proteins and validated transcriptomic trends. The study concludes that SDR42E1 is a critical modulator of vitamin D homeostasis and cancer-related pathways, positioning it as a potential therapeutic target for addressing vitamin D deficiency and related diseases, including colorectal cancer.
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