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CAR-T Growth Multiplies Patient-Specific Runs; Every Quality-System Link Must Scale

Commercial CAR-T growth requires thousands of patient-specific production runs rather than larger batches. PharmaVoice reported on September 1 that patient material, production, quality testing and release, logistics, and treatment schedules must move together. Consequently, expansion can magnify quality-system variability and
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CAR-T Growth Multiplies Patient-Specific Runs; Every Quality-System Link Must Scale

Novocure Devices Stayed Secure; 1,400+ U.S. Patient Records Put Digital Quality Under Scrutiny

Novocure reported that unauthorized access to certain information systems in mid-August exposed records linked to more than 1,400 U.S. patients. The company confirmed that its medical treatment devices were not accessed and all systems remain operational. Nevertheless, the incident highlights
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Novocure Devices Stayed Secure; 1,400+ U.S. Patient Records Put Digital Quality Under Scrutiny

FDA and Duke Advance QMIN; Quantitative Medicine Gains Regulatory Momentum

The FDA and Duke-Margolis Institute for Health Policy convened a virtual summit on September 1 to help shape the Quantitative Medicine Innovation Network (QMIN). The planned cross-sector network would connect regulators, industry, academia, healthcare providers and patient groups to advance
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FDA and Duke Advance QMIN; Quantitative Medicine Gains Regulatory Momentum

3 Deaths Pause 8 Novartis CAR-T Trials; Safety Review Now Expands

Novartis paused eight clinical trials of an experimental CAR-T therapy for autoimmune and neurological disorders in late August after 3 patient deaths linked to a severe immune response. The Swiss drugmaker is reviewing the safety events with independent safety boards
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3 Deaths Pause 8 Novartis CAR-T Trials; Safety Review Now Expands

Cipla Licence Cancellation Withdrawn; Bombay HC Challenges Maharashtra FDA Procedure

The Maharashtra Food and Drugs Administration has withdrawn its cancellation of drug sale licences for Cipla Pharma & Life Sciences Ltd’s carrying and forwarding facility in Wadki, Pune, after the Bombay High Court criticised the procedure behind the action. The
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Cipla Licence Cancellation Withdrawn; Bombay HC Challenges Maharashtra FDA Procedure

Baxter Saline Recall Flags Fiberglass Risk; Particulate Controls Face New Scrutiny

Baxter International has voluntarily recalled two lots of 0.9% Sodium Chloride Injection in the United States because of the potential presence of fiberglass particulate matter. The FDA published Baxter’s announcement on August 26, 2026. The affected 500 mL VIAFLEX products
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Baxter Saline Recall Flags Fiberglass Risk; Particulate Controls Face New Scrutiny

Apitegromab Met Its Trial Goal; Manufacturing Issues Forced Scholar Rock’s EU Reset

Scholar Rock has withdrawn its European application for apitegromab, its experimental spinal muscular atrophy treatment, and plans to resubmit using a different manufacturing site. The decision follows manufacturing compliance, fill-finish facility, and regulatory path issues at the Bloomington, Indiana site
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Apitegromab Met Its Trial Goal; Manufacturing Issues Forced Scholar Rock’s EU Reset

No Quality Defect, Yet EU Supply Is Disrupted: EMA Flags Paliperidone Shortage

The European Medicines Agency has reported a shortage of long-acting injectable paliperidone palmitate medicines in some EU member states after manufacturing problems at Greek contract manufacturer Pharmathen International disrupted supply. The affected medicines treat adults with schizophrenia whose condition has
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No Quality Defect, Yet EU Supply Is Disrupted: EMA Flags Paliperidone Shortage

Boston Scientific Cyberattack Hits Orders; Global Operations Disrupted as Recovery Begins

Boston Scientific said a cybersecurity incident detected on August 25 disrupted global operations, including information systems used to process and ship customer orders. The medical-device manufacturer activated incident-response procedures and began working with third-party cybersecurity specialists. Disruptions are expected to
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Boston Scientific Cyberattack Hits Orders; Global Operations Disrupted as Recovery Begins

FDA Returns to Cipla Pithampur;7 Observations Renew GMP Remediation Pressure

USFDA issued a Form 483 with seven inspectional observations to Cipla Limited’s Pithampur manufacturing facility in Madhya Pradesh after a follow-up cGMP inspection from August 17 to August 25, 2026. The outcome renews scrutiny of a site that received eight
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FDA Returns to Cipla Pithampur;7 Observations Renew GMP Remediation Pressure