Entries by aaron

FDA Accepts sBLA for inhaled insulin for kids and adolescents Following Positive Phase 3 Results

The FDA has accepted MannKind’s supplemental biologics license application (sBLA) for Afrezza (insulin human inhalation powder) to treat children and adolescents with type 1 or type 2 diabetes, with a PDUFA target date of May 29, 2026. The phase 3 INHALE-1 trial demonstrated Afrezza’s noninferiority to multiple daily injections, showing comparable safety and no significant […]

Antiplatelet therapy type Has Minimal Impact on Outcomes After Valve-in-Valve TAVR: Study

Researchers have found in a new study that among patients undergoing valve-in-valve transcatheter aortic procedures, antiplatelet therapy type Dual Versus Single, had little effect on major ischemic or bleeding outcomes at one year, though dual antiplatelet therapy (DAPT) may modestly reduce stroke risk. The study was published in JACC: Cardiovascular Interventions by Francesco B. and […]

High Prevalence of Oral Potentially Malignant Disorders in Central India attributed to tobacco and areca nut use: Study

A new study published in Epidemiological Review reports that the prevalence of oral potentially malignant disorders (OPMDs) in central India is notably higher than global averages, with tobacco and areca nut use identified as the primary contributing factors. The researchers found a prevalence rate of 7.57%, underscoring a substantial public health concern in this region. […]

Dispensing Without Pharmacist to Invite Jail Term, Warns Gwalior CMHO

Gwalior: In a stern move aimed at tightening pharmaceutical regulation, the Chief Medical and Health Officer (CMHO) of Gwalior, Dr Sachin Srivastava, has warned that dispensing medicines without the supervision of a registered pharmacist will now attract strict legal action, including imprisonment. The directive comes as part of a wider crackdown on unlicensed medical practices […]

30 Pharma Firms Under MPFDA, CDSCO Scanner in Madhya Pradesh

Indore: After the tragic deaths of several children allegedly linked to contaminated cough syrups in Chhindwara and Betul, Madhya Pradesh’s pharmaceutical industry has come under intense scrutiny. The Madhya Pradesh Food and Drug Administration (MPFDA) has placed 30 drug manufacturing companies under investigation, launching a sweeping crackdown in collaboration with the Central Drugs Standard Control […]

Sun Pharma Wins Interim Relief in NAXDOM Trademark Row, Delhi HC Bars Alenvision’s NEXADOM Drug

New Delhi: The Delhi High Court has granted an ex-parte ad-interim injunction in favour of Sun Pharmaceutical Medicare, a subsidiary of Sun Pharmaceutical Industries, restraining Alenvision Pharma and its associate company from manufacturing or marketing their migraine drug under the mark NEXADOM, which the court found deceptively similar to Sun Pharma’s registered trademark NAXDOM. The […]

Universal Free School Meals Linked to Lower Childhood Blood Pressure: JAMA

Researchers have determined in a new study that the implementation of the Community Eligibility Provision (CEP), a federal policy of universal free school meals for low-income area schools, was associated with better childhood blood pressure. The study concluded that participation of schools in CEP was linked to a net decrease in measurements of high blood […]

Telitacicept Effectively Reduces Proteinuria in IgA Nephropathy with Safe Tolerability: Study

China: Telitacicept significantly reduced proteinuria in patients with IgA nephropathy, while maintaining an acceptable safety profile comparable to that of standard treatments, offering a potential new therapeutic option, suggests a recent study.  The study published in BMC Nephrology by Hui Li and colleagues from the Department of Nephrology, Xin Hua Hospital, affiliated with Shanghai Jiao […]