Health and Pharma

09/30/2025

Recently granted CE Mark, the novel test delivers improved sensitivity and accuracy, helps clinicians quickly identify heart attack and rule out non-cardiac causes, ensuring patients receive the care they need at the earliest opportunity.

Roche announced the primary results from the TSIX Study Program, which evaluated the performance of its new sixth-generation high-sensitivity for diagnosing . Presented at EUSEM2025 and the European Society of Cardiology (ESC) 2025, the study results showed that the ® Troponin T hs Gen 6 test was able to identify acute infarction (AMI), or heart attack, and identify those not having an AMI, with a high level of precision. This supports the efficient triage of patients arriving at the emergency department, ensuring healthcare resources can be focused where they are needed most. This data announcement follows the recent CE Mark approval for the test.

As one of the top three reasons for emergency care visits, chest pain creates significant anxiety and uncertainty for patients whilst putting pressure on healthcare services. Yet only one in every ten patients who presents with symptoms will actually be experiencing a heart attack. With 49% of emergency departments in Europe reporting overcrowding on a frequent basis, the ability to quickly and reliably identify those patients who are suffering from AMI, and to rule out those who are not, is crucial in ensuring the best possible outcomes for patients.

" disease continues to place an immense strain on global health systems, particularly in emergency care, where cases of chest pain are among the most challenging presentations to evaluate,” said Matt Sause, CEO of Roche Diagnostics. “Our new test enables clinicians to detect even the smallest elevations in troponin levels – a critical biomarker for heart attack – with high confidence. This ensures that in a situation when every second counts, patients receive the life-saving care they need at the earliest opportunity, and emergency services can prioritise resources to deliver care effectively to those in urgent need."

09/30/2025

Results from the phase III trial show that in combination with significantly prolonged progression-free survival in ER+, HER2- advanced following prior CDK4/6 inhibitor therapy, outperforming standard . Benefits were observed in both the overall and ESR1+ populations. The all-oral regimen was well tolerated, with no new safety signals reported.
https://healthandpharma.net/giredestrant-everolimus-er-breast-cancer

09/23/2025

Stealth BioTherapeutics, today announced that has granted accelerated approval to ™ ( HCl) to improve muscle strength in adult and pediatric patients with weighing at least 30 kilograms (kg). Barth syndrome is a life-limiting pediatric mitochondrial cardioskeletal disease that affects approximately 150 individuals in the United States.

"The approval of FORZINITY, the first treatment option for Barth syndrome and the first approved mitochondria-targeted therapeutic, is a pivotal victory for the Barth syndrome community and offers hope for expedited regulatory attention to other ultra-rare diseases," said Reenie McCarthy, Stealth's Chief Executive Officer. "We appreciate the FDA's close engagement in recent months and are grateful to the trial participants, caregivers, advocates, researchers and healthcare providers who persevered in partnership with us over this decade-long journey. We plan to continue providing expanded access to children weighing less than 30 kilograms who are currently receiving treatment or require emergency access."

The approval of FORZINITY is supported by the efficacy and safety data from the TAZPOWER clinical trial. During the open-label portion of the TAZPOWER trial, knee extensor muscle strength improved from study baseline. The most common adverse reactions were injection site reactions which can be treated with oral antihistamines or topical corticosteroids. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

09/23/2025

MavriX Bio, today announced that the U.S. FDA has granted Fast Track designation for MVX-220, an investigational adeno-associated virus (AAV) for the treatment of .

"The FDA's decision to grant Fast Track designation for MVX-220 reflects the urgent need for therapies for individuals living with syndrome" said Allyson Berent, DVM, DACVIM, Chief Development Officer of MavriX Bio. "This designation highlights the promise MVX-220 holds as a potential treatment for AS, and importantly, enables closer collaboration with the FDA and an accelerated path forward."

In May 2025, MavriX announced that FDA had cleared the Investigational New Drug (IND) application for MVX-220. MavriX is preparing to initiate ASCEND-AS, a Phase 1/2 first-in-human study of MVX-220 in Angelman syndrome.

09/20/2025

🚨 A groundbreaking study in Nature Metabolism from MD Anderson reveals that the glucose–fructose mix found in sodas and fruit juices can directly accelerate colorectal in preclinical models.
🧬 The mechanism: activation of sorbitol dehydrogenase (SORD), which fuels glycolysis and the cholesterol pathway, ultimately driving tumor spread—particularly to the liver.
💡 Why it matters:
Blocking SORD slowed metastasis, even with sugar exposure.
Statins, already in clinical use, target the same pathway—opening the door to potential therapeutic repurposing.
⚠️ For patients, this research underscores the importance of limiting . For clinicians and researchers, it highlights SORD as a promising therapeutic target in advanced .
👉 Read more:

A new Nature study suggests that the glucose–fructose blend typical of sodas and juices fuels colorectal cancer metastasis through a metabolic enzyme, raising questions about diet and treatment strategies.

09/20/2025

The EMA’s has issued two positive opinions for Merck’s ( ): approval of a new subcutaneous formulation showing pharmacokinetic equivalence to IV dosing in NSCLC (ORR 45.4% vs 42.1%), and perioperative use in resectable PD-L1+ locally advanced head and neck cancer, where Phase 3 KEYNOTE-689 demonstrated a significant event-free survival benefit.

The EMA’s CHMP has adopted two positive opinions for Merck’s pembrolizumab (KEYTRUDA), potentially expanding its use in Europe to include a new subcutaneous formulation and a new perioperative indication in advanced head and neck squamous cell carcinoma.

09/19/2025

🚨 The has granted Designation to raludotatug ( ) for platinum-resistant , primary peritoneal, and fallopian tube cancers expressing CDH6 after .
🔬 This first-in-class CDH6-directed ADC shows promising activity in a setting with few treatment options. If confirmed in phase 3, R-DXd could represent a new standard for patients with limited therapies after platinum resistance.
https://healthandpharma.net/fda-grant-breakthrough-raludotatug-deruxtecan-ovarian-cancer

09/18/2025

In the next 25 years, climate-driven impacts could result in the loss of more than $1.5 trillion in lost output from select .

In the next 25 years, climate-driven health impacts could result in the loss of more than $1.5 trillion in lost output from select climate-health illnesses. This is according to a new report from the World Economic Forum, developed in collaboration with Boston Consulting Group

09/18/2025

GSK announced plans to invest $30 billion across the United States in research, development, and manufacturing over the next five years, marking one of the largest life sciences commitments in the country. The plan includes a $1.2 billion investment to expand biologics manufacturing in Pennsylvania, integrate AI and digital technologies across five states, and boost clinical trial activity.
https://healthandpharma.net/gsk-invest-30-billion-inrd-manufacturing-us

09/17/2025

The third-generation tyrosine kinase inhibitor olverembatinib may represent a major advance for patients with chronic myeloid leukemia and Ph+ acute lymphoblastic leukemia. In this ONCOLife interview, we'll speak with Dr. Dajun Yang, CEO of Ascentage Pharma, about the latest clinical findings from the global Phase III POLARIS-2 trial of olverembatinib in frontline and relapsed Ph+ acute lymphoblastic leukemia.
We will discuss its unique mechanism of action, the potential of chemotherapy-free regimens, and how this novel TKI is shaping global treatment strategies. Join us to learn more about the science, the data, and what lies ahead for this innovative therapy.

� New to streaming or looking to level up? Check out StreamYard and get $10 discount! �

09/16/2025

The Phase III SUNMO trial could mark a breakthrough for transplant-ineligible patients with relapsed/refractory large B-cell lymphoma. Join us for an in-depth interview with Dr. Jason Westin (MD Anderson Cancer Center) as we discuss:
✔️ SUNMO trial results, Chemo-free innovation with mosunetuzumab + polatuzumab vedotin
✔️ What this means for patients and the future of lymphoma care

The Phase III SUNMO trial could mark a breakthrough for transplant-ineligible patients with relapsed or refractory large B-cell . In this ...

09/15/2025

The Phase III SUNMO trial could mark a breakthrough for transplant-ineligible patients with relapsed or refractory large B-cell lymphoma. In this ONCOLife exclusive interview, we speak with Dr. Jason Westin, Professor of Medical Oncology and Director of the Clinical Research Program at the University of Texas MD Anderson Center about the SUNMO trial, which tested plus vedotin in this challenging patient population. Join us to explore what these results mean for patients

� New to streaming or looking to level up? Check out StreamYard and get $10 discount! �