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Ontario Brain Institute Invests $640K to Drive Innovations in Brain Health

1 week ago | xtalks.com | Ayesha Rashid

Canada’s Ontario Brain Institute (OBI) has announced a $640,000 investment into several new projects through its Centre for Analytics (CfA). The investment will specifically fund eight new initiatives aimed at fostering the development of innovative technologies that better detect, predict and treat brain disorders. The new analytics initiatives span mental health and concussion to eye care.
Inside the Latest in Targeted Radiotherapeutics with Plus Therapeutics CEO Dr. Marc Hedrick - Episode 204

1 week ago | xtalks.com | Ayesha Rashid

In this episode, Ayesha spoke with Marc Hedrick, MD, MBA, president and CEO of Plus Therapeutics, a company focused on developing a novel class of targeted radiotherapeutics. Prior to heading Plus Therapeutics, Dr. Hedrick served in a number of executive leadership roles including president, CEO and director at Cytori Therapeutics, and president and CEO of StemSource. Dr. Hedrick is a trained general, vascular and plastic surgeon.
Livmarli Tablet Formulation Gets FDA Nod to Treat Severe Itch in Rare Pediatric Liver Diseases

1 week ago | xtalks.com | Ayesha Rashid

Mirum Pharmaceuticals has received FDA approval for a tablet formulation of Livmarli (maralixibat), a treatment for skin itching associated with the rare pediatric liver diseases progressive familial intrahepatic cholestasis (PFIC) and Alagille syndrome (ALGS). Livmarli is an ileal bile acid transporter (IBAT) inhibitor used to treat pruritus (intense itching) associated with cholestasis, the slowing of bile flow through the biliary system, in patients with ALGS and PFIC.
Advancing Rare Disease Trials: Innovation, Partnerships and a Patient Focus

1 week ago | xtalks.com | Ayesha Rashid

The landscape of rare disease clinical trials has seen significant transformation over the past decade. However, many challenges remain in ensuring patient access, optimizing trial design and leveraging technological advancements to improve outcomes.
GSK’s Blujepa Wins FDA Approval as First New Class of Antibiotic for UTIs

1 week ago | xtalks.com | Ayesha Rashid

The FDA has approved Blujepa (gepotidacin) for the treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients aged 12 and older. GSK’s Blujepa represents the first new oral antibiotic in almost 30 years to address the growing challenge of antibiotic resistance in UTIs.uUTIs are the most common type of bacterial infection, affecting up to 16 million women in the US each year.
Vykat XR Approved as First Treatment for Excessive Appetite in Prader-Willi Syndrome

1 week ago | xtalks.com | Ayesha Rashid

Soleno Therapeutics has announced that the FDA has approved Vykat XR (diazoxide choline extended-release tablets) for the treatment of hyperphagia — an intense, persistent hunger — in patients with Prader-Willi syndrome (PWS). The approval marks the first FDA-approved therapy specifically targeting hyperphagia in this rare genetic disorder. After a series of failures in the indication, Soleno has achieved a breakthrough with the approval.
UHN Launches “Canada Leads 100 Challenge” to Recruit World-Class Scientists as US Research Climate Grows Uncertain

2 weeks ago | xtalks.com | Ayesha Rashid

The University Health Network (UHN) has launched the Canada Leads 100 Challenge initiative, which aims to recruit 100 early-career scientists to its Toronto facilities. The initiative seeks to bolster Canada’s position as a global leader in medical research and innovation.
From Lab to Launch: Commercializing Gene Therapies for Rare Diseases with Rocket Pharma’s Carlos Martin - Episode 203

2 weeks ago | xtalks.com | Ayesha Rashid

In this episode, Ayesha spoke with Carlos Martin, MBA, chief commercial operations and revenue officer at Rocket Pharmaceuticals, a company developing gene therapy cures for rare diseases through innovative science and platforms. Carlos joined Rocket in April 2021 and established the company’s early commercial strategy and infrastructure as Chief Commercial Officer. Prior to joining Rocket, Carlos was the US Commercial Head of Advanced Accelerator Applications (AAA), a Novartis Oncology Company.
HHS Cuts Ripple Globally, WHO Faces $1.1B Shortfall

2 weeks ago | xtalks.com | Ayesha Rashid

The US HHS cuts are also rippling beyond national borders. According to Reuters, in a memo, the World Health Organization (WHO) has proposed a 21% budget cut from $5.3 billion to $4.2 billion following the US government’s decision to withdraw a substantial portion of its funding. WHO leadership is preparing to lay off staff and scale back operations across regions, including Africa and Southeast Asia.
HHS Layoffs Update: FDA, NIH and CDC Layoffs, Resignations and New Hires

2 weeks ago | xtalks.com | Ayesha Rashid

In its continuing sweeping overhaul of federal health, the Trump administration’s mass layoffs across key US health agencies went into effect April 1. The Health and Human Services (HHS) Department, now under the leadership of Secretary Robert F. Kennedy Jr. (RFK Jr.), announced last week it was slashing approximately 10,000 positions across agencies, including the FDA, CDC and NIH as part of a restructuring plan.