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Migraine sufferers in England may soon be able to access preventative drug – here’s how atogepant works

Retrieved on: 
Tuesday, April 23, 2024

Atogepant (brand name: Aquipta) was recently recommended by the National Institute for Health and Care Excellence (Nice) to prevent episodic and chronic migraine attacks.

Key Points: 
  • Atogepant (brand name: Aquipta) was recently recommended by the National Institute for Health and Care Excellence (Nice) to prevent episodic and chronic migraine attacks.
  • The drug would be recommended to people who have at least four migraine days a month or where at least three previous preventative treatments have failed.
  • Migraine is a complex neurological condition that affects about 10 million people in the UK.
  • It’s characterised by recurrent, severe headaches that can be made worse by physical activity and are often debilitating.
  • However, it’s only suited to patients who suffer from episodic migraines – whereas atogepant can be used by people who have both chronic and episodic migraines.

Consistently effective


Three clinical trials have shown atogepant to be safe and effective for people with episodic or chronic migraines.

  • The Advance trial evaluated how safe and effective different doses of atogepant were compared with a placebo in preventing episodic migraine.
  • The 60mg once-daily tablet was found to be well tolerated and effective, leading to nearly seven fewer migraine days per month.
  • A third trial, the 302-LTS trial, followed participants who suffered from episodic migraine for over a year, finding that atogepant was consistently effective for reducing migraine attacks.
  • Atogenpant was consistently shown to be safe across all studies, including the one that lasted for a year.


Anna Andreou receives funding from the Medical Research Foundation and Brain Research UK. She also received research funding from eNeura, AbbVie and Pfizer. She is affiliated with the International Headache Society, being elected as a Trustee of the Board. She is Chair of the Headache special interest group of the British Pain Society.

Getting a good night’s rest is vital for neurodiverse children – pediatric sleep experts explain why

Retrieved on: 
Friday, April 19, 2024

If you’re a parent with kids at home, it often leaves you and your children on edge.

Key Points: 
  • If you’re a parent with kids at home, it often leaves you and your children on edge.
  • Children with neurodiverse conditions, such as autism and attention-deficit/hyperactivity disorder, or ADHD, are even more susceptible to the effects of poor sleep, given their emotional reactivity and impulsivity..
  • Struggles with sleep have been linked to increased aggression, irritability, inattention and hyperactivity in children with autism spectrum disorder.

The science behind sleep difficulties

  • There are multiple reasons why neurodiverse children don’t sleep well, including medical conditions, biological causes and behavioral and environmental factors.
  • Medical conditions, such as obstructive sleep apnea or epilepsy, can affect a child’s sleep.
  • Medications that are used to treat medical conditions, such as antidepressants for mood disorders or stimulants for ADHD, can further disrupt sleep.

Treating sleep problems


All of these factors can be addressed and treated. A thorough evaluation by the child’s health care provider may reveal a medical cause, or medication, that is interfering with sleep. Behavioral approaches can make a big difference in improving sleep. These might include:
Changes to daytime habits, including getting lots of morning light and physical activity.
Shifts in evening habits, such as removing all screens (TV, computers, phones, etc.) and establishing calming bedtime routines.
Modifications to how a parent interacts with their child for those families who would like a child to fall asleep and stay asleep independently.

  • It’s important to note that not all families want their children to sleep on their own.
  • Because there are so many factors that can cause disrupted sleep, addressing sleep problems cannot be a one-size-fits-all approach and should be done in partnership with parents.
  • Our team has developed a family-centered approach to address sleep problems in neurodiverse children.

The ups and downs of melatonin

  • While behavioral approaches are recommended as a first-line treatment, melatonin can be helpful in jump-starting a behavioral routine.
  • Overdoses can result from children eating a bunch of gummies, or parents not understanding how much melatonin is safe to give.
  • To help parents sift through all the resources and articles on melatonin on the internet and social media, one of us created a video and wrote several blogs on melatonin safety.
  • These include topics like whether children can become dependent on melatonin supplements over time, whether taking melatonin will delay puberty, whether children might experience side effects from taking melatonin and more.

Promoting healthier sleep


Here are some general tips for helping your child sleep better, regardless of whether they are neurodiverse:
Choose a consistent bedtime and wake time. This consistency will help children’s own natural melatonin kick in.
Make sure bedtime isn’t too early. For example, an 8 p.m. bedtime is too early for most 10-year-olds. Neurodiverse children may struggle to sleep and will become more anxious, which makes going to sleep even harder.
Help your child get natural sunlight in the morning. Morning sunlight sets our brain’s internal clock so that we can fall asleep more easily at bedtime.
Ensure your child is getting physical activity during the day.
Minimize naps longer than one hour, or after 4 p.m. for school-age children. Naps can interfere with going to sleep at night.
Avoid caffeine, including many types of soda, tea and chocolate.
Turn off all screens and smartphones at least 30 minutes before bedtime.
In the evening leading up to bedtime, turn down all lights in the house. Consider using red night lights, if possible. Set any devices to night mode in the evening to limit exposure to blue light.
Create wind-down time in place of screens. Have your child identify an activity they enjoy that is calming and soothing, such as reading a book, coloring or listening to music. If a bath is stimulating, move it to earlier in the evening, such as after dinner.
Help your child learn to fall asleep without needing you or their devices to be there with them. That way, they will settle down on their own at bedtime. And when they wake up throughout the night, since we all wake up in the night, they will be able to go right back to sleep without becoming fully awake.
For more tips, see Autism Speaks for free downloads of brochures and visual aids.

  • She also receives funding from the American Academy of Sleep Medicine.
  • She has received funding from the American Academy of Sleep Medicine and Autism Speaks for research on sleep in children with ASD.

Phathom Pharmaceuticals Launches Direct-to-Consumer Campaign, “VOQUEZNA Can Kick Some Acid”

Retrieved on: 
Tuesday, March 26, 2024

FLORHAM PARK, N.J., March 26, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announces the launch of its new broadcast ad and full-scale, Direct-to-Consumer (DTC) campaign, “VOQUEZNA Can Kick Some Acid,” to raise awareness of its powerful first-in-class treatment and encourage people to speak to their doctor about this new treatment option. VOQUEZNA (vonoprazan) is indicated for the healing and maintenance of healing of all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and for the relief of related heartburn. VOQUEZNA represents the first major innovation to the U.S. Erosive GERD market in over 30 years.1

Key Points: 
  • The campaign will also be featured on consumer-facing platforms across Facebook, Instagram, waiting room TVs in doctor offices, and digital banner ads.
  • “Phathom is excited to launch our first campaign directly to, and for, the people whose lives we strive to improve every day.
  • To view a video of the “VOQUEZNA Can Kick Some Acid” commercial, click here.
  • Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Saturday, April 6, 2024

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

The American Dream: Doctors Unite to Educate About Proactive Health on "The World Wellness Show"

Retrieved on: 
Thursday, March 14, 2024

GAINESVILLE, Fla., March 14, 2024 (GLOBE NEWSWIRE) -- The World Wellness Show expands collaborative movement towards proactive health to 137 countries with the help of top wellness experts.

Key Points: 
  • GAINESVILLE, Fla., March 14, 2024 (GLOBE NEWSWIRE) -- The World Wellness Show expands collaborative movement towards proactive health to 137 countries with the help of top wellness experts.
  • Doctors wanting to share "their messages" globally and create personalized content for their clinic's social media and websites can schedule their interview now at: www.TheWorldWellnessShow.com .
  • Trish Gleason, Host of the World Wellness Show, shared: “Together we can educate the world and spark a shift in wellcare from treatment to prevention.
  • Our goal is to spark a paradigm shift to how we perceive and prioritize health and move away from reactive treatments and towards proactive wellness practices.

 Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophrenia International Research Society

Retrieved on: 
Saturday, April 6, 2024

Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia.
  • “These long-term safety results and metabolic outcomes from the EMERGENT program are extremely encouraging, allowing us to further understand the tolerability profile of KarXT in people living with schizophrenia,” said Roland Chen , MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb.
  • In the pooled analysis, KarXT demonstrated a favorable impact on weight and long-term metabolic profile where most patients experienced stability or improvements on key metabolic parameters over 52 weeks of treatment.
  • In the long-term studies, KarXT was generally well-tolerated across 52 weeks of treatment, with a side effect profile consistent with prior trials of KarXT in schizophrenia.

Astria Therapeutics Announces Positive Initial Proof-of-Concept Results from the ALPHA-STAR Phase 1b/2 Trial of STAR-0215 for HAE

Retrieved on: 
Monday, March 25, 2024

Based on the positive results, Astria plans to advance STAR-0215 to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026.

Key Points: 
  • Based on the positive results, Astria plans to advance STAR-0215 to Phase 3 development with trial initiation expected in Q1 2025 and top-line results expected by year-end 2026.
  • Initial safety and efficacy data from Q3M and Q6M dosing in the ALPHA-SOLAR trial are expected mid-2025.
  • Pending regulatory feedback, the Company expects to start a pivotal Q3M Phase 3 trial in Q1 2025, with top-line results expected by year-end 2026.
  • Interested parties may join the webcast via the Investors section of the Astria website, www.astriatx.com or with following the link https://lifescievents.com/event/astriatx/ .

Alnylam Launches Hereditary ATTR (hATTR) Amyloidosis Campaign to Help Shorten Time to Diagnosis for Inherited and Rapidly Progressive Disease

Retrieved on: 
Wednesday, March 13, 2024

“Family history is considered one of the most important risk factors for health problems.

Key Points: 
  • “Family history is considered one of the most important risk factors for health problems.
  • “It took seeing nine doctors over seven years for me to finally receive a diagnosis of hATTR amyloidosis,” said Christine, a Family Health History Road Trip participant who is living with hATTR amyloidosis.
  • If I had, I could have potentially been diagnosed and started on a disease management plan much earlier.”
    With an inherited disease like hATTR amyloidosis that progresses rapidly, early diagnosis is crucial.
  • A genetic test can determine whether a person carries one of the more than 120 variants in the TTR gene associated with hATTR amyloidosis.

Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL®9

Retrieved on: 
Wednesday, March 13, 2024

Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.

Key Points: 
  • Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • The latest addition to the pipeline employs the company’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV type coverage.
  • These randomized, double-blind, multi-year clinical trials will examine the short and long-term efficacy and immunogenicity of a single-dose of GARDASIL 9 versus the currently approved three-dose regimen.

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Wednesday, April 3, 2024

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.