Midazolam

INTRODUCING "HYPNOVELS," A REVOLUTIONARY USE OF GENERATIVE AI TO TRANSFORM BOOKS INTO MESMERIZING ANIMATIONS

Retrieved on: 
Monday, April 8, 2024

SAN FRANCISCO, April 8, 2024 /PRNewswire/ -- Silverside AI unveils Hypnovels, a Generative AI platform that will radically change the way books are consumed, promoted, and enjoyed.

Key Points: 
  • SAN FRANCISCO, April 8, 2024 /PRNewswire/ -- Silverside AI unveils Hypnovels, a Generative AI platform that will radically change the way books are consumed, promoted, and enjoyed.
  • "We are harnessing the amazing power of AI to help authors worldwide better promote their books and engage more readers," says Rob Wrubel, co-founder of Silverside AI and Founding CEO of pioneering search engine, Ask Jeeves.
  • For readers, Hypnovels represents a new way to experience books aimed at making reading interesting for the ficklest audiences.
  • "There are a lot of AI applications out there trying to turn words into movies," says PJ Pereira, award-winning advertising veteran and founder of Silverside AI.

Melt Pharmaceuticals Closes $24 Million Series B Preferred Stock Financing

Retrieved on: 
Tuesday, April 2, 2024

Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing novel approaches for procedural sedation, today announced the completion of its Series B Preferred Stock financing of approximately $24 million from new and existing investors at a pre‑money valuation that increased nearly 150% from the pre-money valuation for Melt’s Series A Preferred Stock financing in 2019.

Key Points: 
  • Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing novel approaches for procedural sedation, today announced the completion of its Series B Preferred Stock financing of approximately $24 million from new and existing investors at a pre‑money valuation that increased nearly 150% from the pre-money valuation for Melt’s Series A Preferred Stock financing in 2019.
  • The capital raised will primarily support the further development of MELT-300, including the MELT-300 Phase 3 program.
  • “With this round of financing, we’ve obtained the funding to further the development of MELT-300, including conducting our recently commenced Phase 3 program.
  • Their shared belief in the vision of MELT-300 and their confidence in its potential to revolutionize short-duration procedural sedation is incredibly valuable to us.”
    Newbridge Securities Corporation acted as the exclusive placement agent for the Series B Preferred Stock Offering.

Reflection paper on investigation of pharmacokinetics in the obese population - Scientific guideline

Retrieved on: 
Wednesday, February 14, 2024

Reflection paper on investigations of pharmacokinetics in

Key Points: 
    • Reflection paper on investigations of pharmacokinetics in
      the obese population
      Table of contents
      1.
    • References .............................................................................................. 9

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 2/12

      1.

    • This is considered
      a shortcoming that is potentially compounded by obese patients often being poorly represented in
      clinical studies.
    • The specific aims of this reflection paper are to:
      ?

      describe how the effects of obesity can be investigated during clinical medicinal product
      development.

    • ?

      provide recommendations on when investigations of the effect of obesity on the PK of a
      medicinal product should be particularly considered.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 3/12

      ?

      discuss how to reflect PK (and/or PK/PD) findings in weight/weight-based dosing
      recommendations.

    • Absorption
      Reduced rate of absorption linked to locally reduced blood flow (8) is reported for the subcutaneous
      and transdermal routes in obese subjects.
    • Distribution
      The distribution of medicinal products is driven by body composition, regional blood flow and binding to
      tissue and plasma proteins.
    • Obese subjects have a larger absolute lean body weight (LBW) as well as fat mass.
    • The physicochemical properties of a medicinal product (lipophilicity, polarity, molecular size, and
      degree of ionization) influence its distribution in the body.
    • In BMI class III obese
      subjects, the blood flow per gram of fat is significantly lower than that observed in class I obese or
      lean subjects (4).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 4/12

      An increased amount of alpha-1-acid-glycoprotein (AAG), linked to a chronic inflammatory state, is
      reported in obese individuals.

    • Fatty infiltrations are present in the liver for 90% of obese subjects, with the extent of the infiltrations
      being proportional to the degree of obesity.
    • In some cases, in particular for CYP3A4 metabolized medicinal products,
      bodyweight normalized clearance can be lower in obese patients (23).
    • Based on presently available data, it has been suggested that uptake transporters

      Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 5/12

      are downregulated while efflux transporters may be upregulated (31).

    • Platelet hyper-reactivity is also observed,
      which can impair the response to anti-platelet medicinal products in obese patients (42, 43).
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 6/12

      3.

      the medicinal product properties and scientific literature indicate that obesity may lead to a
      marked effect on elimination and/or distribution or on the PK/PD relationship.

    • These
      models may aid in extrapolating the known efficacy and safety in the non-obese population to the
      obese population.
    • The Pharmacokinetics of the CYP3A Substrate Midazolam in Morbidly Obese Patients
      Before and One Year After Bariatric Surgery.
    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 11/12

      41.

    • Reflection paper on investigations of pharmacokinetics in the obese population
      EMA/CHMP/535116/2016

      Page 12/12

Recognizing when someone is having a seizure – and how you can help during those first critical moments

Retrieved on: 
Wednesday, February 14, 2024

But experiencing a seizure does not always mean a person has epilepsy.

Key Points: 
  • But experiencing a seizure does not always mean a person has epilepsy.
  • Seizures can be provoked by acute head injuries, alcohol withdrawal and high blood sugar, among other things.

What does a seizure look like?

  • For some people, their seizure is a purely internal sensation.
  • In fact, most people with epilepsy have only relatively subtle, nonconvulsive seizures at first, then develop convulsive seizures over time.
  • This is the type of seizure most of us are familiar with, probably because it’s the kind most frequently depicted, though not always accurately, in movies and on television.
  • The most common type of epileptic seizure are those that are focal – that is, they arise from a confined region of the brain.

What causes a seizure to occur?


Seizures are the result of abnormal electrical activity in the brain. The bursts of activity disrupt normal functioning and initiate hyperactivity in the affected brain area, which then can affect the corresponding body part. For instance, if the seizure arises from the part of the brain involved in arm movement, that arm will experience involuntary hyperactivity.

If you’re a bystander, how can you help?

  • Many seizure-related injuries occur due to falling or coming in contact with sharp or hard objects.
  • If they begin to fall, help them to the floor as gently as possible and put something soft under their head.
  • During the convulsive phase of a seizure, breathing may be intermittent.
  • So turn the person on their side so they can breathe more easily and lower the risk of aspiration.
  • Following the seizure, and as the person gradually recovers and wakes up, help them sit up in a safe space.

Are new treatments available?

  • People with epilepsy, particularly those who experience frequent seizures, will often have emergency medications in their possession.
  • The most common emergency medications – also called seizure rescue medications – are a type of anticonvulsants called benzodiazepines.
  • Patients and their caretakers may have access to rescue medications and know how to use them.

What if it’s not a seizure?


If a bystander does not witness a seizure, but instead finds someone unresponsive or minimally responsive, call 911. They may be suffering from other medical issues, such as a drug overdose. And if you are interested in training and certification for seizure first aid, or if you simply want to know more, the Epilepsy Foundation has more information.

  • Jacob Pellinen has received research support from the Department of Neurology at the University of Colorado School of Medicine, the Colorado Clinical and Translational Sciences Institute, NIH/NINDS, and the American Epilepsy Society.
  • J. Pellinen serves as chair of the professional advisory board for the Epilepsy Foundation of Colorado and Wyoming (unpaid), serves as the Epilepsy Section Editor for Current Neurology and Neuroscience Reports, and has received compensation for serving on the scientific advisory board for SK Life Science.

Melt Pharmaceuticals Provides Corporate Update

Retrieved on: 
Wednesday, January 3, 2024

Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing novel approaches for procedural sedation, today provided a corporate update.

Key Points: 
  • Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing novel approaches for procedural sedation, today provided a corporate update.
  • Melt Pharmaceuticals recently received a written response from the U.S. Food and Drug Administration (FDA) regarding its planned MELT-300 Phase 3 program.
  • Based on the FDA’s response, Melt Pharmaceuticals expects to begin Phase 3 program activities, which will consist of a single pivotal study comparing MELT-300 to sublingual midazolam and placebo in subjects undergoing cataract surgery, in the first quarter of 2024.
  • Following this transaction, in addition to certain royalty rights, Harrow’s equity ownership percentage of Melt is approximately 47%.

Airlangga University Professor develops New Epilepsy Treatment

Retrieved on: 
Monday, October 30, 2023

Surabaya, East Java, Indonesia, Oct 30, 2023 - (ACN Newswire) - A medical professor at Airlangga University, Prastiya Indra Gunawan, has developed a new epilepsy treatment method that involves administering midazolam intramuscularly and intranasally.

Key Points: 
  • Surabaya, East Java, Indonesia, Oct 30, 2023 - (ACN Newswire) - A medical professor at Airlangga University, Prastiya Indra Gunawan, has developed a new epilepsy treatment method that involves administering midazolam intramuscularly and intranasally.
  • Airlangga University professor Prastiya Indra Gunawan has devised a new treatment method that involves providing midazolam intramuscularly and intranasally to epilepsy patients.
  • This is different from rectal diazepam, which takes 180 seconds," Professor Gunawan, a pediatrician from Airlangga University, said.
  • With the establishment of the epilepsy center, Gunawan said he hopes that people with epilepsy will not only receive healthcare, but also see improvements in their social life.

Pulmocide Announces New Clinical Data Confirming Low Potential for Drug-Drug Interactions with Inhaled Opelconazole

Retrieved on: 
Monday, October 16, 2023

The results from these in vitro studies subsequently informed the design of a Phase 1 drug-drug interaction study in 24 healthy volunteers.

Key Points: 
  • The results from these in vitro studies subsequently informed the design of a Phase 1 drug-drug interaction study in 24 healthy volunteers.
  • “Opelconazole was specifically designed to be administered via inhalation in order to achieve high lung concentrations and low systemic uptake.
  • These low systemic levels, now observed in multiple clinical trials and in the UK Special Needs provision, have been estimated to be too low to have an inhibition or induction of a drug-drug interaction effect.
  • We are encouraged that these clinical trial results confirm this low potential for Cytochrome P450 drug-drug interactions for opelconazole.”

NRx Pharmaceuticals Announces Strategic Change in Development of NRX-100 (IV Ketamine) at Dawson James Small Cap Investor Conference

Retrieved on: 
Thursday, October 12, 2023

The full presentation may be viewed on the Company's web page Link .

Key Points: 
  • The full presentation may be viewed on the Company's web page Link .
  • The Company further invites interested parties to subscribe to their email alert service stay up to date on company's progress here: NRX Email Alerts .
  • The findings of this trial confirm the results reported by Grunebaum and coworkers (Am J Psychiatry 2018;175:327 Link ) and numerous smaller trials.
  • Preliminary estimates of this regulatory focused work show that this effort is within the company's current budget.

Melt Pharmaceuticals Announces Exclusive Development and License Agreement with Catalent for Its Zydis® Fast-Dissolve Technology for Use in MELT-300 for Needle- and Opioid-Free Procedural Sedation

Retrieved on: 
Tuesday, September 26, 2023

Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced it recently entered into an exclusive development and license agreement with Catalent, the global leader in enabling the development and supply of better treatments across multiple modalities.

Key Points: 
  • Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing novel approaches for procedural sedation, today announced it recently entered into an exclusive development and license agreement with Catalent, the global leader in enabling the development and supply of better treatments across multiple modalities.
  • Catalent’s Zydis® ODT technology is currently used in over 35 FDA-approved and U.S.-marketed products.
  • “This exclusive license with Catalent is a key milestone for the continued development of MELT-300,” said Larry Dillaha, M.D., CEO of Melt Pharmaceuticals.
  • Melt Pharmaceuticals is currently in discussions with the FDA (U.S. Food and Drug Administration) on the Phase 3 program, which Melt expects to begin in early 2024.

Eagle Pharmaceuticals to Present BYFAVO® (remimazolam) for Injection Abstract at Prestigious Society for Neuroscience in Anesthesiology and Critical Care (SNACC) Conference

Retrieved on: 
Wednesday, August 30, 2023

WOODCLIFF LAKE, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has been selected to present a platform presentation at the Society for Neuroscience in Anesthesiology and Critical Care (“SNACC”) Annual Meeting being held September 8-10, 2023, in Alexandria, VA.

Key Points: 
  • WOODCLIFF LAKE, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced that it has been selected to present a platform presentation at the Society for Neuroscience in Anesthesiology and Critical Care (“SNACC”) Annual Meeting being held September 8-10, 2023, in Alexandria, VA.
  • The conference is designed to meet the educational needs of neurosurgical and critical care anesthesiologists and neuroscientists involved in the care of patients with neurological disorders.
  • “Byfavo is the first new sedative to come to market in over 20 years, and we are extremely grateful for the opportunity to present this analysis to our esteemed colleagues in the perioperative neuroscience community,” stated Mike Greenberg, MD, Vice President of Medical Affairs at Eagle Pharmaceuticals.
  • “Gaining a better understanding of the potential impact of sedation agents on the central nervous system – as they relate to both short- and long-term changes in cognitive function – should help provide more precise patient care.