Absorption

Silo Pharma Completes Successful Dose-Ranging Study of SPC-15 Intranasal Therapeutic for PTSD

Retrieved on: 
Wednesday, February 28, 2024

SARASOTA, FL, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Silo Pharma, Inc. (Nasdaq: SILO) (“Silo” or the “Company”), a developmental stage biopharmaceutical company focused on developing novel formulations and drug delivery systems for traditional therapeutics and psychedelic treatments, today announced positive results from its non-GLP small animal dose-ranging study of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress disorder (PTSD).

Key Points: 
  • The purpose of the non-GLP small animal study was to identify the maximum tolerated intranasal dose of the drug pharmacokinetic and determine the therapeutically relevant dose range to be studied in clinical trials.
  • Data analysis demonstrated rapid absorption of SPC-15 with good exposure over a 24-hour period, suggesting a once-per-day human intranasal dosing regimen would be optimal.
  • “Non-GLP and GLP toxicology and safety pharmacology studies are required steps before seeking approval for our first-in-human clinical-stage trials of SPC-15,” said Eric Weisblum, CEO of Silo.
  • This is an exciting step forward for our Company as we advance our lead therapeutic, SPC-15.”

Strainsforpains Inc. Announces Corporate Update

Retrieved on: 
Friday, February 23, 2024

Strainsforpains is pleased to announce that it has increased the capacity of its Pennsylvania facility to accommodate the company’s growing CBD product line.

Key Points: 
  • Strainsforpains is pleased to announce that it has increased the capacity of its Pennsylvania facility to accommodate the company’s growing CBD product line.
  • Based on updated preliminary orders, Strainsforpains foresees CBD sales exceeding $500,000 for fiscal 2024.
  • Strainsforpains, Inc. is an innovative healthcare data technology Company located in New York, N.Y.
  • Although Strainsforpains, Inc. believes the expectations reflected in any forward-looking statements are based on reasonable assumptions, Strainsforpains, Inc. is unable to give any assurance that its expectations will be attained.

Hemp, Inc. Reports: Hemp-Based Foods Market Set to Reach $8.36 Billion by 2028

Retrieved on: 
Thursday, February 22, 2024

The hemp-based foods market is set to reach $8.36 billion by 2028 according to The Business Research Company’s (TBRC) latest report , “Hemp Based Foods Global Market Report 2024”.

Key Points: 
  • The hemp-based foods market is set to reach $8.36 billion by 2028 according to The Business Research Company’s (TBRC) latest report , “Hemp Based Foods Global Market Report 2024”.
  • Projected to achieve a robust compound annual growth rate (CAGR) of 8.9%, the market is anticipated to burgeon from its current standing to an impressive $8.36 billion by 2028.
  • The report highlights hemp milk, hemp oil, hemp cheese substitutes, and hemp-based protein powders as key products fueling the market's growth.
  • Distributed primarily through supermarkets and convenience stores, hemp-based foods are becoming increasingly accessible to consumers worldwide, further propelling market growth.

NeuroMetrix Reports Q4 and Full Year 2023 Business Highlights

Retrieved on: 
Thursday, February 22, 2024

WOBURN, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter and full year ended December 31, 2023.

Key Points: 
  • WOBURN, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter and full year ended December 31, 2023.
  • "Quell® Fibromyalgia growth accelerated in Q4 2023 reflecting the addition in Q3 2023 of two field business development managers and optimized clinical messaging.
  • In the successive quarters of Q4 2023 versus Q3 2023, all key operating metrics showed substantial growth.
  • The Q4 2023 net loss was $1.6 million ($1.43 per share) versus a net loss of $0.7 million ($0.73 per share) in Q4 2022.

Sunrun Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, February 21, 2024

Customers grew 17% in the fourth quarter of 2023 compared to the fourth quarter of 2022.

Key Points: 
  • Customers grew 17% in the fourth quarter of 2023 compared to the fourth quarter of 2022.
  • Subscriber Value was $50,302 in the fourth quarter of 2023, an 18% increase compared to the fourth quarter of 2022.
  • Total revenue was $516.6 million in the fourth quarter of 2023, down $92.6 million, or 15%, from the fourth quarter of 2022.
  • During the fourth quarter of 2023, Sunrun recorded a $58.7 million non-cash charge related to its investment in Lunar Energy.

ARS Pharma Announces Favorable Topline Results from Repeat Dosing Study of neffy® (Epinephrine Nasal Spray) Under Nasal Allergen Challenge Conditions, Readies Data for Response to FDA’s Complete Response Letter

Retrieved on: 
Tuesday, February 20, 2024

SAN DIEGO, Feb. 20, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (NASDAQ: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect patients from severe allergic reactions that could lead to anaphylaxis, today announced topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection, as requested by the FDA with and without nasal allergen challenge (NAC) conditions.

Key Points: 
  • “The study objective was to compare twice dosing with epinephrine injection and twice dosing with neffy under normal conditions and after nasal allergen challenge.
  • With these results, we are completing the necessary work to submit our response to FDA in the next couple of months.
  • The repeat dose study under NAC conditions was designed with the FDA to address the Agency’s outstanding questions regarding neffy as described in the Complete Response Letter (CRL) from September 2023.
  • In addition, multiple PADAC members highlighted the favorable profile of neffy in our single dose NAC study.

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Retrieved on: 
Tuesday, March 12, 2024

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Key Points: 
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      Guideline on allergen products development for
      immunotherapy and allergy diagnosis in moderate to lowsized study populations

      17

      Table of contents

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      Executive summary ..................................................................................... 3

      19

      1.

    • Specific effects ................................................................................................. 17

      14
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      12.

    • Management for allergies may involve avoidance of the allergen, medications to relieve

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      symptoms, or allergen immunotherapy (AIT) to desensitize the immune system to the allergen.

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      Recommendations are made on the clinical development, potential study designs and safety

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      considerations for allergen products within the scope of the guideline.

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      While allergen specific immunotherapy is the only known disease modifying therapy for type I allergies,

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      there is no such treatment available for type IV allergies.

    • 93

      Several guidelines applicable for allergen products are available (see section 3) and provide advice on

      94

      quality and clinical development according to the current knowledge.

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      However, this guideline does not cover the indication of atopic dermatitis or asthma as these

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      conditions will require separate clinical trials (see Section 6).

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      In addition, the guideline does not cover medicinal allergen products manufactured using recombinant

      130

      DNA technology, synthetic peptides, DNA or RNA constructs and/or cell preparations as they differ

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      substantially to the allergen products as discussed above.

    • 1

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      ?

      Guideline on the clinical development of products for specific immunotherapy for the treatment

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      of allergic diseases - CHMP/EWP/18504/2006
      ?

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      Guideline on Allergen Products: Production and Quality Issues EMEA/CHMP/BWP/304831/2007

      ?

      Guideline on process validation for finished products - information and data to be provided in
      regulatory submissions - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1, Corr.1

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      in moderate to low-sized study populations
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      ?

      Recommendations on common regulatory approaches for allergen products - CMDh/399/2019

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      4.

    • In any

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      case, a reduced validation should include all relevant manufacturing process steps that are considered
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      product specific.

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      Diagnostic allergen products (Type I allergy)

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      A possible target indication is diagnosis of type I hypersensitivity (immediate-type allergy) by prick,

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      intracutaneous or provocation testing.

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      7.1.

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      8.

    • Clinical development of products for AIT: Study design,
      efficacy and safety

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      In general, the clinical development should be performed according to current guidelines.

    • In such single trial, the suitability as a test allergen as well as the

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      in moderate to low-sized study populations
      EMA/CHMP/72790/2024

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      dose finding for the therapeutic allergen could be investigated.

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      8.2.1.

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      In general, sensitivity and specificity of the product should be determined.

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      10.2.

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      4.

    • Allergol Immunopathol, 1989;

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      17(2):53-65

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ViiV Healthcare presents phase I clinical trial findings of a cabotegravir long-acting injectable investigational formulation allowing at least four months between doses

Retrieved on: 
Monday, March 4, 2024

ViiV Healthcare is conducting a registrational study of CAB-ULA in 2024 to further evaluate its use for the prevention of HIV in adults.

Key Points: 
  • ViiV Healthcare is conducting a registrational study of CAB-ULA in 2024 to further evaluate its use for the prevention of HIV in adults.
  • Future areas of study will include its potential use in combination with other medicines as a complete, ultra long-acting HIV treatment regimen.
  • ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the HIV community.
  • Based on these combined findings, ViiV Healthcare is no longer pursuing CAB 200 SC + rHuPH20 for ultra long-acting dosing.

Manitex International Reports Fourth Quarter and Full-Year 2023 Results

Retrieved on: 
Thursday, February 29, 2024

As a result of these factors, gross profit margin increased 162 basis points to 20.9% during the fourth quarter 2023.

Key Points: 
  • As a result of these factors, gross profit margin increased 162 basis points to 20.9% during the fourth quarter 2023.
  • Higher US-based steel prices were once again a headwind to gross profits during the fourth quarter, as steel prices surged late in the third quarter and into the fourth quarter.
  • Operating income was $4.8 million for the fourth quarter 2023, compared to $4.2 million for the same period last year.
  • Net leverage was 2.9x at the end of fourth quarter 2023, down from 3.9x at the end of fourth quarter 2022.

Eurofins Discovery Introduces Innovative DiscoveryAI SAFIRE: A New AI-Driven Platform for Drug Discovery Trained Using Proprietary Datasets

Retrieved on: 
Thursday, February 29, 2024

Eurofins Discovery , an industry-leading provider of products and services for drug discovery research, today announced the launch of DiscoveryAI SAFIRE (Suite of ADMET Predictions For In Silico Refinement and Evaluation).

Key Points: 
  • Eurofins Discovery , an industry-leading provider of products and services for drug discovery research, today announced the launch of DiscoveryAI SAFIRE (Suite of ADMET Predictions For In Silico Refinement and Evaluation).
  • SAFIRE is an advanced platform that leverages proprietary datasets, artificial intelligence (AI), and machine learning (ML), offering a unique capability for expediting discovery.
  • It’s proven effective in accelerating drug discovery projects from initial hit discovery through to lead optimization.
  • For more details about SAFIRE’s benefits and significant value to the drug discovery community, visit eurofinsdiscovery.com/safire .