Absorption

Phathom Pharmaceuticals Announces FDA Acceptance for Filing of VOQUEZNA® (vonoprazan) Tablets New Drug Application for the Treatment of Heartburn Associated with Non-Erosive GERD

Retrieved on: 
Wednesday, December 6, 2023
Quality of life, CYP, Kidney, Risk, Heartburn, Enzyme inhibitor, FDA, TIN, Hypertension, Achlorhydria, Magnesium, Liver, PPI, SJS, Magnesium deficiency, Chest pain, Atazanavir, Endoscopy, Impairment, SCAR, Vitamin B12, Malabsorption, Absorption, PDUFA, CDAD, Calcium, New Drug Application, Gastritis, Enzyme, Food and Drug Administration, Clostridioides, Vonoprazan, Patient, Hip, Hypokalemia, Food, Polyp, GERD, Nelfinavir, Toxicity, EGFR, Wrist, Diarrhea, Hypocalcemia, NDA, Abdominal pain, Urinary tract infection, Hypersensitivity, Stevens–Johnson syndrome, Glomus tumor, Spine, Indigestion, Drug, CGA, Lactation, Pharmaceutical industry

The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.

Key Points: 
  • The FDA has assigned the application a standard 10-month review with a Prescription Drug User Fee Act (PDUFA) target action date of July 19, 2024.
  • “Non-Erosive GERD represents a substantial segment of the U.S. GERD population, affecting millions of individuals and impacting their quality of life.
  • Symptoms impact overall quality of life and can include episodic heartburn, especially at night, regurgitation, problems swallowing, and chest pain.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.

Aspargo Laboratories Inc. Announces Completion of Dosing of All Subjects in Sildenafil Oral Suspension Bioavailability Study and Initiation of Dosing in Companion Food-Effect Study

Retrieved on: 
Tuesday, December 5, 2023
Male, ED, Fed, Absorption, Plasma, Sildenafil, Prevalence, Fasting, Tablet, University, Patient, Erectile dysfunction, Pharmaceutical industry

In addition, today the Company announced the initiation of dosing of 38 subjects in two cohorts in the Company’s food effect study, comparing the amount of active drug in plasma after administration of a single oral dose of Sildenafil Oral Suspension (ASP-001) under fasting and fed (following a meal) conditions.

Key Points: 
  • In addition, today the Company announced the initiation of dosing of 38 subjects in two cohorts in the Company’s food effect study, comparing the amount of active drug in plasma after administration of a single oral dose of Sildenafil Oral Suspension (ASP-001) under fasting and fed (following a meal) conditions.
  • We look forward to providing top-line data from both studies in early 2024.”
    Sildenafil Oral Suspension is an oral liquid suspension of sildenafil citrate administered via a metered-dose pump that dispenses 12.5 mg of sildenafil per actuation.
  • Aspargo uses a metered-dose container that delivers the precise amount of sildenafil citrate per actuation based on patient need.
  • The discreet and easy-to-carry oral formulation allows the user to customize dosing, with physician direction, and avoid pill splitting or crushing common with the traditional tablet medication.

Codex Labs Announces the SGBNET Portal for Genetic Counselling and DECODE DNA Tests for Skin Conditions and Vitamin Deficiencies

Retrieved on: 
Friday, December 1, 2023
Hyperpigmentation, Dermatology, Metabolism, Vitamin, Real-time, Absorption, Diet, Comedo, Mental health, Acne, Silicon

San Jose, Calif., Dec. 01, 2023 (GLOBE NEWSWIRE) -- Codex Labs, Silicon Valley’s biotech skintech company announced the launch of its SGBNET platform.

Key Points: 
  • San Jose, Calif., Dec. 01, 2023 (GLOBE NEWSWIRE) -- Codex Labs, Silicon Valley’s biotech skintech company announced the launch of its SGBNET platform.
  • The platform includes DermSCORE (an AI analytic that monitors acne lesions, comedones, or hyperpigmentation), allows consumers to register their DECODE DNA kits, and schedules consultations with genetic counselors.
  • Codex Labs can then continue working with the consumer to create a personalized regimen to address the skin condition.
  • We believe that data-driven, at-home dermatology represents the future of accessible care to those with skin conditions,” added Dr. Paldus.

Exco Technologies Limited Announces Results for Fourth Quarter and Year Ended September 30, 2023

Retrieved on: 
Wednesday, November 29, 2023
Depreciation, Marketing, Net income, Conference, Tax, Consolidated, Sale, Movement, OEM, PIN, Share repurchase, Extrusion, Absorption, International, Conference call, Public expenditure, ESG, Welding, Exco, Aluminium, Original equipment manufacturer, Plant, International Financial Reporting Standards, COVID, Free cash flow, Traction, Growth, Investment, Management, Carbon, Corporation, UAW, EPS, Video game

Exco expects a muted impact from these strikes in its first quarter results in F2024.

Key Points: 
  • Exco expects a muted impact from these strikes in its first quarter results in F2024.
  • The effective income tax rate was 25% in the current quarter compared 26% in the same quarter last year.
  • Higher fourth quarter net income, depreciation, deferred taxes, and interest expense contributed to the increased operating cash flow in the current quarter.
  • For those unable to participate on November 30, 2023, an archived version will be available on the Exco website until December 15, 2023.

Highstreet Village's Sales Success Proves Strong Demand For Thoughtfully Planned Communities

Retrieved on: 
Tuesday, November 28, 2023
Abbotsford International Airport, AC, CMA, Sale, Principal, School, Marketing, Absorption, Environment, Heart, Housing, Abbotsford-Mission, Appetite, Growth, Congestion, Transport, Population growth, Relaxation, EV, Cineplex, Senior

Highstreet Village is at the heart of the growing Fraser Valley region, driven by a burgeoning economy and increased population growth.

Key Points: 
  • Highstreet Village is at the heart of the growing Fraser Valley region, driven by a burgeoning economy and increased population growth.
  • This masterfully planned residential community features 137 townhomes and nine mid-rise condominiums, totaling 600 homes ranging from 1 to 3-bedroom units.
  • "We are thrilled to see such strong early sales for Highstreet Village," says Alf Wall, Principal of AB Wall Properties.
  • There is a strong appetite for communities that are not only well-designed but also thoughtfully planned to enrich family living and offer convenient access to essential amenities.

Erasca Achieves Key Milestones for Naporafenib and ERAS-801 Programs and Extends Cash Runway

Retrieved on: 
Tuesday, November 28, 2023
MTD, CRC, Index, ASCO, BRAF, Absorption, FDA, Colorectal cancer, EGFR, FTD, Cetuximab, Decompression (diving), ODD, Clinical trial, Glioblastoma, CNS, GBM, NRAS, Patient, Central nervous system, Safety, Food and Drug Administration, Pharmaceutical industry

SAN DIEGO, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, today announced program updates for pan-RAF inhibitor naporafenib and central nervous system (CNS)-penetrant EGFR inhibitor ERAS-801, as well as a strategic program prioritization that extends its projected cash runway from H2 2025 to H1 2026.

Key Points: 
  • “To further maximize resources, we have strategically refined our pipeline to focus on programs with the greatest therapeutic potential for patients with high unmet needs using a data-driven approach.
  • As such, we are deprioritizing our ERAS-601 clinical trial (FLAGSHP-1) and our preclinical ERAS-5 ULK inhibitor and ERAS-10 protein degrader programs.
  • ERAS-801 monotherapy has been granted Orphan Drug and Fast Track Designations (ODD and FTD) by the FDA.
  • Though ERAS-601 achieved confirmed responses as a monotherapy and in combination with cetuximab, preliminary data do not justify further development of this combination in FLAGSHP-1 indications

Alvotech Reports Financial Results for First Nine Months of 2023 and Provides a Business Update

Retrieved on: 
Tuesday, November 28, 2023
Omalizumab, European Economic Area, European Commission, Partnership, Food, Johnson & Johnson, Food and Drug Administration, BLA, Business analyst, FDA, EMA, Marketing, Absorption, Research, Civil service commission, European Medicines Agency, Gross metropolitan product, Committee, Patient, Safety, Stada Arzneimittel, Webcast, G&A, Biosimilar, CHMP, Pharmaceutical industry

Alvotech and JAMP Pharma also announced the receipt of a marketing authorization in Canada for AVT04.

Key Points: 
  • Alvotech and JAMP Pharma also announced the receipt of a marketing authorization in Canada for AVT04.
  • Product Revenue: Product revenue was $29.8 million for the nine months ended September 30, 2023, compared to $11.1 million for the same nine months of 2022.
  • Income tax benefit: Income tax benefit was $67.1 million for the nine months ended September 30, 2023, compared to $14.8 million for the same nine months of 2022.
  • Alvotech will conduct a business update conference call and live webcast on Wednesday, November 29 at 8:00 am ET (13:00 GMT).

Certara introduces Simcyp™ Biopharmaceutics software to increase efficiency of novel and generic drug formulation & development  

Retrieved on: 
Tuesday, November 21, 2023
Holocene, Drug development, PBPK, Absorption, FDA, CMC, VBE, Simcyp, BCS, Complex, Element, Pediatrics, Biopharmaceutical, Safety, Fine chemical

PRINCETON, N.J., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the introduction of Simcyp™ Biopharmaceutics software.

Key Points: 
  • PRINCETON, N.J., Nov. 21, 2023 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced the introduction of Simcyp™ Biopharmaceutics software.
  • It is designed for use by biopharmaceutic, formulation, and CMC scientists to aid in formulating complex novel and generic small molecule medicines quickly and cost effectively.
  • Simcyp Biopharmaceutics software is part of the Simcyp Simulator biosimulation platform, which has supported label claims for more than 100 approved novel therapies .
  • Simcyp Biopharmaceutics software includes a VBE module that automates elements of trial design significantly enhancing opportunities for attaining biowaivers.

Enveric Biosciences Reports Year End Progress for Preclinical Development of Lead Prodrug Candidate EB-373

Retrieved on: 
Wednesday, December 27, 2023
Biotechnology, Natural Resources, Pharmaceutical, General Health, Health, Mental Health, Cannabis, Clinical Trials, Toxicology, DRF, Metabolism, Research, Depression, Absorption, Psilocybin, HERG, Human, Addiction, Clinical trial, Disulfiram-like drug, Rat, ADR, Dog, Anxiety, Mental health, Animal, Cardiotoxicity, CNS, Safety, Therapy, Vomiting, Pharmaceutical industry

In addition, cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies have been completed and are undergoing analyses.

Key Points: 
  • In addition, cardiac, respiratory, CNS safety pharmacology studies, an in vitro hERG current study, and genotoxicity studies have been completed and are undergoing analyses.
  • Enveric expects to finalize all preclinical activities involving EB-373 in the first quarter of 2024 in preparation for a first-in-human clinical trial.
  • “Our research team has continued to diligently advance the preclinical program for our lead novel psilocin prodrug, EB-373, as we anticipate initiating first in human trials in 2024,” said Joseph Tucker, Ph.D., Director and CEO of Enveric.
  • Results from this study also demonstrated rapid conversion of EB-373 to the active metabolite psilocin, consistent with previously reported pharmacokinetic (PK) studies.

U.S. Multifamily Market Faces Challenges Ahead, According to New Yardi Matrix Outlook

Retrieved on: 
Wednesday, December 20, 2023
Housing, Growth, Investment, Sun Belt, Matrix, Absorption, Commercial property

SANTA BARBARA, Calif., Dec. 20, 2023 /PRNewswire/ -- After two years of stellar growth, rents decelerated in 2023, despite demand still at strong levels thanks to a resilient economy. The 2024 Multifamily Outlook from Yardi® Matrix anticipates a year of challenges, including slowing national rent growth.

Key Points: 
  • The 2024 Multifamily Outlook from Yardi® Matrix anticipates a year of challenges, including slowing national rent growth.
  • National rent growth moderated to 0.4 percent year-over-year through November 2023, from a combined 23.5 percent in 2021 and 2022.
  • Yardi Matrix expects that rent growth and occupancy will be heavily tested next year.
  • Yardi Matrix covers multifamily, student housing, vacant land, industrial, office, retail and self storage property types.