Capsule

X4 Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates

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星期二, 五月 7, 2024
Birth, FDA, Capsule, Myelokathexis, Research and development, Priority review, Safety, WHIM syndrome, Food, Security (finance), Conference call, WHIM, Research, Conference, Wart, Neutrophil, CIS, Patient, Society, EMA, Hypogammaglobulinemia, Infection, G-CSF, Interim, Immune system, Lymphocyte, Clinical trial, ID, European Medicines Agency, Pharmaceutical industry

BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the first quarter ended March 31, 2024 and highlighted key recent and upcoming expected milestones.

Key Points: 
  • ET
    BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the first quarter ended March 31, 2024 and highlighted key recent and upcoming expected milestones.
  • “Concurrent with this approval, we received a Rare Pediatric Disease Priority Review Voucher, which we intend to monetize.
  • X4 currently expects to seek approval from the European Medicines Agency (EMA) for mavorixafor in WHIM syndrome in late 2024/early 2025.
  • The live webcast will be accessible through the investor relations section of X4 Pharmaceuticals’ website at www.x4pharma.com.

Ironwood Pharmaceuticals Reports First Quarter 2024 Results

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星期四, 五月 9, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, PS, Phase, Capsule, The Lancet, Gastrointestinal disease, Safety, AbbVie, Food, Interstitial cystitis, SBS, Depreciation, Interest, Trial of the century, Endometriosis, Research, Hepatology, IQVIA, Disease, Autoimmune disease, Patient, Liver, Acquisition, Short bowel syndrome, Constipation, DDW, STARS, Primary biliary cholangitis, Bank statement, Adjustment, Standard of care, Clinical trial, PBC, GAAP, Food and Drug Administration, Income tax, Ageing, Pharmaceutical industry

LINZESS commercial margin, excluding the gross-to-net change in estimate, was 71% in the first quarter of 2024, compared to 73% in the first quarter of 2023.

Key Points: 
  • LINZESS commercial margin, excluding the gross-to-net change in estimate, was 71% in the first quarter of 2024, compared to 73% in the first quarter of 2023.
  • Total revenue in the first quarter of 2024 was $74.9 million, compared to $104.1 million in the first quarter of 2023.
  • Operating expenses in the first quarter of 2024 were $63.9 million, compared to $44.0 million in the first quarter of 2023.
  • Ironwood generated $45.0 million in cash from operations in the first quarter of 2024, compared to $80.2 million in cash from operations in the first quarter of 2023.

Andall Biosciences Introduces 23WELL: A Breakthrough New Brand with Ovary Care Capsules (1+1) as its Stellar Debut Product

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星期三, 五月 8, 2024
FDA, Capsule, Genetics, ABI, Woman, Food, Dietary supplement, Health, Medicine, Collection, Inositol, Research, Disease, Incidence, Coenzyme Q10, CAC, Multimedia, Codex Alimentarius, POI, Primary ovarian insufficiency, Certificate, Global health

The brand takes center stage with its debut offering, Ovary Care Capsules (1+1) at Circle Harmony, a high-end medical service institution located within InterContinental Shanghai Ruijin.

Key Points: 
  • The brand takes center stage with its debut offering, Ovary Care Capsules (1+1) at Circle Harmony, a high-end medical service institution located within InterContinental Shanghai Ruijin.
  • This revolutionary new product, 23WELL Ovary Care Capsules (1+1), is dedicated to women's health, specifically ovary care.
  • With 23WELL, ABI delivers a brand that not only represents premium quality but also champions the pursuit of optimal health.
  • 23WELL introduces its Ovary Care Capsules in a special 1+1 offer, uniquely blending the best of Western and Chinese medicinal traditions.

Neurocrine Biosciences to Present Phase 3 Baseline Characteristics Data from the CAHtalyst™ Program of Crinecerfont in CAH, and Data for Modified-Release Hydrocortisone in Primary Adrenal Insufficiency and CAH Studies at ECE 2024

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星期二, 五月 7, 2024
Safety, Patient, Neurocrine Biosciences, CAH, Abstract, Hydrocortisone, Congenital adrenal hyperplasia, ECE, Adrenal crisis, Treatment, Adrenocorticotropic hormone, Capsule, SAN, Incidence, Pharmaceutical industry

SAN DIEGO, May 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present key information from its neuroendocrinology pipeline, including baseline characteristics data from its CAHtalyst™ Program of crinecerfont in congenital adrenal hyperplasia (CAH), as well as data from its modified-release hydrocortisone studies in primary adrenal insufficiency and CAH, at the European Congress of Endocrinology 2024 meeting in Sweden, May 11–14.

Key Points: 
  • SAN DIEGO, May 7, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that it will present key information from its neuroendocrinology pipeline, including baseline characteristics data from its CAHtalyst™ Program of crinecerfont in congenital adrenal hyperplasia (CAH), as well as data from its modified-release hydrocortisone studies in primary adrenal insufficiency and CAH, at the European Congress of Endocrinology 2024 meeting in Sweden, May 11–14.
  • Neurocrine Biosciences will be presenting several abstracts and posters at ECE 2024, including:
    Baseline Characteristics of Children and Adolescents with Classic Congenital Adrenal Hyperplasia Enrolled in CAHtalyst Pediatric, a Phase 3 Study of Crinecerfont, a Corticotropin-Releasing Factor Type 1 Receptor Antagonist
    Baseline Characteristics of Adults with Classic Congenital Adrenal Hyperplasia Enrolled in CAHtalyst Adult, a Phase 3 Study of Crinecerfont, a Corticotropin-Releasing Factor Type 1 Receptor Antagonist
    CHAMPAIN study: Initial Results from a Phase II Study of Efficacy, Safety and Tolerability of Modified-Release Hydrocortisones: Chronocort® (Efmody®) versus Plenadren, in Primary Adrenal Insufficiency,
    Biochemical Control with Dose Reduction in Chronic Glucocorticoid Therapy over 4 Years: A Phase III Extension Study of Chronocort (Efmody®) in the Treatment of Congenital Adrenal Hyperplasia (CAH)
    Incidence of Adrenal Crisis in Congenital Adrena Hyperplasia (CAH) Patients During a Prospective Monitored Long-Term study of Modified-Release Hydrocortisone (MRHC) Capsules, (Efmody)

Lykos Therapeutics Announces FDA Advisory Committee Meeting to Review Investigational MDMA-Assisted Therapy for PTSD

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星期一, 五月 6, 2024
Federal Register, FDA, Capsule, Person, Priority review, NDA, Post-traumatic stress disorder, Food, Safety, PTSD, MAPS, Psychotherapy, PDAC, MDMA, PDUFA, Volume, OPH, Diagnosis, PBC, Therapy, SAN, Pharmaceutical industry

This will be the first FDA advisory committee meeting to review a potential new PTSD treatment in 25 years.1 As with all advisory committee meetings, there will be an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing.

Key Points: 
  • This will be the first FDA advisory committee meeting to review a potential new PTSD treatment in 25 years.1 As with all advisory committee meetings, there will be an open public hearing (OPH) session, during which interested persons may present relevant information or views orally or in writing.
  • "This will be the first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee, a significant milestone in the field of psychedelic medicine, resulting from decades of clinical research and advocacy," said Amy Emerson, Chief Executive Officer of Lykos Therapeutics.
  • The FDA granted the application Priority Review and has assigned a Prescription Drug User Fee Act ("PDUFA") target action date of August 11, 2024.
  • At Lykos Therapeutics, a public benefit corporation (PBC) founded by MAPS, our mission is to transform mental healthcare.

Dr. Reddy's Laboratories Announces the Launch of Doxycycline Capsules, 40 mg* in the U.S.

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星期五, 五月 3, 2024
FDA, Health, General Health, Research, Pharmaceutical, Science, Laboratory, USP, Capsule, Doxycycline, USFDA, RDY, Food

Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced its launch of Doxycycline Capsules, 40 mg* in the U.S. market, a therapeutic generic equivalent of ORACEA® (doxycycline, USP) Capsules, 40 mg approved by the U.S. Food and Drug Administration (USFDA).

Key Points: 
  • Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy's"), today announced its launch of Doxycycline Capsules, 40 mg* in the U.S. market, a therapeutic generic equivalent of ORACEA® (doxycycline, USP) Capsules, 40 mg approved by the U.S. Food and Drug Administration (USFDA).
  • Dr. Reddy’s Doxycycline Capsules, 40 mg*, are supplied in bottle counts of 30.
  • *Each capsule contains: 26 mg immediate-release pellets and 14 mg delayed-release pellets equivalent to 40 mg of anhydrous doxycycline, USP.
  • ORACEA® is a trademark of Galderma Holdings, S.A.

Pharmaceutical Packaging Market to Be Worth $176.54 Billion by 2031 - Exclusive Report by Meticulous Research®

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星期五, 五月 3, 2024
PFS, United Nations, Polyvinyl chloride, Investment, PP, Ampoule, PVC, Polymer, Medicine, Paper, AptarGroup, Gas, Sachet, Blister, Drug discovery, PET, Inhaler, Catalent, Drug packaging, Cellulose, Tablet, Corning Inc., Regulation (European Union), Conditional sentence, Research, Transport, Carbon, QR, Shield, Government, WestRock, Polyethylene, Capsule, Syringe, Glass, Route of administration, Environment, United, Amcor, Growth, Fine chemical

Pharmaceutical companies are increasingly focusing on sustainable pharmaceutical packaging in order to cut waste and reduce their carbon footprint.

Key Points: 
  • Pharmaceutical companies are increasingly focusing on sustainable pharmaceutical packaging in order to cut waste and reduce their carbon footprint.
  • Key findings in the pharmaceutical packaging market report:
    Among all the materials studied in this report, in 2024, the polymer segment is expected to account for the largest share of 43% of the pharmaceutical packaging market.
  • Among all the packaging types studied in this report, in 2024, the primary packaging segment is expected to account for the largest share of 72% the pharmaceutical packaging market.
  • However, Asia-Pacific pharmaceutical packaging market is expected to growth with the highest CAGR of 8.5% over the forecast period.

Pharmaceutical Packaging Market to Be Worth $176.54 Billion by 2031 - Exclusive Report by Meticulous Research®

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星期五, 五月 3, 2024
PFS, United Nations, Polyvinyl chloride, Investment, PP, Ampoule, PVC, Polymer, Medicine, Paper, AptarGroup, Gas, Sachet, Blister, Drug discovery, PET, Inhaler, Catalent, Drug packaging, Cellulose, Tablet, Corning Inc., Regulation (European Union), Conditional sentence, Research, Transport, Carbon, QR, Shield, Government, WestRock, Polyethylene, Capsule, Syringe, Glass, Route of administration, Environment, United, Amcor, Growth, Fine chemical

Pharmaceutical companies are increasingly focusing on sustainable pharmaceutical packaging in order to cut waste and reduce their carbon footprint.

Key Points: 
  • Pharmaceutical companies are increasingly focusing on sustainable pharmaceutical packaging in order to cut waste and reduce their carbon footprint.
  • Key findings in the pharmaceutical packaging market report:
    Among all the materials studied in this report, in 2024, the polymer segment is expected to account for the largest share of 43% of the pharmaceutical packaging market.
  • Among all the packaging types studied in this report, in 2024, the primary packaging segment is expected to account for the largest share of 72% the pharmaceutical packaging market.
  • However, Asia-Pacific pharmaceutical packaging market is expected to growth with the highest CAGR of 8.5% over the forecast period.

Lykos Therapeutics Strengthens Commercial Organization with Key Hires as it Prepares for Potential Commercial Launch

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星期五, 五月 3, 2024
Social stigma, FDA, University, Capsule, Social work, CCO, Simmons University, Safety, Food, Marketing, Coy, PTSD, MAPS, Market access, Policy, MDMA, Senior, Psychology, Bristol Myers Squibb, Cell biology, Patient advocacy, Multimedia, PBC, Therapy, SAN, McGill University, Pharmaceutical industry

Coy Stout has also joined Lykos as Vice President (VP) of Market Access,  a critical function in the growing commercial organization.

Key Points: 
  • Coy Stout has also joined Lykos as Vice President (VP) of Market Access,  a critical function in the growing commercial organization.
  • "The appointment of Allison, our first chief commercial officer, marks a critical milestone as we build out our commercial organization and prepare for a potential product launch of MDMA-assisted therapy if approved by the FDA," said Amy Emerson, Chief Executive Officer of Lykos Therapeutics.
  • Ms. Rosenthal brings to Lykos more than 25 years of pharmaceutical experience introducing innovative therapies.
  • At Lykos Therapeutics, a public benefit corporation (PBC) founded by MAPS, our mission is to transform mental healthcare.

IFF to Highlight Comprehensive Clean-label Portfolio at Vitafoods Europe 2024

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星期四, 五月 2, 2024
Lead, Digestion, E90, Tablet, Menopause, Dietary supplement, Health, OTC, Science, PRM, Probiotic, All rights reserved, Ageing, Food, Metabolism, Marketing, Creativity, Capsule

NEW YORK, May 2, 2024 /PRNewswire/ -- IFF, a global leader in food and beverage, home and personal care and health, will introduce its full suite of plant-based and cellulosic-derived solutions for dietary supplements and over-the-counter (OTC) drugs at Vitafoods Europe 2024. This is the first time IFF Pharma Solutions will showcase its full clean-label portfolio for oral dosage forms at Vitafoods Europe, May 14-16, Geneva, Switzerland, booth E90.

Key Points: 
  • This is the first time IFF Pharma Solutions will showcase its full clean-label portfolio for oral dosage forms at Vitafoods Europe, May 14-16, Geneva, Switzerland, booth E90.
  • "Our plant-based ingredients are meeting the rising demand for clean-label products," said Dr. Michael Baumann, marketing manager, Pharma Solutions, IFF.
  • Visit here to learn more about IFF Health and register here to schedule a meeting with IFF's Pharma Solutions experts.
  • IFF, the IFF Logo, and all trademarks and service marks denoted with ™, ℠ or ® are owned by IFF or affiliates of IFF unless otherwise noted.