Recombinant

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

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星期三, 三月 13, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Hypersensitivity, Pregnancy, Wart, Head, Congress, Recombinant, Multiple endocrine neoplasia, Dizziness, Safety, Vain, Headache, Bruise, Public, Syncope, Ageing, Merck & Co., Cervical intraepithelial neoplasia, Vulvar intraepithelial neoplasia, Anal cancer, Virus-like particle, Observation, CIN, Thigh, Human, HPV, Plant, Vaginal intraepithelial neoplasia, Nausea, MRK, VLP, Investment, Immunity, Fever, Erythema, Vaccination, Injury, Vaccine, Allergy, Itch, AIN, Swelling

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.

Altamira Therapeutics’ Peptide-Based Delivery Platform Shown to Enhance Potency of Commonly Used Gene Delivery Method as Published in Peer-Reviewed Journal

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星期三, 二月 7, 2024
Vivisection, Peptide, Cell, RNA, Therapy, Alternative medicine, Recombinant, Safety, FDA, Dicarboxylic acid, AVV, Mouse, Food, AAV, Risk, Journal, Tissue, Cytoplasm, Melittin, Vaccine

HAMILTON, BERMUDA, Feb. 7, 2024 -- Altamira Therapeutics Ltd. (Nasdaq: CYTO) ("Altamira" or the "Company"), a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets, announced today the publication of a peer-reviewed article in the Journal of Integrative Medicine titled, "Melittin analog p5RHH enhances recombinant adeno-associated virus transduction efficiency". This work evaluates the use of various peptides to enhance adeno-associated virus (AAV) cell transduction and was conducted by an independent research group.1 Recombinant AAVs are commonly used as carriers to introduce nucleic acids in cells for gene therapy; several AAV-based gene therapy drugs have already been approved by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • The study sought to find ways of increasing the endosomal release of AAV-based therapeutics by using peptides derived from melittin, a component of bee venom known for its ability to permeabilize biological membranes.
  • The research group evaluated 76 melittin derivatives, including p5RHH, the peptide underlying Altamira’s OligoPhore™ / SemaPhore™ nanoparticle platform for RNA delivery.
  • The scientists discovered that insertion of p5RHH into the AAV vector (p5RHH-rAAV) not only enhanced cell transduction, but also succeeded in transducing cell lines typically considered resistant to AAVs.
  • “Better transduction efficiency means that lower doses of AAVs may be used, which could lower the risk for deleterious immune responses and increase the safety of AAV-based vectors.

Takeda’s HYQVIA® Approved by European Commission as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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星期一, 一月 29, 2024
Neurology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Medication package insert, Patient, CHMP, Immunodeficiency, Nausea, Itch, PID, Erythema, Civil service commission, European Commission, Edema, Research and development, Aes, Recombinant, Skin, Food, Disease, Safety, Primary immunodeficiency, Committee, Absorption, IVIG, Peripheral nervous system, Headache, Diagnosis, Pharmaceutical industry

Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous immunoglobulin therapy (IVIG).
  • The majority of AEs were mild or moderate, local, did not require suspension of infusions, and resolved without sequelae.
  • The most common (reported in >5% of patients) causally related AEs included headache and nausea, as well as local AEs including infusion site pain, erythema, pruritis, and edema.
  • HYQVIA first received approval from the EC for the treatment of primary immunodeficiency (PID) in 2013 as well as secondary immunodeficiency (SID) in 2020.8

Takeda’s GAMMAGARD LIQUID® Approved by U.S. FDA for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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星期一, 一月 29, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, CIDP, Rasch, Patient, Chronic inflammatory demyelinating polyneuropathy, Facial muscles, Paresthesia, Common, Leukopenia, Neutropenia, Anemia, Migraine, University, Abdominal pain, Chills, Head, Recombinant, Tremor, Food, Safety, Antibody, Pain, Neurology, Weakness, Headache, IVIG, Somnolence, Vomiting, Trial of the century, Dizziness

“Together with the recent HYQVIA approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.”

Key Points: 
  • “Together with the recent HYQVIA approval in the U.S., we can now offer induction and maintenance therapy options to adults living with CIDP that may accommodate their personal treatment needs.”
    The approval is based on results from a prospective, open-label, single-arm, multicenter clinical study (ADVANCE-CIDP 2) that evaluated the efficacy and safety of GAMMAGARD LIQUID in adults with CIDP who developed a relapse in the randomized, double-blinded, placebo-controlled study evaluating efficacy, safety and tolerability of HYQVIA (ADVANCE-CIDP 1) in adults with CIDP.
  • Efficacy in ADVANCE-CIDP 2 was based on responder rate, where a responder was defined as a subject who demonstrated an improvement of functional disability.
  • The responder rate was 94.4% (N=18, 95% CI: 74.2% to 99.0%).
  • “Because CIDP is a progressive and complex disease, multiple treatment options are needed, and clinicians now have an additional therapy that can help adults with CIDP manage their disease.”
    GAMMAGARD LIQUID is the only IVIG with multiple neuromuscular disorder indications in the U.S. since it is now approved for CIDP and it is the only FDA-approved IVIG to treat multifocal motor neuropathy as a maintenance therapy to improve muscle strength and disability in adults.1 It is also indicated in the U.S. as a replacement therapy for people two years of age or older living with primary immunodeficiency.1

U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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星期二, 一月 16, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, CIDP, Patient, CHMP, Itch, Nausea, SCIG, Fatigue, Erythema, European Commission, European, Abdominal pain, Lipase, EMA, Recombinant, Skin, Back pain, Food, Safety, Caregiver, Primary immunodeficiency, Pain, Marketing, Committee, Headache, Absorption, IVIG, Diagnosis, Pharmaceutical industry

Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults.
  • Because it is delivered subcutaneously, HYQVIA can be administered by a healthcare professional in a medical office, infusion center or at a patient’s home.
  • “We’re excited that this therapy could offer some adults with CIDP an alternative subcutaneous option that may address some of these challenges and help personalize treatment.”
    HYQVIA is now available as a maintenance therapy for adult patients with CIDP in the U.S.
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union.6

China Medical System: 4 Products Have Been Newly Included or Continued to be Included in the NRDL

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星期三, 十二月 13, 2023
Marketing, Shanghai Stock Exchange, Quality of life, Epilepsy, A&B, Peptide, Absorption, National Healthcare, Methotrexate, National Healthcare Security Administration, Insurance, Safety, Tetrabenazine, Heart failure, CMS, Protein, Light, Recombinant, Acute decompensated heart failure, Sun Pharma, Nasal mucosa, PASI, Tablet, Patient, Psoriasis, Chemokine, Diazepam, Huntington's disease, Sale, Social Security, Tildrakizumab, Social, Vitamin E

China Medical System actively responds to national policies to promote innovative products to be included in the NRDL.

Key Points: 
  • China Medical System actively responds to national policies to promote innovative products to be included in the NRDL.
  • In addition, innovative drug Methotrexate Injection (Metoject) indicated for psoriasis approved in March 2023 has been included in category A of the National Reimbursement Drug List.
  • It is the first nasal spray formulation of diazepam in China and the first drug approved in China for the treatment of seizure clusters.
  • CMS actively responds to national policies to promote innovative products to be included in the National Reimbursement Drug List.

GenSci Launches Global Innovation Hub in Shanghai

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星期六, 十二月 23, 2023
Quality of life, LBP, Science, Government, Hearing loss, Menopause, Health, Shandong University, Transgender hormone therapy, Obesity, Allergy, Zhangjiang, Precocious puberty, Multimedia, Shanghai Jiao Tong University, Body image, Zhejiang University, Life, Pregnancy, Recombinant, Near-sightedness, Outline, Prize, AI, Puberty, Child, Patient, Drug resistance, University, Research, Hospital, Incidence, Intelligence, Pediatrics, Growth, Investment, Vaginitis, Gynaecology, ADC, Medical device

SHANGHAI, Dec. 22, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), held a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th. With an increasing focus on women`s and children`s health, the Chinese government has been intensifying efforts to improve healthcare services for these demographics, embedding their care within the wider framework of the country's economic and social development policies. The establishment of the R&D center sets the stage for GenSci to further advance the convergence of industry, academia, research and the medical community. By leveraging cutting-edge R&D capabilities and the application of artificial intelligence technologies, GenSci is well-positioned to provide premium health solutions for women and children. The initiative aligns with GenSci's commitment to harnessing science and technology to protect and enhance the health of these vulnerable groups.

Key Points: 
  • SHANGHAI, Dec. 22, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), held a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th.
  • Integrating AI technology, GenSci covers the entire drug innovation process, from initial design and screening to process development and formulation.
  • GenSci has formed enduring and robust partnerships with nearly 20 prominent universities, including Shanghai Jiao Tong University and Zhejiang University.
  • The groundbreaking of GenSci's global innovation hub and R&D center enpowers the company to fully utilize its expertise in gynecology and pediatrics.

Takeda Receives Positive CHMP Opinion for HYQVIA® as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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星期五, 十二月 15, 2023
Pharmaceutical, Science, Health, Research, Peripheral nervous system, European Commission, European Academy of Neurology, Research and development, Chronic inflammatory demyelinating polyneuropathy, European Medicines Agency, Disease, Clinical trial, EMA, Patient, European, CHMP, Marketing, Committee, Caregiver, Advanced Therapy Medicinal Product, CIDP, Neurology, Recombinant, IGS, IVIG, Pharmaceutical industry, Takeda

Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG).
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union.
  • This proposed extension of indication for HYQVIA is based on data from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial, which investigated HYQVIA as maintenance therapy in adult patients with CIDP.
  • HYQVIA is also under regulatory review in the United States for use as a maintenance therapy in adult patients with CIDP.

Medical Segment Dominates, Expected to Reach $70.4 Billion by 2030 in the Global Recombinant DNA Technology Market

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星期三, 十一月 1, 2023
Cloning, Growth, Integrated DNA Technologies, Recombinant, Pet industry

DUBLIN, Oct. 31, 2023 /PRNewswire/ -- The "Recombinant DNA Technology: Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Oct. 31, 2023 /PRNewswire/ -- The "Recombinant DNA Technology: Global Strategic Business Report" report has been added to ResearchAndMarkets.com's offering.
  • The global market for Recombinant DNA Technology estimated at US$64.7 Billion in the year 2022, is projected to reach a revised size of US$93.7 Billion by 2030, growing at a CAGR of 4.7% over the analysis period 2022-2030.
  • Medical, one of the segments analyzed in the report, is projected to record 5.2% CAGR and reach US$70.4 Billion by the end of the analysis period.
  • The U.S. Market is Estimated at $18.9 Billion, While China is Forecast to Grow at 4.4% CAGR
    The Recombinant DNA Technology market in the U.S. is estimated at US$18.9 Billion in the year 2022.

Long-Term Follow-up Data on Sustained Immunogenicity and Safety for GARDASIL®9 Published in Pediatrics

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星期二, 九月 5, 2023
Research, Teens, Infectious Diseases, Children, Clinical Trials, Biotechnology, Pharmaceutical, Consumer, Health, Science, MSD, Hypersensitivity, CIN, Male, Female, Pediatrics, Allergy, Life, Vaccination, CIN1, Human papillomavirus infection, Cancer, MRK, Vulvar cancer, Woman, Head, Month, AIS, Vulvectomy, Merck & Co., CDC, Incidence, Death, PIN, Anal cancer, Cervical cancer, Wart, Vain, Vaginal intraepithelial neoplasia, HPV, VIN, Cervical intraepithelial neoplasia, Anus, NYSE, Disease, Vaccine, Birth control, Recombinant, Merck

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.

Key Points: 
  • The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • As part of the primary objective of immunogenicity, data showed sustained HPV-antibody responses at 10 years after the third dose in boys and girls.
  • With the exception of cervical cancer, there is no routinely recommended screening for the detection of HPV-related cancers.