Teriparatide

Rani Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results; Provides Corporate Update

Retrieved on: 
Wednesday, March 20, 2024
Research, Teriparatide, Conference call, Conference, Obesity, Serum, SAN, Weight loss, Female, Adalimumab, Volunteering, Human, Society, Osteoporosis, Workforce, Expansion, Growth, GIP, Business operations, GLP, Animal, HC, Pharmaceutical industry

SAN JOSE, Calif., March 20, 2024 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter and full year ended December 31, 2023 and provided a corporate update.

Key Points: 
  • ET / 1:30 p.m. PT -
    SAN JOSE, Calif., March 20, 2024 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter and full year ended December 31, 2023 and provided a corporate update.
  • In February 2024, Rani announced RT-111 achieved high bioavailability and was well-tolerated, with no serious adverse events in humans, in a Phase 1 study.
  • In December 2023, Rani announced preclinical data demonstrating the transenteric delivery of an incretin triagonist of GLP-1, GIP, glucagon receptors elicits rapid weight loss in animal study.
  • In October 2023, Rani announced preclinical data from a 60-day, repeat oral-administration GLP safety study of the RaniPill capsule in healthy animals.

Human medicines European public assessment report (EPAR): Yorvipath, Palopegteriparatide, Date of authorisation: 17/11/2023, Status: Authorised

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Tuesday, January 2, 2024
Gland, Medical Subject Headings, Marketing, INN, ATC, EMA, International, Parathyroid hormone, Headache, Needle, Disease, Language, Blood, Calcium, Teriparatide, PTH, Heart, Pseudohypoparathyroidism, European Medicines Agency, EMEA, Select, Patient, Diagnosis, Anatomy, Paresthesia, IIA, Neck, Skin, Medical device

Hypoparathyroidism is rare, and Yorvipath was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 October 2020.

Key Points: 
  • Hypoparathyroidism is rare, and Yorvipath was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 19 October 2020.
  • Teriparatide replaces the missing hormone in patients with hypoparathyroidism, acting through bone tissue and the kidneys to help restore calcium levels.
  • The European Medicines Agency therefore decided that Yorvipath’s benefits are greater than its risks and it can be authorised for use in the EU.
  • Yorvipath : EPAR - Medicine overview
    Product information
    Yorvipath : EPAR - Product information
    Latest procedure affecting product information: EMEA/H/C/005934
    This medicine’s product information is available in all official EU languages.

Rani Therapeutics Announces Preclinical Pharmacodynamic Data on Transenteric Delivery of GLP-1 Incretin Triagonist

Retrieved on: 
Thursday, December 14, 2023
Șaeș, Weight loss, Group 2, Therapy, Teriparatide, Pharmacokinetics, PD, Obesity, Osteoporosis, Biomarker, Ustekinumab, Human, Group 1, Safety, GIP, Pharmaceutical industry

SAN JOSE, Calif., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced pharmacodynamic data of an incretin triagonist of the GLP-1, GIP, and glucagon receptors delivered transenterically, which mimics the RaniPill route of administration. This follows Rani’s prior study demonstrating oral delivery of a GLP-1 receptor agonist with high bioavailability via the RaniPill capsule.

Key Points: 
  • - Transenteric delivery of incretin triagonist of GLP-1, GIP, glucagon receptors elicits rapid weight loss in animal study –
    SAN JOSE, Calif., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today announced pharmacodynamic data of an incretin triagonist of the GLP-1, GIP, and glucagon receptors delivered transenterically, which mimics the RaniPill route of administration.
  • “The preclinical data announced today are highly encouraging, as the data highlights that transenteric delivery mimicking the RaniPill’s route of drug administration results in pharmacodynamics comparable to subcutaneous injection for an incretin triagonist,” said Talat Imran, Chief Executive Officer of Rani Therapeutics.
  • “In a previous preclinical study, Rani showed that the RaniPill capsule can orally deliver a GLP-1 receptor agonist with bioavailability and pharmacokinetics comparable to a subcutaneous injection.
  • In the recent study of an incretin triagonist, Rani obtained pharmacodynamic data showing weight loss and reduction in serum lipids comparable to that observed via the subcutaneous injection route.

Entera Bio Reports Q3 2023 Financial Results, Highlights Transformational Steps and Unveils Vision as Premier Oral Peptide Company with Five Potential Programs in Development

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Tuesday, November 14, 2023
Woman, Absorption, Annual general meeting, Bone fracture, Type, Peptide, Stress fracture, D&O, Patient, Research, Oxyntomodulin, Hypoparathyroidism, Osteoporosis, Safety, Food, Teduglutide, Fracture, Intellectual property, BMD, OPKO Health, Athlete, Society, Type D, NDA, Three Months, PTH, Risk, Insurance, Consultant, Short bowel syndrome, Appetite, Pharmacokinetics, Nutrient, SBS, Glucagon, Teriparatide, SABRE, OXM, Disease, Tablet, FDA, Obesity, Hypercalcaemia, Injection, Weight loss, Fine chemical, Pharmaceutical industry, Cryptocurrency, Jews, Entera

“Today, after over a year of steadfast transformation and execution, Entera stands as a premier oral peptide company.

Key Points: 
  • “Today, after over a year of steadfast transformation and execution, Entera stands as a premier oral peptide company.
  • We are also exploring the potential use of EB613 to accelerate stress fracture healing due to high intensity athletic or military training.
  • Entera Q3 2023 Updates and Goals for 5 Oral Peptide Programs:
    EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis.
  • Entera published pre-clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide, as a convenient potential tablet alternative to daily injections.

Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full Qualification Plan to Approve BMD as a Surrogate Endpoint for Osteoporosis

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Thursday, November 9, 2023
NDA, Osteoporosis, Woman, Food, Type, PTH, Risk, Patient, Fracture, BMD, FDA, 21st Century Cures Act, Teriparatide, Biomarker, Society, SABRE, Medical imaging, Entera

“This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies.

Key Points: 
  • “This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies.
  • We would like to sincerely acknowledge and thank the ASBMR-FNIH-SABRE team for its significant contributions and for furthering this key initiative with the FDA,” said Miranda Toledano, Chief Executive Officer of Entera.
  • “The last 15 months have been intense for Entera from a regulatory standpoint, and we believe EB613 stands as the first program to potentially avail itself of the ASBMR-SABRE BMD endpoint.
  • EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis.

Ambio Announces US FDA Approval of a Generic Version of Forteo® (Teriparatide Injection) for Its Partner Apotex

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Friday, December 1, 2023
Science, Biotechnology, Research, Pharmaceutical, Managed Care, General Health, Health, FDA, Teriparatide, Food, Peptide, Patient, Osteoporosis, Partnership, Apotex, Quality of life, SVP, Generic drug, Ambio

Ambio, Inc., an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, announced today that a generic version of Forteo®1 (teriparatide injection) developed by Ambio and to be marketed and sold by Apotex has been approved by the U.S. Food and Drug Administration (FDA).

Key Points: 
  • Ambio, Inc., an innovative biotech company developing novel peptide drugs, biosimilar, bioequivalent, and other complex generic drugs, announced today that a generic version of Forteo®1 (teriparatide injection) developed by Ambio and to be marketed and sold by Apotex has been approved by the U.S. Food and Drug Administration (FDA).
  • “Ambio is a world leader in developing complex peptides.
  • Our highly skilled techniques in controlling various kinds of peptide-related synthetic impurities together with expertise in developing advanced analytical methods to thoroughly characterize the peptides sets us apart in the pharmaceutical industry,” said Simrat Singh, President of Ambio, Inc. “We are thrilled that the teriparatide injection developed by Ambio has received FDA approval.”
    “The approval further validates our expertise and technological innovation as a developer and manufacturer of complex generic drugs and supports our commitment to bring high quality and affordable therapies to patients,” said Chris Bai, Founder, Chairman of the Board, and Chief Executive Officer of Ambio, Inc. “We are pleased to partner with Apotex in this effort which allowed them to expeditiously secure FDA approval and immediately execute product launch.”
    "The launch of Teriparatide Injection reflects Apotex's continued focus on improving access for patients to affordable complex generic drugs,” said Kiran Krishnan, SVP of Global Regulatory Affairs at Apotex.
  • "We are pleased to deliver this critical product, in partnership with Ambio, that we believe will be essential in improving the quality of life for Osteoporosis patients in the US."

Teva Announces Approval of a Generic Version of Forteo® (teriparatide injection), in the U.S.

Retrieved on: 
Friday, November 17, 2023
FDA, Pharmaceutical, Health, Medicine, Vomiting, Digoxin, Osteoporosis, Woman, Urine, Antares, NYSE, Bone disease, Calcium, Spine, Prednisone, Constipation, Allergy, History, IQVIA, Patient, Arthralgia, Medication, TEVA, Fracture, Muscle weakness, System, Blood, Tongue, Vitamin, Bone tumor, Nausea, Kidney, Pain, Swelling, Osteosarcoma, Skin, Rat, TASE, Injection, Face, Blood pressure, Generic drug, Dietary supplement, Pharmaceutical industry, Vaccine, Birth control, Injection moulding, Medical imaging, Poultry farming, Phosphorus, Teriparatide, Teva

Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States.

Key Points: 
  • Teva Pharmaceuticals Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the approval of a generic version of Forteo®1, in the United States.
  • Currently, 1 in 12 generic prescriptions dispensed in the U.S. is filled with a Teva generic product.
  • Teva’s generic equivalent of Forteo® (teriparatide injection) utilizes the Antares Pharma, Inc. multi-dose pen device.
  • Teriparatide injection can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis.

Apotex Corp. Launches Teriparatide Injectable for Osteoporosis Treatment in the United States

Retrieved on: 
Tuesday, November 21, 2023
Osteoporosis, Ambio, Contraindication, Bone density, Peptide, Medication, Patient, Marketing, Doctor of Philosophy, Pharmaceutical industry, Teriparatide, Apotex

WESTON, Fla., Nov. 21, 2023 /PRNewswire/ - Apotex Corp. announced today the launch of Teriparatide Injection, a single-patient-use pre-filled pen used for the treatment of osteoporosis in the United States.

Key Points: 
  • WESTON, Fla., Nov. 21, 2023 /PRNewswire/ - Apotex Corp. announced today the launch of Teriparatide Injection, a single-patient-use pre-filled pen used for the treatment of osteoporosis in the United States.
  • Teriparatide Injection is supplied as a single-patient-use pre-filled pen containing 250 mcg/mL, capable of administering 28 daily doses of 20 mcg per pen.
  • "Osteoporosis impacts approximately 10 million Americans, and millions more have low bone density, placing them at high risk.
  • "The approval of Teriparatide bioequivalent showcases Ambio's strength in the development of complex peptides," says Chris Bai, CEO at Ambio.

Rani Therapeutics Reports Third Quarter 2023 Financial Results; Provides Corporate Update

Retrieved on: 
Wednesday, November 8, 2023
Female, Research, Growth, Clinical trial, Longest increasing subsequence, Workforce, Volunteering, Biosimilar, Society, American Society for Bone and Mineral Research, Interleukin, Expansion, Antibody, GLP, HC, Business, Animal, Osteoporosis, Serum, Ustekinumab, Safety, Therapy, Teriparatide, SAN, Risk management, Medical imaging, Dietary supplement, Pharmaceutical industry, Birth control, Vaccine, Cryptocurrency, Adalimumab

In October 2023, Rani announced preclinical data from a 60-day, repeat oral-administration GLP safety study of the RaniPill capsule in healthy animals.

Key Points: 
  • In October 2023, Rani announced preclinical data from a 60-day, repeat oral-administration GLP safety study of the RaniPill capsule in healthy animals.
  • Presented an Abstract on RT-102 at the 2023 Annual Meeting of the American Society for Bone and Mineral Research.
  • Rani has completed two preclinical studies of the RaniPill HC with antibodies, adalimumab and an undisclosed interleukin (“Interleukin”).
  • Initiation of Phase 2 clinical trial of RT-102, a RaniPill GO containing teriparatide for osteoporosis, expected by year-end 2023.

Rani Therapeutics Announces Strategic Program Prioritization, Expansion of Manufacturing and Plans to Streamline Business Operations to Support Near-Term Value Drivers and Long-Term Growth of the RaniPill® Technology Platform; Reports Preliminary Third Qu

Retrieved on: 
Wednesday, November 1, 2023
Osteoporosis, HC, Ustekinumab, Growth, Workforce, Therapy, Celltrion, Patient, Teriparatide, SAN, Pharmaceutical industry, Cryptocurrency

“We are laser-focused on driving forward our key programs to create near-term value and fuel long-term growth.

Key Points: 
  • “We are laser-focused on driving forward our key programs to create near-term value and fuel long-term growth.
  • We are also expanding our manufacturing footprint to support scale for late-stage development and partnering.
  • Rani is also entering into a lease for approximately 33,000 square feet to expand its manufacturing footprint.
  • Rani estimates that cash, cash equivalents and marketable securities will be approximately $60.5 million as of September 30, 2023.