PTH

Entera Bio Announces Publication of Oral PTH(1-34) Peptide Tablets (EB613) Phase 2 Trial Data in the Journal of Bone and Mineral Research

Retrieved on: 
Monday, April 8, 2024
Tablet, Woman, Osteoporosis, Hip, Parathyroid hormone, Patient, Journal, BMD, Treatment, Injection, Spine, PTH, Dietary supplement

Miranda Toledano, CEO of Entera, commented, “We are excited to share that data from our successful Phase 2 study of EB613 has been accepted and now published in the prestigious JBMR.

Key Points: 
  • Miranda Toledano, CEO of Entera, commented, “We are excited to share that data from our successful Phase 2 study of EB613 has been accepted and now published in the prestigious JBMR.
  • We believe EB613 addresses the current treatment gap in osteoporosis as the first oral, osteoanabolic (bone building) once-daily tablet treatment due to its unique format and potential dual mode of action.
  • The highest EB613 oral PTH tablet dose (2.5 mg), produced an increase in markers of bone formation while simultaneously decreasing the markers of bone breakdown.
  • The 2.5 mg oral PTH tablet dose was well tolerated when patients were instructed to titrate up to the full dose.

Entera Bio Announces Key Regulatory Milestone for Oral PTH(1-34) Peptide (EB613) Phase 3 Program: FDA Ruling on Qualifying BMD as a Surrogate Endpoint for Osteoporosis Drugs is Expected Within 10 Months

Retrieved on: 
Tuesday, March 26, 2024
Fracture, SABRE, Bone disease, Hip, Risk, Patient, Quality of life, BMD, Woman, Society, Osteoporosis, Ecosystem, PTH, FDA, Ageing, Food

The proposed registrational Phase 3 study for EB613, Entera’s lead clinical candidate, which is a first-in-class PTH(1-34) daily tablet treatment for osteoporosis is designed to meet the quantitative BMD thresholds proposed by SABRE.

Key Points: 
  • The proposed registrational Phase 3 study for EB613, Entera’s lead clinical candidate, which is a first-in-class PTH(1-34) daily tablet treatment for osteoporosis is designed to meet the quantitative BMD thresholds proposed by SABRE.
  • In November 2023 we issued a press release echoing ASBMR’s announcement that SABRE had submitted its final qualification package to FDA for the replacement of fracture as a regulatory endpoint.
  • Today we are thrilled to echo ASBMR’s announcement that FDA has set a concrete timetable to issue its ruling.
  • Fractures, particularly of the hip, are considered the most serious consequence of osteoporosis, which predominantly affects postmenopausal women and older men.

Entera Bio Announces Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Friday, March 8, 2024
OXM, Woman, Injection, Research, Bone fracture, Clinical research associate, Type D, FDA, BMD, PTH, Food, Hypoparathyroidism, Obesity, Coeliac disease, Weight loss, Oxyntomodulin, Cmax, Elective surgery, Sport, Short bowel syndrome, OPKO Health, DSM-IV codes, Ecosystem, SABRE, Patient, D&O, Intellectual property, Fracture, Athlete, Sports medicine, Tablet, Osteoporosis, Insurance

JERUSALEM, March 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • JERUSALEM, March 08, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides, today reported financial results and key business updates for the fourth quarter and year ended December 31, 2023.
  • Following our December 2023 financing, we expect to have sufficient cash to fund operations through the first half of 2025,” said Miranda Toledano, CEO of Entera.
  • Financial Results for the year Ended December 31, 2023
    As of December 31, 2023, Entera had cash and cash equivalents of $11.0 million.
  • Operating expenses for year ended December 31, 2023 were $8.9 million, as compared to $13.0 million for the year ended December 31, 2022.

SparkFun Electronics Unleashes the ESP32-C6 Thing Plus: A Wireless Innovation Powerhouse

Retrieved on: 
Friday, February 9, 2024
Lithium polymer battery, Electronics, PTH, Ecosystem, SparkFun Electronics, Life, JST, Internet of things, Payment card, Hertz, GPIO, Power management, Benefit, Video game

BOULDER, Colo., Feb. 9, 2024 /PRNewswire/ -- SparkFun Electronics releases the ESP32-C6 Thing Plus, a game-changing wireless development board set to elevate your projects to new heights. For over eight years SparkFun has been designing around Espressif technologies, and the release of the ESP32-C6 signals the completion of SparkFun's first major roadmap for development boards using ESP-based modules.

Key Points: 
  • The SparkFun ESP32-C6 Thing Plus is poised to revolutionize IoT projects with its intuitive design, powerful features, and seamless connectivity.
  • BOULDER, Colo., Feb. 9, 2024 /PRNewswire/ -- SparkFun Electronics releases the ESP32-C6 Thing Plus , a game-changing wireless development board set to elevate your projects to new heights.
  • The SparkFun ESP32-C6 Thing Plus combines cutting-edge technology with a compact, user-friendly design.
  • "We're thrilled to introduce the SparkFun Thing Plus - ESP32-C6," says Kirk Benell, CTO at SparkFun Electronics.

Ascendis Pharma Launches 2nd TransCon™ Product: YORVIPATH® Now Available in Germany and Austria for Adults with Chronic Hypoparathyroidism

Retrieved on: 
Wednesday, January 31, 2024
Vision 2030, PTH, Patient, Physician, Parathyroid hormone, Hypoparathyroidism, Pharmaceutical industry

COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria.

Key Points: 
  • COPENHAGEN, Denmark, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide, developed as TransCon PTH), a parathyroid hormone (PTH) replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, is now available in Germany and Austria.
  • YORVIPATH is the second product developed with Ascendis Pharma’s TransCon technology platform to be launched commercially.
  • “We are pleased to initiate the launch of YORVIPATH to address the needs expressed within the hypoparathyroidism community for a new PTH-based treatment option,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer.
  • With an increasingly broad commercial infrastructure in place, we are well positioned to accomplish this by expanding the availability of YORVIPATH and our other approved products to meet the needs of physicians and patients around the world.”

RALIANCE Awards $300,000 in Grants for Projects to End Sexual Harassment, Misconduct and Abuse

Retrieved on: 
Thursday, January 18, 2024
ACT, National Football League, Indigenous, Knowledge, Data collection, NFL, HBCU, PTH, Growth, City, Curriculum, Punishment, Environment, Assault, Safety, Organization, AFL, Alaska Natives, CJ, Survivor, Hip hop music, Disability, Child, Risk, Trauma, Partnership, Liberation, Social justice, Trust, Dillard University, HEAL, Creativity, Accountability, Violence, Nursing

WASHINGTON, Jan. 18, 2024 /PRNewswire/ -- RALIANCE, a trusted adviser for organizations committed to creating equitable, respectful, and safe environments, announced today that it will award a total of $300,000 in grants to six organizations across the United States that are entrenched in their communities working to support survivors and prevent sexual harassment, misconduct, and abuse. In 2022, RALIANCE and the National Football League (NFL) announced the renewal of its grant partnership to expand RALIANCE's efforts to offer more resources and grant funding to organizations at the intersection of sexual misconduct prevention and social justice.

Key Points: 
  • "RALIANCE is honored to welcome these exceptional grantees to our growing roster of organizations making positive impacts in their communities," said Yolanda Edrington, a Managing Partner at RALIANCE.
  • "This year's cohort stands out in the innovative ways many are using the arts and creativity as a transformative tool.
  • Through this latest round of funding, RALIANCE will support initiatives in new communities, spanning various geographic regions across the U.S. and territories.
  • We are excited to partner with RALIANCE in our shared vision of ending sexual violence, which includes child sexual abuse.

Er-Kim Announces Exclusive Distribution Agreement with Ascendis Pharma A/S to Commercialize 3 Endocrinology Disease Treatments Across Central & Eastern Europe and Turkey

Retrieved on: 
Monday, January 8, 2024
Achondroplasia, CFO, ACH, European, Osteochondrodysplasia, PTH, Endocrinology, Patient, Phase II, Pharmaceutical industry

BUCHAREST, Romania, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Er-Kim , an international pharmaceutical company specializing in the commercialization of novel therapies, today announced it has entered into an exclusive distribution agreement with Danish Company Ascendis Pharma A/S (Nasdaq: ASND) for its endocrinology portfolio.

Key Points: 
  • BUCHAREST, Romania, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Er-Kim , an international pharmaceutical company specializing in the commercialization of novel therapies, today announced it has entered into an exclusive distribution agreement with Danish Company Ascendis Pharma A/S (Nasdaq: ASND) for its endocrinology portfolio.
  • Under the agreement, Er-Kim is appointed as the exclusive Ascendis A/S endocrinology distributor in Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czechia, Estonia, Greece, Hungary, Kosovo, Latvia, Lithuania, Malta, Montenegro, North Macedonia, Poland, Romania, Serbia, Slovakia, Slovenia, and Türkiye.
  • He added, “Leveraging our exceptional expertise in rare diseases and our preeminent status in endocrinology throughout the region, we eagerly anticipate collaborating with Ascendis and the healthcare community.
  • “We are therefore very pleased to partner with Er-Kim, a company that shares this commitment, to broaden and accelerate access to our innovative Endocrinology Rare Disease treatment options across Central and Eastern Europe and Turkey.”

Specialised Therapeutics signs exclusive agreement with Ascendis Pharma A/S for distribution and commercialisation of three endocrinology therapies in Australia and select South-East Asia countries

Retrieved on: 
Sunday, January 7, 2024
Growth hormone, Hypoparathyroidism, Quality of life, Partnership, Achondroplasia, Vitamin D, ACH, European, Disease, Osteochondrodysplasia, Therapy, PTH, Endocrinology, CNP, Patient, Phase II, Pharmaceutical industry

Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFATM (lonapegsomatropin), hypoparathyroidism treatment YORVIPATHTM (palopegteriparatide) and investigational achondroplasia therapy TransCon™ CNP (navepegritide).

Key Points: 
  • Under the terms of the agreement, ST will commercialise Ascendis Pharma's weekly injectable paediatric human growth hormone treatment SKYTROFATM (lonapegsomatropin), hypoparathyroidism treatment YORVIPATHTM (palopegteriparatide) and investigational achondroplasia therapy TransCon™ CNP (navepegritide).
  • The agreement spans ST's key regions of Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam.
  • Announcing the partnership, ST Chief Executive Officer Carlo Montagner said this agreement was an important company milestone, signalling ST's expansion into both endocrinology and paediatric medicine.
  • "We are delighted to partner with Specialised Therapeutics to broaden the reach of our endocrinology rare disease portfolio, contributing to our shared goal of making a meaningful difference for patients facing unmet medical needs," she said.

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

Retrieved on: 
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.

FDA Accepts for Review Resubmitted NDA for TransCon PTH (Palopegteriparatide) in Adult Patients with Hypoparathyroidism

Retrieved on: 
Monday, December 11, 2023
Hypoparathyroidism, FDA, PDUFA, Parathyroid hormone, NDA, PTH, Patient, Pharmaceutical industry

COPENHAGEN, Denmark, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism. The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act (PDUFA) goal date of May 14, 2024. In the United States, TransCon PTH (palopegteriparatide) is an investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism.

Key Points: 
  • – PDUFA goal date is May 14, 2024
    COPENHAGEN, Denmark, Dec. 11, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism.
  • In the United States, TransCon PTH (palopegteriparatide) is an investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism.
  • “We are pleased that the FDA can continue its review of TransCon PTH and look forward to working with the agency during its review,” said Jan Mikkelsen, President and CEO at Ascendis Pharma.
  • “Given the significant unmet needs of the hypoparathyroidism community, we remain committed to making TransCon PTH available for U.S. patients as rapidly as possible.”