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Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 16, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 16, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Wakix, pitolisant, Date of authorisation: 31/03/2016, Revision: 16, Status: Authorised

EQS-News: MorphoSys’ Pelabresib Improves All Four Hallmarks of Myelofibrosis in Phase 3 MANIFEST-2 Study 

Retrieved on: 
Saturday, December 30, 2023

Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.

Key Points: 
  • Average hemoglobin levels were greater in patients receiving pelabresib and ruxolitinib than in those receiving placebo plus ruxolitinib, starting at week 9 and continuing to week 24.
  • Increased cytokine levels are associated with all four disease hallmarks; increased IL-8 levels are also associated with worse survival outcomes.
  • Discontinuation rates due to adverse events were 10.7% with pelabresib and ruxolitinib and 6.5% with placebo plus ruxolitinib.
  • “The four hallmarks of myelofibrosis – enlarged spleen, anemia, bone marrow fibrosis and disease-associated symptoms – have a strong impact on a patient’s life.

ZURZUVAE™ (zuranolone) CIV, a Landmark Oral Treatment for Women with Postpartum Depression (PPD), is Now Available in the U.S.

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Thursday, December 14, 2023

CAMBRIDGE, Mass., Dec. 14, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Sage Therapeutics, Inc. (Nasdaq: SAGE) announced ZURZUVAE™ (zuranolone) 50 mg (two 25 mg capsules per day) CIV is now available by prescription for the treatment of postpartum depression (PPD) for adults in the United States, with product already at specialty pharmacies and delivered to patients. ZURZUVAE is the first and only oral, 14-day treatment course for adults with PPD that can provide rapid improvements in depressive symptoms at Day 15 and as early as Day 3.

Key Points: 
  • “For women with PPD, delayed improvement in depressive symptoms can significantly worsen outcomes.
  • The program also includes financial assistance, such as a copay assistance program, and product at no cost for eligible patients.
  • The companies are partnering with several of the leading national specialty pharmacies and ZURZUVAE will be shipped directly to women with PPD who are prescribed the treatment.
  • ZURZUVAE is not for use in children
    How can I watch for and try to prevent suicidal thoughts and actions?

Altamira Therapeutics Provides Investor and Business Update

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Monday, December 11, 2023

HAMILTON, BERMUDA, Dec. 11, 2023 -- Altamira Therapeutics Ltd. (Nasdaq: CYTO) ("Altamira" or the "Company"), a company dedicated to addressing unmet medical needs, today provided an investor and business update highlighting recent activities and milestones achieved following the Company’s partial spin-off of its Bentrio® business and pivot towards becoming a pure-play RNA delivery business.

Key Points: 
  • Company hosts Investor and Business Update call on December 11 at 8:30 a.m.
  • ET
    HAMILTON, BERMUDA, Dec. 11, 2023 -- Altamira Therapeutics Ltd. (Nasdaq: CYTO) ("Altamira" or the "Company"), a company dedicated to addressing unmet medical needs, today provided an investor and business update highlighting recent activities and milestones achieved following the Company’s partial spin-off of its Bentrio® business and pivot towards becoming a pure-play RNA delivery business.
  • Meanwhile, Altamira is also pursuing the partnering of its other legacy assets, which include several development programs in inner ear therapeutics.
  • ET to discuss its investor and business update.

Moleac’s NeuroAiD™II Improves Post-Concussion Symptoms, Quality of Life, and Mood after a Mild Traumatic Brain Injury

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Tuesday, December 5, 2023

SINGAPORE, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Moleac announced promising results from the SAMURAI double-blind study in patients with mild traumatic brain injury (mTBI) receiving a 6-month course of NeuroAiD™II.

Key Points: 
  • SINGAPORE, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Moleac announced promising results from the SAMURAI double-blind study in patients with mild traumatic brain injury (mTBI) receiving a 6-month course of NeuroAiD™II.
  • In the study, the NeuroAiD™II group showed significant improvement in their post-concussion symptoms, quality of life and mood, compared to those in the placebo group.
  • In the SAMURAI study, mTBI patients underwent a series of tests assessing various types of impairments and their recovery over time.
  • For cognition, a self-assessment was done by the patient using a computerized scale, the Computerized Neurocognitive Assessment-Vital Signs (CNS-VS).

CorMedix Inc. Announces Partnership With The Leapfrog Group

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Monday, December 4, 2023

BERKELEY HEIGHTS, N.J., Dec. 04, 2023 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening diseases and conditions, today announced an agreement with The Leapfrog Group, an independent national watchdog organization of employers and other purchasers focused on health care safety, whereby CorMedix Inc. will become a member of the Leapfrog Partners Advisory Committee.

Key Points: 
  • As a Leapfrog partner, CorMedix will advise the Leapfrog board and management on industry and policy trends and help shape the organization’s long-term strategic vision.
  • “An alliance between The Leapfrog Group and CorMedix brings together two organizations both focused on a common goal: improving patient safety and quality of care across the U.S. healthcare system,” said Joseph Todisco, Chief Executive Officer, CorMedix.
  • “CorMedix is dedicated to developing solutions that reduce the risk of healthcare associated infections, in particular catheter-related bloodstream infections (CRBSIs).
  • Every American deserves the highest quality health care, and together with CorMedix we can achieve our shared vision for excellence,” said Leah Binder, Leapfrog president and CEO.

Phathom Pharmaceuticals Announces Commercial Availability of VOQUEZNA® (vonoprazan) Tablets, a Powerful First-In-Class PCAB for the Treatment of Erosive GERD and Relief of Associated Heartburn

Retrieved on: 
Tuesday, November 28, 2023

“We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.

Key Points: 
  • “We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.
  • “Erosive GERD is a highly prevalent condition affecting over 20 million people in the U.S.,3,4 many of whom experience troubling symptoms, including painful heartburn.
  • Phathom is offering programs for eligible patients who face coverage or affordability issues, including co-pay assistance for patients with commercial insurance.
  • for up to 6 months to maintain healing of Erosive Acid Reflux and for relief of heartburn related to Erosive Acid Reflux.

HALO Hydration Announces Exclusive Partnership with World Pickleball Tour to Revolutionize On-Court Hydration

Retrieved on: 
Tuesday, December 19, 2023

NEW YORK, Dec. 19, 2023 /PRNewswire/ -- HALO Hydration ("HALO"), a trailblazer in cutting-edge electrolyte hydration products, proudly announces its exclusive partnership with the World Pickleball Tour ("WPT"), the largest amateur pickleball series globally.

Key Points: 
  • NEW YORK, Dec. 19, 2023 /PRNewswire/ -- HALO Hydration ("HALO"), a trailblazer in cutting-edge electrolyte hydration products, proudly announces its exclusive partnership with the World Pickleball Tour ("WPT"), the largest amateur pickleball series globally.
  • This strategic collaboration positions HALO as the official and exclusive hydration and electrolytes partner for WPT, showcasing its revolutionary electrolyte hydration products at dozens of major pickleball events nationwide.
  • "Partnering with The World Pickleball Tour is perfect timing for us as we pursue our national retail rollout.
  • "We are thrilled to collaborate with HALO as the Official and Exclusive Hydration and electrolytes Partner of The World Pickleball Tour.

HALO Hydration Announces Exclusive Partnership with World Pickleball Tour to Revolutionize On-Court Hydration

Retrieved on: 
Tuesday, December 19, 2023

NEW YORK, Dec. 19, 2023 /PRNewswire/ -- HALO Hydration ("HALO"), a trailblazer in cutting-edge electrolyte hydration products, proudly announces its exclusive partnership with the World Pickleball Tour ("WPT"), the largest amateur pickleball series globally.

Key Points: 
  • NEW YORK, Dec. 19, 2023 /PRNewswire/ -- HALO Hydration ("HALO"), a trailblazer in cutting-edge electrolyte hydration products, proudly announces its exclusive partnership with the World Pickleball Tour ("WPT"), the largest amateur pickleball series globally.
  • This strategic collaboration positions HALO as the official and exclusive hydration and electrolytes partner for WPT, showcasing its revolutionary electrolyte hydration products at dozens of major pickleball events nationwide.
  • "Partnering with The World Pickleball Tour is perfect timing for us as we pursue our national retail rollout.
  • "We are thrilled to collaborate with HALO as the Official and Exclusive Hydration and electrolytes Partner of The World Pickleball Tour.

Head-to-head Trial of Prolonged-Release Oral Ketamine Formulation, KET01, and Intranasal SPRAVATO®, Finds Less Incidence of Dissociation or Cardiovascular Effects with Oral Treatment, at doses used for Treatment-Resistant Depression

Retrieved on: 
Monday, November 13, 2023

MUNICH, Germany, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Ketabon GmbH (“Ketabon” or “the Company”), a joint venture between HMNC Brain Health and Develco Pharma, announced today favorable results from its head-to-head trial with KET01, the Company’s proprietary lead asset, versus SPRAVATO®, the FDA-approved intranasal spray for patients with Treatment-Resistant Depression (TRD). KET01 is an IP protected oral prolonged-release formulation of ketamine and is being studied in patients with TRD. Due to its unique metabolite profile, the incidence of dissociation with KET01 was very low and statistically significantly lower relative to SPRAVATO®, pointing to a clinically meaningful difference, which could offer the potential for a safe at-home unsupervised administration. During the summer Ketabon also released data from its Phase 2 KET01-02 trial with KET01, which demonstrated rapid and durable improvements in depressive symptoms in TRD. 

Key Points: 
  • KET01 is an IP protected oral prolonged-release formulation of ketamine and is being studied in patients with TRD.
  • During the summer Ketabon also released data from its Phase 2 KET01-02 trial with KET01, which demonstrated rapid and durable improvements in depressive symptoms in TRD.
  • Only minimal signs of dissociative symptoms were detected by the CADSS scale, and no changes in cardiovascular parameters were detected.
  • “Data continues to suggest rapid and clinically relevant reduction of depressive symptoms after oral treatment with 240 mg/day of KET01.