Ureas

Protagonist Therapeutics Announces Amendment of Agreement with Janssen Biotech for the Continued Development and Commercialization of IL-23 Antagonists

Retrieved on: 
Wednesday, July 28, 2021

The amended agreement provides for the concurrent development of multiple oral IL-23 receptor antagonists against a broad range of indications.

Key Points: 
  • The amended agreement provides for the concurrent development of multiple oral IL-23 receptor antagonists against a broad range of indications.
  • Protagonist remains eligible to potentially receive approximately $900 million in future development and sales milestones, in addition to the $80 million in payments already received under the original agreement.
  • Janssen will have the right to continue research on IL-23 receptor antagonists developed during the collaboration for three years from the closing of the Restated Agreement.
  • The Company has a worldwide license and collaboration agreement with Janssen Biotech, Inc., for the development of oral peptide IL-23 receptor antagonists.

FDA Approves KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

Retrieved on: 
Thursday, July 22, 2021

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Key Points: 
  • KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
  • KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC).
  • Of the patients who developed pneumonitis, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.
  • In KEYNOTE-775, when KEYTRUDA was administered in combination with LENVIMA to patients with advanced endometrial carcinoma that were not MSI-H or dMMR (n=342), fatal adverse reactions occurred in 4.7% of patients.

The New England Journal of Medicine Publishes Results from the Phase 3 HARMONY Study Evaluating Pimavanserin in Patients with Dementia-Related Psychosis

Retrieved on: 
Wednesday, July 21, 2021

Second, in the 26-week double-blind period, patients on pimavanserin had a nearly three-fold reduction of risk of psychosis relapse compared to patients on placebo.

Key Points: 
  • Second, in the 26-week double-blind period, patients on pimavanserin had a nearly three-fold reduction of risk of psychosis relapse compared to patients on placebo.
  • We are very pleased that the New England Journal of Medicine has chosen to publish the important results of this study.
  • HARMONY was a Phase 3 study designed to evaluate the efficacy and safety of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis.
  • The HARMONY study included a 12-week, open-label stabilization period during which patients with dementia-related psychosis began treatment with pimavanserin 34 mg once daily.

Acadia Pharmaceuticals to Present New Scientific Data on Pimavanserin in Neurodegenerative Diseases at the Alzheimer’s Association International Conference 2021 (AAIC)

Retrieved on: 
Wednesday, July 14, 2021

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimers Association International Conference 2021 (AAIC), being held July 26-30, 2021 in Denver, Colo., and virtually.

Key Points: 
  • Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimers Association International Conference 2021 (AAIC), being held July 26-30, 2021 in Denver, Colo., and virtually.
  • The poster presentations include two analyses of patients who have neurodegenerative disease taking pimavanserin while also receiving other antidementia medication.
  • In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors.
  • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components.

Gedeon Richter's first participation in the World Congress of Biological Psychiatry

Retrieved on: 
Wednesday, July 7, 2021

BUDAPEST, Hungary, July 7, 2021 /PRNewswire/ -- At the 15th World Congress of Biological Psychiatry, whichwas held virtually between the 28-30thJune 2021, Gedeon Richter Plc presented new analyses of cariprazine studies in form of two scientific posters and a free communication presentation.

Key Points: 
  • BUDAPEST, Hungary, July 7, 2021 /PRNewswire/ -- At the 15th World Congress of Biological Psychiatry, whichwas held virtually between the 28-30thJune 2021, Gedeon Richter Plc presented new analyses of cariprazine studies in form of two scientific posters and a free communication presentation.
  • Gedeon Richter organised and sponsored a satellite symposium where knowledgeable psychiatrists discussed the unmet medical needs and cariprazine's efficacy in the treatment of bipolar disorder.
  • Schizophrenia is a chronic psychiatric disorder that is comprised of positive, negative, and affective symptoms, as well as cognitive impairment.
  • The illness affects about 1% of the population globally; and an estimated 5 million people struggle with this disorder in the EU.

Gedeon Richter's first participation in the World Congress of Biological Psychiatry

Retrieved on: 
Wednesday, July 7, 2021

BUDAPEST, Hungary, July 7, 2021 /PRNewswire/ -- At the 15th World Congress of Biological Psychiatry, whichwas held virtually between the 28-30thJune 2021, Gedeon Richter Plc presented new analyses of cariprazine studies in form of two scientific posters and a free communication presentation.

Key Points: 
  • BUDAPEST, Hungary, July 7, 2021 /PRNewswire/ -- At the 15th World Congress of Biological Psychiatry, whichwas held virtually between the 28-30thJune 2021, Gedeon Richter Plc presented new analyses of cariprazine studies in form of two scientific posters and a free communication presentation.
  • Gedeon Richter organised and sponsored a satellite symposium where knowledgeable psychiatrists discussed the unmet medical needs and cariprazine's efficacy in the treatment of bipolar disorder.
  • Schizophrenia is a chronic psychiatric disorder that is comprised of positive, negative, and affective symptoms, as well as cognitive impairment.
  • The illness affects about 1% of the population globally; and an estimated 5 million people struggle with this disorder in the EU.

Nature's Bounty® Optimal Solutions® Launches First-Ever Advanced Hair, Skin & Nails Jelly Beans

Retrieved on: 
Wednesday, June 23, 2021

RONKONKOMA, N.Y., June 23, 2021 /PRNewswire/ -- It's no surprise beauty starts from within and with 22% percent of consumers taking supplements to support hair, skin and nails nutrient gaps1 Nature's Bounty Optimal Solutions , the #1 brand for Hair, Skin & Nails today unveiled Advanced Hair, Skin & Nails Jelly Beans.

Key Points: 
  • RONKONKOMA, N.Y., June 23, 2021 /PRNewswire/ -- It's no surprise beauty starts from within and with 22% percent of consumers taking supplements to support hair, skin and nails nutrient gaps1 Nature's Bounty Optimal Solutions , the #1 brand for Hair, Skin & Nails today unveiled Advanced Hair, Skin & Nails Jelly Beans.
  • Each serving (or 2 jelly beans) includes 6,000 mcg of Biotin to support beautiful hair, glowing skin and healthy nails, along with added Keratin and Vitamins A, C and E:
    Beautiful Hair: Advanced formula with Keratin + 6,000 mcg of Biotin per serving to support healthy, beautiful hair.
  • *
    Glowing Skin: Vegetarian formula with Vitamins A, C and E to support glowing skin.
  • The new Nature's Bounty Optimal Solutions Advanced Hair, Skin & Nails Jelly Beans are available now on Amazon.com and coming to Walmart, CVS, Kroger and more, shelves this summer.

The Law Offices of Frank R. Cruz Reminds Investors of Looming Deadline in the Class Action Lawsuit Against Acadia Pharmaceuticals Inc. (ACAD)

Retrieved on: 
Wednesday, June 16, 2021

In June 2020, Acadia submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) to expand pimavanserins label to include treatment for dementia-related psychosis.

Key Points: 
  • In June 2020, Acadia submitted a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) to expand pimavanserins label to include treatment for dementia-related psychosis.
  • On this news, Acadias stock price fell $20.76 per share, or 45.35%, to close at $25.02 per share on March 9, 2021, thereby injuring investors.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Acadia Pharmaceuticals, Inc. Investors: Last Days to Participate Actively in the Class Action Lawsuit; Portnoy Law Firm

Retrieved on: 
Monday, June 14, 2021

Investors are encouraged to contact attorney Lesley F. Portnoy , to determine eligibility to participate in this action, by phone 310-692-8883 or email , or click here to join the case.

Key Points: 
  • Investors are encouraged to contact attorney Lesley F. Portnoy , to determine eligibility to participate in this action, by phone 310-692-8883 or email , or click here to join the case.
  • The complaint alleges that Acadia misrepresented facts concerning their supplemental new drug application for NUPLAZID (pimavanserin), which treats dementia-related psychosis.
  • Thereafter, Acadia repeatedly stated the FDA had not identified any potential review issues, reiterating the efficacy of the drug.
  • The Portnoy Law Firm represents investors in pursuing arising from corporate wrongdoing.

Biotin Water® Hair, Skin, & Nails Makes Its Way To Publix Supermarkets

Retrieved on: 
Friday, June 11, 2021

ROME, Ga., June 11, 2021 /PRNewswire/ --2T Water, LLC, the maker of Biotin Water Hair, Skin, and Nails announced today that Biotin Water will be sold at Publix Supermarkets across the southeast region of the United States starting June 2021.

Key Points: 
  • ROME, Ga., June 11, 2021 /PRNewswire/ --2T Water, LLC, the maker of Biotin Water Hair, Skin, and Nails announced today that Biotin Water will be sold at Publix Supermarkets across the southeast region of the United States starting June 2021.
  • 2T Water, LLC owns the exclusive rights to distribute Biotin Water Hair, Skin, and Nails which is the first biotin infused beverage that delivers 300 mcg per 16oz with zinc and folic acid included in the proprietary formula.
  • Biotin Water Hair, Skin, and Nails is formulated to ensure the body is properly hydrated while enjoying the many benefits of B7, often considered the most overlooked vitamin.
  • This new introduction of Biotin Water gives consumers more locations throughout the southeast to purchase Biotin Water in a great grocery chain.