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Cara Therapeutics to Present at the the 2021 Cantor Virtual Global Healthcare Conference

Friday, September 24, 2021 - 12:00pm

STAMFORD, Conn., Sept. 24, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc.(Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs), today announced that Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer, will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 3.20 p.m.

Key Points: 
  • STAMFORD, Conn., Sept. 24, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc.(Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors (KORs), today announced that Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer, will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on Tuesday, September 28, 2021 at 3.20 p.m.
  • A live webcast of the fireside chat can be accessed under "Events & Presentations" in the News & Investors section of the Company's website at www.CaraTherapeutics.com .
  • An archived webcast recording will be available on the Cara website for approximately 30 days.
  • Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs.

Incyte Announces U.S. FDA Approval of Opzelura™ (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD)

Tuesday, September 21, 2021 - 9:13pm

Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.

Key Points: 
  • Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States.
  • Many patients and their dermatologists are looking for additional options to meet current unmet needs in the management of AD.
  • The approval of Opzelura is exciting news, and we welcome a new treatment option for our community.
  • Incyte has worldwide rights for the development and commercialization of ruxolitinib cream, marketed in the United States as Opzelura.

Lauren Streicher, M.D. OB/GYN Introduces Francey, the 49-Year-Old, Newly Single Woman Who Shares Her Journey through Menopause in ‘Slip Sliding Away: Turning Back the Clock on Your Vagina’

Tuesday, September 21, 2021 - 4:55pm

With the kids out of the house, Francey is ready to bring her vagina out of retirement.

Key Points: 
  • With the kids out of the house, Francey is ready to bring her vagina out of retirement.
  • But, like millions of perimenopausal and menopausal women across the country, Franceys vagina appears to be out of business.
  • Slip Sliding Away is the story of Franceys dry vagina, and how she got her lube back.
  • Many women assume that menopause is temporary, and once the hot flashes go away, menopause is over, adds Dr. Streicher.

Bug Bite Thing Continues Massive Retail Expansion, Announces New Retail Partners, Academy Sports + Outdoors, Ace Hardware, Big 5 Sporting Goods, Casey's, JOANN's and Lowe's

Tuesday, September 21, 2021 - 4:02pm

Bug Bite Thing will be available in stores in the following locations:

Key Points: 
  • Bug Bite Thing will be available in stores in the following locations:
    Academy Sports + Outdoors in the Midwest, Southeast and Southwest regions.
  • Customers can now run to their nearest retail store to purchase Bug Bite Thing using the retail locator on BugBiteThing.com ," says Bug Bite Thing Founder & CEO Kelley Higney.
  • Bug Bite Thing is also Amazon's #1 selling product for insect bite relief with over 40,000 reviews.
  • Learn more at Bug Bite Thing , and follow along on Facebook , Instagram , LinkedIn , TikTok and Twitter .

FDA Approves LEXETTE (R) for Adolescent Plaque Psoriasis

Tuesday, September 21, 2021 - 3:00pm

LEXETTE, a super potent topical corticosteroid,is now approved for the treatment of plaque psoriasis in patients aged 12 years and older.

Key Points: 
  • LEXETTE, a super potent topical corticosteroid,is now approved for the treatment of plaque psoriasis in patients aged 12 years and older.
  • The FDA approved LEXETTE in 2018 based on evidence from two multicentre, randomized, double-blind, vehicle-controlled studies (n=560) in patients with plaque psoriasis involving between 2% to 12% body surface area.
  • LEXETTE (halobetasol propionate) foam is a potent corticosteroid indicated for the topical treatment of plaque psoriasis in patients twelve years of age and older.
  • LEXETTE foam was evaluated for the treatment of moderate to severe plaque psoriasis in two multicentre, randomised, double-blind, vehicle-controlled studies.

Mirum Pharmaceuticals and Takeda Enter into Exclusive Licensing Agreement to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan

Tuesday, September 21, 2021 - 1:00pm
Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20210921005502/en/
    Under the terms of the agreement, Takeda will be responsible for regulatory approval and commercialization of maralixibat in Japan.
  • We are excited for Takeda to engage in the development of maralixibat and collaborate in our effort to advance this potentially life-changing therapy.
  • This agreement reinforces Takedas commitment to developing highly differentiated medicines to improve the health and quality of life of patients.
  • Maralixibat is a novel, minimally absorbed, orally administered investigational drug being evaluated in several rare cholestatic liver diseases.

Verrica Pharmaceuticals Receives Complete Response Letter from the FDA identifying deficiencies at a facility of a Contract Manufacturer for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum

Monday, September 20, 2021 - 9:05pm

WEST CHESTER, Pa., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (the “Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum). The Company had previously disclosed that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for the NDA by three months to September 23, 2021 to allow the Agency additional time to review information submitted by the Company in response to comments from the Agency regarding the Company’s human factors study.

Key Points: 
  • More importantly, the FDA did not identify any clinical, safety or product specific Chemistry, Manufacturing, and Controls (CMC) deficiencies related to VP-102.
  • Molluscum is a highly contagious viral skin disease that affects approximately six million people primarily children in the United States.
  • Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.
  • A Complete Response Letter was received from the FDA regarding the NDA for VP-102 onSeptember 17, 2021.

Melinta Therapeutics Announces Two Key Milestones Expanding Reimbursement and Access for KIMYRSA™ (oritavancin)

Monday, September 20, 2021 - 1:03pm

Melinta Therapeutics (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced two important milestones for KIMYRSA (oritavancin), a lipoglycopeptide antibiotic that was launched in July.

Key Points: 
  • Melinta Therapeutics (Melinta), a commercial-stage company providing innovative therapies for acute and life-threatening illnesses, today announced two important milestones for KIMYRSA (oritavancin), a lipoglycopeptide antibiotic that was launched in July.
  • We are thrilled to announce these two milestones that will expand reimbursement and access for KIMYRSA, said Christine Ann Miller, Melintas President and Chief Executive Officer.
  • Thats why we intentionally designed KIMYRSA to provide patients with more flexibility and accessibility in ABSSSI treatment.
  • Said John Harlow, Chief Commercial Officer for Melinta, Having a unique J-code for KIMYRSA underscores the distinct value that KIMYRSA brings to the oritavancin franchise.

Avicanna Completes Registration and Commercial Export of its Evidence-Based CBD Dermacosmetics Brand, Pura Earth, in Ecuador

Thursday, September 16, 2021 - 12:30pm

TORONTO, Sept. 16, 2021 (GLOBE NEWSWIRE) -- Avicanna Inc. ("Avicanna" or the "Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing and commercialization of plant-derived cannabinoid-based products is pleased to announce that it has completed product registration and its first commercial export of its Pura Earth branded dermacosmetics products in Ecuador.

Key Points: 
  • In addition to the completed clinical trials all Pura Earth products are not tested on animals and are vegan.
  • The 3 cosmetic clinical studies were completed on Avicannas formulations targeting cosmetic factors associated with aging, acne-prone skin, and eczema-prone skin.
  • Intersive Moisturizing Cream: Oil-based formula uniquely marries CBD, colloidal oatmeal and hemp seed oil aimed at relieving skin redness 2,10.
  • Pura H&W/Pura Earth: these registered, clinically tested, cosmetic products include a portfolio of functional CBD consumer derma-cosmetic and topical products.

MacroGenics Announces Clinical Results from Cohort A Part 1 of Phase 2/3 MAHOGANY Study of Margetuximab in Combination with Retifanlimab in Gastroesophageal Adenocarcinoma at ESMO 2021

Thursday, September 16, 2021 - 7:45am

The dataset is available in a poster titled Margetuximab With Retifanlimab in HER2+, PD-L1+ First-Line Unresectable/Metastatic Gastroesophageal Adenocarcinoma (GEA): MAHOGANY Cohort A (Poster #1379P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021.

Key Points: 
  • The dataset is available in a poster titled Margetuximab With Retifanlimab in HER2+, PD-L1+ First-Line Unresectable/Metastatic Gastroesophageal Adenocarcinoma (GEA): MAHOGANY Cohort A (Poster #1379P) at the 2021 European Society for Medical Oncology (ESMO) Virtual Conference taking place September 16-21, 2021.
  • The efficacy data and safety cutoff dates were July 19, 2021 and August 3, 2021, respectively.
  • Twenty-five patients (58%) had gastric cancer and 18 patients (42%) had gastroesophageal junction cancer; 36 patients (84%) had metastatic disease at study entry.
  • Anti-tumor activity was observed in patients treated with margetuximab plus retifanlimab in MAHOGANY Cohort A after the first scan.