Dermatology

Sol-Gel’s Collaboration Partner First-to-File ANDA Drug Product Generic to Zoryve® Cream

Retrieved on: 
Monday, April 1, 2024
Cream, Psoriasis, Abbreviated New Drug Application, NESS, Partnership, District court, Patient, Nevoid basal-cell carcinoma syndrome, Dermatology, Patent, IQVIA, FDA, Sol–gel process, Food, Generic drug

On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.

Key Points: 
  • On March 26, 2024, Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) (“Arcutis”) initiated a patent infringement action in the U.S. District Court for the District of New Jersey regarding the Padagis Roflumilast Cream, 0.3% ANDA.
  • Annual market sales for Zoryve Cream, 0.3% were approximately $95 million in the 12 months ended in January 2024, as measured by IQVIA.
  • Should its ANDA for Roflumilast Cream, 0.3% be approved by the FDA, Padagis believes that its product may be entitled to 180 days of generic market exclusivity.
  • Submissions such as Padagis’s Roflumilast Cream, 0.3% ANDA demonstrate the historic value of Sol-Gel’s partnership with Padagis.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against NYCB, Amylyx, Xponential, and InMode and Encourages Investors to Contact the Firm

Retrieved on: 
Saturday, March 30, 2024
SSS, Signature, Vii, Apoptosis, ALS, Patient, AUV, Bloomberg Businessweek, ACL, Food and Drug Administration, Defendant, AMX0035, Amyotrophy, Sale, News, Dermatology, Prescription, New York Community Bank, NYCB, IBD, Complaint, P.C, Geisler, Investor's Business Daily, Assumption, Confidentiality, Amylyx Pharmaceuticals, Injury, Category, Dentist, FDA, BBC World Service, Evercore, Food, Pharmaceutical industry

NYCB is a large commercial-real estate lender in the New York City market area, where it specializes in rent-regulated, non-luxury apartment buildings.

Key Points: 
  • NYCB is a large commercial-real estate lender in the New York City market area, where it specializes in rent-regulated, non-luxury apartment buildings.
  • NYCB is engaged in several national businesses, including multi-family lending, mortgage originations and servicing, and warehouse lending.
  • On January 31, 2024, before the market opened, NYCB announced its fiscal fourth quarter 2023 financial results.
  • For more information on the InMode class action go to: https://bespc.com/cases/INMD

Fortress Biotech Reports 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 28, 2024
AstraZeneca, Exercise, Fortification, New Drug Application, Patient, GBM, CRL, NDA, Menkes, Minocycline, Therapy, Marketing, Radiation, CKPT, Rosacea, Investigational New Drug, Erythema, Safety, BLA, Fortress Biotech, Food, Red, Amyloidosis, Dermatology, Carcinoma, FDA, Hyperhidrosis, Mustang Bio, Menkes disease, PDUFA, Pharmaceutical industry

MIAMI, March 28, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.

Key Points: 
  • Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In 2023, we built a significant amount of momentum to position our Company to achieve multiple milestones in 2024.
  • In March 2024, the FDA accepted the NDA and has set a PDUFA goal date of November 4, 2024.
  • In December 2023, the FDA issued a complete response letter (“CRL”) for the cosibelimab BLA.
  • Fortress’ consolidated net revenue totaled $84.5 million for the full year ended December 31, 2023, which included $59.7 million in net revenue generated from our marketed dermatology products.

Photomedicine Pioneer CLINUVEL Unveils Clinical, Cosmetic Ambitions to German Investors

Retrieved on: 
Thursday, March 28, 2024
Dermatology, Vitiligo, Growth, Science, History, Female, American Academy, Light, Skin, Melanocortin, Depigmentation, Peptide

DÜSSELDORF, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- Pioneering biopharmaceutical company CLINUVEL yesterday hosted a wide-ranging market briefing discussing its novel drug SCENESSE® (afamelanotide) and the future of photomedicine.

Key Points: 
  • DÜSSELDORF, Germany, March 28, 2024 (GLOBE NEWSWIRE) -- Pioneering biopharmaceutical company CLINUVEL yesterday hosted a wide-ranging market briefing discussing its novel drug SCENESSE® (afamelanotide) and the future of photomedicine.
  • Over 70 guests discussed the Company’s unique history and future growth potential at an invitation-only event in Düsseldorf.
  • CLINUVEL is now investing heavily in R&D with an ambitious clinical pipeline, including a phase III clinical trial for the pigment loss disorder vitiligo.
  • “German investors have been pivotal in supporting our work thus far and we hope to share our success with the wider investment community.”

China Medical System （867.HK）2023 Annual Results: Despite of the Temporary Financial Performance Pressure Fresh Catalysts Emerged from Successive Innovation Breakthroughs

Retrieved on: 
Thursday, March 28, 2024
Sclerotherapy, RMB, Conditional sentence, NDA, IND, Creativity, Small RNA, Marketing, Gastroenterology, Central nervous system, FIC, City, BIC, CMS, NRDL, Injection, Dermatology, CDMO, Commercialization, Tablet, Pharmacy, Methotrexate, Hospital, Acquisition, Gonadotropin-releasing hormone, RCT, VBP, Rheumatoid arthritis, Growth, Varicose veins, Ecosystem, Blue, Government, Ophthalmology

SHENZHEN, CHINA, March 27, 2024 (GLOBE NEWSWIRE) -- On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results.

Key Points: 
  • SHENZHEN, CHINA, March 27, 2024 (GLOBE NEWSWIRE) -- On March 27, 2024, China Medical System (“CMS” or the “Company”) released its 2023 annual results.
  • Based on above, CMS has successfully entered into its “New Period” of innovation and internationalization development.
  • 4 innovative drugs have started large-scale clinical application, unveiling CMS’s first year of commercialization era of innovative drugs.
  • Under its compliant and efficient commercialization system, the Company's innovative products and exclusive drugs will grow steadily.

STRATA Skin Sciences Reports Fourth Quarter and Full-Year 2023 Earnings

Retrieved on: 
Wednesday, March 27, 2024
Growth, Webcast, Tax, International, Bank statement, Dermatology, DTC, Acne, Direct, Annual report, Report, Interest, Safety, SSKN, ID, Marketing, STRATA, Video game

Global recurring revenues for the fourth quarter of 2023 were $5.6 million, as compared to global recurring revenues of $6.5 million for the fourth quarter of 2022.

Key Points: 
  • Global recurring revenues for the fourth quarter of 2023 were $5.6 million, as compared to global recurring revenues of $6.5 million for the fourth quarter of 2022.
  • Equipment revenues were $3.1 million for the fourth quarter of 2023, as compared to $4.1 million for the fourth quarter of 2022.
  • Selling and marketing costs for the fourth quarter of 2023 were $2.8 million, as compared to $3.8 million for the fourth quarter of 2022.
  • Other expenses for the fourth quarter of 2023 were $0.4 million, compared to $0.2 million for the fourth quarter of 2022.

INMD INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Announces that InMode Ltd. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit!

Retrieved on: 
Wednesday, March 27, 2024
Food and Drug Administration, Dermatology, Complaint, Confidentiality, Injury, Dentist, FDA, Court, Person

InMode is a global provider of aesthetic medical devices and technology including devices purporting to offer body sculpting and other rejuvenation technologies.

Key Points: 
  • InMode is a global provider of aesthetic medical devices and technology including devices purporting to offer body sculpting and other rejuvenation technologies.
  • Specifically, Defendants repeatedly touted the demand for InMode’s devices and told investors that those devices were never sold at a discount.
  • or his Law Clerk and Client Relations Manager, Yael Nathanson of Bronstein, Gewirtz & Grossman, LLC at 332-239-2660.
  • Bronstein, Gewirtz & Grossman, LLC is a nationally recognized firm that represents investors in securities fraud class actions and shareholder derivative suits.

Verrica Pharmaceuticals Announces that YCANTH™ Receives New Chemical Entity Status and Orange Book Listing from the FDA

Retrieved on: 
Tuesday, March 26, 2024
The Orange Book, NCE, Orange Book, Dermatology, Skin, Patent, Therapy, FDA, Approved drug, Food, Pharmaceutical industry

WEST CHESTER, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the Company’s lead product, YCANTH™, has received New Chemical Entity (“NCE”) Status and a listing in the Orange Book from the U.S. Food and Drug Administration (“FDA”), providing a minimum five years of regulatory exclusivity.

Key Points: 
  • The Company’s U.S. patents and pending patent applications related to YCANTH™ are projected to expire between 2034 and 2041, excluding any patent term adjustment or patent term extension
    WEST CHESTER, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica” or “the Company”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the Company’s lead product, YCANTH™, has received New Chemical Entity (“NCE”) Status and a listing in the Orange Book from the U.S. Food and Drug Administration (“FDA”), providing a minimum five years of regulatory exclusivity.
  • “We could not be more pleased to announce YCANTH™ has been granted NCE Status by the FDA,” said Ted White, Verrica’s President and Chief Executive Officer.
  • “Today’s announcement represents the continued execution of our Company’s comprehensive intellectual property strategy to maximize the patent and regulatory protections surrounding YCANTH™ and further underscores the product’s innovation and intrinsic value in the dermatology market.
  • While NCE status will provide YCANTH™ with a minimum of five years of protection, we anticipate our full patent portfolio to provide protection from generic competition for the next decade and potentially beyond.”
    Formally described as the Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book is an FDA publication that provides a list of drugs approved as safe and effective and also serves as the regulatory resource for information on drug marketing availability, bioequivalence, drug substitution, and patent and exclusivity data.1 The Orange Book also lists patents covering those drugs, approved methods of their use, and regulatory exclusivities to which they may be entitled.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Cassava, NYCB, Amylyx, and InMode and Encourages Investors to Contact the Firm

Retrieved on: 
Tuesday, March 26, 2024
Apoptosis, Patient, AMX0035, Science, New York Community Bank, NYCB, P.C, Initiative, ACL, Scientific misconduct, IBD, Confidentiality, Safety, Injury, Data management, Food, Signature, Cassava Sciences, ALS, Alzheimer's disease, Defendant, Food and Drug Administration, Journal, Amyotrophy, News, Prescription, Amylyx Pharmaceuticals, Dentist, FDA, City University, Biomarker, Dermatology, Complaint, Investor's Business Daily, Neurobiology of Aging, Cognition, Assumption, Category, BBC World Service, Evercore, Cassava, Pharmaceutical industry

The Company's lead therapeutic drug candidate is PTI-125 (or "simufilam"), a small molecule drug for the proposed treatment of Alzheimer's disease.

Key Points: 
  • The Company's lead therapeutic drug candidate is PTI-125 (or "simufilam"), a small molecule drug for the proposed treatment of Alzheimer's disease.
  • However, in response, Cassava denied the allegations in the Citizen Petition and instead touted the effectiveness of simufilam and the efficacy of the Company's research programs.
  • On this news, Cassava's stock price fell $2.68 per share, or 15.28%, to close at $14.86 per share on October 13, 2023.
  • For more information on the InMode class action go to: https://bespc.com/cases/INMD

La Roche-Posay Expands Best-Selling Healing Cicaplast Collection with Cicaplast Gel B5 Skin Protectant and Cicaplast Lips Hydration Restore Lip Balm

Retrieved on: 
Monday, April 8, 2024
Pantothenic acid, SKIN, Panthenol, Face, Hyaluronic acid, Environment, Associate, Patient, Pharmacy, Dermatology, B5, Selenium, MD, Glycerol, Mineral, Skin, LIP, Sustainability, Water, Safety, LIPS, La Roche-Posay, Collection, Lip, Shea butter, Element, Cosmetics

Created for dry to very dry and sensitive lips, CICAPLAST LIPS HYDRATION RESTORE LIP BALM soothes and softens with a non-greasy texture.

Key Points: 
  • Created for dry to very dry and sensitive lips, CICAPLAST LIPS HYDRATION RESTORE LIP BALM soothes and softens with a non-greasy texture.
  • Formulated with Vitamin B5 (Panthenol), sustainably sourced Shea Butter and La Roche-Posay Thermal Spring Water, CICAPLAST LIPS HYDRATION RESTORE LIP BALM restores the skin's hydrolipidic film and helps soothe skin.
  • Now, with the launch of CICAPLAST LIPS HYDRATION RESTORE LIP BALM and CICAPLAST GEL B5 SKIN PROTECTANT, La Roche-Posay is proud to continue to expand its best-selling and healing CICAPLAST collection.
  • CICAPLAST LIPS HYDRATION RESTORE LIP BALM and CICAPLAST GEL B5 SKIN PROTECTANT are: