DEB

N-able Receives Advancing Diversity in Technology Leadership Award from CompTIA

Retrieved on: 
Thursday, April 4, 2024
Professional Services, Data Management, DEI (Diversity, Equity and Inclusion), Security, Technology, Software, Networks, Certification, Culture, NABL, Environment, CompTIA, DEB, Workforce, Nursing

N-able was awarded the Advancing Diversity in Technology Leadership Award for its commitment to diversity, equity, and inclusion in the industry, and making a positive impact on the lives and careers of others through its values.

Key Points: 
  • N-able was awarded the Advancing Diversity in Technology Leadership Award for its commitment to diversity, equity, and inclusion in the industry, and making a positive impact on the lives and careers of others through its values.
  • “The 2024 North America Spotlight Award winners have shown outstanding passion and commitment in advancing and improving the entire technology industry,” said MJ Shoer, CompTIA’s chief community officer.
  • “These members help shape the global CompTIA Community through their continued thought leadership, engagement and innovation, and diversity, equity, and inclusion.
  • Belonging: When individuals feel included, leveraged, valued, and celebrated for who they are and what they bring to the table.

Global Cell Counting Market to Hit $15.72 Billion by 2029, Fueled by Advancements in Cell Biology and Therapy - ResearchAndMarkets.com

Retrieved on: 
Friday, March 29, 2024
Research, Technology, University, Genetics, Artificial Intelligence, Education, Science, Nanotechnology, Biotechnology, Stem Cells, Other Technology, Health, Other Science, Automation, Quality control, Interdisciplinarity, Acute lymphoblastic leukemia, Growth, Prevalence, Application, Novartis, Patient, Conditional sentence, Cell biology, Lung, Concha bullosa, Hospital, Artificial intelligence, National Cancer Institute, AI, Regenerative medicine, Duchenne muscular dystrophy, Therapy, DEB, Miniaturization, Sarepta Therapeutics, CGT, FDA, DMD, Tisagenlecleucel, PDUFA, Pharmaceutical industry

The global cell counting market was valued at US$9.98 billion in 2023 and is expected to reach US$15.72 billion by 2029.

Key Points: 
  • The global cell counting market was valued at US$9.98 billion in 2023 and is expected to reach US$15.72 billion by 2029.
  • Advancements in cell biology, biotechnology, and medical research are driving demand for precise cell counting, especially with the rise of personalized medicine and regenerative therapies.
  • PDUFA dates for therapies could translate into an order book boost for the cell counting players in the market, resulting in market growth.
  • The global cell counting market is consolidated, with top five players holding approximately 70% share of the market.

Krystal Biotech Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Monday, February 26, 2024
Research, Investment, Form 10-K, Sale, Form, HSV, Society, KRYS, Immunotherapy, Trial of the century, Genotype, Eye, PI, Krystal, Transgene, European Medicines Agency, Security (finance), Pharmacology, NCT, DEB, Jeune, ID, ODD, AATD, Safety, Survival, Medicaid, IND, Bronchoscopy, IL-12, Gene, MAA, FDA, Patent, Priority review, Cell, Lung, Patient, Medicine, Pharmaceutical industry

(the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today reported financial results and key business updates for the fourth quarter and year ending December 31, 2023.

Key Points: 
  • (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today reported financial results and key business updates for the fourth quarter and year ending December 31, 2023.
  • Financial results for the quarter ended December 31, 2023:
    Cash, cash equivalents, and investments totaled $594.1 million on December 31, 2023.
  • The Company recorded net product revenue of $42.1 million from sales of VYJUVEK during the quarter ended December 31, 2023.
  • For additional information on the Company’s financial results for the year ended December 31, 2023, please refer to the Form 10-K filed with the Securities and Exchange Commission.

Krystal Biotech Announces Publication in the New England Journal of Medicine on the Application of B-VEC to Treat Ocular Complications in Patient with Dystrophic Epidermolysis Bullosa

Retrieved on: 
Thursday, February 8, 2024
Manuscript, KRYS, Paratriathlon, Pannus, Patient, Disease management, Scar, Ophthalmology, FDA, Abrasion, Concha bullosa, DEB, Risk, Research and development, Gene, Blister, Associate, Suma, Doctor of Philosophy, NEJM, Eye, Pharmaceutical industry

PITTSBURGH, Feb. 08, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced data on the compassionate use of beremagene geperpavec (B-VEC), administered as an eyedrop to treat a patient with dystrophic epidermolysis bullosa (DEB) with cicatrizing conjunctivitis has been published in the New England Journal of Medicine (NEJM). The full manuscript, titled “Ocular Gene Therapy in a Patient with Dystrophic Epidermolysis Bullosa,” can be found in the February 8, 2024 issue of the NEJM.

Key Points: 
  • The full manuscript, titled “Ocular Gene Therapy in a Patient with Dystrophic Epidermolysis Bullosa,” can be found in the February 8, 2024 issue of the NEJM.
  • Over 25% of patients with DEB develop ocular complications such as corneal erosions, abrasions, blistering and scarring that can lead to impaired vision.
  • The NEJM publication describes the first application of B-VEC to treat ocular complications in a patient with DEB under a compassionate use program.
  • If approved, this approach could drastically benefit these patients.”
    A patient presented with severe cicatrizing conjunctivitis secondary to DEB.

Krystal Biotech Receives Permanent J-code (J3401) for VYJUVEK®

Retrieved on: 
Thursday, January 4, 2024
Food, Government, DEB, Medicare, KRYS, Patient, Food and Drug Administration, CMS

The J-code for VYJUVEK became effective on January 1, 2024.

Key Points: 
  • The J-code for VYJUVEK became effective on January 1, 2024.
  • “The permanent J-code will help ensure efficient and accurate reimbursement of VYJUVEK and further enable us to bring this important treatment to DEB patients in need,” said Krish S. Krishnan, Chairman & CEO at Krystal Biotech.
  • J-codes are permanent reimbursement codes used by government payers and commercial insurers to facilitate billing of treatments that must be administered by a healthcare professional.
  • J-codes simplify and streamline the billing and reimbursement processes, allowing for efficient claims processing.

Chiesi Global Rare Diseases Receives FDA Approval for FILSUVEZ® (birch triterpenes) topical gel for the Treatment of Epidermolysis Bullosa

Retrieved on: 
Tuesday, December 19, 2023
European Commission, Food, Risk, Infection, Caregiver, System, FDA, Acquisition, JEB, Disease, Civil service commission, DEB, Dermatitis, Hypersensitivity, Blister, Patient, EB, Skin, Pharmaceutical industry

BOSTON, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, announced today that the U.S. Food and Drug Administration (FDA) approved FILSUVEZ® (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB). FILSUVEZ is the first approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of EB with blisters beginning in infancy. FILSUVEZ joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January of this year.

Key Points: 
  • FILSUVEZ is the first approved treatment for wounds associated with JEB, a rare, moderate-to-severe form of EB with blisters beginning in infancy.
  • FILSUVEZ joined the Chiesi portfolio as part of the agreement reached during the acquisition of Amryt Pharma in January of this year.
  • "At Chiesi Global Rare Diseases we are driven by a need to alleviate the burdens faced in the rare disease community by providing innovative therapies and solutions that address debilitating unmet needs.” Giacomo Chiesi, Head of Chiesi Global Rare Diseases, said.
  • FILSUVEZ topical gel is indicated for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa in adult and pediatric patients 6 months of age and older.

Krystal Biotech Receives Orphan Drug Designation from the Japanese MHLW for Beremagene Geperpavec-svdt (B-VEC)

Retrieved on: 
Tuesday, December 19, 2023
Research and development, Suma, Concha bullosa, Research, MHLW, ODD, DEB, KRYS, Patient, Safety, Pharmaceutical industry

PITTSBURGH, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to beremagene geperpavec-svdt (B-VEC or VYJUVEK) for the treatment of dystrophic epidermolysis bullosa (DEB).

Key Points: 
  • PITTSBURGH, Dec. 19, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Japan Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation (ODD) to beremagene geperpavec-svdt (B-VEC or VYJUVEK) for the treatment of dystrophic epidermolysis bullosa (DEB).
  • “Receiving ODD is an important step in expediting the development of B-VEC in Japan and underscores the unmet needs of patients with DEB,” said Suma Krishnan, President, Research & Development, Krystal Biotech, Inc. “We look forward to working closely with MHLW to bring this important treatment to patients in Japan as soon as possible.”
    The orphan drug designation system in Japan aims to support the development of drugs for diseases that affect fewer than 50,000 patients in Japan, for which significant unmet medical need exists.
  • An investigational therapy is eligible to qualify for ODD if there is no approved alternative treatment option or if there is high efficacy or safety compared to existing treatment options expected.
  • Specific measures to support the development of orphan drugs include subsidies for research and development expenditures, prioritized consultation regarding clinical development, reduced consultation fees, tax incentives, priority review of applications, reduced application fees, and extended registration validity period.

Krystal Biotech Announces EMA Validation of Marketing Authorization Application for VYJUVEK for the Treatment of Dystrophic Epidermolysis Bullosa

Retrieved on: 
Monday, November 27, 2023
Research and development, Marketing, Suma, Concha bullosa, EMA, MAA, Orphan, DEB, KRYS, Committee, Patient, CHMP

PITTSBURGH, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Company’s Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review.

Key Points: 
  • PITTSBURGH, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, today announced that the Company’s Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for VYJUVEK (beremagene geperpavec-svdt, also known as B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB) has been validated and is now under CHMP review.
  • A CHMP opinion is anticipated in the second half of 2024.
  • Based on this positive opinion, the Company would be eligible for up to an additional two years of marketing exclusivity in the EU, on top of the ten-year EU market exclusivity after market approval in the EU.
  • Previously, VYJUVEK received Orphan Drug Designation and PRIority Medicines (PRIME) eligibility from the EMA.

IFF Expands Partnership with Kemira to Commercialize New Designed Enzymatic Biomaterials

Retrieved on: 
Tuesday, December 19, 2023
Science, All rights reserved, Marketing, Polymer, Paper, Health, Biopolymer, DEB, Biorefinery, Water, Food, Sugar, SVP, Creativity, Renewable energy

WILMINGTON, Del., Dec. 19, 2023 /PRNewswire/ -- IFF (NYSE:IFF) and Kemira today announced their next step in the collaboration to commercialize a portfolio of unique, renewable polymers derived from IFF's cutting-edge Designed Enzymatic Biomaterials (DEB) technology platform. These unique, renewable polymers derived from plant sugars will be available for the first time at industrial scale to supply a range of markets. This new market development biomanufacturing facility will be integrated into Chemigate Ltd's biorefinery, a member of the Berner Group in Finland, and will be operational in mid-2024.

Key Points: 
  • IFF's DEB technology was launched earlier in 2023 for use in home and personal care markets.
  • This will enable IFF to commercially supply lead customers and support strategic application development programs at scale.
  • "Manufacturers will now have access to commercially relevant quantities of IFF's Designed Enzymatic Biomaterials, to improve sustainability across a series of market segments."
  • IFF, the IFF Logo, and all trademarks and service marks denoted with TM, SM or ® are owned by IFF or affiliates of IFF unless otherwise noted.

New InstallAware Multi Platform Builds GUI Setups with Console Fallbacks, Ensuring 100% Successful Deployments on All (Linux) OS's

Retrieved on: 
Monday, December 18, 2023
Mixed-mode, Linux, GUI, Java, SSH, GTK, SAN, DEB, IDE, RPM, URL, MacOS, Console

SAN FRANCISCO, Dec. 18, 2023 /PRNewswire-PRWeb/ -- InstallAware Software, the leader in software installation, repackaging, and virtualization solutions for application developers and enterprises, is launching InstallAware Multi Platform 1.0 on Friday this week. InstallAware is extending its two decades of thought leadership on the Windows platform to new Linux and macOS platforms, as bona fide first class citizens.

Key Points: 
  • Building a GUI installer that runs everywhere is literally impossible, because GUI widgets are also non-standard – with platforms fragmented between GTK, Qt, and others still.
  • InstallAware Multi Platform has tackled these challenges and succeeded in generating universal installers, successfully deploying on all (Linux) operating systems; irrespective of GUI widgets or package managers.
  • InstallAware sidesteps the whole GUI widget issue by implementing a new Console Setup Engine, where all developer designed setup wizards render in character mode.
  • New "Mixed Mode" setups include both engines, with the Console taking over when the GUI does not boot for any reason.