Medication

Cosette Pharmaceuticals Receives U.S. Patent (US 11,291,628) For Welchol® Chewable Bar, A Novel Oral Drug Delivery System to Deliver Colesevelam Hcl

Retrieved on: 
Tuesday, June 7, 2022
Health, Pharmaceutical, Suppository, Avista Capital Partners, Patent, Joint Medical Service (Germany), CEO, 1836 U.S. Patent Office fire, Medication, Therapy, Multimedia, Compliance, USPTO, Pharmaceutical industry, Colesevelam

Cosette Pharmaceuticals, Inc., a New Jersey-based specialty pharmaceutical company, announced today that the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent No.

Key Points: 
  • Cosette Pharmaceuticals, Inc., a New Jersey-based specialty pharmaceutical company, announced today that the U.S. Patent and Trademark Office (USPTO) issued U.S. Patent No.
  • 11,291,628 for Welchol Chewable Bar, the Companys novel drug delivery system of Colesevelam that is easy to handle and ingest, which provides patent protection until 2037.
  • View the full release here: https://www.businesswire.com/news/home/20220607005137/en/
    Cosette has now obtained valuable patent protection for a novel drug delivery system that can deliver high load therapeutics, increasing patient convenience and compliance.
  • Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations.

Newron presents encouraging interim results for evenamide in patients with Treatment-Resistant Schizophrenia (TRS) at the 33rd CINP Hybrid World Congress of Neuropsychopharmacology

Retrieved on: 
Tuesday, June 7, 2022
Health, Other Science, General Health, Research, Science, Pharmaceutical, Biotechnology, Psychosis, Positive, International Classification of Functioning, Disability and Health, Clozapine, Medication, TRS, Patient, XETRA, Schizophrenia, Safety, PANSS, Population, Peripheral nervous system, CNS, Severity, LOF, CINP, Pharmaceutical industry, Newron Cup

These patients represent about one third of the overall schizophrenia population and thus a significant unmet medical need.

Key Points: 
  • These patients represent about one third of the overall schizophrenia population and thus a significant unmet medical need.
  • Evenamide acts through selective attenuation of an abnormal release of glutamate and synergizing with the background antipsychotic activity.
  • The outcome of this study may change the treatment of future TRS patients when confirmed in a larger, placebo-controlled study.
  • Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia.

Pharmaceutical Drug Development Sector Scorecard 2022: High-Value Deals Continue to Drive the Immuno-oncology and Genomics Markets But Several Companies Sell Biosimilar Portfolios - ResearchAndMarkets.com

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Tuesday, June 7, 2022
Pharmaceutical, Genetics, Health, Oncology, Sanofi, Nanotechnology, Drug development, Regenerative medicine, Artificial intelligence, Charles River Laboratories, Merck Group, Partnership, Bristol Myers Squibb, Pfizer, Takeda, Therapy, BMS, Biosimilar, Century, Cros, Acquisition, Thermo Fisher Scientific, Research, Novartis, Update, Medication, Biogen, Industry, Drug discovery, Health, Pharmaceutical industry, Fine chemical, Genomics

The "Pharmaceutical Drug Development Sector Scorecard - Q1 2022 Update - Thematic Research" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Pharmaceutical Drug Development Sector Scorecard - Q1 2022 Update - Thematic Research" report has been added to ResearchAndMarkets.com's offering.
  • Like Q4 2021, the deal landscapes for both immuno-oncology and genomics markets were highly active with several high-value strategic partnerships and acquisitions announced.
  • In immuno-oncology, this includes a $3 billion partnership between Bristol Myers Squibb (BMS) and Century Therapeutics and a $1.2 billion acquisition of Amunix Pharma by Sanofi.
  • Many companies included in the Drug Development scorecard have continued to announce partnerships in the artificial intelligence (AI) space since December 2021.

SIFI ANNOUNCES EMA VALIDATION OF ITS MARKETING AUTHORISATION APPLICATION FOR AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS AND THE OPENING OF AN EARLY ACCESS PROGRAM

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Tuesday, June 7, 2022
Severe cognitive impairment, Marketing, Leadership, Eye, Company, Acanthamoeba keratitis, Research, EMA, EC, UCL Institute of Ophthalmology, Standard of care, Transplant, University College London, Disease, CEO, Committee, European Directive on Traditional Herbal Medicinal Products, Partnership, Trophozoite, CHMP, Medicines and Healthcare products Regulatory Agency, Patient, Fungal keratitis, SIFI, EAPS, Committee for Medicinal Products for Human Use, Polyhexanide, Phase, Medication, Incidence, Quality of life, European Medicines Agency, Royal commission, European Commission, Drug development, West Pharmaceutical Services, Marketing Authorisation Application, Institute, AK, Cyst, Medical device, Pharmaceutical industry, Acanthamoeba, Ophthalmology

"We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.

Key Points: 
  • "We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.
  • "We look forward to helping facilitate broader access to polihexanide for patients with critical unmet medical needs suffering from acanthamoeba keratitis."
  • AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.
  • Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.

SIFI ANNOUNCES EMA VALIDATION OF ITS MARKETING AUTHORISATION APPLICATION FOR AKANTIOR® FOR THE TREATMENT OF ACANTHAMOEBA KERATITIS AND THE OPENING OF AN EARLY ACCESS PROGRAM

Retrieved on: 
Tuesday, June 7, 2022
Severe cognitive impairment, Marketing, Leadership, Eye, Company, Acanthamoeba keratitis, Research, EMA, EC, UCL Institute of Ophthalmology, Standard of care, Transplant, University College London, Disease, CEO, Committee, European Directive on Traditional Herbal Medicinal Products, Partnership, Trophozoite, CHMP, Medicines and Healthcare products Regulatory Agency, Patient, Fungal keratitis, SIFI, EAPS, Committee for Medicinal Products for Human Use, Polyhexanide, Phase, Medication, Incidence, Quality of life, European Medicines Agency, Royal commission, European Commission, Drug development, West Pharmaceutical Services, Marketing Authorisation Application, Institute, AK, Cyst, Medical device, Pharmaceutical industry, Acanthamoeba, Ophthalmology

"We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.

Key Points: 
  • "We are incredibly pleased to be working in partnership with SIFI on this important access program," said Dan Piggott, Managing Director of Uniphar Group's Product Access Division.
  • "We look forward to helping facilitate broader access to polihexanide for patients with critical unmet medical needs suffering from acanthamoeba keratitis."
  • AKANTIOR (polihexanide) stands to become the first approved drug for the treatment of acanthamoeba keratitis in the world.
  • Polihexanide is also being developed by SIFI for the treatment of fungal keratitis for which indication it also has FDA Orphan Drug Designation.

ChemoCentryx Reports Safety Results Available from Ongoing Phase I Trial of Orally Administered PD-L1 Inhibitor, CCX559, at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting

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Monday, June 6, 2022
Molecule, Degenerative disease, PK, Adult, Achievement, Goal, Company, AES, Society, Safety, AACR, Annual report, Medication, News, Security (finance), ASCO, U.S. Securities and Exchange Commission, Annual general meeting, Nasdaq, ANCA, American Association, Risk, American Society of Clinical Oncology, Hidradenitis suppurativa, GLOBE, Patient, Private Securities Litigation Reform Act, PD-1, CD80, Infrared spectroscopy correlation table, SAN, SEC, Association, HS, PD, Full, Cancer, PD-L1, Terminology, Pharmaceutical industry, Vaccine

SAN CARLOS, Calif., June 06, 2022 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (Nasdaq: CCXI), today announced the presentation of safety results from the ongoing Phase I clinical study of CCX559, the Company’s highly potent, orally administered PD-L1 checkpoint inhibitor, in patients with advanced solid tumors during a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

Key Points: 
  • The primary objectives of the study are to evaluate the safety and tolerability, and to inform dose selection for the planned Phase Ib/II clinical trial.
  • To date, there have been no dose limiting toxicities (DLTs) or treatment-related serious or severe ( grade 3) adverse events (AEs) reported.
  • Two patients receiving 120 mg once daily CCX559 presented with three probable immune-related AEs, which provides supportive evidence of immune activation.
  • ChemoCentryx expects to present additional findings from this ongoing Phase I study at major oncology conferences through 2022.

ClearPoint Neuro Announces Receipt of MDSAP Certification

Retrieved on: 
Thursday, June 2, 2022
Medical device, Company, Program, Research, Food, Device, Quality, Security (finance), U.S. Securities and Exchange Commission, Biopsy, Nasdaq, Solution, Therapy, Brain, FDA, Growth, GLOBE, Health Canada, Patient, FDA Center for Devices and Radiological Health, Medication, MDSAP, COVID-19, Compliance, Quality of life, Lists of diseases, Industry, Certification, Medicines and Healthcare products Regulatory Agency, CNS, Particular, Paper, Health

SOLANA BEACH, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced the receipt of certification for the Medical Device Single Audit Program (MDSAP).

Key Points: 
  • SOLANA BEACH, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced the receipt of certification for the Medical Device Single Audit Program (MDSAP).
  • The fourth pillar of ClearPoints growth strategy is global expansion for which MDSAP certification is essential.
  • This certification validates our ongoing commitment to maintaining the highest quality assurance standards within the medical device industry as required by regulatory authorities across the world, said Megan Faulkenberry, Vice President of Quality and Regulatory at ClearPoint Neuro.
  • The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and is installed in over 60 active sites in the United States, Canada, and Europe.

Concert Pharmaceuticals Raises Gross Proceeds of $66.4 Million Through Public Offering and Exercise of Warrants

Retrieved on: 
Monday, June 6, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Exercise, Madison Avenue, DCE, RA, Jefferies, Mizuho Securities, Telephone, Security (finance), U.S. Securities and Exchange Commission, Medication, Alopecia areata, Sale, Prospectus, NASDAQ, SEC, Jefferies Group, Attention, CNCE, Deuterium

Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced the closing of its previously announced underwritten public offering of 10,000,000 shares of its common stock to the public at $4.75 per share.

Key Points: 
  • Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) today announced the closing of its previously announced underwritten public offering of 10,000,000 shares of its common stock to the public at $4.75 per share.
  • The aggregate gross proceeds to Concert from this offering were $47.5 million, before deducting underwriting discounts and commissions and other offering expenses payable by Concert.
  • Concert also announced the receipt of $18.9 million upon the exercise of tranche 1 warrants to purchase 3,981 shares of Series X1 Preferred Stock issued to BVF Partners L.P. and RA Capital Management in November 2021.
  • Through the public offering and warrant exercise, Concert raised aggregate gross proceeds of $66.4 million.

Clinical Trials Management System Market Analysis Report 2022 - ResearchAndMarkets.com

Retrieved on: 
Monday, June 6, 2022
Health, Clinical Trials, Cloud, Conditional sentence, Clinical trial management system, Oracle, Clinical trial, Biotechnology, CTMS, Component, USD, AI, IQVIA, Lundbeck, Chapter Three, List of international sports federations, Enterprise, IFPMA, Solution, Investment, Vaccine, Machine learning, EHR, Cancer, Neurology, Medication, Infection, Cros, COVID-19, Adoption, Prevalence, EDC, Drug development, Patient safety, Calendar, CAGR, ML, Retail, Pharmaceutical industry, Fine chemical, Medical device, Medical imaging

The "Clinical Trials Management System Market Size, Share & Trends Analysis Report by Solution Type (Enterprise, Site), by Delivery Mode (Web & Cloud-based, On-premise), by Component, by End User, by Region, and Segment Forecasts, 2022-2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Clinical Trials Management System Market Size, Share & Trends Analysis Report by Solution Type (Enterprise, Site), by Delivery Mode (Web & Cloud-based, On-premise), by Component, by End User, by Region, and Segment Forecasts, 2022-2030" report has been added to ResearchAndMarkets.com's offering.
  • The global clinical trials management system market size is anticipated to reach USD 4.72 billion by 2030.
  • The key factors driving the market growth include the rising number of clinical trials, digitalization across healthcare R&D, number of decentralized trials, and product enhancements.
  • The Clinical Trial Management System offered by SimpleTrials, for instance, includes features such as contact management, calendar & monitoring, project planning, document management & eTMF, contract & payment system, subject tracking, visit report authoring & letter generation, EDC integration, and reporting and business analytics.

Mirum Pharmaceuticals Appoints Saira Ramasastry to Board of Directors

Retrieved on: 
Monday, June 6, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, Science, Marketing, Biliary atresia, Aspen Institute, Company, Wasserstein Perella & Co., IBAT, LLC, Glenmark Pharmaceuticals, Security (finance), University of Cambridge, U.S. Securities and Exchange Commission, Cholestasis, Medication, Primary biliary cholangitis, Primary sclerosing cholangitis, Nasdaq, Solution, University, Cholestatic pruritus, VISTAS, Patient, Biotechnology, Private Securities Litigation Reform Act, Economics, COVID-19, Institute of Liver and Biliary Sciences, Pregnancy, Judgement, Alagille syndrome, European Medicines Agency, Aspen, Board, Stanford University, Engineering, PFIC, Merrill (company), Management, Pharmaceutical industry, Spiroplasma mirum

Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced the appointment of Saira Ramasastry to the Companys board of directors and as a member of the audit committee where she will bring to bear her more than 20 years of financial leadership.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced the appointment of Saira Ramasastry to the Companys board of directors and as a member of the audit committee where she will bring to bear her more than 20 years of financial leadership.
  • Mirum is an exciting company with a talented team that has demonstrated its ability to create ambitious goals and deliver value for patients, said Saira Ramasastry.
  • I am honored to join its Board and support Mirum as they continue to advance important medicines for rare diseases.
  • Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare liver diseases.