BFS

Zevra Therapeutics Announces Top-Line Data from the Phase 2 Clinical Trial of KP1077 for Idiopathic Hypersomnia

Retrieved on: 
Tuesday, March 26, 2024
Brain, Disease, Somnolence, Appetite, Partnership, Headache, Visual analogue scale, Patient, Insomnia, EDS, Anxiety, SDX, Doctor of Philosophy, Epworth Sleepiness Scale, Nausea, Clinical trial, Therapy, Safety, Narcolepsy, ESS, IHSS, Idiopathic hypersomnia, Clouding of consciousness, BFS, Food, Pharmaceutical industry

CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial (NCT05668754) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH). This proof-of-concept study was not powered to demonstrate statistical significance.   The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Visual Analog Scale (SIVAS) will inform the Phase 3 study design.

Key Points: 
  • CELEBRATION, Fla., March 26, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company) a rare disease therapeutics company, today announced top-line data from its placebo-controlled, double-blind Phase 2 clinical trial ( NCT05668754 ) evaluating the safety and tolerability of KP1077 (serdexmethylphenidate, or SDX) in patients with idiopathic hypersomnia (IH).
  • The data gathered for several secondary and exploratory endpoints, including the Epworth Sleepiness Scale (ESS), Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Visual Analog Scale (SIVAS) will inform the Phase 3 study design.
  • The results from the completed Phase 2 trial provide key information for the design of a potentially pivotal Phase 3 trial of KP1077 in patients with IH.
  • The Company plans to request an end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration to seek guidance on the Phase 3 clinical trial design.

Kestra Financial Welcomes $600 Million Borger Financial Services

Retrieved on: 
Thursday, March 28, 2024
Asset Management, Professional Services, Finance, Principal, Partnership, Growth, BFS, Financial adviser

Kestra Financial , an industry-leading wealth management platform, today announced the addition of Borger Financial Services (“BFS”) to its community of advisors.

Key Points: 
  • Kestra Financial , an industry-leading wealth management platform, today announced the addition of Borger Financial Services (“BFS”) to its community of advisors.
  • BFS’s financial professionals bring to the platform north of $600 million in client assets under management.
  • "We are thrilled to welcome Borger Financial Services to the Kestra Financial family," said Stephen Langlois, President of Kestra Financial.
  • Partnering with Kestra Financial, BFS aims to enhance its capabilities and deliver even greater value to clients seeking comprehensive financial guidance.

DifGen Pharmaceuticals Acquires the Operating and Manufacturing Assets of an FDA-Registered Finished Dosage Manufacturing Facility in Florida, Enhancing its Manufacturing Footprint in the United States With the Addition of Manufacturing Capabilities in St

Retrieved on: 
Monday, March 18, 2024
Growth, LVP, Holland & Knight, Inhalation, News, Acquisition, The central science, FDA, BFS, Administration

The facility has state-of the art manufacturing capability to handle solutions/ suspension/ emulsions through blow-fill-seal, form fill seal technology and traditional filling of liquid and semi-solid products in a variety of dosage forms including stick packs and unit-dose cups.

Key Points: 
  • The facility has state-of the art manufacturing capability to handle solutions/ suspension/ emulsions through blow-fill-seal, form fill seal technology and traditional filling of liquid and semi-solid products in a variety of dosage forms including stick packs and unit-dose cups.
  • This transaction is expected to be accretive to our revenue and growth in 2024."
  • In related news, DifGen also announced that it is in the process of relocating its corporate headquarters to a state-of the art 40,000 sq.ft facility in Miramar, Florida beginning April 1, 2024.
  • Holland & Knight LLP represented DifGen Pharmaceuticals in this transaction.

 Marketing application of Diquafosol Sodium eye drops has been officially accepted by the China National Medical Products Administration (NMPA)

Retrieved on: 
Tuesday, January 30, 2024
Telecanthus, Patient, Dry eye syndrome, Ophthalmology, BFS, API, Marketing, Growth, Fine chemical

This acceptance marks a pivotal step in expanding the Group’s ophthalmology drug repertoire and providing patients with more diverse treatment options upon successful marketing approval.

Key Points: 
  • This acceptance marks a pivotal step in expanding the Group’s ophthalmology drug repertoire and providing patients with more diverse treatment options upon successful marketing approval.
  • Diquafosol Sodium eye drops complement the Group's robust ophthalmic drug portfolio, following GeneSoft®, which is expected to be approved for marketing in the first quarter of 2025.
  • Aligned with the surging demand within China's ophthalmic drug market, the Group identifies the significant potential, as over 360 million patients suffer from dry eye disease in the country.
  • This site is primed for the production of Diquafosol Sodium eye drops, employing the latest Blow-Fill-Seal (BFS) technology to ensure a seamless, aseptic process from bottle creation to filling and sealing.

Bibby Financial Services Chooses FGI T.R.U.S.T.™ for Strategic Partnership

Retrieved on: 
Tuesday, November 28, 2023
Finance, Professional Services, Technology, Insurance, Software, BFS, Bibby Financial Services, Professional, Partnership, FGI

FGI Worldwide LLC (“FGI”), a global leader in commercial finance, today announced that the UK’s largest independent invoice finance provider, Bibby Financial Services (“BFS”), has chosen FGI T.R.U.S.T.™ as its software platform for bad debt protection management and administration.

Key Points: 
  • FGI Worldwide LLC (“FGI”), a global leader in commercial finance, today announced that the UK’s largest independent invoice finance provider, Bibby Financial Services (“BFS”), has chosen FGI T.R.U.S.T.™ as its software platform for bad debt protection management and administration.
  • FGI T.R.U.S.T.™ is a cloud-based platform that combines technology with functionality to enable corporations, brokers, and lenders to maximize and automate the administration of credit insurance policies.
  • BFS chose T.R.U.S.T.™ over other platforms due to its robust features and the team’s flexible, solutions-oriented approach to the partnership.
  • “BFS is a world-renowned leader in the financial services industry, and FGI is proud to support its continued advancement with our T.R.U.S.T.™ technology,” commented Sami Altaher, President of FGI.

Canada Nickel Files Bankable Feasibility Study For its Crawford Nickel Sulphide Project

Retrieved on: 
Friday, November 24, 2023
Carbon, National instrument, EBITDA, AISC, FCF, Ausenco, Iron, Platinum, Chrome, CO2, Feasibility study, CNC, C1, Crawford, Cobalt, Carbon capture and storage, Technical report, Nickel, National Instrument 43-101, BFS, News, Confederation, IPT, IRR, Palladium, Iron ore, Fine chemical, Timmins

TORONTO, Nov. 24, 2023 /PRNewswire/ - Canada Nickel Company Inc. ("Canada Nickel" or the "Company") (TSXV: CNC) (OTCQB: CNIKF), has filed a Bankable Feasibility Study ("BFS") for its wholly-owned Crawford Nickel Sulphide Project ("Crawford") located in Timmins, Ontario, Canada.

Key Points: 
  • TORONTO, Nov. 24, 2023 /PRNewswire/ - Canada Nickel Company Inc. ("Canada Nickel" or the "Company") (TSXV: CNC) (OTCQB: CNIKF), has filed a Bankable Feasibility Study ("BFS") for its wholly-owned Crawford Nickel Sulphide Project ("Crawford") located in Timmins, Ontario, Canada.
  • Crawford, located in the Timmins nickel district, is the world's second largest nickel reserve1.
  • Proven & Probable reserves of 3.8 million tonnes contained nickel from 1.7 billion tonnes ore grading 0.22% nickel make Crawford the world's 2nd largest nickel reserve[1].
  • With additional Inferred mineral resources of 3.7 million tonnes contained nickel, Crawford is the world's 2nd largest nickel resource1.

Financial Institutions See Technology More Than Ever as Key Differentiator in Customer Experience, Says ISG

Retrieved on: 
Friday, September 15, 2023
Technology, Finance, Security, Fintech, Banking, Professional Services, Software, Data Analytics, Artificial Intelligence, Intelligence, Standard, Eye, Starling Bank, Artificial intelligence, Morale, Automation, ISG, Neobank, Conseil, Technology Business Management Council, BFS, Paris-Saclay University, Starling, Research, Organization, Trương, Tech Mahindra, Machine learning, Standard Chartered, Accenture, Revolution, Le Jardin des Modes, Citigroup, National Council, Growth, CFO, Ethics, Wipro, France, Partnership, Financial services, TBM, AI, Kyndryl, Cryptocurrency, Management, Cognizant, Engine, Talis evidens

Featured speakers include executives with Standard Chartered Bank, Citi, Santander Germany, Crédit Mutuel, Conseil National Stratégique de l’Intelligence Artificielle, France FinTech, OCBF, Cognizant and Engine by Starling.

Key Points: 
  • Featured speakers include executives with Standard Chartered Bank, Citi, Santander Germany, Crédit Mutuel, Conseil National Stratégique de l’Intelligence Artificielle, France FinTech, OCBF, Cognizant and Engine by Starling.
  • “High-performing firms in the BFS industry are seeing opportunities even in times of macroeconomic and market upheaval,” said Colas Truong, ISG partner and host of the event.
  • Customers are examining which financial institutions are behind crypto-related services and new digital assets to determine if they are a safe form of investment and trading.
  • The ISG TechXchange: Banking and Financial Services is sponsored by Wipro, Accenture, Cognizant, Eviden, Tech Mahindra and Kyndryl.

Woodstock Sterile Solutions Expands BFS Services to Diagnostics Market

Retrieved on: 
Tuesday, June 27, 2023
COVID-19, Diagnosis, CDMO, Blood, Pregnancy, Patient, COVID, BFS, Risk, Medical device, Vaccine

Company completes first diagnostics project, demonstrating benefits of BFS for diagnostic testing

Key Points: 
  • Woodstock, Illinois--(Newsfile Corp. - June 27, 2023) - Woodstock Sterile Solutions, a leading blow-fill-seal (BFS) contract development and manufacturing organization (CDMO), has expanded its advanced aseptic BFS services to the diagnostics market, having recently completed its first project for a customer in the diagnostics space.
  • For its first project, Woodstock Sterile Solutions used its BFS packaging to hermetically seal the ampules included in at-home COVID tests.
  • Woodstock is now actively exploring modifications to its manufacturing facility to accommodate the increased demand and is dedicated to providing exceptional BFS solutions to healthcare companies in the diagnostics market.
  • Woodstock Sterile Solutions has expanded its advanced aseptic blow-fill-seal services to the diagnostics market, recently completing its first project for a customer in the diagnostics space.

EQS-News: Eckert & Ziegler: PentixaPharm Receives BfArM-Clearance for its Therapeutic to conduct a Clinical Trial in Lymphoma

Retrieved on: 
Saturday, June 10, 2023
Lymphoma, PMID, Medical device, CXCR4, BFS, TecDAX, CNS, Teaching hospital, Radioligand, University Hospital (Newark, New Jersey), DOI, ISIN, Yttrium, T-cell lymphoma, Eckert, Safety, Pharmaceutical industry, Patient

The Yttrium-90 labelled CXCR4-compound PentixaTher will be tested as a radiotherapeutic against recurrent or refractory primary or isolated secondary central nervous system lymphoma.

Key Points: 
  • The Yttrium-90 labelled CXCR4-compound PentixaTher will be tested as a radiotherapeutic against recurrent or refractory primary or isolated secondary central nervous system lymphoma.
  • The phase I/II, dose-finding study will be conducted at the University Hospital in Essen, North Rhine Westphalia, Germany.
  • The study will start after getting final endorsement from the German Radiation Safety Department (BfS),“ commented Dr. Hakim Bouterfa, Chief Medical Officer at Eckert & Ziegler.
  • C-X-C Motif Chemokine Receptor 4-Targeted Radioligand Therapy in Patients with Advanced T-Cell Lymphoma.

EQS-News: CGM appoints Michael Rauch as CEO and reports on successful financial year and board changes at virtual AGM

Retrieved on: 
Wednesday, May 17, 2023
CGM, Executive officer, AGM, AIS, Administration Board of the Swedish Armed Forces, Marketing, Zur Rose Group, EUR, Patient, Supervisory board, Connectivity, CFO, Growth, BFS, Management

CompuGroup Medical SE & Co. KGaA, one of the world’s leading e-health providers, held its Annual General Meeting for the financial year 2022 today in virtual form.

Key Points: 
  • CompuGroup Medical SE & Co. KGaA, one of the world’s leading e-health providers, held its Annual General Meeting for the financial year 2022 today in virtual form.
  • The AGM also confirmed Reinhard Lyhs as new Supervisory Board Member with a majority of more than 99.6 %.
  • To the regret of CGM, our Managing Director Angela Mazza Teufer subsequently has decided to leave CGM at her own request.
  • I sincerely thank Angela Mazza Teufer for her important contribution to the success of CGM, especially the “Doctors First” initiative.