Authorization

Cortexa Leads the World in First Supply of Psilocybin Under the TGA’s Authorized Prescriber Scheme

Retrieved on: 
월요일, 3월 18, 2024
Psilocybin, Depression, Patient, Research, MDXX, Sale, BHC, Ahmad Adaya, Prescription, GMP, Clinical trial, OTC, Authorization, MDMA, Special access program, Pharmaceutical industry

Ltd. (Cortexa), in what is an Australian and the Company believes a world first, has supplied GMP Psilocybin for therapeutic use outside of a clinical trial to a patient under the authorised prescriber scheme.

Key Points: 
  • Ltd. (Cortexa), in what is an Australian and the Company believes a world first, has supplied GMP Psilocybin for therapeutic use outside of a clinical trial to a patient under the authorised prescriber scheme.
  • The patient was being treated with Psilocybin for treatment resistant depression.
  • In doing so, Cortexa is now established as the only Australian company able to immediately supply and deliver both GMP MDMA and Psilocybin for both clinical trials and prescriptions via the TGA’s Authorised Prescriber Scheme.
  • Cortexa has created a national network of relationships with research institutes, key opinion leaders and emerging clinicians, and supported psychiatrists for obtaining their authorised prescriber status.

Concerned Stockholders of Nikola Corp. Introduce Slate of Independent Director Candidates for Election to the Company’s Board at the 2024 Annual Meeting

Retrieved on: 
화요일, 2월 20, 2024
Professional Services, Automotive, Automotive Manufacturing, EV, Electric Vehicles, Manufacturing, Finance, Engineering, Iveco, Certificate, Sale, University, PLLC, M&M, Supply chain management, Concerned, Social media, Transport, Business administration, Security (finance), Brigham Young University, Partnership, Common stock, WHEN, Shop, Safety, Authorization, Business, Chair, Marriott School, Marketing, TSR, Entrepreneurship, Risk, WAV, Nikola Corporation, UPON, Management

Today, the Concerned Stockholder Group issued the below statement regarding its nomination of five highly qualified and independent director candidates for election to the Company’s nine-member Board of Directors (the “Board”) at the 2024 Annual Meeting of Stockholders (the “2024 Annual Meeting”).

Key Points: 
  • Today, the Concerned Stockholder Group issued the below statement regarding its nomination of five highly qualified and independent director candidates for election to the Company’s nine-member Board of Directors (the “Board”) at the 2024 Annual Meeting of Stockholders (the “2024 Annual Meeting”).
  • Our slate of director candidates is highly qualified, wholly independent and focused on one goal: implementing a lasting turnaround that unlocks the significant potential of Nikola.
  • In fact, our Group has been approached by numerous stockholders who want to see CEO Steve Girsky and his Board replaced with high-integrity individuals.
  • TSR includes dividends reinvested using a closing price of February 8, 2024, the day before Nikola made the Group’s nomination public.

Barracuda doubles down on partner and distributor profitability; enhances global partner program

Retrieved on: 
화요일, 3월 5, 2024
Barracuda, Investment, SVP, MSP, LAER, Growth, SYNNEX, Learning, ARR, Element, Software as a service, Authorization, Partner, TD SYNNEX, Marketing

CAMPBELL, Calif., March 5, 2024 /PRNewswire/ -- Barracuda Networks, Inc., a trusted partner and leading provider of cloud-first security solutions, today announced new enhancements to the Barracuda Partner Success Program aimed at increasing partner margin and profitability and expanding technical enablement for channel partners and distributors.

Key Points: 
  • Investments in the global Barracuda Partner Success Program include:
    Improving partner compensation models globally.
  • The Barracuda Partner Success Program was launched in December 2023 with the goal of ensuring partner success around the globe through two core elements: the shared success model and partner agility.
  • Partners participating in the global Barracuda Partner Success Program benefit from a clear path to success under the Premier, Preferred, and Authorized levels.
  • Resellers interested in learning more about the features and benefits of the Barracuda Partner Success Program can visit www.barracuda.com/partners .

Clarion Clinics Open for Psychedelic-Assisted Treatments

Retrieved on: 
목요일, 2월 1, 2024
PTSD, Post-traumatic stress disorder, Clarion, TGA, Prohibition of drugs, Therapeutic Goods Administration, Clinical trial, Environment, Patient, Safety, Depression, Psilocybin, TRD, MDMA, Authorization, Psychotherapy, Schedule, Pharmaceutical industry

MELBOURNE, Australia and NEW YORK, Feb. 01, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc (Nasdaq: IXHL) (‘Incannex’ or ‘the Company’) a pharmaceutical company developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs is pleased to announce that Clarion Clinic’s co-Founder and Head of Psychiatry, Professor Suresh Sundram, has received Authorised Prescriber approval from the Therapeutic Goods Administration (TGA) to prescribe MDMA in the treatment of Post-traumatic Stress Disorder (PTSD) and psilocybin for Treatment-resistant Depression (TRD) at its first built-for-purpose clinic based in Melbourne, Australia, a city of approximately 5.2M people.

Key Points: 
  • Clarion Clinics’ built-for-purpose clinic in Melbourne is now open for treatment, and will begin screening patients immediately.
  • Clarion Clinics is a collaboration between Australia’s leading psychedelic-assisted therapy professionals and scientists, and Incannex.
  • Clarion Clinics, Abbottsford, will be the first dedicated psychedelic-assisted therapy clinic in Australia.
  • Clarion is at the leading edge of mental healthcare, has the right protocols, and an experienced team ready to help people through these challenging conditions,” Peter Widdows, Incannex Director responsible for Clarion Clinics, said.

PharmAla releases Profitable Q1 Interim Financial Statement and Business Update

Retrieved on: 
수요일, 1월 31, 2024
PTSD, Prohibition of drugs, Research, History, Substance, CDSL, MDXX, Patient, FDA, Authorization, OTC, MDMA, Health Canada, IP, Post-traumatic stress disorder, Bank statement, Pharmaceutical industry

VANCOUVER, British Columbia, Jan. 31, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to present its Q1 Interim Financial Statement for the period ending November 30, 2023.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 31, 2024 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is pleased to present its Q1 Interim Financial Statement for the period ending November 30, 2023.
  • PharmAla showed a quarterly profit for the first time in its history, validating its low-overhead manufacturing business model.
  • PharmAla believes that this is the first quarterly profit for any publicly-traded psychedelics company.
  • PharmAla will be hosting an investor webinar on Friday the 2nd to further elaborate on its financial report as well as discuss their recent achievement of obtaining a Controlled Drugs & Substances Dealer’s License (CDSL) from Health Canada.

EQS-News: OHB SE: Capital increase of EUR 77 million successfully completed

Retrieved on: 
화요일, 1월 30, 2024
Rocket Factory Augsburg, Authorization, KKR, DIGITAL, Kohlberg Kravis Roberts, EUR, OHB, RFA, SPACE, Security (finance)

OHB SE's share capital was increased by 10 % against cash contributions, making partial use of the Authorized Capital 2020 and excluding shareholders' statutory subscription rights.

Key Points: 
  • OHB SE's share capital was increased by 10 % against cash contributions, making partial use of the Authorized Capital 2020 and excluding shareholders' statutory subscription rights.
  • A total of 1,746,809 new shares were issued as part of the capital increase for gross proceeds of around EUR 77 million.
  • The company's share capital therefore amounts to EUR 19,214,905.00, divided into 19,214,905 no-par value ordinary bearer shares with a calculated share in the share capital of EUR 1.00 each.
  • Marco Fuchs, CEO of OHB: "With the capital increase now completed, we have taken a further step towards our goal of becoming the leading provider of space solutions in Europe.

Keeper® Security Adds Support for Hardware Security Keys as Sole 2FA Method

Retrieved on: 
수요일, 1월 17, 2024
Cloud, YubiKey, Architecture, FIDO2, Android, Authorization, NIST, SMS, SIM, Heel, PIN, Organization, Privilege (evidence), IOS, Online shopping

CHICAGO, Jan. 17, 2024 /PRNewswire/ -- Keeper Security, the leading provider of zero-trust and zero-knowledge cybersecurity software protecting passwords, passkeys, privileged access, secrets and remote connections, today introduces support for hardware security keys as a single Two-Factor Authentication (2FA) method. Implementing user authentication with only a hardware security key enhances overall security by providing a robust physical second factor, mitigating remote attacks and reducing dependency on mobile devices. Administrators can enforce the use of a hardware key as the sole 2FA method and mandate even more robust restrictions by requiring the use of a PIN.

Key Points: 
  • CHICAGO, Jan. 17, 2024 /PRNewswire/ -- Keeper Security , the leading provider of zero-trust and zero-knowledge cybersecurity software protecting passwords, passkeys, privileged access, secrets and remote connections, today introduces support for hardware security keys as a single Two-Factor Authentication (2FA) method.
  • While support for hardware security keys is not new to Keeper®, users were previously required to have a backup 2FA option in addition to their security key.
  • Keeper enables users to have multiple security keys, allowing users to have backup keys, keys in multiple locations or keys for multiple devices.
  • However, setup of a security key as the sole 2FA method must be performed on the Web Vault or Keeper Desktop App.

Cronos Enters Australian Cannabis Market

Retrieved on: 
화요일, 1월 9, 2024
ASX, Patient, Authorization, Pharmacist, Ecosystem, TSX, AP, TGA, Education, Drug

TORONTO, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON) (“Cronos” or the “Company”) announced today that it is expanding distribution into the Australian market with its first shipment of cannabis flower to Vitura Health Limited (“Vitura”) (ASX: VIT).

Key Points: 
  • TORONTO, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON) (“Cronos” or the “Company”) announced today that it is expanding distribution into the Australian market with its first shipment of cannabis flower to Vitura Health Limited (“Vitura”) (ASX: VIT).
  • Cronos owns approximately 10% of the common shares of Vitura, formerly known as Cronos Australia, and will supply cannabis for Vitura.
  • “Supplying the Australian market, which has grown significantly in the past three years, is a great milestone for Cronos as we aim to enter and expand within international markets,” said Mike Gorenstein, Chairman, President, and CEO, Cronos.
  • Vitura is focused on creating medicinal cannabis products and digital health solutions that connect and strengthen the ecosystem between patients, prescribers, pharmacists, and suppliers within the Australian medical cannabis market.

Vertex Announces Approval of First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™, for the Treatment of Sickle Cell Disease (SCD) and Transfusion-Dependent Beta Thalassemia (TDT) in Kingdom of Saudi Arabia

Retrieved on: 
화요일, 1월 9, 2024
Health, Genetics, Clinical Trials, General Health, Pharmaceutical, Biotechnology, SCD, Vertex Pharmaceuticals, Patient, KFSH, Kingdom, Hospital, CRISPR, Authorization, Medicine, Sickle cell disease, TDT, SFDA, Marketing, ATC, VRTX, Prevalence, Pharmaceutical industry

CASGEVY is approved for the treatment of people 12 years of age and older with SCD or TDT.

Key Points: 
  • CASGEVY is approved for the treatment of people 12 years of age and older with SCD or TDT.
  • The Kingdom of Saudi Arabia has among the highest prevalence rates of SCD and TDT in the world, with thousands of patients living with these genetic blood disorders.
  • Vertex is working to qualify additional hospitals as ATCs to bring CASGEVY to patients, including the King Faisal Specialist Hospital (KFSH).
  • In order to enable rapid access to CASGEVY, Vertex is working to secure listing on hospital formularies to support reimbursement as soon as possible.

PharmAla Files Audited Financials for Year Ending August 31, 2023

Retrieved on: 
금요일, 12월 29, 2023
Psilocybin, MDXX, Patient, USFDA, Research, MDMA, Clinical trial, Bank statement, GMP, PTSD, OTC, Authorization, Pharmaceutical industry

- PharmAla’s LaNeo™ GMP Drug Product was submitted and allowed for clinical trial use by the USFDA; PharmAla is currently supporting over 10 clinical trials globally with LaNeo.

Key Points: 
  • - PharmAla’s LaNeo™ GMP Drug Product was submitted and allowed for clinical trial use by the USFDA; PharmAla is currently supporting over 10 clinical trials globally with LaNeo.
  • “This has been an exciting year for PharmAla, and for MDMA more broadly,” said Nick Kadysh, CEO, PharmAla Biotech.
  • We are excited to continue to build off of the milestones we achieved at PharmAla in 2023.
  • The recent filing of the MAPS New Drug Application for MDMA-Assisted Therapy for PTSD provides a favourable industry tailwind.