Medicines and Healthcare products Regulatory Agency

Northwest Biotherapeutics Announces Completion of Prerequisites, and Plans for Submission of Marketing Authorization Application

Retrieved on: 
Tuesday, August 29, 2023
Biotechnology, MHRA, Medicines and Healthcare products Regulatory Agency, OTCQB, MAA, Medication, Patient, Northwest Biotherapeutics, Glioblastoma, Pharmaceutical industry

The Company believes that it has now completed all of the remaining prerequisites for such an application, including certain steps related to implementation of the approved Pediatric Investigation Plan and submission of the required formal notification to the MHRA of the upcoming MAA.

Key Points: 
  • The Company believes that it has now completed all of the remaining prerequisites for such an application, including certain steps related to implementation of the approved Pediatric Investigation Plan and submission of the required formal notification to the MHRA of the upcoming MAA.
  • As the Company reported in its recent 10-Q filing, the Company is in the final stages of completing the application package itself.
  • The Company anticipates submitting the MAA in approximately the next 30-45 days.
  • The Company plans to request that the MHRA review the MAA under the 150-business day process that the MHRA has established to accelerate the availability of new medicines for patients in the U.K.

Northwest Biotherapeutics Announces Completion of Prerequisites, and Plans for Submission of Marketing Authorization Application

Retrieved on: 
Tuesday, August 29, 2023
Biotechnology, MHRA, Medicines and Healthcare products Regulatory Agency, OTCQB, MAA, Medication, Patient, Northwest Biotherapeutics, Glioblastoma, Pharmaceutical industry

The Company believes that it has now completed all of the remaining prerequisites for such an application, including certain steps related to implementation of the approved Pediatric Investigation Plan and submission of the required formal notification to the MHRA of the upcoming MAA.

Key Points: 
  • The Company believes that it has now completed all of the remaining prerequisites for such an application, including certain steps related to implementation of the approved Pediatric Investigation Plan and submission of the required formal notification to the MHRA of the upcoming MAA.
  • As the Company reported in its recent 10-Q filing, the Company is in the final stages of completing the application package itself.
  • The Company anticipates submitting the MAA in approximately the next 30-45 days.
  • The Company plans to request that the MHRA review the MAA under the 150-business day process that the MHRA has established to accelerate the availability of new medicines for patients in the U.K.

EDAP Announces Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 24, 2023
Operating cost, University of Zurich, Assistant professor, CMS, University, AUC, Prostate cancer, TMS, Marketing, AUA, Medicines and Healthcare products Regulatory Agency, EDAP, League, American Urological Association, Woman, DACH, League of European Research Universities, USC, EDT, USD, Hospital, MD, Urology, Patient, Investment, Annual general meeting, High-intensity focused ultrasound, Growth, Lithotripsy, Conference, Cryptocurrency, Video game, Medical imaging, Pharmaceutical industry, Film industry, Lithium, EUR, Distribution

We are also pleased with strong U.S. Focal One HIFU procedure growth, which grew 85% during the second quarter of 2023 versus the second quarter of 2022.

Key Points: 
  • We are also pleased with strong U.S. Focal One HIFU procedure growth, which grew 85% during the second quarter of 2023 versus the second quarter of 2022.
  • The increase was driven by four Focal One units sold in the second quarter 2023 versus one unit sold in the second quarter of 2022.
  • Operating loss for the second quarter of 2023 was EUR 4.2 million (USD 4.6 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the second quarter of 2022.
  • A conference call and webcast to discuss second quarter 2023 financial results will be hosted Ryan Rhodes, Chief Executive Officer, François Dietsch, Chief Financial Officer and Ken Mobeck, Chief Financial Officer of the U.S. subsidiary, today, Thursday, August 24th, 2023 at 8:30am EDT.

Voyce From One Health Group Wins “Overall Healthcare Product Of The Year” In 2023 Pet Innovation Awards

Retrieved on: 
Thursday, August 17, 2023
Pet, Fullerton Health Group, Retail, Service, Internet of things, Veterinary medicine, Health status of Asian Americans, Ultra-wideband, Quality of life, Animal, Vital signs, Collection, Algorithm, Medicines and Healthcare products Regulatory Agency, Diagnosis, Entrepreneurship, Data, Food, Medical device, Medical imaging, Health, Housing

Voyce is a companion pet wearable with health diagnostic sensors, extensive remote monitoring capabilities and advanced analytics via the cloud and mobile apps.

Key Points: 
  • Voyce is a companion pet wearable with health diagnostic sensors, extensive remote monitoring capabilities and advanced analytics via the cloud and mobile apps.
  • The comprehensive animal health and wellness solution collects, analyzes, and communicates context-based, clinically actionable data anywhere, at any time.
  • The 2023 Pet Innovation Awards attracted more than 2,000 nominations from around the world.
  • This is a true breakthrough in the space of animal health, and we’re pleased to acknowledge Voyce as our ‘Overall Healthcare Product of the Year,’” said Travis Grant, Managing Director, Independent Innovation Awards.

Cocrystal Pharma Reports Second Quarter 2023 Financial Results and Provides Updates on its Antiviral Drug Development Programs

Retrieved on: 
Monday, August 14, 2023
Vaccine, Cocrystal, PK, Disease, Norovirus, Therapy, Medicine, SARS-CoV-2, COVID-19, API, Enzyme, Health, SARS, Pharmacokinetics, World Health Organization, G&A, Research, Influenza, RNA, CDC, Gastroenteritis, Death, OPKO Health, MERS, Korea Disease Control and Prevention Agency, Protease, Warburg Pincus, Viral, CFO, Medicines and Healthcare products Regulatory Agency, Merck, Severe acute respiratory syndrome outbreak, Liver, FDA, R, Safety, IND, HCV, COCP, Pharmaceutical industry, Cryptocurrency, Medical device, Management, Video game

Our drug discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level.

Key Points: 
  • Our drug discovery process focuses on the highly conserved regions of the viral enzymes and inhibitor-enzyme interactions at the atomic level.
  • Research and development (R&D) expenses for the second quarter of 2023 were $2.8 million, compared with $2.4 million for the second quarter of 2022.
  • Cocrystal reported unrestricted cash as of June 30, 2023 of $32.4 million, compared with $37.1 million as of December 31, 2022.
  • During the second quarter of 2023, the Company raised $4.0 million in a private placement offering of common stock that was priced “at-the-market” under Nasdaq Listing Rules.

Organigram to Enter the United Kingdom with Agreement to Supply Medical Cannabis to 4C LABS

Retrieved on: 
Tuesday, August 15, 2023
Natural Resources, Alternative Medicine, Medical Supplies, Health, Specialty, Supply Chain Management, Cannabis, Retail, Agreement, Channel, Multimedia, Patient, OGI, United Kingdom, TSX, Medical cannabis, Medicines and Healthcare products Regulatory Agency, LABS, Health Canada, Drug, Organizational chart

View the full release here: https://www.businesswire.com/news/home/20230815619279/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230815619279/en/
    Organigram to Enter the United Kingdom with Agreement to Supply Medical Cannabis to 4C LABS (Photo: Business Wire)
    Under the terms of the Agreement, the Company expects to supply approximately 600 kilograms of high-quality, indoor-grown dried flower product to 4C LABS within the first year of the Agreement, and grant 4C LABS strain exclusivity within the geographical boundaries of the United Kingdom & Channel Islands for as long as minimum purchase commitments are satisfied.
  • “Medical Cannabis has been legal in the UK since 2018.
  • “We are excited to partner with 4C LABS to increase access to Medical Cannabis for UK Medical Cannabis patients."
  • “4C LABS is focused on delivering a value proposition to UK patients, 4C LABS provides top quality products, industry leading pricing, best in class customer service and a robust supply chain," says Greg Dobbin, Chief Executive Officer of 4C LABS.

Director’s update – Delivering more strategic regulation in 12 months than in the lifetime of FOI

Retrieved on: 
Thursday, August 10, 2023
Exercise, Review, Environment, Ministry, PRS, London boroughs, Feedback, EIR, Policy, ICO, Medication, Environmental Information Regulations 2004, Environment Agency, Medicines and Healthcare products Regulatory Agency, Public sector, Freedom of information, Transparency, Publishing, Kensington and Chelsea London Borough Council, Liverpool City Council, FOI, PR, Cryptocurrency
Key Points: 

“We are continuing to deliver for the public” – ICO publishes practice recommendations and enforcement notices on FOI

Retrieved on: 
Thursday, August 10, 2023
Environment, Ministry, Environmental Information Regulations 2004, EIR, Telephone, Wiluszynski v London Borough of Tower Hamlets, ICO, Information privacy, Privacy, Medication, Environment Agency, Data wrangling, London Borough of Tower Hamlets, Freedom of Information Act 2000, Freedom of information, PECR, FOIA, Publishing, Freedom of Information Act, Telecommunications, Council, United Kingdom, Medicines and Healthcare products Regulatory Agency, Liverpool City Council, FOI, Information commissioner, Data Protection Act 1998, UK, Privacy and Electronic Communications (EC Directive) Regulations 2003, Medical device, Cryptocurrency, London boroughs, Information

The action coincides with a year since the ICO published our new Freedom of Information (FOI) regulatory manual, which set out its approach to more strategic enforcement of FOI in line with its statutory powers.

Key Points: 
  • The action coincides with a year since the ICO published our new Freedom of Information (FOI) regulatory manual, which set out its approach to more strategic enforcement of FOI in line with its statutory powers.
  • In a blog post today, Warren Seddon marked the anniversary by highlighting increased action taken by the ICO over the last year.
  • - Practice recommendation issued to the Medicines & Healthcare Products Regulatory Agency for failures to conform to the Freedom of Information Act Code of Practice.
  • - To report a concern to the ICO telephone call our helpline on 0303 123 1113, or go to ico.org.uk/concerns.

Adverum Biotechnologies Completes Enrollment of Phase 2 LUNA Trial in Wet AMD and Reports Second Quarter 2023 Financial Results

Retrieved on: 
Thursday, August 10, 2023
Insurance, CFI, Partnership, Doctor of Pharmacy, Anticipation, Optogenetics, AMD, OPTIC, European Medicines Agency, Eye, Complement, Geographic atrophy, Research, LUNA, GA, Inflammation, AAV, PRIME, Messenger, IVT, Data, Patient, Complement factor I, Investment, Annual general meeting, United Kingdom, Diagnosis, NHP, United, Medicines and Healthcare products Regulatory Agency, Innovation, FDA, Safety, Three Months, Caregiver, Pharmaceutical industry, Vaccine, Medical device, Cryptocurrency, Adverum Biotechnologies

REDWOOD CITY, Calif., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases, today provided an update on its ongoing Phase 2 LUNA trial evaluating ixoberogene soroparvovec (Ixo-vec) for the treatment of wet age-related macular degeneration (wet AMD) and reported financial results for the second quarter ended June 30, 2023.

Key Points: 
  • “We are pleased to announce completion of enrollment in our Phase 2 LUNA trial,” stated Laurent Fischer, M.D., president and chief executive officer of Adverum Biotechnologies.
  • “The LUNA study design allows us to evaluate efficacy and safety of two Ixo-vec doses, while optimizing the prophylactic steroid regimens.
  • Stock-based compensation expense included in research and development expenses was $1.4 million for the second quarter of 2023.
  • Stock-based compensation expense included in general and administrative expenses was $3.1 million for the second quarter of 2023.

Catalyst Pharmaceuticals Reports Strong Second Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, August 9, 2023
Amifampridine, Epilepsy, Vamorolone, Cash, Duchenne muscular dystrophy, BioMarin Pharmaceutical, Bank statement, Medicines and Healthcare products Regulatory Agency, COVID-19, Intangible asset, NDA, GAAP, Duchenne, Accounting, Medication, Pharmaceuticals and Medical Devices Agency, Development, State Administrative Expenses, Shanda, Acquisition, Lambert–Eaton myasthenic syndrome, Administration, PMDA, PDUFA, Webcast, Intangibles, Yoy, ESG, Research, Catalysis, Bank, Beauty salon, Video game, Pharmaceutical industry, Cryptocurrency

CORAL GABLES, Fla., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (“Catalyst” or “the Company”) (Nasdaq: CPRX) today reported financial results for the second quarter of 2023 and provided a corporate update.

Key Points: 
  • Research and Development Expenses: Research and development expenses were $4.0 million in both the second quarter of 2023 and 2022.
  • Selling, General, and Administrative Expenses: Selling, general, and administrative expenses for the second quarter of 2023 were $28.4 million, compared to $12.9 million in the second quarter of 2022.
  • Amortization of Intangible Assets: Amortization of intangible assets was $8.5 million in the second quarter of 2023, compared to $0 million in the second quarter of 2022.
  • Operating Income: Operating income for the second quarter of 2023 was $46.7 million, compared to $28.6 million in the second quarter of 2022, representing an increase of 63.5% year-over-year.