DMF

Teako Minerals Establishes Project Hub in Norway Spanning over 3,818 Square Kilometres From North to South and Becomes Norway's Largest Mineral Exploration Company

Retrieved on: 
Tuesday, March 12, 2024

Vancouver, British Columbia--(Newsfile Corp. - March 12, 2024) - TEAKO MINERALS CORP. (CSE: TMIN) (the "Company" or "Teako") is delighted to announce the establishment of a substantial Norwegian Project Hub (or "The Hub") divided into four (4) districts and spanning thirty-one (31) projects over an area of 3,818 square kilometers ("sq.km") (or 381,800 hectares) realized through staking of prospective copper, cobalt, nickel, zinc, gold, molybdenum and rare-earth-elements (or "REE's") projects for further assessment (see Figure 1,2,3,4 and Table 1). This strategic move positions Teako as the country's largest exploration company in terms of total project size.

Key Points: 
  • This strategic move positions Teako as the country's largest exploration company in terms of total project size.
  • Teako Minerals Corp establishes itself as Norway's most significant mineral exploration company in terms of project size, with thirty-one (31) hub projects and three (3) main projects in four (4) districts.
  • Teako's total landholding in Norway, including the Vaddas and Lomunda-Venna projects, now measures 5,458 sq.km (or 545,800 hectares).
  • Furthermore, the Project Hub functions as a de-risking mechanism by providing flexibility in project development within the Company.

Enrollment Opens for Vineyard Wind 1 Fisheries Compensation Program

Retrieved on: 
Monday, March 4, 2024

The launch of the program opens a 90-day window for fishermen to qualify for compensation at www.vw1fisheriescomp.com .

Key Points: 
  • The launch of the program opens a 90-day window for fishermen to qualify for compensation at www.vw1fisheriescomp.com .
  • The Vineyard Wind Fisheries Compensation Fund will bolster our commercial fisheries during this time of transition to clean energy—we hope this fund can be a model for ensuring offshore wind and commercial fisheries thrive together."
  • To support the program, Vineyard Wind 1 has established three escrow funds to compensate affected fishermen in Massachusetts, Rhode Island, Connecticut, New Jersey, and New York.
  • Fishermen will not need to demonstrate economic impacts from Vineyard Wind 1 to qualify for the program or receive compensation payments.

Quolet announces completion of Phase 1 healthy volunteer study evaluating the safety and bioavailability of Cannabidiol in a novel formulation intended for treatment of various neurological and psychiatric diseases

Retrieved on: 
Thursday, February 22, 2024

Quolet , a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) ( clinicaltrials.gov NCT05032807 ).

Key Points: 
  • Quolet , a private clinical stage biopharmaceutical company, is announcing the completion of a Phase 1 healthy volunteer study evaluating pure Cannabidiol (CBD) ( clinicaltrials.gov NCT05032807 ).
  • Researchers at King’s College London partnered with the SEEK group to test whether its bioavailability could be improved by administering CBD in a novel patented lipid formulation.
  • This lipid formulation allows high doses of CBD (200mg) to be administered in capsules including only GRAS and/or pharmaceutical approved ingredients.
  • In one visit they were given the lipid-CBD, and in the other visit they were given standard CBD-only formulation.

ITM and Alpha-9 Oncology Announce Global Supply Agreement to Support Alpha-9’s Clinical Radiopharmaceutical Development Program

Retrieved on: 
Tuesday, January 30, 2024

GARCHING / MUNICH, Germany and VANCOUVER, British Columbia, January 30, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Alpha-9 Oncology (Alpha-9) , a clinical stage biotechnology company developing differentiated and highly targeted radiopharmaceuticals, today announced the signature of a global master clinical supply agreement to support the development of Alpha-9’s Radiopharmaceutical Therapy (RPT) pipeline candidates for the treatment of cancer.

Key Points: 
  • GARCHING / MUNICH, Germany and VANCOUVER, British Columbia, January 30, 2024 – ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, and Alpha-9 Oncology (Alpha-9) , a clinical stage biotechnology company developing differentiated and highly targeted radiopharmaceuticals, today announced the signature of a global master clinical supply agreement to support the development of Alpha-9’s Radiopharmaceutical Therapy (RPT) pipeline candidates for the treatment of cancer.
  • Under the terms of the agreement, ITM will supply its medical radioisotope, non-carrier-added Lutetium-177 (n.c.a.
  • 177Lu for the clinical development of Alpha-9 radiopharmaceutical candidates comprising n.c.a.
  • ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a.

Teako Minerals Announces Strategic Pivot to Focus on Norway; Pausing Operations in British Columbia

Retrieved on: 
Thursday, January 18, 2024

The EU has introduced a goal that 10% of all critical minerals consumed in the EU in 2030 will need to be produced in the EU by 2030.

Key Points: 
  • The EU has introduced a goal that 10% of all critical minerals consumed in the EU in 2030 will need to be produced in the EU by 2030.
  • This means that the production of battery metals within the EU must be dramatically increased to attain this goal.
  • The event was followed by a networking gathering where Teako and another Service Alliance partner, Kuniko Limited (KNI.ASX), and Norsk Bergindustri, met.
  • The Company will maintain a minor focus on Finland, based on the following:-
    Ranked as one of the best mining jurisdictions.

Optimi Health Secures Amendment to Increase Quantities Of MDMA, MDA, And 2C-B Under Controlled Drugs And Substances Dealer’s Licence

Retrieved on: 
Friday, January 19, 2024

Effectively implemented on January 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the Food and Drug Regulations.

Key Points: 
  • Effectively implemented on January 16, 2024, the amendment allows substantial increases in the quantities of MDMA, MDA, and 2CB under subsection J.01.059(4) of Part J of the Food and Drug Regulations.
  • Terms of the amendment now permit the following increases:
    N-METHYL-3,4-METHYLENEDIOXY AMPHETAMINE (MDMA) – from 2kg to 20kg.
  • It enhances our competitive advantage and perfectly aligns with our vision to be the leading global supplier of GMP MDMA and other psychedelic substances."
  • Optimi now has Health Canada approval to manufacture the following controlled substances:

European Commission revokes all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm

Retrieved on: 
Wednesday, December 20, 2023

BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.

Key Points: 
  • BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.
  • This decision contradicts the European Medicines Agency's own prior scientific review, when the Commission granted an unconditional marketing permission to Neuraxpharm in 2022.
  • Neuraxpharm will swiftly contest this decision at the General Court of the European Union, with the aim of reintroducing Dimethyl Fumarate Neuraxpharm to the European market as soon as possible.
  • Neuraxpharm remains committed to our mission of providing affordable, high-quality medication to patients across the European Union, including patients who depend on the more affordable generic versions of Tecfidera such as Dimethyl Fumarate Neuraxpharm."

European Commission revokes all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm

Retrieved on: 
Wednesday, December 20, 2023

BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.

Key Points: 
  • BARCELONA, Spain and DÜSSELDORF, Germany, Dec. 20, 2023 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, today announces that it has been notified by the European Commission of its decision to revoke all centrally granted generic marketing permissions for dimethyl fumarate ('DMF'), including Dimethyl Fumarate Neuraxpharm.
  • This decision contradicts the European Medicines Agency's own prior scientific review, when the Commission granted an unconditional marketing permission to Neuraxpharm in 2022.
  • Neuraxpharm will swiftly contest this decision at the General Court of the European Union, with the aim of reintroducing Dimethyl Fumarate Neuraxpharm to the European market as soon as possible.
  • Neuraxpharm remains committed to our mission of providing affordable, high-quality medication to patients across the European Union, including patients who depend on the more affordable generic versions of Tecfidera such as Dimethyl Fumarate Neuraxpharm."

BIO-TECHNE ANNOUNCES SUBMISSION OF FDA DRUG MASTER FILE FOR EXCELLERATE GMP IPSC EXPANSION MEDIUM SUPPORTING STEM CELL THERAPY

Retrieved on: 
Wednesday, December 20, 2023

ExCellerate GMP iPSC Expansion Medium is optimized to support robust expansion and maintenance of stem cell culture for enhanced consistency and reproducibility throughout the stem cell manufacturing process.

Key Points: 
  • ExCellerate GMP iPSC Expansion Medium is optimized to support robust expansion and maintenance of stem cell culture for enhanced consistency and reproducibility throughout the stem cell manufacturing process.
  • The recently released GMP medium complements Bio-Techne's industry leading regenerative medicine therapy workflow solutions, which includes the widest range of GMP cytokines and growth factors available on the market.
  • The DMF submission provides the FDA with detailed information about the facilities and processes used in the manufacturing, processing, packaging, and storing of ExCellerate GMP iPSC Expansion Medium.
  • Regenerative medicine and stem cell therapy developers who integrate the medium into their GMP cell manufacturing workflows can easily reference these important details when filing Investigational New Drug (IND) applications with the FDA.

Touchlight’s enzymatic doggybone DNA used in the manufacture of Versameb’s VMB-100 for first-in-human clinical study

Retrieved on: 
Tuesday, November 21, 2023

This FDA clearance represents a further milestone for Touchlight’s enzymatic dbDNA and follows the prior announcement from February 2023 of the first client adopting dbDNA for clinical development in the US.

Key Points: 
  • This FDA clearance represents a further milestone for Touchlight’s enzymatic dbDNA and follows the prior announcement from February 2023 of the first client adopting dbDNA for clinical development in the US.
  • This IND marks the third product to enter clinical development using the dbDNA platform, further demonstrating its regulatory adoption in both the US and Europe.
  • Karen Fallen, CEO, Touchlight commented: “We would like to congratulate Versameb on this achievement and wish them success with their upcoming first-in-human study.
  • dbDNA is uniquely positioned for the rapid, synthetic, and scalable manufacture of GMP DNA using a small, simple footprint.