Health Canada

BioCina officially opens full-service CDMO in Adelaide, Australia, including mRNA and pDNA cGMP manufacturing

Tuesday, November 30, 2021 - 4:37pm

SAN DIEGOandADELAIDE, Australia, Nov. 30, 2021 /PRNewswire/ -- BioCina , a leading contract development and manufacturing organization (CDMO) specializing in process development and cGMP manufacturing of microbial-based therapeutics and mRNA vaccines announces the official opening of its new biologics manufacturing facility in Adelaide, Australia.

Key Points: 
  • SAN DIEGOandADELAIDE, Australia, Nov. 30, 2021 /PRNewswire/ -- BioCina , a leading contract development and manufacturing organization (CDMO) specializing in process development and cGMP manufacturing of microbial-based therapeutics and mRNA vaccines announces the official opening of its new biologics manufacturing facility in Adelaide, Australia.
  • BioCina opens new full-service CDMO to meet demand for world-class mRNA and pDNA cGMP manufacturing.
  • Since transitioning from Pfizer, capabilities for BioCina have been expanded to now include manufacturing of GLP and, available in Q1 2022, cGMP-grade plasmid DNA.
  • BioCina Pty Ltd. is a multi-product biologics contract development and manufacturing organization (CDMO), focused on the development and cGMP manufacture of microbial-based biological pharmaceuticals, including proteins, mRNA, vaccines and biosimilars, from early development through to commercialization.

Diamond Therapeutics Announces Four Critical Hires to Further Accelerate Drug Development

Tuesday, November 30, 2021 - 1:05pm

Working with Dr. McDonnell is Dr. Jeffrey Sprouse, Diamond's Director of Pipeline Development and Jamie Jarecki-Smith, the company's new Director of Clinical Operations.

Key Points: 
  • Working with Dr. McDonnell is Dr. Jeffrey Sprouse, Diamond's Director of Pipeline Development and Jamie Jarecki-Smith, the company's new Director of Clinical Operations.
  • Dr. Sprouse brings more than 20 years of experience leading successful preclinical drug efforts for top-tier pharmaceutical organizations in neuroscience and psychiatry-based disease.
  • "These additions to our executive bring expertise that will be key to furthering our intellectual property portfolio while accelerating our drug development efforts.
  • Diamond Therapeutics is a drug development company based inToronto, Ontario.

Spectral Medical Schedules Conference Call to Provide Clinical Update and Discuss Latest Developments

Tuesday, November 30, 2021 - 1:00pm

TORONTO, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (Spectral or the Company) (TSX: EDT) and its wholly-owned subsidiary Dialco Medical Inc. (Dialco), today announced that it will host a conference call at 2:00 PM EST on Thursday, December 2, 2021, to provide a clinical update and discuss the latest business developments.

Key Points: 
  • TORONTO, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (Spectral or the Company) (TSX: EDT) and its wholly-owned subsidiary Dialco Medical Inc. (Dialco), today announced that it will host a conference call at 2:00 PM EST on Thursday, December 2, 2021, to provide a clinical update and discuss the latest business developments.
  • The conference call will be available via telephone by dialing toll free 877-407-0789 for U.S. callers or for international callers +1 201-689-8562.
  • A webcast of the call may be accessed at https://viavid.webcasts.com/starthere.jsp?ei=1517076&tp_key=36dec0df72 or on the Companys Investor Events section of the website here .
  • Spectral is a Phase III company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin (PMX).

Novo Integrated Sciences Acquires Majority Stake in Terragenx and Intellectual Property for FDA and Health Canada Approved Water-Soluble Iodine Micro-Nutrient

Tuesday, November 30, 2021 - 1:00pm

Iodine is a naturally occurring element and essential nutrient used by the thyroid gland to manufacture necessary hormones in the human body.

Key Points: 
  • Iodine is a naturally occurring element and essential nutrient used by the thyroid gland to manufacture necessary hormones in the human body.
  • The human immune system uses iodine to deactivate viruses in the bloodstream, which may facilitate the production of antibodies for various indications.
  • Novo acquired a 91% interest in Terragenx through an all-share transaction at $3.35 per share which closed November 17, 2021.
  • Novo Integrated Sciences, Inc. is pioneering a holistic approach to patient-first health and wellness through a multidisciplinary healthcare ecosystem of services and product innovation.

Jazz Pharmaceuticals Announces Commercial Availability in Canada of Zepzelca™ (lurbinectedin), the First New Treatment for Stage III or Metastatic Small Cell Lung Cancer in More Than a Decade

Tuesday, November 30, 2021 - 12:45pm

says Paul Petrelli,general manager, Jazz Pharmaceuticals Canada Inc."We areproudto introduce this meaningful new treatment to patients in Canada."

Key Points: 
  • says Paul Petrelli,general manager, Jazz Pharmaceuticals Canada Inc."We areproudto introduce this meaningful new treatment to patients in Canada."
  • "Patients with small cell lung cancer in the second line and their families have been on the sidelines for far too long.
  • The availability of Zepzelca in Canada is a great new option," says Shem Singh, executive director,Lung Cancer Canada.
  • Small cell lung cancer is sometimes, but not often, called oat cell cancer because the small, oval-shaped cells look like oat grains under a microscope.

CannabCo Reveals 41% Odourless Cannabis™ Dry Flower Strain.

Tuesday, November 30, 2021 - 12:43pm

The main distinguishing feature of the strain, other than its high THC content, is that it was created with Purecann, CannabCo's proprietary Odourless Cannabis technology.

Key Points: 
  • The main distinguishing feature of the strain, other than its high THC content, is that it was created with Purecann, CannabCo's proprietary Odourless Cannabis technology.
  • The deployment of Purecann makes the product virtually odourless when smoked or stored allowing for a reduced impact on others sensitive to the pungent odour of cannabis.
  • Currently the highest THC dry flower in the Ontario Cannabis Store lists at a maximum of 32% THC.
  • CannabCo maintains full ownership and rights to Purecann and the odourless cannabis technology.

MedX Health Corp. Announces Third Quarter 2021 Results

Monday, November 29, 2021 - 10:59pm

MedX Health Corp. (MedX or the Company) (TSXV: MDX) announced its results for the three and nine months ended September 30, 2021, which are also available on SEDAR ( www.sedar.com ).

Key Points: 
  • MedX Health Corp. (MedX or the Company) (TSXV: MDX) announced its results for the three and nine months ended September 30, 2021, which are also available on SEDAR ( www.sedar.com ).
  • Third Quarter 2021 Financial Highlights:
    The Company reported revenue of $94,146 for the three months ended September 30, 2021, compared with revenue of $172,889 for the three months ended September 30, 2020.
  • The MedX and Vitamed pilot program in Italy is expected to be in-market for 60 days from October to November 2021.
  • MedX Announces Board Changes (August 23, 2021)
    The Company announces changes to its Board of Directors.

Beyond Medical Technologies Ramps Up COVID Mask Manufacturing in Response to New South Africa COVID Variant

Monday, November 29, 2021 - 2:15pm

The World Health Organization (WHO) declared the new variant identified in South Africa, named "Omicron", as a "variant of concern" .

Key Points: 
  • The World Health Organization (WHO) declared the new variant identified in South Africa, named "Omicron", as a "variant of concern" .
  • Micron Technologies has been manufacturing and selling three-ply medical grade Level 3 face masks in Delta, B.C.
  • Micron Technologies is manufacturing three-ply medical grade face masks pursuant its Medical Device Establishment License issued by Health Canada.
  • As previously announced, Micron Technologies' medical grade face masks are available to purchase through Walmart, Amazon and Shopify.

REPEAT - TAAT™ Becomes an Official Supplier of H.T. Hackney, One of the Largest U.S. Wholesale Distributors

Monday, November 29, 2021 - 2:00pm

The Company has developed TAAT, which is a tobacco-free and nicotine-free alternative to traditional cigarettes offered in "Original", "Smooth", and "Menthol" varieties.

Key Points: 
  • The Company has developed TAAT, which is a tobacco-free and nicotine-free alternative to traditional cigarettes offered in "Original", "Smooth", and "Menthol" varieties.
  • TAAT's base material is Beyond Tobacco, a proprietary blend which undergoes a patent-pending refinement technique causing its scent and taste to resemble tobacco.
  • The statements in this news release have not been evaluated by Health Canada or the U.S. Food and Drug Administration.
  • Disclosures relating to investor relations firms retained by TAAT Global Alternatives Inc. can be found under the Company's profile on http://sedar.com .

Spectral Medical Announces U.S. FDA Approval of Tigris Trial Protocol Amendment to Expand Inclusion Criteria

Monday, November 29, 2021 - 1:00pm

TORONTO, Nov. 29, 2021 (GLOBE NEWSWIRE) -- Spectral Medical Inc. (“Spectral” or the “Company”) (TSX: EDT), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as commercializing a new proprietary platform targeting the renal replacement therapy market through its wholly-owned subsidiary Dialco Medical Inc. (Dialco), today announced that the United States Federal Food and Drug Agency (“FDA”) has approved a protocol amendment to its Tigris trial allowing for the use of sequential organ failure assessment (“SOFA”) scoring as inclusion criteria into the study. Additionally, the Company announced five additional clinical sites to begin enrollment, including Louisiana State University, Cleveland Clinic, University of Arkansas, University of Michigan and Colorado Springs bringing the total number of participating sites to fifteen.

Key Points: 
  • Dr. John Kellum, Chief Medical Officer of Spectral, commented, We are very pleased with the FDA approval of our Tigris protocol amendment to allow the use of SOFA, which is an alternative scoring system used to quantify severity of illness.
  • I would expect this enrollment impact to be universal across other Tigris sites, and should greatly reduce the time needed to complete the trial.
  • Despite a challenging clinical environment due to COVID-19, Spectral has had success in adding new trial sites into the Tigris trial.
  • As a clinical site partner, we view the Tigris trial as a well designed study positioned for a positive outcome.