Pharmaceutical

Company kicks off the Jamieson brand’s 100 th year with commitments for a sustainable future Jamieson Wellness Inc. is celebrating the 100 th anniversary of its flagship brand, Jamieson Vitamins, with long-term plans for the creation of a sustainable future. “We are incredibly proud of this historic milestone we have reached as a Company in 2022,” said Mike Pilato, President and CEO of Jamieson Wellness. ...

Company kicks off the Jamieson brand's 100 th year with commitments for a sustainable future

Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX:JWEL) is celebrating the 100 th anniversary of its flagship brand, Jamieson Vitamins, with long-term plans for the creation of a sustainable future.

"We are incredibly proud of this historic milestone we have reached as a Company in 2022," said Mike Pilato, President and CEO of Jamieson Wellness. "What began in 1922 as a small, family-owned brand is now Canada's number one consumer health brand with products available in more than 45 countries around the world. I am grateful to the Jamieson team and our retail partners for their hard work and passion for building this brand together, and to our consumers for the century of trust they have placed in us for their health and wellness needs.

"While we are celebrating this achievement this year, we also recognize that we have a responsibility to forge a sustainable path for our next 100 years and the generations to come. As such, we are committing to a 50% emissions reduction by 2030, and to establishing a formal action plan to reach Net Zero by 2050. These goals are aligned to the United Nations Paris Agreement goals, and as we enter our 100 th year, projects have already begun to help us achieve them."

The Company has released an environmental, social and governance (ESG) document highlighting significant achievements in its diversity and inclusion efforts, as well as recent additions and improvements to its governance practices. It also identifies new sustainability projects currently underway and targeted for completion by 2030, including:

  • increasing recycled content in all branded packaging by 50%

  • reducing packaging cartons by 50%

  • reducing shipper corrugate content by 20%

  • reducing landfill waste by 75%

The complete document with additional details on these and the Company's other ESG projects can be found in the presentations section of the Company's corporate website or accessed directly here .

"We know that this is not going to be a simple or straightforward process, but as we look to expand our leadership beyond this 100-year mark we believe it is the right thing to do, and we welcome the challenge of creating real and positive change," said Mr. Pilato. "We are excited about the plans we have in place and look forward to sharing our progress as we begin another century of improving the world's health and wellness."

About Jamieson Wellness Inc.

Jamieson Wellness is dedicated to improving the world's health and wellness with its portfolio of innovative natural health brands. Established in 1922, Jamieson is the Company's heritage brand and Canada's #1 consumer health brand. Jamieson Wellness manufactures and markets sports nutrition products and specialty supplements under its Progressive, Precision and Iron Vegan brands. The Company also markets Smart Solutions, the #1 women's natural health focused brand in Canada. For more information please visit jamiesonwellness.com.

Forward-Looking Information

This press release may contain forward-looking information within the meaning of applicable securities legislation. Such information includes, but is not limited to, statements related to the Company's future plans, goals, strategies, intentions, beliefs, objectives, economic performance or expectations. Words such as "expect", "anticipate", "intend", "may", "will", "estimate" and variations of such words and similar expressions are intended to identify such forward-looking information. This information reflects the Company's current expectations regarding future events. Forward-looking information is based on a number of assumptions and is subject to a number of risks and uncertainties, many of which are beyond the Company's control that could cause actual results and events to differ materially from those that are disclosed in or implied by such forward-looking information. Such risks and uncertainties include, but are not limited to, the factors discussed under "Risk Factors" in the Company's Annual Information Form dated March 30, 2021 and under the "Risk Factors" section in the Company's MD&A dated November 3, 2021. This information is based on the Company's reasonable assumptions and beliefs in light of the information currently available to it and the statements are made as of the date of this press release. The Company does not undertake any obligation to update such forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable law or regulatory authority.

The Company cautions that the list of risk factors and uncertainties is not exhaustive and other factors could also adversely affect the Company's results. Readers are urged to consider the risks, uncertainties and assumptions associated with these statements carefully in evaluating the forward-looking information and are cautioned not to place undue reliance on such information. See "Forward-looking Information" and "Risk Factors" within the Company's MD&A for a discussion of the uncertainties, risks and assumptions associated with these statements.

Investor and Media Contact:
Ruth Winker
Jamieson Wellness
416-705-5437
rwinker@jamiesonlabs.com

News Provided by Business Wire via QuoteMedia

JWEL:CA

Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiency

Pfizer Inc. (NYSE: PFE) and OPKO Health, Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon. Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Pfizer is evaluating the FDA's comments and will work with the agency to determine an appropriate path forward.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220121005474/en/

"We remain confident in the potential treatment benefits that somatrogon has to offer patients around the world," said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. "We will work closely with the FDA to determine the best path forward to bring this important once-weekly treatment option to pediatric growth hormone deficiency patients and their families."

Regulatory applications for somatrogon have been submitted to several countries around the world for review. Earlier this week, Japan's Ministry of Health, Labour and Welfare approved NGENLA® (somatrogon) Inj. 24 mg Pens and 60mg Pens, for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. In 2021, Health Canada approved NGENLA ® for the long-term treatment of pediatric patients who have GHD, and Australia's Therapeutic Goods Administration (TGA) approved NGENLA ® for the long-term treatment of pediatric patients with growth disturbance due to insufficient secretion of growth hormone. Furthermore, in December 2021, the Committee for Medicinal Products for Human Use (CHMP) of EMA issued a positive opinion recommending somatrogon for marketing authorization in the EU, to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. A decision from the European Commission (EC) is expected in early 2022.

In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product for GHD.

About Growth Hormone Deficiency

Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 children. 1,2 In children, this disease can be caused by genetic mutations or acquired after birth. 1,3 Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, a child's height may be affected and puberty may be delayed. 1,3,4 Without treatment, affected children will have persistent growth attenuation and a very short height in adulthood. 3,4 Children may also experience other problems with physical health and mental well-being. 3,4

Pfizer Rare Disease

Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac and inherited metabolic disorders.

Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures.

Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

About Pfizer: Breakthroughs That Change Patients' Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com . In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News , LinkedIn , YouTube and like us on Facebook at Facebook.com/Pfizer .

Disclosure Notice

The information contained in this release is as of January 21, 2022. Pfizer and OPKO assume no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about an investigational growth hormone deficiency therapy, somatrogon, including a potential indication in the U.S. for once-weekly treatment of pediatric patients with growth hormone deficiency, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; uncertainties regarding the company's ability to address the comments in the complete response letter to the satisfaction of the FDA; whether and when drug applications may be filed in any other jurisdictions for any potential indication for somatrogon; whether and when the BLA pending with the FDA for somatrogon for the treatment of pediatric patients with growth hormone deficiency may be approved and whether and when regulatory authorities in any jurisdictions may approve any such other applications that may be pending or filed (including the application filed in the EU), which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether somatrogon will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of somatrogon; uncertainties regarding the impact of COVID-19 on Pfizer's and OPKO's business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's and OPKO's respective Annual Report on Form 10- K for the fiscal year ended December 31, 2020 and in their respective subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in their respective subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov , www.pfizer.com , and www.opko.com .

About OPKO Health, Inc.

OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.OPKO.com .

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BetterLife Receives FDA Response On Its Pre-IND Application For Major Depressive Disorder Treatment With BETR-001

BetterLife Pharma Inc. ("BetterLife" or the "Company") (CSE: BETR OTCQB: BETRF FRA: NPAU ), an emerging biotech company focused on the development and commercialization of 2nd-generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, is pleased to announce it has received a written response from the U.S. Food and Drug Administration (FDA) to its pre-investigational new drug (pre-IND) application for the treatment of MDD with BETR-001. BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD) and is currently undergoing IND-enabling non-clinical studies and GMP manufacturing for clinical trials. The FDA response is in general agreement with the Company's planned program for the development of BETR-001 and provided guidance regarding the BETR-001 IND-enabling non-clinical toxicology studies, its manufacturing strategy, and initial proposed clinical trial parameters.

"We are very pleased with the outcome of the BETR-001 pre-IND meeting with the FDA. The response from the FDA confirms that our current program will support the filing of BETR-001's IND application and initiation of human clinical trials by the third quarter of this year. Being a non-hallucinogenic derivative of LSD makes BETR-001 a unique molecule with therapeutic potential for the treatment of debilitating psychiatric and neurological disorders with high unmet need, such as major depressive disorders and cluster headaches. Our team is fully dedicated to start the human clinical trials in the United States by early second half of this year," said BetterLife's Chief Executive Officer, Dr. Ahmad Doroudian.

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Results From Pivotal Phase 3 KEYNOTE-775/Study 309 Trial of KEYTRUDA® Plus LENVIMA® in Advanced Endometrial Carcinoma Published in the New England Journal of Medicine

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced the publication of results from the Phase 3 KEYNOTE-775/Study 309 trial in the January 19, 2022 edition of the New England Journal of Medicine . The pivotal study evaluated the combination of KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus chemotherapy (treatment of physician's choice of doxorubicin or paclitaxel) for patients with advanced endometrial carcinoma following at least one prior platinum-based regimen in any setting.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220120005102/en/

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Frank Clyburn to Leave Merck

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Frank Clyburn, executive vice president and president, Human Health, will leave Merck on Feb. 1, 2022, to assume a leadership opportunity with another company. Leadership of Human Health following Frank's departure will be announced in the coming weeks.

"I am extremely appreciative of Frank's significant contributions to our company during his fourteen years with Merck. Frank has been a key catalyst for value creation, an incredible business strategist, a dedicated people leader and a fierce advocate for patients everywhere," said Robert M. Davis, chief executive officer and president, Merck. "Frank's strategic and operational excellence helped establish Merck as a global leader in oncology. Our human health business has delivered strong and sustainable growth under Frank's leadership, and we are well-positioned to continue this momentum with the strong human health team we have in place."

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Merck's KEYTRUDA® Significantly Improved Overall Survival Versus Placebo in Certain Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib

First Presentation of OS Data From Phase 3 KEYNOTE-394 Trial at ASCO GI 2022

KEYNOTE-394 Is One of Seven Clinical Trials in Merck's Global Development Program in HCC

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Merck Animal Health's Third Veterinarian Wellbeing Study Reveals Increased Health Challenges and Psychological Distress Among Veterinarians

- Merck Animal Health, known as MSD Animal Health outside the United States and Canada a division of Merck & Co., Inc., Kenilworth, N.J. USA (NYSE:MRK), today released findings of its comprehensive study conducted in collaboration with the American Veterinary Medical Association (AVMA) examining the wellbeing and mental health of U.S. veterinarians. Conducted in the fall of 2021, the wide-ranging Veterinary Wellbeing Study is the third survey since 2017 and the first since the COVID-19 pandemic began, with a goal to examine and bring critical awareness to the challenges impacting the veterinary profession, while highlighting the impact that the pandemic has on practitioners and staff. For the first time, the study includes responses from veterinary technicians and support staff and their perspectives on the challenges they are currently facing in work.

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