Love Pharma Inc. continues to prioritize the necessity for clinical validation as a vital step in bringing its products to market.  The Vancouver, Canada-based company, which operates as a specialized health and wellness company that licenses and distributes psychedelic and cannabis-infused products, has established a practice of offering proven products with clinical data, user studies, and scientific research to ...

Love Pharma Inc. (CSE: LUV) (FSE: G1Q0) continues to prioritize the necessity for clinical validation as a vital step in bringing its products to market.  The Vancouver, Canada-based company, which operates as a specialized health and wellness company that licenses and distributes psychedelic and cannabis-infused products, has established a practice of offering proven products with clinical data, user studies, and scientific research to support its claims.  It's a practice that gives Love Pharma a distinct market advantage over many of its competitors.  And now, Love Pharma is set to broaden that advantage with its recent announcement that the company has signed a Letter of Intent to acquire MicroDoz Therapy, Inc.

The benefit of this acquisition to Love Pharma, its shareholders and worldwide consumers is that the company gains MicroDoz's exclusive partnership with a world-renowned university to conduct a landmark study into the efficacy of psilocybin assisted treatment of cannabis use disorder.  Love Pharma can leverage this relationship to further expand its product lineup, strengthen its clinical validation program, and add to its comprehensive portfolio of intellectual property.

Specifically, the acquisition will further substantiate the company's efforts to become a frontrunner in the psychedelics and therapeutics space.  Love Pharma's Chief Executive Officer (CEO), Zach Stadnyk, said his company's existing portfolio, which consists of the exclusive rights to 7 novel therapeutic products focused on mental and sexual wellness, is already at the leading edge of innovation in the industry.  So, continued new product development will further build upon what is already a strong foundation.  Stadnyk's goal is to establish a growing and loyal customer base as the company seeks to define the psychedelics and therapeutics industry with solid science that leads to effective products.

When explaining the acquisition of MicroDoz Therapy, the CEO stated, "Science and efficacy are paramount to our strategy, as a result we seized the opportunity to acquire MicroDoz to expedite what will be a landmark study with a world-leading university."

As an entry point into the burgeoning psychedelics market, the company acquired the rights to the patent-pending psilocybin strip in addition to the acquisition of MicroDoz, which has the exclusive partnership to the landmark study at an unnamed leading global university.  Love Pharma announced it expects to release the university's name along with details of the program when the definitive agreement is closed.

Psilocybin is the psychoactive chemical in "magic mushrooms," and the company's biosynthetic psilocybin-infused oral strip utilizes the already-proven and existing novel technology implemented for the company's mucoadhesive CBD strip product, "Auralief."  Auralief, the company's discreet cannabis-infused oral strip that speeds-up and enhances the desired effects of THC and CBD, is supported by a recent human trial that demonstrated a greater than 30% increase in efficacy and speed to performance of THC and CBD.

Following the U.S. Food and Drug Administration's (FDA) "breakthrough" designation in 2018, psilocybin gained legitimacy in the mental health field.  The breakthrough designation has prompted the FDA to fast-track drug trials using psilocybin, and it has become the empetus behind an emerging health and wellness market.  Love Pharma has stated that ensuring the safety of users through reliable systems of accurate dosing remains of paramount importance.  Achieving accurate dosing is difficult with botanicals; however, pioneering companies, including Love Pharma, are developing new extracted products designed to deliver the most consistently accurate dosing possible.

In late October, Love Pharma announced that it's currently developing a mucoadhesive sublingual strip.  The Company is partnering with the strip's creator, a US-based pharmaceutical company, to develop the strip for use as a psilocybin delivery system.

And as prominent medical institutions and research facilities in the United Kingdom and the U.S. continue to conduct clinical studies and trials to determine the efficacy of psilocybin in treating a host of debilitating conditions, Love Pharma's acquisition should thrust the company into a leading role as it expedites what will be a landmark study into the efficacy of psilocybin assisted treatment of cannabis use disorder.

To learn more about Love Pharma Inc., visit or email

About Love Pharma Inc.

Love Pharma Inc. is a new-age pharma/nutraceutical company specializing in the global sexual health, wellness, and psychedelics markets.  Founded in 2020, Love Pharma's mission is to bring innovative products to market that enhance sexual health and wellness while providing an improved quality of life.  Love Pharma holds exclusive licenses to produce, market, package, sell, and distribute patent-protected therapeutic and pharmaceutical products throughout Europe, the United Kingdom, and North America.

About Stock Market Media Group

Stock Market Media Group is a news and media content development IR firm offering a platform for corporate stories to unfold in the media with press releases, feature news articles, research reports, corporate videos, and radio-style CEO interviews.

This article was written based on publicly available information. Stock Market Media Group may, from time to time, include our own opinions about the companies, their business, markets and opportunities in our articles. Any opinions we may offer about any of the companies we write about are solely our own and are made in reliance upon our rights under the First Amendment to the U.S. Constitution, and are provided solely for the general opinionated discussion of our readers. Our opinions should not be considered to be complete, precise, accurate, or current investment advice, or construed or interpreted as research. Any investment decisions you may make concerning any of the securities we write about are solely your responsibility based on your own due diligence. Our publications are provided only as an informational aid, and as a starting point for doing additional independent research. We encourage you to invest carefully and read the investor information available at the web site of the U.S. Securities and Exchange Commission at We also recommend, as a general rule, that before investing in any securities, you consult with a professional financial planner or advisor, and you should conduct a complete and independent investigation before investing in any security after prudent consideration of all pertinent risks.  We are not a registered broker, dealer, analyst, or advisor. We hold no investment licenses and may not sell, offer to sell, or offer to buy any security. Our publications about Love Pharma are not a recommendation to buy or sell a security.

Should Stock Market Media Group and its management own shares in the profiled company, they may benefit from any increase in the share price of the profiled companies and hold the right to sell the shares bought at any given time including shortly after the release of the company's profile. Section 17(b) of the 1933 Securities and Exchange Act requires publishers who distribute information about publicly traded securities for compensation, to disclose who paid them, the amount, and the type of payment.  Under the Securities Act of 1933, Section 17(b), Stock Market Media Group discloses that it was remunerated one-thousand, two hundred dollars paid for by a third party via bank wire, to produce this content related to Love Pharma.

Stock Market Media Group and its management do not own any shares in Love Pharma and never accepts compensation in free-trading shares for its marketing services of the company being profiled, however third parties that have compensated Stock Market Media Group may hold free-trading shares of the company being profiled and could very well be selling, holding or buying shares of the company's stock at the same time the content is being disseminated to potential investors; this should be viewed as a definite conflict of interest and as such, the reader should take this into consideration.

If Stock Market Media Group ever accepts compensation in the form of free trading shares of the company being profiled and decides to sell these shares into the public market at any time before, during, or after the release of the company's profile, our disclaimer will be updated accordingly to reflect the current position of any free trading shares received as compensation for our services.

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Attitudes about sexual wellness are changing, and the market is directly reflecting these changes. Sexual wellness is a general term that refers to the physical, mental and social well-being of an individual. This broad market is made up of any product related to sexual wellness, such as supplements, contraceptives, lingerie, and other holistic products.

A report conducted by KBV Research estimates that the global sexual wellness market size will reach US$125.1 billion by 2026, with the potential for a 12.4 percent CAGR during this period. This steady growth has been driven by a renewed interest in sexual discovery, rising prevalence of sexually transmitted diseases, and the broader shift to ecommerce.

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U.S. FDA Approves Pfizer's CIBINQO® for Adults with Moderate-to-Severe Atopic Dermatitis

CIBINQO is a once-daily oral treatment with proven efficacy to manage symptoms for adults who have not yet found relief with current options

Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved CIBINQO ® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

CIBINQO is approved at the recommended doses of 100 mg and 200 mg, with the 200 mg dose being recommended for patients who are not responding to the 100 mg dose. Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate renal impairment (kidney failure), certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19, or patients who are known or suspected to be poor metabolizers of CYP2C19. For patients with moderate renal impairment who are not responding to 50 mg once daily, 100 mg once daily may also be prescribed.

"The reality for patients living with chronic inflammatory skin disease such as moderate-to-severe atopic dermatitis is that many experience debilitating symptoms that are not managed by current treatment options. Today's approval of CIBINQO will provide an important new oral option that could help those who have yet to find relief," said Jonathan Silverberg, MD, PhD, MPH, Department of Dermatology, The George Washington University School of Medicine and Health Sciences. "In multiple large-scale clinical trials, CIBINQO demonstrated strong efficacy at clearing skin, improving itch, and managing the extent and severity of eczema, offering a benefit-risk profile that supports the use of this treatment in the FDA-approved patient population."

The FDA approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The safety and efficacy of CIBINQO was evaluated in three randomized, placebo-controlled, Phase 3 trials. Additionally, safety was evaluated through a randomized, placebo-controlled, dose-ranging trial and an ongoing long-term open-label extension trial. Across the trials, CIBINQO demonstrated a consistent safety profile and profound improvements in skin clearance, extent of disease, and severity, as well as rapid improvement in itch after two weeks, for some people living with AD versus placebo. In addition, a higher proportion of subjects treated with CIBINQO in two monotherapy trials achieved improvement in itching at week 12 compared to placebo.

"The FDA's approval offers hope to the millions of patients across the U.S. who are suffering daily with an immuno-inflammatory condition that can cause intense and persistent itching, pain, discomfort, and distress if left uncontrolled," said Mike Gladstone, Global President of Pfizer Inflammation & Immunology. "CIBINQO, an efficacious once-daily pill, is a medical breakthrough made possible by Pfizer researchers and the people living with moderate-to-severe atopic dermatitis who participated in our clinical trials."

"Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin. It's a chronic condition that can both significantly disrupt patients' daily lives and negatively impact their emotional well-being," said Julie Block, President and CEO, National Eczema Association. "We appreciate Pfizer's commitment to this resilient patient community and eagerly await the positive impact CIBINQO could have on the treatment landscape for moderate-to-severe atopic dermatitis."

The most common adverse events reported in ≥5% of patients with CIBINQO included nasopharyngitis (12.4% with CIBINQO 100 mg, 8.7% with CIBINQO 200 mg, and 7.9%, with placebo), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively).

The full prescribing information for CIBINQO can be found here . CIBINQO will be made available in the coming weeks.

Additional Details on the CIBINQO Clinical Trial Program

Five clinical trials in the CIBINQO JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program were included in the New Drug Application (NDA) to support the FDA approval.

The safety and efficacy of CIBINQO was evaluated in three Phase 3, randomized, placebo-controlled clinical trials. The trials evaluated measures of improvements in skin clearance, itch, disease extent, and severity, including the Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), and Peak Pruritus Numerical Ratings Scale (PP-NRS). In each of the trials, over 40% of patients had prior exposure to a systemic therapy:

  • JADE MONO-1 and JADE MONO-2: A pair of randomized, double-blind, placebo-controlled trials designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of CIBINQO monotherapy in 778 patients 12 years of age and older with moderate-to-severe AD. The trials assessed the co-primary endpoints of IGA and EASI-75 responses at Week 12.
  • JADE COMPARE: A randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of CIBINQO in 837 adult patients with moderate-to-severe AD on background topical medicated therapy. The trial also included an active control arm with dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo. The trial assessed the co-primary endpoints of IGA and EASI-75 responses at Week 12.

Select findings for CIBINQO 100 mg, 200 mg, and placebo follow (*p

  • JADE MONO-1:
    • IGA Response Rate (Week 12): 24%*, 44%**, and 8%, respectively
    • EASI-75 Response Rate (Week 12): 40%**, 62%**, and 12%, respectively
    • IGA Response Rate (Week 12): 28%**, 38%**, and 9%, respectively
    • EASI-75 Response Rate (Week 12): 44%**, 61%**, and 10%, respectively
    • IGA Response Rate (Week 12): 36%**, 47%**, and 14%, respectively
    • EASI-75 Response Rate (Week 12): 58%**, 68%**, and 27%, respectively

Safety was additionally evaluated through a randomized dose-ranging trial and a long-term, open-label, extension trial (JADE EXTEND).



Serious Infections

Patients treated with CIBINQO may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with CIBINQO were herpes simplex, herpes zoster, and pneumonia.

If a serious or opportunistic infection develops, discontinue CIBINQO and control the infection.

Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions:

  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens.

Avoid use of CIBINQO in patients with an active, serious infection, including localized infections. The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections or those who have resided or traveled in areas of endemic tuberculosis or endemic mycoses.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Consider yearly screening for patients in highly endemic areas for TB. CIBINQO is not recommended for use in patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, or for patients with a negative test for latent TB but who are at high risk for TB infection, start preventive therapy for latent TB prior to initiation of CIBINQO.

Viral reactivation, including herpes virus reactivation (eg, herpes zoster, herpes simplex), was reported in clinical studies with CIBINQO. If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves. Hepatitis B virus reactivation has been reported in patients receiving JAK inhibitors. Perform viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting therapy and during therapy with CIBINQO. CIBINQO is not recommended for use in patients with active hepatitis B or hepatitis C.


In a large, randomized postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality (including sudden cardiovascular death) was observed with the JAK inhibitor. CIBINQO is not approved for use in RA patients.


Malignancies, including non-melanoma skin cancer (NMSC), were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. Perform periodic skin examination for patients who are at increased risk for skin cancer. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

In a large, randomized postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. CIBINQO is not approved for use in RA patients. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Major Adverse Cardiovascular Events

Major adverse cardiovascular events were reported in patients treated with CIBINQO. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.


Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of overall thrombosis, DVT, and PE were observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients.

Avoid CIBINQO in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO and treat patients appropriately.


CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.

Laboratory Abnormalities

Hematologic Abnormalities : Treatment with CIBINQO was associated with an increased incidence of thrombocytopenia and lymphopenia. Prior to CIBINQO initiation, perform a complete blood count (CBC). CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO. Discontinuation of CIBINQO therapy is required for certain laboratory abnormalities.

Lipid Elevations: Dose-dependent increase in blood lipid parameters were reported in patients treated with CIBINQO. Lipid parameters should be assessed approximately 4 weeks following initiation of CIBINQO therapy, and thereafter patients should be managed according to clinical guidelines for hyperlipidemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.


Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including prophylactic herpes zoster vaccinations. Avoid vaccination with live vaccines immediately prior to, during, and immediately after CIBINQO therapy.

Renal Impairment

Avoid use in patients with severe renal impairment or end stage renal disease, including those on renal replacement therapy.

Hepatic Impairment

Avoid use in patients with severe hepatic impairment.

Adverse Reactions

Most common adverse reactions (≥1%) in subjects receiving 100 mg and 200 mg include: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatinine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis.

Most common adverse reactions (≥1%) in subjects receiving either 100 mg or 200 mg also include: impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.

Use in Pregnancy

Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Advise females of reproductive potential that CIBINQO may impair fertility.

There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770.


Advise women not to breastfeed during treatment with CIBINQO and for one day after the last dose.


CIBINQO is indicated for the treatment of adults with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

About CIBINQO ® (abrocitinib)

CIBINQO is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).

In addition to receiving regulatory approval in the U.S., CIBINQO has received marketing authorization in the European Union, Great Britain, Japan, Korea, the United Arab Emirates, Norway, Iceland, and Singapore.

About Atopic Dermatitis

AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. i,ii Most people know AD is a skin condition. But many don't realize it can be caused in part by an abnormal immune response beneath the skin. This dysregulated immune response is thought to contribute to inflammation within the skin and the signs of AD on the surface. Lesions of AD are characterized by erythema (red/pink or discolored skin patches, depending on normal skin color), itching, lichenification (thick/leathery skin), induration (hardening)/papulation (formulation of papules), and oozing/crusting. i,ii

AD is one of the most common inflammatory skin diseases, affecting approximately 5-10% of adults in the U.S. iii,iv Approximately 1 in 3 adults with AD have moderate-to-severe disease. v,vi

About Pfizer Inflammation & Immunology

At Pfizer Inflammation & Immunology, we strive to deliver breakthroughs that enable freedom from day-to-day suffering for people living with autoimmune and chronic inflammatory diseases, which can be debilitating, disfiguring and distressing, dramatically affecting what they can do. With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents. Our differentiated R&D approach resulted in one of the broadest pipelines in the industry, where we purposefully match molecules to diseases where we believe they can make the biggest difference. Building on our decades-long commitment and pioneering science, we continue to advance the standard of care for patients living with immuno-inflammatory diseases and are working hand-in-hand with patients, caregivers and the broader healthcare community on healthcare solutions for the many challenges of managing chronic inflammatory diseases, allowing patients to live their best lives.

Pfizer Inc.: 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 170 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 . In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer_News , LinkedIn , YouTube and like us on Facebook at .

DISCLOSURE NOTICE: The information contained in this release is as of January 14, 2022. Pfizer assumes 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 CIBINQO (abrocitinib), including its potential benefits, an approval in the U.S. and anticipated product availability, 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; whether and when drug applications may be filed in any other jurisdictions for any potential indication for CIBINQO; whether and when any such other applications that may be pending or filed for CIBINQO may be approved by regulatory authorities, 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 CIBINQO 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 CIBINQO; uncertainties regarding the commercial or other impact of the results of Janus kinase (JAK) inhibitor studies and data and actions by regulatory authorities based on analysis of such studies and data, which will depend, in part, on benefit-risk assessments and labeling determinations; uncertainties regarding the impact of COVID-19 on our business, operations, and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its 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 its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at and .

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Responses elicited by PREVNAR 20 for all 20 serotypes were similar whether given with a dose of the Pfizer-BioNTech COVID-19 Vaccine (n=190) or with placebo (n=191). Responses to a booster dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when given with PREVNAR 20 or given with placebo (n=189). The safety profile of co-administering PREVNAR 20 with a booster dose of the Pfizer-BioNTech COVID-19 Vaccine generally reflected that observed with the Pfizer-BioNTech COVID-19 Vaccine booster dose.

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Top Canadian Pharma Stocks

Click here to read the previous top Canadian pharma stocks article.

The Canadian pharmaceutical industry has positioned itself firmly on the global map thanks to advances in biotechnology and investments in medical research and development.

The life science sector is one of Canada’s key industries, and as a sub-sector the pharmaceutical industry represents 41 percent of Canada’s life science gross domestic product.

“Canada’s commercially oriented research network takes innovation from lab to market; joint investment opportunities in research allow for R&D result optimization; and the responsive and efficient regulatory environment facilitates business operations,” according to Invest in Canada.

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Merck's KEYTRUDA® Showed Statistically Significant Improvement in Disease-Free Survival Versus Placebo as Adjuvant Treatment for Patients With Stage IB-IIIA Non-Small Cell Lung Cancer Regardless of PD-L1 Expression

First Positive Study for KEYTRUDA in Adjuvant Stage IB-IIIA NSCLC

Merck (NYSE: MRK), known as MSD outside the United States and Canada, the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP) today announced that the Phase 3 KEYNOTE-091 trial, also known as EORTC-1416-LCGETOP-8-15 PEARLS, investigating KEYTRUDA, Merck's anti-PD-1 therapy, met one of its dual primary endpoints of disease-free survival (DFS) for the adjuvant treatment of patients with stage IB-IIIA non-small cell lung cancer (NSCLC) following surgical resection regardless of PD-L1 expression. Based on an interim analysis review conducted by an independent Data Monitoring Committee, adjuvant treatment with KEYTRUDA resulted in a statistically significant and clinically meaningful improvement in DFS compared with placebo in the all-comer population of patients with stage IB-IIIA NSCLC.

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