Life Science News

AbbVie Announces Provincial Reimbursement for RINVOQ® for the Treatment of Rheumatoid Arthritis and Psoriatic Arthritis in Alberta, New Brunswick, Ontario, Quebec and Saskatchewan

 ABBVie (NYSE: ABBV), today announced that RINVOQ is now listed as a special authorization medication or exception medication status on the formularies of Alberta 1 New Brunswick 2 Ontario 3 Quebec 4 and Saskatchewan 5 for the treatment of adults with rheumatoid arthritis (RA) and psoriatic arthritis (PsA). In addition, RINVOQ is now listed as a Limited Use product on the formulary of the Non-Insured Health Benefits program (NIHB) 6 for the treatment of RA and PsA.

Information regarding the specific reimbursement criteria for each province and jurisdiction may be found by consulting the links below:

This announcement comes two months after AbbVie successfully reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA), bringing a new treatment option to patients living with RA and PsA.

Rheumatoid arthritis (RA) is a chronic, progressive autoimmune disease that can affect multiple joints in the body and lead to pain, stiffness and swelling. 7 RA affects about one in 100 Canadians, which is approximately 300,000 people. 7

Psoriatic arthritis (PsA) is a type of inflammatory arthritis that usually appears in people living with psoriasis. 8 Between 10 and 30% of people with psoriasis will develop PsA, which can cause swelling, pain and inflammation in the joints. 8

About RINVOQ® (upadacitinib) 9

RINVOQ is a once-daily oral medication in an extended-release tablet. It is a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, which is thought to play a role in inflammatory response.

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate, for adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other DMARDs, for adults and adolescents 12 years of age and older with refractory moderate to severe atopic dermatitis (AD) who are not adequately controlled with a systemic treatment or when use of those therapies is inadvisable, and for adults with active ankylosing spondylitis (AS) who have had an inadequate response to a biologic DMARD or when use of those therapies is inadvisable.

For important therapeutic and safety information, please consult the RINVOQ Product Monograph at www.abbvie.ca.

About AbbVie in Rheumatology

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Anchored by a longstanding commitment to discovering and delivering transformative therapies, we pursue cutting-edge science to help improve our understanding of promising new pathways and targets, as we ultimately hope to help more people living with rheumatic diseases to reach their treatment goals.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca . Follow AbbVie Canada on Twitter , on Instagram , or find us on LinkedIn .

References

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1 Alberta Health. https://idbl.ab.bluecross.ca/idbl/drugDetails?_cid=ebdeaaaa-9331-4bcc-a6d8-ac0d0518c373&id=0000092897&intchg_grp_nbr=1&detailId=7618569 . Accessed November 18, 2022.

2 New Brunswick Drug Plans Formulary. http://www.gnb.ca/0212/BenefitUpdates-e.asp . Accessed November 22, 2022.

3 Ontario Ministry of Health. https://www.formulary.health.gov.on.ca/formulary/ Accessed November 18, 2022.

4 Régie de l'assurance maladie de Québec. https://www.ramq.gouv.qc.ca/fr/a-propos/liste-medicaments Accessed November 22, 2022.

5 Government of Saskatchewan. https://formulary.drugplan.ehealthsask.ca/SearchFormulary/BG/799398 Accessed November 18, 2022.

6 Non-Insured Health Benefits Program. https://nihb-ssna.express-scripts.ca/en/0205140506092019/16/160407 . Accessed November 10, 2022.

7 Arthritis Society of Canada. https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/rheumatoid-arthritis Accessed November 2, 2022.

8 Arthritis Society of Canada. https://arthritis.ca/about-arthritis/arthritis-types-(a-z)/types/psoriatic-arthritis . Accessed November 2, 2022.

9 AbbVie Corporation. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/RINVOQ_PM_EN.pdf . Accessed November 2, 2022.

SOURCE AbbVie Canada

Cision View original content: http://www.newswire.ca/en/releases/archive/December2022/01/c9358.html

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ABBV
Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Announces Exclusive Global Licensing Agreement with Allergan Aesthetics

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona ") is pleased to announce it has entered into a global exclusive licensing agreement with Allergan Aesthetics, an AbbVie company (NYSE: ABBV), pursuant to which Allergan Aesthetics will develop and commercialize topical skin care treatments based on active ingredients derived from certain of Sirona's patents for TFC-1067 and related family of compounds.

"We are very pleased to have finalized terms with a global leader in medical aesthetics and the innovator behind SkinMedica™, a leader in the science of skin rejuvenation," said Dr. Howard Verrico, CEO of Sirona Biochem. "Our most recent clinical trial of TFC-1067 was a collaborative effort with Allergan Aesthetics to demonstrate the clinical potential in topical skin care treatments. This further validates our platform technology as viable for additional commercial products which we are actively pursuing. We would like to thank Dr. Linda Pullan of Pullan Consulting who assisted with our current success."

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Biogen and AbbVie Receive Positive Opinion from the CHMP on ZINBRYTA™ (Daclizumab) for Treatment of Multiple Sclerosis

CAMBRIDGE, Mass. & NORTH CHICAGO, Ill.–(BUSINESS WIRE)–The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) has adopted a positive opinion
recommending the granting of a marketing authorization for ZINBRYTA™
(daclizumab) intended for the treatment of relapsing forms of multiple
sclerosis (RMS), Biogen
(NASDAQ: BIIB) and AbbVie (NYSE:
ABBV) announced today. ZINBRYTA is a once-monthly, self-administered,
subcutaneous investigational treatment for RMS. ZINBRYTA is also
currently under regulatory review in the United States, Switzerland,
Canada and Australia.
For people with relapsing forms of MS (RMS) and active disease,
ZINBRYTA has the potential to offer robust efficacy, a manageable safety
profile through patient monitoring, and once-monthly subcutaneous
dosing,” said Alfred Sandrock, M.D., Ph.D., executive vice president and
chief medical officer at Biogen. “ZINBRYTA may offer another option for
people with multiple sclerosis (MS) with its targeted mechanism of
action (MOA) which did not cause broad and prolonged immune cell
depletion.”
The CHMP positive opinion is now referred to the European Commission
(EC), which grants marketing authorizations for centrally authorized
medicines in the European Union. A decision from the EC is expected
within the coming months.
Together with Biogen, AbbVie is committed to meeting the needs of
patients with MS, and the positive opinion issued by the CHMP is a
critical step that moves us closer to bringing ZINBRYTA to patients in
Europe,” said Michael Severino, M.D., executive vice president, research
and development and chief scientific officer, AbbVie.
According to the CHMP opinion, the benefits of ZINBRYTA are its ability
to reduce the annualized relapse rate (ARR), as well as the risk of
24-week confirmed disability progression. The opinion is based on
results from two clinical trials, DECIDE and SELECT, in which ZINBRYTA
150 mg, administered subcutaneously every four weeks improved results on
key measures of MS disease activity in patients with RMS compared to
AVONEX 30 mcg intramuscular injection administered weekly and placebo,
respectively.
In the DECIDE study, the overall incidence of adverse events was similar
in the ZINBRYTA and AVONEX groups. In patients treated with ZINBRYTA
compared to AVONEX, there was an increased incidence of serious
infections (4% versus 2%), serious cutaneous reactions (2% versus <1%),
elevations of liver transaminases greater than five times the upper
limit of normal (6% versus 3%), gastrointestinal disorders (31% versus
24%), and depression (8% versus 6%).
About ZINBRYTA™ (daclizumab)
ZINBRYTA (daclizumab) is an investigational compound being developed for
the treatment of relapsing forms of MS. ZINBRYTA is a new form of a
humanized monoclonal antibody that selectively binds to the
high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is
expressed at high levels on T-cells that become activated in people with
MS. ZINBRYTA modulates IL-2 signaling without general immune cell
depletion.
Biogen and AbbVie are jointly developing ZINBRYTA.
About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops
and delivers worldwide innovative therapies for people living with
serious neurological, autoimmune and rare diseases. Founded in 1978,
Biogen is one of the world’s oldest independent biotechnology companies
and patients worldwide benefit from its leading multiple sclerosis and
innovative hemophilia therapies. For more information, please visit www.biogen.com.
Follow us on Twitter.
Biogen Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated timing of the EC’s decision on the
marketing authorization for ZINBRYTA, and potential impact of ZINBRYTA,
if approved. These statements may be identified by words such as
“believe,” “expect,” “may,” “potential,” “will” and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements. Drug development and
commercialization involve a high degree of risk. Factors which could
cause actual results to differ materially from our current expectations
include the risk that the EC may fail to approve or may delay approval
of ZINBRYTA or may not follow the recommendation of the CHMP,
uncertainty of success in commercialization of ZINBRYTA For more
detailed information on the risks and uncertainties associated with our
drug development and commercialization activities and risks relating to
our collaborations with third parties, please review the Risk Factors
section of our most recent annual or quarterly report filed with the
Securities and Exchange Commission. Any forward-looking statements speak
only as of the date of this press release and we assume no obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in
2013 following separation from Abbott Laboratories. The company’s
mission is to use its expertise, dedicated people and unique approach to
innovation to develop and market advanced therapies that address some of
the world’s most complex and serious diseases. Together with its
wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000
people worldwide and markets medicines in more than 170 countries. For
further information on the company and its people, portfolio and
commitments, please visit www.abbvie.com.
Follow @abbvie on
Twitter or view careers on our Facebook or LinkedIn
page.
Forward-Looking Statements
Some statements in this news release may be forward-looking statements
for purposes of the Private Securities Litigation Reform Act of 1995.
The words “believe,” “expect,” “anticipate,” “project” and similar
expressions, among others, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements are
subject to risks and uncertainties that may cause actual results to
differ materially from those indicated in the forward-looking
statements. Such risks and uncertainties include, but are not limited
to, challenges to intellectual property, competition from other
products, difficulties inherent in the research and development process,
adverse litigation or government action, and changes to laws and
regulations applicable to our industry.
Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie’s operations is
set forth in Item 1A, “Risk Factors,” in AbbVie’s 2014 Annual Report on
Form 10-K, which has been filed with the Securities and Exchange
Commission. AbbVie undertakes no obligation to release publicly any
revisions to forward-looking statements as a result of subsequent events
or developments, except as required by law.

Enbrel Biosimilar Marks Victory for Merck and Samsung

The biosimilar alliance between Merck (NYSE:MRK) and Samsung Bioepis appears to have paid off, as the companies have won South Korean approval for their copy of Amgen’s (NASDAQ:AMGN) blockbuster drug Enbrel.
According to Fierce Biotech:

Korea’s Ministry of Food and Drug Safety signed off on the injection, to be marketed as Brenzys, to treat rheumatoid arthritis, psoriatic arthritis, spondyloarthritis and psoriasis in adults. The biosimilar, developed as SB4, proved itself equivalent to Amgen’s cash cow in a 596-patient study disclosed this year, reducing symptoms of rheumatoid arthritis on pace with its reference product, according to Merck and Samsung.
Brenzys’ approval marks the first marketing victory for the two companies, a milestone Merck hopes will be a harbinger of future success in biosimilars.
The approval could also have major implications for Samsung Bioepis, long rumored to be considering a U.S. IPO. Details of the company’s Wall Street plans have been tricking out for months, and The Wall Street Journal reported in August that Samsung is planning a $1 billion debut offering for its biologics division, valuing the company at about $7 billion.
Samsung Bioepis, a joint venture with Biogen ($BIIB) that is 85% owned by the South Korean company, joined forces with Merck in 2013 in a wide-ranging deal designed to crack the growing market for off-patent biological treatments. Beyond Enbrel, the pair are working on copies of the similar Humira from AbbVie ($ABBV) and Remicade from Johnson & Johnson ($JNJ). The companies are also developing biosimilars of Sanofi’s ($SNY) blockbuster insulin Lantus and Roche’s ($RHHBY) cancer treatment Herceptin.

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BELLUS Health to Present on the Patient Experience and the Burden of Refractory Chronic Cough at the American Academy of Allergy, Asthma & Immunology Annual Meeting

BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough ("RCC") and other cough hypersensitivity indications, today announced that two abstracts describing the patient medical journey and the negative impact of RCC on quality of life will be presented at the upcoming American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, being held in San Antonio, Texas from February 24-27, 2023.

Poster Presentation Details:

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Oncology Stocks: 8 Biggest NASDAQ Companies in 2023

Oncology Stocks: 8 Biggest NASDAQ Companies in 2023

The wide-ranging oncology market covers every area of cancer care, from diagnosis to treatment.

Coming in only after cardiovascular disease, cancer is the second leading cause of death worldwide; unsurprisingly, oncology is one of the biggest sectors in the life science space. With that in mind, biotechnology and pharmaceutical companies alike are working to develop best-in-class therapeutics for the treatment of various cancers, including lung, breast and prostate cancer.

At this point, their work is far from finished — Precedence Research projects that the global oncology market will increase at a compound annual growth rate of 8.2 percent to reach US$581.25 billion in 2030.

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Aurinia Pharmaceuticals to Release Fourth Quarter and Full Year Financial and Operational Results on February 28, 2023

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today announced that it will release financial and operational results for fourth quarter and full year 2023 on Tuesday, February 28, 2023, before markets open. Aurinia's management team will host a conference call/webcast at 8:30 am ET that day to review these results and provide a general business update. Interested participants can dial 877-407-9170 (Toll-free U.S. & Canada). The audio webcast can also be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com . A replay of the audio webcast will be available on Aurinia's website.

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Komo Doubles Retail Distribution to 840 Stores

Komo Doubles Retail Distribution to 840 Stores

Komo Plant Based Foods Inc. (CSE: YUM) (OTCQB: KOMOF) (FSE: 9HB0) (the "Company", "Komo"), a premium plant‐based food company, reports significant growth in the number of retail stores carrying Komo products with an increase of over 100% in 3 months.

Komo Plant Based Foods Inc., a fast-growing plant-based food products manufacturer, announces a 100% increase in retail distribution since November of 2022, now available in 840 grocery retail locations across Canada. This impressive growth includes Loblaw's and Loblaws' banner stores and the addition of 50 new retail stores in January 2023, including Georgia Main Group (IGA West and Fresh St. Market), Sobey's West, Safeway and Freson Brothers locations in western Canada, and key natural accounts such as Boites à Grain in Quebec.

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Komo Plant-Based Foods Inc.

Komo Plant-Based Foods Announces Private Placement Financing

Komo Plant Based Foods Inc. (CSE: YUM) (OTCQB: KOMOF) (FRA:9HB) ("Komo" or the "Company"), a premium plant-based food company, announces a non-brokered private placement of units of the Company (the "Units") at a price of $0.15 per Unit for gross proceeds of up to $500,000 (the "Offering"). Each Unit consists of one common share of the Company (each, a "Share") and one common share purchase warrant (each, a "Warrant"). Each Warrant is exercisable to acquire one common share of the Company (a "Warrant Share") at a price of $0.20 per Warrant Share for a period of 36 months from the closing of the Offering.

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U.S. FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer

-- First Trop-2 Directed ADC to Demonstrate Overall Survival Benefit in HR+/HER2- Metastatic Breast Cancer Patients who had Received Prior Endocrine-based Therapy and at Least Two Chemotherapies --

-- Trodelvy has Now Improved Survival in both Pre-Treated HR+/HER2- Metastatic Breast Cancer and in Second-Line Metastatic Triple-Negative Breast Cancer --

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