Life Science News

A RECORD-BREAKING NUMBER OF CONSUMERS PARTICIPATED, WITH BOGO GIFT CARDS SELLING OUT IN JUST A FEW HOURS 11

Yesterday, Allergan Aesthetics, an ABBVie company (NYSE: ABBV ), celebrated the fourth annual and most successful BOTOX ® Cosmetic Day yet.

Once again, the day was met with record-breaking numbers, with BOTOX ® Cosmetic seeing the largest treatment day on the books in the brand's 20-year history. 11

  • The day saw the highest single day of Allē registrations in the history of the company. 11
  • Within the first hour, the BOTOX ® Cosmetic Day site had more than 285,000 visitors. 11
  • The site also saw a 130% increase in searches for local healthcare providers online to explore BOTOX ® Cosmetic treatment options in their area, compared to last year. 11
  • The highest number of BOGO gift cards were sold in BOTOX ® Cosmetic Day history exceeding 2021 by 20%. 11
  • The brand saw over 25,000 social media posts and mentions leading up to BOTOX ® Cosmetic Day. 11

"Our record-breaking traffic this BOTOX ® Cosmetic Day demonstrates how excited people are about BOTOX ® Cosmetic. I think that is because of the natural looking results BOTOX ® Cosmetic offers at the hands of our esteemed providers 12,*,** ," said Jasson Gilmore , Senior Vice President, Allergan Data Labs. "The proof of this successful day is in the numbers and we hope to make this holiday an even better experience for our customers and providers next year."

BOTOX ® Cosmetic is the first and only product of its kind FDA approved to temporarily improve the look of moderate to severe frown lines, crow's feet lines and forehead lines in adults, with full results in 30 days. 2-6 No other product on the market has received FDA approval for use in crow's feet lines or forehead lines. 2-6 Based on results from an online market research survey, 94% of neurotoxin patients deemed FDA approval as very (73%) to somewhat (21%) important to them. 7 BOTOX ® Cosmetic offers more than 20 years of research and real-world experience. 8 It is the most widely researched and studied treatment of its kind and is approved for use in 98 countries. 9 The safety and efficacy of BOTOX ® Cosmetic have been described in more than 604 peer-reviewed articles in scientific and medical journals. 9

For those unable to secure a gift card, the two-week-long offer of double points on BOTOX ® Cosmetic treatments powered by Allē is still available until November 30, 2022. To stay current on the latest information, consumers can join Allē, a resource hub for additional information, exclusive offers, personalized content and more. Check out https://alle.com/botoxcosmeticday for the terms and conditions of this offer.

* Patients combined from two studies treated for their forehead and frown lines reported being "Mostly or Very Satisfied" with the natural looking result of treatment.

** In two clinical trials, 90% and 82% of patients reported they were "Mostly or Very Satisfied" (top 2 out of 5 responses) with their treatment results at Day 60.

Results from an online market research survey of patients who received a neurotoxin at least once within the last 2 years.

BOTOX ® Cosmetic Important Safety Information & Approved Uses

BOTOX ® Cosmetic may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX ® Cosmetic:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, and trouble swallowing.

BOTOX ® Cosmetic dosing units are not the same as, or comparable to, any other botulinum toxin product.

There has not been a confirmed serious case of spread of toxin effect when BOTOX ® Cosmetic has been used at the recommended dose to treat frown lines, crow's feet lines, and/or forehead lines.

BOTOX ® Cosmetic may cause loss of strength or general muscle weakness, vision problems, or dizziness within hours to weeks of taking BOTOX ® Cosmetic. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint.

Do not receive BOTOX ® Cosmetic if you: are allergic to any of the ingredients in BOTOX ® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc ® (rimabotulinumtoxinB), Dysport ® (abobotulinumtoxinA), or Xeomin ® (incobotulinumtoxinA); have a skin infection at the planned injection site.

Tell your doctor about all your muscle or nerve conditions, such as ALS or Lou Gehrig's disease, myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including difficulty swallowing and difficulty breathing from typical doses of BOTOX ® Cosmetic.

Tell your doctor about all your medical conditions, including: plans to have surgery; had surgery on your face; have trouble raising your eyebrows; drooping eyelids; any other abnormal facial change; are pregnant or plan to become pregnant (it is not known if BOTOX ® Cosmetic can harm your unborn baby); are breast-feeding or plan to (it is not known if BOTOX ® Cosmetic passes into breast milk).

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using BOTOX ® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX ® Cosmetic in the past.

Tell your doctor if you have received any other botulinum toxin product in the last 4 months; have received injections of botulinum toxin such as Myobloc ® , Dysport ® , or Xeomin ® in the past (tell your doctor exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; take a sleep medicine; take aspirin-like products or blood thinners.

Other side effects of BOTOX ® Cosmetic include: dry mouth; discomfort or pain at the injection site; tiredness; headache; neck pain; and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids and eyebrows, swelling of your eyelids and dry eyes.

APPROVED USES
BOTOX ® Cosmetic is a prescription medicine that is injected into muscles and used to temporarily improve the look of moderate to severe forehead lines, crow's feet lines, and frown lines between the eyebrows in adults.

For more information refer to the Medication Guide or talk with your doctor.

To report a side effect, please call Allergan at 1-800-678-1605.

Please see BOTOX ® Cosmetic full Product Information including Boxed Warning and Medication Guide .

About Allergan Aesthetics
Allergan Aesthetics, an AbbVie company, develops, manufactures, and markets a portfolio of leading aesthetics brands and products. Their aesthetics portfolio includes facial injectables, body contouring, plastics, skin care, and more. Their goal is to consistently provide customers worldwide with innovation, education, exceptional service, and a commitment to excellence, all with a personal touch.

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 its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

References

  1. Data on File. AbbVie. Neurotoxin Monthly Tracker Report, August 2022 .
  2. BOTOX ® Cosmetic Prescribing Information, July 2020 .
  3. Dysport ® Prescribing Information, 2020.
  4. Xeomin ® Prescribing Information, 2020.
  5. Jeuveau ® Prescribing Information, 2020.
  6. Daxxify™ Prescribing Information, 2022.
  7. Data on File. AbbVie. Facial Injectables Neurotoxins Consumer A&U Tracker, 2014.
  8. Data on File. AbbVie. FDA Product Approval Information, 2019.
  9. Data on file, Allergan, 2018; Country Approvals Worldwide Marketing Authorization.
  10. Data on File. AbbVie. Botulinum Toxin Peer-Reviewed Publications, 2021.
  11. Data on File. Allergan. November 2022 .
  12. Data on File. AbbVie. Ogilvie, "Pooled Subject-Reported Outcomes From 2Phase 3 Studies of OnabotulinumtoxinA for Simultaneous Treatment of Forehead and Glabellar Lines," 2020.

BOTOX® Cosmetic (onabotulinumtoxinA)

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SOURCE AbbVie

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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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New Data for Trodelvy Demonstrate Clinical Efficacy Across Trop-2 Expression Levels in HR+/HER2- Metastatic Breast Cancer

Late-Breaking TROPiCS-02 Analysis Shows that Trodelvy Demonstrates Consistent Efficacy Across Trop-2 Expression Levels –

Trop-2 is Highly Expressed in 90% of Breast Cancers

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AbbVie Launches Strategic Collaboration with HotSpot Therapeutics to Further Expand Immunology Pipeline

  • Collaboration leverages HotSpot's Smart Allostery™ drug discovery platform for the development of the first and only small molecule IRF5 (interferon regulatory factor 5) inhibitor for the potential treatment of autoimmune diseases
  • HotSpot to receive an upfront cash payment of $40 million with potential for further milestones and royalties

ABBVie (NYSE: ABBV) and HotSpot Therapeutics, Inc., a biotechnology company pioneering the discovery and development of small molecule allosteric therapies for the treatment of cancer and autoimmune diseases, today announced an exclusive worldwide collaboration and option to license agreement for HotSpot's discovery-stage IRF5 program for the treatment of autoimmune diseases.

"This collaboration with HotSpot has the potential to deliver an entirely new target class of modulators to patients with serious autoimmune diseases, such as systemic lupus erythematosus, and will help to further strengthen our robust immunology pipeline," said Jonathon Sedgwick , Ph.D., vice president and global head of discovery research, AbbVie.  "HotSpot's drug discovery platform has been able to identify molecules that bind to IRF5 in a predictable, reproducible manner potentially enabling effective drugging of what has been considered an undruggable target."

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The Gummy Project Officially Launches in U.S. Market with Ecommerce Site and Nationwide Shipping

The Gummy Project Officially Launches in U.S. Market with Ecommerce Site and Nationwide Shipping

  • U.S. customers can now purchase Watermelon Sharks and Peachy Bees at www.shopgummies.com.
  • Product is shipped nationwide across the U.S. within 5-7 days.

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is pleased to announce the official launch of its U.S. ecommerce site at www.shopgummies.com.

"We are excited to officially launch our products into the U.S. market, which is a major milestone for the company," said Charlie Lamb, CEO at GUMY. "We are now ready to ship product to all 50 states, which represents a tremendous growth opportunity for the Company beyond the existing Canadian market."

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AbbVie to Showcase Migraine Portfolio and Pipeline During the 16th European Headache Federation Congress

AbbVie to present late-breaking data from the Chronic Migraine Epidemiology and Outcomes International (CaMEO-I) study on neck pain with headache in people with and without migraineResults from the PROGRESS Phase 3 trial on atogepant for the preventive treatment of chronic migraine in Europe will also be presented

NORTH CHICAGO, Ill. , Dec. 6, 2022 /PRNewswire/ -- ABBVie (NYSE: ABBV) today announced that data from its robust migraine portfolio will be presented at the 16 th European Headache Federation Congress 2022 (EHC 2022) taking place in Vienna, Austria , December 7-10 . A total of 15 abstracts will cover a wide range of studies across AbbVie's migraine portfolio, including data on onabotulinumtoxinA and atogepant.

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The Gummy Project Announces Warrant Repricing

The Gummy Project Announces Warrant Repricing

The Gummy Project Inc. (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") announces today that it has reduced the exercise price of 7,261,700 warrants (the "Amended Warrants") of the Company. All dollar figures are quoted in Canadian dollars.

The reduced exercise price is $0.05. The Amended Warrants include an accelerated expiry provision such that the exercise period of each of the Amended Warrants is reduced to 30 days if for any 10 consecutive trading days, the closing price of the Company's common shares is equal or greater than $0.05, with the 30-day expiry period commencing on the day the Company disseminates a press release announcing the commencement of the accelerated expiry period.

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AMGEN PRESENTS NEW AMG 133 PHASE 1 CLINICAL DATA AT WCIRDC 2022

AMG 133 is a First-in-Class Investigational Bispecific Molecule That Activates GLP-1R and Inhibits GIPR

Phase 1 Results Showed up to 14.5% Reduction in Body Weight at the Highest Dose After 12 Weeks

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