Life Science News

The Law Offices of Vincent Wong announce that class actions have commenced on behalf of certain shareholders in the following companies. If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. There will be no obligation or cost to you

Acutus Medical, Inc. (NASDAQ:AFIB)

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/acutus-medical-inc-loss-submission-form?prid=25704&wire=1
Lead Plaintiff Deadline: April 18, 2022
This lawsuit is on behalf of all purchasers of Acutus common stock between May 13, 2021 and November 11, 2021, inclusive.

Allegations against AFIB include that: (a) a material percentage of the Company's AcQMap imaging and mapping systems under evaluation had been randomly installed at sites with little, if any, consideration given to whether the healthcare providers at the selected locations were likely to adopt, or desire, the Company's products; (b) a material percentage of the AcQMap systems under evaluation had been installed in locations where the Company did not possess the infrastructure necessary to appropriately educate, train, and support medical service providers on the system's operations; (c) as a result of (a) and (b) above, defendants were in the process of designing a strategic plan to terminate and relocate approximately 20% of then-existing AcQMap systems evaluation arrangements; (d) the Company's management discussion and analysis was materially false and misleading and failed to disclose that the termination and relocation of approximately 20% of existing AcQMap systems evaluation arrangements was reasonably likely to have a material adverse effect on the Company's 2021 financial results; and (e) the Company's risk factor discussions were materially false and misleading and made reference to potential risks without disclosing that such risks were then-existing or adequately describing the specific nature of the risks then facing the Company.

Celsius Holdings, Inc. (NASDAQ:CELH)

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/celsius-holdings-inc-loss-submission-form?prid=25704&wire=1
Lead Plaintiff Deadline: May 16, 2022
Class Period: August 12, 2021 - March 1, 2022

Allegations against CELH include that: (1) the Company had improperly recorded expenses for non-cash share-based compensation for second and third quarters of 2021; (2) as a result, the Company's financial statements for those periods would be restated, including to report a net loss for the third quarter of 2021; (3) there was a material weakness in Celsius's internal controls over financial reporting; and (4) as a result of the foregoing, defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

AbbVie Inc. (NYSE:ABBV)

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/abbvie-inc-loss-submission-form-2?prid=25704&wire=1
Lead Plaintiff Deadline: June 6, 2022
Class Period: April 30, 2021 - August 31, 2021

Allegations against ABBV include that: (1) safety concerns about Pfizer Inc.'s drug Xeljanz extended to ABBVie's drug Rinvoq and to other Janus kinase enzyme inhibitor drugs; (2) as a result, it was likely that the U.S. Food and Drug Administration would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, defendants' statements about the Company's business, operations, and prospects lacked a reasonable basis.

To learn more contact Vincent Wong, Esq. either via email vw@wongesq.com or by telephone at 212.425.1140.

Vincent Wong, Esq. is an experienced attorney who has represented investors in securities litigations involving financial fraud and violations of shareholder rights. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
Vincent Wong, Esq.
39 East Broadway
Suite 304
New York, NY 10002
Tel. 212.425.1140
Fax. 866.699.3880
E-Mail: vw@wongesq.com

SOURCE : The Law Offices of Vincent Wong



View source version on accesswire.com:
https://www.accesswire.com/696591/SHAREHOLDER-ALERT-AFIB-CELH-ABBV-The-Law-Offices-of-Vincent-Wong-Reminds-Investors-of-Important-Class-Action-Deadlines

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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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Boosh Settles $190,000 In Debt

Boosh Settles $190,000 In Debt

Boosh Plant-Based Brands Inc. (CSE: VEGI) (OTCQB: VGGIF) (FSE: 77i) ("Boosh" or the "Company") announces that it has entered into a settlement agreement with an arm's length third party for the settlement of $191,428.52 in debt for services previously provided through the issuance of 1,519,274 common shares at a deemed price of $$0.126 per share.

All securities issued in the debt settlement are subject to a four month and one day hold period expiring on December 04, 2022.

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AMGEN REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS

Amgen (NASDAQ:AMGN) today announced financial results for the second quarter of 2022. Key results include:

  • Total revenues increased 1% to $6.6 billion in comparison to the second quarter of 2021, resulting from 3% growth in global product sales partially offset by lower Other Revenue from our COVID-19 manufacturing collaboration.
    • Volumes grew double-digits for a number of products including Repatha ® (evolocumab), Prolia ® (denosumab), LUMAKRAS ® /LUMYKRAS™ (sotorasib) and EVENITY ® (romosozumab-aqqg).
  • GAAP earnings per share (EPS) increased from $0.81 to $2.45 driven by a decrease in operating expenses due to the write-off of $1.5 billion in Acquired In-Process Research & Development (Acquired IPR&D) associated with our acquisition of Five Prime Therapeutics in Q2 2021 and lower weighted-average shares outstanding in Q2 2022, partially offset by an impairment charge related to the divestiture of GENSENTA, a generics subsidiary in Turkey .
    • GAAP operating income increased from $0.8 billion to $2.2 billion , and GAAP operating margin increased 21.1 percentage points to 34.6%.
  • Non-GAAP EPS increased from $1.77 to $4.65 driven by a decrease in operating expenses due to the write-off of $1.5 billion in Acquired IPR&D associated with our acquisition of Five Prime Therapeutics in Q2 2021 and lower weighted-average shares outstanding in Q2 2022.
    • Non-GAAP operating income increased from $1.6 billion to $3.3 billion , and non-GAAP operating margin increased 26.8 percentage points to 53.1%.
  • The Company generated $1.7 billion of free cash flow for the second quarter versus $1.7 billion in the second quarter of 2021.
  • 2022 total revenues guidance revised to $25.5 - $26.4 billion ; EPS guidance revised to $11.01 - $12.15 on a GAAP basis, and reaffirmed at $17.00 - $18.00 on a non-GAAP basis.

"We are focused on delivering our long-term objectives by serving an ever-increasing number of patients around the world with our medicines," said Robert A. Bradway , chairman and chief executive officer. "We are advancing our pipeline and look forward to important readouts over the next few months."

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The Gummy Project Secures Additional Repeat Order from Existing Customer Flair Airlines

The Gummy Project Secures Additional Repeat Order from Existing Customer Flair Airlines

  • The Company had previously announced its first repeat order with existing customer Bard on the Beach.
  • Partnership with Flair rapidly accelerates The Gummy Project's growth across Canada with GUMY products being featured for sale on all Flair flights.
  • As the "Better for You" gummy company, The Gummy Project, through its Flair Airlines partnership, will extend the reach and effectiveness of its purpose driven mission to support endangered keystone species.

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is excited to announce that the Company has received a repeat order from its existing customer Flair Airlines ("Flair").

"We are very pleased to receive our second repeat order from an existing customer. We view this as another vote of confidence that our customers are very much enjoying our gummies and strongly embracing our mandate to support endangered keystone species," said Charlie Lamb, President & CEO of The Company. "We look forward to building upon the momentum that the Company has created as we continue to accelerate revenue generation and brand awareness."

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Gilead Sciences to Acquire MiroBio

Acquisition Provides Gilead with MiroBio's Pipeline of Immune Checkpoint Agonists and Proprietary Discovery Platform –

– MiroBio's Scientific Approach to Restoring Immune Balance for the Treatment of Autoimmune Diseases Complements Gilead's Inflammation Research and Development Strategy –

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AMGEN TO ACQUIRE CHEMOCENTRYX FOR $4 BILLION IN CASH

Acquisition Includes TAVNEOS ® (avacopan), a First-in-Class Medicine for Patients With Serious Autoimmune Disease

Tavneos Adds to Amgen's Decades-Long Leadership in Inflammation and Nephrology

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Aurinia Reports Second Quarter and Six Months 2022 Financial and Operational Results

Net revenue increased to $28.2 million for Q2 2022; Maintains net revenue guidance range of $115-$135 million from sales of LUPKYNIS ® (voclosporin) for 2022

Continued increases in LUPKYNIS Patients on Treatment; Steady Conversion Rates and Payor Coverage

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