Life Science News

The securities litigation law firm of The Gross Law Firm issues the following notice on behalf of shareholders in the following publicly traded companies. Shareholders who purchased shares in the following companies during the dates listed are encouraged to contact the firm regarding possible Lead Plaintiff appointment. Appointment as Lead Plaintiff is not required to partake in any recovery

ABBVie Inc. (NYSE:ABBV)

Investors Affected : April 30, 2021 - August 31, 2021

A class action has commenced on behalf of certain shareholders in AbbVie Inc. The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose 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.

Shareholders may find more information at https://securitiesclasslaw.com/securities/abbvie-inc-loss-submission-form/?id=27590&from=1

Ironnet, Inc. (NYSE:IRNT)

Investors Affected : September 15, 2021 - December 15, 2021

A class action has commenced on behalf of certain shareholders in Ironnet, Inc. The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (i) the Company had materially overstated its business and financial prospects; (ii) the Company was unable to predict the timing of significant customer opportunities which constituted a substantial portion of its publicly- issued FY 2022 financial guidance; (iii) the Company had not established effective disclosure controls and procedures to reasonably ensure its public disclosures were timely, accurate, complete, and not otherwise misleading; and (iv) as a result, the Company's public statements were materially false, misleading, and/or lacked any reasonable basis in fact at all relevant times.

Shareholders may find more information at https://securitiesclasslaw.com/securities/ironnet-inc-loss-submission-form/?id=27590&from=1

Bakkt Holdings, Inc. f/k/a VPC Impact Acquisition Holdings (NYSE:BKKT)

This lawsuit is on behalf of persons and entities that purchased or otherwise acquired: (a) Bakkt securities between March 31, 2021 and November 19, 2021, both dates inclusive; and/or (b) Bakkt Class A common stock pursuant and/or traceable to documents issued in connection with the business combination between the Company and Bakkt Holdings, LLC completed on or about October 15, 2021.

A class action has commenced on behalf of certain shareholders in Bakkt Holdings, Inc f/k/a VPC Impact Acquisition Holdings. The filed complaint alleges that defendants made materially false and/or misleading statements and/or failed to disclose that: (i) the Company had defective financial controls; (ii) as a result, there were errors in the Company's financial statements related to the misclassification of certain shares issued prior to the business combination between the Company and Bakkt Holdings, LLC; (iii) accordingly, the Company would need to restate certain of its financial statements; (iv) the Company downplayed the true scope and severity of these issues; (v) the Company overstated its remediation of its defective financial controls; and (vi) as a result, the documents issued in connection with the business combination and defendants' public statements throughout the class period were materially false and/or misleading and failed to state information required to be stated therein.

Shareholders may find more information at https://securitiesclasslaw.com/securities/bakkt-holdings-inc-f-k-a-vpc-impact-acquisition-holdings-loss-submission-form/?id=27590&from=1

The Gross Law Firm, Monday, May 23, 2022, Press release picture

The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a Company lead to artificial inflation of the Company's stock. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
The Gross Law Firm
15 West 38th Street, 12th floor
New York, NY, 10018
Email: dg@securitiesclasslaw.com
Phone: (212) 537-9430
Fax: (833) 862-7770

SOURCE: The Gross Law Firm



View source version on accesswire.com:
https://www.accesswire.com/702320/The-Gross-Law-Firm-Announces-Class-Actions-on-Behalf-of-Shareholders-of-ABBV-IRNT-and-BKKT

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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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Health Canada Approves OPDIVO® as Monotherapy for the Adjuvant treatment of Adults with Urothelial Carcinoma at High Risk of Recurrence after Undergoing Radical Resection of UC

First adjuvant Immunotherapy for patients at high risk of disease recurrence

Today, Bristol Myers Squibb Canada (BMS) announced Health Canada has issued a Notice of Compliance with Conditions (NOCc) for OPDIVO ® , as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC. i OPDIVO ® is the first immuno-oncology treatment to bring benefit in the adjuvant setting of UC and represents a potential new standard of care for patients at high risk of disease recurrence. ii Unlike traditional cancer therapies that target the tumour directly, immuno-oncology activates the body's own immune system to help recognize and attack cancer cells. iii

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Kite's CAR T-cell Therapy Yescarta® Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Follicular Lymphoma

Pivotal ZUMA-5 Study Demonstrates Overall Response Rate of 91% and a Complete Response rate of 77% in Patients Who Received Yescarta After Three or More Lines of Therapy –

Kite's Third Approved Cell Therapy Indication in Europe

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Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor

NDA Resubmission Addresses Issues Related to Vial Compatibility –

If Approved, Lenacapavir Would be the First and the Only HIV-1 Treatment Option Administered Twice-Yearly

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Cardiol Therapeutics to Webcast Virtual Annual General Meeting on June 28th at 4:30 P.M. EDT

Cardiol Therapeutics to Webcast Virtual Annual General Meeting on June 28th at 4:30 P.M. EDT

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of cardiovascular diseases ("CVD"), is pleased to announce that the Company's virtual Annual General Meeting of Shareholders (the "AGM") will be webcast on June 28, 2022, at 4:30 p.m. EDT.

Cardiol Therapeutics 2022 AGM

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Gilead Endorses The Kigali Declaration On Preventing, Controlling and Eliminating Neglected Tropical Diseases

- By signing the Kigali Declaration, Gilead joins the global community committed to ending neglected tropical diseases by 2030 -

Gilead Sciences today announced that the company has signed onto the Kigali Declaration on neglected tropical diseases (NTDs) which succeeds the London Declaration on NTDs. It was launched on the margins of the Commonwealth Heads of Government Meeting (CHOGM), at a high-level session that was attended by Heads of State, other global dignitaries, industry partners and global community as part of a joint malaria and NTDs Summit. This high-level political declaration is an important milestone for the World Health Organization's 2030 road map which includes global targets to prevent, control and in some cases eliminate 20 diseases and disease groups by 2030.

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Approximately 15,000 AbbVie Employees to Volunteer Globally to Support Local Communities in Annual Week of Possibilities

AbbVie's Week of Possibilities returns in 2022 for its seventh year with approximately 15,000 employees participating in volunteer activities globally to strengthen local communities, expand educational programs and make a positive environmental impact Week of Possibilities is AbbVie's global, in-person volunteering program that unites employees around the world with a single purpose: to give back to local communities through volunteering

NORTH CHICAGO, Ill. , June 27, 2022 /PRNewswire/ -- AbbVie kicks off its seventh Week of Possibilities today with approximately 15,000 employees volunteering in more than 50 countries to serve local communities around the world. From June 27 to July 1 , AbbVie employees will work with trusted community partners to complete hands-on projects, including renovating schools, playgrounds and community centers, to benefit local communities impacting tens of thousands of people.

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