Life Science News

The Class : Shareholder rights law firm Robbins LLP informs investors that a shareholder filed a class action on behalf of persons and entities that purchased or otherwise acquired ABBVie Inc. (NYSE: ABBV) securities between April 30, 2021 and August 31, 2021, for violations of the Securities Exchange Act of 1934. ABBVie is one of the world's largest pharmaceutical companies.

If you would like more information about AbbVie Inc.'s misconduct, click here .

What is this Case About: ABBVie Inc. (ABBV) Misled Investors Regarding the Efficacy of its Drug Rinvoq

According to the complaint, during the class period, defendants touted the safety of its Rinvoq drug for further application. Specifically, AbbVie was looking to expand Rinvoq's application from treating severe rheumatoid arthritis to treating psoriatic arthritis, ankylosing spondylitis, and atopic dermatitis. Rinvoq is pharmacologically similar to Xeljanz, which is manufactured by Pfizer and comes with a warning that certain doses are associated with elevated risks of serious heart-related issues, cancer, and other adverse events. Notwithstanding, defendants led investors to believe Rinvoq was far safer than Xeljanz and downplayed the likelihood that the FDA would take regulatory action against Rinvoq as a result of Xeljanz's problematic safety profile.

On June 25, 2021, Abbvie revealed that the FDA would not complete its review of several of the expended treatment indications for Rinvoq by the end of June, as previously announced, due to ongoing evaluation of safety concerns associated with Xeljanz. Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq because of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

On December 3, 2021, AbbVie announced the FDA had updated Rinvoq's label in accordance with its September 1, 2021, decision. Specifically, the label would indicate the risks of malignancy and thrombosis, and the addition of mortality and MACE. Further, AbbVie can only market Rinvoq as an alternative option after other anti-inflammatory drugs have failed. On January 11, 2022, defendants admitted these changes would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

Next Steps: If you own shares of ABBVie Inc. (ABBV) you have legal options. Contact us for more information.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.

Contact us to learn more:

Aaron Dumas
(800) 350-6003
adumas@robbinsllp.com
Shareholder Information Form

About Robbins LLP : A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002. To be notified if a class action against AbbVie Inc. settles or to receive free alerts when corporate executives engage in wrongdoing, sign up for Stock Watch today.

Attorney Advertising. Past results do not guarantee a similar outcome.

Aaron Dumas
Robbins LLP
5040 Shoreham Place
San Diego, CA 92122
adumas@robbinsllp.com
(800) 350-6003
www.robbinsllp.com

News Provided by Business Wire via QuoteMedia

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."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

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.

Keep reading...Show less
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."

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

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 –

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

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

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

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

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Boosh Plant-Based Brands Announces Delay of Filings

Boosh Plant-Based Brands Announces Delay of Filings

Boosh Plant-Based Brands Inc. (CSE: VEGI) (OTCQB: VGGIF) (FSE: 77i) ("Boosh" or the "Company") a premier plant-based brand in the in-health food sector, announces today that a management cease trade order was granted on August 2, 2022 (the "MCTO") by the British Columbia Securities Commission under National Policy 12-203 - Management Cease Trade Orders ("NP 12-203"), as the Company anticipates delays in filing its financial statements for the year ended March 31, 2022, and the related management's discussion and analysis ("MD&A") and certifications (the "Annual Filings"). The MCTO does not affect the ability of investors who are not insiders to trade in the securities of the Company.

The Company will work with its auditors to complete the audit of the Company's consolidated financial statements and expects to file the Annual Filings by August 31, 2022. The delays are primarily the result of the close proximity of the Company's acquisition of substantially all of the assets of Beanfields, Inc. on February 16, 2022, and the Company's financial year end of March 31, and the work required to consolidate those operations.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

Bristol Myers Squibb to Host Virtual Investor Event to Discuss ESC 2022 Highlights

Bristol Myers Squibb (NYSE: BMY) today announced that the company will host a virtual Investor Event on Sunday, August 28, 2022, at 7:00 p.m. CET/ 1:00 p.m. ET to discuss data from the AXIOMATIC-SSP Phase 2 trial of milvexian in secondary stroke prevention presented at the European Society of Cardiology Congress 2022 in Barcelona, Spain.

Company executives will provide an overview of data presented and address questions from investors and analysts.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×