Life Science News

The Klein Law Firm announces that class action complaints have been filed on behalf of shareholders of the following companies. There is no cost to participate in the suit. If you suffered a loss, you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff

Rivian Automotive, Inc. (NASDAQ:RIVN)
This lawsuit is on behalf of investors that purchased or otherwise acquired Rivian common stock pursuant and/or traceable to Rivian's initial public offering on November 10, 2021 and/or between November 10, 2021, and March 10, 2022.
Lead Plaintiff Deadline: May 6, 2022

Documents issued in connection with the initial public offering contained representations that were materially inaccurate, misleading, and/or incomplete because they failed to disclose, among other things, that the R1T electric pickup truck and R1S electric SUV were underpriced to such a degree that Rivian would have to raise prices shortly after the IPO and that these price increases would tarnish Rivian's reputation as a trustworthy and transparent company and would put a significant number of the existing backlog of 55,400 preorders, along with future preorders, in jeopardy of cancellation.

Learn about your recoverable losses in RIVN: https://www.kleinstocklaw.com/pslra-1/rivian-automotive-inc-loss-submission-form?id=25770&from=1

Grab Holdings Limited (NASDAQ:GRAB)
Class Period: November 12, 2021 - March 2, 2022
Lead Plaintiff Deadline: May 16, 2022

Grab Holdings Limited allegedly made materially false and/or misleading statements and/or failed to disclose that: (1) Grab's driver supply declined during the third quarter; (2) as a result, Grab continued to invest heavily in driver and consumer incentives to "preemptively recalibrate driver supply"; (3) as a result, the Company's financial results would be adversely impacted, including, among other things, a significant decline in revenue; 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.

Learn about your recoverable losses in GRAB: https://www.kleinstocklaw.com/pslra-1/grab-holdings-limited-loss-submission-form?id=25770&from=1

ABBVie Inc. (NYSE:ABBV)
Class Period: April 30, 2021 - August 31, 2021
Lead Plaintiff Deadline: June 6, 2022

The ABBV lawsuit alleges that throughout the class period, ABBVie Inc. 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.

Learn about your recoverable losses in ABBV: https://www.kleinstocklaw.com/pslra-1/abbvie-inc-loss-submission-form-2?id=25770&from=1

Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. If you suffered a loss during the class period and wish to obtain additional information, please contact J. Klein, Esq. by telephone at 212-616-4899 or visit the webpages provided.

J. Klein, Esq. represents investors and participates in securities litigations involving financial fraud throughout the nation. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:
J. Klein, Esq.
Empire State Building
350 Fifth Avenue
59th Floor
New York, NY 10118
jk@kleinstocklaw.com
Telephone: (212) 616-4899
Fax: (347) 558-9665
www.kleinstocklaw.com

SOURCE: The Klein Law Firm



View source version on accesswire.com:
https://www.accesswire.com/696756/The-Klein-Law-Firm-Reminds-Investors-of-Class-Actions-on-Behalf-of-Shareholders-of-RIVN-GRAB-and-ABBV

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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 Reports Second Quarter 2022 Financial Results and Business Highlights

- Completed positive End-of-Phase 2 meeting with the Food and Drug Administration ("FDA") and received scientific advice from the European Medicines Agency ("EMA") to support design of its CALM Phase 3 program, which is expected to initiate in Q4 2022 -

- Ended second quarter 2022 with approximately US$384.6 million in pro-forma cash, cash equivalents and short-term investments, including net proceeds from the July 2022 financing; Cash runway extended to 2H 2025 and through the topline results of both CALM-1 and CALM-2 trials -

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Bristol Myers Squibb and 2seventy bio Announce Topline Results from KarMMa-3 Trial Showing Abecma Significantly Improves Progression-Free Survival Versus Standard Regimens in Relapsed and Refractory Multiple Myeloma

Abecma is the first BCMA-directed CAR T cell therapy to demonstrate superiority versus standard regimens in relapsed and refractory multiple myeloma

Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced positive topline results from KarMMa-3, a Phase 3, global, randomized, multicenter, open-label study evaluating Abecma (idecabtagene vicleucel) compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory after two to four prior lines of therapy and refractory to the last regimen. KarMMa-3 is the first randomized clinical trial to evaluate a CAR T cell therapy in multiple myeloma. Results of a pre-specified interim analysis conducted through an independent review committee showed that KarMMa-3 met its primary endpoint of demonstrating a statistically significant improvement in progression-free survival. Treatment with Abecma also showed an improvement in the key secondary endpoint of overall response rate compared to standard regimens. Follow-up for overall survival, a key secondary endpoint, remains ongoing.

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Gilead Sciences and a Coalition of LGBTQ+ and Human Rights-Focused Organizations Mobilize to Address Monkeypox Public Health Emergency

Gilead Will Provide up to $5 Million in Global Grant Funding to Immediately Support Public Education and Vaccine Hesitancy Communications, a Public Policy Response and a Global Outbreak Emergency Fund for Community Organizations in Regions with Active Monkeypox Outbreaks –

Gilead Sciences, Inc. (Nasdaq: GILD), GLAAD, the Human Rights Campaign (HRC), the National Black Justice Coalition (NBJC), the National Center for Lesbian Rights (NCLR) and NMAC today announced immediate action in response to the emerging monkeypox virus (MPV) outbreak, which is disproportionately impacting the LGBTQ+ community, particularly men who have sex with men (MSM), as well as those who are living with HIV. Gilead will provide up to $5 million in global grant funding to help support three areas of focus: a public education and vaccine hesitancy communications campaign, a public policy response and a global outbreak emergency fund.

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The Gummy Project Announces That Its Gummies Land on North America's Largest Passenger Ferry Line

The Gummy Project Announces That Its Gummies Land on North America's Largest Passenger Ferry Line

  • The Ferry line is one of the largest ferry operators in the world carrying millions of passengers and vehicles each year.
  • The Ferry line to provide high traffic opportunities on board to grow brand awareness while forming strong consumer connections.

 The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is excited to announce that its Peachy Bees and Watermelon Sharks will be rolling out on North America's largest passenger ferry line later this summer.

"Our multi-channel sales strategy is designed to build significant brand awareness and connection with our purpose-driven mandate through highly strategic partnerships, such as this one, our Flair Airlines partnership along with Bard on the Beach - all supported by a growing retail presence and online ecommerce availability," said Mr. Charlie Lamb, CEO of The Gummy Project. "Having our product available on this ferry line puts our gummies and purpose-driven mandate in front of millions of people each year allowing us to engage consumers and drive revenue growth while aligning the brand and our great tasting gummies with people in the community."

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AMGEN PRESENTS NEW TARLATAMAB CLINICAL DATA AT WCLC 2022

Phase 1 Tarlatamab Study Showed Encouraging Antitumor Activity With Median Duration of Response of 13 Months in Small Cell Lung Cancer

No Approved Treatment Options Available to Patients in Third-line Setting

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AMGEN DATA AT WCLC 2022 HIGHLIGHTS POTENTIAL TO DELIVER TRANSFORMATIVE MEDICINES FOR HISTORICALLY DIFFICULT-TO-TREAT LUNG CANCERS

First Data From LUMAKRAS Plus Immunotherapy and LUMAKRAS Plus SHP2 Inhibitor Combinations Show Clinical Activity and Support Ongoing Investigation

Updated Phase 1 Tarlatamab Data Reinforce Potential of BiTE ® Therapy in Small Cell Lung Cancer

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