Monoclonal antibodies

Schrödinger Announces a Multi-Target Drug Discovery, Development, and Commercialization Collaboration with Bristol Myers Squibb

Monday, November 23, 2020 - 11:30am

Bristol Myers Squibb will then be responsible for the development, manufacturing, and commercialization of the candidates.

Key Points: 
  • Bristol Myers Squibb will then be responsible for the development, manufacturing, and commercialization of the candidates.
  • We see tremendous potential in bringing together our drug discovery expertise with Bristol Myers Squibb's depth of experience in development and commercialization.
  • Additionally, Schrdinger is entitled to receive royalties on net sales of each product commercialized by Bristol Myers Squibb.
  • Schrdinger has agreed to grant Bristol Myers Squibb exclusive worldwide rights to develop and commercialize the development candidates generated by the collaboration.

Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

Sunday, November 22, 2020 - 1:17am

The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.

Key Points: 
  • The safety and effectiveness of this investigational therapy for use in the treatment of COVID-19 continues to be evaluated.
  • A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19.
  • Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system," said FDA Commissioner Stephen M. Hahn, M.D.
  • Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses.

Coherus BioSciences Announces New Employment Inducement Grants

Friday, November 20, 2020 - 9:01pm

The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Companys board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.

Key Points: 
  • The stock options were granted pursuant to the Coherus BioSciences, Inc. 2016 Employment Commencement Incentive Plan, which was approved by the Companys board of directors in June 2016 under Rule 5635(c)(4) of the Nasdaq Global Select Market for equity grants to induce new employees to enter into employment with the Company.
  • Coherus is a leading biosimilar company that develops and commercializes its own high-quality therapeutics as well as those of others seeking capable access to the United States market.
  • Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production, sales and marketing, clinical-regulatory development and commercialization, Coherus is positioned as a leader in the global biosimilar marketplace.
  • Coherus commercializes UDENYCA (pegfilgrastim-cbqv) in the United States and is advancing additional product candidates including CHS-1420, a Humira (adalimumab) biosimilar, Bioeqs Lucentis (ranibizumab) biosimilar, Innovents Avastin (bevacizumab) biosimilar towards commercialization, as well as CHS-2020, an Eylea (aflibercept) biosimilar.

IMFINZI® (durvalumab) Approved In The US For Less-Frequent, Fixed-Dose Use

Friday, November 20, 2020 - 12:00pm

IMFINZI is also approved for previously treated patients with advanced bladder cancer in the US and several other countries.

Key Points: 
  • IMFINZI is also approved for previously treated patients with advanced bladder cancer in the US and several other countries.
  • Immune-mediated colitis occurred in 1.6% (31/1889) of patients receiving IMFINZI, including Grade 4 (0.1%) and Grade 3 (0.3%) adverse reactions.
  • Immune-mediated hepatitis occurred in 1.0% (19/1889) of patients receiving IMFINZI, including fatal (
  • Immune-mediated adrenal insufficiency occurred in 0.4% (7/1889) of patients receiving IMFINZI, including Grade 3 (

2020 Market Study on the Acute Myeloid Leukemia Market in Europe - ResearchAndMarkets.com

Friday, November 20, 2020 - 11:47am

The "Europe Acute Myeloid Leukemia Market and Competitive Landscape - 2020" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Europe Acute Myeloid Leukemia Market and Competitive Landscape - 2020" report has been added to ResearchAndMarkets.com's offering.
  • This report provides comprehensive insights into the Acute Myeloid Leukemia pipeline, epidemiology, market valuations, drug sales, market forecast, drug forecasts, and market shares.
  • This research covers the following: Acute Myeloid Leukemia treatment options, Acute Myeloid Leukemia late stage clinical trials pipeline, Acute Myeloid Leukemia prevalence by countries, Acute Myeloid Leukemia market size and forecast by countries, key market events and trends, drug sales and forecast by countries, and market shares by countries.
  • Acute Myeloid Leukemia pipeline: Find out drugs in clinical trials for the treatment of Acute Myeloid Leukemia by development phase 3, phase 2, and phase 1, by pharmacological class and company
    Acute Myeloid Leukemia drugs: Identify key drugs marketed and prescribed for Acute Myeloid Leukemia in the US, including trade name, molecule name, and company
    Acute Myeloid Leukemia drugs sales: Find out the sales value for Acute Myeloid Leukemia drugs by countries
    Acute Myeloid Leukemia market valuations: Find out the market size for Acute Myeloid Leukemia drugs in 2019 by countries.

The Law Offices of Frank R. Cruz Announces Investigation of Biogen, Inc. (BIIB) on Behalf of Investors

Thursday, November 19, 2020 - 8:30pm

The Law Offices of Frank R. Cruz announces an investigation of Biogen, Inc. (Biogen or the Company) (NASDAQ: BIIB ) on behalf of investors concerning the Companys possible violations of federal securities laws.

Key Points: 
  • The Law Offices of Frank R. Cruz announces an investigation of Biogen, Inc. (Biogen or the Company) (NASDAQ: BIIB ) on behalf of investors concerning the Companys possible violations of federal securities laws.
  • On November 6, 2020, Reuters reported that an FDA panel found it cannot ignore unsuccessful trial data on Biogen Alzheimers drug.
  • The panel had also voted that an earlier-stage study does not offer supportive evidence of Biogens application for the drug, aducanumab.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Biogen, Inc. (BIIB) on Behalf of Investors

Thursday, November 19, 2020 - 6:00pm

Law Offices of Howard G. Smith announces an investigation on behalf of Biogen, Inc. (Biogen or the Company) (NASDAQ: BIIB ) investors concerning the Companys possible violations of federal securities laws.

Key Points: 
  • Law Offices of Howard G. Smith announces an investigation on behalf of Biogen, Inc. (Biogen or the Company) (NASDAQ: BIIB ) investors concerning the Companys possible violations of federal securities laws.
  • One of its product candidates is aducanumab (BIIB037), an investigational human monoclonal antibody studied for use as a treatment for early Alzheimers disease.
  • On November 6, 2020, Reuters reported that an FDA panel found it cannot ignore unsuccessful trial data on Biogen Alzheimers drug.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

 Alvotech Announces That the U.S. FDA and EMA Have Accepted Regulatory Submissions for AVT02, a Proposed Biosimilar to HUMIRA® (adalimumab)

Thursday, November 19, 2020 - 2:55pm

Additionally, the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.

Key Points: 
  • Additionally, the European Medicines Agency (EMA) has accepted for review a Marketing Authorization Application (MAA) for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.
  • Joseph E. McClellan, Chief Scientific Officer commented: We are excited to announce that our filing for AVT02 has been accepted for review.
  • This is also an important milestone for Alvotech and aligns with our mission to accelerate the introduction and adoption of new biosimilars.
  • The secondary objectives of this study are to assess the safety, tolerability, and immunogenicity of AVT02 to EU- HUMIRA and US- HUMIRA.

Global Acute Myeloid Leukemia Therapeutics Market Could Exceed $3.5 Billion By 2027

Thursday, November 19, 2020 - 1:30pm

New drug approvals for the acute myeloid leukemia treatment, are expected to drive the growth of global acute myeloid leukemia treatment market.

Key Points: 
  • New drug approvals for the acute myeloid leukemia treatment, are expected to drive the growth of global acute myeloid leukemia treatment market.
  • In fact, a report in iHealthcareAnalyist said that the global market for acute myeloid leukemia expected to reach $2.2 billion by 2025, growing at CAGR 19.6% over the forecast period, driven by introduction of high-priced products and strong pipeline of upcoming drugs.
  • During the forecast period, the marketed drugs, pipeline drugs and others are predicted to contribute 55%, 35%, and 10% market share of the global AML market, respectively.
  • Nonetheless, the high cost of the therapeutic process and its security concerns are foreseen to hinder the growth of the market.

Global Acute Myeloid Leukemia Therapeutics Market Could Exceed $3.5 Billion By 2027

Thursday, November 19, 2020 - 1:30pm

New drug approvals for the acute myeloid leukemia treatment, are expected to drive the growth of global acute myeloid leukemia treatment market.

Key Points: 
  • New drug approvals for the acute myeloid leukemia treatment, are expected to drive the growth of global acute myeloid leukemia treatment market.
  • In fact, a report in iHealthcareAnalyist said that the global market for acute myeloid leukemia expected to reach $2.2 billion by 2025, growing at CAGR 19.6% over the forecast period, driven by introduction of high-priced products and strong pipeline of upcoming drugs.
  • During the forecast period, the marketed drugs, pipeline drugs and others are predicted to contribute 55%, 35%, and 10% market share of the global AML market, respectively.
  • Nonetheless, the high cost of the therapeutic process and its security concerns are foreseen to hinder the growth of the market.