Biologics license application

Alvotech Provides Update on FDA Action Regarding AVT02, Proposed High-Concentration Biosimilar to Humira® (adalimumab)

Monday, September 20, 2021 - 3:23pm

Alvotech, a multinational biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets, today announced that the FDA is deferring action on the application for AVT02, the companys proposed biosimilar to Humira, until facility assessments can be completed.

Key Points: 
  • Alvotech, a multinational biopharmaceutical company focused on the development and manufacturing of high quality biosimilars for global markets, today announced that the FDA is deferring action on the application for AVT02, the companys proposed biosimilar to Humira, until facility assessments can be completed.
  • Alvotech continues to work with the FDA to coordinate the required inspection(s) in a safe and adequate manner.
  • Our fully integrated approach, with high-quality in-house competencies throughout the value chain, enables the accelerated development of biosimilar products.
  • AVT02 is a monoclonal antibody and a proposed biosimilar to Humira (adalimumab).

ROSEN, A TOP RANKED LAW FIRM, Encourages Sesen Bio, Inc. Investors with Losses to Secure Counsel Before Important October 18 Deadline in Securities Class Action – SESN

Saturday, September 18, 2021 - 9:30pm

WHAT TO DO NEXT: To join the Sesen Bio class action, go to http://www.rosenlegal.com/cases-register-2149.html or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the Sesen Bio class action, go to http://www.rosenlegal.com/cases-register-2149.html or call Phillip Kim, Esq.
  • WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

Seres Therapeutics Achieves Enrollment of 300 Subjects with Phase 3 ECOSPOR IV Open-Label Extension Study of SER-109, a Potentially First-in-Class Investigational Microbiome Therapeutic for Recurrent C. difficile Infection

Wednesday, September 15, 2021 - 12:00pm

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced it has achieved enrollment of 300 subjects with the ECOSPOR IV open-label study evaluating SER-109, an investigational oral microbiome therapeutic for recurrent C. difficile infection (rCDI).

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today announced it has achieved enrollment of 300 subjects with the ECOSPOR IV open-label study evaluating SER-109, an investigational oral microbiome therapeutic for recurrent C. difficile infection (rCDI).
  • The target enrollment of a minimum of 300 subjects for the SER-109 safety database was reached in conjunction with a prior completed Phase 3 study, ECOSPOR lll.
  • The SER-109 ECOSPOR III Phase 3 study ( ClinicalTrials.gov identifier: NCT03183128) was a multicenter, randomized, placebo-controlled study.
  • The SER-109 program is being advanced for the treatment of recurrent C. difficile infection and has potential to become a first-in-class FDA-approved microbiome therapeutic.

Innate Pharma Reports First Half 2021 Financial Results and Business Update

Wednesday, September 15, 2021 - 6:00am

The companies are currently in a transition period, in which Innate will remain the Biologics License Application (BLA) holder in the U.S until September 30, 2021.

Key Points: 
  • The companies are currently in a transition period, in which Innate will remain the Biologics License Application (BLA) holder in the U.S until September 30, 2021.
  • AstraZeneca will reimburse Innate for all Lumoxiti related costs and expenses, and Innate will remit proceeds from net sales to AstraZeneca.
  • The Company has not made any investments in tangible, intangible or significant financial assets during the first half of 2021.
  • An update of that risk is presented in note G) of the half-year management review as of June 30, 2021.

Legend Capital Led a New Round of Investment of Etana

Tuesday, September 14, 2021 - 12:42am

HONG KONG, Sept 14, 2021 - (ACN Newswire) - Legend Capital led a new round of investment of PT Etana Biotechnologies Indonesia (Etana), along with Innovent Biologics, Inc. (Innovent) (HKEX: 01801), and a consortium led by UOB Venture Management (UOBVM).

Key Points: 
  • HONG KONG, Sept 14, 2021 - (ACN Newswire) - Legend Capital led a new round of investment of PT Etana Biotechnologies Indonesia (Etana), along with Innovent Biologics, Inc. (Innovent) (HKEX: 01801), and a consortium led by UOB Venture Management (UOBVM).
  • Hong Tan, Managing Director of Legend Capital, said "We appreciate Etana's vision to provide Indonesia with cost-effective biopharmaceuticals.
  • Legend Capital is an independent professional venture capital company under Legend Holdings.
  • Its core business is positioned at the initial stage of venture capital and expansion stage growth investment.

ROSEN, A LEADING LAW FIRM, Encourages Sesen Bio, Inc. Investors with Losses Exceeding $100K to Secure Counsel Before Important Deadline in Securities Class Action – SESN

Tuesday, September 14, 2021 - 12:30am

WHAT TO DO NEXT: To join the Sesen Bio class action, go to http://www.rosenlegal.com/cases-register-2149.html or call Phillip Kim, Esq.

Key Points: 
  • WHAT TO DO NEXT: To join the Sesen Bio class action, go to http://www.rosenlegal.com/cases-register-2149.html or call Phillip Kim, Esq.
  • WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles.
  • The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation.
  • 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017.

Y-mAbs Announces Priority Review of BLA for DANYELZA® (naxitamab-gqgk) in China

Monday, September 13, 2021 - 2:00pm

We are pleased to see SciClone Pharmaceuticals receive priority review of the DANYELZA BLA in China.

Key Points: 
  • We are pleased to see SciClone Pharmaceuticals receive priority review of the DANYELZA BLA in China.
  • Priority review in China is intended to expedite review and approval, which means that we could potentially be facing approval and launch of DANYELZA in China as soon as the first quarter of 2022, commented Thomas Gad, founder, Chairman and President at Y-mAbs.
  • Researchers at MSK developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs.
  • DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis.

MIMEDX Reports Top-line Data from Two Late-Stage Musculoskeletal Trials with Proprietary Amniotic Tissue Technology

Monday, September 13, 2021 - 11:30am

MARIETTA, Ga., Sept. 13, 2021 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced top-line results from two late-stage musculoskeletal clinical trials of the Company’s micronized dehydrated Human Amnion Chorion Membrane (mdHACM): a Phase 2B clinical trial for the treatment of Knee Osteoarthritis (KOA) and a Phase 3 clinical trial for the treatment of Plantar Fasciitis (PF).

Key Points: 
  • On behalf of MIMEDX, I extend our gratitude to all the patients, families, and physicians who participated in these important and informative trials.
  • MIMEDX is an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare.
  • We derive our products from human placental tissues and process these tissues using our proprietary methods, including the PURION process.
  • We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts.

CytoDyn to Present at Emerging Growth Conference on September 15 Follow by Live Q/A

Monday, September 13, 2021 - 11:00am

The conference sponsor provides corporate visibility services to CytoDyn for a fee.

Key Points: 
  • The conference sponsor provides corporate visibility services to CytoDyn for a fee.
  • The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC).
  • It binds to CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells.
  • Leronlimab does not work on other strains of HIV (for example X4), however, R5 is the most dominant strain of HIV.

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Spectrum Pharmaceuticals, Inc of Class Action Lawsuit and Upcoming Deadline – SPPI

Thursday, September 9, 2021 - 11:33pm

NEW YORK, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Spectrum Pharmaceuticals, Inc (Spectrum or the Company) (NASDAQ: SPPI) and certain of its officers.

Key Points: 
  • NEW YORK, Sept. 09, 2021 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Spectrum Pharmaceuticals, Inc (Spectrum or the Company) (NASDAQ: SPPI) and certain of its officers.
  • To discuss this action, contact Robert S. Willoughby at newaction@pomlaw.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext.
  • Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.