China Biologic Products

FDA Approves First Biosimilar to Treat Macular Degeneration Disease and Other Eye Conditions

Monday, September 20, 2021 - 3:58pm

Byooviz is also approved to treat macular edema (fluid build-up) following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).

Key Points: 
  • Byooviz is also approved to treat macular edema (fluid build-up) following retinal vein occlusion (blockage of veins in the retina) and myopic choroidal neovascularization, a vision-threatening complication of myopia (nearsightedness).
  • Neovascular (wet) age-related macular degeneration destroys the sharp, central vision needed to see clearly and can affect daily activities like reading, driving and watching television.
  • Patients can expect the same safety and effectiveness from the biosimilar over the course of treatment as from the reference product.
  • To date, the FDA has approved 31 biosimilars, including one interchangeable biosimilar , for the treatment of a variety of health conditions.

Certis Biologicals Adds Florida Citrus Expert

Monday, September 20, 2021 - 2:17pm

Certis Biologicals is investing additional expertise and resources to bring biologicals to aid in fighting Floridas growing citrus concerns.

Key Points: 
  • Certis Biologicals is investing additional expertise and resources to bring biologicals to aid in fighting Floridas growing citrus concerns.
  • Lee Shekels has joined the biologicals leader in a newly created role, Florida Citrus Sales Specialist, working alongside the companys existing Florida sales and field development teams.
  • View the full release here: https://www.businesswire.com/news/home/20210920005058/en/
    Lee Shekels has joined Certis Biologicals in a newly created role, Florida Citrus Sales Specialist.
  • (Photo: Business Wire)
    The Florida citrus industry contributes $6.76 billion to the states economy and consumers around the world rely upon our growers to produce the best produce possible, says Chuck Goodowns, Certis Biologicals Florida Regional Manager.

FDA Advances Data, IT Modernization Efforts with New Office of Digital Transformation

Wednesday, September 15, 2021 - 9:11pm

The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level.

Key Points: 
  • The office has been realigned to report directly to the FDA commissioner, elevating the office and its functions to agency-level.
  • This reorganization will advance the agency's information technology transformation with improved data and IT competencies that improve agency operations to support the public health mission.
  • The reorganization is a significant step in the FDA's technology and data modernization efforts that began more than two years ago.
  • The FDA FY 2022 budget request included funding to support the agency's data and IT modernization efforts for enterprise-wide data modernization, demonstrating the commitment to and the progress of these institutional changes.

4D pharma Presents Two Clinical Posters for Live Biotherapeutic MRx0518 at the European Society for Medical Oncology (ESMO) Congress 2021

Wednesday, September 15, 2021 - 12:00pm

These new findings indicate the potential to predict patients most likely to respond to MRx0518 therapy based on tumor biology.

Key Points: 
  • These new findings indicate the potential to predict patients most likely to respond to MRx0518 therapy based on tumor biology.
  • We look forward to utilizing and implementing these important new findings as we work to progress this novel oncology Live Biotherapeutic through development towards approval.
  • Both ePosters will be available under the Posters and Publications section of the 4D pharma website at www.4dpharmaplc.com at 7:30 GMT on Thursday 16th September 2021.
  • 4D pharma's Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut.

Ginkgo Bioworks to Go Public with Over $1.6 Billion in Proceeds

Tuesday, September 14, 2021 - 2:13pm

Upon the closing of the Business Combination (the Closing), Ginkgo Bioworks expects to receive $1.633 billion of gross proceeds, including $775 million in committed funding from a PIPE plus approximately $858 million from the Soaring Eagle trust account.

Key Points: 
  • Upon the closing of the Business Combination (the Closing), Ginkgo Bioworks expects to receive $1.633 billion of gross proceeds, including $775 million in committed funding from a PIPE plus approximately $858 million from the Soaring Eagle trust account.
  • Ginkgo Bioworks is building the worlds leading horizontal platform for cell programming.
  • In addition to its cell programming work, Ginkgo last year launched Concentric by Ginkgo, the companys public health and biosecurity initiative, to provide a response to the COVID-19 pandemic.
  • Soaring Eagle and Ginkgo caution readers not to place undue reliance upon any forward-looking statements, which speak only as of the date made.

Pyxis Oncology Appoints Jay M. Feingold, M.D., Ph.D., as Chief Medical Officer

Tuesday, September 14, 2021 - 1:00pm

CAMBRIDGE, Mass., Sept. 14, 2021 (GLOBE NEWSWIRE) -- Pyxis Oncology ("Pyxis" or the Company) today announced the appointment of Jay M. Feingold, M.D., Ph.D., as Chief Medical Officer.

Key Points: 
  • CAMBRIDGE, Mass., Sept. 14, 2021 (GLOBE NEWSWIRE) -- Pyxis Oncology ("Pyxis" or the Company) today announced the appointment of Jay M. Feingold, M.D., Ph.D., as Chief Medical Officer.
  • Dr. Feingold holds 20 years of experience in clinical development and medical affairs with a history of successfully bringing new hematology and oncology drugs to market.
  • Most recently, Dr. Feingold served as Chief Medical Officer and Senior Vice President of ADC Therapeutics, where he led the clinical development of six ADCs for hematologic malignancies and solid tumors.
  • Previously, Dr. Feingold worked as Vice President of U.S. Medical Affairs and Chairman of the Global Medical Affairs Oversight Committee at Daiichi Sankyo.

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.

Trane Technologies to Acquire Farrar Scientific, a Leader in Ultra-Low Temperature Control for Biopharmaceutical and other Life Science Industries

Monday, September 13, 2021 - 11:30am

Trane Technologies (NYSE: TT), a global climate innovator, announced that it has signed an agreement to acquire Farrar Scientific, a leader in ultra-low temperature control for biopharmaceutical and other life science applications.

Key Points: 
  • Trane Technologies (NYSE: TT), a global climate innovator, announced that it has signed an agreement to acquire Farrar Scientific, a leader in ultra-low temperature control for biopharmaceutical and other life science applications.
  • Farrar Scientifics proprietary technology fills an unmet need for flexible, modular, and efficient ultra-low temperature process and storage, including cooling and heating/thawing.
  • Farrar Scientific has revolutionized ultra-low temperature control for biopharmaceutical companies and become a critical supplier to large pharma customers, said Dave Regnery, CEO of Trane Technologies.
  • Trane Technologies will acquire 100% of Farrar Scientifics assets, including its patented ultra-low temperature control technologies, a development and assembly operation in Marietta, Ohio, and a specialized team of engineers, sales engineers, operators, and technicians.

4D pharma to Participate in Upcoming Virtual Investor Conferences in September

Thursday, September 9, 2021 - 12:00pm

Archived replays of the webcasts will be available for 90 days following the presentation.

Key Points: 
  • Archived replays of the webcasts will be available for 90 days following the presentation.
  • 4D has developed a proprietary platform, MicroRx, that rationally identifies Live Biotherapeutics based on a deep understanding of function and mechanism.
  • 4D pharma's Live Biotherapeutic products (LBPs) are orally delivered single strains of bacteria that are naturally found in the healthy human gut.
  • Preclinical-stage programs include candidates for CNS disease such as Parkinson's disease and other neurodegenerative conditions.

Albireo Sells Priority Review Voucher (PRV) for $105 Million

Tuesday, September 7, 2021 - 1:30pm

BOSTON, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare pediatric liver disease company developing novel bile acid modulators, today announced that it has entered into a definitive agreement to sell its Priority Review Voucher (PRV) for $105 million. The PRV was granted to Albireo under a U.S. Food and Drug Administration (FDA) provision that encourages the development of treatments for rare pediatric diseases. The Company received the voucher with the approval of Bylvay for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC).

Key Points: 
  • BOSTON, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare pediatric liver disease company developing novel bile acid modulators, today announced that it has entered into a definitive agreement to sell its Priority Review Voucher (PRV) for $105 million.
  • The Company received the voucher with the approval of Bylvay for the treatment of pruritus in all types of progressive familial intrahepatic cholestasis (PFIC).
  • The sale of the PRV provides Albireo with an important source of non-dilutive capital and further strengthens our balance sheet.
  • Jefferies LLC acted as financial advisor to Albireo on this transaction and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.