ADMA Biologics, Inc. (NASDAQ: ADMA) announces that the U.S. Food and Drug Administration (“FDA”) has approved ASCENIV™, Immune Globulin Intravenous, Human – slra 10% Liquid, formerly referred to as RI-002. ASCENIV™ is an Intravenous Immune Globulin (“IVIG”) drug product for the treatment of Primary Humoral Immunodeficiency Disease (“PIDD” or “PI”) in adults and adolescents (12 to 17 years of age). The Company anticipates having the product available for commercial launch during the second half of 2019.
ADMA Biologics announces that it has received formal notice from the FDA of the successful close-out for the April 2018 compliance inspection of the Boca Raton, FL production facility. This is the first EIR issued to the site since 2012.
Quest Analytics, the leading provider of network access and adequacy services to health plans and insurance regulatory agencies, today announced that it has acquired BetterDoctor, the nation’s most accurate provider data management platform. Together, the companies will provide the first comprehensive platform that enables health plans to optimize their member experience while complying with federal and state regulations for network adequacy and accuracy.
Celgene Corporation (NASDAQ:CELG) and Juno Therapeutics, Inc. (NASDAQ:JUNO) today announced the signing of a definitive merger agreement in which Celgene has agreed to acquire Juno. Under the terms of the merger agreement, Celgene will pay $87 per share in cash, or a total of approximately $9 billion, net of cash and marketable securities acquired and Juno shares already owned by Celgene (approximately 9.7% of outstanding shares). The transaction was approved by the boards of directors of both companies.
JHL Biotech Submits Clinical Trial Application in Europe for Proposed Dornase Alfa Biosimilar to Affordably Manage Symptoms of Cystic Fibrosis
JHL Biotech Inc. (Stock Code: 6540.TWO) announced today that it has submitted a Phase 1 Clinical Trial Application to the Dutch Healthcare Authority for its proposed dornase alfa biosimilar, JHL1922, to improve pulmonary function of cystic fibrosis patients.
JHL Biotech, at December 15, 2017, has submitted a Phase I Clinical Trial Application (“CTA”) to European authorities for its proposed bevacizumab biosimilar, JHL1149.
ADMA Biologics announced today that its acquisition of the assets of Biotest Pharmaceuticals Corporation’s Therapy Business Unit (BTBU) has been completed. ADMA has assumed operational control of the assets and has formally commenced integration activities.
JHL Biotech Inc. (Stock Code: 6540.TWO) is announcing that its Clinical Trial Application for use of JHL1101 in Phase 1 and Phase 3 clinical trials in Non-Hodgkin’s Lymphoma patients has been accepted by the China Food and Drug Administration.
JHL Biotech Inc. (Stock Code: 6540.TWO) today announced that the first patient has been dosed in the company's Phase I clinical trial of JHL1101 (a proposed rituximab biosimilar) in rheumatoid arthritis patients.
HyperMed Imaging, Inc. announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for the company’s new medical imaging device called HyperView™. The HyperView product is a handheld, battery operated, portable diagnostic imaging device that is used to assess tissue oxygenation without contacting the patient
Sanofi (EURONEXT: SAN and NYSE: SNY), a global healthcare leader and JHL Biotech, Inc. (6540.TWO), a biopharmaceutical company with development and manufacturing facilities in Wuhan and Taiwan, announced today a strategic alliance to collaborate on the development and commercialization of biological therapeutics in China and with potential international expansion.
Scientific Publication by a Group Including Juno Therapeutics Scientific Co-Founder Michel Sadelain Is Featured in Endpoints News Article
CAR-Ts won’t be on the market before next year, but the technology arms race inspired by the prospect of a multibillion-dollar market has inspired a group of prominent investigators to design a new, 3.0 model in the lab that includes a built-in checkpoint mechanism. And it worked like a charm in mouse models of solid tumors - a critical hurdle that the key players have been struggling to clear.
JHL Biotech (TWEM: 6540) and GE Healthcare’s Life Sciences business (NYSE: GE) are proud to announce mechanical completion of JHL Biotech’s JHL-1 biopharmaceutical manufacturing facility in the Biolake area of Wuhan, China.
JHL Biotech Intends to Manufacture Biosimilars in Its New Facility, the Company Is Featured in Fierce Pharma Manufacturing and Bloomberg Articles
First prefab biologics plant goes up in China, in 11 days. JHL Biotech intends to manufacture biosimilars in its new facility.
(GenomeWeb) – Strand Life Sciences is aiming to position its 152-gene cancer sequencing test for solid tumors as a tool that can be used early on in a patient's disease in order to inform first-line therapy.
JHL Biotech (TWEM: 6540), an emerging biosimilars company incorporated in Cayman Islands and based in Taiwan and China, announced today it has been publicly listed on the Taiwan Emerging Stock Board, effective September 17, 2015.
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics, announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's Biologics License Application (BLA) for RI-002 intended for the primary immunodeficiency (PI) population.
JHL Biotech, Inc., an emerging biopharmaceutical company, today announced that it has closed a Series C fundraising of $45.6 million, led by funds managed by a global renowned crossover fund with over US$1.6 trillion in AUM, with participation from existing investor Milestone Capital and new investors Sungent BioVenture and Liwick Investment Management.
Opus Bio, Inc., today announced that Juno Therapeutics, Inc. has entered into an agreement to obtain a license for the company’s CAR-T cell product candidate targeting CD22, a protein expressed on most B cell leukemias and lymphomas.