Pharmaceuticals

Luminex Corporation Submits VERIGENE(R) II Respiratory Flex Assay for FDA Clearance

AUSTIN, Texas, March 2, 2020 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX) today announced that the company has submitted an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of the VERIGENE® II RespiratoryFlex Assay, the second VERIGENE II assay to be submitted...

2020-03-02 10:00 6114

Tessa Therapeutics Announces U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to its CD30 CAR-T Cell Therapy for the Treatment of Relapsed or Refractory CD30-positive Classical Hodgkin Lymphoma

SINGAPORE, Feb. 27, 2020 /PRNewswire/ -- Tessa Therapeutics (Tessa), a clinical-stage cell therapy company developing next-generation cancer treatments, today announced that the Company's investigational CD30-directed autologous chimeric antigen receptor T cell (CD30 CAR-T) therapy has been gran...

2020-02-27 20:00 2242

European Medicines Agency accepts submission of GSK's Marketing Authorisation Application for Zejula (niraparib) in first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer

-  Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically meaningful outcomes of niraparib maintenance treatment in the first-line setting regardless of biomarker status LONDON, Feb. 27, 2020 /PRNewswire/ -- GlaxoSmithKline plc announced that the European M...

2020-02-27 17:00 1425

Clinical Trial of Ganovo® and Ritonavir Combination Therapy on Novel Coronavirus Pneumonia

HANGZHOU and SHAOXING, China, Feb. 27, 2020 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) announces today the advancement in Novel Coronavirus Pneumonia clinical trial of oral Ganovo® and Ritonavir combination therapy, led by Dr. Hongyi CHEN, the director of the Ninth Hospital ofNanchang...

2020-02-27 08:00 4061

Global Pharmaceutical Contract Manufacturing Organization Market to Reach $102.14 Billion by 2024

Advancements in flexible manufacturing technology to help address new demand in personalized medicine, finds Frost & Sullivan SANTA CLARA, California, Feb. 27, 2020 /PRNewswire/ -- Contract manufacturing organizations (CMOs) are currently transitioning from transactional relationships to strateg...

2020-02-27 01:28 1522

KAHR Medical Raises $18 Million in Private Funding Round

Funds will be used for advancing the Company's next generation immuno-oncology drug candidates, including lead anti-CD47 product for the treatment of solid tumors through Phase I/II study in addition to advancing preclinical pipeline JERUSALEM, Feb. 26, 2020 /PRNewswire/ -- KAHR Medical

2020-02-26 08:30 2884

WuXi Biologics and Vir Biotechnology Announce Collaboration for Global Development of Antibodies to Treat COVID-19

SAN FRANCISCO and SHANGHAI, Feb. 25, 2020 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, and Vir Biotechnology, Inc. ("Vir") (Nasdaq: VI...

2020-02-25 21:30 2956

Connect Biopharma Enhances its Intellectual Property Estate for CBP-307, a Targeted Therapy with Potential in Multiple Autoimmune Diseases, with Patent Issuances in the United States, EU, Japan and Australia

Novel, next-generation S1P1 agonist currently in Phase 2 clinical development for treatment of inflammatory bowel disease SAN DIEGO and TAICANG, China, Feb. 25, 2020 /PRNewswire/ -- Connect Biopharma, a clinical-stage biopharmaceutical company focused on identifying and developing potent and spe...

2020-02-25 21:00 1084

InDex Pharmaceuticals Publishes Mechanism of Action Data for Cobitolimod in Scientific Journal

STOCKHOLM, Feb. 25, 2020 /PRNewswire/ -- InDex Pharmaceuticals Holding AB (publ) today announced the publication of scientific data on the mechanism of action of cobitolimod, the company's lead drug candidate in development for the treatment of moderate to severe ulcerative colitis. The paper, pu...

2020-02-25 15:26 1320

U.S. FDA accepts GSK's sNDA application for Zejula (niraparib) for first-line maintenance treatment for women with platinum-responsive advanced ovarian cancer

-  Submission based on data from the Phase III PRIMA clinical study that demonstrated clinically-meaningful outcomes of niraparib maintenance treatment in the first-line setting regardless of biomarker status -  The application is being reviewed under the FDA's Real-Time Oncology Review pilot pr...

2020-02-24 22:00 1352

Nearly VND 20 billion sponsored by Vingroup for research projects on response to novel coronavirus

HANOI, Vietnam, Feb. 21, 2020 /PRNewswire/ -- 3 units funded by Vingroup Innovation Foundation (VINIF) include The Company for Vaccine and Biological Production No.1 (Vabiotech), Pasteur Institute inHo Chi Minh City and Institute of Preventive Medicine and Public Health.

2020-02-21 10:09 3621

Sihuan Pharmaceutical Announces Acquisition of All Interests and Intellectual Property Rights of Plazomicin, A New Generation of Aminoglycoside Antibiotics in the Greater China Region

HONG KONG, Feb. 20, 2020 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460, "Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce that Xuanzhu (HK) Biopharmaceutical Limited (''Xuanzhu''), a wholly-owned subsidiary of the...

2020-02-20 18:59 13222

NeuroVive Pharmaceutical AB Year End Report January - December 2019

STOCKHOLM, Feb. 19, 2020 /PRNewswire/ -- Important events in 2019 KL1333            * NeuroVive enrolls first subject in its European KL1333 phase Ia/b clinical study            * NeuroVive initiates second part of its ongoing KL1333 Phase Ia/b clinical study            * NeuroVive compl...

2020-02-19 16:08 6364

WuXi Biologics' Subsidiary WuXi Vaccines Signed Long-Term Vaccine Manufacturing Contract with a Global Vaccine Leader

SHANGHAI, Feb. 18, 2020 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, announced that WuXi Vaccines, its joint venture with Shanghai ...

2020-02-18 18:42 2724

Sihuan Pharmaceutical: Production Approval Granted For Rivastigmine Hydrogen Tartrate Capsule, The First Drug Passing Consistency Evaluation And Levetiracetam Tablet And The First Registration Approval Granted For Midazolam Oromucosal Solution

HONG KONG, Feb. 18, 2020 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460, "Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce that rivastigmine hydrogen tartrate capsule and levetiracetam tablet developed by the Group...

2020-02-18 18:07 7021

Ascletis' IND Filing for Its Non-alcoholic Steatohepatitis (NASH) Drug Accepted by NMPA

HANGZHOU, China and SHAOXING, China, Feb. 18, 2020 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX code: 1672) announces today the application for in-house developed Category 1 Drug ASC41 for clinical trials of NASH indication has been accepted byChina's National Medical Products Administration (NMPA)...

2020-02-18 08:00 3436

A New Expert Consensus Publication Provides Practical Guidance on the Use of Omega-3 Fatty Acids in Parenteral Nutrition

BAD HOMBURG, Germany, Feb. 17, 2020 /PRNewswire/ -- Fresenius Kabi, a global leader in clinical nutrition, announces that the Journal of Parenteral and Enteral Nutrition (JPEN) has recently published "Lipids in Parenteral Nutrition: Translating Guidelines into Clinical Practice".[1] The publicati...

2020-02-17 17:00 5233

Eirgenix Receives Approval from Japan's PMDA

TAIPEI, Feb. 14, 2020 /PRNewswire/ -- EirGenix, Inc. (6589, TT) had undertaken the transfer of drug substance manufacturing of a marketed drug from a Japanese pharmaceutical company and has since fulfilled all the regulatory requirements necessary to complete the manufacturing site transfer. The ...

2020-02-14 15:14 2868

Sihuan Pharmaceutical Accelerates Product Expansion in Digestive System and Liver Related Diseases

HONG KONG, Feb. 14, 2020 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd.(HKEX: 0460) ("Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce that the progress achieved by the Group in the research and development of drugs for treati...

2020-02-14 10:35 7528

Sirtex Medical announces collaboration with MIM Software Inc.

Partnership advances innovation and increases precision of liver-directed oncology therapies for patients WOBURN, Massachusetts, Feb. 12, 2020 /PRNewswire/ -- Sirtex Medical, a leading manufacturer of targeted liver cancer therapies, today announced a collaboration with MIM Software Inc., a lead...

2020-02-12 22:00 1720