Pharmaceuticals

FDA Approves TEPMETKO® as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations

Not intended for distribution in the USA, Canada or UK - TEPMETKO is approved for both treatment naïve and previously treated MET ex14 positive NSCLC patients - TEPMETKO demonstrated consistent and durable responses in both treatment naïve and previously treatedMETex14 patients in the VISION stud...

2021-02-04 02:57 1906

Innovent and Lilly Jointly Announce the Approval of TYVYT® (sintilimab injection) by China NMPA in Combination with Pemetrexed and Platinum Chemotherapy as First-Line Therapy for Nonsquamous Non-Small Cell Lung Cancer

SAN FRANCISCO and SUZHOU, China, Feb. 3, 2021 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major disease...

2021-02-03 12:30 10199

Elekta's MOSAIQ and Versa HD earn top honors in 2021 Best in KLAS: Software and Services Report

ATLANTA, Feb. 3, 2021 /PRNewswire/ -- Elekta (EKTA-B.ST) today announced that itsMOSAIQ® Oncology Information System (OIS) and Versa HD™ linear accelerator have been named "Best in KLAS" in the 2021 Best in KLAS: Software and Services Report. MOSAIQ was ranked first in the Oncology (Radiation) ca...

2021-02-03 00:30 3986

Kira Pharmaceuticals Announces First Participant Dosed in Phase 1 Clinical Trial for P014, a Bifunctional Biologic Medicine

CAMBRIDGE, Mass. and SUZHOU, JIANGSU, China, Feb. 2, 2021 /PRNewswire/ -- Kira Pharmaceuticals, a global biotechnology company pioneering a new generation of complement-targeted therapies to treat immune-mediated diseases, announced today that the first healthy volunteer has been successfully dos...

2021-02-02 20:00 2227

Ascentage Pharma Released Preclinical Results of MDM2-p53 Inhibitor APG-115 in an Oral Presentation at WCLC 2020, Demonstrating Therapeutic Potential in STK11-Mutant Non-Small Cell Lung Cancer

SUZHOU, China and ROCKVILLE, Md., Feb. 2, 2021 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, announced that the company recently released ...

2021-02-02 17:24 2389

Globally unique MRI Guarantee: The highest MRI safety with hearing implants from MED-EL

Worry-free, safe magnetic resonance imaging (MRI) with MED-EL cochlear, middle ear or bone conduction implants – now with lifetime guarantee. For immediate access to an MRI examination without surgery, discomfort or hearing downtime. INNSBRUCK, Austria, Feb. 2, 2021 /PRNewswire/ -- The innovative...

2021-02-02 15:00 3250

Inmagene launched U.S. subsidiary; Dr. Jean-Louis Saillot joined the company.

SAN DIEGO, Calif. and SHANGHAI, Feb. 2, 2021 /PRNewswire/ -- Inmagene Biopharmaceuticals ("Inmagene"), a leading biotech company focused on immunology-related therapeutic areas, today announced the launch of its wholly-owned subsidiary inSan Diego. Jean-Louis Saillot, MD has joined the company a...

2021-02-02 14:48 3350

CF PharmTech and Chengdu Shangyi Launch the "Home-Based Recovery Program for Discharged Covid-19 Patients" and Announce Today's Global Release of the "R Plus Health" Free App

SUZHOU, China, Feb. 2, 2021 /PRNewswire/ -- CF PharmTech, Inc. is a fully integrated pharmaceutical company inChina specializing in the treatment of respiratory diseases. Chengdu Shangyi Information Technology Co., Ltd is a professional IT service company in the healthcare industry inChina.

2021-02-02 09:00 3794

Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine Candidate

* Clover plans to initiate a global Phase 2/3 efficacy trial of its protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alumin the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. * The Coalition for Epid...

2021-02-01 14:00 6540

Antengene Announces Collaboration with WuXi Biologics and WuXi STA to Advance Antibody-Drug Conjugate Candidate into Clinical-stage

SHANGHAI and HONG KONG, Feb. 1, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncolo...

2021-02-01 08:09 5620

Phase 1 Drug Candidate GLR2007 Developed by Gan & Lee has been Granted Fast Track Designation by the U.S. FDA

BEIJING and BRIDGEWATER, N.J., Jan. 29, 2021 /PRNewswire/ -- Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee) (Shanghai: 603087.SH), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation fo...

2021-01-29 22:53 8745

RedHill Biopharma Announces Positive DSMB Futility Review for Phase 2/3 COVID-19 Study of Opaganib

TEL AVIV, Israel and RALEIGH, N.C., Jan. 29, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the independent Data Safety Monitoring Board (DSMB) for the globa...

2021-01-29 20:26 7003

Ascentage Pharma Announces the Fifth Orphan Drug Designation Granted to Bcl-2 Inhibitor APG-2575 by the US FDA, and the Tenth Obtained by the Company

SUZHOU, China and ROCKVILLE, Md., Jan. 29, 2021 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that the US Food and Drug A...

2021-01-29 08:29 2819

RedHill Biopharma Further Expands Opaganib Manufacturing Capacity for COVID-19 with Cosmo Pharmaceuticals

TEL AVIV, Israel and RALEIGH, N.C., Jan. 28, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced a manufacturing agreement with Cosmo Pharmaceuticals NV (SIX: COPN) ("...

2021-01-28 22:03 5964

Clinical Trial of Proxalutamide's Trial of Hospitalized Covid-19 Patients Was Approved in Brazil

SUZHOU, China, Jan. 28, 2021 /PRNewswire/ -- Kintor Pharmaceutical Limited (HKEX: 9939) is pleased to announce that the clinical trial (the "Trial") of Proxalutamide's treatment of hospitalized COVID-19 patients was approved by the Institutional Review Board ("IRB") ofBrazil. The trial was accept...

2021-01-28 19:57 7036

Sai Life Sciences announces plans to double headcount and expand capabilities in Manchester, UK

MANCHESTER, England and HYDERABAD, India, Jan. 28, 2021 /PRNewswire/ -- Sai Life Sciences, one ofIndia's fastest growing Contract Research, Development & Manufacturing Organizations  (C...

2021-01-28 15:30 3642

Harbour BioMed's Batoclimab (HBM9161) Receives China CDE Breakthrough Therapy Designation for Treatment of Adult Patients with Myasthenia Gravis

CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Jan. 28, 2021 /PRNewswire/ -- Harbour BioMed (HBM) (HKEX: 02142.HK), announced today that China Center for Drug Evaluation (CDE) has granted Breakthrough Therapy designation to Batoclimab (HBM 9161), a fully human anti-FcRn monoclonal a...

2021-01-28 12:54 8026

Mallinckrodt Receives Approval in Japan of the CELLEX® Extracorporeal Photopheresis System for Treatment of Chronic Graft Versus Host Disease

DUBLIN, Jan. 28, 2021 /PRNewswire/ -- Mallinckrodt plc, a global biopharmaceutical company, announced today thatJapan's Ministry of Health, Labour and Welfare (MHLW) approved the CELLEX® extracorporeal photopheresis (ECP) system for the treatment of steroid-resistant or intolerant chronic graft...

2021-01-28 09:00 5241

Antengene Announces the Acceptance of ATG-010 (Selinexor) NDA by the NMPA for the Treatment of rrMM

SHANGHAI and HONG KONG, Jan. 28, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncol...

2021-01-28 08:00 3778

Antengene Announces the Acceptance of ATG-010 (Selinexor) NDA by the NMPA for the Treatment of rrMM

SHANGHAI and HONG KONG, Jan. 28, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncol...

2021-01-28 08:00 5261