Pharmaceuticals

iX Biopharma Reports on Outcome of Wafermine End-of-phase 2 Meeting with US FDA

SINGAPORE, Dec. 11, 2019 /PRNewswire/ -- Specialty pharmaceutical company iX Biopharma Ltd(SGX:42C) ("iX Biopharma" or, "the Company") is pleased to announce that it has successfully concluded an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding Wafermine, a sublin...

2019-12-11 22:00 283

Gracell Announces Progressive Outcomes from Multiple Human Clinical Trials to Investigate FasTCAR and Dual CAR Cell Platform Technologies

SUZHOU, China and SHANGHAI, Dec. 9, 2019 /PRNewswire/ -- Gracell Biotechnologies Co., Ltd ("Gracell"), a clinical-stage immune cell therapy company, today announced the progressive clinical outcomes for leading product candidates FasTCAR-19, Dual CAR-19-22, and Dual CAR-BCMA-19 at the American...

2019-12-09 22:00 401

Hebron Announces $6.5 Million Private Placement

WENZHOU, China, Dec. 9, 2019 /PRNewswire/ -- Hebron Technology Co., Ltd. (" Hebron" or the "Company") (Nasdaq: HEBT), a developer, manufacturer and installer of valves and pipe fittings for use in the pharmaceutical, biological, food and beverage, and other clean industries, today announced that ...

2019-12-09 21:30 434

BJ Bioscience Announces First Patient Dosed in FIH Trial of BJ-001 in Patients with Locally Advanced/Metastatic Solid Tumors

HANGZHOU, China, Dec. 9, 2019 /PRNewswire/ -- BJ Bioscience Inc. (the 'company') today announced that the first patient was successfully dosed on December 4, 2019 in the first-in-human (FIH) trial of the company's BJ-001 program at NEXT ONCOLOGY inSan Antonio, Texas.

2019-12-09 21:00 343

Lumosa Announces FDA Acceptance of IND Application for LT1001, an Extended-Release Analgesic Injection - Lumosa to Initiate the Bridging Study in the US

TAIPEI, Dec. 3, 2019 /PRNewswire/ -- Opioid misuse, addiction, and overdoses have caused significant social and economic burdens leading to the opioid crisis. LT1001 (brand name Naldebain®) is a prodrug of nalbuphine, an abuse-free analgesic that has been marketed worldwide for decades. Naldebain...

2019-12-03 17:36 219

New Early Breast Cancer Drug Approved by Singapore Health Sciences Authority

* NERLYNX® (neratinib) now approved in Singapore for HER2+ breast cancer patients following adjuvant trastuzumab-based therapy * NERLYNX is the first therapy in the Specialised Therapeutics' portfolio approved inSE Asia * Five-year follow up data show NERLYNX reduces risk of invasive disease...

2019-12-03 05:30 267

Innovent Presents Co-developed Cancer-Fighting Tyvyt(R) (Sintilimab Injection) at CIIE 2019 with Eli Lilly

SUZHOU, China, Nov. 28, 2019 /PRNewswire/ -- Innovent Biologics (01801.HK), a multinational biopharmaceutical company, and Eli Lilly and Company presented their co-developed Tyvyt® (generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal anti...

2019-12-02 09:37 3454

Ascentage Pharma Breaks Ground on its Global Headquarters, R&D Center and Manufacturing Facility in the Suzhou Industrial Park

SUZHOU, China and ROCKVILLE, Md., Nov. 20, 2019 /PRNewswire/ -- Ascentage Pharma (6855.HK), a globally-focused, clinical-stage biotechnology company engaged in developing novel therapies, announced that the groundbreaking ceremony for the Company's global headquarters, R&D center, and manufacturi...

2019-11-21 11:30 506

3SBio Selects Verseau's PSGL-1-targeted Antibody VTX-0811 as First Partnered Macrophage Checkpoint Modulator in Immuno-Oncology Collaboration

SHENYANG, China and BEDFORD Mass., Nov. 17, 2019 /PRNewswire/ -- 3SBio Inc. ("3SBio") (HKEX:1530) and Verseau Therapeutics, Inc.  ("Verseau") today announced the selection of VTX-0811, a monoclonal antibody targeting PSGL-1, as the first lice...

2019-11-18 08:30 2307

Viva Biotech Partnership Summit Successfully Launched in Shanghai

SHANGHAI, Nov. 15, 2019 /PRNewswire/ -- 2019 Viva Biotech Partnership Summit (the "Summit") was successfully launched on8 November 2019 in Pudong, Shanghai, themed "Innovation Partnership Growth". Founders from over 30 global innovative and biopharmaceutical companies incubated/ invested by Viva ...

2019-11-15 14:16 485

I-Mab Biopharma Receives IND Approval from NMPA to Initiate Clinical Trials for its Anti-GM-CSF Monoclonal Antibody TJM2 in China

SHANGHAI, Nov. 14, 2019 /PRNewswire/ -- I-Mab Biopharma ("I-Mab"), a China and U.S.-based clinical-stage biopharmaceutical company exclusively focused on the discovery and development of novel or highly differentiated biologics in immuno-oncology and autoimmune diseases today announced that Natio...

2019-11-14 23:45 430

Samsung Biologics Enhances Its Trusted Service as the First and Only ISO27001 Certified CDMO

INCHEON, South Korea, Nov. 14, 2019 /PRNewswire/ -- Samsung Biologics announced that it has obtained ISO 27001 certification, the most prestigious international standard on information security management. Samsung Biologics is the first CDMO company to be ISO 27001 certified globally. A ceremony...

2019-11-14 20:00 277

China Biologic Reports Financial Results for the Third Quarter of 2019

BEIJING, Nov. 13, 2019 /PRNewswire/ -- China Biologic Products Holdings, Inc. (NASDAQ: CBPO, "China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company inChina, today announced its unaudited financial results for the third quarter of 2019. Third Quarter...

2019-11-14 05:43 5454

Akesobio Presents Phase 1 Clinical Data from First-in-class Bispecific Drug Candidate AK104 (PD1/CTLA4) As Oral Presentation, at 2019 SITC Annual Meeting

NATIONAL HARBOR, Md., Nov. 11, 2019 /PRNewswire/ -- Akeso Biopharma ("Akeso") presented results of phase 1 study of its first-in-class bispecific drug candidate  AK104, in patients with advanced solid tumors in 2019 Society for Immunotherapy of Cancer ("SITC"). AK104 is a novel, tetrameric bispec...

2019-11-11 17:35 299

Enzene Opens its First Continuous Biologics Manufacturing Facility With a Promise to Disrupt the mAb Manufacturing Cost

PUNE, India, Nov. 7, 2019 /PRNewswire/ -- Enzene Biosciences today formally opened its first fully connected continuous Biologics manufacturing facility in Pune, India. This first-of-its-kind facility was built in half the time as compared to the conventional biologics manufacturing plants. The s...

2019-11-07 20:24 398

TransThera Biosciences Lead Product TT-00420 Granted Orphan Drug Designation from FDA to Treat Cholangiocarcinoma

NANJING, China, Nov. 7, 2019 /PRNewswire/ -- TransThera Biosciences Co. Ltd, announced today that company received Orphan Drug Designation from US Food and Drug Administration (FDA) for TT-00420, a clinical stage investigational drug, for the treatment of cholangiocarcinoma. Dr. Frank Wu, Founde...

2019-11-07 20:08 325

Polynoma Presenting Interim Phase III Data for Its Investigational Melanoma Vaccine, Seviprotimut-L, at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting

-- MAVIS Study Identifies Most Responsive Patient Subpopulations, Supporting the Continued Study of Adjuvant Treatment in Localized Melanoma Patients -- SAN DIEGO, Nov. 6, 2019 /PRNewswire/ -- Polynoma LLC, a U.S. immuno-oncology focused biopharmaceutical company and wholly-owned subsidiary ofHon...

2019-11-06 20:00 4995

Samsung Biologics and Ichnos Sciences Announce Agreement for Manufacture of ISB 830

INCHEON, South Korea, Nov. 4, 2019 /PRNewswire/ -- Samsung Biologics announced the signing of a long-term agreement with Ichnos Sciences for manufacturing drug substance for ISB 830, an anti-OX40 monoclonal antibody in development as a potential treatment for moderate-to-severe atopic dermatitis....

2019-11-05 08:22 352

Luye Pharma's LY03004 Manufacturing Facility Successfully Passes U.S. FDA Pre-approval Inspection with Zero Observation

SHANGHAI, Nov. 4, 2019 /PRNewswire/ -- LY03004, Luye Pharma's innovative, independently developed Extended-Release Microspheres for Injection has taken another step closer to going on the U.S. market. The company has announced that it has received the Establishment Inspection Report from the U.S....

2019-11-05 00:39 388

China Biologic Products to Report Third Quarter 2019 Financial Results

BEIJING, Nov. 4, 2019 /PRNewswire/ -- China Biologic Products Holdings, Inc. (NASDAQ: CBPO) ("China Biologic" or the "Company"), a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company plans to release its third quarter 2019 financial results o...

2019-11-04 21:30 6121
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