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Gracell Biotechnologies Receives Medical Products Manufacturing Certificate for CAR-T Cell Therapy Products
1/15/2021
Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted the Medical Products Manufacturing Certificate (MPMC) from the Jiangsu Medical Products Administration
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Dr. Reddy’s Receives Approval to Conduct Phase 3 Clinical Trial for Sputnik V Vaccine in India
1/15/2021
Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) announced today that it has received approval from the Drugs Control General of India (DCGI) to conduct phase 3 clinical trial for the Sputnik V vaccine in India. The phase 3 study of Sputnik V will be conducted on 1500 subjects as part of the randomized, double-blind, parallel-group, placebo-controlled study in India. Earlie
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VBL Therapeutics Enters Into Ordinary Share Purchase Agreement of up to $20 Million With Aspire Capital Fund, LLCAgreement extends current cash runway to Q1 2023
1/15/2021
VBL Therapeutics (Nasdaq: VBLT), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for areas of unmet need in cancer and immune/inflammatory indications, today announced that it has entered into an Ordinary Share Purchase Agreement with Aspire Capital Fund, LLC. Proceeds from any sales of ordinary shares pursuant to the Purchase Agreement will be used for workin
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Qilian International Holding Group Limited Announces Closing of Initial Public Offering
1/14/2021
Qilian International Holding Group Limited (the “Company”) (Nasdaq: QLI), a China-based pharmaceutical and chemical products manufacturer, today announced the closing of its initial public offering ("Offering") of 5,000,000 ordinary shares at a public offering price of US$5.00 per share.
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Teva Announces Launch of a Generic Version of NuvaRing® (etonogestrel and ethinyl estradiol) Vaginal Ring in the United States
1/14/2021
Teva Announces Launch of a Generic Version of NuvaRing ® (etonogestrel and ethinyl estradiol) Vaginal Ring in the United States
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Pregna Launches CryoPop – a Carbon Dioxide (CO2) Based Innovative Cryotherapy Device to Fight Cervical Cancer
1/14/2021
Pregna International Ltd. has furthered its status as a leading women's healthcare organisation with the launch of its ground-breaking cryotherapy device - CryoPop.
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Tikcro Technologies Reports Third Quarter 2020 Results
1/14/2021
Tikcro Technologies Ltd. (OTCQB: TIKRF), today reported its financial results for the third quarter ended September 30, 2020 . "We continue to consider businesses for a reverse merger and other corporate alternatives," said Aviv Boim , CEO of Tikcro. Financial Results for the Third Quarter Ended September 30, 2020 N
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RedHill Biopharma Announces Closing of $25 Million Bought Deal Offering
1/14/2021
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of its previously announced underwritten offering of 3,188,776 American Depositary Shares (ADSs) of the Company, at a price to the public of $7.84 per ADS
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Charles River Partners with JADE Biomedical to Expand Biologics Capabilities
1/14/2021
Charles River Laboratories International, Inc. (NYSE: CRL) today announced that it has entered into a strategic partnership with JADE Biomedical (JADE) , a provider of end-to-end quality management services for the biopharmaceutical industry. The partnership will expand Charles River’s biologics testing capabilities
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Nucleai and Debiopharm Launch Research Collaboration Utilizing Nucleai's Ai-Powered Biomarker Platform
1/14/2021
Nucleai (www.Nucleaimd.com), a global provider in pathology-based biomarker discovery, and Debiopharm (www.debiopharm.com), a Swiss-based biopharmaceutical company specializing in drug development, announced that they have entered into a long-term collaboration to leverage Nucleai's artificial intelligence (AI) -powered biomarker research & discovery platform for one of Debiopharm's clinical stage oncology assets.
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Fujifilm and the Center for Advanced Biological Innovation and Manufacturing Announce $76M in Funding for Manufacturing and Innovation Center
1/14/2021
FUJIFILM Corporation (COO: Kenji Sukeno ) and the Center for Advanced Biological Innovation and Manufacturing (CABIM), today announced that it has secured $76 million in financing and signed a lease for a 40,000 square-foot site in Watertown, Massachusetts at The Arsenal on the Charles , owned and operated by Alexandria Real Estate Eq
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China National Medical Products Administration Approves Tislelizumab in Combination with Chemotherapy in First-Line Advanced Squamous Non-Small Cell Lung Cancer
1/14/2021
BeiGene, Ltd., a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that its anti-PD-1 antibody tislelizumab has received approval from the China National Medical Products Administration for use in combination with two chemotherapy regimens as a first-line treatment for patients with advanced squamous non-small cell lung cancer.
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Chi-Med Highlights Savolitinib Clinical Data to be Presented at Virtual WCLC
1/14/2021
Hutchison China MediTech Limited announces that the final analysis of savolitinib in Phase Ib TATTON study Parts B and D will be presented at the upcoming virtual 2020 World Conference on Lung Cancer, taking place on January 28-31, 2021, virtually.
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As the Pfizer-BioNTech COVID-19 vaccine is being evaluated by the U.S. FDA and the Moderna vaccine is soon to follow, here’s a look at several of the top COVID-19 vaccine candidates and where they stand as of today.
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As is typical, the second day of the JP Morgan Annual Healthcare Conference—conducted virtually this year because of the pandemic—had plenty of news from the largest biopharma companies globally.
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Major players in the biotech industry are moving full steam ahead in their 2021 operations goals despite the ongoing pandemic, with global pharmaceutical giant Takeda being no exception.
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Kamada Enters into Two New Agreements for the Distribution of Three Biosimilar Products in Israel
1/13/2021
The Three Products Are Expected to Be Launched, Subject to Israeli Ministry of Health Approval, Between 2022 and 2024 Potential Collective Maximum Sales of the Three Products in the Israeli Market is Estimated at $5-$7 Million Annually These Sales Are i n Addition to the Potential $20-$30 Million from the Recently Licensed Alvotech Biosimilar Portfolio REHOVOT, Israel, Jan. 13, 2021 (GLOBE NEWSWIRE) -- Kamada Ltd. (Nasdaq: KMDA; TASE: KMDA.TA), a plasma-derived biopharmaceutical c
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Nuvo Group Submits 510(k) to Federal Drug Administration for Remote Monitoring of Maternal Uterine Activity
1/13/2021
Nuvo Group—a private company commercializing INVU by Nuvo™, an FDA-cleared, prescription-initiated, remote pregnancy monitoring platform—today announced that it has filed a 510(k) notice with the U.S. Food and Drug Administration (FDA) to add a new uterine activity module that provides capability for remote monitoring of maternal uterine activity (MUA).
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Asahi Kasei to Build a Second Plant for Ceolus™ Microcrystalline Cellulose
1/13/2021
Asahi Kasei's Specialty Solutions SBU will build a second plant for microcrystalline cellulose [1] (trade name Ceolus™) at its Mizushima Works in Kurashiki, Okayama, Japan.
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China NMPA Grants Approval for the Registrational Phase 1/2 Clinical Study for GC007g - an Allogeneic CAR-T Cell Therapy for the Treatment of Relapsed or Refractory B-ALL
1/13/2021
Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted approval for a pivotal seamless Phase 1/2 clinical trial for GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy,