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Abstract: FDA’s latest approval of Imfinzi (durvalumab) in combination with chemotherapy for treating resectable non-small cell lung cancer before and after surgery is based on Phase III trial results showing that the regimen reduced the risk of recurrence, progression, or death by 32%. PubDate: Wed, 28 Aug 2024 21:00:00 +000
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Abstract: PiaSky (crovalimab) has previously been approved in countries such as the United States and Japan for monthly, subcutaneous use that may be self-administered with adequate training. PubDate: Wed, 28 Aug 2024 11:40:00 +000
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Abstract: With the completion of its acquisition of Morphic, Lilly expands its immunology pipeline to include Morphic's oral integrin therapies to address inflammatory bowel disease. PubDate: Tue, 27 Aug 2024 21:00:00 +000
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Abstract: Webinar Date/Time: Thurs, September 19, 2024 Session 1: 9:00am EDT 1:00pm GMT 2:00pm CETSession 2: 1:00pm EDT 5:00pm GMT 6:00 am CET PubDate: Tue, 27 Aug 2024 04:00:00 +000
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Abstract: Webinar Date/Time: Tue, Sep 17, 2024 11:00 AM EDT PubDate: Tue, 27 Aug 2024 04:00:00 +000
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Abstract: Opaganib was given orphan drug designation for the treatment of neuroblastoma in children, which is rare, but the most common infancy malignancy. PubDate: Mon, 26 Aug 2024 23:25:49 +000
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Abstract: In a 24-week study of patients with PAH, six-minute walking distance improved by an average of 40.8 meters, and risk of death or clinical worsening was reduced by 82%. PubDate: Mon, 26 Aug 2024 21:10:06 +000
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Abstract: The collaboration builds on Novartis’ acquisition of Chinook Therapeutics just over a year ago. PubDate: Fri, 23 Aug 2024 18:54:27 +000
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Abstract: Christian Cobaugh, CEO and founder of Vernal Biosciences, conside the outsourcing landscape for mRNA production. PubDate: Fri, 23 Aug 2024 12:00:00 +000
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Abstract: The approvals and authorizations come amid a late summer surge in the virus that is tracking a bit earlier than the early fall wave in the US in 2023. PubDate: Thu, 22 Aug 2024 20:13:48 +000
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Abstract: In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss submitting biologics license applications and working with suppliers. PubDate: Thu, 22 Aug 2024 19:00:00 +000
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Abstract: The combination of Opdivo plus Yervoy is already established as a second-line treatment for patients with advanced hepatocellular carcinoma. PubDate: Wed, 21 Aug 2024 20:55:13 +000
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Abstract: The International Coalition of Medicines Regulatory Authorities’ new Collaborative Hybrid Inspection Pilot program allows a CDMO to gain approval from multiple countries simultaneously, as opposed to separately phased inspections from different corners of the globe. PubDate: Wed, 21 Aug 2024 20:48:14 +000
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Abstract: Downstream processes may be streamlined by using automation. PubDate: Wed, 21 Aug 2024 17:12:00 +000
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Abstract: Under a deal worth potentially up to $1.3 billion, Merck, known as MSD outside of the United States and Canada, will acquire CN201, a next-generation bispecific antibody, from Curon Biopharmaceutical. PubDate: Wed, 21 Aug 2024 17:00:00 +000
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Abstract: Fasenra, which has been approved since 2019 in the United States in a pre-filled, single-use auto-injector form that can be administered either in a doctor’s office or at home, is now approved in China for age 12 and up. PubDate: Wed, 21 Aug 2024 11:41:00 +000
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Abstract: Webinar Date/Time: Wed, Sep 4, 2024 11:00 AM EDT PubDate: Wed, 21 Aug 2024 04:00:00 +000
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Abstract: Approximately 15% of all lung cancers diagnosed in the US are of the small-cell variety, and of those, 70% are considered extensive-stage. PubDate: Tue, 20 Aug 2024 20:37:42 +000
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Abstract: Breyanzi demonstrated an overall high response rate in adults with relapsed or refractory follicular lymphoma in a Phase II study. PubDate: Tue, 20 Aug 2024 11:36:00 +000
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Abstract: NexoBrid, a topically administered biological product, is now authorized for use in all age groups in the United States, European Union, and Japan. PubDate: Mon, 19 Aug 2024 21:31:57 +000
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Abstract: Genentech will leverage Sangamo’s proprietary capsid delivery platform and epigenetic regulation capabilities to develop genomic medicines to address certain neurodegenerative diseases. PubDate: Mon, 19 Aug 2024 13:40:00 +000
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Abstract: National Institutes of Health’s National Institute of Allergy and Infectious Diseases collaborated with the University of Sciences, Techniques and Technologies of Bamako, Mali to conduct the trials. PubDate: Sun, 18 Aug 2024 18:58:00 +000
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Abstract: Imfinzi may be used alone, or with chemotherapy in tandem with the other approved treatment, Lynparza. PubDate: Sat, 17 Aug 2024 18:55:00 +000
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Abstract: Yorvipath is a prodrug of parathyroid hormone (PTH) (1-34), designed to be administered once daily to provide continuous exposure to released PTH. PubDate: Fri, 16 Aug 2024 20:52:07 +000
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Abstract: AstraZeneca and Daiichi Sankyo first entered into an agreement to develop Enhertu in March 2019, and the antibody-drug conjugate has since been approved for various groups in more than 65 countries. PubDate: Fri, 16 Aug 2024 18:49:05 +000
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Abstract: The 94.3% efficacy of the Octapharma product was just a shade ahead of the 94.2% measured in a comparative product, Kcentra. PubDate: Wed, 14 Aug 2024 14:42:30 +000
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Abstract: The virus, which is contagious and a common cause of respiratory illness, hospitalizes up to 160,000 people and is responsible for as many as 13,000 deaths in the United States every year. PubDate: Mon, 12 Aug 2024 20:50:29 +000
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Please help us test our new pre-print finding feature by giving the pre-print link a rating. A 5 star rating indicates the linked pre-print has the exact same content as the published article.
Abstract: Under the license agreement, Andelyin Biosciences will expand its AAV Curator Platform by including MyoAAV plasmids developed by Broad Institute of MIT and Harvard. PubDate: Fri, 09 Aug 2024 19:34:00 +000
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Abstract: Automation technologies used in the development and manufacture of biopharmaceuticals continue to evolve, providing the potential for reduced costs and time. PubDate: Fri, 09 Aug 2024 15:55:00 +000