Will receive one year of lab space at BioLabs LA at The Lundquist Institute and additional facility benefits and connections to Amgen's scientific leaders.
Initiative, together with the Broad Institute of MIT and Harvard, aims to accelerate efforts to mine genetic data for insights into disease mechanisms.
To oversee all businesses related to healthcare, encompassing product solutions for medical devices, diagnostics, drug delivery and sterilizable materials.
Veklury (remdesivir) with sales of $829 million offsets loss of exclusivity of Truvada and Atripla in the U.S. with sales down 72% and 42%, respectively.
State-of-the-art R&D lab at Florence, KY site expands technical feasibility capabilities for long-acting delivery of small molecules, biologics and nucleotides.
Acquisition is part of the cigarette maker’s ‘Beyond Nicotine’ strategy and expands its product pipeline development capabilities in inhaled therapeutics.
Will leverage integrated services from Selexis and KBI as part of Immatics’ development of TCR Bispecifics, designed to detect, target and attack tumor cells.
Supports Mirus’ expansion of GMP production of its flagship product TransIT VirusGEN for large scale manufacturing of AAV and LV viral vectors for gene therapy.
Will integrate Cryoport's Cryoportal Logistics Management Platform and LabConnect's SampleGISTICS platform to provide Triumvira with advanced logistics support.
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.
CDMOs have been some of the biggest winners from COVID contracts and will see benefits for several more years to come. A Q&A with GlobalData’s Peter Shapiro.
How today’s life sciences manufacturers can effectively monitor processes, integrate with sub-contractors and align with regulatory reporting requirements.
New site in Haimen, Jiangsu province has been established following an invitation to participate in the Yangtze Delta Advanced Drug Development platform.
Recognizes manufacturing facility and processes are in compliance with GMP requirements and readiness to provide commercial aseptic fill/finish services.
Phase II trial to investigate Novo’s semaglutide and a combination of Gilead’s cilofexor and firsocostat, alone and in combination in cirrhosis due to NASH.
Overcoming challenges of implementation and achieving increased volume, reduced timelines, decreased footprint, lower cost of goods, and increased flexibility.
Priyanka Gupta, Head of Market Entry Strategy for Protein Based Therapeutics, Sartorius03.09.21
rfXcel’s AI-enabled SaaS platform more than doubles Antares Vision’s software business and adds a high share of contracted, recurring and scalable revenues.
Adds Project Farma's unique expertise to Precision's suite of end-to-end cell and gene therapy capabilities to support development and commercialization.
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".
Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups01.05.21
With vaccines against COVID-19 on the horizon, our focus is shifting to 2021 and the major issues life sciences companies face and reasons for optimism.
Arda Ural , EY Americas Health Sciences and Wellness Industry Leader, Ernst & Young LLP12.11.20
Instead of closing its doors on China, Western pharma industry needs to take a balanced approach and perform proper due diligence based on objective criteria.
The labeling process is highly complex and constantly in flux, making it ideal for digital transformation, but AI and ML cannot be implemented overnight.
Kiran Chinnalla, Associate Director Global Regulatory Affairs, Julian Backhouse, Associate Director Regulatory Technology Product Management, Cham Williams, Associate Director Business Systems , IQVIA11.13.20
ProBioGen is conducting cell line development, process development and GMP manufacturing of the mAb intermediates of Heidelberg’s ATAC molecules for cancer.
Allows companies to proactively monitor their serialized operations and gain actionable insights to avoid costly delays and ensure product availability.
Serge Bodart of IDDI provides insight on the pharma and biopharma trends impacting CROs, outsourcing in today’s market, and advances in clinical research.
Auxilium Pharmaceuticals, Inc. has submitted a BLA to the FDA for Xiaflex (clostridial collagenase for injection), a novel orphan-designated biologic for the treatment of Dupuytren's contracture.