Cell & Gene by Oxford Global’s Post

Do you represent a UK Biotechnology Company working on Market Access in Europe? Are you aware of the new EU HTA Regulation coming into force in 2025 for oncology and ATMP (cell & gene) products, and the need to submit a Joint Clinical Assessment (JCA) dossier?   If you are not yet up to speed or wondering if you are fully aware of the new requirements and how they will affect your business, please drop me a note. Our Subject Matter experts would be delighted to talk you through the implications, ensuring that you can collect and deliver appropriate evidence for a successful launch. #marketaccess #hta #jca #biotechnology

BRAINCURES Biological Intelligence is Key to Preclinical and Clinical Success. To estimate BRAINCURES Discovery Engine (BDE)'s power to predict success rate we identified a set of 331 gene – drug pairs associated with real world data outcomes (i.e., success/failure) from Phase III Clinical trials [1]. For example, BDE-Hubs Prioritization eliminated 57 of 72 Drug-Gene Pairs linked to Phase III Clinical Failures yielding a 79% Phase III Clinical Failure Elimination Rate. Reference for RWE-dataset used for BDE benchmarking: [1] Roullaird et al., Plos Comput Biol 2018, 14(5): e1006142

Great to see the growth across the industry in not just the big players, but also providers excelling in specialised areas. With a new wave of collaborations and mergers rising, how we can collectively leverage this momentum to expedite next-generation therapies?  #CDMOGrowth #PharmaceuticalInnovation #StrategicPartnerships

Biotech company #bluebirdbio Inc (NASDAQ:BLUE) has priced its underwritten #publicoffering , making 83,333,333 shares of common stock available at $1.50 per share. The offering, expected to yield $125 million in gross proceeds, provides underwriters a 30-day option to purchase an additional 12,499,999 shares. Proceeds will primarily support the commercialization and manufacturing of three approved gene therapies, Zynteglo, Skysona, and Lyfgenia, and fund general corporate purposes, the company said in a statement. The closing is anticipated around December 22, 2023. Shares of bluebird slid over 45% on Wednesday morning to sit at US$1.33 on the Nasdaq. The company recently gained FDA approval for its gene therapy, Lyfgenia, to treat sickle cell disease. However, the FDA did not grant the company a valuable Priority Review Voucher (PRV), which was unexpected. More at #Proactive #ProactiveInvestors #NASDAQ #BLUE http://ow.ly/9OlG1056j1k

Whatever artificial intelligence (AI) can do for drug discovery and clinical development success rates, biological intelligence (BI) can do it better. See https://lnkd.in/e7_fR5Rz for a 1-minute explainer for why BI outperforms AI

SuperNuclease® is a versatile endonuclease that efficiently degrades all forms of DNA and RNA, including single-stranded, double-stranded, linear, circular, and supercoiled structures.

Orchard Therapeutics’ (NASDAQ: ORTX) Shares Skyrocket: How To Predict Biotech M&A Orchard Therapeutics (NASDAQ: ORTX) experienced a remarkable 97% surge in its shares following a major announcement on October 5th, 2023. The renowned global gene therapy leader, Orchard, has been successfully acquired by Kyowa Kirin (OTC: KYKOF), solidifying its position as a fully owned subsidiary. The Agreement: The agreement outlines that Kyowa plans to buy all […] The post Orchard Therapeutics’ (NASDAQ: ORTX) Shares Skyrocket: How To Predict Biotech M&A first appeared on Micro Cap Daily. The post Orchard Therapeutics’ (NASDAQ: ORTX) Shares Skyrocket: How To Predict Biotech M&A appeared first on Micro Cap Daily.

Do you represent a Germany or Austria based Biotechnology Company working on Market Access in Europe? Are you aware of the new EU HTA Regulation coming into force in 2025 for oncology and ATMP (cell & gene) products, and the need to submit a Joint Clinical Assessment (JCA) dossier?   If you are not yet up to speed or wondering if you are fully aware of the new requirements and how they will affect your business, please drop me a note. Our Subject Matter experts would be delighted to talk you through the implications, ensuring that you can collect and deliver appropriate evidence for a successful launch. #IQVIA #JCA #DrivingHealthcareForwardTogether #MarketAccess #WeAreIQVIA

Today is #RNADay! #RNA is vital for transmitting genetic information, regulating genes, and enabling protein synthesis. At Elixirgen Therapeutics, we're reimagining the power of RNA by developing life-changing therapies for patients in need. Learn more: https://bit.ly/4euOyXI

What does the Pharma and Biopharma #CDMO landscape look like in Europe? This infographic gives an overview of the main CDMO players in Small Molecules, Biologics and Cell & Gene therapies. With state-of-the-art facilities and 30+ years expertise in contract development and manufacturing, Merck is a major player in all these fields, supporting programs across multiple modalities and at all stages, from pre-clinical to commercial. You can download the infographic by PharmaSource here: https://lnkd.in/eZszdPfn If you are looking for a CDMO partner for your small molecule program, you can contact our experts here: https://bit.ly/3zIoyrM We can accelerate your drug development and support any of the following programs: #HPAPIs, #APIs, #ADCs, Next-Generation Conjugates, Linker-Payloads, PEGs, or Targeted Protein Degradation.