Weave Bio secures $10m in seed funding round
Pharmaceutical Business Review
by vbandhakavi
2d ago
The company also launched AutoIND, an AI-powered platform designed to optimise the drafting, reviewing, and submitting of regulatory documents in drug development. AutoIND is the first product on the company’s Regulatory Automation and Lifecycle Management (ReALM) platform. It automates and expedites the planning, writing, and review process for Investigational New Drug (IND) applications. With the latest funding, Weave Bio plans to continue enhancing the therapeutic lifecycle, having already doubled the development pace of AutoIND and established a roadmap for the ReALM platform. The IND appl ..read more
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ExpressionEdits secures $13m to develop protein-based therapies
Pharmaceutical Business Review
by vbandhakavi
3d ago
Octopus Ventures and Redalpine co-led the investment round with contributions from Wilbe Capital, BlueYard Capital, Acequia Capital, Amino Collective, and Hawktail. This funding is set to accelerate the development of a pipeline of protein-based therapeutics, particularly targeting recombinant proteins that have faced production challenges with existing technologies. The company, established in 2021, focuses on a new approach to gene design that mirrors the natural genetic landscape. By integrating multiple short noncoding DNA sequences, known as introns, into artificial genes, ExpressionEdits ..read more
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Lucy Therapeutics secures $12.5m for neurological treatment development
Pharmaceutical Business Review
by vbandhakavi
4d ago
The funding round was spearheaded by existing investors Engine Ventures and Safar Partners, with new participations from Bill Gates, Parkinson’s UK, and the Michael J. Fox Foundation, which offered a $2m non-dilutive grant. The latest capital injection increased LucyTx’s total funding to over $36m. These funds are earmarked for the progression of the company’s research programmes targeting Alzheimer’s and Parkinson’s diseases and the continued development of a new drug target for Rett syndrome. LucyTx’s innovative approach involves the development of therapies based on mitochondrial small-mole ..read more
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EMA validates MAA for Prolia and Xgeva (denosumab) biosimilar candidate HLX14
Pharmaceutical Business Review
by vbandhakavi
4d ago
Denosumab has secured approval in several countries and regions under different trade names for a range of several indications such as for osteoporosis treatment in postmenopausal women who are at high risk for fracture, among others. In 2019, it was estimated that 32 million Europeans aged 50 or above had osteoporosis, of which 25.5 million were women. The validation of HLX14’s MAAs is based on a comprehensive Phase III clinical trial. This international, randomised, double-blind, parallel-controlled multicentre study was designed to evaluate HLX14’s efficacy, safety, tolerability, and immuno ..read more
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Radar Therapeutics secures $13.4m to develop programmable medicines
Pharmaceutical Business Review
by vbandhakavi
1w ago
NfX Bio led the financing which will bolster the company’s development of programmable ribonucleic acid (RNA)-based therapeutics utilising molecular RNA sensors for precise drug delivery. The funding round attracted significant investment from key industry players, including Eli Lilly and Company, KdT Ventures and Biovision Ventures. Contributions also came from PearVC, BEVC, and other investors. The proceeds from this funding round will be channelled into advancing Radar’s internal programmes, expanding the team, and exploring potential partnerships. Radar’s focus is on creating genetic and m ..read more
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Amneal Pharmaceuticals launches supply of Naloxone HCI Nasal Spray in US
Pharmaceutical Business Review
by vbandhakavi
1w ago
The product, which received approval from the US Food and Drug Administration in April 2024, is now available for direct distribution to states and municipalities nationwide. Naloxone HCI Nasal Spray rapidly reverses the effects of life-threatening opioid emergencies. By binding to opioid receptors in the brain, it blocks the effects of opioids, potentially restoring normal breathing within two to three minutes in individuals experiencing an overdose from opioids such as heroin, fentanyl, and prescription medications. Amneal’s Naloxone HCI Nasal Spray is the generic equivalent to OTC NARCAN HC ..read more
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AstraZeneca targets $80bn revenue by 2030
Pharmaceutical Business Review
by vbandhakavi
1w ago
The company said it aims to achieve this target by registering growth in its current portfolio in biopharmaceuticals, oncology, and rare diseases.  The effort also includes the launch of approximately 20 new medicines, all before the end of 2030.   AstraZeneca plans to continue investing in new technologies as well as platforms that are poised to transform the future of medicine, to ensure sustained growth beyond 2030.   In addition, the company has committed to maintaining its focus on research and development (R&D) while enhancing productivity across the organisa ..read more
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Teva and Alvotech launch SIMLANDI in US for arthritis
Pharmaceutical Business Review
by vbandhakavi
1w ago
This marks the first biosimilar launched under the strategic partnership between the two companies. SIMLANDI has been approved by the US Food and Drug Administration (FDA) as the first high-concentration, citrate-free biosimilar to Humira with interchangeability exclusivity for the 40mg/0.4ml injection. It is indicated for the treatment of various adult inflammatory conditions, including rheumatoid arthritis in adults, psoriatic arthritis, juvenile idiopathic arthritis, and Crohn’s disease, among others. In August 2020, Teva and Alvotech signed a strategic collaboration to exclusively commerci ..read more
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ERS Genomics and IRBM sign deal for CRISPR technology
Pharmaceutical Business Review
by vbandhakavi
1w ago
With this agreement, IRBM will be able to leverage CRISPR/Cas9 technology to advance its drug discovery processes. The editing technology will also be integrated into the comprehensive drug discovery services of IRBM. IRBM, a contract research organisation (CRO) specialising in drug discovery, has expertise in various therapeutic areas, including oncology, infectious diseases, and neuroscience. The company has a track record of contributing to the discovery and development of four marketed drugs for diseases such as HCV, ovarian cancer, HIV and cutaneous T-cell lymphoma. ERS Genomics offers ac ..read more
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Sol-Gel, Beimei sign deal for TWYNEO commercialisation
Pharmaceutical Business Review
by vbandhakavi
2w ago
TWYNEO is claimed to be the first and only US Food and Drug Administration (FDA)-approved fixed-dose cream which combines tretinoin and benzoyl peroxide for treating acne vulgaris in adults as well as paediatric patients aged nine and above.  As per the terms of latest agreement, Beimei will handle the commercialisation, which includes purchases and licenses rights of TWYNEO in the specified territories.   Meanwhile, Sol-Gel is set to receive upfront and milestone payments totalling $10m, however it is currently subject to government approvals.  The company will also r ..read more
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