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Policy debate: HTA systems in Europe and Canada ‘undervalue’ innovation
No Patient Left Behind released a report arguing that foreign health technology assessments used in countries such as Canada and Germany undervalue innovative medicines by about 90%. The group...
M&A: Lilly expands non-opioid pain pipeline with acquisition of 4E Therapeutics
Eli Lilly agreed to buy 4E Therapeutics, aiming to expand its pain pipeline with a non-opioid strategy that targets peripheral sensory neurons rather than centrally dulling pain signals. The...
FDA/coverage technology: Diasorin wins clearance and CLIA waiver for Group A strep on Liaison Nes
The FDA granted 510(k) clearance and a CLIA waiver to Diasorin’s Liaison Nes Group A streptococcus rapid molecular test, enabling outpatient and decentralized testing with results in roughly 15...
Clinical safety evidence: Second primary malignancies after T-cell–engaging bispecifics
A systematic review and meta-analysis estimated the frequency of second primary malignant neoplasms after T-cell–engaging bispecific antibody therapy in adult NHL and multiple myeloma. The...
Clinical development: Prime Medicine’s PM-577a clears for Wilson’s disease trial in New Zealand
Prime Medicine received clearance from New Zealand’s Medsafe to proceed with its clinical trial application for PM-577a, an investigational Prime Editor targeting Wilson’s disease. The company...
Diagnostics: Global rollout of PlusLife near point-of-care TB testing begins
The Global Fund and partners began deploying PlusLife MiniDock Ultra near point-of-care TB test systems across 13 countries, supported by $50 million from the Children’s Investment Fund...
Funding/IPO markets: Sophia Genetics closes upsized public offering
Sophia Genetics closed its previously announced underwritten public offering after strong investor demand, selling 12,104,900 ordinary shares at $4.75 per share for total gross proceeds of $57.5...
Academic biotech: German DZNE launches NeuroGenomeHub with €6M for brain genomics
Germany’s DZNE launched NeuroGenomeHub, a brain genomics initiative funded with about €6 million to build a global genome database for neurodegenerative diseases. The program plans to sequence...
Research breakthrough: AI model predicts protein–protein interactions at atomic scale
Researchers unveiled a generative AI model that enables atomic-scale prediction of protein–protein interactions, aiming to accelerate both antibody discovery and other structure-driven therapeutic...
US targets Germany drug pricing with Section 301 probe
The U.S. Trade Representative (USTR) launched a Section 301 investigation into Germany’s drug pricing policies, arguing the country’s approach shifts an unfair share of global R&D costs onto the...
International drug value assessments undercut innovation incentives
A new report from No Patient Left Behind (NPLB) argues that health technology assessment (HTA) value determinations in countries such as Canada and Germany substantially underestimate the societal...
Lilly buys 4E Therapeutics to expand non-opioid pain pipeline
Eli Lilly agreed to acquire Austin, Texas-based 4E Therapeutics, extending its search for non-opioid pain relief that works outside the opioid paradigm. The deal price was not disclosed. The...
Biogen pays up to $1B to buy RayThera immunology small molecules
Biogen announced it will acquire San Diego-based RayThera in a transaction valued at up to $1 billion, aiming to strengthen its immunology pipeline with small-molecule anti-inflammatory assets....
Diasorin adds rapid group A strep to Liaison Nes POC PCR
The FDA granted 510(k) clearance and a CLIA waiver to Diasorin’s Liaison Nes multiplex group A streptococcus test, the company said. The assay is designed for rapid point-of-care use, delivering...
FDA voucher program draws renewed scrutiny
The FDA’s Commissioner’s National Priority Review Voucher (CNPV) pilot is coming under fresh pressure as stakeholders say key operational details are missing, including how candidate products are...
Biotech funding: Sophia Genetics raises via oversubscribed public offering
Sophia Genetics closed an oversubscribed underwritten public offering, securing $57.5 million of gross proceeds before underwriting discounts and commissions. The company sold 12,104,900 ordinary...
PlusLife MiniDock Ultra rollout starts in TB test push
The Global Fund and other partners began rolling out PlusLife MiniDock Ultra systems across 13 countries, supported by $50 million from the Children’s Investment Fund Foundation. The initiative is...
Gene editing clinic: Prime Medicine PM-577a cleared in New Zealand for Wilson’s disease
Prime Medicine said the New Zealand regulator Medsafe cleared its clinical trial application for PM-577a in Wilson’s disease. PM-577a is a prime editor investigational therapy, advancing toward...
Artificial intelligence finds antibiotic leads in prion-like proteins
Researchers at the Perelman School of Medicine at the University of Pennsylvania reported that AI can point to unexpected antibiotic candidate sites within prion proteins. The work focuses on...
Point-of-care infectious disease diagnostics
FDA cleared and CLIA-waived a new group A streptococcus molecular test for decentralized use on Diasorin’s Liaison Nes point-of-care PCR instrument. The test delivers results in about 15 minutes...