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Clinical Trial News

Alvotech Acquires Swiss Packaging Specialist Ivers-Lee to Expand Biosimilar Manufacturing Capacity

  • Alvotech has acquired Ivers-Lee Group, a Swiss family-owned pharmaceutical packaging company founded in 1947, to expand its assembly and packaging capabilities ahead of three new biosimilar launches in 2025.
  • The acquisition integrates Ivers-Lee's GMP-licensed and FDA-approved facilities in Switzerland and Germany into Alvotech's Technical Operations division while maintaining the company as a separate legal entity.
  • Ivers-Lee brings specialized capabilities in autoinjector assembly, pre-filled syringe packaging, and safety device manufacturing to support Alvotech's growing global demand for biosimilar medicines.
  • The strategic move strengthens Alvotech's manufacturing infrastructure as the company prepares for increased sales growth in global markets with existing approved biosimilars to Humira and Stelara.

Phesi CEO Warns of Impending Phase 3 Trial Failures Due to Site Oversaturation and Complex Design

AI
  • Phesi analysis reveals Phase 3 trials across multiple indications face avoidable failure due to overly complex design and lack of real-world data integration.
  • Atopic dermatitis trials exemplify the crisis, with recruiting sites surging 205% in four years while one California investigator manages 14 concurrent AD studies.
  • AI-powered data analytics could simplify trial metrics and improve site selection, with EASI and %BSA showing near-perfect correlation in AD patient populations.
  • The company's Digital Patient Profile analysis suggests opportunities to reduce patient burden without compromising scientific rigor through smarter endpoint selection.

Centivax Secures $45 Million Series A to Advance Universal Flu Vaccine into Phase I Clinical Trial

  • Centivax raised an oversubscribed $45 million Series A round led by Future Ventures to advance its universal flu vaccine through Phase I clinical trials beginning within eight months.
  • The company's epitope-focusing platform technology demonstrated universal immunity against all tested influenza viruses in preclinical studies across multiple animal models and human immune organoids.
  • Former Pfizer and Merck vaccine executive Dr. Emilio Emini joined the board of directors, bringing extensive experience in vaccine development including contributions to Prevnar.
  • The Phase I trial will test the vaccine's efficacy against over twenty flu strains using the gold-standard hemagglutination inhibition assay in direct comparison with existing seasonal flu vaccines.

Lupin Secures $50 Million Licensing Deal with Zentiva for Global Certolizumab Pegol Biosimilar Rollout

  • Lupin has entered into a strategic licensing and supply agreement with Czech-based Zentiva to commercialize its biosimilar version of Certolizumab Pegol across multiple global markets.
  • Under the agreement, Zentiva will handle marketing and distribution in Europe and CIS countries while Lupin retains commercialization rights in the United States, Canada, and other regions.
  • Zentiva will make milestone-based payments of up to $50 million to Lupin, including a $10 million upfront payment, with both companies jointly investing in biosimilar development.
  • The partnership aims to expand Lupin's market reach and provide cost-effective biosimilar alternatives to patients worldwide through Zentiva's extensive European commercial infrastructure.

Johnson & Johnson Seeks European Approval to Expand AKEEGA for Metastatic Prostate Cancer with Genetic Alterations

Drug ApprovalPrecision Medicine
  • Janssen-Cilag applied to the European Medicines Agency to expand AKEEGA usage for adults with metastatic hormone-sensitive prostate cancer who have homologous recombination repair gene alterations.
  • Over 20% of mHSPC patients have HRR gene alterations, including BRCA1/2 genes, and these patients often experience worse outcomes with limited treatment options.
  • The application is supported by Phase 3 AMPLITUDE study results showing the niraparib and abiraterone acetate combination significantly delayed cancer progression and symptom worsening.
  • AKEEGA combines niraparib and abiraterone acetate, targeting a specific patient population with genetic changes that affect DNA repair mechanisms.

BioMed X and Servier Launch First European XSeed Labs to Advance AI-Driven Bispecific Antibody Design

AIDrug DiscoveryOncology
  • BioMed X and Servier have launched the first XSeed Labs in Europe at the Spartners incubator in Paris-Saclay, implementing a crowdsourcing model that embeds academic researchers within pharmaceutical R&D facilities.
  • The inaugural research project focuses on developing an AI-empowered platform for sterically guided design of bispecific antibodies, addressing key physical constraints that limit therapeutic effectiveness.
  • The initiative seeks to overcome steric hindrance, epitope accessibility, and spatial dynamics challenges that currently evade systematic design principles in bispecific antibody development.
  • Researchers worldwide are invited to submit interdisciplinary proposals combining antibody engineering, AI/machine learning, structural biology, and immuno-oncology expertise by August 31, 2025.

Merck Announces $10 Billion Acquisition of Verona Pharma to Expand COPD Treatment Portfolio

Drug Approval
  • Merck has entered into a definitive agreement to acquire Verona Pharma for $10 billion, adding the first-in-class COPD treatment Ohtuvayre to its respiratory portfolio.
  • Ohtuvayre represents the first novel inhaled mechanism for COPD maintenance treatment in over 20 years, combining bronchodilator and anti-inflammatory effects in a single molecule.
  • The acquisition addresses Merck's need to diversify revenue streams ahead of Keytruda's patent expiry in 2028, with the transaction expected to close in Q4 2025.
  • Ohtuvayre generated over 96% of Verona's $76 million first-quarter revenue and is also being evaluated for non-cystic fibrosis bronchiectasis treatment.

Aktiia's Hilo Band Becomes First FDA-Cleared Cuffless Blood Pressure Monitor for Over-the-Counter Use

  • Neuchâtel-based Aktiia has received FDA 510(k) clearance for its Hilo Band, marking the first cuffless blood pressure monitor authorized for over-the-counter use in the United States.
  • The device uses optical sensors to continuously measure blood pressure without traditional cuffs and will launch in the U.S. market in 2026 following online availability.
  • Aktiia has already sold over 130,000 devices worldwide and recently raised $42 million in Series B funding to support international expansion.
  • The FDA clearance represents a paradigm shift in hypertension management, breaking down barriers that previously kept cuffless blood pressure monitoring from consumers.

Two New Tuberculosis Drugs Show Superior Safety Profile Over Linezolid in Phase 2b Trials

  • Two Phase 2b clinical trials led by LMU University Hospital Munich demonstrated that sutezolid and delpazolid, both oxazolidinone antibiotics, offer safer alternatives to linezolid for tuberculosis treatment with no cases of nerve damage or blood toxicity observed.
  • The SUDOCU and DECODE trials, conducted in South Africa and Tanzania, tested these drugs in combination with bedaquiline, delamanid, and moxifloxacin, marking the first studies to evaluate these specific four-drug combinations.
  • Delpazolid at 1200 mg once daily achieved optimal drug levels and was well tolerated over 16 weeks, while sutezolid showed strong antibacterial activity across all tested doses.
  • The findings, published in The Lancet Infectious Diseases, address the urgent need for safer TB treatments as linezolid's prolonged use frequently causes serious adverse events including anemia and optical neuropathy.

Aptar Develops Dual-Active Material Science Technology for GLP-1 Drug Protection

  • AptarGroup has developed a breakthrough dual-active material science technology that simultaneously controls moisture and oxygen to protect sensitive pharmaceutical formulations.
  • The technology extends Aptar CSP Technologies' 3-Phase Activ-Polymer™ technology to address degradation challenges in oral solid dose GLP-1 drugs and various medical devices.
  • This singular solution helps pharmaceutical companies meet strict ICH stability requirements while maintaining drug efficacy, safety, and shelf life for sensitive formulations.
  • The customizable technology supports products from early R&D through commercial launch and can be applied to multiple platforms including implantable devices and transdermal systems.

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