News & Analysis on the Clinical Development and Manufacture of Large Molecule Drugs
A new case study released by AllazoHealth reveals that a leading rare disease pharmaceutical company achieved a 10.4% increase in therapy initiation, driven by AI-enabled patient outreach and personalized communications.
In a move set to transform drug discovery, CRO NovAliX has partnered with Bruker, a leader in scientific instruments, through a strategic investment aimed at enhancing drug development success rates.
The FDA has simultaneously granted approval to Astellas’ cancer drug Vyloy and to a companion diagnostic test developed by Roche.
Investors and big pharma companies are waking up to the potential of techbio companies after years of avoidance, say experts at TechBio UK 2024, an event run by the BioIndustry Association (BIA).
The US Biosecure Act was passed by the House of Representatives in September and seems likely to become law.
The UK cell therapy biotech will now advance its first candidate cell therapy to clinical trials for treatment of liver disease.
As CPHI Milan 2024 approaches, Symbiosis Pharmaceutical Services is gearing up to showcase major expansions and innovations in sterile biopharmaceutical manufacturing.
CPHI 2024
At this October’s CPHI event being held in Milan, dsm-firmenich, is inviting stakeholders across the pharmaceutical market to immerse themselves in its patient-inspired innovations.
Enzene's monoclonal antibody production costs to dip below $40 per gram by 2025.
The new company focuses on producing components needed to manufacture RNA-based therapies for which there is increasing demand.
New data from the QWINT clinical trial may get Eli Lilly closer to bringing a once-weekly insulin injection to the US, following the FDA’s rejection of Novo Nordisk’s own weekly insulin formulation earlier this year.
Clinical trials are becoming increasingly complex as emerging technologies such as immunotherapy enter the mainstream.
The San Diego-based biotech company Candid Therapeutics has launched with a huge $370 million with the aim to develop T-cell engager therapies for autoimmune diseases.
Neurocrine Biosciences has achieved late-stage success with muscarinic M4 selective agonist in schizophrenia.
Microbiotica has received the green light from EU and UK regulatory authorities to start phase 1b studies for its microbiome medicines in advanced melanoma and ulcerative colitis.
Eisai and Biogen’s new Alzheimer’s treatment, lecanemab, received a green light from UK regulators, marking a significant advance in treating early-stage Alzheimer’s disease.
In the rapidly evolving field of drug discovery, Melanie Adams-Cioaba stands at the forefront, leading transformative advancements in cryo-electron microscopy (cryo-EM) at Thermo Fisher Scientific.
Recent advancements in injectable hydrogels are setting the stage for a new era in tissue engineering and regenerative medicine.
In a significant leap forward for therapeutic science, researchers at Cornell University have developed a pioneering method to 'cloak' proteins, enabling their efficient delivery into living cells.
CVC Capital Partners has entered an agreement with specialty pharmaceutical company Mallinckrodt to acquire its Therakos business.
With the FDA’s endorsement, Amgen and AstraZeneca are getting closer to adding chronic obstructive pulmonary disease (COPD) as a new indication to Tezspire.
Experience with severe mental health disorders in close friends and family gave Sam Clark the drive to found Terran Biosciences to explore new approaches to therapeutics in neuropsychiatry.
Red Queen Therapeutics, a new clinical-stage biotechnology company, has launched with a mission to develop antiviral treatments for serious viral diseases, including coronaviruses, influenza, and respiratory syncytial virus (RSV).
In this Q&A, we delve into the collaboration between Skye Bioscience and Beacon Biosignals to enhance the evaluation of nimacimab, a promising treatment for obesity and its comorbid conditions, including obstructive sleep apnea (OSA).
A book, a computer and some sage words from her physicist father set Tehmina on her path to a successful career in science.
The oversubscribed fundraising will enable Third Arc Bio to enter the clinic with multiple programs in 2025.
As advanced therapies drive increasing market consolidation, the US giant Agilent Technologies has acquired the Canadian contract development and manufacturing organization (CDMO) BIOVECTRA for $925 million.
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Alvotech and Stada launch Stelara biosimilar following European approval earlier this year and expiry of exclusivity rights on the original molecule.
Data integrity is a paramount concern for pharmaceutical manufacturers, particularly as they navigate the complexities of modern production with legacy equipment.
Samsung Bioepis Co., Ltd. announced yesterday (July 23) that the US Food and Drug Administration (FDA) has approved Epsyqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab).
In a bid to make biologic treatments more accessible to patients, Boehringer Ingelheim is harnessing the reach and scale of the prescription savings platform GoodRx to provide its Humira biosimilar adalimumab-adbm at a low price.
The fundraising will support the development of the company’s technology platform for silencing RNA (siRNA), which has the potential to enable dosing patients every six months to treat a wide range of conditions.
The contract development and manufacturing organization (CDMO) arm of the Israeli company Pluri will deploy automated and 3D cell expansion technology to produce cell therapies developed by compatriot firm Kadimastem.
Ionis Pharmaceuticals antisense therapy for Angelman syndrome achieved good early safety and efficacy results and the company now plans to advance the therapy to phase 3.
Dr. Antonella Favit-VanPelt, a distinguished neurologist, has had a lifelong passion for understanding the 'why' behind sickness, ignited by her childhood curiosity.
As a strategic brand consultant at ramarketing, Laura combines her extensive background in clinical research with strategic leadership and creative expression.
Roche’s recent $2.7 billion acquisition of Carmot Therapeutics is paying off, with positive results for new oral GLP-1 receptor agonist.
CordenPharma, a US-based contract development and manufacturing organization (CDMO), will be making a €900 million investment over the next three years into expanding its peptide technology platform at its US and Europe sites.
Integrated DNA Technologies (IDT) is doubling down on its commitment to innovation with the launch of a new 25,000-square-foot synthetic biology facility in Coralville, Iowa.
Esteve Pharmaceuticals has announced a substantial investment of €100 million ($108 million) to build a new manufacturing unit at its Girona plant.
RNA therapeutics have emerged as a transformative approach to treating many conditions, but the industry still typically relies on inefficient batch manufacturing methods.
Andelyn Biosciences, a leading cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has been chosen by UMass Chan Medical School to manufacture clinical-grade AAV9-CSA vector using its suspension AAV Curator Platform to...
CureVac has signed a new licensing agreement with GSK shortly after announcing the decision to reduce its workforce by 30% and refocus its research and development priorities.
CAR-T therapies have big potential to take on blood cancer but also have major drawbacks.
The US FDA has delayed approval of Rocket Pharmaceuticals’ gene therapy for treatment of a rare immune condition known as leukocyte adhesion deficiency, citing a need for more information about the manufacturing process.
Results from the Vivacity-MG3 study will support Johnson & Johnson’s application for regulatory approval of nipocalimab.
The new generative AI model released by EvolutionaryScale will be used by researchers and pharma companies to empower drug discovery.
As Saudi Arabia seeks to make its healthcare system more cost-efficient, the private equity firm TVM Capital Healthcare is betting $35 million on the Saudi Arabia-based bio-generics provider Boston Oncology Arabia.
At BIO 2024, Purolite made waves in the biopharmaceutical industry with the launch of their innovative DurA Cycle A50 resin.
Alnylam’s experimental drug vutrisiran has shown promise for the treatment of transthyretin amyloidosis (ATTR) in a phase 3 clinical trial.