Research & Development News

The CDMO's Pathway TPUs are well-recognized as an effective option for many drug delivery systems.

Scancell’s DNA vaccine could provide long-lasting immunity against COVID-19 by generating protection against this and new strains of coronavirus.

Ahead of the world’s largest ever virtual pharma expo – the CPHI Festival of Pharma – Informa Markets spoke with Ramesh Subramanian, Chief Commercial Officer at GVK BIO on how they are preparing for the event.

Hugh Purity New England's solution can utilize other vendors' components and can be implemented directly into any process.

Novel therapy developed by Australian biotech company, Ena Respiratory, shown to significantly reduce COVID-19 virus levels in the nose and throat.

The companies will commercialize six new biosimilar candidates addressing multiple therapeutic areas.

Expanded CRO services to support biotechs and mid-sized pharma companies across trials in more than 40 countries.

The targeted removal of one particular bacterial species from the skin microbiome, while preserving the beneficial ones, represents a new way to treat atopic dermatitis.

Catalent to manufacture clinical batches of T-knife's platform process for TCR-based cell therapy at its site in Gosselies, Belgium, for European trials in 2021.

Acquisition will add Trodelvy, a first-in-class antibody-drug conjugate approved to treat breast cancer.

Humanigen's proprietary monoclonal antibody may prevent and treat cytokine storm, which is believed to trigger the acute respiratory distress syndrome in severe cases of COVID-19.

Together, the companies will aim to put forward new research projects against infectious diseases and antimicrobial resistance, potentially creating new therapies and technologies.

The partnership will focus on developing multiple ADCs using Catalent’s proprietary SMARTag site-specific bioconjugation technology.

Hybrid clinical trials leveraging safety-focused, direct-to-consumer logistical solutions are taking center stage, ensuring research continuity.

Trial enrolling up to 30,000 adults aged 18 years or over to assess safety, efficacy and immunogenicity of AZD1222 for the prevention of COVID-19.

Researchers have designed a simple, low-cost device for subcutaneous injection of viscous formulations.

Forbius's lead investigational asset, AVID200 holds promise as an effective and well-tolerated therapeutic in fibrotic diseases and immuno-oncology.

The company will prepare the Harmans facility to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance commencing later this year.

The company will target working with small and medium biotechs who require a science-driven, rather than a volume-driven partner.

Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators.

One of India's fastest growing CDMOs goes "beyond the norm" to reinvent itself as a new generation global CDMO.

The transaction will enable Sanofi to expand and accelerate development of BTK inhibitors across multiple indications, including MS and other central nervous system diseases.

Atomwise technology removes the barriers of physical screening that have limited the success of traditional methods for small molecule drug discovery.

The company is also scaling up its manufacturing capability with its partners — Lonza, Catalent and Rovi — should the vaccine get the green light.

Customers in the region will have the opportunity to conduct laboratory-scale compression and coating trials, using automated coating equipment.

The company expects to manufacture the clinical-stage gene therapy product in its commercial-scale GMP manufacturing facilities.

The companies are set to manufacture globally up to 100 million doses by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

The company will adapt its digital platform to digitize any COVID-19 antibody rapid test assay and embed this within an app available on smartphones and tablets.

The data generated through the partnership will help biopharma companies to develop robust manufacturing processes and minimize challenges during scale-up and commercialization.

Acryl-EZE formulations provide significant time savings and targeted drug delivery.

Data on the first clinical use of lenzilumab in patients with severe COVID-19 pneumonia suggest promising results.

The company is also involved in projects that aim to enable population-level screening for the current coronavirus.

Further milestone paves the way for production of novel gene therapy drug candidate designed to treat drug-resistant focal epilepsy.

The center will host a new BioReliance End-to-End Solutions GMP manufacturing facility offering CDMO services to customers in China and Asia-Pacific.

The company began scaling up manufacturing of REGN-COV2 at business risk earlier this year to ensure the immediate availability of the product if clinical trials prove successful.

The CRO will undertake this clinical trial at multiple sites worldwide, starting at the AZ Sint Maarten hospital in Mechelen, Belgium.

AJILITY is designed to speed novel or existing therapeutics from development to manufacturing and into the clinic.

The CDMO will work on developing a solution and a solid oral dosage form of ViralClear's merimepodib.

The French pharma company will also invest EUR 120 million to create a new research center at Marcy-l'Etoile dedicated to vaccines

Optimizing the dosage form's efficiency reduces the amount of drug required in each patch.

The company will provide CDMO capabilities, capacities, and expertise to support the US government’s Warp Speed Program to pave the way for innovators to advance COVID-19 programs.

SeraNovo enters into a second license agreement with Carna Biosciences for development of oral formulation of Carna’s kinase inhibitor.

Researchers endorse a switch from the current first-filer system in the US to a system that instead rewards the first successful challenger.

The invention could pave the way for treatments to cure Parkinson's and Alzheimer's disease.

AbCellera, will use its antibody drug discovery platform to identify antibodies against up to nine targets.

The novel method paves the way towards the mass production of affordable therapeutic drugs that are made with recyclable materials.

CDMO is contracted to produce multiple clinical batches from German facility

New application study describes the separation and characterisation of adeno associated virus serotypes by AF4.

Collaborations focus on gene therapies for serious eye and muscle diseases using Dyno’s CapsidMap artificial intelligence platform to design AAV vectors.

Using this critical antibody reagent at the preclinical stage of development will minimize the need to revalidate assays with different reagents at the clinical development stage.

Independent Data Monitoring Committee (IDMC) recommends unblind Phase III trial of Tagrisso 2 years ahead of schedule.

The biotech pioneer is one of the first companies to develop corporate partnerships in this application of artificial intelligence (AI) for drug discovery.

The head of the leading German pharmaceutical industry organization says German firms are working top-speed to find coronavirus medications.

Symphogen becomes the antibody center of excellence within Servier.

The platform enables collaboration between pharmaceutical institutions, healthcare and academic researchers to generate valuable insights and advance medical research.

The patent covers the crosslinking of certain carrier molecules, for example, antibodies, via specific binding sites to amatoxins.

Study data support blood test's ability to detect 50 types of cancer and identify where in the body the cancer is located.

Together, the companies will provide APAC markets with a cost-effective alternative to the largest-selling blockbuster medicine worldwide.

Collaboration with MedPharm delivers data profiling new XF‐platform drug formulations as potential treatments for dermal and ocular infections.

The Contract Development and Manufacturing Organization (CDMO) and technology provider will use its CHO.RiGHT expression platform for high-titer cell line development.

Company awarded US$5 million grant for clinical study of measles and rubella vaccination using Vaxxas’ high-density, micro-array patch.

Postnova Analytics' CF2000 Centrifugal Field Flow Fractionation (CF3) system is delivering exciting new data to scientists developing drug delivery systems.

The trial is the first controlled trial in the US to evaluate the effect of IL-6 inhibition prospectively in COVID-19 patients.

Company launches BIOSTAT STR Generation 3 bioreactor with BIOBRAIN automation platform.

Phase III study evaluating Empliciti plus Revlimid and dexamethasone in patients with newly diagnosed, untreated multiple myeloma fails to meet primary endpoint.

Active pharmaceutical ingredients (APIs) nanoformed using the CESS process demonstrate promise for overcoming solubility and bioavailability challenges.

Biotech firm Gilead Sciences said Monday it is set to acquire clinical-stage oncology specialist Forty Seven in a transaction worth $4.9 billion.

The company’s immediate priority is to address the opioid crisis by developing a non-hallucinogenic version of the psychedelic ibogaine.

The US Food and Drug Administration (FDA) accepts for review Pfizer and Eli Lilly's Biologics License Application (BLA) for tanezumab — a non-opioid treatment for patients with chronic pain due to moderate-to-severe osteoarthritis.

A cooperation agreement between German pharma firm Merck KGaA and additive manufacturing specialist AMCM on 3D printing of tablets could eventually lead to scalable active pharmaceutical ingredient (API) formulation and faster, cheaper production, the ...

Agreement gives BIA Separations access to proprietary technology to better preserve integrity, infectivity and potency of immunoaffinity-purified viral vectors for gene therapy.

The study will evaluate the efficacy of SJX-653 in reducing the frequency and severity of VMS due to menopause, as well as improving measures of sleep and quality of life.

Beovu is the only anti-VEGF treatment approved in Europe for wet AMD that offers the option to start eligible patients on 3-month dosing intervals immediately after the loading phase.

Gene therapies have the potential to revolutionize treatment options for patients suffering from cancer, cystic fibrosis, heart disease, diabetes, Parkinson's, AIDS and Alzheimer's by replacing, inactivating or introducing genes into cells &mda...

The facility will triple the company’s cGMP clinical trial manufacturing capacity.

Evolving patient needs, growing demand for traceability and increasing cost pressures have awakened innovation in the pharmaceutical packaging sector.

Agreement will facilitate clinical trial translations in China.

If proven safe and effective, mAb CIS43LS might be used prophylactically by tourists, medical workers or military personnel who travel to areas where malaria is common.

€250 million to be invested during the 2019-2022 period in new facility bridging research and manufacturing.

No need to draw blood; researchers develop smart technology to diagnose diabetes and treat diabetic retinopathy.

The company targets ERAP antigen presentation pathways with the aim of ‘illuminating’ non-responsive tumours for attack and destruction by the immune system.

BMN 307 represents a potential third PKU treatment option from BioMarin and its second gene therapy clinical program.

The French National Agency for Medicines and Health Product Safety (ANSM) has agreed that Innate Pharma’s Tellomak (lacutamab) Phase II trial can resume recruitment of new patients with relapsed/refractory Sézary syndrome and mycosis fungoides (MF) in ...

PF-05251749 complements the company’s pipeline of potential disease-modifying therapies for Alzheimer’s and Parkinson’s diseases.

The product being developed will use proprietary drug formulation technology platform Arestat to deliver new reformulations of existing, complex products.

Platform gives researchers access to previously undiscovered data to guide evaluation and validation of new drug targets, pathogen identification, disease diagnosis, and the advancement of regenerative medicine.

End-to-end robotic platform provides biotechnology companies, pharmaceutical corporations and academic centres with cost-effective and reproducible drug discovery data.

Mutations in the RIPK1 gene responsible for CRIA syndrome.

Collaboration discovers potent and selective inhibitors of enzymes associated with the development of some cancers and neurodegenerative diseases.

NEI-led study to test safety of treatment for a form of age-related macular degeneration that currently lacks treatment.

Lead asset THOR-707 being explored across multiple solid tumor types alone and in combination with immune checkpoint inhibitors and other future IO combinations.

New innovation has considerable potential to be used as a new environmentally friendly matrix for the microencapsulation and controlled release of a wide range of actives.

Lilly Gateway Labs will provide biotech companies direct access to Lilly scientists and expertise.

Unprecedented levels of investment cited as a major force driving the expansion.

Marks the latest step in the company’s ongoing efforts to engage with other organisations working to tackle antimicrobial resistance.

New models can help researchers investigate disease development and find new treatment approaches.

But personalized medicines will require new logistics and manufacturing systems.

Services including method development, method validation, and stability program design and implementation.

The approval of Eli Lilly's Reyvow represents the first new class of acute migraine treatment approved by the FDA in more than two decades.

Company's Ibex Design planned to take Genmab’s pre-clinical candidates from gene to potential IND within 12 months.

European financing to support Univercells’ R&D investments to develop four essential and undersupplied global health vaccines to be produced at affordable prices, high quality and large volumes.

Coordinated purification process development service accelerates progress to clinical trials, and scale-up manufacturing.

Research aims to identify novel dermocosmetic active ingredients via unique microbiome-on-a-chip technology.

IKS01 shows marked anti-tumour efficacy in pre-clinical models of ovarian and lung cancer.

Platform will enable scientists and biotechnology entrepreneurs worldwide to make discoveries faster and more efficiently,

Epidyolex (cannabidiol) approved for the treatment of seizures in patients with two rare, severe forms of childhood-onset epilepsy.

New drug works like a ‘magic bullet’ that is delivered directly to the mitochondria of cancer cells.

To support its strong growth, M2i Life Sciences has concluded a capital increase of 60 million Euros with five leading investors (ADM Capital, Eurazeo Growth, Téthys Invest, Creadev and France 2i fund managed by RAISE Impact).

Ground-breaking trial demonstrates potential of blood test which harnesses the power of the immune system to reduce late detection of lung cancer.

Delivers enhanced galactosylation for improved protein quality, and antibody binding and function.

Maxwellia considered to have the skills and the expertise to deliver and reach their goal of creating the big OTC brands of the future.

The test can accurately predict the risk of having metastases present in the lymph nodes without having to undergo surgery to remove lymph nodes.

Independent Data Monitoring Committee recommended terminating the study due to lack of survival benefit.

New data shows pharmaceutical-quality lavender oil significantly improves anxiety-induced insomnia when taken as a daily capsule.

Australian researchers produce early-stage vaccine which is inhaled into the lungs.

Atelerix Consortium awarded £267,000 Innovate UK Grant for collaboration with the Cell and Gene Therapy Catapult and Rexgenero on cell therapy stabilisation technologies.

Company's antibody screening platform minimizes the risk of missing a blockbuster.

The longest, highest fidelity, and ready-to-use custom oligo pools on the market.

rfxcel, the global leader in supply chain compliance and serialization solutions, has been approved by the U.S. Food and Drug Administration (FDA) to conduct a pilot to extend the testing of the Verification Router Service (VRS) for saleable returns.

rfxcel, the leader in track and trace solutions for global supply chains announced that it is now ISO 9001:2015 certified for Quality Management Systems.