Research & Development News

Company now able to serialise commercial batches manufactured by them for clients; it can also offer standalone serialisation services as an outsourcing partner.

The financing will power the global commercial launch of the company's Fluidity One system.

The new treatment will leverage OnDosis’ proprietary technology, which integrates oral drugs in form of micro units and individualised dosing, in a handheld device.

The gel formulation includes the progestin compound segesterone acetate, in combination with testosterone, and is applied to the back and shoulders and absorbed through the skin.

Expansion supports the growing needs of the company's pharmaceutical, biotechnology and CRO partners.

Cobra Biologics, Pall, and the Cell and Gene Therapy Catapult share £1.5 million grant from the UK's innovation agency.

The absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial.

Th company's CombiCult combinatorial cell culture technology will be used to generate high fidelity, progenitor and terminally differentiated neuronal and glial cell subtypes for incorporation into next-generation models.

Acquisition further strengthens Lonza’s commitment to drive the next generation of manufacturing patient-specific and personalized therapies.

The new ‘Centre of Excellence’ already boasts one of the world’s most advanced gummy production line designed to meet demand from global markets.

One study uses the company's proprietary TurChub model, to evaluate the diffusion and subsequent activity of drugs in human nails.

Partnership aims to increase the robustness and reduce costs for the manufacturing of AAV vectors.

Encorafenib in combination with binimetinib demonstrated 14.9 months median progression-free survival compared with vemurafenib monotherapy (7.3 months).

Company to use its combinatorial stem cell screening platform to develop technologies for the conversion of pluripotent stem cells into platelets.

SGS's expansion will enable the service provider to offer a full ICH Q6B physico-chemical characterization of biological products.

New service to reliably and reproducibly isolate exosomes from almost any biofluid.

Company moves away from manual processing in favour of automated, scalable platforms.

EU approves Novartis's Aimovig, a first-of-its-kind treatment specifically designed for migraine prevention.

WuXi STA chosen for its end-to-end CMC platform for new drug development.

The ability to micro size drug-cell interactions will allow pharmaceutical and biotech companies to do 100x more testing for the same money spent as well as increasing productivity.

Parallel cell line development and analysis will allow for optimal cell line selection while compressing the development timeline.

Scientists see therapeutic potential against bacteria, viruses.

Consortium to develop advanced technologies for the manufacturing of ex vivo gene therapies.

The topical treatment for hair loss boasts a 'commercial' formulation.

Researchers to benefit by receiving a rapid and cost-effective scaled supply of new compounds.

TAOS matrix system and products hailed as potential ‘game changers’ in the field of regenerative medicine.

New poster describes how the EAF4 module enabled simultaneous measurement of size and surface charge characteristics of antibodies and proteins.

Bosch's new Xelum R&D for continuous production of oral solid dosage forms ensures a short time-to-market and optimum dosing of APIs.

Acquisition of AurKa Pharma expands Lilly's oncology pipeline with early-phase asset being studied in multiple tumour types.

Allows for easy and intuitive scale-up from research.

Customers to gain a greater insight into their projects, better track project progress and improve communications.

NIAID-funded research could aid antimalarial drug development.

Integrated one-site solution for partners to push forward innovative APIs and advanced intermediates from preclinical to commercial stage.

The aboratory’s primary function is to broaden analytical support for customer projects being developed and manufactured at the High Point site.

MD-026 is the first RSK inhibitor to demonstrate potential disease-modifying properties in triple-negative breast cancer.

NIH-funded study finds omega-3 fails to yield beneficial results in the clinic.

First patient treated in Follicum’s Phase IIa study of FOL-005 for stimulation of hair growth.

PF-04958242 is an AMPA receptor potentiator designed to facilitate neurotransmission.

Majority of patients with scalp psoriasis on Cosentyx (secukinumab) achieved clear skin at Weeks 12 and 24 and improved quality of life.

The Centers of Excellence will allow custoners to access customer-centric solutions.

Successful MHRA inspection at Dundee site confirms GLP accreditation for in vitro safety studies and bioanalysis.

German Medicines Agency sees potential in FOL-005 - a modified version of the endogenous protein, osteopontin - the green light for further studies.

Funding will support further development of recently acquired small molecule assets for treatment of autoimmune disease.

PAA showcases its complete range of automation solutions, suitable for any type of laboratory or application, at SLAS2018.

Fexinidazole would be first all-oral treatment under investigation for both first and second stages of sleeping sickness, a fatal disease, endemic in Africa.

Enamine REAL database of synthetic compounds accessible via UCSF’s online ZINC platform.

LifeArc and Milner Therapeutics Institute to develop, validate and integrate cutting-edge machine learning approaches into drug discovery processes.

KWS increases Charles River's ability to support clients’ early-stage drug research in critical therapeutic areas.

A summary and highlights of new drug therapy approvals and other drug therapy advances in 2017 by FDA's CDER.

The MedStat-HT and MedFlux-HT help to de-risk development programs and shorten development timelines.

New 3D technology provides a powerful platform for skin care researchers wishing to study the function of sebaceous glands, in relation to a range of age-related, microbial and inflammatory skin disorders.

"The precision and flexibility of zinc finger proteins enables targeting of virtually any genetic mutation."

Data supporting designation showed over half of treatment-naïve SAA patients achieved complete response with Promacta when given with standard immunosuppressive therapy, with overall response rate of 85%.

Targeting the initiation of a pivotal patient clinical trial in the first half of 2018.

Designation based on Phase III MONALEESA-7 results demonstrating superior efficacy of Kisqali in combination with oral endocrine therapy compared to oral endocrine therapy in pre- or perimenopausal women who received no prior endocrine therapy for adva...

SRK-015 to move into clinical development for Spinal Muscular Atrophy (SMA) in first half of 2018; development in additional neuromuscular disorders to follow.

Company envisions the development and IND filings of multiple “next-frontier” CAR-T programs in 2018 and beyond, which will position the company as a potential major player in the fast-growing CAR-T space of immunotherapies against cancers.

If approved, Tafinlar + Mekinist expected to be the first adjuvant targeted therapy combination to demonstrate a significant clinical benefit in patients with a BRAF V600 mutation.

The PDUFA goal date for completion of the FDA review of the Epidiolex NDA is 27 June 2018.

First and only CML therapy with Treatment-free Remission data in its label.

Sanofi and Alnylam's patisiran MAA to be reviewed under accelerated assessment.

iMatrix recombinant Laminin-511 E8 protein fragments permit ES/iPS cells to be maintained in xeno-free, feeder-free culture conditions enabling easy application in medical trials.

Human polyclonal antibodies show promise as effective treatment.

New collaboration agreement to identify new antisense oligonucleotide drug candidates.

First and only FDA-cleared PK dosing software to support healthcare professionals in creating personalized dosing regimens for patients 16 and older with hemophilia A.

Project will innovate technologies in epigenetic characterisation for patient stratification in renowned precision medicine.

Researchers find target to protect hearing during chemotherapy treatment.

Collaboration to conduct clinical trials of the combination treatment in both cervical and head-and-neck cancer.

Drug trials provide mind-blowing results.

Freeze-dried, or lyophilized, formulation aims to improve supply management by providing the same dosing regimen as liquid Oncaspar but with a three-times longer shelf life of up to 24 months.

First clinical candidate, HPN424, is in development for the treatment of metastatic prostate cancer and expected to enter Phase I clinical trials in 2018.

IDMC concludes that the study is unlikely to meet its primary objective.

Study provides further evidence that it is possible to reduce the burden of long-term inhaled steroids in many COPD patients.

Quotient Sciences Translational Pharmaceutics platform integrates formulation development, real-time adaptive GMP manufacturing and clinical research.

New ARB technology rejuvenates existing antibiotics to outsmart antibiotic resistance.

The launch of avelumab marks a step-change in the way that mMCC can be treated.

For the first time for any biologic, data show almost 80% of ankylosing spondylitis patients on Cosentyx have no radiographic progression of the spine at 4 years.

Financing to advance its pipeline of neoantigen cancer-based immunotherapies to the clinic.

Post-hoc analysis shows pain improvement was consistent regardless of a patient's baseline pain severity.

Rizaport is a proprietary oral thin-film formulation of rizatriptan for the treatment of acute migraines.

This nanomedicine candidate is specifically designed to enable enhanced tumour accumulation and local drug release at the target site, to boost the therapeutic efficacy and to overcome the shortfalls associated with current docetaxel products.

Accelerated approval of Bruton tyrosine kinase inhibitor in MCL marks AstraZeneca's entry into the treatment of blood cancers.

The deadliest malaria parasite needs two proteins to infect red blood cells.

7 out of 10 users preferred seawater to traditional serum, claiming it even reduces sick days.

In pre-clinical studies, Metablok has shown it has the ability to prevent acute kidney injury by blocking the inflammatory response triggered by kidney ischemia/reperfusion.

Project will build upon the results of Phase II trials undertaken by Bavarian Nordic.

Use of PnuVax’s unique patented conjugation platform technology to produce the vaccine is expected to speed up biomanufacturing and increase yield for a greatly reduced per-dose cost.

CDMO on target to become a one-source contract partner for early-phase development.

Whether you're a small, virtual firm or Big Pharma, Recipharm Pathway to Clinic can remove the complexity out of first in human projects.

The combination therapy reduced the risk of death by 37% versus standard of care, sunitinib, in intermediate- and poor-risk patients.

The drug is the first and only fully human monoclonal antibody of its kind, uniquely designed to specifically block the CGRP receptor, which plays a critical role in activation of migraine.

Major new tiotropium bromide DPI development programme accelerated through licensing of Pulmatrix technology.

The pivotal Phase III study demonstrated that treatment with Abraxane in combination with gemcitabine can offer patients a median overall survival improvement of 1.8 months.

PARADIGMS is a first of its kind study in pediatric MS. Other current treatments have not been evaluated in head to head trials specifically designed for children and adolescents.

Company consolidates its consultancy portfolio into a single, comprehensive offering.

Midatech on track to start clinical development with MTD201 in Q4 2017.

Pivotal studies with BAY94-9027 showed that bleed protection was achieved with extended dosing intervals.

StemFit Basic02 offers superior and stable growth performance, high colony forming efficiency and robust scalable cell expansion.

MEDI1341 has the potential to achieve a better efficacy and safety profile than other alpha-synuclein antibodies.

ENDEAVOR study long-term data show Kyprolis and dexamethasone reduced the risk of death by 24% versus Velcade and dexamethasone.

Resubmission package will include new safety and efficacy data.

First carbapenem-based combination product – combination of meropenem with a new class of beta-lactamase inhibitor.

Scientists at the NCBS using Krystal 384-well black microplates to produce a standard drug testing assay for Plasmodium vivax infection.

Collaboration to focus on a disease target in Parkinson's disease with Berg's Interrogative Biology technology.

No evidence of a leveling off of effect and no new safety concerns were identified in this analysis.

Presentations include results from ODYSSEY APPRISE, an open-label study in 16 European countries and Canada in patients with severe hypercholesterolemia at high cardiovascular risk.

Mavenclad has shown sustained clinical efficacy for up to 4 years with a maximum of 20 days of oral treatment over 2 years.

Application based on positive results of Phase III study in adults and adolescents with hemophilia A with inhibitors and interim Phase III results in children.

Data suggest that NanoFlu has the potential to elicit a broader, more robust immune response, resulting in greater protection than the market-leading licensed influenza vaccine in older adults.

Compound has potential to be a game-changer in malaria elimination, rapidly clearing malaria infection, including resistant strains, and blocking parasite transmission.

Models will be used in AstraZeneca's oncology R&D programs in breast and lung cancer.

Eliquis clinical data include results from a Phase IV trial to be featured in late-breaking science sessions,

Study demonstrates that a complex consisting of tobacco mosaic virus and vcMMAE can kill cancer cells.

Novo Nordisk will have an option to license the FGF1 program upon achievement of certain research milestones.

Phase III study fails to meet its primary endpoint.

Inotersen on track for marketing authorization filings this year.

Subsidiary to develop novel AAV gene therapy treatments for complement-mediated.

The Phase II study is designed to generate the pharmacokinetic and safety data, at multiple dose levels, that will be required by the FDA.

The last FDA approved treatment for advanced primary head and neck cancer was over 50 years ago.

NIH-led clinical trial suggests that drug slows progression of rare neurological disease.