Research & Development News

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.

Juniper Pharma Services now has CrystecPharma’s supercritical fluid technology platform on-site.

This knowledge could speed the development of a new category of drugs.

FDA approval is supported by an overall 98% cure rate in patients who received the recommended duration of treatment .

The launch represents a major step towards therapeutic use of CRISPR.

Approval based on CheckMate -142, in which Opdivo demonstrated an objective response rate of 28% among patients who received prior treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Results from the Phase III study included in the sBLA submission showed that treatment with Prolia for 12 months led to statistically significant greater gains in BMD at the lumbar spine and total hip compared to risedronate.

Pivotal Phase III trials planned for 2017 will evaluate Rubraca + Opdivo, Rubraca as monotherapy, and Opdivo as monotherapy in first line maintenance treatment for advanced ovarian and advanced triple-negative breast cancers.

Dalton Pharma Services is preparing glass vials in three varying dose formulations for the clinical kits needed to support the Phase I safety trial for AB569 at the CVAMC later this year.

First study in the US to investigate an interchangeability designation for an adalimumab biosimilar candidate.

Collaboration aims to maximize the potential of PARP and MEK inhibitors in combination with PD-L1/PD-1 medicines, based on growing scientific evidence that these combinations offer new potential for the treatment of a range of tumor types.

Deal builds on ongoing collaboration to develop vaccines for Human Papillomavirus (HPV) and Ebola.

New approval for treatment of active psoriatic arthritis (PsA).

Study results showed that long-acting cabotegravir and rilpivirine maintained viral suppression.

NKTR-358 has the potential to treat a number of autoimmune and other chronic inflammatory conditions.

If approved, Rydapt would represent the first targeted treatment for newly diagnosed FLT3-mutated AML in the EU.

Goal of the collaboration is to identify therapies and diseases for which there is a high need for pediatric-friendly formulations.

These data, combined with positive results from two Phase III efficacy studies, support NDA filing planned for fourth quarter of 2017.

With support from the CRO, TopiVert has been able to accelerate scale-up and produce GMP batches, which are now being used in clinical trials.

Shire obtains worldwide license to pursue development and commercialization of a novel, potentially differentiated, pre-clinical bi-specific antibody candidate for Hemophilia A.

Array to advance preclinical program for autoimmune disorders; Amgen responsible for clinical development and worldwide commercialization.

Presentations highlight recent discovery of inhibition of formation of toxic beta amyloid oligomers and new insights for Precision Medicine approach for ALZ-801 targeting APOE4 carriers.

KalGene’s Alzheimer’s therapeutics candidate, licensed from the NRC (KAL-ABP-BBB), crosses the blood-brain barrier, and reduces amyloid-beta burden in a transgenic rat model after a 4-week treatment.

Cosentyx continues to demonstrate it can provide what psoriasis patients want - a life with clear skin.

A BLA for this indication is under FDA priority review; if approved, CTL019 could become first CAR-T cell therapy available.

Blincyto is the first and only Bispecific T cell Engager (BiTE) immunotherapy to demonstrate superior overall survival versus standard of care chemotherapy.

The collaboration will leverage the expertise of Queen’s University and Erytech’s ERYCAPS platform technology.

Viberzi proven safe and effective in patients who reported inadequate response to prior loperamide use.

Parties to optimize certain novel compounds that target cancer cell transcription and proliferation.

Owlstone Medical and Cancer Research UK initiate pan cancer clinical trial.

SHP654 aims to deliver sustained protection against bleeds for patients with hemophilia A.

ALM201 is a therapeutic peptide developed to mimic some of the properties of the naturally occurring protein FKBPL.

Opdivo demonstrates superior recurrence-free survival versus Yervoy in adjuvant setting in CheckMate -238.

NOX-A12 has the potential to transform cancer types that are resistant to checkpoint inhibitor therapy into checkpoint inhibitor sensitive tumours

NIAID-funded trial counters current thinking about treatment effectiveness.

In ALK-positive advanced NSCLC patients, Zykadia demonstrated superior median progression-free survival compared with SOC chemotherapy with maintenance.

The patch can dramatically reduce the cost of vaccination, as self-administration can eliminate the need to have health workers oversee the process.

Company to consider whether to file new drug applications with the FDA and other regulatory agencies.

Cladribine Tablets is the first and only investigational medicinal product to have shown a sustained 4 years of disease control with a maximum of 20 days of oral treatment over 2 years in clinical trials.

New indication supported by results of Phase III PALOMA-3 Trial of Ibrance in combination with fulvestrant.

If approved, Imraldi will be the third anti-TNF biosimilar in Biogen’s portfolio in Europe.

AMG 334 (erenumab) is the first anti-CGRP monoclonal antibody developed for migraine prevention to receive EMA regulatory filing acceptance.

Xgeva is indicated for the prevention of skeletal-related events in patients with bone metastases from solid tumours and is the number one prescribed agent by oncologists for this indication in the US.

The pause is to allow for additional information to be collected to better understand more reports of death in the Keytruda groups.

Preliminary findings from pilot study validate use of wearable technologies to collect data and manage clinical trials more effectively and efficiently.

Demonstrated significant improvements in disease signs and symptoms at 24 weeks among patients with active psoriatic arthritis who had prior inadequate response or intolerance to TNF inhibitors.

Investment will focus on new innovations in therapeutics for neurodegeneration, antibiotic resistance, cancer and respiratory diseases.

Company adds fifth building in Southern California.

Study successfully met its primary endpoint and Bekinda 24 mg was shown to be effective, safe and well tolerated in patients with acute gastroenteritis and gastritis.

Currently there are no approved topical NSAIDs indicated for the treatment of migraine.

New results presented at AHS.

Collaboration to focus on a potential new class of treatments for metabolic disorders.

The Committee will review analytical, pharmacokinetic and clinical data from studies involving ABP 215, including results from a Phase III study in patients with NSCLC.

Phase I/II study to evaluate the combination of Opdivo (nivolumab) and Opdivo +Yervoy (ipilimumab) regimen with Mekinist (trametinib) in patients with colorectal cancer.

Combination of nivolumab plus ipilimumab can fundamentally change survival expectations.

Robust data from Phase III studies demonstrated positive impact on motor milestone achievement; increased survival in infants with SMA.

NICE has recommended immunotherapy drug nivolumab for the treatment of adult patients with classical Hodgkin lymphoma.

Finding may lead to therapies that prevent pituitary tumor recurrence.

TheraT mediated alarmin release crucial for active immunization in cancer immunotherapy.

Application is based on results from the Phase I/II CheckMate -040 trial.

Amongst highest levels of immune responses ever demonstrated in an HIV vaccine human study.

First clinical study using a patent protected minocycline API and formulation developed by Hovione.

Separate subgroup analysis demonstrates long-term efficacy of Ofev in slowing disease progression is maintained for up to 96 weeks in IPF patients who require dose adjustments to manage adverse events.

New analyses from the FLAME study suggest dual bronchodilator Ultibro Breezhaler provides similar or better efficacy versus steroid-containing therapies, regardless of blood eosinophil counts.

In all analyses, people experiencing uncontrolled asthma symptoms saw improvements in their breathing by adding Spiriva Respimat to an ICS or combination ICS/LABA.

Sixth FDA approval for Actemra since its US launch in 2010,

Catalent Biologics will use its proprietary GPEx technology to produce different protein variants for Therachon,

New pivotal results for Perjeta and Alecensa demonstrating improvement over standards of care.

NIH-funded clinical trial shows use of either drug improved vision and had few side effects.

FDA approves Keytruda as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) irrespective of PD-L1 expression.

IMvigor211 failed to meet its primary endpoint of overall survival (OS) compared with chemotherapy.

Goldfinch Bio’s researchers select StarDrop to guide successful drug discovery.

When compared with current hard sublingual tablets, the novel formulation dissolved quickly with no increased safety concerns and no demonstrable difference in efficacy.

Strain represents one of the common current circulating strains of influenza of a pandemic origin.

With lower rates of obesity, the researchers say rates of heart disease, diabetes, and other diseases that tend to increase with age, including cancer and Alzheimer’s disease, could fall as well.

Library claimed to offer "the most efficient route to therapeutic antibody lead identification".

Imfinzi is the cornerstone in an extensive immuno-oncology program across multiple cancer types and stages of disease.

Trial designed to evaluate the safety and efficacy of CTP-543 after 12 months of dosing with the primary efficacy analysis at week 24.

P-321 is a Phase II investigational topical treatment for dry eye disease.

Alunbrig approved for ALK+ metastatic non-small Cell lung cancer patients who have progressed on or are intolerant to crizotinib.

NIH rat study suggests amitriptyline temporarily inhibits the blood-brain barrier, allowing drugs to enter the brain.

Monthly dosing schedule now approved in both US and EU.

Novartis and Amgen to co-commercialize AMG 334 (erenumab) in the US; Novartis to gain exclusive rights in Canada,

The Phase III study compared abemaciclib in combination with an aromatase inhibitor versus an aromatase inhibitor alone in patients with HR+, HER2- advanced breast cancer.

Company receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers.

Primary endpoint of significant reduction in liver fat achieved following 16 weeks of treatment with BMS-986036.