Biopharma Business

Clinical Trials

The EMA Grants Priority to an Enzyme to Avoid Liver Transplant Rejection

    The EMA Grants Priority to an Enzyme to Avoid Liver Transplant Rejection

Hansa Medical has accessed the EMA’s priority medicines scheme to accelerate the development of a therapy that broadens the access to kidney transplants. Hansa Medical, based in Lund, Sweden, develops

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Irish Biotech developing New Antibiotics attracts €58M in Series B Round

    Irish Biotech developing New Antibiotics attracts €58M in Series B Round

Iterum Therapeutics has raised €58M to fund Phase III and bring a new antibiotic to a market where innovation is lacking. Iterum Therapeutics is a biotech based in Dublin that

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Treatment for hyperkalaemia receives European marketing approval recommendation

    Treatment for hyperkalaemia receives European marketing approval recommendation

Veltassa (patiromer), developed by Relypsa, has received a recommendation for marketing approval from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the

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Ingestible balloon could help reduce obesity

    Ingestible balloon could help reduce obesity

A new study has shown that an ingestible gastric balloon could be used to help obese people lose weight without the need for invasive surgery. When swallowed the Elipse balloon

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Promising Preclinical Results of Zika Virus Vaccine

    Promising Preclinical Results of Zika Virus Vaccine

  Preclinical results of research by City College of New York scientists and TechnoVax, Inc. in animal models demonstrate favorable outcomes in developing a vaccine against the mosquito-borne Zika virus.

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Pfizer gifts the NHS with breast cancer drug

Pfizer has announced it will provide its breast cancer drug, palbociclib — which has been provisionally rejected by NICE for routine use as a result of cost — to the

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Landmark clinical trial to help juvenile idiopathic arthritis sufferers

A clinical trial funded by Arthritis Research UK and the National Institute for Health Research (NIHR) led by professors from the Universities of Liverpool and Bristol has discovered a drug

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Aeterna Zentaris’ endometrial cancer drug fails in Phase III

A late stage clinical study of Aeterna Zentaris’ Zoptrex in women with locally advanced, recurrent or metastatic endometrial cancer has failed to meet its primary endpoint of demonstrating a statistically

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French Biotech Could Be Taking its Diabetes Drug to Phase III on its own

Poxel was able to score positive results for its type 2 diabetes drug in a Phase IIb study in Japan, preparing the company to go for a Phase III program. Poxel, one of

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Phase 3 readout keeps Amgen in pole position for CGRP migraine drug

Amgen has firmed up its lead in the race to bring the first CGRP inhibitor to market for migraine after presenting positive results from its two phase 3 trials. The

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First patient recruited in Phase Ib trial of TG02

The first patient has been recruited in an exploratory Phase Ib clinical trial of Targovax’s second product from its RAS-peptide immunotherapy platform, TG02. In the open-label, non-randomised trial — to

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Norway Brings Another Cancer Vaccine to the Clinic

Targovax has recruited its first patient in a Phase Ib trial for its new cancer vaccine TG02 targeting mutations of the RAS gene. Mutations of the RAS gene disrupt normal cell

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Allergan and Novartis Collaborate on Multi-Therapy Treatment for NASH

Allergan, a global biopharmaceutical company, announced that it has entered into a clinical trial agreement with Novartis to conduct a Phase 2b study, using Allergan’s cenicriviroc (CVC) and Novartis’ lead FXR

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Trial of new triple inhaler shows 20 percent reduction in COPD flare-ups

Flare-ups in chronic obstructive pulmonary disease, the UK’s fourth leading cause of death, can be reduced by 20% by a combined triple inhaler, according to the results of a trial

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Data Supports Advancement of Botox as Depression Treatment

Allergan plc, a global pharmaceutical company announced topline data from a phase II study with major depressive disorder (MDD). The study evaluated the efficacy, safety and tolerability of a single administration

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Novartis’ lung cancer drug combination receives EU approval

The European Commission has approved Novartis’ Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). The

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Verona Pharma pens trial deal with QuintilesIMS for RPL554

Last year, Cardiff, U.K.-based Verona secured £44.7 million ($65.6 million) from big-name investors on both sides of the Atlantic for work on its PDE3/PDE4 inhibitor RPL554, and has now teamed

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Operating expenses rise at Mainstay Medical as new trial begins

Medical device firm Mainstay Medical said operating expenses rose by $3.9 million for 2016 to $16.8 million as Mainstay kicked off its ReActiv-8 B clinical trial and began commercialising the

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Shire’s HAE drug Cinryze secures label extension in Europe

Shire has secured label expansion approval from the European Commission for its hereditary angioedema therapy Cinryze. The European Commission (EC) has approved the label extension application, granting three new indications

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French Biotech fails Second Phase II Trial for Cardiovascular Disease

Cerenis therapeutic’s lead candidate CER-001 has failed Phase II for the treatment of patients with post-acute coronary syndrome (ACS). The French-based Biotech Cerenis is developing therapies for the treatment ofcardiovascular and

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Debiopharm’s triptorelin 6-month formulation receives EU approval

Debiopharm International, a Swiss-based company, part of Debiopharm Group, announced that triptorelin 6-month formulation (Decapeptyl and Pamorelin 22.5 mg) received approval for the treatment of central precocious puberty (CPP) in

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MedImmune and Sanofi Pasteur form alliance to develop and commercialise potential next-generation respiratory syncytial virus antibody MEDI8897

MedImmune, the global biologics research and development arm of AstraZeneca, and Sanofi Pasteur, the vaccines division of Sanofi, have announced an agreement to develop and commercialise MEDI8897 jointly. MEDI8897 is

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Physical inactivity and sedentary behaviors associated with cardiometabolic risk factors

The results are from the first investigation to be conducted with baseline data from the PREDIMED-PLUS study, an 8-year multicenter

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Heart of the matter: Spain’s first artificial heart transplant

A medical team from Clínica Universidad de Navarra in Pamplona has successfully performed Spain’s first implant of the SynCardia temporary

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EU Grants Orphan Drug Designation for Epidermolysis Bullosa Treatment

Abeona Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing gene therapies for life-threatening rare diseases, announced today that the

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Italy Adopts Gender-Neutral HPV Vaccination Program

Italy adopts gender-neutral HPV vaccination program, citing study by health economics expert from Kingston University London’s Business School. The Italian

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Owlstone Medical to provide breath biomarker services for 4D Pharma

Diagnostics company, Owlstone Medical, who is developing a breathalyser for disease has announced it has signed a master service agreement

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Sanofi and AstraZeneca to Collaborate on Antibody for Prevention of Respiratory Illnesses

Sanofi and its vaccines global business unit Sanofi Pasteur announced today an agreement with MedImmune, the global biologics research and development arm of

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Sheffield Hospitals to lead new virtual surgical centre

Sheffield Teaching Hospitals NHS Foundation trust will lead a new virtual specialist surgical centre, designed to tackle complex rare urogenital

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Amarin reports 59% jump in sales for Vascepa drug

Amarin, the Irish biotech that has developed a drug to help reduce very high blood fat levels, saw sales jump

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Richmond Pharmacology opens new London research facility

Early-phase contract research organisation Richmond Pharmacology has opened its new research facility in London Bridge, at the site formerly known

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Dutch and German Biotechs enter the Clinic with their First Lanthipeptide

Lanthio Pharma has initiated a Phase I clinical trial with its lanthipeptide candidate MOR107, which is being developed as a

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Faron Pharmaceuticals recruits first patient for new Traumakine trial

Faron Pharmaceuticals has recruited its first patient to a phase II clinical trial of its lead drug, Traumakine, in the

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Swedish Fundraising brings Sickle Cell Disease Drug Closer to the Market

Modus Therapeutics has raised €3.4M to support the completion of a Phase II trial for sickle cell disease, a painful condition

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Liverpool Uni leads clinical trial of promising osteoarthritis drug

The University of Liverpool, in partnership with AKL Research and Development, will lead a clinical trial testing the potential of

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