Biopharma Business

Posts From editor

Brexit – Implications For the Pharma Industry in Ireland

    Brexit – Implications For the Pharma Industry in Ireland

The UK’s referendum decision to leave the EU in May 2016 undoubtedly sent shockwaves throughout Europe. European countries are still struggling to interpret what ‘Brexit’ will mean for them. Ireland,

Read Full Article

EMA to Work With Stakeholders to Improve Product Information For EU Medicines

    EMA to Work With Stakeholders to Improve Product Information For EU Medicines

The European Medicines Agency (EMA) has published an action plan to improve the product information (PI) for EU medicines, an information package for patients and healthcare professionals that accompanies every single medicine authorised in

Read Full Article

New Precision Medicine Centre of Excellence Will Improve Patient Treatment

    New Precision Medicine Centre of Excellence Will Improve Patient Treatment

A £10 million Centre of Excellence in Precision Medicine has been launched by Invest Northern Ireland and Queen’s University Belfast. The Centre of Excellence in Precision Medicine will develop an

Read Full Article

Diaceutics Wins at Export Industry Awards

    Diaceutics Wins at Export Industry Awards

Diaceutics, the Irish data insights and solutions company helping patients receive potentially lifesaving medicine through better testing, won the Small & Emerging Exporter of the Year Award at the recent Export

Read Full Article

Brexit – Key Issues For the Pharmaceutical Industry

    Brexit – Key Issues For the Pharmaceutical Industry

Brexit – the stark reality is that the UK’s EU membership and the application of all EU legislation in the UK ends automatically at midnight on 30th  March 2019! Current understanding

Read Full Article

European Commission Diagnoses the State of Health in the EU

    European Commission Diagnoses the State of Health in the EU

Only by rethinking our health systems can we ensure that they remain fit-for-purpose and provide patient-centred care. This is what the 28 Country Health Profiles recently published by the Commission,

Read Full Article

Anti-Pancreatic Cancer Drug In Research Focus

    Anti-Pancreatic Cancer Drug In Research Focus

Intriguing antitumor activity is found in a very promising class of natural compounds: cyclic depsipeptides, which have a challenging structure that makes their investigation difficult. Now, Chinese scientists have established

Read Full Article

Biopharma firm Regeneron to create 300 jobs in Limerick

    Biopharma firm Regeneron to create 300 jobs in Limerick

US biopharma company Regeneron Pharmaceuticals is to create 300 new jobs in Ireland as part of a new $100 million investment. The company has announced a further expansion of its

Read Full Article

Brexit: Implications for the Pharma Industry in Ireland

    Brexit: Implications for the Pharma Industry in Ireland

The UK’s referendum decision to leave the EU in May 2016 undoubtedly sent shockwaves throughout Europe. European countries are still struggling to interpret what ‘Brexit’ will mean for them. Ireland,

Read Full Article

FDA collaboration uses Organs-on-Chips to improve drug development

    FDA collaboration uses Organs-on-Chips to improve drug development

CN Bio Innovations Limited has announced today that it has entered into a Research Collaboration Agreement with the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research

Read Full Article

Rapid Micro Biosystems to develop final implementation of rapid sterility test for vaccines

    Rapid Micro Biosystems to develop final implementation of rapid sterility test for vaccines

The company as been awarded the contract by the US Biomedical Advanced Research and Development Authority (BARDA). Rapid Micro Biosystems, a provider of automated, non-destructive, rapid microbial detection, has received

Read Full Article

Ireland and the Life Science Industry – 2017

    Ireland and the Life Science Industry – 2017

The Life Science Industry The manufacturing industry in Ireland is now enjoying a renewed period of growth on the back of increased consumer demand in both Irish and overseas markets. This

Read Full Article

Tarloxitinib puts tumour-seeking tail on anti-EGFR drug to target lung cancer

    Tarloxitinib puts tumour-seeking tail on anti-EGFR drug to target lung cancer

EGFR is a common genetic target in lung cancer, but not all EGFR mutations are created equal. Patients with a type of EGFR anomaly called an “EGFR exon 20 insertion”

Read Full Article

Anticoagulant drugs appear to reduce the risk of stroke in patients with AF

    Anticoagulant drugs appear to reduce the risk of stroke in patients with AF

Blood-thinning drugs not only reduce the risk of stroke in patients with atrial fibrillation (AF) but are also associated with a significant reduction in the risk of dementia, according to

Read Full Article

Responsibilities of the Marketing Authorisation Holder

    Responsibilities of the Marketing Authorisation Holder

Marketing Authorisation Holder: EU guidance states that the ultimate responsibility for the performance of a medicinal product over its lifetime in relation to its safety, quality and efficacy, lies with

Read Full Article

Biogen takes up option to co-develop Eisai AD drug

    Biogen takes up option to co-develop Eisai AD drug

Biogen and Eisai have expanded their existing collaboration agreement to develop and commercialise investigational therapies for Alzheimer’s Disease. Eisai has taken up its option to co-develop and co-promote aducanumab, Biogen’s

Read Full Article

Ketamine may help treat migraine pain unresponsive to other therapies

    Ketamine may help treat migraine pain unresponsive to other therapies

Ketamine, a medication commonly used for pain relief and increasingly used for depression, may help alleviate migraine pain in patients who have not been helped by other treatments. The study

Read Full Article

Spotlight on Trends for API Warning Letters from October 2015 – June 2017

    Spotlight on Trends for API Warning Letters from October 2015 – June 2017

API Warning Letters Each spring, the FDA publishes data on its website related to Form 483 inspection observations and warning letters issued by the Centre for Drug Evaluation and Research (CDER) during

Read Full Article

Reduce SOP Complexity – Top 10 Tips

    Reduce SOP Complexity – Top 10 Tips

Standard operating procedures (SOP’s) define the essential steps, their order and the instructions necessary to formally repeat a quality performance. SOPs essentially are a blue print for risk mitigation. Industry

Read Full Article

PHE launches campaign to reign in use of antibiotics

    PHE launches campaign to reign in use of antibiotics

Public Health England has launched a major new campaign designed to further reign in inappropriate use of antibiotics, as estimates show that around 5,000 people in England alone die every

Read Full Article

FDA approves Bydureon BCise for patients with type-2 diabetes

    FDA approves Bydureon BCise for patients with type-2 diabetes

The FDA has approved Bydureon BCise for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines. AstraZeneca has announced that the US Food and Drug Administration

Read Full Article

New project to bring world-class medicines ‘smart’ packaging capability to the UK

    New project to bring world-class medicines ‘smart’ packaging capability to the UK

The Centre for Process Innovation (CPI), the UK’s technology innovation provider for process manufacturing, announced it has begun the first phase of its ‘Medicines Smart Packaging’ project. This phase of

Read Full Article

Scientists find where HIV ‘hides’ to evade detection by the immune system

  Scientists find where HIV ‘hides’ to evade detection by the immune system

In a decades-long game of hide and seek, scientists from Sydney’s Westmead Institute for Medical Research have confirmed for the

Read Full Article

Lilly signs up to cancer vaccines with CureVac deal

  Lilly signs up to cancer vaccines with CureVac deal

Eli Lilly has signed up CureVac to develop cancer vaccines based on its mRNA technology, in a deal that could

Read Full Article

US approves second CAR-T therapy

  US approves second CAR-T therapy

Gilead’s Yescarta – recently acquired through its purchase of Kite Pharma -has become the second gene therapy to be approved

Read Full Article

Cork-based AventaMed eyes FDA approval after raising €1.8m

  Cork-based AventaMed eyes FDA approval after raising €1.8m

AventaMed, a Cork-based medtech firm focused on simplifying surgical procedures, has secured a €1.8 million investment to enable the company

Read Full Article

More than 70 medtech companies to vie for investment

  More than 70 medtech companies to vie for investment

More than 70 Irish medical technology companies will seek investment from 300 international blue-chip company buyers from 42 countries on

Read Full Article

Agreement formed to develop and commercialise infectious diseases programme

  Agreement formed to develop and commercialise infectious diseases programme

Visterra and Vir Biotechnology have entered into a research collaboration, exclusive licence and option agreement for the development and commercialisation

Read Full Article

FDA accepts regulatory submission for Lynparza in metastatic breast cancer

  FDA accepts regulatory submission for Lynparza in metastatic breast cancer

Lynparza has the potential to offer a new treatment option for patients with metastatic breast cancer. AstraZeneca and Merck &

Read Full Article

Plasticell and GSK collaborate to produce hematopoietic cells

  Plasticell and GSK collaborate to produce hematopoietic cells

Plasticell, a biotechnology company specialising in stem cell screening and cell therapy development, has entered into a collaboration with GSK

Read Full Article

Mutabilis selected to join ENABLE consortium aimed at fighting antibiotic resistance

  Mutabilis selected to join ENABLE consortium aimed at fighting antibiotic resistance

A specialist in therapeutic approaches to treat resistant bacterial infections, Mutabilis has been selected to join the European consortium ENABLE

Read Full Article

Janssen announces FDA approval of Stelara for plaque psoriasis

  Janssen announces FDA approval of Stelara for plaque psoriasis

The FDA has approved an expanded indication for Stelara for the treatment of adolescents with moderate plaque psoriasis. Janssen Biotech,

Read Full Article

Titan gets under the skin of Parkinson’s with first patient administered with ropinirole implant

  Titan gets under the skin of Parkinson’s with first patient administered with ropinirole implant

Titan Pharmaceuticals has announced that the first patient has been treated in a Phase I/II trial of its ropinirole subdermal

Read Full Article

Development of new respiratory syncytial virus vaccine

  Development of new respiratory syncytial virus vaccine

SGS announced it has entered into collaboration with Bavarian Nordic A/S, an international biotechnology company specialising in vaccines, to develop

Read Full Article

NIH launches $215m partnership for cancer immunotherapy strategies

  NIH launches $215m partnership for cancer immunotherapy strategies

The NIH and 11 leading biopharmaceutical companies have launched the Partnership for Accelerating Cancer Therapies (PACT), totalling $215m as part

Read Full Article

CEL-SCI receives new European patent for investigational immunotherapy

  CEL-SCI receives new European patent for investigational immunotherapy

The European Patent Office has issued a new patent to biotechnology company, CEL-SCI, for its lead investigational immunotherapy, which is

Read Full Article

Industrial robot market booming

  Industrial robot market booming

The industrial robotics market is expected to be worth $71.7 billion by 2023, according to new research. The rapid growth

Read Full Article

Myeloma UK trial to test novel myeloma treatment approach

  Myeloma UK trial to test novel myeloma treatment approach

Myeloma UK has launched a nationwide trial aiming to assess the effectiveness of a novel treatment combination that includes Darzalex

Read Full Article

FDA Gives Positive Review Of Aerie’s Experimental Glaucoma Drug

  FDA Gives Positive Review Of Aerie’s Experimental Glaucoma Drug

A study by the U.S. Food and Drug Administration has backed up Aerie Pharmaceutical’s evidence that its experimental drug is

Read Full Article

Team develop device to improve dialysis treatment

  Team develop device to improve dialysis treatment

A team of researchers from Imperial College London have used machine learning to develop a device that could potentially improve

Read Full Article

Gel Developed To Fight Rheumatoid Arthritis

  Gel Developed To Fight Rheumatoid Arthritis

IBS scientists at the Center for Self-Assembly and Complexity, within the Institute for Basic Science (IBS), invented a hydrogel to

Read Full Article

Busting biotech wide open: BiOspace lab now open in Manchester

  Busting biotech wide open: BiOspace lab now open in Manchester

The first open-access biotech laboratory has opened in Manchester, affording early-stage biotech and medtech companies, as well as entrepreneurial individual

Read Full Article

Mental health patients to receive better care with connected technologies

  Mental health patients to receive better care with connected technologies

Ahead of World Mental Health Day, a new project that uses connected technologies has been developed by the NHS to

Read Full Article

Future quality of NHS and social care is “precarious”, says CQC

  Future quality of NHS and social care is “precarious”, says CQC

The future of the health and social care system is in peril as it struggles to cope with the increasingly

Read Full Article

Synthetic biologists can now create novel vector constructs

  Synthetic biologists can now create novel vector constructs

Double Helix Technologies (Doulix) announced it will collaborate with Agilent Technologies to promote Agilent’s SureVector next-generation cloning kits through Doulix’s web

Read Full Article

Researchers Help Develop New Antifungal Drug

  Researchers Help Develop New Antifungal Drug

University of Liverpool researchers, working with F2G Limited (Eccles, Manchester), have developed a new antifungal drug to help in the

Read Full Article

Tjoapack invests in bottle packing capabilities

  Tjoapack invests in bottle packing capabilities

Tjoapack, a Dutch contract packaging organisation (CPO), has added an additional bottling line to its facility in Etten-Leur, the Netherlands,

Read Full Article

Most approved oncology drugs do not offer better survival rate or quality of life, say researchers

  Most approved oncology drugs do not offer better survival rate or quality of life, say researchers

A retrospective cohort study, published in the British Medical Journal, has found no conclusive evidence that most oncology treatments approved

Read Full Article

Alcohol aversion drug Disulfiram may combat chemotherapy resistance

  Alcohol aversion drug Disulfiram may combat chemotherapy resistance

Scientists have had positive results from a laboratory-based study using a well-known alcohol aversion drug disulfiram, to combat chemotherapy resistance

Read Full Article

Researchers seek 500 NHS patients to test new universal flu jab

  Researchers seek 500 NHS patients to test new universal flu jab

The BBC has reported that researchers from the University of Oxford’s Jenner Institute are seeking 500 NHS patients to test

Read Full Article

Successor to PD-1 inhibitors the focus of cancer immunotherapy

  Successor to PD-1 inhibitors the focus of cancer immunotherapy

The cancer immunotherapy pipeline, displays a high level of first-in-class innovation with novel developments focusing heavily on producing the next

Read Full Article

Synthetic mini-protein binders may provide a new class of drugs

  Synthetic mini-protein binders may provide a new class of drugs

Scientists at the University of Washington (UW) have designed mini-protein binders on a computer platform, which are not naturally occurring

Read Full Article

GE Healthcare opens its first Eu 3D printing and design centre

  GE Healthcare opens its first Eu 3D printing and design centre

A 3D printed part can combine 20 parts into a single part and improve performance, reducing parts in a manufacturing

Read Full Article

Partnership formed for regenerative medicines

  Partnership formed for regenerative medicines

The Cell and Gene Therapy Catapult (CGT Catapult) has signed a Memorandum of Understanding (MoU) with the Forum for Innovative

Read Full Article

Upcoming Events

  • No upcoming events
AEC v1.0.4

The Magazine

New Subscriber





Subscribe Here



Advertisements