Biopharma Business

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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,

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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 treatment of life threatening invasive fungal infections such as invasive aspergillosis.

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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 for use by the European Medicines Agency (EMA) offered survival

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Commission not ranking preferences for key EU agencies post-Brexit

    Commission not ranking preferences for key EU agencies post-Brexit

The publication on Saturday of the EU Commission’s unranked and unshortlisted assessment of the 27 bids from member states to host the London-based European Banking Authority (EBA) and the European

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European Medicines Agency fears losing staff after it leaves London

    European Medicines Agency fears losing staff after it leaves London

Losing valuable staff is the major concern in the impending relocation of the European Medicines Agency. The agency which is responsible for the evaluation, authorisation and pharmacovigilance of all medicines

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Brexit move creates EMA risk: report

    Brexit move creates EMA risk: report

The Brexit-inspired need to move the London HQ of the European Medicines Agency will throw up two major risks when it comes to patients and the approval of new medicines,

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EMA to Evaluate Liver Problems Linked to Zinbryta

    EMA to Evaluate Liver Problems Linked to Zinbryta

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) discussed the safety reviews of a variety of medications during its June 2017 meeting. The medicines in review included treatments for

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EU review for Sandoz’ Humira, Remicade biosimilars

    EU review for Sandoz’ Humira, Remicade biosimilars

European regulators have accepted for review Sandoz’ marketing applications for biosimilars to AbbVie’s Humira (adalimumab) and Janssen’s Remicade (infliximab). The company is seeking approval for its biosimilars for use in

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Aptar Pharma’s electronic lockout device approved by EMA

    Aptar Pharma’s electronic lockout device approved by EMA

The European Medicines Agency (EMA) has approved Aptar Pharma’s integrated electronic nasal lockout device (e-Lockout) following a multi-year development with Takeda Pharmaceuticals International. Aptar Pharma agreed to supply Takeda with its

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EMA approves once-daily therapy for partial-onset epilepsy

    EMA approves once-daily therapy for partial-onset epilepsy

The European Medicines Agency (EMA) has approved Zebinix (eslicarbazepine acetate) for use as once-daily monotherapy to treat adults with newly-diagnosed partial-onset epilepsy. It is already indicated in Europe as an

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EMA Builds Collaboration with African Regulators

    EMA Builds Collaboration with African Regulators

The European Medicines Agency (EMA) met with a delegation from the East African Community (EAC) from May 18–19, 2017 as part of the agency’s collaboration with African regulators. The meeting

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EMA Launch of New EudraVigilance System Moves Forward

    EMA Launch of New EudraVigilance System Moves Forward

On May 22, 2017, the European Medicines Agency (EMA) announced that its Pharmacovigilance Risk Assessment Committee has completed an audit and evaluation of the new EudraVigilance information system for tracking

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European countries offer goodies in bid to win EMA after Brexit

    European countries offer goodies in bid to win EMA after Brexit

Even before European officials present the groundwork for relocating the bloc’s drug regulator, a fight has emerged between countries vying for the economic lift and status that come with hosting the

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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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EMA’s CHMP backs Novartis’ Zykadia for first-line use in lung cancer

    EMA’s CHMP backs Novartis’ Zykadia for first-line use in lung cancer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval to expand the use of Novartis’ Zykadia (ceritinib) in anaplastic lymphoma kinase (ALK)-positive non-small cell

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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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A Spanish Biosimilar of Amgen’s Blockbuster gets Ready for EU Approval

    A Spanish Biosimilar of Amgen’s Blockbuster gets Ready for EU Approval

Cinfa Biotech announced trial results for a biosimilar of Amgen’s Neulasta, a multi-billion blockbuster to treat chemotherapy-induced neutropenia. Cinfa Biotech is a Spanish company specialized in developing biosimilars. The biotech

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European Medicines Agency’s 2016 annual report published

    European Medicines Agency’s 2016 annual report published

The European Medicines Agency’s (EMA) 2016 annual report focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and

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Ireland reiterates bid to host the European Medicines Agency post-Brexit

    Ireland reiterates bid to host the European Medicines Agency post-Brexit

Ireland has stepped up its bid to host the European Medicines Agency (EMA) with the official announcement being delivered and reiterated by Minister of Health, Simon Harris over the past

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EMA Promotes Understanding and Use of Biosimilars

EMA and the European Commission released a biosimilars information guide for health professionals during the EC’s biosimilars conference. In an effort to provide healthcare professionals with information on the science

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Diamond BioPharm’s Response to the United Kingdom’s Withdrawal from the European Union

On May 2, 2017, the EMA and European Commission published a notice alerting Marketing Authorization Holders of centrally authorized medicines of their obligations in relation to Brexit. Although the final

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EMA and EU Member States Begin Brexit Discussions

The agency met with EU National Competent Authorities to begin making plans for the distribution of workload because of the UK’s departure from the EU. On April 28, 2017, the

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FDA Approves More Drugs, and Faster, than Europe, Study Says

Contrary to some political claims, the U.S. Food and Drug Administration approved more drugs, and two to three months faster on average, than

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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

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Indian CRO’s meds hit with suspension as EMA dubs tests ‘unreliable’

The European Medicines Agency (EMA) wants to suspend around 300 marketed generic meds (and applications) coming out of Indian CRO

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EMA Recommends Approval of New Treatment for Brain Cancer

Apeiron Biologics has announced that the EMA’s CHMP has recommended the approval of APN311 for immunotherapy of high risk neuroblastoma.

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EMA Suspends Drugs Associated with Micro Therapeutic Research Labs

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic

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Brexit: The Luck of the Irish?

The move by Great Britain to step away from the European Union may be sending chills of uncertainty to many

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European experts meet with African regulators to discuss collaboration

Representatives from the European Medicines Agency (EMA) met with medicines regulators from Africa last week to discuss how to improve

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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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Merck and Pfizer’s diabetes therapy under US, EU review

Regulators on both sides of the Atlantic are reviewing three new submissions for medicines containing ertugliflozin, an investigational SGLT2 inhibitor

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EU and US Pledge to Recognize Each Other’s GMP Inspections

In a landmark decision, the United States FDA and the European Commission announced on March 2, 2017 that they will recognize

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EMA Recommends Six Medicines for Market Approval

On Feb. 24, 2017, the European Medicines Agency (EMA) announced that its Committee for Medicinal Products for Human Use (CHMP) recommended six

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Orphan Drug Natpar Receives EMA Recommendation

The European Medicines Agency (EMA) announced on Feb. 24, 2017 that its Committee for Medicinal Products for Human Use (CHMP) has

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EMA examines key Actelion med Uptravi following 5 patient deaths in France

Johnson & Johnson is counting on new buy Actelion’s pulmonary arterial hypertension (PAH) meds to provide a top-line boost once

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