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Europe's top biotech expects delays from drugs watchdog's HQ move
LONDON (Reuters) - Europe's biggest biotechnology company, Denmark's Genmab, expects some delays to regional drug approvals as the European Medicines Agency is uprooted from London to Amsterdam. (Source: Reuters: Health)
Source: Reuters: Health - November 30, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

EFPIA-PhRMA Principles successfully enable responsible clinical trial data sharing
Stakeholders are gathering in London this week for a workshop entitledData Anonymization – a Key Enabler for Clinical Data Sharing. The workshop, jointly organized by the European Medicines Agency (EMA) and theMulti-Regional Clinical Trials Center of Brigham and Women ’s Hospital and Harvard, is but one example of efforts by a broad range of stakeholders to enhance clinical trial data sharing. The workshop will seek to propose guiding principles to enable international data sharing – an area in which PhRMA and its member companies are leading the way.   (Source: The Catalyst)
Source: The Catalyst - November 29, 2017 Category: Pharmaceuticals Authors: Olivia Shopshear Tags: Clinical Trials Source Type: news

Application submitted to the European Medicines Agency (EMA) for use of Pradaxa ® in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE
Application submitted to the European Medicines Agency (EMA) for use of Pradaxa ® in treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE (Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - November 27, 2017 Category: Research Source Type: news

European Medicines Agency (EMA) approves the use of Ingelvac CircoFLEX ® during pregnancy and lactation in sows
European Medicines Agency (EMA) approves the use of Ingelvac CircoFLEX ® during pregnancy and lactation in sows (Source: Boehringer Ingelheim Corporate News)
Source: Boehringer Ingelheim Corporate News - November 27, 2017 Category: Research Source Type: news

EMA to relocate to Amsterdam, the Netherlands
The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken by the EU 27 Member States in the margins of the General Affairs Council (Art. 50). The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest. (Source: World Pharma News)
Source: World Pharma News - November 22, 2017 Category: Pharmaceuticals Tags: Featured EMA Regulatory Affairs Source Type: news

EU Drugs Agency Move to Amsterdam Minimizes Likely Staff Losses EU Drugs Agency Move to Amsterdam Minimizes Likely Staff Losses
Amsterdam's success in winning the battle to host the European Medicines Agency (EMA), which is relocating from London because of Brexit, was welcomed by drug manufacturers on Monday hoping for the least disruption due to staff losses at the regulator.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 21, 2017 Category: Consumer Health News Tags: Family Medicine/Primary Care News Source Type: news

UK pharmaceutical sector prepares for hard Brexit as regulator exits
Departure of European Medicines Agency focuses minds on challenges ahead (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - November 21, 2017 Category: Pharmaceuticals Source Type: news

Brexit gets real for drugmakers as regulator moves to Amsterdam
LONDON (Reuters) - Drugmakers are racing to implement Brexit contingency plans to prepare for a jolt to their regulatory system as the European Medicines Agency is uprooted from London to Amsterdam. (Source: Reuters: Health)
Source: Reuters: Health - November 21, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

The Latest: Amsterdam wins vote to host EU medicine agency
Danish representatives to the European Union say Milan, Amsterdam and Copenhagen have made it to the final three in the race to host the European Medicines Agency (Source: ABC News: Health)
Source: ABC News: Health - November 20, 2017 Category: Consumer Health News Tags: Health Source Type: news

Amsterdam has been picked to host the European Medicines Agency after Britain leaves European Union.
(Source: ABC News: Health)
Source: ABC News: Health - November 20, 2017 Category: Consumer Health News Tags: Health Source Type: news

Milan, Amsterdam face off to host EU drug agency: sources
BRUSSELS (Reuters) - Milan and Amsterdam will run off later on Monday for the right to host the European Medicines Agency (EMA) when the EU drugs body must leave London after Brexit, diplomats said after a vote. (Source: Reuters: Health)
Source: Reuters: Health - November 20, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

The Latest: Milan, Amsterdam, Copenhagen in EU agency rac
Danish representatives to the European Union say Milan, Amsterdam and Copenhagen have made it to the final three in the race to host the European Medicines Agency (Source: ABC News: Health)
Source: ABC News: Health - November 20, 2017 Category: Consumer Health News Tags: Health Source Type: news

Orexo nabs regulatory win for fast-dissolving opioid dependence therapy
Orexo (STO:ORX) said today that the European Medicines Agency granted marketing authorization for its Zubsolv rapidly-disintegrating treatment for opioid dependence. The buprenorphine and naloxone sublingual tablet is the first to be approved in Europe with six different strengths, according to the Sweden-based company. Get the full story at our sister site, Drug Delivery Business News. The post Orexo nabs regulatory win for fast-dissolving opioid dependence therapy appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - November 20, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Pharmaceuticals Regulatory/Compliance Wall Street Beat Orexo AB Source Type: news

SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)- pdf
This is the CBER SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA). (Source: What's New at CBER)
Source: What's New at CBER - November 20, 2017 Category: Biomedical Science Source Type: news

Spain Says Barcelona Back in the Race to Host EU Drugs Agency Spain Says Barcelona Back in the Race to Host EU Drugs Agency
Spain's move to take direct control of Catalonia and thwart the region's independence bid has put Barcelona back in the race to host the European Medicines Agency (EMA) once it leaves London after Brexit, Spain's health minister said on Wednesday.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 16, 2017 Category: Consumer Health News Tags: Family Medicine/Primary Care News Source Type: news

Italy pushes Milan bid to host European Medicines Agency
Italy's president hopes that Milan wins the right to host the hotly sought-after European Medicines Agency, which has to be relocated from London due to Britain's divorce from the European Union (Source: ABC News: Health)
Source: ABC News: Health - November 14, 2017 Category: Consumer Health News Tags: Health Source Type: news

CHMP Backs Rurioctocog alfa pegol (Adynovi) for Hemophilia A CHMP Backs Rurioctocog alfa pegol (Adynovi) for Hemophilia A
The European Medicines Agency committee recommended approval of rurioctocog alfa pegol for the treatment and prophylaxis of bleeding in patients aged 12 years and older with hemophilia A.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 10, 2017 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

Amgen Receives Positive CHMP Opinion To Expand Use Of Nplate ® (romiplostim) In Pediatric Patients With Chronic Immune Thrombocytopenic Purpura
Positive Opinion Based on Five Studies Demonstrating Nplate Reduces Rates of Bleeding in Children With Rare Blood Disorder THOUSAND OAKS, Calif., Nov. 10, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to expand the current indication for Nplate® (romiplostim) to include the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) for patients one year of age and older who are refractory to other treatments (e.g., corticosteroids, immunoglobulins). T...
Source: Amgen News Release - November 10, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Amgen And Allergan Receive Positive CHMP Opinion For ABP 215 (Biosimilar Bevacizumab) For The Treatment Of Certain Types Of Cancer
First Avastin® (Bevacizumab) Biosimilar Candidate Recommended for European Approval THOUSAND OAKS, Calif., Nov. 10, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 215, a biosimilar to Avastin® (bevacizumab). ABP 215 has been recommended for approval for the treatment of certain types of cancer, including in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rec...
Source: Amgen News Release - November 10, 2017 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Drug bingo: EU readies vote for London-based pharma agency
BRUSSELS (Reuters) - Nineteen EU governments will slug it out in a series of secret ballots in 10 days' time for the right to host the European Medicines Agency (EMA) once it leaves London after Brexit, EU officials said on Thursday. (Source: Reuters: Health)
Source: Reuters: Health - November 9, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Bayer submits application for marketing approval of rivaroxaban for patients with coronary or peripheral artery disease to European Medicines Agency (for specialized target groups only)
The rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin 100 mg once daily, demonstrated a 24% reduction in the combined risk of stroke, cardiovascular death and heart attack / The application for marketing approval is based on the COMPASS study / If approved, the rivaroxaban vascular dose, 2.5 mg twice daily plus aspirin low dose once daily, will be the only non-vitamin K antagonist oral anticoagulant (NOAC) indicated for this patient population (Source: Bayer Company News)
Source: Bayer Company News - November 6, 2017 Category: Pharmaceuticals Source Type: news

Pharmaceutical use during pregnancy resulting in premature births, birth defects, and massive costs to insurers
(Natural News) The European Medicines Agency will go over the evidence concerning the harmful effects of an epilepsy pill on unborn babies and decide if the warnings are sufficient enough. The drug, sodium valproate, has been connected to nearly 20,000 babies born with disabilities ever since its introduction in the 1970s, reported the DailyMail.co.uk. Also... (Source: NaturalNews.com)
Source: NaturalNews.com - October 26, 2017 Category: Consumer Health News Source Type: news

ECDC, EFSA and EMA Joint Scientific Opinion on a List of Outcome Indicators as Regards Surveillance of Antimicrobial Resistance and Antimicrobial Consumption in Humans and Food-Producing Animals
European Union, European Centre for Disease Prevention and Control. 10/26/2017 This 70-page document details a list of harmonized outcome indicators jointly established by the European Centre for Disease Prevention and Control (ECDC), European Food Safety Authority (EFSA), and European Medicines Agency (EMA) to assist EU Member States in assessing their progress in reducing the use of antimicrobials and antimicrobial resistance (AMR) in both humans and food-producing animals. For all sectors, the chosen indicators, which should be reconsidered at least every five years, are expected to be valid tools in monitoring antimicr...
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - October 26, 2017 Category: International Medicine & Public Health Authors: The U.S. National Library of Medicine Source Type: news

Merck brings customers closer to gene therapy product commercialization
Merck today announced that its Carlsbad, California-based manufacturing facility for the production of BioReliance® viral and gene therapy products has completed both a U.S. Food & Drug Administration (FDA) Pre-License inspection and a European Medicines Agency (EMA) Marketing Authorization Application inspection. (Source: World Pharma News)
Source: World Pharma News - October 19, 2017 Category: Pharmaceuticals Tags: Featured Merck Group Business and Industry Source Type: news

AstraZeneca ’s Faslodex receives CHMP opinion for advanced breast cancer treatment
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for AstraZeneca ’s Faslodex (fulvestrant) to treat hormone receptor-positive (HR+) advanced breast cancer in combination wi… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 16, 2017 Category: Pharmaceuticals Source Type: news

Shire ’s lyophilised Oncaspar receives positive CHMP opinion for ALL in Europe
Irish-headquartered biopharmaceutical company Shire ’s lyophilised Oncaspar (pegaspargase) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for patients with acute ly… (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 15, 2017 Category: Pharmaceuticals Source Type: news

Milan hopes to gain from Barcelona's pain in race for EU drugs agency
MILAN (Reuters) - Milan is hoping that Spain's Catalonia crisis will give the Italian city a boost in getting to host the European Medicines Agency (EMA), the European Union agency quitting London because of Brexit. (Source: Reuters: Health)
Source: Reuters: Health - October 13, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

Roche's Alecensa wins EU panel's nod against mutated lung cancer
ZURICH (Reuters) - Swiss drugmaker Roche's Alecensa has been recommended for approval in Europe as a first-line treatment for mutated lung cancer, a key European Medicines Agency (ESA) experts panel said on Friday. (Source: Reuters: Health)
Source: Reuters: Health - October 13, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

EMA accepts marketing application for Imfinzi to treat NSCLC patients
The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for AstraZeneca and MedImmune ’s Imfinzi (durvalumab) to treat patients with locally advanced, unresectable non-small-cell lung cancer (NSCLC). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - October 9, 2017 Category: Pharmaceuticals Source Type: news

European Medicines Agency moves to plug staffing gap after Brexit
London-based EU drugs regulator in £32m bid for temporary staff after it leaves UK capital (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - October 6, 2017 Category: Pharmaceuticals Source Type: news

Many new cancer drugs show 'no clear benefit', argues review
Conclusion Most of us assume that when a drug has been approved by a regulator for use, that means it has been shown to work. This study suggests that is not necessarily the case, or that even if it works they might not make a meaningful difference. The absence of evidence about the two outcomes that matter most to patients and their families – how long they will live, and how good their quality of life will be during that time – from half of the cancer drugs approved during a five-year period, is worrying. Patients cannot be expected to make informed decisions about which treatments to take, without good quali...
Source: NHS News Feed - October 5, 2017 Category: Consumer Health News Tags: Cancer Source Type: news

Over half of new cancer drugs 'show no benefits' for survival or wellbeing
Of 48 cancer drugs approved between 2009-2013, 57% of uses showed no benefits and some benefits were ‘clinically meaningless’, says BMJ studyMost cancer drugs that have recently arrived on the market have come with little evidence that they boost the survival or wellbeing of patients, research reveals.Forty-eight cancer drugs were approved by the European Medicines Agency between 2009 and 2013 for use as treatments in 68 different situations.Continue reading... (Source: Guardian Unlimited Science)
Source: Guardian Unlimited Science - October 5, 2017 Category: Science Authors: Nicola Davis Tags: Pharmaceuticals industry Cancer research Drugs Regulators Medical research Drugs policy Health policy Life expectancy Business Medicine Science UK news Source Type: news

The costly cancer drugs that don't help patients
Researchers found this was true of 57 per cent of treatments approved by the European Medicines Agency between 2009 and 2013. Many were provided in Britain through the Cancer Drugs Fund. (Source: the Mail online | Health)
Source: the Mail online | Health - October 4, 2017 Category: Consumer Health News Source Type: news

Study questions European approval process for cancer drugs
A new study finds that only about half of the cancer drug approvals by the European Medicines Agency in the last few years helped patients live longer or improved their lives. (Source: ABC News: Health)
Source: ABC News: Health - October 4, 2017 Category: Consumer Health News Tags: Health Source Type: news

Spoils of Brexit: EU cities race to get EU agencies from UK
Competition to host the European Medicines Agency and the European Banking Authority heats up this week with many EU nations still confident they can land one of the prestigious organizations (Source: ABC News: Health)
Source: ABC News: Health - October 3, 2017 Category: Consumer Health News Tags: Health Source Type: news

European panel backs Janssen's psoriasis drug
(Reuters) - A European Medicines Agency (EMA) panel recommended the approval of Johnson& Johnson unit Janssen's drug, guselkumab, for the treatment of plaque psoriasis in adults. (Source: Reuters: Health)
Source: Reuters: Health - September 15, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

GSK ’s triple-med COPD inhaler wins recommendation for approval in EU
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency panel recommended marketing authorization for the Trelegy Ellipta triple-combination inhaler for adults with COPD. The device uses fluticasone furoate, umeclidinium and vilanterol to help adults with COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist. It’s also the first once-daily single inhaler triple therapy to win a positive opinion by the Committee for Medicinal Products for Human Use, the companies reported. Get the full story at our sister...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Pharmaceuticals Regulatory/Compliance Respiratory Wall Street Beat GlaxoSmithKline plc Innoviva Source Type: news

Tesaro's ovarian cancer drug gets EU agency backing
(Reuters) - A European Medicines Agency (EMA) panel recommended the approval of Tesaro Inc's key drug, niraparib, for the treatment of recurrent ovarian cancer. (Source: Reuters: Health)
Source: Reuters: Health - September 15, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

GSK's three-in-one inhaler gets positive opinion from EU agency
(Reuters) - GlaxoSmithKline said on Friday that a European Medicines Agency (EMA) panel has recommended the company's three-in-one inhaled lung drug. (Source: Reuters: Health)
Source: Reuters: Health - September 15, 2017 Category: Consumer Health News Tags: healthNews Source Type: news

EMA accepts Pfizer ’s bosulif Type II Variation application for Ph+ CML
The European Medicines Agency (EMA) has approved for review a Type II Variation application for the use of Pfizer ’s bosulif (bosutinib) to treat patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - August 30, 2017 Category: Pharmaceuticals Source Type: news

FDA, EMA Strengthen Drug Inspection Cooperation FDA, EMA Strengthen Drug Inspection Cooperation
A new confidentiality agreement allows the FDA to share full drug inspection reports with the European Commission and the European Medicines Agency.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 25, 2017 Category: Consumer Health News Tags: Family Medicine/Primary Care News Source Type: news

Drug blocked by European regulators improves quality of life for MS patients
A study by researchers at the Queen Mary University of London has found that a drug blocked by European regulators can improve the quality of life for people with multiple sclerosis. The team of researchers reached this conclusion after uncovering previously unpublished clinical trial data from the European Medicines Agency. The European Commission is currently considering whether it will reverse its decision to deny a license for the oral formulation of the drug, cladribine. Get the full story at our sister site, Drug Delivery Business News. The post Drug blocked by European regulators improves quality of life f...
Source: Mass Device - August 18, 2017 Category: Medical Devices Authors: Sarah Faulkner Tags: Pharmaceuticals Regulatory/Compliance queenmaryuniversityoflondon Source Type: news

Positive CHMP Assessment for Haselmeier Pergoveris ® Pen
The new Pergoveris ® Pen by Haselmeier has received a positive assessment by Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - August 16, 2017 Category: Pharmaceuticals Source Type: news

Brexit relocation of EU medicines regulator 'will hit UK researchers hard'
Amsterdam says in its bid to house the EMA that two of Britain ’s top research agencies would lose much of their businessTwo of the UK ’s foremost research organisations will lose much of their business to Amsterdam if the city is successful in securing the relocation of the EU’s medicines regulator, the Netherlands’ formal bid for the prized agency claims.Amsterdam, which has been tipped as an early favourite to secure the European Medicines Agency (EMA), says in its application submitted to the European commission that losing the agency will prove a double blow to London when Brexit forces its mov...
Source: Guardian Unlimited Science - August 8, 2017 Category: Science Authors: Daniel Boffey in Brussels Tags: Brexit Netherlands London Medical research Europe European Union Foreign policy Politics Science UK news Source Type: news

Kite Pharma submits MAA for axicabtagene ciloleucel in Europe
US-based cell therapy company Kite Pharma has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for axicabtagene ciloleucel. (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - August 1, 2017 Category: Pharmaceuticals Source Type: news

ECDC/EFSA/EMA Second Joint Report on the Integrated Analysis of the Consumption of Antimicrobial Agents and Occurrence of Antimicrobial Resistance in Bacteria from Humans and Food-Producing Animals
European Union, European Centre for Disease Prevention and Control. 07/27/2017 This 135-page document is the second joint report from the European Centre for Disease Prevention and Control (ECDC), European Food Safety Authority (EFSA), and European Medicines Agency (EMA), on the integrated analysis of antimicrobial consumption (AMC) and antimicrobial resistance (AMR) in bacteria from humans and food-producing animals. It addresses data obtained by the Agencies'European Union-wide surveillance networks for 2013-2015. AMC in both sectors was compared at country and European levels, and substantial variations between countrie...
Source: Disaster Lit: Resource Guide for Disaster Medicine and Public Health - July 28, 2017 Category: International Medicine & Public Health Authors: The U.S. National Library of Medicine Source Type: news

Eisai seeks marketing authorisation for lenvatinib from EMA
Eisai has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for first-line use of lenvatinib in patients with unresectable hepatocellular carcinoma (uHCC). (Source: Pharmaceutical Technology)
Source: Pharmaceutical Technology - July 27, 2017 Category: Pharmaceuticals Source Type: news

EU report: More evidence on link between antibiotic use and antibiotic resistance
(European Centre for Disease Prevention and Control (ECDC)) The European Food Safety Authority, the European Medicines Agency and the European Centre for Disease Prevention and Control are concerned about the impact of use of antibiotics on the increase in antibiotic-resistant bacteria. The report presents new data on antibiotic consumption and antibiotic resistance and reflects improved surveillance across Europe. (Source: EurekAlert! - Biology)
Source: EurekAlert! - Biology - July 27, 2017 Category: Biology Source Type: news