EU says second China company made tainted heart drug
The European Medicines Agency (EMA) said on Friday that a second Chinese contract manufacturer, Zhejiang Tianyu, had produced a common blood pressure and heart drug with an impurity that could cause cancer. (Source: Reuters: Health)
Source: Reuters: Health - August 10, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Selumetinib granted orphan designation in Europe for neurofibromatosis type 1
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) announced that the European Medicines Agency (EMA) has granted orphan designation to selumetinib, a MEK 1/2 inhibitor, for the treatment of neurofibromatosis type 1 (NF1). (Source: World Pharma News)
Source: World Pharma News - August 9, 2018 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news

PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington ’s disease
Roche today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company ’s investigational medicine RG6042 (formerly known as IONIS-HTTRx) for the treatment of people with Huntington’s disease (HD). (Source: Roche Media News)
Source: Roche Media News - August 3, 2018 Category: Pharmaceuticals Source Type: news

PRIME designation granted by European Medicines Agency for RG6042 for treatment of Huntington ’s disease
Roche today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company ’s investigational medicine RG6042 (formerly known as IONIS-HTTRx) for the treatment of people with Huntington’s disease (HD). (Source: Roche Investor Update)
Source: Roche Investor Update - August 3, 2018 Category: Pharmaceuticals Source Type: news

EU Drugs Agency Sees 30 Pct Staff Losses, More Cuts in Brexit Move EU Drugs Agency Sees 30 Pct Staff Losses, More Cuts in Brexit Move
The European Medicines Agency (EMA) is to scale back operations further as it copes with higher than expected staff losses, triggered by the watchdog's forced relocation from London to Amsterdam because of Brexit.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 2, 2018 Category: Consumer Health News Tags: Business of Medicine News Source Type: news

Seeking the Holy Grail of RWE
Billion-dollar acquisitions tend to make a lot of noise. Markets react, competitors get jittery and share prices can spike or tumble.When Roche bought Flatiron Health, a tech platform that captures and synthesizes structured and unstructured oncology data, for $1.9 billion back in February, it sent tremors throughout the healthcare industry.The ripple effect cannot be chalked up to corporate muscle-flexing however. The deal sent an unequivocal message that the time has come to establish a regulatory-grade standard for real-world evidence.Commenting on the tie-up, Roche ’s CEO said, “This is an important step in...
Source: EyeForPharma - August 2, 2018 Category: Pharmaceuticals Authors: Adam Chapman Source Type: news

EU sees one in 5,000 cancer risk from tainted China heart drug
The European Medicines Agency estimates there could be one extra case of cancer for every 5,000 patients taking a common blood pressure and heart drug manufactured in bulk by a Chinese company that has been found to contain an impurity. (Source: Reuters: Health)
Source: Reuters: Health - August 2, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

EU drugs agency sees 30 percent staff losses, more cuts in Brexit move
The European Medicines Agency (EMA) is to scale back operations further as it copes with higher than expected staff losses, triggered by the watchdog's forced relocation from London to Amsterdam because of Brexit. (Source: Reuters: Health)
Source: Reuters: Health - August 1, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

EU drugs agency fears 30 percent staff losses due to Brexit move
The European Medicines Agency is to scale back operations further as it copes with higher than expected staff losses, triggered by the watchdog's forced relocation from London to Amsterdam because of Brexit. (Source: Reuters: Health)
Source: Reuters: Health - August 1, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

EMA Panel Backs Tezacaftor, Ivacaftor Combo for CF EMA Panel Backs Tezacaftor, Ivacaftor Combo for CF
The Committee for Medicinal Products for Human Use of the European Medicines Agency recommended Symkevi for patients aged 12 years and older with cystic fibrosis (CF).International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 30, 2018 Category: Consumer Health News Tags: Pulmonary Medicine News Alert Source Type: news

Tildrakizumab Gets EMA Panel Nod for Plaque Psoriasis Tildrakizumab Gets EMA Panel Nod for Plaque Psoriasis
A European Medicines Agency panel has recommended tildrakizumab for the treatment of moderate to severe plaque psoriasis.International Approvals (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 30, 2018 Category: Consumer Health News Tags: Dermatology News Alert Source Type: news

GSK's severe pediatric asthma drug wins European panel thumbs-up
GlaxoSmithKline drug Nucala has won a key recommendation from a European Medicines Agency (EMA) panel for use in the treatment of children with severe asthma, the company said in a statement on Friday. (Source: Reuters: Health)
Source: Reuters: Health - July 27, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Bayer wins EU watchdog's endorsement for wider Xarelto use
Bayer won the European Medicines Agency's (EMA) recommendation for widening the use of its blockbuster clot prevention drug Xarelto to include atherosclerosis patients, opening a potentially lucrative new market. (Source: Reuters: Health)
Source: Reuters: Health - July 27, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

AstraZeneca's key lung cancer drug wins European panel thumbs-up
AstraZeneca's cancer drug Imfinzi has won a key recommendation from a European Medicines Agency (EMA) panel less than six months after the first global approvals in Western markets. (Source: Reuters: Health)
Source: Reuters: Health - July 27, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

First-ever qualified Parkinson's biomarker is vital step toward improved clinical trials
(Critical Path Institute (C-Path)) The Critical Path Institute's (C-Path) Critical Path for Parkinson's Consortium (CPP), in partnership with Parkinson's UK, announces that the European Medicines Agency (EMA) has issued a positive qualification opinion on an imaging test (biomarker) as a tool to enrich Parkinson's clinical trials. The purpose of this enrichment biomarker, is to serve as a measurement that can be used to select people with Parkinson's who are most suitable to take part in clinical trials. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 26, 2018 Category: International Medicine & Public Health Source Type: news

Certara experts highlight quantitative systems pharmacology's role in first-in-human clinical trials
(Rana Healthcare Solutions LLC) Certara announced today that Clinical Pharmacology& Therapeutics has published its 'Letter to the Editor' describing the important role that quantitative systems pharmacology (QSP) can play in defining dosing criteria for first-in-human (FIH) clinical trials, together with the European Medicines Agency's (EMA's) response. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - July 26, 2018 Category: International Medicine & Public Health Source Type: news

3 Companies Recall Blood Pressure Medications Over Cancer Fears
Some drugs used to control high blood pressure and prevent heart failure were voluntarily recalled this past week due to an impurity that could possibly lead to cancer, the U.S. Food and Drug Administration said. These products — with the active ingredient valsartan, a generic drug used to treat high blood pressure — may contain N-nitrosodimethylamine (NDMA), a possible human carcinogen. The FDA asked three companies, Major Pharmaceuticals, Solco Healthcare and Teva Pharmaceuticals Industries Ltd., to recall their valsartan products. Solco and Teva were also asked to recall their drugs containing valsartan/hydr...
Source: TIME: Health - July 17, 2018 Category: Consumer Health News Authors: Jennifer Calfas Tags: Uncategorized medicine onetime Source Type: news

Restriction of Radium-223 Dichloride Recommended in Europe Restriction of Radium-223 Dichloride Recommended in Europe
Use of the novel radiopharmaceutical radium-223 dichloride (Xofigo, Bayer) in prostate cancer should be restricted, according to the European Medicines Agency.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 13, 2018 Category: Consumer Health News Tags: Hematology-Oncology News Alert Source Type: news

Supply of 100 UK medicines to be disrupted, warns EMA
European Medicines Agency said work to license them after Brexit has not been done (Source: FT.com - Drugs and Healthcare)
Source: FT.com - Drugs and Healthcare - July 11, 2018 Category: Pharmaceuticals Source Type: news

Common Heart Drug Recalled In 22 Countries For Possible Cancer Link
(CNN) — A common drug used to control blood pressure and help prevent heart failure is being recalled in 22 countries because it contains a chemical that poses a potential cancer risk. Valsartan is off-patent and is used as a component of other generic medicines. Novartis, the company that originally developed the drug, said Sandoz valsartan and valsartan/HCT film-coated tablets are being recalled since they “do not meet our high quality standards.” Pharmacies in the UK are advised to recall valsartan batches containing medicines made by Dexcel Pharma Ltd and Accord Healthcare. The recall involves about 2...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - July 6, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Valsartan Source Type: news

EMA recalls drugs made with Chinese API due to cancer fears
The European Medicines Agency is recalling a number of high blood pressure and heart drugs containing an ingredient made in China after an impurity that may cause cancer was found in them. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - July 6, 2018 Category: Pharmaceuticals Source Type: news

EU Officials Recall Some Valsartan Medicines Due to Impurity EU Officials Recall Some Valsartan Medicines Due to Impurity
The European Medicines Agency is reviewing the medicines after an impurity, thought to be a probable human carcinogen, was detected in the active ingredient supplied by a Chinese company.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 5, 2018 Category: Consumer Health News Tags: Cardiology News Alert Source Type: news

Rival Novartis, Gilead CAR-T therapies win European panel recommendation
Rival cancer cell therapies from Swiss drugmaker Novartis and U.S.-based Gilead Sciences won a key recommendation from a European Medicines Agency panel, likely clearing their way for approval within a couple of months. (Source: Reuters: Health)
Source: Reuters: Health - June 29, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Puma Biotech gets EU panel nod for breast cancer drug
(Reuters) - Puma Biotechnology Inc   on Friday won a key recommendation from a European Medicines Agency panel on its lead breast cancer drug, five months after the regulator recommended against approving it. (Source: Reuters: Health)
Source: Reuters: Health - June 29, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Puma Biotech breast cancer drug likely approved in Europe after reexamination
A committee of the European Medicines Agency is likely to approve the drug, five months after regulators recommended against approval (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - June 26, 2018 Category: Pharmaceuticals Source Type: news

Puma Biotech says Europe likely to approve breast cancer drug
(Reuters) - Puma Biotechnology Inc said on Tuesday a committee of the European Medicines Agency was likely to give positive opinion on its breast cancer drug, five months after the regulator recommended against approving it. (Source: Reuters: Health)
Source: Reuters: Health - June 26, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Talazoparib for Metastatic Breast Cancer Patients with an Inherited BRCA Mutation
June 7, 2018 - Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration accepted for filing and granted Priority Review designation to the company ’s New Drug Application for talazoparib. The submission is based on results... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 7, 2018 Category: Drugs & Pharmacology Source Type: news

Audentes Announces Priority Medicines (PRIME) Designation Granted by the European Medicines Agency to AT132 for the treatment of X-Linked Myotubular Myopathy
SAN FRANCISCO, June 5, 2018 -- (Healthcare Sales & Marketing Network) -- Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-... Biopharmaceuticals, Regulatory Audentes Therapeutics, gene therapy, Myotubular Myopathy (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - June 5, 2018 Category: Pharmaceuticals Source Type: news

Novartis receives positive CHMP opinion for Aimovig ® (erenumab) for the prevention of migraine
Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for Aimovig® (erenumab) for the prevention of migraine in adults who have at least four migraine days per month. The World Health Organization (WHO) has listed migraine as one of the top ten causes of years lived with disability worldwide[1]. (Source: World Pharma News)
Source: World Pharma News - June 4, 2018 Category: Pharmaceuticals Tags: Featured Novartis Business and Industry Source Type: news

EMA Panel Recommends Metreleptin for Leptin Deficiency EMA Panel Recommends Metreleptin for Leptin Deficiency
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use recommended metreleptin for leptin deficiency complications in those with generalized or partial lipodystrophy.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 1, 2018 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

EMA Panel Recommends Brexipiprazole for Schizophrenia EMA Panel Recommends Brexipiprazole for Schizophrenia
A European Medicines Agency (EMA) panel has recommended granting marketing authorization for the atypical antipsychotic brexipiprazole for the treatment of schizophrenia.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 1, 2018 Category: Consumer Health News Tags: Psychiatry News Alert Source Type: news

EU Panel Endorses Erenumab for Migraine Prevention EU Panel Endorses Erenumab for Migraine Prevention
An expert panel of the European Medicines Agency has recommended granting marketing authorization for erenumab, the first human monoclonal antibody for migraine prevention.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - June 1, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Alert Source Type: news

EMA committee recommends approval for migraine prevention drug
Novartis (NYSE:NVS) said today that a committee for the European Medicines Agency has recommended that the regulatory agency approve Aimovig, a self-administered drug designed to prevent migraines in adults who have at least four migraine days each month. The drug is the first of a new class of medicines, called CGRP inhibitors. It’s a monoclonal antibody that blocks the receptor for a protein that is linked to migraine pain, known as the calcitonin gene-related peptide. Just last month Aimovig, developed by Amgen (NSDQ:AMGN), won FDA approval in the U.S. Get the full story at our sister site...
Source: Mass Device - June 1, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Neurological Pharmaceuticals Regulatory/Compliance Wall Street Beat Amgen Novartis Source Type: news

EMA recommends restrictions on Merck, Roche immunotherapies
ZURICH (Reuters) - The European Medicines Agency on Friday recommended restricting use of two immunotherapies, one from Roche and the other from Merck, in initial bladder cancer treatment, saying they may not work as well as chemotherapy in some patients. (Source: Reuters: Health)
Source: Reuters: Health - June 1, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

EMA issues measures to minimize liver damage risk from Richter's Esmya
(Reuters) - European Medicines Agency issued guidelines on Friday to help minimize the risk of rare but serious liver injury associated with Hungarian drugmaker Richter's Esmya. (Source: Reuters: Health)
Source: Reuters: Health - June 1, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

EMA retracts license from Taiwanese sterile drugmaker over serious non-compliance
The European Medicines Agency found that Savior Lifetec had a critical deficiency relating to aseptic processing (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - May 22, 2018 Category: Pharmaceuticals Source Type: news

BioCryst lands European approval for flu treatment
Ahead of its planned merger with Exton, Pennsylvania-based Idera Pharmaceuticals, Durham ’s BioCryst Pharmaceuticals has landed European approval for its flu treatment.  BioCryst (Nasdaq: BCRX) said Tuesday that the European Medicines Agency has approved the treatment – an intravenous infusion in adults and children 2 years of age and older – under the brand name Alpivab. “AL PIVAB approval in the European Union represents a significant advancement for influenza patients, representing the… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - May 2, 2018 Category: Health Management Authors: Jennifer Henderson Source Type: news

Amgen Receives Positive CHMP Opinion To Add Overall Survival Results From The Phase 3 ASPIRE Study To KYPROLIS ® (carfilzomib) Label
KYPROLIS is the First and Only Relapsed or Refractory Multiple Myeloma Treatment to Demonstrate Overall Survival in two Phase 3 Studies THOUSAND OAKS, Calif., April 30, 2018 /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 recommending a label variation for KYPROLIS® (carfilzomib) to include the final overall survival (OS) data from the Phase 3 ASPIRE trial. The ASPIRE trial demonstrated that the addition of KYPROLIS to lenalidomide and dexamethasone (KRd) reduced the risk of deat...
Source: Amgen News Release - April 30, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

CHMP recommends EU approval of Roche ’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence
Roche today announced the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast c ancer (eBC) at high risk of recurrence. (Source: Roche Media News)
Source: Roche Media News - April 27, 2018 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence
Roche today announced the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast c ancer (eBC) at high risk of recurrence. (Source: Roche Investor Update)
Source: Roche Investor Update - April 27, 2018 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Perjeta for post-surgery treatment of HER2-positive early breast cancer at high risk of recurrence
Roche today announced the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) for post-surgery (adjuvant) treatment of adult patients with HER2-positive early breast c ancer (eBC) at high risk of recurrence. (Source: Roche Media News)
Source: Roche Media News - April 27, 2018 Category: Pharmaceuticals Source Type: news

Gilead's three-drug HIV regimen wins European panel approval
(Reuters) - Gilead Sciences Inc said on Friday its three-drug regimen to treat HIV infection was recommended for approval by a panel of the European Medicines Agency, paving the way for the biotech company to capture more sales in the multibillion-dollar market. (Source: Reuters: Health)
Source: Reuters: Health - April 27, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Krystal Biotech receives approval in Europe for gene therapy treatment
A gene therapy company has received a designation for one of its treatments from the European Medicines Agency. Krystal Biotech, developing and commercializing novel treatments for dermatological diseases, announced that KB103, a treatment for a severe skin disorder, was granted an Orphan Medicinal Product Designation by the agency, according to a news release. In November 2017, the FDA granted the same de signation for the treatment, which is meant for dystrophic epidermolysis bullosa, an incurable… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 19, 2018 Category: Biotechnology Authors: Stacey Federoff Source Type: news

In Europe, CHMP missed an opportunity for osteoporosis patients at high risk of fracture
(International Osteoporosis Foundation) Experts from the International Osteoporosis Foundation and the European Society for Clinical and Economic Aspects of Osteoporosis, Osteoarthritis and Musculoskeletal Diseases regret the recent decision by the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) to deny the marketing application for abaloparatide, a potential new treatment for postmenopausal women at high risk of fragility fracture which has been approved for use in the USA. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - April 5, 2018 Category: International Medicine & Public Health Source Type: news

U.S. FDA and European Medicines Agency Accept Regulatory Submissions for Review of Dacomitinib to Treat Metastatic Non-Small Cell Lung Cancer with EGFR-Activating Mutations
April 4, 2018 - Pfizer Inc. today announced that the U.S. Food and Drug Administration (FDA) accepted the company ’s New Drug Application and granted priority review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 4, 2018 Category: Drugs & Pharmacology Source Type: news

European Medicines Agency to review Sanofi-Regeneron's Dupixent, Cemiplimab
PARIS (Reuters) - The European Medicines Agency (EMA) will review the Dupixent (dupilumab) and Cemiplimab products being developed by drugmakers Sanofi and Regeneron, the companies said on Tuesday. (Source: Reuters: Health)
Source: Reuters: Health - April 3, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

EU Body Endorses Restrictions on Valproate in Pregnancy EU Body Endorses Restrictions on Valproate in Pregnancy
The CMDh, a body representing European Union member states, has endorsed new measures to limit prenatal exposure to valproate, according the European Medicines Agency.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - March 27, 2018 Category: Neurology Tags: Neurology & Neurosurgery News Source Type: news

SOPP 8001.6: Procedures for Parallel Scientific Advice with European Medicines Agency (EMA)
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 - March 27, 2018 Category: Biomedical Science Source Type: news

Acorda seeks EU approval for inhaled Parkinson ’ s disease drug
Acorda Therapeutics (NSDQ:ACOR) submitted a marketing authorization application to the European Medicines Agency for its inhaled Parkinson’s disease therapy, Inbrija, according to the Ardsley, N.Y.-based company. The investigational drug is designed to treat people with Parkinson’s disease who are experiencing “off” periods, or a re-emergence of symptoms. Get the full story at our sister site, Drug Delivery Business News. The post Acorda seeks EU approval for inhaled Parkinson’s disease drug appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - March 26, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Neurological Pharmaceuticals Regulatory/Compliance Wall Street Beat Acorda Therapeutics Source Type: news