Sanofi MS drug under safety review in the EU for dangerous side effects
The European Medicines Agency is taking a closer look at safety issues linked to the use of a Sanofi multiple sclerosis drug, Lemtrada. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - April 15, 2019 Category: Pharmaceuticals Source Type: news

Janssen Announces Investigational CAR-T Therapy JNJ-68284528 Granted PRIME Designation by the European Medicines Agency
(Source: Johnson and Johnson)
Source: Johnson and Johnson - April 15, 2019 Category: Pharmaceuticals Source Type: news

EMA panel recommends approval of Bluebird Bio's first gene therapy
A European Medicines Agency panel on Friday recommended a conditional marketing approval for a gene therapy from Bluebird Bio Inc as a genetic blood disorder treatment, setting the stage for the U.S. biotech to win its first regulatory nod. (Source: Reuters: Health)
Source: Reuters: Health - March 29, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Report: French commission calls for massive medtech regulation overhaul
A French parliamentary body is calling for a significant overhaul of medical device regulations in the country and across Europe, calling the existing system “massively dysfunctional,” according to a new report from the International Consortium of Investigative Journalists’ Implant Files. A French Specially Convened Commission on Medical Devices, composed of parliamentarians Julein Borowczyk and Pierre Dharréville, recently endorsed a 97-page report advocating for 36 separate reforms, according to the report. Endorsed reforms include the creation of a centralized European agency in control of appro...
Source: Mass Device - March 19, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Regulatory/Compliance European Medicines Agency (EMA) Source Type: news

EMA Starts Review on DPD Testing Before Chemotherapy EMA Starts Review on DPD Testing Before Chemotherapy
The European Medicines Agency (EMA) has launched a review into screening patients with cancer before they start certain chemotherapy.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - March 15, 2019 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

CHMP Recommends Approval of Dupixent(R) (dupilumab) for Asthma Indication
TARRYTOWN, N.Y. and PARIS, March 1, 2019 -- (Healthcare Sales & Marketing Network) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has ... Biopharmaceuticals, Regulatory Regeneron Pharmaceuticals, Sanofi, Dupixent, dupilumab, asthma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - March 1, 2019 Category: Pharmaceuticals Source Type: news

CHMP Recommends Approval of Praluent(R) (alirocumab) Injection to Reduce Cardiovascular Risk in People with Established Atherosclerotic Cardiovascular Disease
TARRYTOWN, N.Y. and PARIS, Feb. 4, 2019 -- (Healthcare Sales & Marketing Network) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has a... Biopharmaceuticals, Cardiology, Regulatory Regeneron Pharmaceuticals, Sanofi, Praluent, alirocumab, ASCVD (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - February 4, 2019 Category: Pharmaceuticals Source Type: news

Forxiga receives positive EU CHMP opinion for the treatment of adults with type-1 diabetes
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a new indication for the marketing authorisation of Forxiga (dapagliflozin), after adopting a positive opinion for use as an oral adjunct treatment to insulin in adults with type-1 diabetes (T1D). (Source: World Pharma News)
Source: World Pharma News - February 4, 2019 Category: Pharmaceuticals Tags: Featured AstraZeneca Business and Industry Source Type: news

Teva's migraine drug gets EU panel nod
Teva Pharmaceutical Industries said a European Medicines Agency (EMA) panel on Friday recommended approving migraine treatment Ajovy, a drug that the company has been counting on to revive its fortune. (Source: Reuters: Health)
Source: Reuters: Health - February 1, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

CHMP recommends EU approval of Roche ’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab), in combination with Avastin® (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) . (Source: Roche Media News)
Source: Roche Media News - February 1, 2019 Category: Pharmaceuticals Source Type: news

CHMP recommends EU approval of Roche ’s Tecentriq in combination with Avastin and chemotherapy as an initial treatment for lung cancer
Roche today announced that the European Medicines Agency ’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Tecentriq® (atezolizumab), in combination with Avastin® (bevacizumab), paclitaxel and carboplatin, for the first-line treatment of adults with metastatic non-squamous non-small cell lung cancer (NSCLC) . (Source: Roche Investor Update)
Source: Roche Investor Update - February 1, 2019 Category: Pharmaceuticals Source Type: news

Teva's migrane drug gets EU panel nod
Teva Pharmaceutical Industries said a European Medicines Agency (EMA) panel on Friday recommended approving migraine treatment Ajovy, a drug that the company has been counting on to revive its fortune. (Source: Reuters: Health)
Source: Reuters: Health - February 1, 2019 Category: Consumer Health News Tags: healthNews Source Type: news

Pfizer receives positive CHMP opinion for Vizimpro ® (dacomitinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR-activating mutations
Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending Vizimpro® (dacomitinib) 45 mg, as monotherapy, be granted marketing authorization in the European Union (EU) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations. (Source: World Pharma News)
Source: World Pharma News - February 1, 2019 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Gold standard: Standardizing RWD
Within healthcare circles, the hype around the potential of real-world evidence to transform health outcomes through new patient insights has been considerable.But as the pool of RWD swells daily – driven by growing demand from drug development, regulatory decision-making and patient care and enhanced by advances in technology, study design and data collection methods – there is one very large stumbling block on the horizon.“As data is collected in multiple languages, formats, ontologies, structures, and platforms, you end up with a Tower of Babel challenge,” says Nigel Hughes, Scientific Director, ...
Source: EyeForPharma - January 4, 2019 Category: Pharmaceuticals Authors: Nicola Davies Source Type: news

PRIME designation granted by European Medicines Agency for Roche ’s risdiplam for treatment of spinal muscular atrophy (SMA)
Roche today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company ’s investigational oral medicine risdiplam (RG7916) for the treatment of people with SMA. (Source: Roche Media News)
Source: Roche Media News - December 17, 2018 Category: Pharmaceuticals Source Type: news

PRIME designation granted by European Medicines Agency for Roche ’s risdiplam for treatment of spinal muscular atrophy (SMA)
Roche today announced that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation for the company ’s investigational oral medicine risdiplam (RG7916) for the treatment of people with SMA. (Source: Roche Investor Update)
Source: Roche Investor Update - December 17, 2018 Category: Pharmaceuticals Source Type: news

CHMP Recommends Approval of Opioid-Induced Constipation Drug CHMP Recommends Approval of Opioid-Induced Constipation Drug
The European Medicines Agency's committee recommended approval of the mu-opioid receptor antagonist for treatment of opioid-induced constipation in adults previously been treated with a laxative.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 14, 2018 Category: Consumer Health News Tags: Neurology & Neurosurgery News Source Type: news

EU Panel Recommends Tobramycin PARI for Pseudomonas in CF EU Panel Recommends Tobramycin PARI for Pseudomonas in CF
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended Tobramycin PARI for Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis.International Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 14, 2018 Category: Consumer Health News Tags: Pulmonary Medicine News Alert Source Type: news

Pfizer's cut-price version of Avastin wins EU panel greenlight
A panel of European Medicines Agency (EMA) on Friday recommended approval for Pfizer Inc's Zirabev, a cheaper version to Roche Holding AG's leading cancer drug Avastin. (Source: Reuters: Health)
Source: Reuters: Health - December 14, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Pfizer receives positive CHMP opinion for oncology biosimilar, ZIRABEV ™ (bevacizumab)
Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for ZIRABEV™ (bevacizumab), a potential biosimilar to Avastin (bevacizumab). (Source: World Pharma News)
Source: World Pharma News - December 14, 2018 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

EMA Curtails Use of Fluoroquinolone, Quinolone Antibiotics EMA Curtails Use of Fluoroquinolone, Quinolone Antibiotics
The occurrence of disabling and potentially permanent side effects associated with quinolone and fluoroquinolone antibiotics has led the European Medicines Agency (EMA) to restrict or suspend their use.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - November 16, 2018 Category: Consumer Health News Tags: Infectious Diseases News Alert Source Type: news

Amgen Receives CHMP Positive Opinion To Expand Use Of BLINCYTO ® (Blinatumomab) In Patients With Minimal Residual Disease-Positive B-Cell Precursor Acute Lymphoblastic Leukemia
First and Only EU Marketing Authorization Application to Include Presence of Minimal Residual Disease Application Based on Data From the Phase 2 BLAST Study, the Largest Prospective Trial in Minimal Residual Disease-Positive Acute Lymphoblastic Leukemia THOUSAND OAKS, Calif., Nov. 16, 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 to expand the current indication for BLINCYTO® (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative CD19 ...
Source: Amgen News Release - November 16, 2018 Category: Pharmaceuticals Tags: Uncategorized Source Type: news

Jazz Pharmaceuticals Submits Marketing Authorization Application to European Medicines Agency for Solriamfetol as a Treatment to Improve Wakefulness and Reduce Excessive Daytime Sleepiness in Adult Patients with Narcolepsy or Obstructive Sleep Apnea
DUBLIN, Nov. 9, 2018 -- (Healthcare Sales & Marketing Network) -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for solriamfetol, a selective dopamine... Biopharmaceuticals, Regulatory Jazz Pharmaceuticals, solriamfetol, narcolepsy, obstructive sleep apnea (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - November 9, 2018 Category: Pharmaceuticals Source Type: news

Amid Deepening Addiction Crisis, FDA Approves Powerful New Opioid
(CNN) — Despite the ongoing opioid crisis plaguing the nation, the US Food and Drug Administration on Friday approved a new opioid medication five to 10 times more powerful than fentanyl. Dsuvia, made by AcelRx Pharmaceuticals Inc., is a tablet in a single-dose, prefilled applicator to be administered under the tongue by health care providers to patients in settings such as hospitals, surgical centers and emergency rooms, according to the company. FDA Commissioner Dr. Scott Gottlieb was quick to defended the approval in a statement Friday: “The agency is taking new steps to more actively confront this crisis, ...
Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - November 5, 2018 Category: Consumer Health News Authors: Health – CBS Boston Tags: Health News Local TV opioids Source Type: news

What does Brexit mean for clinical research?
Melissa Wollerman, clinical research associate, IMARC Research As Brexit negotiations continue between the UK and EU, clinical research sponsors are carefully considering the future of research in the UK, as the number of clinical trials held there has begun to decrease. From an average of 806 trials a year conducted between 2009 and 2016, to 597 trials in 2017, the numbers have diminished by over 25 percent. One medical research firm-based in the US has halted its clinical trial activities in the UK due to the uncertainty in approval of medicines and acceptance of data by the European Medicines Agency.   Along with t...
Source: Mass Device - October 23, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news

Sanofi dengue vax gets EMA ok, despite Philippines scandal
Sanofi's dengue vaccine, Dengvaxia, has been recommended for approval in Europe by the European Medicines Agency's Committee for Medicinal Products for Human Use. (Source: PharmaManufacturing.com)
Source: PharmaManufacturing.com - October 19, 2018 Category: Pharmaceuticals Source Type: news

Mylan and Biocon Announce Positive CHMP Opinion for Ogivri(R), Biosimilar Trastuzumab
HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Oct. 19, 2018 -- (Healthcare Sales & Marketing Network) -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the European Medicines Agency's Committee for... Biopharmaceuticals, Generics, Oncology, Regulatory Mylan, Biocon, Ogivri, Herceptin, trastuzumab, breast cancer, biosimilar (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 19, 2018 Category: Pharmaceuticals Source Type: news

Shire's drug for rare swelling disorder wins European panel green light
A European Medicines Agency (EMA) panel on Friday recommended approving a potential blockbuster drug from Shire Plc to treat patients aged 12 and older with a rare hereditary disease that causes swelling in different parts of the body. (Source: Reuters: Health)
Source: Reuters: Health - October 19, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Huge variations between countries in time for reimbursement decisions on new cancer drugs
(European Society for Medical Oncology) Some European countries take more than twice as long as others to reach health technology assessment (HTA) decisions to reimburse new cancer drugs following their approval by the European Medicines Agency (EMA). The average decision time is longer than one year in some countries, according to a study to be reported at ESMO 2018 Congress. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - October 19, 2018 Category: International Medicine & Public Health Source Type: news

EMA Takes Further Action in Ongoing Review of Tainted'Sartans'EMA Takes Further Action in Ongoing Review of Tainted'Sartans '
The European Medicines Agency (EMA) has placed Zheijiang Huahai Pharmaceuticals under increased supervision and stopped Aurobindo Pharma from supplying irbesartan to the European Union.News Alerts (Source: Medscape Pathology Headlines)
Source: Medscape Pathology Headlines - October 15, 2018 Category: Pathology Tags: Cardiology News Alert Source Type: news

EU places China's Zhejiang Huahai under increased supervision
European authorities are placing Zhejiang Huahai Pharmaceutical Co Ltd under higher supervision, the European Medicines Agency said on Monday, in the latest crackdown on the Chinese firm after a probable carcinogen was found in its blood pressure drug valsartan. (Source: Reuters: Health)
Source: Reuters: Health - October 15, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

EU places China's Zheijiang Huahai under increased supervision
European authorities are placing Zhejiang Huahai Pharmaceutical Co Ltd under higher supervision, the European Medicines Agency said on Monday, after an inspection revealed lapses in quality management at the drugmaker's factory in China. (Source: Reuters: Health)
Source: Reuters: Health - October 15, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Rigel Receives EMA Validation of the Marketing Authorization Application for Fostamatinib Disodium Hexahydrate in Chronic Immune Thrombocytopenia (ITP) in Adult Patients
First SYK inhibitor for the treatment of adult chronic ITP SOUTH SAN FRANCISCO, Calif., Oct. 11, 2018 -- (Healthcare Sales & Marketing Network) -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the European Medicines Agency (EMA) has v... Biopharmaceuticals, Regulatory Rigel Pharmaceuticals, fostamatinib, TAVALISSE, thrombocytopenia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 11, 2018 Category: Pharmaceuticals Source Type: news

Novartis Announces FDA and EMA Filing Acceptance of Siponimod for Secondary Progressive Multiple Sclerosis (SPMS)
Basel, October 08, 2018 - Novartis today announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company's New Drug Application (NDA) and Marketing Authorization Application (MAA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - October 8, 2018 Category: Drugs & Pharmacology Source Type: news

PRAC Again Warns Against Dolutegravir Use During Pregnancy PRAC Again Warns Against Dolutegravir Use During Pregnancy
The European Medicines Agency has confirmed its earlier precaution regarding the use of dolutegravir in women who are or who could become pregnant; it expects to make final recommendations next year.News Alerts (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - October 5, 2018 Category: Consumer Health News Tags: HIV/AIDS News Alert Source Type: news

EMA committee recommends restrictions on fluoroquinolone, quinolone antibiotics
The European Medicines Agency's risk assessment committee has recommended restrictions on the use of broad-spectrum antibiotics fluoroquinolone and quinolone following a review of side effects, the EMA said on Friday. (Source: Reuters: Health)
Source: Reuters: Health - October 5, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

European advisory panel recommends approval of Spark's gene therapy
The European Medicines Agency advisory panel voted Friday to recommend approval of Luxturna, a one-time gene therapy developed by Philadelphia-based Spark Therapeutics for an inherited eye disorder that leads to blindness if untreated. Luxturna received Food and Drug Administration approval in late 2017. The European Medicines Agency typically follows the removal of its advisory panels. If the treatment is approved in Europe, it would become the first gene therapy for a genetic disease approved… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 21, 2018 Category: Biotechnology Authors: John George Source Type: news

Lilly Receives Positive CHMP Opinion for Emgality(TM) (galcanezumab) for the Prophylaxis of Migraine in Adults
INDIANAPOLIS, Sept. 21, 2018 -- (Healthcare Sales & Marketing Network) -- Eli Lilly and Company (NYSE :LLY ) announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for... Biopharmaceuticals, Neurology, Regulatory Eli Lilly, Emgality, galcanezumab, migraine (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - September 21, 2018 Category: Pharmaceuticals Source Type: news

Lilly migraine drug wins European panel thumbs-up
A European Medicines Agency panel on Friday recommended the approval of U.S. pharmaceutical group Eli Lilly's migraine treatment, bringing the drug one step closer to being sold in the European Union. (Source: Reuters: Health)
Source: Reuters: Health - September 21, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

Bayer hemophilia treatment wins thumbs-up from EU panel
Bayer AG's long-acting treatment for hemophilia A has won a recommendation from a European Medicines Agency (EMA) panel for the treatment of the rare genetic disorder in which blood does not clot easily. (Source: Reuters: Health)
Source: Reuters: Health - September 21, 2018 Category: Consumer Health News Tags: healthNews Source Type: news

New educational materials on biosimilars
The European Medicines Agency has published educational material on the use of biosimilar medicines. (Source: Society for Endocrinology)
Source: Society for Endocrinology - September 14, 2018 Category: Endocrinology Source Type: news

Britain loses medicines contracts as EU body anticipates Brexit
European Medicines Agency ends pharma evaluations work and moves contracts to blocBritain ’s leading role in evaluating new medicines for sale to patients across the EU has collapsed with no more work coming from Europe because of Brexit, it has emerged.The decision by theEuropean Medicines Agency to cut Britain out of its contracts seven months ahead of Brexit is a devastating blow to British pharmaceutical companies already reeling from the loss of the EMA ’s HQ in London and with it 900 jobs.Continue reading... (Source: Guardian Unlimited Science)
Source: Guardian Unlimited Science - September 2, 2018 Category: Science Authors: Lisa O'Carroll and Hannah Devlin Tags: Pharmaceuticals industry Brexit Medical research UK news European Union Business Science Source Type: news

EU Says Second China Company Made Tainted Heart Drug 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.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 13, 2018 Category: Consumer Health News Tags: Medscape Today News Source Type: news

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