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

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