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Showing "regulation regulatory" News Articles 51 to 75 of 6,500+

Monday 20th April 2015

Implanet Announces Definitive Clinical Results in a Comparative Study of the JAZZ Band in Idiopathic Scoliosis Surgery

Excellent performance of JAZZ compared with the Zimmer Universal Clamp JAZZ offers improved tensioning capabilities Enhanced corrective power, improved profile, easy-to-learn procedure, reduced operative time and blood loss with a global reduction in the overall cost of surgery Regulatory News: ...

Innophos Holdings, Inc. Schedules Call To Discuss First Quarter 2015 Results

CRANBURY, N.J., April 20, 2015 /PRNewswire/ -- Innophos Holdings, Inc. (NASDAQ: IPHS), a leading international producer of performance-critical and nutritional specialty ingredients, today announced that it will host a live conference call on Tuesday, April 28, 2015 at 10:00 am ET to discuss its first quarter 2015 results. The press release detailing first quarter results will be issued on ...

Review of Whole Slide Imaging for Pediatric Specimens Advances Validation Process

Whole slide imaging is an emerging technology that is poised to impact the practice of medicine by extending the virtual reach of pathologists. A study in the new issue of Pediatric and Developmental Pathology offers guidance for further development of whole slide imaging systems and advances the technology toward regulatory approval for use in primary diagnosis. (PRWEB) April 20, 2015 Pediatric ...

Catalent Awarded Grant as Part of Vaccine Research Consortium

Catalent’s Zydis® Technology Used to Develop Thermo Stable and Cold-Chain Independent Vaccines Somerset, NJ (PRWEB) April 20, 2015 Catalent, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, today announced that it has received a significant project grant as part of a consortium looking to evaluate, de...

Absorption Systems Chief Scientist Ismael Hidalgo to Present at International Workshop on Drug Transporters

EXTON, Pa., April 20, 2015 /PRNewswire/ -- The preclinical contract research organization Absorption Systems, a global leader in pharmacokinetic testing of drugs and safety testing of medical devices, announces that its Chief Scientist, Ismael Hidalgo, will present at this week's workshop "Drug Transporters in ADME: From the Bench to the Bedside" in Baltimore, MD. The title of Dr. Hidalgo's talk i...

PPD® Laboratories Opens Central Lab in Shanghai, China

Provides clients with broad range of standardized lab testing services and capabilities Pharmaceutical Product Development, LLC (PPD) has opened a central laboratory in Shanghai, China, to deliver global scienti

Mauna Kea Technologies Obtains Regulatory Approval for the Commercialization of Cellvizio® in Mexico

PARIS, April 20, 2015 /PRNewswire/ -- Mexico is the second largest medical device market in Latin America after Brazil  The local distributor, Endomédica, is now able to deploy its marketing and sales resources  Mauna Kea Technologies (Euronext: MKEA, FR0010609263), inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, announced today it ha...

Acetylon Announces Preclinical Anti-cancer Activity of Selective HDAC1/2 Inhibitors in Neuroblastoma and Acute Myeloid Leukemia

--Data to be Presented in Poster Sessions at the American Association for Cancer Research Annual Meeting-- Acetylon Pharmaceuticals, Inc., the leader in the development of selective histone deacetylase (HDAC) inhibitors for enhanced therapeutic outcomes, today announced that it will present preclinical data on selective HDAC1/2 inhibition, demon...

Epizyme to Present Updated Data from Ongoing Phase 1 Dose Escalation Trial of EZH2 Inhibitor EPZ-6438 at International Conference on Malignant Lymphoma

Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, announced today that updated data from the Phase 1 portion of the ongoing Phase 1/2 study of EPZ-6438 will be presented during the 13th International Conference on Malignant Lymphoma (ICML), to be held in Lugano, Switzerla...

TetraLogic and Merck to Collaborate on the Evaluation of Birinapant in Combination with KEYTRUDA® (pembrolizumab) in Solid Tumors

TetraLogic Pharmaceuticals Corporation (Nasdaq: TLOG), a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, and Merck (NYSE:MRK), known as MSD outside the United States and Canada, announced today they have entered into an oncology clinical study collaboratio...

More than 78 Million Consumers Will Utilize Home Health Technologies by 2020, According to Tractica

Growth to be Driven by Expanded Capabilities for Medical Monitoring, Remote Consultations, Eldercare, and Health and Wellness Applications Home health technologies are emerging as a distinct segment within the larger mobile and digital health market. The ability to remotely monitor patients with chronic conditions, utilize technology for improved elder...

Power Morcellator Lawyers at Bernstein Liebhard LLP Comment on Insurance Trade Group’s Call for Greater Regulation of Medical Devices

New York, New York (PRWEB) April 20, 2015 America’s Health Insurance Plans (AHIP), the trade association representing the U.S. health insurance industry, is seeking greater regulation of medical devices as a result of the recent controversy i...

Bruker Introduces Novel Solid-State NMR Probe with Ultra-high Spinning Frequency

World’s Fastest 111 kHz Magic-Angle Spinning (MAS) Probe Enables Highest Performance NMR Analysis up to 1 GHz on Biological Solids and Materials with Unprecedented Convenience At the 56th Experimental Nuclear Magnetic Resonance Conference (www.enc-conference.org), Bruker (NASDAQ: BRKR) this week is introducing a unique, new ultra-high ...

Pfizer and Provectus Biopharmaceuticals Receive Patent Allowance for Use of PV-10 in Combination with Systemic Immunotherapy Agents in Treatment of Cancer

Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT, http://www.pvct.com), a clinical-stage oncology and dermatology biopharmaceutical company (“Provectus” or the “Company”), announced today that it has received from the US Patent and Trademark Office a Notice of Allowance for a joint patent application made w

Hospital Costs Lower in Michigan than in Indiana, Wisconsin; Michigan's Certificate of Need Laws, Dominant Insurer Likely Contributed to Differences

ANN ARBOR, Mich., April 20, 2015 /PRNewswire-USNewswire/ -- A report released today by the Center for Healthcare Research & Transformation (CHRT) shows substantial variation in hospital costs between Indiana, Michigan and Wisconsin, with Michigan as the lowest cost among the three states. Many complex factors contributed to these differences, and likely included state regulations such as Certi...

Ibrutinib (IMBRUVICA®) Improves Outcomes for Pancreatic Ductal Adenocarcinoma in Mouse Models

PHILADELPHIA, April 20, 2015 /PRNewswire/ -- Ibrutinib (IMBRUVICA®) data presented yesterday by Pharmacyclics, Inc. (NASDAQ: PCYC) at the American Association for Cancer Research (AACR) Annual Meeting suggest that ibrutinib may be an effective therapeutic option for pancreatic ductal adenocarcinoma (PDAC), as shown in both a transgenic mouse model and an in-vivo model of patient-derived ...

PointCross Life Sciences and InterpretOmics partner for Clinical and Genomic Biomarker Management for Drug Development

FOSTER CITY, Calif., April 20, 2015 /PRNewswire/ -- PointCross Life Sciences today announced a strategic partnership with InterpretOmics Pvt. Ltd. to provide an integrated Big Data and globally accessible environment for genomic interpretation and analysis of all biomarkers collected in the context of clinical trials and nonclinical studies. This platform will serve the needs of precise or multi-t...

Tandem Diabetes Care Now Shipping t:slim® Insulin Pump with Updated Software

SAN DIEGO, April 20, 2015 /PRNewswire/ -- Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the t:slim® and t:flex™ Insulin Pumps, today commenced  shipments of t:slim Pumps featuring enhanced software.  The updated software, based on customer and healthcare provider feedback, includes an expansion of the reverse correction func...

IMBRUVICA® (ibrutinib) Longer-Term Follow-Up Data Demonstrate Durable Responses, Including Complete Responses, in Patients with Chronic Lymphocytic Leukemia (CLL)

PHILADELPHIA, April 20, 2015 /PRNewswire/ -- Pharmacyclics, Inc. (NASDAQ: PCYC) today announced that IMBRUVICA® (ibrutinib) follow-up data in treatment-naive (TN) and relapsed/refractory (R/R) patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL, respectively) demonstrated that, with up to 45 months of follow-up, the 94 patients (27 TN and 67 R/R) who received ...

PTC Therapeutics to Host Conference Call to Discuss First Quarter 2015 Financial Results

SOUTH PLAINFIELD, N.J., April 20, 2015 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the Company will host a webcast conference call to report its first quarter 2015 financial results on Monday, May 4, 2015 at 4:30 p.m. (ET) after the closing of the market. The call can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-81522 (international) five minutes pr...

Poster Presentations at 2015 AACR Annual Meeting to Highlight Clinical Utilities and Advantages of Trovagene's ctDNA Precision Cancer Monitoring Platform

SAN DIEGO, April 20, 2015 /PRNewswire/ -- Trovagene, Inc., (NASDAQ:  TROV) a developer of cell-free molecular diagnostics, announced today that clinical and analytical data for the Company's  Precision Cancer MonitoringSM platform will be presented at the American Association for Cancer Research Annual Meeting in Philadelphia. The data will be presented during the Circulating Free D...

WIRB-Copernicus Group Supports Adoption of Accelerated Clinical Trial Agreement by WCG Global Research Network

PRINCETON, N.J., Apr. 20, 2015 /PRNewswire/ -- WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for human research and a leading provider of software solutions designed to accelerate clinical trials safely, announced today that it will encourage members of its Global Research Network (GRN) to accept the Accelerated Clinical Trial Agreement (A...

Phase 1 Data from Spinal Muscular Atrophy Program to be Presented at the 2015 American Academy of Neurology Annual Meeting

WASHINGTON, April 20, 2015 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that Phase 1 clinical data from the company's joint development program with Roche and the SMA Foundation in spinal muscular atrophy (SMA) will be presented at the 2015 American Academy of Neurology 67th Annual Meeting. The late-breaking abstract titled "SMN2 splicing modifier RG7800 shows dose-de...

NanoViricides Reports that Its Topical Anti-Herpes Treatment Dramatically Improves Clinical Symptoms in an Animal Model

SHELTON, Conn., April 20, 2015 /PRNewswire/ -- NanoViricides, Inc., (NYSE MKT: NNVC) (the "Company"), a nanomedicine company developing anti-viral drugs, reports dramatic improvement in clinical symptoms associated with herpes simplex virus infection in the recently completed studies in mice. The studies were performed in the laboratory of Dr. Ken S. Rosenthal at Northeast Ohio Medical University ...

Whitehouse Laboratories Completes FDA Inspection with No Form 483 – No Observations

This represents the fifth FDA inspection in a row that Whitehouse Laboratories has been through resulting on no observable actions being taken (PRWEB) April 20, 2015 Whitehouse Laboratories is pleased and overly excited to announce that it has undergone its most recent Food and Drug Administration (FDA) inspection and received no observations and thus no form-483 issued. The five day, GMP complia...


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