The companies are required to remove the products from store shelves by midnight April 22 and complete recalling the products within 30 days, the FDA said. When magnesium carbonate and calcium carbonate are used as the major ingredients in pharmaceutical products, those two compounds must be of pharmaceutical grade, which requires a certificate fro
Anika Therapeutics reported that it has filed an Investigational Device Exemption with the U.S. Food and Drug Administration to conduct a pivotal Phase III clinical trial for Hyalofast, a biodegradable, 3 D, HA-based scaffold with autologous bone marrow aspirate concentrate. Hyalofast is CE Marked in Europe for the entrapment of mesenchymal stem ce
Dr. Ryan is an experienced senior executive with an impressive background in working in the pharmaceutical and biotechnology industry. Prior to this position, Dr. Ryan served for over a decade at Forest Laboratories, a specialty pharmaceutical company in New York, as its Senior Vice President& Chief Intellectual Property Counsel. "With a career sp
"Mylan is fully committed to its stand-alone strategy, including its proposal to acquire Perrigo," the company said. Mylan, which earlier this year moved its headquarters to the Netherlands but maintains its base of operations in Cecil, last week revealed it had made an unsolicited, roughly $30 billion bid for the store-brand medication specialist
Brad Bradshaw, a Democrat running for lieutenant governor, and former Rep. Both men will discuss their opinions on state issues that range from "right to work" laws, tax credit reform and health care policy, to Medicaid and the influence of money on government. The half-hour public affairs program airs at 7:30 a.m. on FOX 26 KNPN.
The Evolution of Care Bundles for Sepsis, the latest white paper from Hayes, Inc., reviews how and why sepsis care bundles came to be and discusses how they may evolve in the future. Sepsis may lead to death in a large percentage of patients who come to the hospital for treatment, says David Wade, MD, FACS, Chief Medical Officer at Hayes, Inc
-The Clinical Data Interchange Standards Consortium is pleased to announce the participation of high-level representatives from the U.S. Food and Drug Administration, European Medicines Agency and the Japan Pharmaceuticals and Medical Devices Agency, as well as CDISC experts and innovators from industry and academia at the 2015 CDISC Europe and Jap
Ceylinco Healthcare service has been providing patient management and services for the last 15 years along with specialisation in oncology and treatment. The collaboration with Credence enables Ceylinco Healthcare to provide diagnostics and prediction, which is 99.7% accurate for the first time in Sri Lanka. Ceylinco Healthcare will also offer a te
Eagle Pharmaceuticals reported that the United States Patent and Trademark Office has granted Patent No. 9,000,021 for the use of bendamustine for treating patients requiring restricted fluid and/or sodium intake. In a release, the Company noted that on February 13, it submitted a New Drug Application to the U.S. Food and Drug Administration for...
Enanta Pharmaceuticals, a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, reported abstracts of research on regimens containing either one of Enanta's two protease inhibitors for hepatitis C virus identified and developed in its ongoing collaboration with...
At the 2015 American Society of Cataract and Refractive Surgery Annual Symposium in San Diego, ZEISS Medical Technology highlights its new Humphrey Field Analyzer 3 as part of the Glaucoma Suite, a connected solution for accurate diagnosis and confident disease management. The minimally invasive, flapless SMILE procedure 3 rd generation of la
ABU DHABI, 18th April, 2015 National Ambulance has been awarded Joint Commission International Accreditation for its high quality Emergency Patient Transport service in the northern regions. The award makes National Ambulance the only pre-hospital service in the UAE to have achieved this prestigious international standard. Ahmed Saleh Al Hajeri D
NORTH East drug manufacturer Quantum Pharma Plc has acquired pharmaceutical development and licensing out-fit Lamda for Pounds 6.9 m. Lamda provides outsourced research and development services to customers in the UK, Germany, Italy, Scandinavia and Greece, from its laboratories near Athens. Andrew Scaife, chief executive officer of Quantum Pharma
Prolong Pharmaceuticals reported that the U.S. The company said the FDA defines rare diseases as those affecting fewer than 200,000 people in the United States. "Our Orphan Drug Designation has been issued based in part on SANGUINATE's unprecedented ability to un-sickle sickle cells," stated Glenn Kazo, president of Prolong Pharmaceuticals.
AstraZeneca today announced that the US Food and Drug Administration has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma. The Orphan Drug Designation is an important regulatory advancement as we further our development plans for selumetinib in uveal melanoma, "said Antoine Yver, Head of Oncolog
Sitraa Health's chronic care platform comprises a telehealth virtual system, ecommerce platform and a network of healthcare providers like registered dietitians, diabetes educators and behavioral therapists. Sitraa Health is a trusted partner of ACOs, physician practices, hospitals, insurers and employers in dealing with the chronic care epidemic.
By a News Reporter-Staff News Editor at Marketing Weekly News SOHM, Inc., a manufacturer of generic Pharmaceutical, Nutraceutical and Cosmeceutical products, announced they have signed private label contract manufacturing for their Nutraceutical units. Shailesh Shah, President and CEO, announced that SOHM India has signed a private label contract
ZeOmega has launched Jiva Integrated Medication Management, which gives providers and health plans the embedded intelligence and workflow needed to integrate medication management into the overall care management process. Healthcare organizations that recognize this are looking for ways to break the traditional silos between their care management..
Regulatory leaders in the pharmaceutical industry continue to watch closely the newly released bipartisan discussion draft called "21 st Century Cures." This 393- page draft document is planned to be taken up by Congress soon and if enacted into law, it could alter how pharmaceutical and medical device products are developed and marketed in the U
3 DS has been at the forefront of surgical planning and personalized medical solutions for almost two decades. Shafkat Anwar, a member of the Pediatric Cardiology team at Washington University who worked with 3 DS to develop the model heart for this particular surgical procedure said, "With 3 D printing, we were able to print a replica of the patie
-Adamis Pharmaceuticals Corporation today announced the results of a clinical efficacy trial that was conducted outside of the United States for its albuterol HFA product, APC-2000. The study was performed in 124 stable, mild to moderate asthmatic subjects and was designed to reflect the FDA's Albuterol Sulfate June 2013 Draft Guidance.
The Food and Drug Administration is announcing a public workshop, cosponsored by FDA and the University of Maryland Center for Excellence in Regulatory Science and Innovation, entitled "Methodological Considerations to Address Unmeasured Information About Important Health Factors in Pharmacoepidemiology Studies that Rely on Electronic Healthcare...
Pursuant to a 2013 settlement agreement with Forest Laboratories, and subject to FDA final approval of its ANDA, Amerigen may launch its generic product on the date that is the later of three calendar months prior to the expiration of U.S. Amerigen Pharmaceuticals is a group of companies engaged in all phases of the generic pharmaceutical business,
LONDON- AstraZeneca announced that the US Food and Drug Administration or FDA has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma. In addition to uveal melanoma, selumetinib is being investigated in Phase III studies in KRAS mutation positive lung cancer and thyroid cancer and in Phase II in ch
LONDON- AstraZeneca PLC on Friday said the US Food and Drug Administration has granted orphan drug designation for its selumetinib treatment for uveal melanoma. Uveal melanoma is a rare disease in which cancer cells form in the tissues of the eye, AstraZeneca said. The Orphan Drug Designation is an important regulatory advancement as we further our