EMA Stops Import of Products from US Company
20 September 2016
The European Medicines Agency (EMA) announced on Sept. 16, 2016 that the agency was recommending that non-critical drugs manufactured by Pharmaceutics International Inc. (Hunt Valley, MD) no longer be available in the European Union, except for Ammonaps (sodium phenylbutyrate), because of failures in good manufacturing practices (GMPs).
The European Medicines Agency (EMA) announced on Sept. 16, 2016 that the agency was recommending that non-critical drugs manufactured by Pharmaceutics International Inc. (Hunt Valley, MD) no longer be available in the European Union, except for Ammonaps (sodium phenylbutyrate), because of failures in good manufacturing practices (GMPs).
HHS takes steps to provide more information about clinical trials to the public
19 September 2016
In an effort to make information about clinical trials widely available to the public, the U.S. Department of Health and Human Services today issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information to ClinicalTrials.gov.
Biopharmas bite back at UN’s scathing life science R&D report
19 September 2016
A highly influential and long-awaited report from the United Nations has attacked the market-based R&D approach used by the biopharma industry, but an industry group has hit back at its “narrow focus.”
EMA Recommends Approval of 11 Drugs
19 September 2016
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of 11 drugs during their Sept. 12–15, 2016 meeting. The approved drugs treat a range of conditions including different forms of cancer, type 2 diabetes, secondary hyperparathyroidism, heart failure, and HIV.
Pitch dark? In funding bid, be open about challenges they'll find anyway: panel
16 September 2016
Tweaks were made this year to the format of Biopharm America, which featured shorter, snappier sessions intended to stimulate exactly the kind of early partnering talks that the event is designed to foster.
U.K. biopharma sector delivers wish list for Brexit negotiations
16 September 2016
After a summer of concerted effort to scope out and reach a unified view, the life sciences sector had its first meeting with the government's new Department for Exiting the EU, to put forward the industry's wish list and requirements once negotiations on U.K. withdrawal from the EU get underway.
16 September 2016
Biotechnology companies received the second largest amount of corporate venture dollars in the second quarter, attracting $407 million in 25 deals, representing 33 percent of corporate venture dollars invested and 12.6 percent of deals. As a share of overall venture dollars invested in biotechnology companies, corporate venture groups accounted for 24.2 percent of total dollars invested, which was substantially over-weighted in the sector.
New drug combo targets an aggressive blood cancer at lower cost
15 September 2016
Patients with chronic myeloid leukemia (CML) face not only a life-threatening cancer but also the high cost of the current therapy. A team at the University of Texas has now shown a drug combo that might stop the cancer--while offering the drug at a more reasonable price tag.
A Global Fight Against Antimicrobial Resistance
14 September 2016
The European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) met on Sept. 1–2, 2016 to discuss a worldwide regulatory response to the development of new antibiotics to fight antimicrobial resistance. The agencies agreed at the meeting, which was hosted by EMA, that regulatory activities were only one facet of the response needed to fight antimicrobial resistance worldwide.
New medicines in development for autoimmune diseases offer patients hope for brighter futures
14 September 2016
Currently, more than 23.5 million Americans are affected by one of the more than 80 autoimmune diseases identified to date. These diseases range in severity, with their own characteristics and their own struggles. Because of this, the need for innovative treatments and cures has never been greater. But today, patients with an autoimmune disease can have more hope than ever before with the tremendous progress that science offers patients and their families.
14 March 2024
26 February 2024
NovaMedica team wishes you a Merry Christmas and a Happy New Year!
26 December 2023
Putin has stated that Russia will support Africa in the struggle against epidemics
19 April 2024
The Russian government has expanded the list of vital and essential drugs
19 April 2024
Achieving FAIR bacterial identification
18 April 2024
Unique testing regimen could prevent nuclease contamination
18 April 2024