Category Archives: Regulations

Polyphor’s antibiotic murepavadin receives US FDA Qualified Infectious Disease Product designation in four new indications

Polyphor’s antibiotic murepavadin receives US FDA Qualified Infectious Disease Product designation in four new indications Polyphor AG (SIX: POLN) today announced that the US Food and Drug Administration (FDA) has designated murepavadin as a Qualified Infectious Disease Product (QIDP) in four additional indications; hospital-acquired bacterial pneumonia, acute bacterial skin and skin structure infection, bloodstream infection […]

Motif Bio Submits NDA for iclaprim

NEW YORK, June 14, 2018 (GLOBE NEWSWIRE) — Motif Bio plc (AIM:MTFB) (NASDAQ:MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, today announced the completion of its rolling submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for iclaprim, a targeted, Gram-positive investigational antibiotic, for the treatment of acute bacterial skin and skin structure […]

LK-01 Granted Orphan Drug Designation by the U.S. FDA for Acute Myeloid Leukemia

BARCELONA, Spain – Leukos Biotech, a spin-off company founded by the Barcelona based Jose Carreras Leukaemia Research Institute and supported by VCF Inveready, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for LK-01, a product based on Apomorphine, for the treatment of Acute Myeloid Leukemia. Acute Myeloid Leukaemia (AML) is […]

General Data Protection Regulation (GDPR)

The new regulation for General Data Protection Regulation (GDPR) is effective as of May 25th, 2018. Any company that does not comply with the new regulation, can face significant fines. This change is one of the most important, if not THE MOST important in the field of privacy regulations in 20 years, and it effects […]

NEW Medical Device Regulations!

New regulations in the Medtech industry (MDR) is calling for swift action to ensure timely implementation and continuous availability of medical devices. An interesting article on a call for action! Click HERE for more information. Do you need support with your existing or new medical devices? Hemex offers support at competitive conditions. Contact us today […]

Information on revision of the Medical Devices Law in Switzerland

After various incidents the control mechanisms for medical devices are being reinforced throughout Europe. Switzerland is also revising its medical devices legislation, closely modelled on the various new EU-requirements, with the aim of improving the safety and quality of medical devices. Up-to-date information (in English) can be found via THIS LINK. Let us know if […]

EMA’s new Q&A re: orphan medicines

EMA has recently published a question-and-answer document, addressing common misunderstandings about the meaning of orphan designation and other aspects pertaining to orphan medicines. Here we have a document that explains key concepts in the regulation of medicines for rare diseases such as orphan designation and significant benefit. Hemex frequently submits ODD applications for Sponsors of […]