> Drug Development Strategy

FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

The U.S. Food and Drug Administration today approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH. “Primary HLH is a [...]

2018-11-20T19:50:09+00:00 21.11.2018|Drug Development Strategy, Regulatory Affairs|

FDA approves new drug to treat travelers’ diarrhea

The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. "Travelers' diarrhea affects millions of people each year and having treatment options for this condition can [...]

2018-11-18T12:10:11+00:00 19.11.2018|Drug Development Strategy, Regulatory Affairs|

FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs

The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As part of this commitment, we require evidence from premarket clinical trials that the medicine will be both effective and safe for use when prescribed according to its labeling. However, it’s not unusual for the FDA to identify issues that [...]

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The U.S. Food and Drug Administration today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval [...]

2018-11-18T12:00:21+00:00 19.11.2018|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018

EMA’s human medicines committee (CHMP) recommended four medicines for approval, including a medicine for use in countries outside the European Union, at its November 2018 meeting. The CHMP adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. This is [...]

EMA: CHMP recommends first oral-only treatment for sleeping sickness

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on [...]

2018-11-18T11:42:25+00:00 18.11.2018|Drug Development Strategy, Regulatory Affairs|

EMA: Human medicines highlights – November 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. Information is selected based on recommendations from consulted patients, consumers and healthcare professionals, and does not necessarily cover all [...]

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic [...]

2018-11-11T13:02:36+00:00 12.11.2018|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín trimestral de la AEMPS sobre productos sanitarios y cosméticos Julio – Septiembre 2018

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Recoge información sobre la evolución de la legislación de estos productos, los documentos técnicos y científicos publicados, las actuaciones de vigilancia y [...]

FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery

Today, the U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands). “For some patients with parathyroid disease, treatment may mean a surgical [...]

2018-11-08T22:44:22+00:00 07.11.2018|Drug Development Strategy, Regulatory Affairs|

FDA authorizes first direct-to-consumer test for detecting genetic variants that may be associated with medication metabolism

Today, the U.S. Food and Drug Administration permitted marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test as a direct-to-consumer test for providing information about genetic variants that may be associated with a patient’s ability to metabolize some medications to help inform discussions with a health care provider. The FDA is [...]

2018-11-06T20:21:06+00:00 06.11.2018|Drug Development Strategy, Regulatory Affairs|

FDA permits marketing of a diagnostic test to aid in the determination of menopausal status

Today, the U.S. Food and Drug Administration permitted marketing of the PicoAMH Elisa diagnostic test as an aid in the determination of a patient’s menopausal status. “Diagnostic results about a woman’s menopausal status may prompt discussions about preventative care for women experiencing menopausal symptoms,” said Courtney Lias, Ph.D. director of the Division of Chemistry and [...]

2018-10-30T21:11:24+00:00 30.10.2018|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2018

The CHMP recommended six medicines for approval, three extensions of indications and elected its new vice-chair at its October 2018 meeting. Six medicines recommended for approval, including two orphan medicines The CHMP recommended granting a marketing authorisation for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE). This medicine was reviewed under EMA's accelerated assessment procedure, reserved for medicines of [...]

2018-10-22T21:55:47+00:00 23.10.2018|Drug Development Strategy, Regulatory Affairs|

EMA: New medicine for hereditary angioedema, a rare disease causing swelling beneath the skin

The European Medicines Agency has recommended granting a marketing authorisation for Takhzyro (lanadelumab), the first monoclonal antibody therapy for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. HAE is a long-term debilitating disease characterised by attacks of swelling beneath the skin that can occur anywhere in the body, such [...]

2018-10-22T21:50:34+00:00 23.10.2018|Drug Development Strategy, Regulatory Affairs|

EMA: First treatment for rare inherited muscle contraction disorders

The European Medicines Agency has recommended granting a marketing authorisation for Namuscla (mexiletine hydrochloride) for the treatment of adult patients with non-dystrophic myotonia, a group of inherited muscle disorders where muscles are slow to relax after contraction. These disorders are chronic life-long debilitating conditions characterised by pain, fatigue, and muscle stiffness, resulting in frequent falls and disability. [...]

2018-10-21T11:57:36+00:00 22.10.2018|Drug Development Strategy, Regulatory Affairs|

EMA: First vaccine for prevention of dengue

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Dengvaxia (dengue tetravalent vaccine (live, attenuated)), for the prevention of dengue caused by dengue virus serotypes 1, 2, 3 and 4 in people who are between 9 and 45 years old, live in an endemic area and already had a [...]

2018-10-22T21:46:29+00:00 22.10.2018|Drug Development Strategy, Regulatory Affairs|

FDA approves new DNA-based test to determine blood compatibility

The U.S. Food and Drug Administration today approved ID CORE XT, a molecular-based assay used in blood transfusion medicine to help determine blood compatibility. The assay can be used to determine blood donor and patient non-ABO red blood cell (RBC) types. ID CORE XT is the second molecular assay approved for use in transfusion medicine, [...]

2018-10-16T21:59:18+00:00 17.10.2018|Drug Development Strategy, Regulatory Affairs|

EMA: Human medicines highlights – October 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. Information is selected based on recommendations from consulted patients, consumers and healthcare professionals, and does not necessarily cover all [...]