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FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance

The U.S. Food and Drug Administration today approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options. “Today’s approval provides an additional treatment option for patients with [...]

2019-11-19T20:23:22+00:0019.11.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage

Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow. This [...]

2019-11-19T20:18:34+00:0019.11.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Regulators’ advice can make a difference for faster patient access to highly innovative therapies

Early dialogue and frequent interactions between medicine developers, regulators, health technology assessment bodies (HTAs) and patients can play a key role in delivering robust data needed to enable accelerated access of patients to highly innovative therapies that address unmet medical needs. The chair of EMA’s committee for advanced therapies (CAT), Martina Schussler-Lenz, the chair of EMA’s human medicines committee [...]

2019-11-17T20:38:42+00:0017.11.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first therapy to treat patients with rare blood disorder

Today the U.S. Food and Drug Administration granted approval to Reblozyl (luspatercept–aamt) for the treatment of anemia (lack of red blood cells) in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. “When patients receive multiple blood transfusions, there is a risk for iron overload, which can affect many organs,” said [...]

2019-11-17T20:10:54+00:0017.11.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new breakthrough therapy for cystic fibrosis

The U.S. Food and Drug Administration today approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which [...]

2019-10-30T21:45:16+00:0030.10.2019|Drug Development Strategy, Regulatory Affairs|

ANSM: Accès à l’innovation thérapeutique, l’ANSM pérennise ses circuits accélérés d’autorisation d’essais cliniques de médicaments dits “fast-track”

Access to innovative treatments: ANSM maintains its “Fast Track” programme for medicinal product (18/10/2019)  (27 ko) Compte tenu du succès de la phase test, l’ANSM a décidé de pérenniser les deux dispositifs accélérés d’autorisation d’essais cliniques (Fast Track) portant sur le médicament, mis en place le 15 octobre 2018, et élargis aux essais à design complexe et [...]

2019-10-27T17:55:20+00:0027.10.2019|Drug Development Strategy, Regulatory Affairs|

EMA: First vaccine to protect against Ebola

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ervebo (rVSVΔG-ZEBOV-GP), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the Ebola virus. “This is an important step towards relieving the burden of this deadly disease,” said Guido Rasi, EMA’s Executive Director. “The CHMP’s [...]

2019-10-25T19:42:02+00:0025.10.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019

Seven new medicines recommended for approval, including the first Ebola vaccine EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its October 2019 meeting. The Committee recommended granting a conditional marketing authorisation for Ervebo (Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP, live)), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with [...]

EMA: First non-injectable treatment for severe low blood sugar levels

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Baqsimi (glucagon), the first treatment for severe hypoglycaemia (low blood sugar levels) that can be administered without an injection to patients with diabetes aged four years and older. Severe hypoglycaemia is a serious acute complication of diabetes. It occurs when the [...]

2019-10-23T22:38:16+00:0024.10.2019|Drug Development Strategy, Regulatory Affairs|

FDA Statement on continued progress enhancing patient access to high-quality, low-cost generic drugs

Affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public health. Safe, effective and high-quality generic drugs play a vital role in our health care system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition [...]

2019-10-22T21:21:31+00:0022.10.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatment for patients with migraine

The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the preventive treatment of migraine. “Reyvow is a new option for the acute treatment of migraine, a painful [...]

2019-10-20T20:40:24+00:0020.10.2019|Drug Development Strategy, Regulatory Affairs|

FDA allows marketing of first rapid diagnostic test for detecting Ebola virus antigens

Today, the U.S. Food and Drug Administration allowed marketing of a rapid diagnostic test (RDT) to detect Ebola virus antigens (proteins) in human blood from certain living individuals and samples from certain recently deceased individuals suspected to have died from Ebola (cadaveric oral fluid). The OraQuick Ebola Rapid Antigen Test is the first rapid diagnostic test the [...]

2019-10-20T20:35:12+00:0020.10.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first treatment to increase pain-free light exposure in patients with a rare disorder

The U.S. Food and Drug Administration today granted approval to Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria. For patients who are suffering from erythropoietic protoporphyria, a rare disorder, exposure to light may be extremely painful. Prior to today’s approval, there [...]

2019-10-15T22:12:28+00:0015.10.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de julio de 2019

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 nuevos medicamentos, cambios de especial interés en medicamentos ya autorizados, información sobre seguridad y otra información de interés. En la sección [...]

EMA Management Board: highlights of October 2019 meeting

At its 3 October 2019 meeting in Amsterdam, the European Medicines Agency's Management Board elected Lorraine Nolan as vice-chair of the Board for a three-year period. Dr Nolan is Chief Executive of the Health Products Regulatory Agency (HPRA) in Ireland, a post she has held since January 2016. She has served as a member of EMA's Management Board since March 2016. [...]

2019-10-15T21:06:03+00:0015.10.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves second drug to prevent HIV infection as part of ongoing efforts to end the HIV epidemic

The U.S. Food and Drug Administration today approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sex, excluding those who have receptive vaginal sex. Descovy is not indicated in individuals at risk [...]

2019-10-13T20:48:38+00:0013.10.2019|Drug Development Strategy, Regulatory Affairs|

EMA: How to ensure that novel analytic methods are fit for decision-making

The past decade has seen the increased generation and availability of new data sources such as real-world evidence, as well as patient-level data from completed randomised clinical trials. While these data provide an opportunity to learn more about a medicine’s benefits and risks, and can complement the main body of evidence coming from randomised clinical trials, they [...]

2019-10-09T19:20:09+00:0009.10.2019|Drug Development Strategy|

FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels

The U.S. Food and Drug Administration today approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones). It is the first approved treatment for children with these rare vasculitis diseases, in which a patient’s small blood vessels [...]

2019-10-03T22:04:35+00:0003.10.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox

The U.S. Food and Drug Administration announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the only currently FDA-approved vaccine for the prevention [...]

2019-10-02T20:38:55+00:0002.10.2019|Drug Development Strategy, Regulatory Affairs|