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Genfit's double agonist was awarded orphan drug status by the FDA and EMA
Time of Update: 2021-02-24
April 2019, the FDA also awarded Elafibranor Breakthrough Drug Qualification (BTD) for the treatment of adult PBC patients who did not respond well to UDCA.
Genfit plans to launch Phase III clinical studies in 2019 to further evaluate the efficacy and safety of elafibranor's treatment of PBC.
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Puma Biotech Licensing Partners are market-licensed by Nerlynx
Time of Update: 2021-02-24
Puma Biotechnology corporation announced that the Argentine Medicines, Food and Medical Devices Authority (ANMAT) has approved Nerlynx (neranib) to extend complementary treatment for adult patients w
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FDA approves new antimicrobial drugs to treat complex urinary tract infections
Time of Update: 2021-02-24
The U.S. Food and Drug Administration recently approved cefiderocol, an antimicrobial drug used to treat patients 18 years of age or older with complex urinary tract infections (cUTI), including kidney infections caused by susceptible Gloran-negative microorganisms, who have limited or no other treatment options.
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FDA approves Lilly Taltz (ixekizumab) treatment for active orthodlamitis
Time of Update: 2021-02-24
In the ixekizumab group of COAST-V and COAST-W trials, 48% and 25% of patients reached the main endpoint ASASAS40, respectively, while the placebo group achieved 18% and 13%, respectively.
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CHMP recommends approval of Trogarzo for multidrring-resistant TREATMENT of HIV-1
Time of Update: 2021-02-24
Trogarzo is the first approved single anti-drug in the field of HIV treatment, and the first long-acting new drug for HIV, unlike other antiretroviral drugs, which are mainly combined with the second extracellular domain of CD4-T cellular mediators, far from the MHC II molecular binding site, which can potentially prevent HIV from infecting CD4-plus immune cells while retaining normal immune function.
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FDA approves first treatment for patients with rare lung disease
Time of Update: 2021-02-24
Recently, the U.S. Food and Drug Administration approved Gifraj to treat acute hepatodiasis in adults, a genetic disorder that can lead to the accumulation of toxic molybrene molecules formed during the production of hemoerin (which helps bind oxygen to the blood).
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FDA approves new treatment for migraines in adults
Time of Update: 2021-02-24
U.S. Food and Drug Administration recently approved Ubrivevy tablets for acute (immediate) treatment of migraines in adults, with or without precursors (sensory phenomena or visual impairments), and Ubrelvy was not used to prevent migraines.
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Lilly announces the survival benefits of the new drug Verzenio
Time of Update: 2021-02-24
The drug is the first and only CDK4 and 6 inhibitors used in combination with fluovirus groups, and based on phase III MONARCH 2 studies, there is a significant statistical improvement in total survival rates in patients/post-menoanth and post-menoanthetic women who progress after endocrine therapy for cancer.
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Non-diabetic patients had a 27% reduced risk of heart failure, and AZ published a net detailed Phase 3 result for Dagly
Time of Update: 2021-02-24
AstraZeneca has published detailed results from its SGLT2 inhibitor Farxiga (dapagliflozin) in a Phase 3 clinical trial for patients with heart failure at the Annual Meeting of the European Society of Cardiology (ESC2019).
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Gilead published clinical data on GS-9688, a new functional drug for hepatitis B
Time of Update: 2021-02-24
In a multi-center, randomized, double-blind Phase II study of 48 patients with chronic HBV infections who had achieved virological suppression, GS-9688 (once a week oral) combined oral antiviral drugs (OAVs) were well toned during extended administration and showed pharmacological activity of dose dependence.
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Takeda protease inhibitor Ninlaro Phase 3 test reached the main end of the test
Time of Update: 2021-02-24
Today, Takeda announced that its protease inhibitor Ninlaro (ixazomib) as a first-line maintenance therapy, in the treatment of adult patients with multiple myeloma (MM) who have not received stem cell transplant therapy in phase 3 trials, the patient's progression-free survival (PFS) has been significantly improved to reach the main end of the trial.
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Novart confirms The long-term efficacy and safety of Emwave
Time of Update: 2021-02-24
new data from Novarma confirm the long-term efficacy and safety of erenumab for most people with seizure migraines. The pharmaceutical giant announced the results of a five-year open-label treatme
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Roche's new drug Gazyva treats lupus nephritis CRR up to 40%
Time of Update: 2021-02-24
November 11, Roche announced that its small-molecule drug for SMA, Risdiplam and CD20 monoantigen Gazyva, had achieved positive results in phase III SUNFISH studies and Phase II NOBILITY studies, respectively.
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Turalio, a new drug used to treat tendon cytoblastoma, has been approved by the FDA for the first time
Time of Update: 2021-02-24
the U.S. Food and Drug Administration (FDA) approved Dayichi Sankyo's Pexidartinib capsule for the treatment of adult patients with tendon cytomoma (TGCT) symptoms, who are associated with severe morbidity or functional limitations and have not improved through surgery.
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Johnson and Johnson submitted an application for an Ebola vaccine to the EMA
Time of Update: 2021-02-24
Johnson and Johnson announced that it would submit its Ebola vaccine research program to the European Medicines Agency (EMA) for a listing permit.
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The ground-breaking PCSK9-targeted RNAi drug inclisiran III was successfully studied
Time of Update: 2021-02-24
This is the second of three key Phase III clinical studies (ORION-9, ORION-10, ORION-11) of the drug, which showed that 300mg inclisiran was given 2 subsurfic injections a year, reaching all major and secondary endpoints, with good tolerance and safety.
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The FDA has awarded AstraZeneta Imfinzi an orphan drug to treat small cell lung cancer
Time of Update: 2021-02-24
Based on this result, Imfinzi became the first immunotherapy to be shown to have a three-year survival benefit in the non-excisive Phase III NSCLC population.
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Xofluza: An effective anti-flu drug
Time of Update: 2021-02-24
. Roche announced that in the IIIBLOCKSTONE study, the risk of influenza was significantly reduced by 86% compared to placebo, using Xofluza for preventive treatment after contact with infected family members.
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FDA approves first treatment of patients with rare blood diseases
Time of Update: 2021-02-24
recently, the U.S. Food and Drug Administration approved luspatercept-aamt treatment for adults who require routine red blood cell infusions β “ When a patient receives multiple blood transfusions, there is a risk of iron overload, which affects many organs," said Dr. Richard Pazdur, director of the FDA Center of Excellence in Oncology and acting director of the U.S. Food and Drug Administration's Office of Oncology at the Center for Drug Evaluation and Research.
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FDA approves Xeris ready-to-use liquid glucreatic glucemic Gvoke
Time of Update: 2021-02-24
Xeris Pharmaceuticals Inc. announced Tuesday that the U.S. Food and Drug Administration has approved Gwalk (gluatic glucin) for the treatment of severe hypoglycemia in children and adults 2 years of age and older with diabetes.