-
The European Union has approved Talzenna to treat breast cancer with the gBRCA mutation
Time of Update: 2021-02-16
The approval is based on the results of the EMBRACA trial - the largest Phase III study of PARP inhibitors in gBRCA mutations, HER2-LA, or MPC, which evaluated Talzenna daily compared to standard chemotherapy selected by physicians.
-
Lilly oral JAK inhibitor Olumiant treatment of adesthetic dermatitis (AD) 2 Phase III studies were successful
Time of Update: 2021-02-16
Eli Lilly and partner Incyte recently announced the evaluation of oral anti-inflammatory drug Olumiant (baricitinib) single-drug treatment of moderate to severe endemic dermatitis (AD) adult patients 2 III Phased clinical studies (BREEZE-AD1, BREEZE-AD2) reached the main endpoint: a significantly higher proportion of patients in the Olumiant treatment group achieved AD IGA scores of clear or almost clear (IGA 0,1) in the 16th week of treatment compared to the placebo group.
-
AstraZeneia's Symbicort reduces asthma attacks
Time of Update: 2021-02-16
he continued, "Compared to the most commonly used asthma relievers, the new START trial demonstrates the effectiveness of Symbicort as an anti-inflammatory reliever that reduces the risk of asthma attacks in people with mild illness." In a trial that reflected real-world practice, the data reinforced the evidence in the SYGMA trial and established clinical characteristics of Symbicort in moderate to severe diseases.
-
Xi'an Jansen biologics Starano is on the market
Time of Update: 2021-02-16
Another Phase III clinical trial, LOTUS, for Chinese groups, showed that 82.5 percent (132/60) of patients using Starano ® reached the main endpoint of the trial, PASI75, at 12 weeks, and 11.1 percent in the placebo group.
-
Prevention of respiratory package virus (RSV)! FDA grants AstraZeneta a breakthrough drug for next-generation antibody MEDI8897:
Time of Update: 2021-02-16
British pharmaceutical giant AstraZeneca recently announced that the U.S. Food and Drug Administration (FDA) has awarded MEDI8897 Breakthrough Treatment Designation (BTD), a half-life-extending respiratory syncytial virus (RSV) fusion (F) protein monoclonal antibody (Mab) that is being developed to prevent lower respiratory infection (LRTI) caused by RSV.
-
MHLW approves Alexion's new drug for the treatment of adult patients with PNH
Time of Update: 2021-02-16
recently, Alexion announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Ultomiris (ravulizumab) for the treatment of adult patients with hairy sleep haemoglobinuria (PNH).
U.S., Ultomiris was approved by the FDA in December 2018 for the treatment of adult patients with PNH.
-
FDA approves Lilly Cyramza monotherapy for patients with hepatocellular carcinoma
Time of Update: 2021-02-16
, the FDA announced approval of Eli Lilly's Cyramza as a single-drug treatment for patients with hepatocellular carcinoma (HCC).
These patients have been treated with sorafenib and have levels of AFP above 400 ng/ml.
-
Sanofi/DNDi's world's first full-oral drug fexinidazole has been approved
Time of Update: 2021-02-16
French pharmaceutical giant Sanofi recently announced that fexinidazole has been approved by the Democratic Republic of the Congo (DRC) for the treatment of The African Trypanosomiasis (HAT), commonly known as "sleeping sickness".
-
Soryuan Bio has been granted a new drug to treat Alzheimer's disease
Time of Update: 2021-02-16
recently, precision medicine company Soyuan Bio announced that it has obtained authorization from Finland's Orion Corporation to treat ORM-12741, a new drug for Alzheimer's disease.
, more than 540 patients in 11 clinical studies have taken ORM-12741, confirming the drug's safety and tolerance.
-
Darolutamide significantly delays the metastasis of de-resistant prostate cancer
Time of Update: 2021-02-16
new study, published in new England Journal of Medicine, showed that treating non-metastatic despotical prostate cancer with drarolutamide significantly extended patients' non-metastatic survival compared to placebos, and was presented on the same day at the Annual Meeting of the American Society of Clinical Oncology in San Francisco.
-
New medicine for rare diseases! Fda grants powerful ATX inhibitor BBT-887 treatment for idiotrexic pulmonary fibrosis (IPF) orphans:
Time of Update: 2021-02-16
BBT-877 is the second molecule that Bridge Biotherapeutics has been approved for clinical study by the U.S. FDA, and another molecule, BBT-401, is currently in Phase II clinical practice, the first anti-ubilin-connecting enzyme Pellino-1 compound for the treatment of ulcerative colitis, and is expected to be given to selective patient groups for the first time in February.
-
Bollinger Ingham and Leigh's Trajenta showed positive results
Time of Update: 2021-02-16
These new data from CAROLINA, as well as data from the placebo-controlled cardiovascular outcome trial CARMELINA, expand liglitatin's evidence and experience and give medical personnel more confidence in the long-term safety of patients treating a wide range of adult type II patients with Trajenta.
-
Novaral reached its target in a late-stage QMF149 asthma trial
Time of Update: 2021-02-16
novart announced that its Phase III QUERTZ study on its research-based inhalation joint treatment QMF149 has met the primary and critical secondary endpoints for patients with poor asthma control.
Daily fixed-dose treatment showed significant improvements in lung function and asthma control compared to inhalation of corticosteroids (ICS) alone.
-
The FDA has expanded its approval of cystic fibrosis treatments
Time of Update: 2021-02-16
The U.S. Food and Drug Administration today expanded the adaptation of Symdeko, a tezacaftor/ivacaftor tablet, to treat pediatric patients 6 years of age and older with cystic fibrosis and certain genetic mutations.
-
GSK's new ICS/LABA Wanrui Shu is listed in China
Time of Update: 2021-02-16
As the only ICS/LABA drug on the market once a day, Wan Ruishu helps improve the management of chronic respiratory diseases.
-
Apellis says the timeline is still stalling on eyelids
Time of Update: 2021-02-16
apellis said it would be able to restart two trials of its APL-2 drug for ophthalmological atrophy (GA) next year after finding the cause of the side effects that led to the program's discontinuation.
-
The Johnson and Johnson NMDA regulator spravato (esketamine) was recommended by the FDA board for approval
Time of Update: 2021-02-16
The Advisory Committee's support for the approval of Spravato nasal sprays is based on safety and efficacy data from five Phase III clinical studies conducted in adult patients with refroutable depression, including 3 short-term studies, one maintenance effect study, and one long-term safety study.
-
Lilly Emgality injections are FDA approved
Time of Update: 2021-02-16
recently, Eli Lilly, the world's leading biopharmaceutical company, announced that its new drug, Emgality Injection, has FDA approval to treat cluster headaches in adults.
It is also the third approved CGRP drug on the market to treat migraines in adults, with aimovig and Ajovy the other two drugs.
-
Fda approves Piqray pills in combination with fullvestrant therapy
Time of Update: 2021-02-16
recently, the U.S. Food and Drug Administration (FDA) announced that Piqray (alpelisib) pills in combination with fullvestrant therapy have been approved for the treatment of hormone-positive (HR), human skin growth factor 2 (HER2) negative, PIK3CA mutation of advanced or metastasis breast cancer.
-
The FDA awarded Bayer's Aliqopa a breakthrough treatment designation
Time of Update: 2021-02-16
the company is conducting two other Phase III studies - CHRONOS-3 and CHRONOS-4 - to confirm the effectiveness and safety of aliqopa and other therapies that relapse after one or more previous treatments in patients with iNHL, including MZL.
