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The first new drug to treat obesity caused by specific genetic defects has been approved
Time of Update: 2021-03-05
Recently, Rhythm Pharmaceuticals ("Rhythm Pharmaceuticals") announced that the U.S. FDA has approved its Imcivree™ (setmelanotide) for chronic weight management in adults and children (6 years and older) caused by obesity caused by obesity caused by POMC, pre-protein-converting enzyme oxalolytic 1 (PCSK1) or leptin-infested (LEPR) gene defects.
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Lilly's application for a new drug to develop RNAi gene therapy is authorized
Time of Update: 2021-03-05
November 16, RNA Interference (RNAi) gene therapy drug developer Dicerna Pharmaceuticals, Inc., announced that the FDA has now authorized a new drug application (IND) code-named LY3561774, the first clinical phase drug candidate for Dierna in partnership with Lilly.
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Pfizer's Abrotini won the third stage of the special dermatitis
Time of Update: 2021-03-05
the 52-week Phase III JADE REGIMEN study, which looked at patients 12 years of age and older with moderate to severe idyna specialty dermatitis (AD), responded to the initial 200 mg abusotinib with open label induction.
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Sanofi Pompe bay disease therapy is eligible for FDA priority review
Time of Update: 2021-03-05
, Sanofi announced that the U.S. FDA has accepted the company's Biological Products Licensing Application (BLA) for avalglucosidase alfa for the treatment of glycogen accumulation disease (I.
A key double-blind drug-controlled Phase 3 clinical trial assessed the safety and efficacy of avalglucosidase alfa compared to α-glucosidease (standard treatment) in patients with late-haired Pompeidase.
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Dupixent's treatment of child-like dermatitis is approved by the European Union
Time of Update: 2021-03-05
At 16 weeks, patients in the treatment group who used 300 mg Dupixent (N=122) or 200 mg Dupixent (N=59) every two weeks experienced the following changes: to improve the extent and severity of the disease: .
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The FDA stopped Voyager gene therapy to treat Huntington's disease
Time of Update: 2021-03-05
Later on Tuesday, Cambridge, Massachusetts-based Voyager announced that the FDA had issued a clinical stay on its application for a new drug (IND) for the company's gene therapy VY-HTT01 for huntington's disease.
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Sanofi Rilzabrutinib is eligible for the FDA Fast Track
Time of Update: 2021-03-05
In terms of ITP therapeutic drugs, Nplate (romiplostim) is the first FDA-approved drug to treat ITP, a platealine-producing analog peptide that opens up new avenues for long-term treatment of this chronic disease by increasing and maintaining plate concentrations.
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Mercadon's "Keytruda and Yervoy" treatment of NSCLC failed
Time of Update: 2021-03-05
announced on November 9th that it would stop clinical trials codenum KEYNOTE-598, a study on the use of Keytruda in association with Yervoy® Therapy) is a first-line treatment for metastasis non-small cell lung cancer (NSCLC) that treats tumor expression PD-L1 (tumor ratio score (TPS) ≥50%) and is free of EGFR or ALC gene mutations compared to Keytruda monodrings.
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Novarma Adakveo is rejected to prevent relapse sickle cell crises
Time of Update: 2021-03-05
Within The scope of Adakveo's listing license, cost watchdog NICE does not recommend that the drug be used to prevent relapsed sickle cell crises (or vascular obstructive crisis, VOCs) in patients aged 16 or older with sickle cell disease.
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Gilead's oral JAK1 inhibitor Jyseleca is available in Japan
Time of Update: 2021-03-05
Sciences K.K., a Japanese subsidiary of Gilead Sciences, and partner Akihon recently announced the launch of Jyseleca (filgotinib, 200mg and 100mg tablets) in Japan, a new, daily The oral, selective JAK1 inhibitor was approved by Japan's Ministry of Health, Labour and Labour (MHLW) in September to treat adult patients with rheumatoid arthritis (RA) who do not respond well to conventional therapies, including the prevention of structural joint injuries.
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The world's first treatment for premature aging has been approved by the FDA
Time of Update: 2021-03-05
recently, Eiger announced that its ZokinvyTM (lonafarnib) has been approved by the U.S. FDA to treat patients 12 months and older with early aging syndrome (HGPS or premature aging) and premature aging-like nuclear fiber protein disease (PL).
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AZ announced that its new crown vaccine has reached its primary efficacy endpoint
Time of Update: 2021-03-05
· Two different dosing options showed efficacy, one of which performed better . Of the subjects who were given AZD1222, there were no coVID-19 hospitalizations or severe cases AstraZeneca announced t
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Krintafel of GSK is effective in treating interstite malaria in children
Time of Update: 2021-03-05
In July 2018, Krintafel was approved by the U.S. FDA for malaria in patients 16 years of age and older who are receiving appropriate antimalarial drugs to treat acute P.vivax infection, and to treat (prevent recurrence) malaria caused by P.vivax.
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AstraZeneta's new crown vaccine is 90% effective because it is wrong
Time of Update: 2021-03-05
The New York Times published a weighty article on November 25th revealing the secrets behind the two issues; The article begins by pointing out that astraZenecon's COVID-19 vaccine, AZD1222, works better in half the dose of the inoculation group, which is the unintended result of mistakes made by the company in clinical trials, rather than intentionally.
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FDA approves first drug to treat rare metabolic disorders
Time of Update: 2021-03-05
The U.S. Food and Drug Administration today approved Oxlumo as the first treatment for type 1 primary oxalic aciduria (PH1), a rare genetic disorder.
In the Oxlumo group, the average reduction in oxalic acid in the patient's urine was 65 percent, while in the placebo group, the average reduction was 12 percent.
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The late trial of migraine drugs was successful
Time of Update: 2021-03-03
Axsome's share increased by more than 80 percent last month after the Phase III study of the experimental drug AXS-05 in adults with moderate to severe depression reached its primary endpoint.
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Janssen submits Spravato's expansion in the EU
Time of Update: 2021-03-03
The application was based on two phase iii clinical studies (aspire i and ii) that assessed the efficacy and safety of the drug and aimed at extending its use to adult patients with severe depression who currently have suicidal intentions.
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Novartis will test hydroxychloroquine for the treatment of coronavirus
Time of Update: 2021-03-03
'We recognize the importance of answering the scientific question of whether hydroxychloroquine is beneficial to patients with COVID-19 disease, and in a randomized, double-blind, placebo-controlled study, we will quickly mobilize to address this issue,' said john Tsai .
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Redsiwe is authorized for emergency use by fda in the United States
Time of Update: 2021-03-03
The EUA is based on available data from two global clinical trials - the placebo-controlled Phase III trial conducted by the National Institute of Allergy and Infectious Diseases (NIAID) for patients with moderate to severe new coronavirus pneumonia, including critically ill patients, and the global Phase III trial of Rydersiwe's 5-day and 10-day dosage time in Gilead's assessment of critically ill patients.
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The first gist precision therapy ayvakit Phase 3 clinical failure
Time of Update: 2021-03-03
In 2017, a Phase 1 clinical study showed that the drug had a 100% disease control rate, a 100% tumor reduction rate, and a 12-month PFS rate of 78% in patients with PDGFR alpha exon 18 D842V mutant GIST.
