FDA
Jan 31, 2023
Eli Lilly’s Jaypirca Approval; Novartis’ Adakveo EMA Review; Janssen’s CARTITUDE-4 Study of CARVYKTI; Negative Review on Ipsen’s Palovarotene; Gilead Sciences and Kite’s Yescarta NICE Recommendations; Daiichi Sankyo and AstraZeneca’s Enhertu EU Approval
FDA Approves Eli Lilly’s Jaypirca for Relapsed Mantle Cell Lymphoma Eli Lilly has received FDA approval for Jaypirca, a non-covalent BTK inhibitor, in relapsed mantle cell lymphoma (MCL) patients who have relapsed after treatment with other drugs in the class. Adult MCL patients who have previously received at l...
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Jan 24, 2023
BeiGene’s Brukinsa Approval; FDA Approval to Seagen’s TUKYSA; NICE Recommends Alnylam’s Amvuttra; FDA Approves Brenzavvy for Type 2 Diabetes; Roche’s Tecentriq to be Filed for Early-stage Liver Cancer; FDA Lifts Hold on Astellas’ Pompe Gene Therapy
FDA Approves BeiGene’s Brukinsa for CLL/SLL BeiGene's Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) has been approved by the US Food and Drug Administration. CLL is a common type of leukemia, accounting for approximately 25% of all new cases each year. SLL is...
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Jan 19, 2023
First Patient Enrolled in Kaizen Clinical Study in Japan; Koneksa’s At-Home Mobile Spirometry Clinical Trial; Medcura’s LifeGel™ Absorbable Surgical Hemostat; FDA Clearance to Abbott’s NAVITOR; Enovis’s DynaClip Delta™ and DynaClip Quattro™ bone staples; Bausch + Lomb Acquired AcuFocus
First Patient Enrolled in Kaizen Clinical Study in Japan On January 11, 2023, Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional treatment systems for patients suffering from peripheral and coronary artery disease, announced the initiation of the...
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Dec 20, 2022
Fourth FDA Approval for AbbVie’s Vraylar; FDA Approves Ferring’s Adstiladrin for NMIBC; Merck and Moderna’s mRNA Cancer Vaccine Trial; EMA Recommends the CSL’s Gene Therapy for Hemophilia B; CHMP Backs Amicus’ Pompe Disease Therapy; Takeda Announces the Phase 3 AURORA Study Result
AbbVie Secures Fourth FDA Approval for Vraylar AbbVie has received its fourth FDA approval for Vraylar, adding major depressive disorder (MDD) adjunctive therapy to a list that includes schizophrenia and manic and depressive episodes in bipolar disorder. According to AbbVie, the approval makes Vraylar (cariprazi...
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Nov 29, 2022
C4X Discovery and AstraZeneca Signs Deal; FDA Rejects Spectrum’s Poziotinib; Orphan Drug Designation to Tenaya’s Gene Therapy; EC Approves Regeneron’s Libtayo; Response Letter to Poziotinib for Metastatic NSCLC Harboring HER2 Exon 20 Mutations; Japan Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer
C4X Discovery Holdings and AstraZeneca Signs Exclusive USD 402 Million Global License C4X Discovery Holdings has signed an exclusive global license with AstraZeneca worth up to USD 402 million for the development and commercialization of the NRF2 Activator program. The agreement will allow AstraZeneca to develop...
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Jun 22, 2021
Horizon/ Arrowhead Deal; Dr Reddy’s Lab’s Drug US Launch; Targovax’s ONCOS-102; RedHill’s Oral Opaganib in COVID-19
Horizon Dishes Out Million Dollars to get Arrowhead's RNAi Drug Arrowhead Pharmaceuticals and Horizon Therapeutics have announced a research and development collaboration to advance the treatment landscape for uncontrolled gout. Under the terms and conditions, Arrowhead is bound to receive an upfront sum of U...
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Jun 16, 2020
HCQ/ CQ failure; AZ/ Catalent’s deal; Sinovac’s CoronaVac and Lilly’s Olumiant trial results
The US FDA nullified the Emergency Use Authorization (EUA) granted to chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19. The regulatory authority had granted the EUA to malarial drugs to be used in hospitalized COVID-19 patients only when a clinical trial was unavailable, or participation in...
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Oct 29, 2019
AZ announces positive results for durvalumab and tremelimumab; FDA nods to extend LILETTA’s use to prevent pregnancy; Gilead, Glympse Bio teams up to advance NASH clinical development
AstraZeneca recently has announced the results of the clinical trials POSEIDON which included the study of a combination of drugs Imfinzi (durvalumab) and tremelimumab with chemotherapy in lung cancer. Imfinzi is a human monoclonal antibody which blocks the interaction of PD-L1 with PD-1 by binding itself with ...
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Oct 22, 2019
FDA approval to AZ’s Farxiga for heart failure; GSK divests two travel vaccines to Bavarian Nordic; New breakthrough therapy for Cystic Fibrosis
The US FDA today has given its nod to Trikafta (elexacaftor/ivacaftor/tezacaftor) of Vertex Pharmaceuticals, the first of its kind triple combination therapy for the patients with cystic fibrosis. The drug, Trikafta, has been approved for patients of age 12 years and older who have at least one F508del mutation...
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Oct 10, 2019
First oral GLP-1 treatment approved for type2 Diabetes
The US FDA has approved Rybelsus (semaglutide) oral tablets to improve blood sugar in adult patients with Type II Diabetes. Rybelsus is an oral glucagon-like peptide (GLP-1) receptor protein treatment which has been approved after 15 years of the approval first GLP-1 agonist. GLP-1 is a hormone found in insuffi...
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