Carvykti gains new ground and competes with its "predecessor"!
Apparatus
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Apparatus
FDA Grants Orphan Drug Status To Two New Therapies In a Row, And These Two Groups Of Patients Are Expected To Benefit!
Recently, the US FDA has granted orphan drug status to two new therapeutics in a row. One is a small molecule inhibitor, PCLX-001, for the treatment of acute myeloid leukaemia; the other is a T-cell therapy, ET140203, for the treatment of hepatoblastoma. Both therapies are currently in relevant trials.
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Apparatus
Angry FDA & CDC: $5 Billion Bivalent Moderna New Crown Vaccine Not As Effective As Monovalent
Was the omission of key data intentional or unintentional?
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The FDA has granted accelerated approval to Adagrasib for the treatment of patients with KRAS G12C mutations in non-small cell lung cancer. In the trial, the drug resulted in disease control in 80% of patients, of which, 43% had substantial tumour shrinkage.
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Under the terms of the collaboration agreement, GenKOre will receive up to US$300 million, including upfront fees, fees for exercising its option, and milestone payments for successfully reaching development and commercialisation milestones against two in vivo disease targets.
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Apparatus
Stavudol Paediatric Indication Approved For The Treatment Of Children Aged 3 Months And Older With Complicated Intra-Abdominal Infections
There is an urgent clinical need for new antimicrobial drugs to break through the dilemma of cIAI treatment in children and address the growing challenge of drug resistance.
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The "me better" strategy has always been a great story for pharmaceutical companies.
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Apparatus
New Drug For IDH1 Mutation/Relapsed/Refractory Acute Myeloid Leukaemia With Good Complete Remission Rates And Manageable Toxicity
The results of a new study recently showed that Olutasidenib monotherapy in patients with relapsed/refractory acute myeloid leukaemia carrying the IDH1 mutation elicited high rates of complete remission with manageable toxicity.
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Biopharmaceutical company Airway has announced that the first patient will be administered AT-100 (rhSP-D) in a phase 1b randomised trial to prevent the risk of bronchopulmonary dysplasia (BPD) in very preterm infants. The novel prophylactic AT-100 reduces the incidence and severity of the severe respiratory disease BPD and may improve the prognosis of very preterm infants.
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New therapy for lung cancer!