Treatment

Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020

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Shots: The additional insight from the P-IIb CaLIPSO study showed that SNF472 slowed the progression of CAC across key subgroups of patients on hemodialysis participating in the study. The presentation highlights the PK/PD and exposure-response analyses Sanifit also presents the design of its ongoing P-III… Read More »Sanifit Presents Results of SNF472 for the Treatment of Vascular Calcification at ASN Kidney Week 2020

AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

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Shots: AstraZeneca’s Tagrisso has received sNDA’s acceptance and has been granted PR in the US for the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFRm NSCLC after complete tumor resection with curative intent The sNDA is based on the P-III ADAURA trial… Read More »AstraZeneca’s Tagrisso (osimertinib) Receives the US FDA’s Priority Review for the Adjuvant Treatment of Patients with Early-Stage EGFR-Mutated Lung Cancer

AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD

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Shots: The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials P-III ETHOS study results reported that triple-combination therapy showed a reduction in the… Read More »AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat COPD

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

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Shots: The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of… Read More »Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer

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Shots: The approval is based on P-III PRIMA study assessing Zejula in patients with newly diagnosed advanced ovarian cancer with complete/partial response to Pt.-based CT regardless of biomarker status The therapy is now approved in Canada for monothx. treatment of female adult patients with advanced… Read More »GSK’s Zejula (niraparib) Receives Health Canada Approval for 1L Treatment of Women with Advanced Ovarian Cancer

Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

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Shots: The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies Results: 42% reduction in… Read More »Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

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Shots: The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline The expected PDUFA date for the therapy as… Read More »Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma

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Shots: The Health Canada has approved Darzalex SC (daratumumab) in four regimens across five indications in patients with MM, notably newly diagnosed, transplant-ineligible patients as well as relapsed/refractory patients The approval is based on P-III COLUMBA and P-II PLEIADES studies. The P-III study demonstrated a… Read More »Janssen’s Darzalex (daratumumab, SC) Receives Health Canada Approval for the Treatment of Patients with Multiple Myeloma

Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

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Shots: The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the… Read More »Centus Biotherapeutics’ Equidacent (bevacizumab, biosimilar) Receives CHMP’s Positive Opinion for the Treatment of Multiple Cancer Indications

Mental Health and Substance Use State Fact Sheets

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This analysis and series of state fact sheets examine mental health and substance use disorder needs in the states and capacity to meet residents’ needs prior to the COVID-19 pandemic, which is expected to place additional strains on the system.

BeiGene’s Tislelizumab Receives NMPA’s Approval for the Treatment of 2L Classical Hodgkin’s Lymphoma (cHL)

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Shots: The approval is based on P-II BGB-A317-203 (NCT03209973) trial which involves assessing of tislelizumab with median follow up of 14 months The study resulted in ORR as 76.9% and CR as 61.5% with no fatal adverse reactions. BieGene’s Tislelizumab is the first drug to… Read More »BeiGene’s Tislelizumab Receives NMPA’s Approval for the Treatment of 2L Classical Hodgkin’s Lymphoma (cHL)

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

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Shots: The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer… Read More »AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s Approval as a 1L Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer