BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

Shots:The EC has approved Opdivo + CT as neoadj. therapy followed by surgery & adj. Opdivo alone to treat adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1% in all 30 EEA statesApproval was based on P-III (CheckMate-77T) study assessing neoadj. Opdivo + CT vs neoadj. PBO & CT…

ByRidhi RastogiMay 19, 2025

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Alnylam Pharmaceuticals and Sanofi Report the US FDA’s Approval of Qfitlia (Fitusiran) to Treat Hemophilia A or B

Shots:The US FDA has approved Qfitlia to treat routine prophylaxis and prevent or reduce the frequency of bleeding episodes in pts. (age≥ 12yrs.) with hemophilia A or B, with or without factor VIII or IX inhibitors. Regulatory submissions have been completed in China & BrazilQfitlia published clinical data in the NEJM in 2017, showing…

ByRidhi RastogiApril 1, 2025

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Eli Lilly Reports P-II (ALPACA) Trial Data of Lepodisiran for Heart Diseases

Shots:The P-II (ALPACA) trial assessed lepodisiran (16, 96, or 400mg) vs PBO for ~18mos. in 320 pts, who were dosed at baseline & day 180, with an additional arm receiving 400mg at baseline & PBO at day 180; P-III [ACCLAIM-Lp(a)] trial enrollment is ongoingTrial met its 1EP, with 400mg reducing Lp(a) by 93.9%…

ByRidhi RastogiMarch 31, 2025

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BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

Shots:The CHMP has recommended Opdivo + Pt-based CT as neoadj. followed by Opdivo alone as adj. treatment of adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1%. If approved, EC’s decision would be valid in all 30 EEA statesThe P-III (CheckMate-77T) study assessed neoadj. Opdivo + CT, followed by surgery…

ByRidhi RastogiMarch 31, 2025

News

Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots:The US FDA has approved Cabometyx for treatment-experienced, inoperable, LA/M, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts (≥12yrs.)Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts (2 arms: pNET: n=99; epNET: n=199) that showed improved PFS; data was presented at ESMO 2024 & published…

ByRidhi RastogiMarch 27, 2025

News

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

Shots:The EC has approved Imfinzi monotx. for the treatment of LS-SCLC adults whose disease has not progressed after receiving Pt-based CRT; regulatory review underway in Japan & other regions Approval was based on P-III (ADRIATIC) trial (n=730) assessing Imfinzi (1500mg, IV, Q4W) with or without Imjudo (75mg, IV, Q4W × 4 cycles) followed by…

ByRidhi RastogiMarch 17, 2025

VIEWPOINTS

EGPA Remission with Fasenra: Michael Wechsler and Andrew Menzies Gow in Conversation with PharmaShots

Shots: An already established biologic treatment for SEA in the US, EU5 & Japan. Fasenra is now showing exemplary remission for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA) Today, at PharmaShots, we have a distinguished panel of speakers shedding light on advancements under the P-III MANDARA study and the recent publication of the study…

BySaurabh ChaubeyMay 15, 2024

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PharmaShots Interview: Dermavant’s Philip M. Brown Shares Insights on the Clinical Data of Tapinarof Published in NEJM

In an interview with PharmaShots, Philip M. Brown, MD, JD, Chief Medical Officer at Dermavant shares his views on the P-III (PSOARING 1 & 2) trials of tapinarof for the treatment of Plaque PsoriasisShots:The P-III (PSOARING 1 & 2) trials evaluate the efficacy and safety of tapinarof (1%, qd) vs vehicle-controlled cream in a ratio (2:1) in 1025 patients aged…

BySenior EditorFebruary 8, 2022

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PharmaShots Interview: Genentech’s Dr. Neil Collinson Shares Insights on Xofluza

In a recent interview with PharmaShots, Dr. Neil Collinson, the Senior Principal Clinical Development Scientist at Genentech / Roche shares his insights and highlights on Xofluza.Shots:The P-III BLOCKSTONE study demonstrated that the proportion of household members who became symptomatically ill following infection with influenza was significantly lower in those treated preventively with Xofluza…

BySenior EditorSeptember 22, 2020

BMS’ Opdivo Receives the EC’s Approval as a Perioperative Treatment of Resectable NSCLC

Alnylam Pharmaceuticals and Sanofi Report the US FDA’s Approval of Qfitlia (Fitusiran) to Treat Hemophilia A or B

Eli Lilly Reports P-II (ALPACA) Trial Data of Lepodisiran for Heart Diseases

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

AstraZeneca Reports the EC’s Approval of Imfinzi to Treat Limited-Stage Small Cell Lung Cancer (LS-SCLC)

EGPA Remission with Fasenra: Michael Wechsler and Andrew Menzies Gow in Conversation with PharmaShots

PharmaShots Interview: Dermavant’s Philip M. Brown Shares Insights on the Clinical Data of Tapinarof Published in NEJM

PharmaShots Interview: Genentech’s Dr. Neil Collinson Shares Insights on Xofluza

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