Shots:
Harnessing in-depth research and data-driven insights, PharmaShots unveils its definitive report on the Top 20 Countries in Healthcare Innovation 2025, a comprehensive guide to the nations setting global benchmarks in healthcare advancement
Through a meticulous blend of quantitative and qualitative analysis, PharmaShots delved into the multifaceted dimensions of healthcare innovation, spotlighting emerging trends such…
Shots:
The EU approved Tezspire as an add-on treatment with intranasal corticosteroids for adults with severe CRSwNP unresponsive to standard therapies; regulatory review is ongoing in China, Japan, and several other countries
Approval was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by…
Shots:
Takeda & Innovent Biologics have entered into a global Partnership (Excluding Greater China) to develop & Commercialize IBI363 & IBI343; Takeda also Gains exclusive Option to license global rights for IBI3001 outside of Greater China
As per the deal, Takeda will pay Innovent $1.2B upfront, including a $100M equity investment, funded from cash on…
Shots:
The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in China
Opinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week…
Shots:
Royalty Pharma has acquired a royalty interest in Amgen’s Imdelltra from BeOne Medicines for ~$950M
As per the deal, Royalty Pharma will acquire BeOne’s ~7% royalty on global Imdelltra sales for ~$950M, including $885M upfront and an option for BeOne to sell more for $65M within 12mos. The royalty, including shared sales above $1.5B…
Shots:
ArkBio has reported positive top-line data from the P-II study conducted across 31 clinical sites in China to evaluate safety, tolerability, and clinical efficacy of AK3280 in IPF pts
Pts who received AK3280 (100/200/300/400mg BID) demonstrated 209.4 mL increase in forced vital capacity (FVC) and a 6.4% adjusted improvement in %pFVC from baseline and…
Shots:
Akeso’s ebdarokimab has received NMPA approval for the treatment of moderate-to-severe plaque psoriasis in adult
Clinical study showed strong efficacy and safety of ebdarokimab (135mg) two doses at weeks 0 and 4, with a PASI 75 response rate of 79.4% at 16wks. and ebdarokimab Q12W 77.9% at 52wks. along with significant improvements in patients'…
Shots:
China’s NMPA has accepted BLA of Tivdak for the treatment of recurrent or metastatic cervical cancer in pts who had disease progression on or after systemic therapy
The BLA was supported by P-III (innovaTV 301) trial data, incl. clinical evidence from Chinese cohort, evaluating Tivdak vs CT in adults. Chinese pts had prior standard…
Shots:
Akeso enrolled the first patient in the P-III (HARMONi-BC1/AK112-308) study of Ivonescimab + CT for the treatment of unresectable locally advanced or metastatic TNBC (already approved for EGFR-TKI-resistant, non-squamous NSCLC in China)
The preliminary efficacy data presented at ESMO’24 showed significant therapeutic efficacy of ivonescimab + CT and a favorable safety profile for…
Shots:
PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 11 small molecules, 7 biologics, 7 cell & gene therapies, 1 antiviral, 1 peptide and 3 devices
Lisata Therapeutics’ LSTA1 received ODD this month and was granted with…

