AstraZeneca and Amgen’s Tezspire (Tezepelumab) Secures the EU Approval for Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

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 countriesApproval was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by…

ByDipanshu Dixit4 days ago

NEWS

Takeda Partners with Innovent Biologics to Boost Oncology Pipeline with Advanced Solid Tumor Therapies

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 ChinaAs per the deal, Takeda will pay Innovent $1.2B upfront, including a $100M equity investment, funded from cash on…

ByDipanshu Dixit4 days ago

NEWS

Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

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 ChinaOpinion 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…

ByDipanshu DixitOctober 22, 2025

NEWS

Royalty Pharma Signs Agreement to Acquire Interest in Amgen’s Imdelltra Royalties from BeOne Medicines for ~$950M

Shots:Royalty Pharma has acquired a royalty interest in Amgen’s Imdelltra from BeOne Medicines for ~$950MAs 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…

ByDipanshu DixitAugust 26, 2025

NEWS

ArkBio Reports P-II Study Data Evaluating AK3280 to Treat Idiopathic Pulmonary Fibrosis (IPF)

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 ptsPts 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…

ByPrince GiriMay 16, 2025

NEWS

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

Shots:Akeso’s ebdarokimab has received NMPA approval for the treatment of moderate-to-severe plaque psoriasis in adultClinical 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'…

ByRidhi RastogiApril 18, 2025

NEWS

China’s NMPA Accepts BLA of Zai Lab’s Tivdak for Recurrent or Metastatic Cervical Cancer

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 therapyThe 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…

ByRidhi RastogiMarch 13, 2025

NEWS

Akeso Reports First Patient Enrollment in P-III Study of Ivonescimab + CT to Treat Triple-Negative Breast Cancer (TNBC) in China

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…

ByRidhi RastogiFebruary 21, 2025

INSIGHTS+

New Drug Designations – April 2024

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…

BySenior EditorMay 30, 2024

INSIGHTS+

New Drug Designations – January 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EC, and China’s NMPA. This month’s report includes 13 small molecules, 7 devices, 3 biologics ADC, 3 gene therapy, 1 antineoplastics, 1 protein, 1 peptide, 1 recombinant enzyme & 1 vaccine NRx Pharmaceuticals’ NRX-101 small molecule, focused…

BySenior EditorFebruary 20, 2024

AstraZeneca and Amgen’s Tezspire (Tezepelumab) Secures the EU Approval for Severe Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Takeda Partners with Innovent Biologics to Boost Oncology Pipeline with Advanced Solid Tumor Therapies

Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

Royalty Pharma Signs Agreement to Acquire Interest in Amgen’s Imdelltra Royalties from BeOne Medicines for ~$950M

ArkBio Reports P-II Study Data Evaluating AK3280 to Treat Idiopathic Pulmonary Fibrosis (IPF)

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

China’s NMPA Accepts BLA of Zai Lab’s Tivdak for Recurrent or Metastatic Cervical Cancer

Akeso Reports First Patient Enrollment in P-III Study of Ivonescimab + CT to Treat Triple-Negative Breast Cancer (TNBC) in China

New Drug Designations – April 2024

New Drug Designations – January 2024

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