Polpharma and Teva Sign Exclusive Licensing Deal for a Biosimilar Candidate to Ocrevus

Shots: Polpharma has granted Teva exclusive rights to commercialize both IV & SC formulations of Polpharma’s proposed biosimilar to Ocrevus (ocrelizumab) for multiple sclerosis, upon regulatory approval As per the deal, Polpharma will lead biosimilar development & manufacturing, while Teva will oversee regulatory filings & commercialization across the US, EU, Brazil, Canada, Australia, New Zealand,…

ByRidhi RastogiJuly 10, 2026

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The US FDA Approves Accord BioPharma’s Ennumo (Biosimilar, Neulasta)

Shots: The US FDA has approved Ennumo, a biosimilar to Neulasta (pegfilgrastim), expanding Accord’s biosimilar portfolio & supporting its goal to launch 20 biosimilars in the US by 2030 Ennumo is approved for adults & pediatric pts (newborn & older) to reduce incidence of infection in febrile neutropenia in non-myeloid malignancies receiving myelosuppressive anti-cancer drugs…

ByRidhi RastogiJuly 10, 2026

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CervoMed Completes Patient Enrollment in P-IIa Study of Neflamapimod for Nonfluent Variant Primary Progressive Aphasia

Shots: CervoMed has completed enrollment in the P-IIa study of neflamapimod for the treatment of nonfluent variant primary progressive aphasia (nfvPPA), a type of frontotemporal dementia, with interim results to be presented at CTAD 2026 The study will evaluate the safety, PK, & clinical effects of neflamapimod (40mg, PO, TID; n=19 and 80mg, BID; n=6)…

ByRidhi RastogiJuly 9, 2026

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Ipsen Reports Topline P-III (BEOND) Trial Program Data on Dysport in Both Episodic and Chronic Migraine

Shots: Ipsen has reported topline P-III (E-BEOND & C-BEOND) trial results assessing Dysport (abobotulinumtoxinA) vs PBO in a total of 1,510 adults with episodic & chronic migraine, respectively Both trials met their 1EP, with a reduction in monthly migraine days vs PBO & demonstrated a favorable safety profile; detailed results will be presented at a future…

ByRidhi RastogiJuly 9, 2026

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Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis

Shots: Roche has received a CE Mark for its Elecsys IGRA TB test, a blood-based assay for detecting tuberculosis infection (latent TB) in routine laboratory settings Test delivers results in <24hrs., with IGRA assay completed in 19min., & automates result calculation, interpretation, & reporting on Roche immunoassay platforms while integrating with third-party liquid handlers to…

ByRidhi RastogiJuly 9, 2026

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Johnson & Johnson Secures FDA Approval for Dual-Energy Catheter Ablation Platform

Shots: The US FDA has approved Dual Energy THERMOCOOL SMARTTOUCH SF (DE STSF) Platform, an integrated catheter ablation system that enables delivery of both radiofrequency (RF) & pulsed field (PF) energy through a single catheter Built on the THERMOCOOL SMARTTOUCH SF Platform, used in >1M US pts, the dual-energy system integrates with the CARTO ecosystem…

ByRidhi RastogiJuly 9, 2026

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iHealthScreen Reports FDA Clearance of iPredict-DR for Diabetic Retinopathy Screening

Shots: The US FDA has granted 510(k) clearance to iPredict-DR, an AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes who have not been previously diagnosed iPredict-DR uses AI to analyze retinal fundus images from the iCare DRSplus camera for non-invasive & affordable diabetic retinopathy screening, with clearance backed…

ByRidhi RastogiJuly 9, 2026

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AstraZeneca Inks $1.9B Exclusive Licensing Deal with Sino Biopharmaceutical for TQC3721

Shots: Sino Biopharmaceutical has entered into an exclusive license agreement with AstraZeneca for the development, manufacturing & commercialization of TQC3721, an inhaled PDE3/4 inhibitor As per the deal, AstraZeneca secured exclusive rights to develop, manufacture, & commercialize TQC3721 outside China, along with exclusive global rights to select future development programs In return, Sino will receive…

ByRidhi RastogiJuly 9, 2026

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Immunome Reports the US FDA’s NDA Acceptance of Varegacestat to Treat Desmoid Tumors in Adults

Shots: The US FDA has accepted the NDA for Immunome’s varegacestat for the treatment of adults with desmoid tumors, with a PDUFA target action date of Apr 28, 2027 NDA is supported by the global P-III (RINGSIDE) trial assessing varegacestat (1.2mg, QD) vs PBO until disease progression or death in 156 pts with progressing desmoid…

ByRidhi RastogiJuly 8, 2026

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Insilico Medicine Advances AI-Designed IPF Drug Rentosertib into P-III Trial

Shots: Insilico has initiated a P-III trial assessing Rentosertib vs PBO in ~320 pts with idiopathic pulmonary fibrosis (IPF) over 52wks. Earlier P-IIa (GENESIS-IPF) trial data showed Rentosertib (30mg, QD or BID, & 60mg, QD) met its 1EP, plus 60mg arm demonstrated a mean FVC change of +98.4mL vs -20.3mL at 12wks. Rentosertib, an oral…

ByRidhi RastogiJuly 8, 2026

Ridhi Rastogi

Polpharma and Teva Sign Exclusive Licensing Deal for a Biosimilar Candidate to Ocrevus

The US FDA Approves Accord BioPharma’s Ennumo (Biosimilar, Neulasta)

CervoMed Completes Patient Enrollment in P-IIa Study of Neflamapimod for Nonfluent Variant Primary Progressive Aphasia

Ipsen Reports Topline P-III (BEOND) Trial Program Data on Dysport in Both Episodic and Chronic Migraine

Roche Receives CE Mark for Rapid Elecsys IGRA TB Test to Detect Latent Tuberculosis

Johnson & Johnson Secures FDA Approval for Dual-Energy Catheter Ablation Platform

iHealthScreen Reports FDA Clearance of iPredict-DR for Diabetic Retinopathy Screening

AstraZeneca Inks $1.9B Exclusive Licensing Deal with Sino Biopharmaceutical for TQC3721

Immunome Reports the US FDA’s NDA Acceptance of Varegacestat to Treat Desmoid Tumors in Adults

Insilico Medicine Advances AI-Designed IPF Drug Rentosertib into P-III Trial

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