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NEWS

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol 

Shots:  The US FDA has approved Lerochol as an LDL-C lowering therapy for adults with hypercholesterolemia, including HeFH; US launch as a PFS is expected in spring 2026, with an autoinjector later in 2026, while EMA approval is anticipated in Jun 2026 alongside additional global regulatory filings   Approval was supported by the global P-III (LIBerate) trial, enrolling over 2,900 CVD patients and without…
December 12, 2025

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NEWS

Innoviva Specialty Therapeutics Receives the FDA Approval for Nuzolvence (Zoliflodacin) for Uncomplicated Urogenital Gonorrhea 

Shots:  The US FDA has approved Nuzolvence for the treatment of uncomplicated urogenital gonorrhea in pts (age ≥12yrs.; Wt.≥35 kg), with US commercialization planned for the H2’26  Approval was based on a pivotal P-III multinational trial (n=930) evaluating a single 3g oral dose of Nuzolvence vs ceftriaxone (500 mg IM) + azithromycin (1 g oral) for uncomplicated urogenital gonorrhea, which demonstrated non-inferiority, comparable tolerability…
December 12, 2025

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NEWS

Orca Bio Presents New Clinical Data On Orca-Q and Orca-T/CAR-T Combination Therapy at ASH 2025

Shots: Orca Bio reported positive P-I study data for Orca-Q, showing rapid neutrophil recovery, low acute/chronic GvHD, reduced infections, and low non-relapse mortality, including in patients treated without any GvHD prophylaxis Patients receiving Orca-Q with tacrolimus (Arm A, n=18) vs. without immunosuppression (Arm C, n=26) showed comparable survival and GvHD outcomes, with faster neutrophil engraftment…
December 9, 2025

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VIEWPOINTS

Evorpacept’s Momentum in HER2+ Gastric Cancer: A Conversation with Jason Lettmann from ALX Oncology 

Shots:  Evorpacept emerges as the only CD47-blocking therapy with strong clinical activity and a highly manageable safety profile, thanks to its unique inactive Fc design that enables targeted tumor destruction while sparing healthy cells  Updated ASPEN-06 data highlights CD47 overexpression as a powerful predictive biomarker, showing dramatic improvements in ORR, DOR, PFS, and OS for patients with…
December 3, 2025

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Hutchmed
NEWS

HUTCHMED Completes Enrollment in Global P-III (SAFFRON) Study of Orpathys + Tagrisso in Lung Cancer Patients

Shots: HUTCHMED completed the pts enrollment in the global P-III (SAFFRON) study evaluating Orpathys (savolitinib) + Tagrisso (osimertinib) vs Pt. based doublet CT in pts with EGFR-mutated, MET-overexpressed, and/or amplified, LA/M NSCLC after progression on Tagrisso, with the last patient being randomized on 31 Oct’25 The Ongoing P-III (SAFFRON) study is evaluating the efficacy and…
November 5, 2025

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EXCLUSIVE

Exclusive: A Stimulating Dialogue with Edmund Ben Ami, Co-Founder & CEO of NeuraLight 

Shots:  Given the high variability and subjectivity of traditional clinical scales, there is an urgent need for objective biomarkers to assess CNS disease progression more reliably    NeuraLight is at the forefront of precision neurology, developing objective and sensitive biomarkers that bring greater accuracy and consistency to CNS research    In this exclusive conversation, Edmund…
October 14, 2025

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VIEWPOINTS

Breaking New Ground in Oncology: Leonard Mazur from Citius Pharmaceuticals in Conversation with PharmaShots 

Shots:   Citius Pharmaceuticals celebrates its first-ever FDA approval with Lymphir, a novel therapy for relapsed or refractory cutaneous T-cell lymphoma     In an exclusive conversation, Leonard Mazur, Co-Founder and CEO at Citius Pharmaceuticals, shares insights on Lymphir’s launch strategy and its potential impact on the oncology landscape    Leonard also highlights Mino-Lok, Citius’ innovative…
October 6, 2025

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EVENTS

Post Conference Highlights: Peptides & Complex Generics Symposium 2025

Day 1 Breakdown The #PCG2025 Symposium commenced on an inspiring note, setting the stage for two days of insightful discussions, collaborations, and knowledge exchange. Opening Session Dr. Ratnesh Jain, Founder & Director, Mumbai Cluster, delivered the inaugural address, sharing his vision of bringing together pharma professionals, R&D experts, CXOs, and academicians to accelerate advancements in…
September 29, 2025

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VIEWPOINTS

Navigating Amorphous Calcium Carbonate Therapies: Eden Ben from Amorphical in Conversation with PharmaShots 

Shots:  ACC therapies introduce a novel treatment approach by modulating local pH, promoting bone remodeling, and reducing inflammation, with potential applications in osteoarthritis, calcium deficiencies, late-stage cancers, and bone disorders.  Amorphical’s AMOR-18 showed encouraging results in an interim Phase II clinical trial involving COVID-19 patients.  PharmaShots speaks with Eden Ben, CEO of Amorphical, to discuss…
September 22, 2025

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Innovative Minds Psychedelics in Medicine
MAGAZINE

PharmaShots Magazine-September-2025 Edition

Medical psychedelics are a fascinating field that modern science has yet to comprehend completely. Researchers are still digging up, trying to find evidence-based outcomes to tap into a whole new opportunity in psychiatry and mental health medicines The September Edition unearths a brand-new perspective on psychedelics through engaging articles, illustrative infographics, trailing BioTrends, illuminating regulatory…
September 11, 2025

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