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Achieve Life Sciences Appoints Dr. Mark Rubinstein as Interim CMO Amid Cytisinicline FDA Review

Drug ApprovalLeadership Change
  • Achieve Life Sciences has named Dr. Mark Rubinstein as Interim Chief Medical Officer, succeeding Dr. Cindy Jacobs as the company advances its smoking cessation drug cytisinicline.
  • The FDA recently accepted the company's New Drug Application for cytisinicline with a PDUFA completion date of June 20, 2026, targeting the estimated 15 million American adults who attempt to quit smoking annually.
  • Cytisinicline has received FDA Breakthrough Therapy designation for e-cigarette cessation, addressing an unmet medical need with no currently approved treatments for vaping cessation.
  • The plant-derived alkaloid works by binding to nicotinic acetylcholine receptors to reduce nicotine cravings and the rewarding effects of tobacco products.

Amneal Receives FDA Approval for Generic Sodium Oxybate, Breaking Jazz Pharmaceuticals' Monopoly in Narcolepsy Treatment

Drug ApprovalRare Disease
  • Amneal Pharmaceuticals received FDA approval for its generic sodium oxybate oral solution 500 mg/mL, referencing Jazz Pharmaceuticals' Xyrem for narcolepsy treatment.
  • The approval provides a more affordable alternative for approximately 150,000 narcolepsy patients in the United States who previously had access to only a single manufacturer.
  • Sodium oxybate is considered standard of care therapy for narcolepsy due to its ability to consolidate nighttime sleep and significantly reduce cataplexy episodes.
  • The drug is indicated for treating cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy.

Lutetium Lu 177 Dotatate Shows Promise in Metastatic Bronchopulmonary Neuroendocrine Tumors

Real World EvidenceDrug ApprovalTargeted Therapy
  • Lutetium Lu 177 dotatate demonstrated antitumor activity in patients with metastatic bronchopulmonary neuroendocrine tumors, achieving partial responses in 17% of patients in a real-world study.
  • The median progression-free survival was 10.8 months across all patients, with patients having higher Krenning scores showing better outcomes at 14.7 months.
  • The treatment was well tolerated with no grade 3 or higher adverse events, with the most common side effects being fatigue, nausea, and abdominal pain.

FDA Approves Obagi saypha MagIQ Injectable Hyaluronic Acid Filler, Marking Waldencast's Entry into US Dermal Filler Market

Drug Approval
  • The FDA has approved Obagi saypha MagIQ, an injectable hyaluronic acid gel developed by Croma-Pharma and distributed under the Obagi Medical brand, marking Waldencast's first entry into the US dermal filler market.
  • The product utilizes proprietary MACRO Core Technology to create a stable 3D HA matrix designed for consistent gel distribution, predictable injection force, and natural-looking results across all skin types.
  • A pivotal 270-patient clinical trial demonstrated non-inferiority to control fillers with similar safety profiles, including the highest representation of diverse Fitzpatrick skin types in HA filler studies.
  • Waldencast plans to launch the product in 2026, projecting that this approval will double Obagi Medical's total addressable market to approximately $4.2 billion by 2029.

FDA Accepts Sobi's NASP Biologics License Application for Uncontrolled Gout Treatment

Drug ApprovalRare Disease
  • The FDA has accepted Sobi's Biologics License Application for NASP, a novel every 4-week infusion therapy for uncontrolled gout patients, with a PDUFA date set for June 27, 2026.
  • Phase 3 DISSOLVE I and II trials demonstrated that NASP met primary endpoints, achieving serum uric acid reduction below 6mg/dL in 51% and 43% of patients at high and low doses respectively.
  • NASP combines nanoencapsulated sirolimus with pegadricase to address the significant unmet need among approximately 200,000 Americans suffering from uncontrolled gout despite conventional therapies.

World's First Koala Chlamydia Vaccine Receives Regulatory Approval in Australia

Drug Approval
  • The University of the Sunshine Coast has developed and received regulatory approval for the world's first single-dose vaccine to protect koalas from chlamydia, a disease that causes up to half of koala deaths in wild populations.
  • Clinical trials demonstrated the vaccine reduces mortality from chlamydia by at least 65% and decreases the likelihood of symptomatic disease during breeding age in wild koala populations.
  • The vaccine targets Chlamydia pecorum's major outer membrane protein and offers three levels of protection: reducing infection, preventing disease progression, and potentially reversing existing symptoms.
  • With some wild koala colonies experiencing infection rates as high as 70%, this breakthrough represents a critical intervention for conserving Australia's endangered marsupial populations.

PALOMA-2 Study Confirms Efficacy of Subcutaneous Amivantamab in EGFR Exon 20 Insertion NSCLC

Targeted TherapyDrug Approval
  • The phase 2 PALOMA-2 study demonstrated that subcutaneous amivantamab plus chemotherapy achieved a 76% objective response rate in patients with EGFR exon 20 insertion-mutated advanced NSCLC.
  • Results showed consistency with the pivotal PAPILLON study, with a clinical benefit rate of 94% and median progression-free survival of 12.2 months at 10-month follow-up.
  • The subcutaneous formulation offers enhanced tolerability and convenience without sacrificing efficacy compared to intravenous administration.
  • European Commission approval in April 2025 for subcutaneous amivantamab formulations is expected to expand clinical applicability and lead to additional regulatory approvals.

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

NCT04538664Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 10/13/2020

A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT04487080Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 9/30/2020

A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer

NCT05498428RecruitingPhase 2
Janssen Research & Development, LLC
Posted 11/11/2022

A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer

NCT05388669Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 8/5/2022

Sandoz Secures Patent Settlement with Regeneron, Clears Path for Aflibercept Biosimilar Launch by End of 2026

Drug Approval
  • Sandoz reached a patent settlement agreement with Regeneron resolving all litigation related to its FDA-approved aflibercept biosimilar Enzeevu, clearing the path for US market entry by the fourth quarter of 2026.
  • The agreement concludes vigorous patent disputes involving up to 46 patents protecting Eylea, with Regeneron initially filing infringement proceedings in August 2024 under the Biologics Price Competition and Innovation Act.
  • Enzeevu received FDA approval on August 12, 2024, for treating neovascular age-related macular degeneration and was provisionally determined to be interchangeable with the reference medicine Eylea.
  • The biosimilar launch will strengthen Sandoz's ophthalmology leadership in the US and advance the company's strategy of providing affordable access to high-quality medicines for patients with wet AMD, a leading cause of vision impairment in patients over 50.

InnoCare's BTK Inhibitor Orelabrutinib Gains Singapore Approval for Relapsed/Refractory Marginal Zone Lymphoma

Drug ApprovalOncology
  • The Health Sciences Authority of Singapore has approved orelabrutinib (HIBRUKA) for treating adult patients with relapsed or refractory marginal zone lymphoma, marking InnoCare's second indication approval in the country.
  • Phase 2 trial data demonstrated a 58.9% objective response rate with a median duration of response of 34.3 months in 90 patients with marginal zone lymphoma at 24.3 months median follow-up.
  • The highly selective BTK inhibitor showed favorable safety profile with most common treatment-related adverse events being hematologic toxicities including anemia (27.9%) and decreased neutrophil count (23.4%).
  • This approval provides a new treatment option for marginal zone lymphoma patients in Singapore, an indolent B-cell non-Hodgkin's lymphoma with limited effective therapies after first-line treatment failure.

A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL)

NCT03797456CompletedPhase 2
Beijing InnoCare Pharma Tech Co., Ltd.
Posted 4/1/2019

FDA Launches Fast-Track Review Program for Nicotine Pouches Under Trump Administration Pressure

Drug Approval
  • The FDA will expedite reviews of nicotine pouches from four major tobacco companies through a pilot program launching Monday, aiming to complete reviews by December.
  • The initiative follows pressure from Trump administration leadership to accelerate the approval process for smoking alternatives, with companies previously waiting years for product clearance.
  • Products from Philip Morris International, Altria, Reynolds American, and Turning Point Brands will undergo streamlined reviews focusing on essential scientific data and manufacturing consistency.

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