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Allarity Therapeutics Receives FDA Fast Track Designation for Stenoparib in Advanced Ovarian Cancer

FDA Approval
  • Allarity Therapeutics received FDA Fast Track designation for stenoparib, an investigational dual PARP/WNT inhibitor for advanced ovarian cancer treatment.
  • The designation accelerates development timelines and enables more frequent FDA interactions with potential eligibility for expedited approval pathways.
  • The company has initiated a Phase 2 clinical trial building on prior data showing patients remaining on treatment for over 22 months.
  • ALLR stock surged over 119% intraday following the regulatory milestone, with trading volume increasing by 2,728% to $304.8 million.

FDA Rejects Blu Disposable E-Cigarette Marketing Application Over Dual-Use Concerns

FDA Approval
  • The FDA denied marketing authorization for Fontem US's Blu disposable classic tobacco-flavored 2.4% nicotine e-cigarette on August 19, citing insufficient evidence of public health benefits.
  • The agency determined that users would likely continue smoking cigarettes while using the Blu product, potentially exposing them to higher toxicant levels than exclusive cigarette use.
  • Fewer than 30 vaping products have received FDA marketing approval, with only four brands currently authorized: Juul, Altria's Njoy, Reynolds American's Vuse, and Japan Tobacco's Logic.
  • The FDA emphasized that authorized e-cigarettes must demonstrate complete switching from cigarettes or significant reduction in cigarette consumption to receive approval.

Vanda Pharmaceuticals Appeals to FDA Commissioner Makary Over Generic Hetlioz Approvals Following Court Victory

FDA Approval
  • Vanda Pharmaceuticals has requested FDA Commissioner Martin Makary to review the agency's approval of two generic versions of Hetlioz, challenging what it calls an "unacceptable culture of bias" toward generic drugs.
  • The company argues that outgoing CDER director Jacqueline Corrigan-Curay upheld generic approvals despite significant study flaws, including bioequivalence studies conducted only in Indian male subjects for use in the general US population.
  • This appeal follows Vanda's recent federal court victory over the FDA regarding Hetlioz's jet lag disorder indication, where the court found the company had provided meaningful evidence of efficacy.
  • Vanda contends that one generic version showed exposure levels more than double those of original Hetlioz, raising safety concerns for American patients.

Boehringer Ingelheim Partners with AnGes for HGF Gene Therapy Manufacturing Ahead of FDA Filing

FDA Approval
  • Boehringer Ingelheim has signed a contract development and manufacturing agreement with AnGes for the drug substance of their investigational hepatocyte growth factor gene therapy targeting peripheral arterial disease.
  • The partnership follows AnGes' completion of clinical trials and plans to submit a biologics license application to the FDA for their HGF gene therapy product.
  • Peripheral arterial disease affects 200 million people worldwide and can lead to severe complications including ulceration, infection, and limb amputation with mortality rates comparable to cancer.
  • The plasmid DNA molecule has been manufactured using proprietary microbial technology in E. coli at Boehringer's Vienna facility for nearly 20 years since the collaboration began.

Agilent's MMR IHC Panel PharmDx Receives FDA Approval as Companion Diagnostic for Colorectal Cancer Immunotherapy

FDA ApprovalPrecision Medicine
  • Agilent Technologies received FDA approval for its MMR IHC Panel pharmDx (Dako Omnis) as a companion diagnostic test to identify mismatch repair deficient colorectal cancer patients eligible for Bristol Myers Squibb's Opdivo immunotherapy treatments.
  • The test detects loss of function in four key mismatch repair proteins (MLH1, PMS2, MSH2, and MSH6) in colorectal cancer tissue, making it the only FDA-approved companion diagnostic IHC panel for this specific indication.
  • This diagnostic tool enhances healthcare providers' ability to tailor immunotherapy treatments for colorectal cancer patients, potentially improving tumor control and progression-free survival outcomes.

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread

NCT02060188CompletedPhase 2
Bristol-Myers Squibb
Posted 3/12/2014

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

NCT04008030Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 8/5/2019

Merit Medical Enrolls First Patient in WRAPSODY Registry for Hemodialysis Vascular Access

FDA ApprovalReal World Evidence
  • Merit Medical Systems has enrolled the first patient in its WRAP North America registry, a prospective multicenter study designed to collect real-world safety and effectiveness data on the WRAPSODY Cell-Impermeable Endoprosthesis for hemodialysis patients.
  • The registry will enroll up to 250 US and Canadian hemodialysis patients experiencing vascular access obstructions such as stenosis or occlusion, with clinical outcomes evaluated over three years.
  • The WRAPSODY CIE received FDA premarket approval in December 2024 and Health Canada approval in April 2025, following superior performance demonstrated in the WAVE pivotal trial.
  • If completed as designed, this registry would represent the largest cohort of patients treated with an implantable device to restore vascular access for hemodialysis.

Merit WRAPSODY™ Endoprosthesis for Treatment of Stenosis or Occlusion (WRAP)

NCT05062291Recruiting
Merit Medical Systems, Inc.
Posted 6/23/2022

WRAP North America

NCT06807099Recruiting
Merit Medical Systems, Inc.
Posted 7/31/2025

Genentech Initiates First Patent Litigation Against Pertuzumab Biosimilar HLX11

Monoclonal AntibodyFDA Approval
  • Genentech filed the first BPCIA litigation against Shanghai Henlius Biotech and Organon on August 14, 2025, alleging infringement of 24 patents by their proposed pertuzumab biosimilar HLX11.
  • The lawsuit represents the first patent challenge for a pertuzumab biosimilar, with Henlius and Organon's aBLA being the only publicly announced application currently pending with the FDA.
  • Genentech asserted 24 of the 47 patents it had listed during the BPCIA patent dance, including 10 method of treatment patents and 10 manufacturing patents.
  • The litigation seeks injunctive relief to prevent commercialization of HLX11 and damages for alleged patent infringement under the BPCIA framework.

MacroGenics Names Eric Risser as New CEO, Succeeding 24-Year Leader Scott Koenig

Leadership ChangeMonoclonal AntibodyOncologyFDA Approval
  • MacroGenics appointed Eric Risser as President and CEO effective August 13, 2025, replacing Scott Koenig who led the company for 24 years.
  • Risser brings nearly 30 years of biotech experience and has generated over $1.6 billion in non-dilutive capital through corporate development efforts since joining MacroGenics in 2009.
  • The leadership transition comes as MacroGenics focuses on developing innovative monoclonal antibody-based cancer therapeutics, with three FDA-approved products already in its portfolio.
  • Risser aims to create a more focused and capital-efficient biotechnology company that delivers high-value cancer therapies to patients.

FDA Approves Expansion of Aquedeon's Duett Vascular Graft System Trial to 90 Patients

FDA Approval
  • The FDA has approved expansion of Aquedeon Medical's IDE clinical trial for the Duett Vascular Graft System, increasing enrollment from the initial study to up to 90 patients across additional U.S. clinical sites.
  • The Duett System is designed to simplify and accelerate vascular anastomosis during complex aortic arch reconstruction surgery, potentially reducing deep hypothermic circulatory arrest duration and associated neurological risks.
  • The novel device addresses critical needs in open surgical repair of aortic arch aneurysms and dissections, procedures that are technically demanding and carry significant cardiac and neurological risks.
  • Principal investigator Dr. Wilson Szeto notes the technology has potential to transform aortic surgery by providing surgeons with innovative tools to enhance patient care for aortic disease.

Xspray Pharma Secures First Patent License Deal with Handa Therapeutics for Dasatinib Commercialization

FDA Approval
  • Xspray Pharma has entered into its first patent licensing agreement with Handa Therapeutics, granting non-exclusive rights to commercialize dasatinib products in the US and selected Asian markets.
  • The deal will generate up to double-digit royalties on Handa's net proceeds, marking an important milestone in capitalizing on Xspray's intellectual property assets.
  • Xspray's lead product candidate Dasynoc awaits FDA approval with a PDUFA date of October 7, 2025, and the agreement ensures its launch won't be affected by regulatory exclusivities.
  • The licensing deal validates Xspray's comprehensive patent portfolio while maintaining the company's core strategy to develop improved protein kinase inhibitor drugs using its HyNap technology platform.

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