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DelveInsight Blog

Map the latest in Pharmaceutical, Healthcare, Medical Devices and Biotech Space with DelveInsight’s panoramic market analysis while the Pharma Industry continues to rapidly evolve with several approvals,failures, acquisitions, and partnerships teeing up the domain.

Johnson & Johnson Medtech Acquired Laminar; BD Launched Advanced Vascular Access Ultrasound System; FDA Cleared Oral Device for Severe Sleep Apnea; FDA Clearanced the Zilia OcularTM FC Retinal Camera; First Patient Enrolled in Penumbra Study of Computer-assisted Vacuum Thrombectomy; US FDA Granted the BiVACOR Total Artificial Heart IDE Approval for First-in-Human Early Feasibility Study

FDA Cleared Oral Device for Severe Sleep Apnea From Vivos Therapeutics On November 29, 2023, Vivos Therapeutics announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Vivos’s removable CARE (Complete Airway Repositioning and Expansion) oral appliances developed for treating severe obstructive sleep apnea (OSA). With this FDA approval, Vivos Therapeutics became the first firm to approve and launch a viable therapy option for patients suffering with severe OSA other than CPAP or surgical neuro-stimulation implants. This latest approval marks the first time the FDA…

Assessing the Emerging Trends in the Evolving Implantable Drug Delivery Device Landscape

The Implantable Drug Delivery Device market has experienced a monumental surge driven by an amalgamation of technological innovation, burgeoning demand, and the strategic maneuvers of key industry players. According to DelveInsight's latest assessment, the global Implantable Drug Delivery Device Market is poised to achieve a 6.31% CAGR between 2023 and 2028. Technological advancements have emerged as the linchpin propelling the market's exponential growth trajectory. Innovations spanning microelectromechanical systems (MEMS), biodegradable materials, and smart sensors have revolutionized drug delivery, ushering in an era of precise, targeted, and sustained therapeutic interventions. This…

FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev; Roche and Carmot Therapeutics’s Definitive Merger Agreement; AbbVie to Acquire ImmunoGen; FDA Grants Orphan Drug Designation to LP-284; Merck Announces Commercialization Agreement With Abbisko; Pfizer and Valneva Complete Recruitment for Phase 3 VALOR Trial

FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Merck, operating as MSD internationally, reported that the U.S. Food and Drug Administration (FDA) has prioritized the review of a supplementary Biologics License Application (sBLA). This application focuses on obtaining approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in conjunction with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate. The intended use is for treating adult patients dealing with locally advanced or metastatic urothelial carcinoma (la/mUC). The FDA is expediting…

Navigating the Booming Cryotherapy Market and Its Future Outlook

Cryotherapy, a therapeutic technique utilizing extreme cold temperatures, has witnessed a significant evolution catalyzed by…

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Dupixent Significantly Reduced COPD Exacerbations; Sosei Heptares to Regain O...

Dupixent Significantly Reduced COPD Exacerbations In Second Positive Phase III Trial The latest trial for…

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Another Feather in the Cap for Xtandi and Keytruda — The Two Main Cancer Drugs

The FDA has approved label extensions for two of the most crucial cancer medications globally—Merck’s…

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Novartis Cosentyx: First Biologic Hidradenitis Suppurativa Treatment After Al...

While another inflammatory biologic is making strides in the hidradenitis suppurativa treatment domain, Cosentyx by…

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Ethicon’s ETHIZIA Hemostatic Sealing Patch; FDA Approves Medtronic’s Minimall...

Ethicon Announced European Approval and Introduction of ETHIZIA™ Hemostatic Sealing Patch Used to Stop Disruptive…

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Innovative Pathways in Joint Reconstruction: Market Dynamics and Future Horizons

In recent years, the joint reconstruction devices market within the realm of orthopedics has undergone…

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netherton-syndrome-treatment
Netherton Syndrome: Unraveling the Uncertainties of a Rare Genetic Skin Disorder

With rise of gene therapy and other innovative therapeutic approaches, we experience profound change in Netherton syndrome treatment space.

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Smart Medical Devices Market Outlook
The Revolution of Healthcare: Smart Medical Devices Transforming the Future

It is not surprising that the healthcare sector is undergoing a significant transi...

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orchards-otl-200-for-metachromatic-leukodystrophy-treatment
Orchard’s OTL-200 to Enter US Metachromatic Leukodystrophy Treatment Space After EU

Orchard Therapeutics received FDA acceptance for its BLA for OTL-200, a gene therapy in pipeline for metachromatic leukodystrophy treatment.

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Launch Landscape Analysis
Launch Landscape Analysis

A mid pharma client based in Germany, involved in late-stage development of a therapy for PID, with effective marketing and commercialisation presence in Europe, wanted to assess the launch readiness of competitors involved in the same arena for strategic positioning of their product. They wished to identify and evaluate the launch timelines, geographies of launch, First Launch company, commercial readiness, and salesforce of competitors.

A mid pharma client based in Germany, involved in late-stage development of a therapy for PID, with effective marketing and commercialisation presence in Europe, wanted to assess the launch readiness of competitors involved in the same arena for strategic positioning of their product. They wished to identify and evaluate the launch timelines, geographies of launch, First Launch company, commercial readiness, and salesforce of competitors.

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Product Assessment
Product Assessment

A large pharma client was working to develop their cyclophosphamide API and FD and was interested to assess competitive products in the same domain and area to provide benchmarking of their asset in comparison to their competitors The client requested periodic reports (Quarterly) on the developmental milestones of competitor companies, thorough assessment of the competitor products through Secondary and Primary CI inputs.

A large pharma client was working to develop their cyclophosphamide API and FD and was interested to assess competitive products in the same domain and area to provide benchmarking of their asset in comparison to their competitors The client requested periodic reports (Quarterly) on the developmental milestones of competitor companies, thorough assessment of the competitor products through Secondary and Primary CI inputs.

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Asset Prioritization
Asset Prioritization

A mid-sized pharma client was working to develop their asset portfolio and was interested in assessing best possible asset for atrial fibrillation for future development and licensing needs. The client requested evidence-based priorities in assets and products for Phase II development in atrial fibrillation, through potential licensing collaborations. Also, the client wanted to prioritise research efforts to determine the best possible asset to leverage their research portfolio.

A mid-sized pharma client was working to develop their asset portfolio and was interested in assessing best possible asset for atrial fibrillation for future development and licensing needs. The client requested evidence-based priorities in assets and products for Phase II development in atrial fibrillation, through potential licensing collaborations. Also, the client wanted to prioritise research efforts to determine the best possible asset to leverage their research portfolio.

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Out Licensing Opportunity
Out-Licensing Opportunity

A small pharmaceutical client based at Sweden, Europe with capabilities around a neonatal mesenchymal cells involved DelveInsight to identify a licensing partner for their stem cells product, from across the globe. They wished to identify a potential list of companies, to become a fit for their neonatal high quality MSCs and can prove to be a good business partner as a licensee for their proprietary “API” of the stem cell therapy domain.

A small pharmaceutical client based at Sweden, Europe with capabilities around a neonatal mesenchymal cells involved DelveInsight to identify a licensing partner for their stem cells product, from across the globe. They wished to identify a potential list of companies, to become a fit for their neonatal high quality MSCs and can prove to be a good business partner as a licensee for their proprietary “API” of the stem cell therapy domain.

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In Licensing Opportunity
In-Licensing Opportunity

A large client based in the USA, involved in drug delivery devices, with effective marketing and commercialisation presence across the globe, wanted to in-license potential dMTS based drug delivery asset from companies involved in microneedle technology research for delivering therapeutic products. They wished to identify and assess the technological competencies, clinical capabilities and commercial readiness of potential companies with a novel and non-invasive way of delivering drugs, which can include a variety of drugs/vaccines in their patch and successfully develop the product for commercial purposes, were of client’s interest.

A large client based in the USA, involved in drug delivery devices, with effective marketing and commercialisation presence across the globe, wanted to in-license potential dMTS based drug delivery asset from companies involved in microneedle technology research for delivering therapeutic products. They wished to identify and assess the technological competencies, clinical capabilities and commercial readiness of potential companies with a novel and non-invasive way of delivering drugs, which can include a variety of drugs/vaccines in their patch and successfully develop the product for commercial purposes, were of client’s interest.

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Go To Market Strategy
Go-To-Market Strategy

A medium pharmaceutical client based in the United States with biosimilar commercial capabilities involved DelveInsight to identify commercial processes and strategies to launch their biosimilar in Europe through Competitive Assessment of their EU based competitors in the same area of interest. They wished to identify manufacturing sites, logistic operations, distribution network, salesforce assessment and their sales targets.

A medium pharmaceutical client based in the United States with biosimilar commercial capabilities involved DelveInsight to identify commercial processes and strategies to launch their biosimilar in Europe through Competitive Assessment of their EU based competitors in the same area of interest. They wished to identify manufacturing sites, logistic operations, distribution network, salesforce assessment and their sales targets.

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