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Fosun Pharma Obtains Greater China Rights to…

Under an exclusive license and option agreement, Fosun Pharma has obtained rights to VerImmune’s lead Anti-tumor Immune Redirection Virus-Inspired Particle (AIR-ViP) product candidate, VERI-101, in China, Hong Kong, Macau, and TaiwanThe deal also includes the option for Fosun to license certain future AIR-ViP products from VerImmune’s VERI-101 pipelineWu Yifang, Chairman and CEO of Fosun Pharma, commented, “We are pleased to partner with VerImmune to bring such a promising immunotherapy to China, and hope the cutting-edge biotherapeutic technologies and products can benefit more patients in China”

Hecken “Worried” That Revised Cost-containment…

Speaking with members of German parliament and industry bodies, impartial chairman of the Federal Joint Committee (G-BA) expressed his “worry” that a newly revised draft of the Statutory Health Insurance Financial Stabilization Act has not yet been submitted“In October the coffers have to draw up their budgets,” he explained, suggesting that the process needs to be expedited in time to be accounted for in budgetingHowever, in a glimmer of hope Martina Stamm-Fibich, pharmaceuticals expert for the SPD parliamentary group, confirmed that the draft is in fact already being voted on by the Federal Ministry for Economic Affairs and Climate (BMWK) and will soon be presented to the Ministry of Finance (BMF)

Procaps to Acquire Mexico’s Grupo Somar

Procaps Group announced it will be acquiring Grupo Somar, which includes Grupo Farmacéutico Somar and Química y Farmacia and, Gelcaps and related entities, from Adevnt InternationalSomar is focused on branded generic, private label, and over the counter (OTC) products and currently has a portfolio of products across six main categories, along with six production facilities in Mexico, two of which are for Softgel capsulesRuben Minski, CEO of Procaps, commented, “With this acquisition, Procaps continues to diversify its products and geographies based on being a leader in innovative oral delivery systems”

MHRA Greenlights Teva's Biosimilar Ongavia

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a license for Teva’s Ongavia (ranibizumab), a biosimilar to Lucentis, for the treatment of neovascular (wet) age-related macular degeneration (AMD) and several other eye diseases, such as diabetic macular edema (DME), treatment of visual impairment due to choroidal neovascularisation (CNV) and proliferative diabetic retinopathyThe UK is the first nation in Europe to grant a license for Teva’s ophthalmology biosimilar OngaviaTeva entered a strategic partnership for the exclusive commercialization of Ongavia with Swiss biopharmaceutical joint venture Bioeq AG across Europe

Health Canada OK’s Alnylam’s Oxlumo for Ultra-rare…

Health Canada has approved Alnylam’s Oxlumo (lumasiran) injection for subcutaneous use for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric and adult patientsThe Notice of Compliance (NOC) authorizing use of Oxlumo was issued based on results from the ILLUMINATE-A study in patients six years and older with PH1 and the ILLUMINATE-B study in patients under six years with PH1Alnylam’s Canada Medical Director Dr. Kristopher Garlick commented, “Previously there have been no authorized treatment options for PH1 in Canada, so this is a potentially life-changing milestone for people diagnosed with this debilitating disease – many of whom are infants and children”

Kyowa Kirin and LUCA to Co-develop Innovative Drugs…

Kyowa Kirin and LUCA Science are teaming up to develop an innovative treatment for mitochondrial diseasesThe deal involves Kyowa leveraging LUCA’s proprietary functional mitochondria therapy platform to come up with an innovative mitochondrial modalitySpecifically, LUCA will use its platform to manufacture, store, and deliver innovative mitochondrial drugs for a wide range of diseases with no effective treatments

FDA Authorizes Comirnaty Boost for 5-11 Year Olds

The U.S. Food and Drug Administration (FDA) has amended the Emergency Use Authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty to include a booster dose for children ages 5 through 11 at least five months after their primary vaccination with ComirnatyThe FDA analyzed immune response data in a subset of children from the ongoing randomized placebo-controlled trail that supported the agency’s authorization of Comirnaty in children five to 11 years of age, finding those who received the booster had increased antibody levels compared to before the dose Comirnaty has now been authorized for individuals aged five years and up since October 2021, while it is fully approved for use in individuals aged 16 years and up

More Canadian Provinces List Ajovy in Public…

Ontario, British Columbia, Nova Scotia, New Brunswick, and Newfoundland are now including Ajovy (fremanezumab) for the preventative treatment of migraine on their public formulariesToday’s announcement follows word from Teva in March, stating that Alberta, Saskatchewan, Quebec, Veteran Affairs Canada (VAC) and the Non-Insured Health Benefits (NIHB) Program had decided to list Ajovy on public formulariesAjovy is administered via subcutaneous injection for the preventative treatment of migraine in adults who have at least four migraine days per month

EUCOPE Hopes Joint EU HTA Will Reduce Burden,…

EUCOPE hopes that a Joint European Union Health Technology Assessment (HTA) system will reduce burden and complexities, and facilitate accessIn 2021, the European Council and the European Parliament, reached a provisional agreement, signing off the implementation of a regulation that will “dramatically reduce duplications of clinical assessments, ensure sustainable cooperation on HTA and provide us with a framework to better face health issues, such as rare diseases, personal medicine, and orphan medicines,” according to German MEP, Tiemo WölkenHowever, speaking to Pharma Boardroom, EUCOPE’s Secretary-General Dr. Alexander Natz says there are both “opportunities and pitfalls” with the EU HTA procedure, he explained, “the next three years will decide the crucial steps and whether the new procedure leads to reduced burdens for developers and faster patient access to innovative therapies”

China Approves Homegrown PD-1 Inhibitor Tuoyi in 5th…

The National Medical Products Administration (NMPA) of China has approved Junshi Bio’s PD-1 inhibitor, Tuoyi (toripalimab), in combination with paclitaxel and cisplatin, for the first-line treatment of patients with unresectable locally advanced, recurrent, or distant metastatic esophageal squamous cell carcinoma (ESCC)In the Phase 3 JUPITER-06 clinical trial, Tuoyi plus chemotherapy achieved greater overall survival (OS) in patients with ESCC as opposed to placebo plus chemotherapy—OS was prolonged by 17 months and the risk of disease progression or death was reduced by 42%, regardless of PD-L1 expressionToday’s announcement marks the fifth approval for Tuoyi in China, following conditional approvals in melanoma, nasopharyngeal carcinoma (NPC), and urothelial carcinoma, as well as full approval in NPC

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