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Hoya Reports Flat IOL Sales in Quarter that Ended Dec. 31, 2018
Japan-based Hoya reported Feb. 1 that sales of IOLs were flat for the three months that ended Dec. 31, 2018. The company said IOL revenues decreased in China and increased in Japan and Europe. Hoya...
Lutronic Vision Begins Preclinical Trial of Laser Therapy in Dry AMD
Lutronic Vision announced Jan. 29 that it has initiated a preclinical trial to determine the optimal setting for its R:GEN laser for the treatment of dry age-related macular degeneration (dry AMD)....
Kyocera Buys Major Assets From Renovis
Kyocera International, the US headquarters of Japan-based Kyocera Corporation, reported Jan. 16 that it has entered an agreement with Renovis Surgical Technologies to purchase Renovis’ operations r...
AlloJoin for Knee OA Approved for Phase II Clinical Trials in China
Cellular Biomedicine Group, a Chinese company, published a press release Jan. 17, which said the company has received approval for a Phase II clinical trial of its AlloJoin therapy in China. AlloJo...
FlowerCube System Saves Time and Money in Clinical Trial
Flower Orthopedics, a Pennsylvania company, announced Jan. 17 that it has completed a 14-month prospective trial of its FlowerCube. This product is a single-use implant and instrument system for fi...
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US FDA Halts Compounding at Ranier’s Compounding Laboratory
The US FDA announced Feb. 6 that compounder Ranier's Rx Laboratory, doing business as Ranier's Compounding Laboratory, of Jeanette, Pennsylvania, is prohibited from manufacturing and distri...
Oculentis Responds to BBC Story on Opacification Related to Old IOL Models
Oculentis again is facing negative media coverage in the UK over lens opacification in patients who received hydrophilic LENTIS lenses that the company no longer manufactures. The German company is...
Graybug Vision Names Frédéric Guerard CEO
Graybug Vision announced Feb. 5 that its board has appointed Frédéric Guerard to be the company’s CEO. Guerard was previously the worldwide business franchise head of ophthalmology at Novartis. His...
Columbia University Scientist Using CRISPR in Embryos to Study Gene Repair in RP
A developmental biologist at Columbia University is studying whether using CRISPR in human embryos can repair a genetic defect that causes retinitis pigmentosa (RP) to prevent the disease from bein...
Stimwave Completes SURF Trial of Wireless SCS System
Florida-based Stimwave Technologies announced Jan. 16 that it has completed its six-month SURF study of a wirelessly powered spinal cord stimulator (SCS). This stimulator is unique from other devic...
EU-5 Ophthalmic Market Will Top $10 Billion in 2023
Market Scope expects growing demand for retinal pharmaceuticals to help manufacturers' ophthalmic revenues top $10 billion in 2023 in the five largest economies of the European Union. The ophth...
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Pressure to Reduce Opioid Use Is a Major Driver of the Neuromodulation Market
The concept of using electrical impulses to treat pain has existed for millennia. Modern neuromodulation—including spinal cord stimulation—got its clinical start in the 1960s and 1970s. Adoption of...
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Orthopedic US 510(k) Clearances
The eight spine fixation devices that received clearance between Jan. 1 and Jan. 25 included one lumbar plate from Choice Spine and three cervical plates from Pioneer Spine, Solco Biomedical, and S...
Monthly Orthopedic Fundraising
The overall value of the orthopedic market increases when companies obtain money from outside sources such as public market fundraising or grants. The goal of this feature is to track these fundrai...
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Company Spotlight: Mo-Sci Corporation
Mo-Sci Corporation, based in Rolla, Missouri, produces specialty glass for orthopedic implants, wound dressing applications, and industrial needs. Delbert Day, PhD, founded the company in 1985 when...
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Cementless Knees Evolve, Boosting Market Demand
Cemented knee implants are the current standard of care for most patients undergoing total knee arthroplasty (TKA). Cementless knees, which are press-fit into bone, have historically been limited t...
Fractures Produce Systemic Effects
Fractures are more common in individuals who have experienced prior fractures. The exact explanation for this phenomenon has yet to be elucidated, but recent studies point to systemic responses tha...
AAHKS Position Statement on Opioid Use in Hip, Knee OA
The American Association of Hip and Knee Surgeons (AAHKS) released a position statement in January stating that opioids should not be a first-line treatment or long-term solution for hip or knee os...
Aldeyra Acquires Helio Vision, Developer of Candidate for Proliferative Vitreoretinopathy
Aldeyra Therapeutics announced Jan. 29 that it has acquired Helio Vision for an upfront payment of $10 million in common stock, plus a potential $15 million in milestone and other payments. Private...
Alcon’s 2018 Net Sales Increase 6 Percent to $7.1 billion Ahead of Planned Spinoff
Alcon’s 2018 net sales totaled $7.1 billion (+6 percent, +5 percent cc), parent Novartis announced Jan. 30. Alcon’s surgical sales growth of 7 percent for the year was due largely to premium IOLs a...
Novartis To Use Priority Review Voucher to Move Up Launch of RTH258; Company’s Lucentis Revenues Increase
Novartis officials told analysts Jan. 30 that the company would use a priority review voucher to speed up the US FDA’s review of RTH258, a retinal drug candidate, and they expected to launch the dr...
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Avedro Files Preliminary Paperwork for $86 Million IPO
Avedro is planning an $86.25 million initial public offering, according to a preliminary prospectus filed Jan. 18 with the SEC. Avedro, founded in 2008, gained US approval for its cross-linking sys...
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Roche Reports Lucentis Revenues of $1.67 Billion in 2018 in the US
Genentech parent Roche reported Jan. 31 that Lucentis’ 2018 sales in the US totaled $1.67 billion (CHF 1.66 billion), an increase of 18 percent over 2017. The Swiss company said growth was driven b...
US FDA Accepts Nicox’ IND for NCX 4251 for Blepharitis
The US FDA has accepted Nicox’ investigational new drug application for NCX 4251 for blepharitis, the France-based company announced Jan. 29. NCX 4251 is a suspension of fluticasone propionate nano...
Allergan’s Restasis Revenues in 2018 Totaled $1.26 Billion
Allergan reported Jan. 29 that Restasis revenues in 2018 totaled $1.26 billion, a decrease of 14.4 percent from $1.47 billion in 2017. The dry eye drug’s Q4-2018 revenues totaled $341.6 million, a ...
Graybug Vision Announces Positive Topline Results for Phase I/IIa Study of Wet AMD Candidate
Graybug Vision's Phase I/IIa study of its wet age-related macular degeneration (AMD) candidate produced positive topline results, the Redwood City, California, company announced Jan. 21. The ca...
Aurinia Plans to Advance Dry Eye Candidate Despite Mixed Results in Phase II Trial
Aurinia Pharmaceuticals’ Phase II study comparing voclosporin ophthalmic solution (VOS) with Restasis for dry eye failed to meet its primary endpoint but outperformed Restasis in two secondary effi...
Wren Therapeutics Raises $20.5 Million in Series A Financing
Wren Therapeutics raised £18 million ($20.5 million) in a Series A financing, the UK-based company announced Jan. 22. The company is focused on protein misfolding diseases in the areas of neurology...
BridgeBio Pharma Raises $299.2 Million
BridgeBio Pharma has raised $299.2 million, the Palo Alto, California, company announced Jan. 23. BridgeBio is a clinical-stage company focused on genetic diseases. Its pipeline includes a treatmen...
J&J Vision’s Surgical Unit Posts Q4-2018 Revenues of $317 Million
J&J Vision’s ophthalmic surgical division posted $317 million in revenues in Q4-2018, a 0.6 percent decrease compared with Q4-2017 revenues of $319 million, J&J reported Jan. 22. The division gener...
Editas Announces CEO Change as CRISPR Candidate Nears Phase I/II Study
Editas Medicine announced Jan. 22 that Katrine Bosley will step down as the company’s president and CEO, effective March 1. Editas is co-developing with Allergan an experimental CRISPR genome editi...
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SpineSource Acquires Two IP Assets From Kisco International
Privately owned, Missouri-based SpineSource disclosed on Jan. 10 that it has acquired IP assets for two of Kisco International’s spinal implant systems. L-Varlock (an expandable interbody cage) has...
Integra and Consortium of Focused Orthopedists Collaborate to Develop Shoulder Systems
Integra LifeSciences Holdings Corporation announced Jan. 8 that it entered into a license and development agreement with Consortium of Focused Orthopedists. The goal is to create a bone-saving shor...
Generex Initiates Two Acquisitions
Florida-based Generex is a publicly owned, integrated health care holding company. It announced Jan. 9 that it has entered a letter of intent to acquire Pantheon Medical, a privately owned orthoped...
HSS Opens First Provider-based 3D Printer Lab
Hospital for Special Surgery (HSS) shared Jan. 7 that it is creating the first provider-based 3D printing lab for custom orthopedic implants. HSS previously sourced custom implants from Italy-based...
2018 in Review: Biggest Stories Included CyPass Recall, Launch of New Glaucoma Drugs
Market Scope’s top 10 ophthalmic stories for 2018 cover the highs and lows of the year, from groundbreaking approvals to product recalls and company failures. Respondents to our weekly poll of surg...
Europe’s Growing Emphasis on Value May Alter Wet AMD Treatment Options
A flurry of decisions in late 2018 set the stage for profound changes in how ophthalmologists treat neovascular age-related macular edema (wet AMD) in the European Union. Those changes could save h...
Brexit Likely to Result in Fewer Surgeons, Longer Wait Times for Eye Patients in UK
The ophthalmic industry in the UK faces doctor flight, growing wait times for patients, regulatory uncertainty, and drug shortages amid uncertainty due to Brexit. Britain’s scheduled exit from the ...
BVI’s Acquisition of PhysIOL Broadens its Portfolio in Cataract Products Market
Beaver-Visitec International’s acquisition of PhysIOL dramatically increases BVI’s participation in the nearly $8 billion global cataract products market, while also broadening the company’s role i...
Market Report: EU-5 Ophthalmic Market Will Top $10 Billion in 2023
Market Scope expects growing demand for retinal pharmaceuticals to help manufacturers' ophthalmic revenues top $10 billion in 2023 in the five largest economies of the European Union. The ophth...
Takeda Completes Shire Acquisition; Xiidra’s Future Unclear
Takeda CEO Christophe Weber told investors they should expect the pharmaceutical company to sell assets in 2019 to reduce debt after completing a $62 billion acquisition of Shire on Jan. 7, accordi...
Clearside Submits NDA for Xipere for ME Associated with Uveitis
Clearside Biomedical has submitted a new drug application to the US FDA for Xipere, a candidate for macular edema (ME) associated with uveitis, the Alpharetta, Georgia, company announced Dec. 19. X...
2018 in Review: Alcon’s Recall of CyPass Causes Anxiety, Raises Questions
Alcon shocked ophthalmologists and the glaucoma industry Aug. 29, 2018, with news of its global voluntary withdrawal of the CyPass Micro-Stent. Alcon advised ophthalmic surgeons to stop implanting ...
2018 in Review: Symfony’s Success as EDOF Lens Attracts Competitors
The continued success of Johnson & Johnson Vision’s TECNIS Symfony extended depth of focus (EDOF) lens led to more companies jumping on the bandwagon in 2018 with their own designs. Market Scope es...
2018 in Review: STAAR Toric ICL Gains Long-Awaited Approval
STAAR Surgical finally received the FDA’s nod in September 2018 for its Visian Toric Implantable Collamer Lens (ICL) for the correction of myopia with astigmatism. The standard Visian phakic ICL se...
2018 in Review: Refractive Segment Shows Healthy Growth
The US refractive segment saw healthy growth in 2018, with estimated procedure volume growth of 7.2 percent over the 2017 total. Factors driving growth were a rebounding US economy with higher cons...
2018 in Review: New Pharmaceuticals Make Gains in Glaucoma Market
Two new approaches for pharmaceutical treatment of glaucoma emerged from the development pipeline in 2018. Bausch + Lomb began commercial sales of Vyzulta (latanoprostene bunod ophthalmic solution)...
2018 in Review: IanTECH’s miLOOP Poses Fresh Challenge to Phaco’s Dominance
The IanTECH miLOOP posed a new challenge to ultrasonic phacoemulsification, the gold standard in cataract removal for half a century. However, few surgeons in 2018 seemed ready to part with their p...
2018 in Review: Anti-VEGF Candidates Hold Promise to Ease Treatment Burden
The advance of two new anti-VEGFs and a new delivery method in 2018 raised hopes about easing the burden of anti-VEGF treatment. Novartis and Allergan each moved a step closer to commercializing th...
2018 in Review: Spark Launches Retinal Gene Therapy, New Payment Plan
Spark Therapeutics launched the first gene therapy in ophthalmology in 2018 and a new payment model to handle the high cost. The first commercial procedure with Luxturna (voretigene neparvovec-rzyl...
2018 in Review: Alcon Eyes Dry Eye Market, Buys Tear Film Innovations
Novartis's plans for spinning off Alcon became clearer in 2018, and dry eye emerged as one of four areas expected to drive Alcon's growth. The first hint of dry eye's position in the ne...
2018 in Review: Presbyopia Segment Proves Challenging for Competitors
ReVision Optics closed its doors in February 2018 and posted a message on its website saying it had halted sales of its Raindrop corneal inlay, as of Jan. 30. The FDA subsequently posted a warning ...
Kala Launches Inveltys for Postoperative Inflammation, Hires Sales Organization
Kala Pharmaceuticals has launched Inveltys, a twice-daily ocular corticosteroid indicated for postoperative inflammation and pain, the Waltham, Massachusetts company announced Jan. 7. The US FDA ap...
FDA Plans to Modernize 510(k), De Novo Pathways for Medical Devices
The US FDA plans to modernize the 510(k) and de novo pathways for reviewing new medical devices in a move intended to support modern technology and protect patients. FDA Commissioner Scott Gottlieb...
Cataract-Only Surgeons Challenge Combo Cataract/Refractive Peers in Tech Adoption
Cataract surgeons appear to be catching up and, in some cases, surpassing their combination cataract/refractive surgeon colleagues in adopting new technology. Market Scope reviewed recent quarterly...
Annexon Biosciences Leads Latest Fundraising Efforts with $75M Series C Financing
Annexon Biosciences led recent fundraising efforts by ophthalmic companies, raising $75 million in a Series C financing. Other firms with financing deals included Outlook Therapeutics, which raised...
January 2019 Ophthalmic News Briefs
EyePoint Set to Launch Dexycu, Yutiq in Q1-2019 Massachusetts-based EyePoint Pharmaceuticals announced Jan. 3 that it expects to launch Dexycu and Yutiq in Q1-2019, moving up the timeline from the ...
US FDA Accepts IND Application for Aerie’s AR-1105, a Dexamethasone Intravitreal Implant
The US FDA has approved Aerie Pharmaceuticals’ investigational new drug (IND) Application for AR-1105 (dexamethasone intravitreal implant) for macular edema due to retinal vein occlusion (RVO), the...
Glaukos Moving to Aliso Viejo from San Clemente
Glaukos will move its headquarters in May to Aliso Viejo, California, from San Clemente, California, according to an SEC filing. The company will lease three existing office buildings in Aliso Viej...
Ocular Therapeutix Seeks to Expand Dextenza’s Indication
Ocular Therapeutix has submitted a supplemental new drug application (sNDA) to the US FDA for Dextenza, the Bedford, Massachusetts, company announced Jan. 10. The sNDA seeks to expand the product’s...
Aerpio Completes Patient Dosing in Phase IIb Study for Diabetic Retinopathy Candidate
Aerpio Pharmaceuticals has completed patient dosing in its Phase IIb clinical trial of AKB-9778 for severe nonproliferative diabetic retinopathy (NPDR), the Cincinnati company announced Jan. 17. AK...
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FDA Accepts Xbrane’s Application to Begin Study of Xlucane, a Biosimilar of Lucentis
Xbrane reported Jan. 18 that the US FDA accepted the company’s application for a pivotal Phase III trial of Xlucane as a biosimilar to Lucentis in patients with wet age-related macular degeneration...
Akorn Receives US FDA Warning Letter Citing Plant Violations
Akorn has received a warning letter from the US FDA after an inspection of its Decatur, Illinois, manufacturing plant, the Lake Forest, Illinois, company announced Jan. 9. The warning letter lists ...
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Flexion Announces Positive Results for Phase II Trial of Zilretta
Massachusetts-based Flexion Therapeutics announced Jan. 2 that its Phase II pharmacokinetic study of Zilretta for OA of the shoulder and hip achieved positive results. Zilretta is the only extended...
Thirty-year Data for Lumbar Fusion With Silicon Nitride
SINTX Technologies announced Jan. 3 that independent research indicated positive 30-year results for silicon nitride implants used for lumbar fusion. The study was led by Ralph Mobbs, MD, and resul...
Miach Appoints Shadan President and CEO
Miach Orthopedics, based in Massachusetts, announced Martha Shadan as its new president and CEO on Jan. 3. Shadan has served as executive chairwoman since September 2018. Before joining Miach, Shad...
Factory-CRO Group and Boston Biomedical Merge
Netherlands-based Factory-CRO Group and Boston Biomedical Associates announced their merger on Jan. 7. Factory-CRO Group recently completed acquisitions of MileStone Research Organization, Five Cor...
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Study Compares InSpace Balloon to Superior Capsular Reconstruction
A recent cadaveric study compared OrthoSpace Ltd’s InSpace balloon spacer to superior capsular reconstruction for massive rotator cuff tears (RCTs). Israel-based OrthoSpace announced Dec. 19 that t...
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Orthopedic US 510(k) Clearances
There were 66 US FDA regulatory clearances in the past 30 days. Forty-five percent of these clearances were for spinal implants. Spine fixation devices included three cervical plates from Atlas Spi...
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Global Demand for Spine Surgery Growing With Access to Care
Global demand for spine surgery is expected to grow at a compound annual rate of 9.7 percent from 2018 to 2023, with annual surgical volume increasing from 3.6 million to 4.3 million procedures. De...
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Double-Network Hydrogel Shows Promise for Meniscus Repair
Doctors have long sought a solution for meniscal tears. A new compound may solve issues faced by current treatment methods. The fibrocartilage of the meniscus is crucial for shock absorption and st...
Monthly Fundraising
The overall value of the orthopedic market increases when companies obtain money from outside sources such as public market fundraising or grants. The goal of this feature is to track the influx of...
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Chinese Policy Changes
Made in China 2025 is a strategic, 10-year plan that began in 2015 with the goal of increasing the Chinese-made content of certain domestic products to 40 percent by 2020 and 70 percent by 2025. Th...
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Overhaul of 510(k) Pathway Aims to Support Modern Technology and Patient Safety
Scott Gottlieb, MD, and the director of the Center for Devices and Radiological Health (CDRH), Jeff Shuren, MD, announced plans on Nov. 26 to revise the 510(k) process, which is part of the FDA’s M...
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Neurostimulation for Spinal Fusion
A relatively common cause of spinal fusion failure is non-union, or pseudarthrosis. Approximately half of fusion revisions are due to pseudarthrosis. Electrostimulation may be an appropriate treatm...
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Trends in Pediatric Opioid Use
Opioids are effective analgesics, but they are also highly addictive and have resale value, which invites abuse. One segment of opioid users that is not commonly evaluated is the pediatric populati...
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Is Outpatient Joint Replacement Surgery More Than an Aspiration?
The US Centers for Medicare and Medicaid Services (CMS) removed total knee replacement surgery from its inpatient-only list in 2018 to encourage outpatient surgery. A similar ruling for total hip a...
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Oculis Raises $15.8 Million in Series B Extension, Licenses Ophthalmic Candidate from Novartis
Oculis announced Jan. 4 that it has raised CHF15.5 million ($15.8 million) in an extension of its Series B financing—bringing the total raised in the round to CHF35.5 million ($36.2 million). Oculi...
Smith & Nephew Acquires Ceterix
London-based Smith & Nephew announced Dec. 18 that it has acquired Ceterix Orthopaedics for up to $105 million ($50 million up front and $55 million installments based on performance). Ceterix deve...
Kala Launches Inveltys, Hires Ophthalmology Sales Organization
Kala Pharmaceuticals has launched Inveltys, a twice-daily ocular corticosteroid indicated for the treatment of postoperative inflammation and pain, the Waltham, Massachusetts company announced Jan....
Regenexx Research Shows Cell-Based Therapy Is Effective for Knee OA
Colorado-based Regenexx shared Dec. 21 that positive results for its cell-based therapy for knee OA were published in the December issue of the Journal of Translational Medicine. The study of 48 pa...
Katalyst Files FTC Complaint Against Iridex over RFID Technology in Laser Systems
Katalyst Surgical announced Jan. 3 that it has filed a complaint with the US Federal Trade Commission against Iridex Corporation, claiming Iridex is using radio-frequency identification (RFID) tech...
US FDA Sends Warning to Stem Cell Product Provider
The US FDA announced Dec. 20 that it sent a letter of warning to Genetech Inc for marketing umbilical stem cell products without FDA approval. Genetech also failed to follow current good tissue pra...
Takeda Completes Shire Acquisition; Xiidra’s Future Unclear
Takeda CEO Christophe Weber told investors they should expect the pharmaceutical company to sell assets in 2019 to reduce debt after completing a $62 billion acquisition of Shire on Jan. 7, accordi...
Ophthotech Names Calvin Roberts, MD, to Board
Ophthotech Corporation has named Calvin Roberts, MD, to its board, the New York-based company announced Jan. 2. Roberts is a senior vice president and chief medical officer of eye care at Bausch He...
Orca Health Launches Waiting Room Education Platform
Orca Health, based in Salt Lake City, announced Dec. 18 that it launched an interactive patient content platform called Waiting Room. The platform provides interactive information on diagnosis, tre...
Allergan’s Bimatoprost SR Meets Endpoint in Second Phase III Glaucoma Study
Allergan reported Jan. 7 that its Bimatoprost SR implant met its primary endpoint of noninferiority to timolol in a second Phase III trial in open-angle glaucoma or ocular hypertension, mirroring p...
BridgeHealth and Hinge Health Partner to Provide Musculoskeletal Care
Denver-based BridgeHealth announced Dec. 20 that it is partnering with Hinge Health to provide digital care for common musculoskeletal (MSK) conditions such as knee OA and low back pain. The care p...
NeuBase Therapeutics Reverse Merges with Ohr Pharmaceutical
Ohr Pharmaceutical on Jan. 2 entered a definitive merger agreement with NeuBase Therapeutics, under which the stockholders of NeuBase will own 80 percent of the new combined company, according to a...
Aerie Pursues Approval for Netarsudil Ophthalmic Solution in Japan
Aerie Pharmaceuticals said it will initiate a Phase II clinical trial for netarsudil ophthalmic solution—marketed as Rhopressa in the US—in Japan in Q1-2019. The Durham, North Carolina, company not...
Aura Outlines Phase III Program for AU-011 in Choroidal Melanoma
Aura Biosciences provided an outline Jan. 4 for its Phase III program for AU-011 in choroidal melanoma after getting a green light from the US FDA. The Cambridge, Massachusetts, company said the pr...
BioTime, Orbit to Study Using Injection Technology with OpRegen in Dry AMD Patients
BioTime and Orbit Biomedical have entered a research and option agreement to study the use of Orbit’s injection technology to deliver BioTime’s OpRegen to the subretinal space. California-based Bio...
Global Demand for Refractive Surgery Growing After Economic Rebound in Major Markets
Global demand for refractive surgery is expected to grow at a compound annual rate of 5.2 percent from 2018 to 2023, with annual surgical volume increasing from 4.3 million to 5.5 million procedure...
Health Canada Approves Bausch + Lomb’s Vyzulta for Glaucoma
Health Canada has approved Vyzulta for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, Bausch + Lomb announced Jan. 3. Vyzulta (latanoproste...
Apellis to Restart Phase III Trials in GA in Q2-2019
Apellis Pharmaceuticals announced Dec. 20 that it plans to restart enrollment in its Phase III studies for APL-2 in geographic atrophy (GA) in Q2-2019, and it expects to complete enrollment by the ...
Xbrane Files FDA Application to Begin Study of Xlucane, a Biosimilar of Lucentis
Xbrane reported Dec. 19 that it has filed an application with the US FDA for a pivotal Phase III trial of Xlucane as a biosimilar to Lucentis in patients with wet age-related macular degeneration. ...
US FDA Accepts for Review Kala’s NDA for Dry Eye Candidate
The US FDA has accepted for review Kala Pharmaceuticals’ new drug application (NDA) for its dry eye candidate and set a target action date of Aug. 15, the Waltham, Massachusetts, company announced ...
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