Category: Medicine

In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora, discusses the unique challenges that developers of cell and gene therapies need to plan for when…

In this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, explains which specific endpoints they’ll be looking at in the Phase I trial to assess LP-284’s potential efficacy and how the…

RxLink will incorporate Cost Plus’ prices into its drug pricing platform MedMap.

Joint venture aims to develop up to 10 new cell and gene therapy products targeting areas with high unmet medical needs.

Significant findings included a 100% biochemical recurrence-free rate at 24 months post-surgery in patients with high-risk localized prostate cancer.

Myhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients.

The two companies will work together to develop gene therapies in oncology.

In this Pharmaceutical Executive video interview, Chris Martin, Chief Commercial Officer, Verona Pharma, discusses which skills or experiences he thinks are most valuable for team members tasked with launching a novel treatment…

The latest news for pharma industry insiders.

Deal includes a number of radioligand therapies targeting solid tumors, such as breast, prostate, and lung cancers.

In this Pharmaceutical Executive video interview, Jesse Mendelsohn, senior vice president at Model N, talks about the influence of Medicare Part D drug price negotiations on manufacturer go-to-market strategies and decision-making, and…

In an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora, offers a synopsis on what questions cell and gene therapy developers need to answer to inform…

Currently in Phase III of clinical trials, eneboparatide has shown promise in normalizing key calcium levels and improving bone health in patients with hypoparathyroidism.

Partnership expected to utilize Walgreens’ pharmacies as recruitment and trial sites for a clinical study regarding obesity, weight issues, and type 2 diabetes, mainly in historically underrepresented groups.

In this Pharmaceutical Executive video interview, Jesse Mendelsohn, senior vice president at Model N, discusses the changing dynamics today for companies in revenue management and planning—and the increasing importance of a well-tooled…

New formulation of Cyltezo aims to complement the existing low-concentration formulation and offer more treatment options for various chronic inflammatory diseases.

Approval of Tivdak was based on promising results from a Phase III innovaTV 301 clinical trial, which demonstrated a 30% reduction in the risk of death in patients with recurrent or metastatic…

Treatment marks the first dissolving stent approved in the United States for treating chronic limb-threatening ischemia in arteries below the knee.

Hercessi marks Accord BioPharma’s first biosimilar to be approved in the United States, with multiple indications for HER2-overexpressing breast and gastric cancers.

Approval of Libervant marks the first orally administered rescue medication for this age group to be cleared by the FDA for epilepsy.

Melton, customer advocacy executive at Magnolia, discusses how new technologies can be used to ensure data is accurate.

The center will offer local residents with opportunities and training to enter the pharmacy work force.

In this Pharmaceutical Executive video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One, discusses what other tactics healthcare marketers can utilize to connect with diverse audiences on a deeper level

Beqvez, a one-time gene therapy, offers hope to patients with moderate to severe hemophilia B who use regular factor IX prophylaxis, suffer severe hemorrhages, or recurrent serious bleeding.

In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a look at the organization’s pipeline.

Approval update comes as a result of findings from Study 5310, which addressed Biktarvy’s pharmacokinetics, safety, and efficacy during pregnancy and postpartum periods in patients with HIV.

Pivya has shown efficacy against bacteria strains such as Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus.

Companies reported that the new formulation of Coartem met required pharmacokinetic profiles and displayed promising efficacy and safety treating malaria in infants.

In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a preview on what the nexts steps are after presenting positive data on Coya 302…

Company aims to provide affordable emergency treatment from overdoses of heroin, fentanyl, and prescription opioids.

Lutathera is the first FDA-approved treatment for younger patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Approval comes amid positive results of a single-arm trial, showing a complete response rate of 77% in patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.

Industry executives dive into trends like utilizing AI and influencers for content creation, personalizing messages to the patient, combatting the spread of misinformation and much more in the video version of our…

Per the agreement, Cellares will integrate and automate some of Bristol Myers Squibb’s CAR T-cell therapies into its Cell Shuttle program.

In an interview with Pharm Exec Associate Editor Don Tracy, Lene Oddershede, SVP, Natural & Technical Sciences, Novo Nordisk Foundation offers a synopsis of upcoming projects from the Novo Nordisk Foundation.

Rahman discusses the new opportunities that digital twins present to researchers.

Data from the Phase III ALINA trial show that Alecensa reduced the risk of disease recurrence or death by 76% vs. platinum-based chemotherapy in patients with completely resected IB to IIIA ALK-positive…

Approval was based on positive data from Takeda’s Phase III VISIBLE 2 study, which displayed long-term clinical remission in approximately half of patients with Crohn disease receiving Entyvio.

Acquisition includes rights to marketing in the European Economic Area, Thailand, South Korea, and other regions for oral treatment of mild to moderately severe dementia associated with Alzheimer disease.

While human infections of the virus are rare, a strain recently appeared in dairy cows before infecting a human in Texas.

According to results of the study, 46% of patients with giant cell arteritis administered Rinvoq achieved sustained remission from weeks 12 to 52.

Importing drugs from Canada may increase the risk of US citizens being exposed to unsafe medicines.

With a final decision expected next February, MenABCWY combines the protective elements of GSK’s existing vaccines to target the five primary serogroups of Neisseria meningitidis.

Click the title above for a link to open the Pharmaceutical Executive April 2024 issue in an interactive PDF format.

Butta discusses how new technologies are being implemented in at-home devices.

Amid lingering questions and uncertainty, a look at ways pharma companies can prioritize incorporating the Inflation Reduction Act into their strategic planning process—and do it now.

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses why their drug isn’t experiencing the same supply issues as the bigger names in the space.

Damien Bailly, president of established markets at Astellas, discusses why partnerships and collaborations are a critical organizational—and wider ecosystem—imperative in ensuring that patients have access to the medicines they need.

The takeover is contingent upon a minimum acceptance rate of 65% and other conditions outlined in the offer document.

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses factors that are contributing to ongoing supply issues and if prices for these therapies are coming down anytime soon.

Elliott Yoo, Senior Media Strategist at epocrates, takes a closer look at the trends in CME consumption and what the future of medical education will be – from the priorities for physicians…

Pharma companies and RPM manufacturers must work together to find solutions to make DCT more commonly available.

Partnership also includes an agreement for Arvinas to sell its preclinical AR-V7 program to Novartis.

Why this role provides a critical ‘boot camp’ for future pharma leaders.

New methods allow the antiseizure treatment to be crushed and mixed with water for oral suspension or for use through a nasogastric tube.

Treatment was initially approved in 2017 for the same indication in children aged 12 and up.

Joint venture aims to implement Invenra’s B-Body bispecific antibody platform to enhance Astellas’ research and development efforts.

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses how access to these weight loss drugs can help the obesity epidemic.

Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis.

A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT (xanomeline-trospium) in providing symptom improvement for people with schizophrenia.

Dovato is the first oral, two-drug, single-tablet regimen approved for patients 12 years of age and older who are living with HIV-1.

According to the letter, the FDA believes that the investigational apomorphine infusion device is not ready for approval in its current form.

The latest news for pharma industry insiders.

FDA’s program will provide guidance to the development of the company’s Delphi-MD technology.

Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who…

In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses their drug Contrave and the data they have to show after a 10 years in the weight loss/obesity space.

The deal, which is worth approximately $13.1 billion, is part of J&J MedTech’s goal to expand into high-growth markets.

Decision to discontinue marketing authorizations for Relyvrio/Albrioza comes as a result of topline results from the Phase III PHOENIX trial in patients with amyotrophic lateral sclerosis.

Early results have demonstrated that mRNA-3927 has led to a 70% reduction in the relative risk for metabolic decompensation events in patients with propionic acidemia.

Agreement comes as Teva aims to strengthen its biosimilar portfolio as part of its “Pivot to Growth” strategy.

Fanapt was previously approved by the FDA in 2009 as an antipsychotic treatment for schizophrenia.

Approval comes amid positive results from TRILUMINATE trial, which demonstrated improvement in 90% of participants treated for a leaky tricuspid heart valve.

The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says.

Approval would mark first HER2-targeted therapy for biliary tract cancer in the United States.

The network will work with DiRx and MakoRX.

Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis.

The latest news for pharma industry insiders.

In this week’s episode, in recognition of international women’s month, Editor Miranda Schmalfuhs has compiled audio clips from interviews with female KOLs that she’s been fortunate enough to speak with over this…

Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies.

Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy.

The news comes less than a year after Pfizer announced that IPG would handle this role.

The study used technology developed by a variety of companies, including RYLTI.

Both products are designed to help radiologists.

In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses how healthcare providers and patients navigate the potential benefits and uncertainties associated with a medication approved through the accelerated…

Action marks the first FDA-approved blood screening test for malaria.

Winrevair is the first FDA-approved activin signaling inhibitor therapy for pulmonary arterial hypertension.

Reportedly, the oral weight loss pill VK2735 showed promising signs of effectiveness and a tolerable safety profile.

Rare Disease Biotech Landscape

In this Pharmaceutical Executive video interview, Marie Teil, Global Head of UCB’s Women of Childbearing Age Program, talks about the program’s creation and their most successful strategies for encouraging the inclusion of…

Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are positive for the anti-aquaporin-4 antibody.

The agency released guidelines for vaccinations guidelines for children as young as 6 months old.

The latest news for pharma industry insiders.

Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of age and older with…

Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings.

The drug was recently cleared to treat cardiovascular risks, making it eligible for Medicare Part D.

In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses the three drugs featured in their Drug Pipeline Insights Report for 2024 and which unmet needs they address.

Cold Spring Harbor Laboratory details how the new tool will help reduce common barriers to trial participation.

In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, talks about what’s coming marketing with the use of AI.

Using the 3 Rs to guide AI transformation in Pharma.

Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies.

Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.

The commitment to advancing the fields of oncology and nuclear medicine is not just about adopting new technologies, but also about embracing a more profound change in how care is delivered.

In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment.

In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, discusses the impact AI will have on thelong-term well-being of founders and CEOs.

As part of the partnership, BeiGene will serve as a sponsor at LLS events.

The latest news for pharma industry insiders.

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) was granted accelerated approval for the treatment of adult patients with noncirrhotic nonalcoholic steatohepatitis (NASH).

CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) approved for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered at least two lines of therapy.

In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses why no novel active substances have yet been brought to market through AI…

Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors.

Acquisition is highlighted by eneboparatide, Amolyt’s Phase III peptide for hypoparathyroidism with a novel mechanism of action.

Ian Baer, Founder and Chief Soothsayer, Sooth, discusses how pharmaceutical companies and healthcare advertising agencies can adapt their strategies to attract Gen-Z.

The voluntary recall was ordered due to potential silicon particulate exposure.

A look at pharma and biotech financing, M&A, and stock market performance in 2023—and where developments may head next as company executives continue to navigate stormy but perhaps stabilizing waters in the…

Four steps to maximize the impact of medical information services as an engagement gateway.

Matt Abrahams, a Lecturer in Organizational Behavior at Stanford University’s Graduate School of Business, discusses the importance for job seekers of investing time on qualitative skills, such as communications.

Regeneron’s PCSK9 inhibitor approved to reduce low-density lipoprotein cholesterol in patients 8 years of age and older with heterozygous familial hypercholesterolemia.

In this Pharmaceutical Executive video interview, Chris Dowd, senior vice president of market development, ConnectiveRx, discusses the evolution of drug copay adjustment programs and the circumstances that fueled their controversy across industry,…

BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies.

Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic…

In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics discusses how the data integrity landscape will evolve over the next five years and what extent bench scientists…

Relyvrio did not significantly alter amyotrophic lateral sclerosis disease progression as measured by the ALSFRS-R total score at Week 48 compared to placebo.

FDA approves Wegovy (semaglutide) to lower the risk of major adverse cardiovascular events in adults with known heart disease and with either obesity or overweight, in addition to a reduced calorie diet…

Anderson discusses how AI can be used to take data collected by different processes and bring it into a usable format.

Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.

The latest news for pharma industry insiders.

The company plans to spend the coming years strengthening its market position and pipeline while also clearing its issues with litigation and debt.

The latest news for pharma industry insiders.

The biosimilars Wyost and Jubbonti (denosumab-bddz) were approved as interchangeable products for Prolia and Xgeva for the treatment of osteoporosis, hypercalcemia, and to prevent skeletal-related events associated with bone metastases from solid…

The paper discusses multiple steps the industry can take to ensure that patients have access to these treatments.

Rebranding aims to align company with its parent company and other subsidiaries.

The latest news for pharma industry insiders.

The agency updated its recommendations after a vote by the ACIP advisory committee.

Simon discusses a recent survey ICON conducted with professionals in obesity-related clinical research.

Phase III DAYBREAK study found consistent safety with Zeposia in patients with relapsing forms of multiple sclerosis.

New guidance suggests that CMS may be ramping up Sunshine Act auditing activities, potentially resulting in monetary liability for noncompliant reporting entities.

JAMA commentary suggests that issues such as high costs, access, and equity will stop patients from obtaining GLP-1 agonists to treat obesity.

The agency teamed up with the software company to develop platforms and networks to collect de-identified data.

Cardinal Health report highlights new biosimilar treatments, legislative developments, and multiple industry perspectives.

The trial reportedly showcased significant weight reduction in those treated with VK2735, a dual GLP-1/GIP receptor agonist.

OSE-230 was developed to activate a unique mechanism for resolving chronic inflammation, focusing on modulation of macrophages and neutrophils.

The device can detect potential warning signs of serious conditions.

The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act.

Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses how climate events and COVID-19 have impacted medicine use and spending.

FDA has approved the medication in adults and children with allergies.

SKYTyphoid showed a positive immunogenicity and safety profile compared to other polysaccharide-protein conjugate typhoid vaccines that obtained prequalification certification by the World Health Organization.

Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses key findings from their Global Use of Medicines 2024 report as well as the significant projected growth in spending…

The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27,…

Funds expected to advance multiple programs into clinical studies, including FMC-376, which targets KRASG12C cancers.

The agency issued a statement reminding the public that it has not approved any such devices for this use.

Results of a study conducted by the National Institutes of Health indicate that the Paxlovid prevented a substantial number of hospitalizations associated with COVID-19.

The gallery will be a part of the HLTH Europe event and will be open to all attendees.

Letter emphasizes the need to protect children from potentially harmful medical advice spread on social media.

Papa will take over the over effective immediately.

The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.

Wong discusses trends regarding M&A and how he expects this to continue and change in the coming months.

Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer.

The FDA has also approved Tagrisso (osimertinib) as a monotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), locally advanced or metastatic EGFR…

Amid shifting healthcare cost strategies, how manufacturers can apply past lessons to best support patients and help boost drug adherence.

Investigators harness machine learning to evaluate response to sertraline treatment for major depressive disorder.

How a multipronged approach to staff recruitment can accelerate trial success.

The FDA previously granted accelerated approval to Tepmetko for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.

In an interview with Pharm Exec Associate Editor Don Tracy, Raj Verma, Chief Diversity, Culture, and Experience Officer, Sanofi, discusses features of the company’s support program for patients diagnosed with cancer and…

Iris Kuss, head of clinical development, and Jorge Ortiz, head of medical affairs, discuss the company’s recent presentation at ASCO GU.

Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above.

Looking to hold an advisory board? Here are a few suggestions.

This acquisition will add asthma treatment A1O-001 to GSK’s portfolio.

The campaign, that started in 2012, is back with seven new faces—many of which included messaging about the harms of menthol cigarettes.

Treatment aims to reduce the risk of finger or toe amputation due to frostbite.

Roche halts agreement with Repare Therapeutics to develop and commercialize camonsertib just weeks after triggering a $40 million milestone payment when the first patient was dosed with the novel cancer drug.

Embracing business imperatives such as operational efficiency and a focus on a patient-centric approach can help pharma leaders provide a stable foundation amid lingering uncertainty.

In clinical trials, bepirovirsen showed the potential to address a significant unmet medical need for patients with chronic hepatitis B by reducing hepatitis B surface antigen levels and HBV DNA.

In this video interview with Pharm Exec Associate Editor Miranda Schmalfuhs, Dr. Jo Varshney, CEO & Founder of VeriSIMLife, discusses how artificial intelligence and machine learning can assist in the drug shortage…

Key steps in relationship-building beyond just treatment options.

Novel oral orexin receptor 2 agonist produced statistically significant and clinically meaningful improvements in wakefulness compared with placebo in patients with narcolepsy type 1.

Joint venture aims to submit an Investigational New Drug application to the FDA by early next year for treatment that targets solid tumors.

The use of artificial intelligence (AI) in drug development has been hampered by issues that have caused a gap between AI’s potential and its full utilization in this space.

According to the study conducted by Technavio, North America will contribute to 37% of the expected growth.

BioNTech will invest $200 million and get access to Autolus’ manufacturing sites.

2024 Rare Disease Summit – 3/19-21

2024 Life Sciences Accounting & Reporting Congress

As the market for biosimilars expands, a nuanced approach is needed to balance cost considerations with patient safety and pharmacovigilance efforts.

Data from the ENHANCE-3 trial of magrolimab in combination with azacitidine plus Venclexta showed futility and an increased risk of death in patients with acute myeloid leukemia.

Patients with relapsed or refractory multiple myeloma administered Blenrep combined with bortezomib plus dexamethasone experienced a 59% reduction in the risk of disease progression or death compared with the standard of care.

In a Phase I trial, data suggest that Amgen’s maridebart cafraglutide (MariTide) may allow patients to take lower and less frequent doses over time while still maintaining significant weight loss.

UV1 plus ipilimumab (Yervoy) and nivolumab (Opdivo) produced a statistically significant and clinically meaningful survival improvement in patients with unresectable malignant pleural mesothelioma.

Synchron’s brain-computer interface device is being developed to allow patients with mobility challenges to operate certain technology with their mind.

The biologics license application for afamitresgene autoleucel, an engineered T-cell receptor drug, was assigned a PDUFA date of August 4, 2024.

Novartis rescinds rights to to develop and commercialize multi-tyrosine kinase inhibitor dovitinib due to a material breach by Allarity for lack of financial payment.

The company has struggled to supply the drug to patients due to overwhelming popularity.

The agency issued the warning against three brands of unapproved eyedrops designed to look like an approved brand.

Beyfortus (nirsevimab-alip), a monoclonal antibody that protects against respiratory syncytial virus-associated lower respiratory tract disease, experienced higher than anticipated demand that led to shortages during the 2023-2024 season.

In an interview with Pharm Exec Associate Editor Don Tracy, Shubh Goel, Head of Immuno-Oncology and Gastrointestinal Tumors, US Oncology Business Unit, AstraZeneca, provides her thoughts on the success of the trial.

Rusfertide is currently in a pivotal Phase III clinical trial as a potential first-in-class treatment for polycythemia vera.

DELFI-Tumor Fraction assay was developed to improve noninvasive assessment of tumor burden and monitoring of treatment efficacy and resistance in patients with advanced cancers.

In an interview with Pharm Exec associate editor Don Tracy, Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences, discusses the FDA’s Breakthrough Therapy Designation for PF614-MPAR, which focuses on protecting patients from drug overdoses.

Aduhelm (aducanumab-avwa) was granted accelerated approval by the FDA in June 2021 despite misgivings from the agency’s Peripheral and Central Nervous System Drugs Advisory Committee.

This is Takeda’s second approval in chronic inflammatory demyelinating polyneuropathy this month after the FDA approved HyQvia to protect against relapse of neuromuscular disability and impairment in this patient population.