FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole with Sertraline for Adults with Post-Traumatic Stress Disorder
admin July 28, 2024 ArticleThe supplemental New Drug Application for brexpiprazole in combination with sertraline is supported by data from three randomized clinical trials that evaluated its safety and efficacy in adult patients with post-traumatic stress disorder.
FDA Clears Investigational New Drug Application for Actinium Pharmaceuticals’ Iomab-ACT in Patients with Sickle Cell Disease
admin July 28, 2024 ArticleThe study is expected to evaluate the safety of Iomab-ACT in sickle cell disease patients who are undergoing allogeneic bone marrow transplants.
Imfinzi with Neoadjuvant Chemotherapy Demonstrates Significant Benefit in Event-Free Survival Treating Resectable Non-Small Cell Lung Cancer
admin July 27, 2024 ArticleFDA’s Oncologic Drugs Advisory Committee acknowledged that Imfinzi met its primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer.
FDA Expands Indication of BioMarin Pharmaceutical’s Brineura to Include Children with Neuronal Ceroid Lipofuscinosis Type 2 Disease
admin July 26, 2024 ArticleExpanded indication of Brineura allows for treatment of neuronal ceroid lipofuscinosis type 2 disease in both symptomatic and presymptomatic children.
Sage and Biogen Halt Phase II Study After Novel Drug Shows No Significant Improvement in Treating Essential Tremor
admin July 25, 2024 ArticleMoving forward, Sage Therapeutics and Biogen intend to cease further clinical development of SAGE-324 for essential tremor.
Vivacelle Bio Launches Phase III Clinical Trial for VBI-S to Treat Hypovolemic Septic Shock
admin July 24, 2024 ArticleThe trial is expected to include 40 patients across the United States who haven’t responded adequately to standard hypovolemic septic shock treatments and are on vasopressors.
Johnson & Johnson Submits Supplemental New Drug Application to FDA for Spravato as Monotherapy for Adults with Treatment-Resistant Depression
admin July 23, 2024 ArticleApproval of Spravato would mark the first monotherapy to be available on the market for treatment-resistant depression in the United States.
The two companies will continue to collaborate on the use of machine learning in improving precision medicine development.
This is the latest approval for Phathom Pharmaceutical’s GI treatment.
Pharma Pulse 7/19/24: Sentiments Surrounding At-Home Diagnostic Testing, Smaller Drugmakers Step Up Hunt for Acquisitions & more
admin July 21, 2024 ArticleThe latest news for pharma industry insiders.
Is There a Correlation Between Medical Debt and Delayed Mental Health Care in the United States?
admin July 20, 2024 ArticleJAMA study aims to determine whether financial barriers impact access to mental health services.
CT-996 Demonstrates Significant Weight Loss in Patients with Obesity and Type 2 Diabetes
admin July 19, 2024 ArticleTreatment with CT-996 led to a significant placebo-adjusted mean weight loss of 6.1% within four weeks in participants with obesity but without type 2 diabetes.
Pharma Pulse 7/18/24: Improving Medication Reconciliation Accuracy, Synchron Says AI Will Be Instrumental for Devices & more
admin July 18, 2024 ArticleThe latest news for pharma industry insiders.
Ripston discusses the Biospecimen Management Consortium and how its working to develop best practices for driving sample excellence.
SOTIO Biotech, Biocytogen Ink Research and License Agreement to Develop Next-Generation Antibody-Drug Conjugates
admin July 17, 2024 ArticleThe agreement enables SOTIO to license multiple fully human bispecific antibodies from Biocytogen’s RenLite platform.
Anthem Blue Cross and Allied Pacific IPA Announce Partnership with Astrana Health Inc.
admin July 16, 2024 ArticleThe two companies will use Astrana’s technology offerings to improve access.
FDA Grants Fast Track Designation to Sumitomo Pharma’s Novel Treatment for Patients with Relapsed or Refractory Acute Myeloid Leukemia
admin July 16, 2024 ArticleDSP-5336 targets the menin and mixed-lineage leukemia protein interaction, crucial in various biological processes, including cell growth and genomic stability.
Congress, Have a More Thoughtful, Bipartisan Pandemic Post-Mortem
admin July 15, 2024 ArticleCongress and our nation’s public health officials should take the current moment to self-reflect and resolve challenges with public confidence in our public and scientific institutions.
The AscellaHealth CEO discusses how new technologies are increasing the options in patient care.
Drug Shortages May Have a Compounding Solution: Q&A with Shawn Hodges
admin July 14, 2024 ArticleThe CEO of Revelation Pharma discusses how compounding pharmacies may help solve the ongoing issue with drug shortages.
Pharma Pulse 7/12/24: The Relationship Between Patients and Drug Shortages, Rise of the Restaurant Robots & more
admin July 14, 2024 ArticleThe latest news for pharma industry insiders.
Cohort Study Compares Weight Loss Effects of Tirzepatide vs. Semaglutide
admin July 13, 2024 ArticleJAMA study aims to discover how weight loss differs between patients receiving tirzepatide compared with semaglutide among a clinical population of overweight of obese adults.
Advancements in periodontal disease could make way for expansions in the dental space and other medical fields.
Amylyx Pharmaceuticals Acquires Phase III-Ready GLP-1 Receptor Agonist Avexitide for Hyperinsulinemic Hypoglycemia from Eiger BioPharmaceuticals
admin July 12, 2024 ArticleAvexitide has received Breakthrough Therapy Designation by the FDA for post-bariatric hypoglycemia, congenital hyperinsulinism, and more.
Dr Peter Wahl, MLA, MS, Global Head of Scientific Affairs at CorEvitas, part of Thermo Fisher Scientific, covers key considerations for choosing registries.
Artificially Discovering New Molecules and Indications: Q&A with Dr. Jo Varshney
admin July 11, 2024 ArticleDr. Varshney discusses how AI is being used to sort data and discover new molecules and indications for existing drugs.
What Happens to Out-of-Pocket Costs When Patients with Type 2 Diabetes Reach the Medicare Age?
admin July 11, 2024 ArticleJAMA study evaluates changes to out-of-pocket costs and utilization of type 2 diabetes medications once patients reach the age of 65 years.
What is the Secret Sauce to Convert Academic Ideas to Valued Offerings That Prospective Buyers Crave?
admin July 10, 2024 ArticleA Harvard Business School Healthcare Alumni Association Q&A with Penn Center for Innovation’s Michael D. Moisel, MS, MBA.
FDA Approves Cordis’ Vascular Closure Device for Cardiac Ablation Procedures
admin July 10, 2024 ArticleApproval of the Mynx Control Venous vascular closure device was based on results from the ReliaSeal trial, which demonstrated 100% procedural and device success in cardiac ablation procedures.
Acquisition of Morphic is aimed to enhance treatment options for inflammatory bowel disease and expand Lilly’s gastroenterology portfolio.
FDA Grants Full Approval to Johnson & Johnson’s Sirturo for Pulmonary Tuberculosis Caused by Mycobacterium Tuberculosis Resistant to Rifampicin and Isoniazid
admin July 9, 2024 ArticleResults from the Phase III STREAM Stage 2 study show the efficacy and safety of an all-oral bedaquiline-containing regimen for multidrug-resistant pulmonary tuberculosis.
Pharma Pulse 7/8/24: New AI Tech Spurs Excitement/Concerns Among Private-Credit Managers, Future Perspectives on Atopic Dermatitis Treatment & more
admin July 8, 2024 ArticleThe latest news for pharma industry insiders.
FDA Grants Fast Track Designation to Inozyme Pharma’s INZ-701, a Treatment for Patients with ABCC6 Deficiency
admin July 8, 2024 ArticleThe Fast Track designation for INZ-701 was based nonclinical pharmacology data and preliminary safety and efficacy data from the ongoing Phase I/II trial of INZ-701 in adults with ABCC6 Deficiency.
Carvykti Demonstrates Clinically Meaningful Improvement in Patients with Relapsed or Lenalidomide-Refractory Multiple Myeloma After One Line of Prior Therapy
admin July 7, 2024 ArticleResults of the Phase III CARTITUDE-4 study showed that treatment with Carvykti achieved a more significant improvement in overall survival (OS) compared to standard therapies.
The platform is similar to other recent digital platforms in that it is designed to reduce drug costs.
Pharma Pulse 7/3/24: What to Know About New and Future ALZ Drugs, Bridging the Gap Between Innovation and Implementation & more
admin July 6, 2024 ArticleThe latest news for pharma industry insiders.
Pharma Pulse 7/5/24: The Impact of FDA's Diversity Action Plan, Apple Poised to Get OpenAI Board Observer Role & more
admin July 6, 2024 ArticleThe latest news for pharma industry insiders.
Femasys Founder Discusses Femaseed Technology Designed to Support Infertility
admin July 5, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Kathy Lee-Sepsick, Founder, CEO, Femasys, offers a description of how Femaseed works to support women who struggle with infertility.
Pharma Pulse 7/4/24: Colder Temperatures May Worsen Asthma Symptoms, New FDA Approved ALZ Drug to Accelerate New Era of Treatment & more
admin July 5, 2024 ArticleThe latest news for pharma industry insiders.
Michael J. Fox Foundation and Parkinson’s UK Award $5.2 Million to Mission Therapeutics for Research into Potential Parkinson’s Treatment
admin July 4, 2024 ArticleMTX325 is in Phase I trials and is believed to be able to modify the course of the disease.
Health In Tech Announces New Partnerships to Expand Health Insurance Options for Employers in Southern Ohio
admin July 4, 2024 ArticleThe company announced that it has partnered with Adena Health and The Ohio State University Health Plan Solutions.
Moderna Awarded $176 Million from the Biomedical Advanced Research and Development Authority to Expedite Development of mRNA-Based Influenza Vaccines
admin July 3, 2024 ArticleFunding from the Biomedical Advanced Research and Development Authority (BARDA) is expected to support the late-stage development and licensure of a pre-pandemic vaccine targeting the H5 influenza virus.
FDA Approves Lilly’s Kisunla for the Treatment of Early Symptomatic Alzheimer’s Disease
admin July 3, 2024 ArticleKisunla is the first amyloid plaque-targeting therapy that allows for stopping treatment upon plaque removal, company says.
As previously announced, Michael assumed the role on July 1.
FDA Approves New Drug Application for Shorla Oncology’s Tepylute, a Ready-to-Dilute Formulation for the Treatment of Breast and Ovarian Cancer
admin July 2, 2024 ArticleReportedly, the liquid formulation of Tepylute eliminates the need for complex and time-consuming reconstitution, providing consistent dosing accuracy and allowing for timely preparation.
Magnolia Medical Announces New Platform to Reduce Misdiagnosis of Sepsis
admin July 1, 2024 ArticleThe platform utilizes standards set forth in a recently published document from the CDC.
UltraSight Announces Partnership with Butterfly Garden AI-Marketplace
admin July 1, 2024 ArticleUltraSight will join the AI marketplace.
Pharma Pulse 6/28/24: Acupuncture Decreases Hot Flashes, The Benefits of Using AI in Data Management & more
admin June 30, 2024 ArticleThe latest news for pharma industry insiders.
FDA Approves Verona’s Ohtuvayre for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease
admin June 30, 2024 ArticleOhtuvayre is the first inhaled product with a novel mechanism of action for chronic obstructive pulmonary disease to be approved in 20 years.
With CEO Turnover Rising to Record Levels, How Can Incoming, Existing Executives Build a Sustainable Role?
admin June 29, 2024 ArticleA Q&A with Russell Reynolds’ Global Lead of CEO & Executive Transition Practice, Ty Wiggins, PhD.
CDC’s Advisory Committee Unanimously Recommends Vaxelis to Prevent Invasive Hemophilus Influenzae Type B in American Indian and Alaska Native Infants
admin June 29, 2024 ArticleThe inclusion of Vaxelis in the CDC’s preferential recommendations is expected to influence vaccine administration strategies and public health policies in high-risk populations moving forward.
Citius Pharmaceuticals Co-Founder and CEO Discusses the Recently Accepted Biologics License Application of Lymphir for the Treatment of Relapsed/Refractory CTCL
admin June 28, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Leonard Mazur, Co-founder, CEO, Citius Pharmaceuticals, offers an update on the recently accepted Biologics License Application for Lymphir by the FDA and other candidates currently in the Citius pipeline.
FDA Issues Complete Response Letter to Merck and Daiichi Sankyo for Patritumab Deruxtecan for Advanced, Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
admin June 28, 2024 ArticleThe Complete Response Letter was issued as a result of inspection findings at a third-party manufacturing facility, unrelated to patritumab deruxtecan’s efficacy or safety in patients with advanced or metastatic EGFR-mutated non-small cell lung cancer.
Citius Pharmaceuticals Co-Founder and CEO Talks Promising Results from a Phase III Clinical Trial for Mino-Lok, a Treatment Designed to Salvage Catheters in Patients with Central-Line Associated Infections
admin June 27, 2024 ArticleIn an interview with Pharm Exec Associated Editor Don Tracy, Leonard Mazur, Co-Founder, CEO, Citius Pharmaceuticals, discusses recent topline results from the pivotal Phase III Clinical Trial of Mino-Lok, which works to salvage catheters infections.
FDA Accepts Otsuka and Lundbeck’s Supplemental New Drug Application for Brexpiprazole to Treat Adults with Post-Traumatic Stress Disorder
admin June 27, 2024 ArticleResults from three randomized clinical trials show safety and efficacy of a brexpiprazole-sertraline combination in adult patients with post-traumatic stress disorder.
Pharma Pulse 6/26/24: Empowering Women in Pharmacy, AI is Helping Scammers & more
admin June 26, 2024 ArticleThe latest news for pharma industry insiders.
Novo Nordisk to Invest $4.1 Billion in Expanding Manufacturing Capabilities in the United States
admin June 26, 2024 ArticleInvestment is expected to fund a new fill and finish manufacturing facility to enhance production of injectable treatments for obesity and chronic diseases.
Not Just Another Tactic: Why Pharmaceutical Brands Need to Build a Strategy Around Point of Care Messaging
admin June 25, 2024 ArticlePoint of care messaging offers unique advantages in pharmaceutical marketing and should be a high priority in brand strategy discussions.
FDA Approves Harmony Biosciences’ Wakix to Treat Excessive Daytime Sleepiness in Pediatric Patients with Narcolepsy
admin June 25, 2024 ArticleApproval of Wakix marks the first time a non-scheduled treatment option for excessive daytime sleepiness has been approved for patients ages 6 years and older.
NABIP Launches 2025 Medicare and Medicare Advantage Compliance Certification
admin June 24, 2024 ArticleThe online program is required for brokers and agents to sell Medicare Advantage Plans.
Novel Therapy Shows Significant Promise Slowing Parkinson Disease Progression
admin June 24, 2024 ArticleData from an early phase trial published in Nature found that Parkinson disease patients treated with UB-312 experienced significant improvements in motor functions and daily living.
The company announced updates to its software to focus on this issue.
Pharma Pulse 6/21/24: Improving Access to Trials Through Decentralization & Flexible Design, South Africa Runs Out of Insulin Pens & more
admin June 23, 2024 ArticleThe latest news for pharma industry insiders.
FDA Expands Approval of Sarepta Therapeutics’ Elevidys for the Treatment of Duchenne Muscular Dystrophy
admin June 22, 2024 ArticleExpansion of Elevidys includes patients over the age of four years with Duchenne muscular dystrophy regardless of their ambulatory status.
Phase III Trial Data Show Lenacapavir Demonstrated 100% Efficacy Preventing HIV in Cisgender Women
admin June 22, 2024 ArticleResults of the PURPOSE 1 trial indicated that a twice-yearly injection of lenacapavir outperformed the once-daily oral Truvada preventing HIV in cisgender women.
The CTO of Authenticx discusses preventing bias from becoming part of AI models.
Q&A with Evaluate’s Paul Verdin digs deeper into the data-backed drivers likely to sway the future growth and jockeying of biopharma’s top players.
Findings from hundreds of interviews of exceptional pharma leaders around the world.
FDA Approves AbbVie’s Skyrizi for the Treatment of Adults with Moderate to Severely Active Ulcerative Colitis
admin June 20, 2024 ArticleApproval of Skyrizi marks the first IL-23 specific inhibitor approved for both ulcerative colitis and Crohn disease of similar severity, according to AbbVie.
Utilizing Biomarkers to Develop First-in-Class Antibody Drug Conjugates to Treat Advanced Solid Tumors
admin June 19, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Pedro Valencia, VP, Solid Tumor Pipeline Strategy & Execution, AbbVie, discusses using novel cancer biomarkers to develop potential first-in-class antibody drug conjugates (ADCs) and the promise that they offer.
FDA Approves Merck’s Keytruda in Combination with Carboplatin and Paclitaxel to Treat Advanced or Recurrent Endometrial Carcinoma
admin June 19, 2024 ArticleApproval of Keytruda combination for patients with primary advanced or recurrent endometrial carcinoma is based on results from the NRG-GY018/KEYNOTE-868 clinical trial, which was Phase III trial to evaluate an anti-PD-1 immunotherapy plus chemotherapy combination in patients with two distinct tumor types.
New Survey Says Digital Health Care Technology Is Benefitting Payers
admin June 18, 2024 ArticleHealth insurance executives say that digital technologies are getting members more involved in the healthcare system.
Highlighted by notable company and product maneuvering at the top and the continued dramatic growth of therapeutic settings such as GLP-1s, Pharm Exec’s latest listing of the top global biopharma sales producers is proof-positive of an industry in transition.
Our June issue of Pharmaceutical Executive offers a uniquely diverse range of coverage and voices—a “sum-of-its-parts” balance that’s not always easy to pull off.
Click the title above for a link to open the Pharmaceutical Executive June 2024 issue in an interactive PDF format.
Imbruvica Demonstrates Long-Term Efficacy, Safety in First-Line Treatment of Chronic Lymphocytic Leukemia
admin June 15, 2024 ArticleData presented at the European Hematology Association Congress indicated that patients with chronic lymphocytic leukemia treated with Imbrivica had a significantly longer median progression-free survival compared to patients treated with chlorambucil.
Supreme Court Unanimously Rules in Against Challenge to Mifepristone
admin June 14, 2024 ArticleThe court ruled that the plaintiffs did not have standing to sue in this situation.
How pharma and biotech leaders can navigate today’s challenging landscape—focusing on revamped approaches in business operations, talent strategy and development, and more to meet the evolving demands.
Leaders must address the root causes of negative public perception.
Study Suggests Individuals Born Preterm Are More Likely to Have Lower Incomes in Adulthood
admin June 13, 2024 ArticleInvestigators followed a group of people born from 1990-1996 to assess whether the association between preterm birth and income differs according to family socioeconomic status at birth.
FDA Grants Emergency Use Authorization to Roche’s Cobas Liat SARS-CoV-2, Influenza A/B, & RSV Nucleic Acid Test
admin June 12, 2024 ArticleThe cobas is classified as a four-in-one molecular test that can identify SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from a single nasopharyngeal or anterior nasal swab sample.
What pharma needs to do to keep up with the rise in value-based care.
The silver lining: Sector fundamentals continue to be positive.
FDA Approves GSK’s Arexvy to Prevent Respiratory Syncytial Virus in Adults Aged 50-59 with Increased Risk
admin June 11, 2024 ArticleArexvy receives expanded indication to include adults aged 59 years and younger to prevent RSV lower respiratory tract disease.
Independence Blue Cross and Benefits Data Trust Partner to Increase Participation in Public Benefits Programs
admin June 10, 2024 ArticleThe partnership is described as the first of its kind.
Bulevirtide Combination Therapy Shows Efficacy Achieving Undetectable Compensated Chronic Hepatitis Delta Virus RNA
admin June 10, 2024 ArticleData published in the New England Journal of Medicine from Gilead’s Phase IIb MYR204 found the bulevirtide/ pegylated interferon alfa-2a combination was more effective in achieving undetectable HDV RNA compared to bulevirtide 10 mg monotherapy in the treatment of chronic hepatitis D.
In this part of his Pharmaceutical Executive video interview, Brice Challamel, Vice President, AI Products & Platforms, Moderna, discusses their internal AI chatbot tool, mChat, and how the launch of ChatGPT Enterprise changed things.
Pharma Pulse 6/7/24: How Much Does a Day of Delay Really Cost? BranchLab Launches Privacy-Safe Healthcare Advertising Solution & more
admin June 9, 2024 ArticleThe latest news for pharma industry insiders.
Evolution Optiks Receives FDA 510(k) Clearance for LFR-260 as the First Light Field Powered Subjective Tele-Fractor
admin June 8, 2024 ArticleAccording to the manufacturer, the LFR-260 features advanced technology that allows patients to compare multiple prescriptions simultaneously, eliminating the need for traditional refraction methods.
FDA Approves Geron Corporation’s Rytelo to Treat Adults with Lower-Risk Myelodysplastic Syndromes
admin June 8, 2024 ArticleApproval of Rytelo could provide patients with lower-risk myelodysplastic syndromes with extended periods without the need for red blood cell transfusions to alleviate symptomatic anemia.
Deerfield Agency Acquires Embedded, Launches New Life Sciences Marketing Brand
admin June 7, 2024 ArticleThe new agency will operate under the name Deerfield Group, and will also include Verge Scientific Communications.
Now more than two years into launching his alternative and transparent drug payment model, the longtime entrepreneur, in an interview with Pharm Exec, discusses the prescription drug cost landscape and shares his recipe for true disruption to the pharma pricing machine.
Pharma Pulse 6/6/24: 3 in 4 Americans Under 65 Concerned About Future of Medicare, The Future of BYOD Adoption & more
admin June 6, 2024 ArticleThe latest news for pharma industry insiders.
Johnson & Johnson Submits Supplemental New Drug Application to Expand Indication of Prezcobix for HIV-1 in Children at Least 6 Years Old
admin June 6, 2024 ArticleA similar application was also submitted to the EMA for the expanded use of Prezcobix to treat children aged 6 years and older with HIV.
The industry has struggled to recruit talent for years, and the challenge is only getting more difficult. Pharma companies need to recruit differently.
Sarclisa Combination Improves Progression-Free Survival in Patients with Newly Diagnosed Transplant-Ineligible Multiple Myeloma
admin June 5, 2024 ArticleReportedly, data from the IMROZ study marks the first time an anti-CD38 monoclonal antibody combined with standard-of-care therapy has demonstrated significant improvement in progression-free survival for newly diagnosed transplant-ineligible multiple myeloma.
Pharma Pulse 6/4/24: Google Rolls Back AI Search Feature, More GLP-1s are on Their Way & more
admin June 4, 2024 ArticleThe latest news for pharma industry insiders.
Phase III Trial Data Presented at ASCO Show Imfinzi Improves Survival in Limited-Stage Small Cell Lung Cancer
admin June 4, 2024 ArticleResults of the ADRIATIC trial indicated that treatment with Imfinzi after standard-of-care concurrent chemoradiotherapy improves overall survival and progression-free survival in patients with limited-stage small cell lung cancer.
ConcertAI Announces Predictive and Generative AI Platforms for Pharma Industry at ASCO 2024
admin June 3, 2024 ArticleThe platforms are described as being first-in-category for the pharma industry.
Alkermes’ chief information officer discusses how he helped develop and build a welcoming workplace.
Pharma Pulse 5/31/24: OpenAI Says Russia & China Used Its AI in Covert Campaigns, FDA Diversity-Related Documents for Clinical Trials & more
admin June 2, 2024 ArticleThe latest news for pharma industry insiders.
Virtual Therapeutics, Akili Interactive Strike Definitive Merger Agreement Seeking to Improve Mental Health Through Immersive Video Games
admin June 2, 2024 ArticleUnder terms of the deal, Akili will become a wholly owned subsidiary of Virtual Therapeutics, with Akili shareholders receiving $0.4340 per share of common stock in cash.
Understanding the Impact of the Veradigm Network on Value-Based Healthcare Delivery
admin June 1, 2024 ArticleUnderstanding the Impact of the Veradigm Network on Value-Based Healthcare Delivery
Scemblix Shows Improved Major Molecular Response Treating Newly Diagnosed Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
admin June 1, 2024 ArticleResults of a Phase III trial indicated that Scemblix was more effective than standard-of-care tyrosine kinase inhibitors in treating newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
Regeneron Global Program Head of Linvosoltamab Discusses the Potential for Linvosoltamab to Become a Frontline Treatment for Multiple Myeloma
admin May 31, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvosoltamab, Regeneron talks about the possibility of linvoseltamab becoming a frontline treatment for multiple myeloma (MM) as well as the company’s Velocsuite technology.
FDA Approves Tris Pharma’s Onyda XR, a Once-Daily, Extended-Release Oral Suspension for the Treatment of ADHD
admin May 31, 2024 ArticleApproval of Onyda XR marks the first liquid non-stimulant medication for attention-deficit hyperactivity disorder to hit the market in the United States.
Pharma Pulse 5/30/24: Strategies for Conducting Strong, Efficient Peer Reviews of Papers, Smart Bandages Are on the Way & more
admin May 30, 2024 ArticleThe latest news for pharma industry insiders.
FDA Grants Priority Review to Keytruda Combination as a First-Line Treatment for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
admin May 30, 2024 ArticlePriority review designation for Keytruda is based on promising results from the Phase II/III IND.227/KEYNOTE-483 trial, which demonstrated improved overall survival in patients with unresectable advanced or metastatic malignant pleural mesothelioma.
Regeneron Global Program Head of Linvosoltamab Discusses Key Findings of a Phase I/II Trial in Multiple Myeloma
admin May 29, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Karen Rodriguez-Lorenc, Global Program Head of Linvosoltamab, Regeneron talks key findings from the ongoing phase I/II trial of linvoseltamab in multiple myeloma that led to the submission of an FDA Biologics License Application (BLA).
Johnson & Johnson Acquires Numab’s Investigational Antibody for the Treatment of Atopic Dermatitis
admin May 29, 2024 ArticleThe acquisition of a novel therapy for atopic dermatitis includes an all-cash transaction totaling approximately $1.25 billion.
The CEO of AION Labs discusses both the new ways that AI is being implemented in drug development and why Israel is becoming the center of AI development in the pharma industry.
Express Scripts Announces New Independent Pharmacy Focused Strategy
admin May 28, 2024 ArticleThe company is collaborating with CPESN USA to bring more services to customers at independent pharmacies across the country.
Pharma Pulse 5/27/24: New Study on Physician Compensation, Overwork, and Shortage, Evolving Clinical Research & more
admin May 27, 2024 ArticleThe latest news for pharma industry insiders.
Pharma Pulse 5/23/24: Healthcare Services Immigrant Children Need the Most, GoodRx Offers Discounts on Fertility Treatments & more
admin May 27, 2024 ArticleThe latest news for pharma industry insiders.
Leveraging Pre-Approval Information Exchange to Accelerate Product Success, Patient Access: Q&A with Alvana Maliqi
admin May 26, 2024 ArticleCencora’s associate director of value and access strategy for its commercialization strategy & access solutions division discusses the current state of pre-approval information exchanges.
AstraZeneca, Nona Biosciences Strike Global License and Option Deal to Develop Monoclonal Antibodies for Tumor Targeted Therapies
admin May 26, 2024 ArticleUnder terms of the agreement, Nona Biosciences is expected to receive an upfront payment of $19 million, with the potential of up to $585 million in milestones.
Cityblock Health Announces Further Partnerships with Centene Corporation to Bring Value-Based Healthcare to Florida
admin May 25, 2024 ArticleCityblock is partnering with Sunshine Health in Florida.
Degron Therapeutics, Takeda Ink Exclusive License and Collaboration Agreement to Develop Molecule Degraders Targeting Multiple Indications
admin May 25, 2024 ArticleJoint venture expected to utilize Degron’s GlueXplorer platform to identify, validate, and optimize molecular glue degraders.
Pharma Pulse 5/24/24: Counsel Patients on Nutrition and Following a Balanced Diet Complementary to GLP-1s, Neuralink’s First Brain-Implant Patient Stays Upbeat & more
admin May 24, 2024 ArticleThe latest news for pharma industry insiders.
FDA Approves Phase III Trial Protocol for Laekna’s LAE002 Plus LAE001 Combination for the Treatment of Prostate Cancer
admin May 24, 2024 ArticleApproval for the Phase III protocol of LAE002 Plus LAE001 come as a result of posiive Phase II data, which showed promising benefits for metastatic castration-resistant prostate cancer (mCRPC) patients.
Using an Omnichannel Approach for a Successful Product Launch: Q&A with Ryan Quigley
admin May 23, 2024 ArticleInizio’s chief operations officer discusses how pharmaceutical companies are tailoring their product launch strategies to meet the diverse needs of stakeholders.
US Pharma and Biotech Summit 2024: Improving Health Policy After the 2024 Election
admin May 23, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses best-case scenarios for health policy amid the 2024 presidential election.
Pharma Pulse 5/22/24: Effects of the FTC's Repeal of Non-Competes on Pharma Industry, Does Legalizing Cannabis Increase Adolescent Use? & more
admin May 22, 2024 ArticleThe latest news for pharma industry insiders.
US Pharma and Biotech Summit 2024: Artificial Intelligence and Machine Learning Through the Eyes of the FDA Part II
admin May 22, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Tala Fakhouri, at Financial Times’ US Pharma and Biotech Summit, Tala Fakhouri, Associate Director for Policy Analysis, FDA, discusses whether the FDA plans on restricting the use of AI and what the future could look like when it comes to machine learning.
Experts discuss how attempts to solve the drug pricing problem in the US are working.
US Pharma and Biotech Summit 2024: The 2024 Presidential Election and the Pharma Industry
admin May 21, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Robert Zirkelback, Chief Public Affairs Officer, Head of Strategic Initiatives, PhRMA discusses the upcoming United States presidential election and the potential impact that it could have on the pharma industry.
US Pharma and Biotech Summit 2024: The Impact of the Presidential Election
admin May 20, 2024 ArticleExperts discuss how the upcoming election is impacting the pharma industry, and how either party’s victory could change the landscape in the following years.
With Layoffs Continuing in 2024 and Employees Paralyzed by Fear for Their Jobs, How Can Leaders Address Crucial Real Problems?
admin May 20, 2024 ArticleA Q&A with Professor Frances Frei of the Harvard Business School, who discusses how leaders create the conditions for organizations and individuals to thrive by designing for excellence in operations, strategy, and culture.
FDA Grants Accelerated Approval to Amgen’s Imdelltra for the Treatment of Adults with Extensive-Stage Small Cell Lung Cancer
admin May 19, 2024 ArticleImdelltra (tarlatamab-dlle) is the first T-cell engager therapy approved for extensive stage small cell lung cancer.
Tala Fakhouri spoke at the conference about FDA’s approach to determining when it even needs to regulate the usage of AI in the pharma industry.
US Pharma and Biotech Summit 2024: Getting Pharma Ready for Generation Alpha
admin May 18, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Carmen Villar, VP, ESG & Corporate Citizenship, Gilead Scienes discusses the changes expected in the pharma industry that will come with the entry of younger professionals.
KOLs in the sector examine the current dealmaking landscape, including the status of available capital.
Pharma Pulse 5/17/24: AI & ML Through the Eyes of the FDA, Johnson & Johnson to Acquire Proteologix & more
admin May 17, 2024 ArticleThe latest news for pharma industry insiders.
US Pharma and Biotech Summit 2024: Artificial Intelligence and Machine Learning Through the Eyes of the FDA
admin May 17, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy at Financial Times’ US Pharma and Biotech Summit, Tala Fakhouri, Associate Director for Policy Analysis, FDA, discusses the use of artificial intelligence and machine learning in drug development.
EmpiRx Announces New AI-Powered Platform as Part of Push to Change PBMs
admin May 16, 2024 ArticleThe platform will use AI technology to provide pharmacists with more tools.
Novo Holdings Acquires Majority Share of Single Use Support to Expand Life Science Tools, Diagnostics Portfolio
admin May 16, 2024 ArticleNovo Holdings is expected to acquire 60% of Single Use Support, with the remaining shares being held by Danaher and the company founders.
Leveraging Lessons from Commercialization and Distribution of Rare Products for Cell and Gene Therapy
admin May 15, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Melissa Lattanzi, VP, Emerging Therapies, Cencora discusses ways that cell and gene therapy developers can follow examples from the commercialization and distribution of orphan drugs.
Click the title above for a link to open the Pharmaceutical Executive May 2024 issue in an interactive PDF format.
Cencora VP of Emerging Therapies Talks Innovative Order-to-Cash Solutions for Cell and Gene Therapies
admin May 14, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Melissa Melissa Lattanzi, VP, Emerging Therapies, Cencora discusses the process of coming up with can innovative order-to-cash solutions help to maximize market reach.
Industry experts, in a roundtable discussion, explore the evolution of brand engagement in the age of AI, including the growing importance of message relevance—and, for pharma, going where the information is.
Study Demonstrates Potential of Psilocybin as an Antidepressant Compared with Non-Psychoactive Drugs
admin May 13, 2024 ArticleStudy findings indicated that psilocybin can reduce the symptoms of depression, with response and remission rates showing significant support.
Improving the US Supply Chain for Better Patient Outcomes
From Big Pharma to biotech—and a globe-spanning journey along the way—Yvonne Greenstreet, this year’s Healthcare Businesswomen’s Association Woman of the Year, is right where she wants to be: leading efforts to advance “bold ideas” in RNAi therapeutics into life-changing gains for patients.
Addressing Unmet Needs with LP-284 for Relapsed/Refractory Lymphomas and Solid Tumors
admin May 12, 2024 ArticleIn this Pharmaceutical Executive video interview, Panna Sharma, CEO, Lantern Pharma, discusses how LP-284 uniquely addresses unmet needs compared to existing or emerging treatments for relapsed/refractory lymphomas and solid tumors.
Now-unclear timing on rate cuts puts onus back on fundamentals.
A greater shift from paper records and physical assets is achievable.
Pharma Pulse 5/10/24: Medicare Advantage, Racing Along, Hits Some Speed Bumps, Anti-Obesity Drugs Global Strategic Business Report & more
admin May 10, 2024 ArticleThe latest news for pharma industry insiders.
Flagship Pioneering, Metaphore Biotechnologies Strike Deal with Novo Nordisk to Develop High-End Obesity Treatments
admin May 10, 2024 ArticleThe collaboration is a part of a broader strategy to combat cardiometabolic and rare diseases.
Michael Jordan and Novant Health Open New Facility in Basketball Player’s Hometown
admin May 9, 2024 ArticleThe new care center will offer primary care services to uninsured and underinsured patients in the Wilmington, North Carolina, area.
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 insights gained will be fed back into RADR®
Pharma Pulse 5/8/24: 5 Facts You Should Know About HIV PrEP, OpenAI Releases ‘Deepfake’ Detector & more
admin May 8, 2024 ArticleThe latest news for pharma industry insiders.
AstraZeneca Finalizes Equity Investment, Research Collaboration with Cellectis
admin May 8, 2024 ArticleJoint venture aims to develop up to 10 new cell and gene therapy products targeting areas with high unmet medical needs.
Pharma Pulse 5/7/24: Challenges With Feasibility Studies, AI Has ‘Enormous Potential for Harm’ & more
admin May 7, 2024 ArticleThe latest news for pharma industry insiders.
FDA Approves Azurity Pharmaceuticals’ Myhibbin as an Oral Suspension for Organ Transplant Recipients
admin May 7, 2024 ArticleMyhibbin is reportedly the first FDA-approved liquid formulation of mycophenolate, a key immunosuppressant used to prevent organ rejection in transplant recipients.
NJ Doctor Becomes First In State to Use PathKeeper Surgical Navigation System on Patient
admin May 6, 2024 ArticleDr. Lewis used the AI-powered device on a patient with severe lumbar stenosis.
Poseida Therapeutics Enters into Partnership with Astellas Subsidiary Xyphos
admin May 6, 2024 ArticleThe two companies will work together to develop gene therapies in oncology.
FDA Grants Fast Track Designation to Amolyt Pharma’s Eneboparatide to Treat Hypoparathyroidism
admin May 5, 2024 ArticleCurrently in Phase III of clinical trials, eneboparatide has shown promise in normalizing key calcium levels and improving bone health in patients with hypoparathyroidism.
Novartis Set to Acquire Mariana Oncology to Enhance Radioligand Therapy Pipeline
admin May 5, 2024 ArticleDeal 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 the industry’s response to the wider dialogue on pricing transparency.
Cencora VP of Emerging Therapies Discusses Cell & Gene Therapy Distribution Strategies
admin May 4, 2024 ArticleIn 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 their distribution strategy.
Pharma Pulse 5/3/24: Wegovy Sales More Than Double, The Effects of the IRA & more
admin May 3, 2024 ArticlePharma Pulse 5/3/24: Wegovy Sales More Than Double, The Effects of the IRA & more
Walgreens, Boehringer Ingelheim Agree to Collaboration on Enhancing Clinical Trial Diversity
admin May 3, 2024 ArticlePartnership 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, 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 in a competitive market.
FDA Approves High Concentration, Citrate-Free Version of Cyltezo, Boehringer Ingelheim’s Humira Biosimilar for Chronic Inflammatory Diseases
admin May 2, 2024 ArticleNew formulation of Cyltezo aims to complement the existing low-concentration formulation and offer more treatment options for various chronic inflammatory diseases.
In this Pharmaceutical Executive video interview, Chris Martin, Chief Commercial Officer, Verona Pharma, discusses specific advantages for a small biotech company in crafting a unique commercialization strategy and the importance of starting early and getting aligned.
FDA Approves Abbott’s Dissolving Stent System for Chronic Limb-Threatening Ischemia in Arteries Below the Knee
admin May 1, 2024 ArticleTreatment marks the first dissolving stent approved in the United States for treating chronic limb-threatening ischemia in arteries below the knee.
The CEO of NewYorkBIO discusses why investors continue to flock to New York in the life sciences industry.
FDA Approves Aquestive Therapeutics’ Libervant for the Treatment of Seizure Clusters in Children Aged 2 to 5 Years
admin April 30, 2024 ArticleApproval of Libervant marks the first orally administered rescue medication for this age group to be cleared by the FDA for epilepsy.
In this Pharmaceutical Executive video interview, Kalim Saliba, Chief Product Officer, Dotmatics discusses their Luma platform, Luma Lab Connect, and what this technology could mean for industry.
Melton, customer advocacy executive at Magnolia, discusses how new technologies can be used to ensure data is accurate.
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
FDA Approves Pfizer’s Beqvez for the Treatment of Adults with Moderate to Severe Hemophilia B
admin April 28, 2024 ArticleBeqvez, 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.
FDA Approves Label Update for Gilead’s Biktarvy to Include Pregnant Adults With HIV
admin April 27, 2024 ArticleApproval 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.
In an interview with Pharm Exec Associate Editor Don Tracy, Howard Berman, Chairman, CEO, Coya Therapeutics offers a look at the organization’s pipeline.
CVS Health Announces New Work Force Development and Community Center in Louisiana
admin April 26, 2024 ArticleThe center will offer local residents with opportunities and training to enter the pharmacy work force.
Novartis, Medicines for Malaria Venture Release Positive Results from Phase II/III Trial of Coartem for Infants with Malaria
admin April 26, 2024 ArticleCompanies reported that the new formulation of Coartem met required pharmacokinetic profiles and displayed promising efficacy and safety treating malaria in infants.
Pharma Pulse 4/25/24: Meta’s AI Assistant Can’t Be Trusted, Remote Patient Monitoring Analysis Report 2024 & more
admin April 25, 2024 ArticleThe latest news for pharma industry insiders.
Coya Therapeutics CEO Discusses Next Steps Amid Positive Results from Coya 302 Trial for ALS Treatment
admin April 25, 2024 ArticleIn 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 for the treatment of ALS.
Pharma Pulse 4/24/24: 5 Things You Should Know About Women's Health, Microsoft Makes Push Into Smaller AI Systems & more
admin April 24, 2024 ArticleThe latest news for pharma industry insiders.
FDA Approves Novartis' Lutathera for Pediatric Patients with Gastroenteropancreatic Neuroendocrine Tumors
admin April 24, 2024 ArticleLutathera is the first FDA-approved treatment for younger patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
LabConnect will utilize the consulting firm’s assets to improve its clinical trial services.
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 executive roundtable discussion
Using AI to Create New Parkinson’s Treatments: Q&A with Mattias Alder
admin April 22, 2024 ArticleAlder, CEO of Gain Therapeutics, discusses how the Magellan platform was used in the creation of GT-02287.
Lene Oddershede Discusses Upcoming Projects from the Novo Nordisk Foundation
admin April 22, 2024 ArticleIn 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.
FDA Approves Roche’s Alecensa as Adjuvant Treatment for ALK-Positive Early-Stage NSCLC
admin April 21, 2024 ArticleData 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 non–small cell lung cancer.
FDA Approves Takeda’s Subcutaneous Form of Entyvio as a Maintenance Therapy in Adults with Moderately to Severe Crohn Disease
admin April 21, 2024 ArticleApproval 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.
Essential Pharma Acquires Reminyl, a Cholinesterase Inhibitor to Treat Mild to Moderately Severe Dementia from Janssen Pharmaceutica NV
admin April 20, 2024 ArticleAcquisition 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.
Will Synthetic, AI-Based Digital Humans Change Pharma and Life Sciences? Q&A with Abid Rahman, SVP Innovation, EVERSANA
admin April 19, 2024 ArticleRahman discusses the new opportunities that digital twins present to researchers.
Phase III SELECT-GCA Trial for Rinvoq Yields Promising Results in Treating Patients with Giant Cell Arteritis
admin April 19, 2024 ArticleAccording to results of the study, 46% of patients with giant cell arteritis administered Rinvoq achieved sustained remission from weeks 12 to 52.
Pharma Pulse 4/18/24: Is it Fair Certain Biotech Investors Get an Early Look? The Health and Healthcare of Millennials & more
admin April 18, 2024 ArticleThe latest news for pharma industry insiders.
Click the title above for a link to open the Pharmaceutical Executive April 2024 issue in an interactive PDF format.
Pharma Pulse 4/17/24: AI has a Measurement Problem, How Advancements in Technology Are Transforming the Field & more
admin April 17, 2024 ArticleThe latest news for pharma industry insiders.
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.
Pharma Pulse 4/16/24: Mitigating Drug Shortages, PBM Legislation in Washington & more
admin April 16, 2024 ArticleThe latest news for pharma industry insiders.
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.
Greater Than One’s Chief Strategy Officer, Andrew Bast, shares his takeaways from 2024 Rare Disease Summit in Philadelphia, PA.
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 as they juggle learning with patient care, to what type of activities resonate most with prescribers.
The Rapid Growth of Remote Patient Monitoring Solutions Can Accelerate Decentralized Clinical Trials
admin April 14, 2024 ArticlePharma companies and RPM manufacturers must work together to find solutions to make DCT more commonly available.
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