Vaccines After COVID: Biopharma's Renewed Public Health and Commercial Push
admin November 10, 2024 ArticleAt the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed the potential of mRNA technology in developing cancer vaccines amid distrust from the public.
FDA Approves Johnson & Johnson’s Varipulse for Drug-Resistant Paroxysmal Atrial Fibrillation
admin November 10, 2024 ArticleThe Varipulse platform includes a single-device workflow with minimal to zero fluoroscopy requirements, real-time imaging, and lesion tagging for paroxysmal atrial fibrillation.
Biotech Investor Sentiment Climbing Steadily, with Growing Enthusiasm Heading into 2025
admin November 9, 2024 ArticleThe sector’s XBI is up 15% year-to-date; rate cuts, election outcome, and M&A are viewed as tailwinds.
In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed ways to prepare for the high number of incoming patent expiries and how to protect key drugs.
Financial Times Global Pharma and Biotech Summit: The Impact of the Election
admin November 8, 2024 ArticleHow will President Trump’s return to office impact the pharma industry?
Dealmaking and Partnerships: The Future of Financing Innovation
admin November 7, 2024 ArticleAt the Financial Times’ Global Pharma and Biotech Summit 2024, a breakout panel discussed how dealmaking remains vital for biopharma companies facing pipeline and revenue pressures.
How to Bring World’s Most Innovative Treatments to Least Wealthy Places
admin November 7, 2024 ArticleAt the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed initiatives aimed at bringing cell and gene therapies to low- and middle-income countries.
Global Pharma and Biotech Summit 2024: Innovation Under Pressure
admin November 6, 2024 ArticleAt the Financial Times’ Global Pharma and Biotech Summit 2024, Christophe Weber, president and CEO, Takeda, discusses how trust and collaboration between the biopharma industry and stakeholders can be implemented to support successful healthcare transformation.
Global Pharma and Biotech Summit: The Impact of Politics on Pharma and Biotech
admin November 6, 2024 ArticleAmgen CEO Robert A. Bradway discusses the potential impact of the election, and politics in general, will have on the industry.
Pharma Pulse 11/4/24: Community Pharmacies in Crisis, Insights Into ADHD Diagnoses in Adult Women & more
admin November 5, 2024 ArticleThe latest news for pharma industry insiders.
Viking Therapeutics Presents Positive Data from VK2735 for Reducing Body Weight Effectively and Safely
admin November 5, 2024 ArticleResults from the VENTURE Phase II trial and a Phase I oral formulation study found that VK2735, a novel a dual GLP-1 and GIP receptor agonist, demonstrated promise in treating obesity.
Explore the latest pharmaceutical validation developments with industry experts from Barry-Wehmiller Design Group, Kneat Solutions, and No Deviation. You’ll gain valuable data-driven insights and discover emerging trends from the State of Validation 2024 industry report that are shaping the validation landscape.
Biopharma Needs a Health System Strategy to Secure Optimal Market Access
admin November 4, 2024 ArticleIn today’s pharmaceutical market access landscape, payers are not the sole decision-makers in utilization management development.
Pharma Pulse 11/1/24: Navigating Diversity and Digital Innovation, Key Clinical Information on Infertility & more
admin November 3, 2024 ArticleThe latest news for pharma industry insiders.
Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab discussed how the use of Real-World Data has evolved in the healthcare industry in terms of privacy and targeting effectiveness.
Eisai Completes Rolling Biologics License Application to FDA for Subcutaneous Maintenance Dosing Option of Leqembi for Alzheimer Disease
admin November 2, 2024 ArticleThe subcutaneous form of Leqembi was previously granted Fast Track designation by the FDA to treat mild cognitive impairment or mild dementia associated with Alzheimer disease based on data from the Clarity AD study.
Wegovy Demonstrates Superiority Over Placebo in Patients with Metabolic Dysfunction-Associated Steatohepatitis
admin November 2, 2024 ArticleResults from Part I of the Phase III ESSENCE trial found that Wegovy 2.4 mg achieved a 37% improvement in liver fibrosis without worsening steatohepatitis in patients with metabolic dysfunction-associated steatohepatitis compared to 22.5% in the placebo group.
Expanded Access Treatment Options: Q&S with Johnson and Johnson Innovative Medicine’s Christine MacCracken
admin November 1, 2024 ArticleThe executive director of patient strategies & solutions discusses J&J’s new Guide to Expanded Access.
AbbVie, EvolveImmune Therapeutics Strike Deal to Develop Biotherapeutics for Resistant Cancer Cells
admin November 1, 2024 ArticleThe deal is expected to leverage EvolveImmune’s T-cell engager EVOLVE platform to develop novel antibody-based therapies for solid and hematologic malignancies.
FDA Grants Accelerated Approval to Novartis’ Scemblix for Newly Diagnosed Chromosome-Positive Chronic Myeloid Leukemia
admin October 31, 2024 ArticleAccelerated approval is based on results of the ASC4FIRST Phase III trial, which demonstrated Scemblix’s superior efficacy in achieving major molecular response compared to standard of care tyrosine kinase inhibitors in patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
Daiichi Sankyo, AstraZeneca Launch Phase III Trials of Datopotamab Deruxtecan in Advanced Nonsquamous Non-Small Cell Lung Cancer
admin October 31, 2024 ArticleThe trials will investigate datopotamab deruxtecan in combination with treatments including rilvegostomig, osimertinib, and chemotherapy in patients with nonsquamous non-small cell lung cancer.
GSK Agrees to Terms to Acquire Novel Treatment for Autoimmune Diseases from Chimagen Biosciences
admin October 30, 2024 ArticleCMG1A46 is currently being developed for B cell-driven autoimmune diseases, primarily systemic lupus erythematosus and lupus nephritis.
FDA Approves Protega Pharmaceuticals’ Roxybond for Severe Pain Management
admin October 30, 2024 ArticleRoxybond is the and only FDA-approved abuse-deterrent immediate-release 10 mg oxycodone formulation designed to reduce abuse of pain medication via intranasal and intravenous routes.
Acquisition includes Aliada’s lead asset, ALIA-1758, which is being developed for the treatment of Alzheimer disease.
Merck, Moderna Launch Phase III Trial of V940 in Combination with Keytruda for Resectable Non-Small Cell Lung Cancer
admin October 29, 2024 ArticleCollaboration seeks to advance the treatment of non-small cell lung cancer by combining Keytruda with Moderna’s novel neoantigen therapy, which has shown positive results across cancer types.
MDMA Therapy for Mental Health Conditions: Do the Benefits Outweigh the Risks?
admin October 28, 2024 ArticleDespite a recent FDA Complete Response Letter issued to Lykos for midomafetamine capsules for the treatment of post-traumatic stress disorder, experts believe that the future is bright for psychedelic drugs that treat mental health conditions.
In this episode of the Pharmaceutical Executive podcast, UpScriptHealth’s Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
Pharma Pulse 10/25/24: Improving Site-Sponsor Collaboration, Communication Skills Crucial for Patient Safety & more
admin October 27, 2024 ArticleThe latest news for pharma industry insiders.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, explains how to identify a compound pharmacy versus and illicit actor.
AbbVie, Gedeon Richter Ink Deal to Develop Novel Targets for Neuropsychiatric Conditions
admin October 26, 2024 ArticleUnder terms of the deal, Richter will receive an upfront cash payment of $25 million, along with potential future development, regulatory, and commercialization milestones.
Report: Radiopharmaceutical Market Expected to Reach $26.51 Billion by 2031
admin October 25, 2024 ArticleGrowth is expected due to increased instances of chronic diseases such as cancer and Alzheimer disease.
The Impact of Artificial Intelligence on the Creation of Medicines
admin October 25, 2024 ArticleNajat Khan, chief R&D officer, chief commercial officer, Recursion, and Fred Hassan, director, Warburg Pincus, discuss how artificial intelligence can help reduce healthcare costs at the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.
Pharma Pulse 10/24/24: Safeguarding Customer Data, Price Transparency Reveals Inequities Beyond Patients & more
admin October 24, 2024 ArticleThe latest news for pharma industry insiders.
Young & Partners Pharmaceutical Executive Summit 2024: Brave New World – Where Are We Heading?
admin October 24, 2024 ArticlePeter Marks, director, Center for Biologics Evaluation and Research, FDA, presented the keynote presentation on the future of gene therapy as part of the 20th Annual Young & Partners Pharmaceutical Executive Summit held at the Yale Club of New York.
The meeting is set to focus on advancing smoking cessation.
Sanofi, CD&R Ink Deal to Support Consumer Healthcare Company Opella
admin October 23, 2024 ArticleUnder terms of the deal, Sanofi would sell a 50% controlling stake in Opella to CD&R, while remaining a significant shareholder.
In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and Pharmaceutical Executive Advisory Board Member identifies marketing trends you expect to be big right away in 2025.
FDA Approves Allergan Aesthetics’ Botox Cosmetic for Moderate to Severe Vertical Platysma Bands
admin October 22, 2024 ArticleRegulatory action marks the fourth aesthetic indication and the first beyond facial treatments for Botox.
Will Pharma Increase Use of Personalized Audio Use in Marketing?
admin October 21, 2024 ArticleIn this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and Pharmaceutical Executive Advisory Board Member discusses how personalized audio will be utilized within the pharma marketing industry in 2025.
In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and Pharmaceutical Executive Advisory Board Member discusses how CMOs effectively measure the return on investment (ROI) of their marketing efforts in the pharmaceutical industry, particularly in light of the long-term nature of drug development and approval processes.
The company includes the technology in drug development, improving efficiency, and other areas.
Healthcare Companies in Florida Partner to Provide Hurricane Relief
admin October 20, 2024 ArticleSun Life U.S. teamed up with several other Florida-based companies to provide needed assistance in areas impacted by the recent storms.
FDA Approves Expanded Indication for Lumryz in Pediatric Patients with Narcolepsy
admin October 19, 2024 ArticleExpanded approval of Lumryz offers a once-nightly treatment option for younger patients, eliminating the need for traditional narcolepsy treatments that often require multiple doses throughout the night.
FDA Grants Priority Review to GSK’s Gepotidacin for Uncomplicated Urinary Tract Infections
admin October 19, 2024 ArticlePriority Review status for GSK’s New Drug Application for gepotidacin was based on promising results from the Phase III EAGLE-2 and EAGLE-3 trials, which demonstrated non-inferiority to nitrofurantoin in uncomplicated urinary tract infections.
Pharma Pulse 10/18/24: Driving Diversity with the Integrated Research Model, More Treatment Options for Schizophrenia & more
admin October 18, 2024 ArticleThe latest news for pharma industry insiders.
Sanofi, Orano Strike Deal to Develop Radioligand Medicines for Rare Cancers
admin October 18, 2024 ArticlePartnership is expected to develop radioligand therapies based on lead-212 alpha-emitting isotopes, which offer the opportunity to destroy cancer cells with minimal damage to healthy tissue.
Mirikizumab Demonstrates Superiority to Ustekinumab in Treating Crohn Disease
admin October 17, 2024 ArticleResults from the Phase III Vivid-1 trial found that more Crohn disease patients treated with mirikizumab achieved histologic response at week 52 compared to ustekinumab.
Nipocalimab Demonstrates Sustained Disease Control in Adolescents with Generalized Myasthenia Gravis
admin October 17, 2024 ArticleResults from the Phase II/III Vibrance-MG study found that patients with generalized myasthenia gravis who were treated with nipocalimab plus standard-of-care achieved sustained disease control.
Click the title above for a link to open the Pharmaceutical Executive October 2024 issue in an interactive PDF format.
Rafaat Rahmani, president and founder of Lifescience Dynamics, grew up in abject poverty, but such hardships—and a later violent brush with racism—would ultimately end up fueling a determined and entrepreneurial path in the life sciences.
The Big Pharma commercialization playbook doesn’t work for emerging life sciences companies bootstrapping their way up. Exploring three strategies that could be the ingredients of a winning formula for startups.
The program will now cover 15 gene and cell therapies.
Integrating Digital Solutions to Enhance Traceability and Safety in Drug Administration
admin October 14, 2024 ArticleLaura Johnson, senior director, sales, life sciences, Loftware, discusses integrating digital solutions with traceability and drug administration.
A value deficit and potential consumer value proposition.
Announcements such as Apple’s come with pros and cons for industry.
FDA Approves Roche’s Itovebi for Endocrine-Resistant, PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
admin October 12, 2024 ArticleApproval was based on results from the Phase III INAVO120 trial, which found that Itovebi in combination with palbociclib and fulvestrant significantly improved progression-free survival in patients with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer.
Three key components to scaling quickly—while maintaining purpose.
FDA Grants Marketing Authorization for Healgen Scientific’s Home Flu and COVID-19 Combination Test
admin October 11, 2024 ArticleHealgen’s Rapid Check COVID-19/Flu A&B Antigen Test is the first non-prescription COVID-19/flu combination test to be authorized by the FDA without emergency use authorization.
Arexvy Demonstrates Sustained Protection From Respiratory Syncytial Virus in Adults Over 60 Years of Age for Three Seasons
admin October 11, 2024 ArticleData from the Phase III AReSVi-006 clinical trial found that Arexvy offered a cumulative efficacy of 62.9% against lower respiratory tract disease caused by respiratory syncytial virus.
DarioHealth Announces Partnership with National Medicare Advantage Plan
admin October 10, 2024 ArticleThe partnership will provide plan members with access to digital services aimed at older patients.
FDA Grants Breakthrough Therapy Designation to Biogen’s Felzartamab for Late Antibody-Mediated Rejection in Kidney Transplants
admin October 10, 2024 ArticleFelzartamab granted Breakthrough Designation after a clinical trial showed a significant improvement in late antibody-mediated rejection in kidney transplant recipients compared with placebo.
FDA Grants Breakthrough Therapy Designation to Boehringer Ingelheim’s Survodutide for Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis
admin October 9, 2024 ArticleBreakthrough Therapy designation for survodutide was based on preliminary clinical data showing potential improvement in patients with non-cirrhotic metabolic dysfunction-associated steatohepatitis over existing therapies.
Astellas, AviadoBio Strike Exclusive Option, License Agreement for Potential Treatment for Frontotemporal Dementia
admin October 9, 2024 ArticleUnder terms of the deal, Astellas will obtain the license for the global development and commercialization of AVB-101 to treat frontotemporal dementia with progranulin mutations.
FDA Approves Increased Dosage of Biofrontera’s Ameluz Topical Gel for Actinic Keratosis
admin October 8, 2024 ArticleApproval was based on results from Phase I clinical safety studies, which demonstrated that using three tubes of Ameluz maintained similar safety and systemic exposure levels as one tube in treating actinic keratosis in patients undergoing photodynamic therapy.
AstraZeneca, CSPC Pharmaceutical Group Reach Exclusive Licensing Agreement to Develop Lipid-Lowering Therapy
admin October 8, 2024 ArticleUnder the agreement, AstraZeneca will be granted access to CSPC’s small molecule candidate, YS2302018, with the goal of treating dyslipidemia and cardiovascular disease.
BCS Financial Introduces Employer Group Gene Therapy Stop Loss
admin October 7, 2024 ArticleThe stop loss is designed to protect against potentially massive costs related to gene therapy treatments.
Combating Diseases with Limited Investment Incentives: Q&A with Dr. Claire Wagner
admin October 7, 2024 ArticleDr. Wagner discusses her work with the Bill and Melinda Gates Medical Research Institute.
The campaign is called #BustTheMyth and is aimed at patient education.
Pharma Pulse 10/4/24: Regulatory Challenges With Data Collection, Poor Sleep Quality Linked to Dementia & more
admin October 6, 2024 ArticleThe latest news for pharma industry insiders.
FDA Approves Bristol Myers Squibb’s Opdivo in Combination with Chemotherapy for Resectable Non-Small Cell Lung Cancer
admin October 5, 2024 ArticleApproval for Opdivo was based on results from the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival and pathologic complete response in adults with resectable non-small cell lung cancer without EGFR or ALK rearrangements.
FDA Approves Exact Sciences' Cologuard Plus Non-Invasive Colorectal Cancer Screening Test
admin October 5, 2024 ArticleApproval of Cologuard Plus follows results from the BLUE-C study, which demonstrated a 95% sensitivity for detecting colorectal cancer.
Sun Pharma, Philogen Ink Global Commercialization Deal for Fibromun, an Anti-Cancer Immunotherapy
admin October 4, 2024 ArticleUnder terms of the deal, Philogen will complete clinical trials for Fibromun, seek approval, and handle manufacturing, with Sun Pharma leading global commercialization.
FDA Approves Fresenius Kabi, Formycon’s Stelara Biosimilar for Multiple Inflammatory Diseases
admin October 3, 2024 ArticleMarketed as a biosimilar to Stelara, approval of Otulfi was based on clinical data demonstrating comparable efficacy in treating inflammatory conditions such as Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis.
The Challenges of Prescription Labeling for the Pharmaceutical Industry
admin October 2, 2024 ArticleLaura Johnson, senior director, sales, life sciences, Loftware, discusses issues faced by the pharmaceutical industry when it comes to proper drug labeling.
Merck Completes Acquisition of Investigational Bispecific Antibody Therapy from Curon Biopharmaceutical
admin October 2, 2024 ArticleCN201 is currently being evaluated in Phase I and Phase Ib/II clinical trials for relapsed or refractory non-Hodgkin lymphoma and B-cell acute lymphocytic leukemia.
sa-mRNA COVID-19 Vaccine Study Demonstrates Longer Protection Against Virus Compared to Other Vaccine Types
admin October 1, 2024 ArticleCSL and Artcurus announced the results of a study on the self-amplifying RNA vaccine.
Murphy previously worked at the Biotechnology Innovation Organization as its chief policy officer.
RxPreferred Launches AI-Powered Savings Program for Members
admin September 30, 2024 ArticleThe program, Rx-Performance, will be available starting in January of next year.
What is the Secret Sauce for Top School Graduates to Convert Start-Up Ideas into Sustainable Firms?
admin September 29, 2024 ArticleA Harvard Business School Healthcare Alumni Association Q&A with Martin Gonzalez, Principal of Org and Leadership Development at Google.
FDA Approves Bristol Myers Squibb’s Cobenfy for Schizophrenia
admin September 29, 2024 ArticleLandmark FDA approval of Cobenfy represents the first new class of drugs indicated to treat schizophrenia in decades.
FDA Approves Dupixent as First-Ever Biologic Treatment for Chronic Obstructive Pulmonary Disease
admin September 28, 2024 ArticleDupixent was found to significantly reduce the rate of moderate to severe exacerbations of chronic obstructive pulmonary disease, according to data from the Phase III BOREAS and NOTUS trials.
Securities Litigation Arising from Alzheimer's Drug Treatments
admin September 26, 2024 ArticleThe legal challenges surrounding Biogen’s Aduhelm and Cassava Sciences’ simufilam underscore the ongoing difficulties in Alzheimer’s drug development, leading to securities litigation over allegedly misleading statements about trial results and commercialization efforts.
In this part of his Pharmaceutical Executive video interview, Jonathan Scheinberg, of the Northeast Science and Technology Center, identifies key factors that pharmaceutical and biotech companies should consider when selecting and developing mega campuses.
FDA Approves Sarclisa for Certain Patients with Multiple Myeloma
admin September 25, 2024 ArticleThe drug is approved for newly diagnosed patients not eligible for transplant and is to be used in combination with standard-of-care treatment.
Max Colao Shares How OncoVerity is Pioneering Oncology Solutions
admin September 24, 2024 ArticleMax Colao, CEO of OncoVerity, discusses his extensive experience in the biotech industry and shares how his company is harnessing computational biology and machine learning to develop personalized cancer treatments that aim to reshape the future of oncology care.
FDA Approves Bimzelx for Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis
admin September 24, 2024 ArticleBimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A and IL-17F, both of which are key cytokines that drive inflammatory processes.
Pharma Pulse 9/23/24: eSource EHR Requirements, Expanding Pharmacy Access & more
admin September 23, 2024 ArticleThe latest news for pharma industry insiders.
Four Key Strategies for Optimizing Your Medical Congress Strategy
admin September 23, 2024 ArticleConferences, congresses, and the digital discussions kicked off by those events create a halo effect that amplifies scientific information more so than other scientific activities.
Webinar Date/Time: Wednesday, October 9th, 2024 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Bringing Marketing to a New Audience: Q&A with Jeremy Truxal
admin September 22, 2024 ArticleTruxal discusses Exact Science’s first Spanish language TV commercial and campaign for Cologuard.
The program is aimed at raising funds for children with cancer and blood disorders.
FDA Approves Rybrevant for Locally Advanced, Metastatic Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer
admin September 21, 2024 ArticleRybrevant is the first targeted second-line regimen to significantly reduce the risk of disease progression by more than 50% in patients with locally advanced or metastatic EGFR mutated non-small cell lung cancer, according to Johnson & Johnson.
Pharma Pulse 9/20/24: The Benefit to Adapting Operating Models, 50% of US Women Skip or Delay Medical Care & more
admin September 20, 2024 ArticleThe latest news for pharma industry insiders.
Patritumab Deruxtecan Demonstrates Significant Survival Improvement in Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung Cancer
admin September 20, 2024 ArticleResults of the Phase III HERTHENA-Lung02 trial demonstrated the superiority of patritumab deruxtecan over platinum plus pemetrexed induction chemotherapy in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
The service will provide compounding pharmacy services to healthcare providers.
FDA Approves Fasenra for Eosinophilic Granulomatosis with Polyangiitis
admin September 19, 2024 ArticleApproval was based on results from the MANDARA Phase III trial, which demonstrated the superiority of Fansenra over Nucala in patients with eosinophilic granulomatosis with polyangiitis.
Keytruda Demonstrates Superior Overall Survival vs. Yervoy in Advanced Melanoma
admin September 18, 2024 ArticleTen-year data from the Phase III KEYNOTE-006 trial found that Keytruda produced a 34% ten-year overall survival rate compared to 23.6% for ipilimumab in patients with advanced melanoma.
Click the title above for a link to open the Pharmaceutical Executive September 2024 issue in an interactive PDF format.
Pharma Pulse 9/17/24: Digital Solution Trends Heading into 2025, Misinformation vs Disinformation & more
admin September 17, 2024 ArticleThe latest news for pharma industry insiders.
FDA Approves Ebglyss for Moderate-to-Severe Atopic Dermatitis
admin September 17, 2024 ArticleResults from the ADvocate 1, ADvocate 2, and ADhere clinical trials found that patients treated with Ebglyss 38% of patients with moderate-to-severe atopic dermatitis achieved clear or almost-clear skin after 16 weeks of treatment.
The profitability of biopharma drug launches in the US will remain in decline until manufacturers reimagine their approach with payers
The industry holds the key to true change to the drug access landscape.
FDA Approves Subcutaneous Tecentriq Hybreza for All Adult Indications of IV Form of Tecentriq
admin September 15, 2024 ArticleSubcutaneous Tecentriq Hybreza will provide patients and physicians increased flexibility for administration of the immunotherapy across approved indications for Tecentriq, including non–small cell lung cancer, small cell lung cancer, and hepatocellular carcinoma.
As new litigation looms in the debate over use of copay accumulator programs, a look at potential next moves for payers—and steps drug manufacturers should take to ward off cost-driven non-adherence.
Gilead's Lenacapavir Reduces HIV Infections by 96%, Surpassing Truvada in Twice-Yearly PrEP Treatment
admin September 14, 2024 ArticleLandmark results from the Phase III PURPOSE 2 trial found that lenacapavir demonstrated 89% greater efficacy than Truvada in preventing HIV infections.
As the digital medium poses new threats to brand equity and public safety for pharma, what can drugmakers do to better balance its essential communications benefits with the risks?
In this part of their Pharmaceutical Executive video interview, UpScriptHealth’s Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss how UpScriptHealth is working to increase access to legitimate weight loss medications, especially for those in underserved communities.
Dupixent Demonstrates Reduced Symptoms of Chronic Spontaneous Urticaria
admin September 13, 2024 ArticleDupixent displayed a nearly 50% reduction in itch and urticaria activity scores in patients with chronic spontaneous urticaria.
How UpScriptHealth Guarantees Authenticity & Prevents Counterfeit Drugs from Entering Their Supply Chain
admin September 12, 2024 ArticleIn this part of their Pharmaceutical Executive video interview, UpScriptHealth’s Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, explain how their company guarantees the authenticity of the medications it dispenses, and the measures are in place to prevent counterfeit drugs from entering their supply chain.
Report: Obesity Drug Market Estimated to be Worth $200 Billion by 2031
admin September 12, 2024 ArticleA recent study by Morningstar predicts that 16 new weight-loss drugs could be on the market by 2029.
WellSync Partners With Marius to Offer Oral TRT Treatment on Digital Platform
admin September 11, 2024 ArticleUsers of the platform will have access to Kyzatrex.
Melissa Krebs Shares GelSana’s Vision for Innovative Wound Care Solutions
admin September 11, 2024 ArticleIn this interview, Melissa Krebs, CEO and founder of GelSana, shares her journey in developing cutting-edge biomaterials that could transform the $78 billion wound care market.
From Endemic to POC: The Journey Pharma Marketers Need to Tread
admin September 10, 2024 ArticleThe digital revolution has brought more efficient ways to reach and touch HCPs.
Filspari is considered the first non-immunosuppressive treatment to significantly slow kidney function decline in adults with IgA nephropathy.
Fenebrutinib Found Effective in Suppressing Relapsing Multiple Sclerosis Disease Activity
admin September 9, 2024 ArticleResults of the FENopta study found that after one year of treatment, 96% of patients experienced no relapses of multiple sclerosis, with an annualized relapse rate of just 0.04.
Beyond the Birthrate: The Societal Costs of Maternal Mortality
admin September 9, 2024 ArticleHead of Medical Affairs and Outcomes Research at Organon, Charlotte Owens, MD, FACOG, discusses the most critical changes needed to close the gaps in R&D for maternal health solutions and how feasible they are to make.
Pharma Pulse 9/6/24: Gaps and Opportunities in Qualitative Systematic Reviews, Companies Grapple With Expanding Cyber Rules & more
admin September 8, 2024 ArticleThe latest news for pharma industry insiders.
FDA Approves Boruzu for Subcutaneous, Intravenous Administration for Multiple Myeloma, Mantle Cell Lymphoma
admin September 8, 2024 ArticleBoruzu is the first ready-to-use version of bortezomib for subcutaneous and intravenous administration in the treatment of multiple myeloma and mantle cell lymphoma.
Texas Biomed announced that research shows that a certain monoclonal antibody treatment could treat all variants of COVID-19, including past, present, and future strains.
Nucala Significantly Reduces Moderate to Severe Exasperations in Chronic Obstructive Pulmonary Disease
admin September 7, 2024 ArticleResults from the MATINEE trial found that Nucala led to a statistically significant and clinically meaningful reduction in moderate/severe exacerbations of chronic obstructive pulmonary disease compared to placebo over 104 weeks.
Pharma companies are facing a higher number of incredibly destructive cyber-threats than ever before.
Efsitora Demonstrates Non-Inferiority vs. Insulin Glargine, Degludec for Type 2 Diabetes
admin September 6, 2024 ArticleResults from the QWINT-1 and QWINT-3 trials found that insulin-naïve patients achieved similar reductions in A1C levels using once-weekly efsitora compared to daily insulin glargine and degludec.
What is the Transformation Playbook for Moving From Digital Pilot to a Truly Scaled Production Solution?
admin September 5, 2024 ArticleA C-suite Q&A with Cristina Ortega Duran, President of Evinova.
High Dose Spinraza Significantly Improves Motor Function in Infants with Spinal Muscular Atrophy
admin September 5, 2024 ArticleData from the Phase II/III DEVOTE study demonstrated that Spinraza showed significant motor function improvements at six months in infants with spinal muscular atrophy.
The “Do It For You & Them” campaign focuses on the impact that virus has on day-to-day lives.
Lumryz Demonstrates Superiority Over Oxybate Treatments in Narcolepsy
admin September 4, 2024 ArticleResults of the RESTORE study revealed that 94% of participants preferred Lumryz over twice nightly oxybate treatments for narcolepsy.
Understanding the Current State of M&A: Q&A with Cheryl Reicin
admin September 3, 2024 ArticleAs the second half of 2024 begins, an industry expert discusses how mergers and acquisitions are trending in the pharma industry.
Personify Health Offers Employers GLP-1s Best Practices for Coverage Options
admin September 3, 2024 ArticleThe insurance company is offering the guidance in response to continued popularity of the drugs which are commonly used for weight-loss management.
Perspective Therapeutics’ CEO explains how this method can be used to determine how to target cancer cells without damaging other organs.
Pharmaceutical companies are seeing the benefits of being able to outsource entire functions through functional service providers.
Strategies that can help maintain and grow your market share. Plus how to adapt to new competitive pressures and evolving customer needs.
Ecolab Continues Mission to Protect What's Vital With Deep Investment in Life Sciences
admin September 1, 2024 ArticleEcolab is looking to the future with new opportunities to partner with Pharma for critical solutions to support drug development and manufacturing.
Sanyou Biopharmaceuticals Announces Line of Monkeypox Treatments
admin August 31, 2024 ArticleThe product line includes vaccines, monoclonal antibodies, and antigens.
Johnson & Johnson Submits Biologics License Application for Nipocalimab in Patients with Antibody-Positive Generalized Myasthenia Gravis
admin August 31, 2024 ArticleSubmission is supported by results from the Phase III Vivacity-MG3 study, which demonstrated that nipocalimab, combined with standard care, significantly improved outcomes for patients with antibody-positive generalized myasthenia gravis.
Pharma Pulse 8/30/24: Working Towards Greater Access and Diversity, Why 'Normalcy' Is Still a Crisis & more
admin August 30, 2024 ArticleThe latest news for pharma industry insiders.
FDA Grants Priority Review to Mirdametinib for Neurofibromatosis Type 1-Associated Plexiform Neurofibromas
admin August 30, 2024 ArticleSubmission of a New Drug Application for mirdametinib included data from the Phase IIb ReNeu trial, which evaluated patients with NF1-associated plexiform neurofibromas causing significant morbidity.
Has Machine Learning Finally Provided Practical Value for the Healthcare Ecosystem?
admin August 29, 2024 ArticleA Harvard Business School Healthcare Alumni Association Q&A with Dr. Hersh Sagreiya at the Hospital of the University of Pennsylvania.
Research Growing into the Use of Psychedelics to Treat Substance Abuse
admin August 29, 2024 ArticleA new National Institutes of Health grant will advance research into the role of the serotonin 5-HT2A receptor in mitigating methamphetamine use.
This makes Aetna the first major insurer to cover these types of services.
Lilly Introduces Single-Dose Vials of Zepbound, Expanding Access for Adults with Obesity
admin August 28, 2024 ArticleThe new vials of Zepbound are available through a new self-pay pharmacy channel, priced over 50% lower than other incretin medications for obesity.
Achieving better outcomes for patients and advancing the fields of nuclear medicine and oncology are not just about adopting new technologies, but also about embracing a profound change in how care is delivered.
Dupixent Demonstrates Efficacy Treating Chronic Obstructive Pulmonary Disease, Asthma
admin August 27, 2024 ArticleResults from the Phase III BOREAS and NOTUS trials found that Dupixent reduced moderate-to-severe COPD exacerbations by 31% over 52 weeks.
BioVaxy Announces Findings For Use of DPX in Vaccine Development
admin August 26, 2024 ArticleThe novel lipid-in-oil delivery platform showed positive results across multiple disease states.
Pharma Pulse 8/23/24: Drug Coverage Changes in Medicare Part D Plans, Law That Shielded Big Tech Now Being Used Against It & more
admin August 26, 2024 ArticleThe latest news for pharma industry insiders.
CDMOs are Exploring Risk-Sharing for Resilient Growth in a BANI World
admin August 25, 2024 ArticleKey industry trends and how the relationships between companies and CDMOs are evolving to better meet the challenges of a BANI world.
Addressing Challenges to Access, Advancement of Myeloma Therapies
admin August 25, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer, IMF, discusses challenges of access and advancement of myeloma therapies.
The updated formulas should provide better protection against the currently circulating strains.
FDA Grants Fast Track Designation to Clarity Pharmaceuticals’ Novel Treatment for PSMA-Positive Prostate Cancer Lesions
admin August 24, 2024 Article64Cu-SAR-bisPSMA has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life in PET imaging of PSMA-positive prostate cancer lesions, Clarity says.
The technology has the potential to be implemented across multiple aspects of the industry.
Study Suggests Promise of Psilocybin in Treating Depressive Symptoms
admin August 23, 2024 ArticleFindings from a recent study demonstrated that high-dose psilocybin provided a superior reduction in depressive symptoms compared to both placebo and escitalopram in patients with major depressive disorder.
Quest Diagnostics to Acquire Assets from University Hospital’s Outreach Laboratory Services
admin August 22, 2024 ArticleThis agreement will allow the diagnostic information services company to expand its operations in Ohio.
FDA Accepts Bristol Myers Squibb’s sBLA for Opdivo and Yervoy Combination for Hepatocellular Carcinoma
admin August 22, 2024 ArticleAcceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial, which demonstrated that the combination of Opdivo and Yervoy significantly improved overall survival in patients with hepatocellular carcinoma.
Kelly discusses how the company takes a different approach to spinal cord injuries.
The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the treatment of heart failure with reduced ejection fraction.
The pharmaceutical company worked with Coursera to develop the three-module course.
FDA Approves Incyte and Syndax Pharmaceuticals’ Niktimvo for Treating Chronic Graft-Versus-Host Disease
admin August 20, 2024 ArticleApproval of Niktimvo was based on positive data from the AGAVE-201 study, which demonstrated a 75% response rate in patients with chronic graft-versus-host disease.
Astellas Pharma’s chief people officer and chief ethics & compliance officer discusses the unique ways he’s brought DE&I to the workplace.
Key approval signals progress in addressing immune-mediated inflammatory diseases.
Surviving a long road, novel next-generation treatment offers hope for major depressive disorder.
Divergent Paths: Pharm Exec Profiles Five Recent Drug Launches
admin August 18, 2024 ArticlePharm Exec’s latest sampling of notable biopharma brand approvals and launches all have unique stories to tell—from the winding journeys to innovative “firsts” to new momentum for milestones to come.
Three pieces of coverage in this month’s issue of Pharmaceutical Executive explore the tipping point that’s seemingly on the cusp in artificial intelligence.
Click the title above for a link to open the Pharmaceutical Executive July/August 2024 issue in an interactive PDF format.
Heidi Capozzi previously served as chief people officer for McDonald’s.
How drugmakers can reap value from using generative AI in their market-entry strategies and decision-making, including mitigating launch challenges and enhancing the customer conversation.
It’s time to see where artificial intelligence is genuinely being utilized in pharma.
Ken Keller, CEO of Daiichi Sankyo’s US business, reflects on the trials, triumphs, and lessons learned in steering the transformation of a legacy cardiovascular company into a global leader in oncology—advancing a vision for a reimagined future in cancer treatment.
The region is moving to the forefront in integrating therapeutic innovation.
Thriving ‘Beyond the Pill’: Closing Key Gap in Patient Support
admin August 14, 2024 ArticleWhy pharma needs to focus on improving—not just extending life.
FDA Issues Complete Response Letter to Lykos Therapeutics for Midomafetamine Capsules in the Treatment of Post-Traumatic Stress Disorder
admin August 13, 2024 ArticleThe Complete Response Letter stated that current data on midomafetamine capsules is insufficient for approval in treating patients with post-traumatic stress disorder.
AstraZeneca VP, Head of Medical Affairs, US Oncology, Discusses the Impact of PARP Inhibitors on Cancer Treatment
admin August 13, 2024 ArticleIn an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, Head of Medical Affairs, US Oncology Business Unit, AstraZeneca, talks PARP inhibitors in cancer treatment and the history of Lynparza.
Pharma Pulse 8/9/24: AI Companies Fight to Stop California Safety Rules, Building Patient-centric Technology & more
admin August 12, 2024 ArticleThe latest news for pharma industry insiders.
The Trinity Life Sciences managing director and head of DE&I strategy discusses recent research on the topic.
FDA Approves Citius Pharmaceuticals’ Lymphir for Relapsed or Refractory Cutaneous T-Cell Lymphoma
admin August 11, 2024 ArticleLymphir is the first therapy to target the IL-2 receptor in the treatment of relapsed or refractory cutaneous T-cell lymphoma and the first FDA-approved product for Citius Pharmaceuticals.
Could the Jobs Report Help Reverse Biotech’s Underperformance?
admin August 11, 2024 ArticleThe data may be a catalyst for sector with a now-likely rate pivot looming.
Merck to Acquire Investigational Bispecific Antibody for B-Cell Associated Diseases From Curon Biopharmaceutical
admin August 10, 2024 ArticleAs part of the acquisition of CN201, Curon is expected to receive an upfront payment of $700 million, with the opportunity to earn an additional $600 million in milestone payments linked to the drug’s development and regulatory approval.
FDA Approves First Epinephrine Nasal Spray for Type I Allergic Reactions Including Anaphylaxis
admin August 10, 2024 ArticleApproval of neffy marks a significant advancement in epinephrine delivery, offering a less painful alternative to traditional needle injections.
FDA Approves Amneal’s Extended-Release Crexont for the Treatment of Parkinson Disease
admin August 9, 2024 ArticleClinical trials for Crexont demonstrated a substantial increase in “Good On” time, representing a period without troubling adverse effects in patients with Parkinson disease.
FDA Grants Accelerated Approval to Novartis’ Fabhalta for Primary IgA Nephropathy
admin August 9, 2024 ArticleAccelerated approval of Fabhalta for treating primary IgA nephropathy was based on positive results from the Phase III APPLAUSE-IgAN study.
ImmunityBio Launches Study to Evaluate Combination of Anktiva, AdHER2DC Cancer Vaccine for Endometrial Cancer
admin August 8, 2024 ArticleThe study aims to explore Anktiva as a potential cornerstone of future immunotherapy treatments for endometrial cancer and other forms of the disease.
FDA Approves Medtronic’s Simplera Continuous Glucose Monitor, Announces Partnership with Abbott
admin August 8, 2024 ArticlePartnership with Abbott for Simplera CGM will expand access to the advanced automated insulin delivery.
Kerendia Demonstrates Significant Efficacy Treating Heart Failure with Left Ventricular Ejection Fraction of 40% or More
admin August 7, 2024 ArticleThe FINEARTS-HF study, which compared Kerendia to a placebo when added to standard therapy, met its primary endpoint by reducing cardiovascular death and total heart failure events.
In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, head of medical affairs, US oncology business unit, AstraZeneca, provides an update on current research efforts for Lynparza and discusses its impact on cancer patients over the past decade.
FDA Approves Expanded Indication for Octapharma’s Fibryga for Patients Experiencing Bleeding Due to Acquired Fibrinogen Deficiency
admin August 6, 2024 ArticleExpanded indication makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication.
In this part of her Pharmaceutical Executive video interview, Charlotte Owens, MD, FACOG, Head of Medical Affairs and Outcomes Research at Organon, discusses how she’s using her in-practice experience as an OB-GYN to inform Organon’s strategic approach to addressing maternal health challenges.
Pharma Pulse 8/2/24: Poor Data is a Population Health Risk, Meta’s Earnings Calm AI Jitters & more
admin August 5, 2024 ArticleThe latest news for pharma industry insiders.
Blue Shield of California Offers Blue Zones Challenge App to Members
admin August 4, 2024 ArticleThe app provides users with lifestyle tips and plans based on the lifestyles of people living in regions with the highest lifespans.
Understanding IDNs and What They Mean to the Pharmaceutical Industry–Q&A with Greg Skalicky
admin August 4, 2024 ArticleIntegrated Delivery Networks have impacted everything from drug launches to sales approaches.
FDA Expands Approval of GSK’s Jemperli in Combination with Chemotherapy for Adults with Primary Advanced or Recurrent Endometrial Cancer
admin August 3, 2024 ArticleApproval marks the first time an immuno-oncology regimen has demonstrated a survival benefit for all adults with primary advanced or recurrent endometrial cancer, company says.
FDA Grants Accelerated Approval to Adaptimmune Therapeutics’ Tecelra for Adults with Synovial Sarcoma Who Have Undergone Prior Chemotherapy
admin August 3, 2024 ArticleRegulatory action marks the first engineered cell therapy approved for a solid tumor cancer in the United States.
Tirzepatide Shows Statistically Significant Improvements in Reducing Heart Failure Risk, Enhanced Symptoms
admin August 2, 2024 ArticleData from the SUMMIT clinical trial demonstrated that tirzepatide lowered the risk of negative heart failure outcomes and enhanced symptoms and physical limitations when tested with three different doses.
Daiichi Sankyo, Merck Launch Phase III Trial Evaluating Safety, Efficacy of Ifinatamab Deruxtecan in Patients with Relapsed Small Cell Lung Cancer
admin August 2, 2024 ArticleIDeate-Lung02 will compare ifinatamab deruxtecan to a physician’s choice of chemotherapy in patients with relapsed small cell lung cancer.
FDA Approves Johnson & Johnson’s Darzalex Faspro in Combination with Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma
admin August 1, 2024 ArticleResults from the PERSEUS study led to the FDA approval of Darzalex Faspro in patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.
Data Show Three Years of Continuous Treatment with Leqembi Reduces Cognitive Decline in Patients with Early Alzheimer Disease
admin August 1, 2024 ArticleResults of the Phase III Clarity AD study found that Leqembi reduced cognitive decline by -0.95 on the Clinical Dementia Rating-Sum of Boxes compared to expected declines in untreated groups.
FDA Grants Priority Review to Novartis’ Scemblix for Newly Diagnosed Patients with Philadelphia Chromosome-Positive Chronic Myeloid Leukemia in Chronic Phase
admin July 31, 2024 ArticleResults from the ASC4FIRST study lead to FDA priority review designation of Scemblix in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
FDA Approves Luye Pharma Group’s Erzofri for Adults with Schizophrenia, Schizoaffective Disorder
admin July 31, 2024 ArticleErzofri is the first patented paliperidone palmitate long-acting injectable developed in China to receive FDA approval for treating schizophrenia and schizoaffective disorder, company says.
FDA Approves Sun Pharma’s Leqselvi for Treating Adults with Severe Alopecia Areata
admin July 30, 2024 ArticleLeqselvi is classified as a novel oral Janus Kinase inhibitor that targets JAK1 and JAK2 pathways, thought to be involved in the autoimmune response that leads to alopecia areata.
FDA Approves Alpha Cognition’s Zunveyl as Oral Therapy for Mild-to-Moderate Alzheimer Disease
admin July 30, 2024 ArticleApproval of Zunveyl offers a novel approach with a dual mechanism of action designed to improve tolerability and efficacy in treating Alzheimer disease, company says.
Fighting the Drop in Vaccination Rates: Q&A with Gregg Sylvester
admin July 29, 2024 ArticleAn unexpected consequence of the COVID 19 pandemic has been a loss in trust of vaccines. Over the past three flu seasons, there has been a drop in vaccination rates that is alarming experts. Dr. Gregg Sylvester, chief health officer at CSL Seqirus, spoke with Pharmaceutical Executive about the causes of the decline and how […]
Pharma Pulse 7/26/24: Research Shows Promise Toward Universal Flu Vaccine, AI Struggles with Math & more
admin July 29, 2024 ArticleThe latest news for pharma industry insiders.
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