Trends in Continuing Medical Education
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…
The Rapid Growth of Remote Patient Monitoring Solutions Can Accelerate Decentralized Clinical Trials
Pharma companies and RPM manufacturers must work together to find solutions to make DCT more commonly available.
Novartis, Arvinas Agree to Strategic Collaboration to Develop Treatment for Prostate Cancer
Partnership also includes an agreement for Arvinas to sell its preclinical AR-V7 program to Novartis.
Aspiring for the C-Suite? Consider Being a Chief of Staff
Why this role provides a critical ‘boot camp’ for future pharma leaders.
FDA Approves New Administration Methods for SK Life Science’s Xcorpi for Adults with Partial-Onset Seizures
New methods allow the antiseizure treatment to be crushed and mixed with water for oral suspension or for use through a nasogastric tube.
FDA Approves AstraZeneca’s Fasenra as Add-On Maintenance Therapy for Children Aged 6 to 11 with Severe Asthma
Treatment was initially approved in 2017 for the same indication in children aged 12 and up.
Invenra, Astellas Launch Partnership Focused on Discovering Therapeutic Bispecific Antibodies
Joint venture aims to implement Invenra’s B-Body bispecific antibody platform to enhance Astellas’ research and development efforts.
Expanding Access to Fight the Obesity Epidemic
In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses how access to these weight loss drugs can help the obesity epidemic.
Lonza, NeuroSense Strike Deal Focused on Exploring Biological Markers for Neurodegenerative Diseases
Collaboration aims to advance the development of treatments for multiple neurodegenerative conditions, including amyotrophic lateral sclerosis.
Bristol Myers Squibb Reveals Promising Data for KarXT, a Potential Treatment for Schizophrenia
A combination of data from the EMERGENT-4 trial and pooled data from the EMERGENT program showed the promise of KarXT (xanomeline-trospium) in providing symptom improvement for people with schizophrenia.
FDA Approves Expanded Indication for Dovato to Include Adolescent Patients with HIV
Dovato is the first oral, two-drug, single-tablet regimen approved for patients 12 years of age and older who are living with HIV-1.
FDA Issues Complete Response Letter to Supernus for SPN-830, a Potential Treatment for Motor Fluctuations in Parkinson Disease
According to the letter, the FDA believes that the investigational apomorphine infusion device is not ready for approval in its current form.
Pharma Pulse 4/5/24: Patient with Pig Kidney Goes Home, Combining AI and Market Access & more
The latest news for pharma industry insiders.
QuantalX Joins FDA’s Total Life Cycle Advisory Program
FDA’s program will provide guidance to the development of the company’s Delphi-MD technology.
FDA Approves Abecma for Patients with Relapsed or Refractory Multiple Myeloma Following Two Prior Lines of Therapy
Abecma was found to triple progression-free survival compared to standard regimens with a 51% decline in the risk of disease progression or death in patients with relapsed or refractory multiple myeloma who were previously administered two or more lines of…
A Decade of Data Under the Belt
In this Pharmaceutical Executive video interview, Currax Pharmaceuticals, CEO, George Hampton, discusses their drug Contrave and the data they have to show after a 10 years in the weight loss/obesity space.
Johnson & Johnson Set to Acquire Shockwave Medical, Aiming to Strengthen Company’s MedTech Division
The deal, which is worth approximately $13.1 billion, is part of J&J MedTech’s goal to expand into high-growth markets.
Amylyx Begins Process of Discontinuing Relyvrio/Albrioza for Treatment of ALS
Decision to discontinue marketing authorizations for Relyvrio/Albrioza comes as a result of topline results from the Phase III PHOENIX trial in patients with amyotrophic lateral sclerosis.
Moderna Releases Promising Data from Phase I/II Clinical Trial on mRNA-3927 for Propionic Acidemia
Early results have demonstrated that mRNA-3927 has led to a 70% reduction in the relative risk for metabolic decompensation events in patients with propionic acidemia.
Teva, mAbxience Strike Licensing Deal for Biosimilar Candidate Focused on Multiple Oncology Indications
Agreement comes as Teva aims to strengthen its biosimilar portfolio as part of its “Pivot to Growth” strategy.
FDA Approves Vanda Pharmaceuticals' Fanapt to Treat Adults with Bipolar I Disorder
Fanapt was previously approved by the FDA in 2009 as an antipsychotic treatment for schizophrenia.
Abbott Receives FDA Approval for TriClip, a Medical Device for Repairing Tricuspid Regurgitation
Approval comes amid positive results from TRILUMINATE trial, which demonstrated improvement in 90% of participants treated for a leaky tricuspid heart valve.
FDA Approves Abbott’s i-STAT TBI Whole Blood Rapid Test to Assess Patients for Concussions at Bedside
The concussion test, which shows results after 15 minutes, can help evaluate patients up to 24 hours after injury, company says.
Jazz Pharmaceuticals Completes Biologics License Application for Zanidatamab for HER2-Positive Metastatic Biliary Tract Cancer
Approval would mark first HER2-targeted therapy for biliary tract cancer in the United States.
FDA Approves Alexion’s Voydeya as Add-on Treatment for Adults with Extravascular Hemolysis
Treatment approved in combination with ravulizumab or eculizumab, representing minority demographic still suffering after receiving C5 inhibitor therapy for extravascular haemolysis.
Pharma Pulse 3/29/24: Super Micro’s AI Boom Carries a Big Price Tag, Leveraging Digital Tools to Optimize Manufacturing & more
The latest news for pharma industry insiders.
Fierce Females in the Life Science Space
In this week’s episode, in recognition of international women’s month, Editor Miranda Schmalfuhs has compiled audio clips from interviews with female KOLs that she’s been fortunate enough to speak with over this past month for content across a few of…
Gilead, Xilio Therapeutics Ink Exclusive Licensing Agreement to Develop Early Phase Tumor-Activated IL-12
Deal aims to commercialize XTX301 for treating advanced solid tumors by leveraging Xilio’s tumor-activated immuno-oncology therapies.
FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients
Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy.
Pfizer Makes Publicis New Global Creative Duties Partner
The news comes less than a year after Pfizer announced that IPG would handle this role.
Researchers Present First Study Using Biomimetic AI Digital Twins
The study used technology developed by a variety of companies, including RYLTI.
FDA Grants 501(k) to Two Avicenna.AI Products
Both products are designed to help radiologists.
Addressing Uncertainties Associated Medication Approved Through Accelerated Approval Pathway
In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses how healthcare providers and patients navigate the potential benefits and uncertainties associated with a medication approved through the accelerated approval pathway.
FDA Approves Roche’s Cobas Malaria Test, Designed to Screen for Malaria in Potential Blood Donors
Action marks the first FDA-approved blood screening test for malaria.
FDA Approves Winrevair, Merck’s Novel Treatment for Pulmonary Arterial Hypertension
Winrevair is the first FDA-approved activin signaling inhibitor therapy for pulmonary arterial hypertension.
Viking Therapeutics Reveals Positive Results from Oral Obesity Drug
Reportedly, the oral weight loss pill VK2735 showed promising signs of effectiveness and a tolerable safety profile.
UCB's Women of Childbearing Age Program
In this Pharmaceutical Executive video interview, Marie Teil, Global Head of UCB’s Women of Childbearing Age Program, talks about the program’s creation and their most successful strategies for encouraging the inclusion of women of childbearing age in clinical trials.
FDA Approves AstraZeneca’s Ultomiris for Neuromyelitis Optica Spectrum Disorder
Action marks the first FDA approval of a long-acting treatment for adult patients with neuromyelitis optica spectrum disorder who are positive for the anti-aquaporin-4 antibody.
CDC Releases Health Alert and Pushes for Increase in Measles Vaccinations
The agency released guidelines for vaccinations guidelines for children as young as 6 months old.
Pharma Pulse 3/22/24: Surgeons Transplant Pig Kidney into a Patient, Effective Ways to Engage Patients, Caregivers, and Advocacy Groups & more
The latest news for pharma industry insiders.
FDA Approves Italfarmaco SpA’s Duvyzat for Duchenne Muscular Dystrophy
Duvyzat (givinostat) is histone deacetylase inhibitor that was previously granted priority review, orphan drug designation, and rare pediatric disease designation by the FDA for patients 6 years of age and older with Duchenne muscular dystrophy.
Addressing Unmet Needs in Schizophrenia, Pulmonary Arterial Hypertension & NASH
In this Pharmaceutical Executive video interview, Optum Rx clinical pharmacist, Arash Sadeghi, discusses the three drugs featured in their Drug Pipeline Insights Report for 2024 and which unmet needs they address.
Medicare to Cover Wegovy for Certain Indications
The drug was recently cleared to treat cardiovascular risks, making it eligible for Medicare Part D.
Clinical Trial of Keytruda and Lynparza Combination Fails to Meet Primary Endpoint for Treatment of Metastatic Nonsquamous Non-Small Cell Lung Cancer
Despite not having a positive outcome, safety profiles for Keytruda and Lynparza were consistent with previous findings.
Research Lab Unveils Tool to Improve Clinical Trial Participation
Cold Spring Harbor Laboratory details how the new tool will help reduce common barriers to trial participation.
Emerging Trends at the Intersection of AI & Marketing
In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, talks about what’s coming marketing with the use of AI.
FDA Approves Idorsia’s Tryvio for Once-Daily Treatment of Difficult-to-Control Hypertension
Tryvio (aprocitentan) approved in combination with other antihypertensive drugs to lower hypertension in adults whose blood pressure is not adequately controlled by other therapies.
FDA Grants Accelerated Approval to Takeda's Iclusig for Ph-Positive Acute Lymphoblastic Leukemia
Label expansion approval for Iclusig (ponatinib) addresses adult patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia.
AstraZeneca Announces Plans to Acquire Fusion
The acquisition will bolster AstraZeneca’s ability to develop radioconjugates for cancer treatments.
FDA’s Oncologic Drugs Advisory Committee Recommends Earlier Treatment with Carvykti for Relapsed or Refractory Multiple Myeloma
In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment.
AI’s Impact on CEO/Founder Sustainability
In this Pharmaceutical Executive video interview, Kaveh Vahdat, Founder and President of RiseOpp, discusses the impact AI will have on thelong-term well-being of founders and CEOs.
BeiGene and Leukemia & Lymphoma Society Sign Three Year Agreement
As part of the partnership, BeiGene will serve as a sponsor at LLS events.
Pharma Pulse 3/15/24:Pharma Dealt Loss Over Discount Program, Adopting New Manufacturing Technologies & more
The latest news for pharma industry insiders.
FDA Approves First Treatment for Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) was granted accelerated approval for the treatment of adult patients with noncirrhotic nonalcoholic steatohepatitis (NASH).
FDA Grants Accelerated Approval to Bristol Myers Squibb’s Breyanzi for Relapsed or Refractory CLL, SLL
CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) approved for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously administered at least two lines of therapy.
FDA Approves Tevimbra, BeiGene’s Treatment for Adults with Unresectable or Metastatic Esophageal Squamous Carcinoma
Tevimbra (tislelizumab-jsgr) has been approved as a monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma who have previously undergone systemic chemotherapy excluding PD-L1 inhibitors.
Hurdles Hindering the Translation of AI-Powered Research into Tangible Clinical Benefits
In this Pharmaceutical Executive video interview, Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses why no novel active substances have yet been brought to market through AI technology despite increasing investments in the space for…
AstraZeneca Acquires Amolyt Pharma with the Aim of Developing Rare Endocrine Disease Treatments
Acquisition is highlighted by eneboparatide, Amolyt’s Phase III peptide for hypoparathyroidism with a novel mechanism of action.
Gen-Z Influence on Pharma M&A
Ian Baer, Founder and Chief Soothsayer, Sooth, discusses how pharmaceutical companies and healthcare advertising agencies can adapt their strategies to attract Gen-Z.
Par Pharmaceutical Issues Recall of Single Lot of Treprostinil
The voluntary recall was ordered due to potential silicon particulate exposure.
Industry Business Check: Market Review Rates the Latest Full-Year Outputs
A look at pharma and biotech financing, M&A, and stock market performance in 2023—and where developments may head next as company executives continue to navigate stormy but perhaps stabilizing waters in the months ahead.
Positioning Medical Information as a Trust Driver for Your Brand
Four steps to maximize the impact of medical information services as an engagement gateway.
If One in Five MBAs Were Unemployed Months After Graduating From a Premier Business School in 2023, What New Skill Sets Should People Pursue in 2024? A Q&A with Stanford’s Matt Abrahams
Matt Abrahams, a Lecturer in Organizational Behavior at Stanford University’s Graduate School of Business, discusses the importance for job seekers of investing time on qualitative skills, such as communications.
FDA Approves Expanded Indication for Praluent to Lower LDL-C in Pediatric Patients with HeFH
Regeneron’s PCSK9 inhibitor approved to reduce low-density lipoprotein cholesterol in patients 8 years of age and older with heterozygous familial hypercholesterolemia.
Behind the Push and Pull of Copay Accumulator Programs
In this Pharmaceutical Executive video interview, Chris Dowd, senior vice president of market development, ConnectiveRx, discusses the evolution of drug copay adjustment programs and the circumstances that fueled their controversy across industry, political, and healthcare community circles.
Boehringer Ingelheim Unveils New Out-of-Pocket Cap Initiative for its Inhaler Product Portfolio
Starting June 1, Boehringer Ingelheim plans to cap inhaler products for respiratory diseases at $35 per month for eligible patients.
Approval of Eli Lilly's Alzheimer Drug Donanemab Delayed as FDA Seeks More Information
Because of the unique trial design of the Phase III TRAILBLAZER-ALZ 2 study, the FDA is seeking additional input regarding the safety and efficacy of donanemab for the treatment of early symptomatic Alzheimer disease.
How Data Integrity Landscape Will Evolve Over the Five Years
In this Pharmaceutical Executive video interview, Daniel Ayala, Chief Security and Trust Officer, Dotmatics discusses how the data integrity landscape will evolve over the next five years and what extent bench scientists in the lab focused on data integrity.
Relyvrio Falls Short of Primary Endpoint in Phase III PHOENIX Trial in Patients with ALS
Relyvrio did not significantly alter amyotrophic lateral sclerosis disease progression as measured by the ALSFRS-R total score at Week 48 compared to placebo.
FDA Approves Expanded Indication for Wegovy to Lower Cardiovascular Risk in Adults with Heart Disease, Obesity
FDA approves Wegovy (semaglutide) to lower the risk of major adverse cardiovascular events in adults with known heart disease and with either obesity or overweight, in addition to a reduced calorie diet and increased physical activity.
FDA Grants Accelerated Approval to Brukinsa Plus Gazyva for Relapsed or Refractory Follicular Lymphoma
BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies.
FDA Approves Opdivo Plus Chemotherapy for Frontline Treatment of Unresectable, Metastatic Urothelial Carcinoma
Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.
Pharma Pulse 3/7/24: Antipsychotic Prescribing Patterns in Pediatric Patients with MDD, AI Hype Is a Two-Edged Sword & more
The latest news for pharma industry insiders.
Bayer Won’t Be Splitting Up
The company plans to spend the coming years strengthening its market position and pipeline while also clearing its issues with litigation and debt.
Pharma Pulse 3/6/24: There’s No Easy Way to Stop Taking Ozempic, Navigating Changes and Trends in the Pharma Supply Chain Post-DSCSA & more
The latest news for pharma industry insiders.
FDA Approves Pair of Interchangeable Denosumab Biosimilars
The biosimilars Wyost and Jubbonti (denosumab-bddz) were approved as interchangeable products for Prolia and Xgeva for the treatment of osteoporosis, hypercalcemia, and to prevent skeletal-related events associated with bone metastases from solid tumors.
FDA Approves Hugel America’s Letybo to Treat Moderate-to-Severe Frown Lines in Adults
Letybo (letibotulinumtoxinA-wlbg) is expected to launch in in the United States toward the second half of the year for moderate-to-severe frown (glabellar) lines in adults.
Amring Changes Name to Nordic Pharma, Inc. Amid Ownership Change
Rebranding aims to align company with its parent company and other subsidiaries.
FDA Approves Rybrevant Plus Chemo for Front-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations
Regulatory action makes Rybrevant plus chemotherapy the first FDA-approved therapy for the first-line treatment of non-small cell lung cancer with EGFR exon 20 insertion mutations.
CDC’s Advisory Committee Recommends Another Round of Covid-19 Shots for Seniors
The agency updated its recommendations after a vote by the ACIP advisory committee.
The State of Obesity-Related Clinical Research: Q&A with Simon Bruce, Vice President, Internal Medicine, Drug Development Solutions, ICON
Simon discusses a recent survey ICON conducted with professionals in obesity-related clinical research.
Bristol Myers Squibb Reveals Promising Results from Trial of Zeposia for Multiple Sclerosis
Phase III DAYBREAK study found consistent safety with Zeposia in patients with relapsing forms of multiple sclerosis.
CMS Signals Looming Sunshine Act Audits: How to Prepare
New guidance suggests that CMS may be ramping up Sunshine Act auditing activities, potentially resulting in monetary liability for noncompliant reporting entities.
With the Rise of GLP-1 Agonists for Treating Obesity, Will Access Challenges Prevent Progress?
JAMA commentary suggests that issues such as high costs, access, and equity will stop patients from obtaining GLP-1 agonists to treat obesity.
FDA and Workflow Services Detail First 100 Days of Data Collection Partnership
The agency teamed up with the software company to develop platforms and networks to collect de-identified data.
Biosimilars Report Shows Challenges, Opportunities Across Disease States
Cardinal Health report highlights new biosimilar treatments, legislative developments, and multiple industry perspectives.
Viking Therapeutics’ GLP-1/GIP Receptor Agonist Shows Positive Results in Obesity Clinical Trial
The trial reportedly showcased significant weight reduction in those treated with VK2735, a dual GLP-1/GIP receptor agonist.
AbbVie, OSE Immunotherapeutics Strike Deal to Develop Monoclonal Antibody for Chronic Inflammation
OSE-230 was developed to activate a unique mechanism for resolving chronic inflammation, focusing on modulation of macrophages and neutrophils.
Reese Pharmaceutical Announces At-Home Colon Cancer Screening Test
The device can detect potential warning signs of serious conditions.
Allecra Therapeutics' Exblifep Approved by FDA for Complicated Urinary Tract Infections
The FDA granted Allecra with a five-year marketing exclusivity extension for Exblifep (cefepime/enmetazobactam) through the Generating Antibiotic Incentives Now Act.
IQVIA Executive Director Discusses Global Use of Medicines 2024 Report – Part 2
Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses how climate events and COVID-19 have impacted medicine use and spending.
Asthma Medication Xolair May Reduce Peanut Allergies, New Study Finds
FDA has approved the medication in adults and children with allergies.
WHO Grants Prequalification to Typhoid Vaccine Developed by SK bioscience, International Vaccine Institute
SKYTyphoid showed a positive immunogenicity and safety profile compared to other polysaccharide-protein conjugate typhoid vaccines that obtained prequalification certification by the World Health Organization.
IQVIA Executive Director Discusses Global Use of Medicines 2024 Report – Part 1
Murray Aitken, Executive Director of the IQVIA Institute for Human Data Science, discusses key findings from their Global Use of Medicines 2024 report as well as the significant projected growth in spending and growth in diabetes and global obesity
FDA Grants Priority Review to Dupixent for Uncontrolled Chronic Obstructive Pulmonary Disease
The FDA has assigned a supplemental Biologics License Application submitted by Regeneron and Sanofi for Dupixent in the treatment of COPD with type 2 inflammation with a PDUFA date of June 27, 2024.
Frontier Medicines Announces Series C Funding to Advance Development of Next Generation KRAS Blocker
Funds expected to advance multiple programs into clinical studies, including FMC-376, which targets KRASG12C cancers.
FDA Warns Against Using Smartwatches or Smart Rings to Measure Blood Glucose Levels
The agency issued a statement reminding the public that it has not approved any such devices for this use.
NIH Study Estimates Pfizer’s Paxlovid Could Reduce COVID-19 Hospitalizations, Saving Billions in Healthcare Costs
Results of a study conducted by the National Institutes of Health indicate that the Paxlovid prevented a substantial number of hospitalizations associated with COVID-19.
HLTH Inc. and GE Healthcare Reveal Healthcare-Themed Art Gallery
The gallery will be a part of the HLTH Europe event and will be open to all attendees.
Senators Pen Letter to FDA Urging Stronger Enforcement on Deceptive Direct-to-Consumer Social Media Ads Promoting Prescription Drugs
Letter emphasizes the need to protect children from potentially harmful medical advice spread on social media.
Emergent BioSolutions Names Joseph C. Papa As CEO
Papa will take over the over effective immediately.
Regeneron's Linvoseltamab Granted FDA Priority Review for Relapsed/Refractory Multiple Myeloma
The FDA assigned the biologics license application for linvoseltamab to treat relapsed/refractory multiple myeloma with a Prescription Drug User Fee Act of August 22, 2024.
Will The Return of Mergers and Acquisitions Continue? Q&A With Arthur Wong, Managing Director, Healthcare, S&P Global Ratings
Wong discusses trends regarding M&A and how he expects this to continue and change in the coming months.
WuXi Advanced Therapies’ Philadelphia Site Approved by FDA to Start Manufacturing Iovance’s Melanoma T-cell Therapy
Amtagvi is the first one-time, individualized T-cell therapy approved by the FDA for any solid tumor cancer.
AstraZeneca’s Tagrisso With Chemotherapy Gets FDA Approval for EGFR-Mutated Non-Small Cell Lung Cancer
The FDA has also approved Tagrisso (osimertinib) as a monotherapy for the first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage…
Copay Adjustment Programs: What’s Next for Manufacturers?
Amid shifting healthcare cost strategies, how manufacturers can apply past lessons to best support patients and help boost drug adherence.
Study Shows Potential of Artificial Intelligence in Predicting Responses to Treatment for Major Depressive Disorder
Investigators harness machine learning to evaluate response to sertraline treatment for major depressive disorder.
Cultivating a Bespoke Recruitment Strategy for Your FSP Partnership
How a multipronged approach to staff recruitment can accelerate trial success.
FDA Grants Traditional Approval to Tepmetko for Metastatic Non–Small Cell Lung Cancer
The FDA previously granted accelerated approval to Tepmetko for metastatic non–small cell lung cancer harboring MET exon 14 skipping alterations.
Cancer & Work: Acting Together: An Interview With Raj Verma, Chief Diversity, Culture, and Experience Officer at Sanofi
In an interview with Pharm Exec Associate Editor Don Tracy, Raj Verma, Chief Diversity, Culture, and Experience Officer, Sanofi, discusses features of the company’s support program for patients diagnosed with cancer and other critical illnesses.
Digging Deeper Into Bayer’s ASCO GU Presentation
Iris Kuss, head of clinical development, and Jorge Ortiz, head of medical affairs, discuss the company’s recent presentation at ASCO GU.
Xolair Approved by FDA as First Treatment for Multiple Food Allergies in Adult, Pediatric Patients
Novartis’ and Roche’s Xolair (omalizumab) is indicated to treat severe allergic reactions after accidental exposure to one or more foods in individuals aged one year and above.
How to Conduct More Impactful Patient and Caregiver Advisory Boards
Looking to hold an advisory board? Here are a few suggestions.
GSK Completes Acquisition of Aiolos Bio
This acquisition will add asthma treatment A1O-001 to GSK’s portfolio.
Two Frameworks for Orphan Drug IDN Launch Planning
A strategic formulation for separate IDN market spaces.
Aurlumyn Becomes First Severe Frostbite Medication to Receive FDA Approval
Treatment aims to reduce the risk of finger or toe amputation due to frostbite.
Sustainability and Progress Continue to Make Headlines in 2024
Recognition of the business case for ESG in pharma is soaring.
Building Resiliency: Essential Leadership Principles for 2024
Embracing business imperatives such as operational efficiency and a focus on a patient-centric approach can help pharma leaders provide a stable foundation amid lingering uncertainty.
FDA Fast Tracks GSK's Bepirovirsen for Chronic Hepatitis B Virus
In clinical trials, bepirovirsen showed the potential to address a significant unmet medical need for patients with chronic hepatitis B by reducing hepatitis B surface antigen levels and HBV DNA.
Using AI to Solve Drug Shortage Issues
In this video interview with Pharm Exec Associate Editor Miranda Schmalfuhs, Dr. Jo Varshney, CEO & Founder of VeriSIMLife, discusses how artificial intelligence and machine learning can assist in the drug shortage problem.
From Numbers to Negotiations
Entrenched and emerging hurdles alike are challenging manufacturer pricing and access strategies.
Takeda's TAK-861 Shows Promising Results in Phase IIb Trial for Narcolepsy Type 1
Novel oral orexin receptor 2 agonist produced statistically significant and clinically meaningful improvements in wakefulness compared with placebo in patients with narcolepsy type 1.
Samgsung Biologics, LegoChem Biosciences Partner on Development of Antibody-Drug Conjugate
Joint venture aims to submit an Investigational New Drug application to the FDA by early next year for treatment that targets solid tumors.
The Promise and Peril of AI in the Physical World
The use of artificial intelligence (AI) in drug development has been hampered by issues that have caused a gap between AI’s potential and its full utilization in this space.
New Report Says Generic Drug Market Is Set to Grow Over $175 Billion by 2027
According to the study conducted by Technavio, North America will contribute to 37% of the expected growth.
BioNTech and Autolus Announce Strategic Alliance to Bolster CAR-T Cell Pipeline
BioNTech will invest $200 million and get access to Autolus’ manufacturing sites.
How to Stand Out in the Wellness Space as a Pharma Brand
Key steps in relationship-building beyond just treatment options.
2024 Life Sciences Accounting & Reporting Congress
2024 Life Sciences Accounting & Reporting Congress
Pfizer Teams With American Cancer Society to Reduce Cancer Care Disparities
The three-year initiative comes with $15 million in funding.
Gilead Discontinuing Development of Magrolimab in Hematologic Cancers Following Full Clinical Hold by FDA for Increased Risk of Death
Data from the ENHANCE-3 trial of magrolimab in combination with azacitidine plus Venclexta showed futility and an increased risk of death in patients with acute myeloid leukemia.
GSK's Blenrep Produces Significant Survival Improvement in Relapsed or Refractory Multiple Myeloma
Patients with relapsed or refractory multiple myeloma administered Blenrep combined with bortezomib plus dexamethasone experienced a 59% reduction in the risk of disease progression or death compared with the standard of care.
Amgen's Novel Weight Loss Drug Shows Potential for Longer Lasting Effect With Less Frequent Dosing Than Wegovy, Zepbound
In a Phase I trial, data suggest that Amgen’s maridebart cafraglutide (MariTide) may allow patients to take lower and less frequent doses over time while still maintaining significant weight loss.
Using GenAI as a Co-Pilot for Regulatory Intelligence
GenAI is on the precipice of breaking new ground in regulatory intelligence; making strategists more efficient by alleviating challenges, streamlining regulatory research and submission processes.
Synchron, Potential Competitor to Elon Musk’s Neuralink, Obtains Equity Interest in Acquandas to Accelerate Development of Brain-Computer Interface
Synchron’s brain-computer interface device is being developed to allow patients with mobility challenges to operate certain technology with their mind.
FDA Grants Priority Review to Adaptimmune's T-Cell Therapy for Advanced Synovial Sarcoma
The biologics license application for afamitresgene autoleucel, an engineered T-cell receptor drug, was assigned a PDUFA date of August 4, 2024.
Novartis Terminates Licensing Rights With Allarity for Cancer Drug Due to Missed Payments
Novartis rescinds rights to to develop and commercialize multi-tyrosine kinase inhibitor dovitinib due to a material breach by Allarity for lack of financial payment.
Novo Nordisk Increases Supply of Lower-Dose Wegovy to Meet Continued Demand
The company has struggled to supply the drug to patients due to overwhelming popularity.
FDA Issues Warning of Contaminated Copycat Eyedrops
The agency issued the warning against three brands of unapproved eyedrops designed to look like an approved brand.
Sanofi Announces New Reservation Program to Mitigate Shortages of RSV Vaccine for Next Season
Beyfortus (nirsevimab-alip), a monoclonal antibody that protects against respiratory syncytial virus-associated lower respiratory tract disease, experienced higher than anticipated demand that led to shortages during the 2023-2024 season.
Shubh Goel, VP, Head of Immuno-Oncology and Gastrointestinal Tumors Franchise, US Oncology Business Unit, AstraZeneca, Discusses Positive Results From Phase III Trial In Patients With HCC
In an interview with Pharm Exec Associate Editor Don Tracy, Shubh Goel, Head of Immuno-Oncology and Gastrointestinal Tumors, US Oncology Business Unit, AstraZeneca, provides her thoughts on the success of the trial.
Takeda, Protagonist Therapeutics Agree to Global Collaboration on Late-Stage Polycythemia Vera Treatment
Rusfertide is currently in a pivotal Phase III clinical trial as a potential first-in-class treatment for polycythemia vera.
DELFI Diagnostics Launches Assay That May Improve Monitoring of Cancer Treatment Response
DELFI-Tumor Fraction assay was developed to improve noninvasive assessment of tumor burden and monitoring of treatment efficacy and resistance in patients with advanced cancers.
Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences, Discusses the Recent Breakthrough Therapy Designation for PF614-MPAR
In an interview with Pharm Exec associate editor Don Tracy, Lynn Kirkpatrick, PhD, CEO, Ensysce Biosciences, discusses the FDA’s Breakthrough Therapy Designation for PF614-MPAR, which focuses on protecting patients from drug overdoses.
Biogen Pulls Plug on Controversial Alzheimer Disease Drug Aduhelm
Aduhelm (aducanumab-avwa) was granted accelerated approval by the FDA in June 2021 despite misgivings from the agency’s Peripheral and Central Nervous System Drugs Advisory Committee.
FDA Approves Takeda's Gammagard Liquid for Chronic Inflammatory Demyelinating Polyneuropathy
This is Takeda’s second approval in chronic inflammatory demyelinating polyneuropathy this month after the FDA approved HyQvia to protect against relapse of neuromuscular disability and impairment in this patient population.
Bristol Myers Squibb's Breyanzi Granted FDA Priority Review for R/R Follicular Lymphoma, Mantle Cell Lymphoma
CAR T-cell therapy Breyanzi (lisocabtagene maraleucel) to be evaluated in patients with relapsed or refractory follicular lymphoma and mantle cell lymphoma following treatment with a Bruton tyrosine kinase inhibitor.
The Hospital of the Future and How Data, Digital, and AI Will Merge to Make Care Better: Q&A With Dr. Pierantonio Russo, Chief Medical Officer, EVERSANA
Dr. Russo discusses how modern innovations will shape the way hospitals operate in years to come.
EMA Grants Bersiporocin Orphan Drug Designation
The agency recognized the medication as a significant advancement for the treatment of IPF.
The Twists and Turns in Biopharma Dealmaking: 2024 Trends
A deep dive into the complex playing field for M&A and partnering pursuits in today’s increasingly make-or-break landscape for biopharma innovation.
Report: Three US Residents Suffering from Hypoglycemia Used Suspected Counterfeit Ozempic
Report comes after the FDA seized thousands of counterfeit Ozempic units.
Combating the Opioid Crisis With Long-Acting Injectables
Substance use disorder is a complex condition that demands innovative solutions, one of which that has shown promise is the use of long-acting injectables.
Recent Licensing Agreement Poised to Advance Company ADC
In an interview with PharmExec Associate Editor Don Tracy, Jingsong Wang discusses Nona Biosciences’ recent exclusive license agreement with Pfizer Inc. for the development and commercialization of HBM9033.
GLP-1 Agonists May Lower Cirrhosis, Liver Cancer Risk in Type 2 Diabetes Patients
Study finds that individuals who took GLP-1 agonists for a long duration had a lower risk of going on to develop more severe forms of liver disease, including cirrhosis and liver cancer.
Citing Severe Health Risks, FDA Issues Warning Against Using Tianeptine Products
Atypical antidepressant linked to severe adverse effects and death as a result of misuse.
FDA Approves Expanded Indication for Dupixent to Treat Eosinophilic Esophagitis in Pediatric Patients
The FDA previously approved Dupixent in May 2022 to treat eosinophilic esophagitis in patients aged 12 years and older.
FDA Urges Caution Following Boxed Warning Requirements on CAR T-Cell Therapies
FDA leadership notes that the overall rate of secondary T-cell cancers among patients administered CAR T-cell therapies appears to be low, even if all reported cases are assumed to be related to treatment.
FDA Warns Drugmakers of Additional Cancer Risks Associated with CAR T-Cell Therapy
New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products.
Reimagining Medical Education for the Digital Age
Embracing new digital-based tools is critical throughout the healthcare landscape to prepare for the rise of telemedicine as a permanent way of life.
FDA Grants Clearance to Clinical Trial for NK CellTech’s Non-Genetically Modified Natural Killer Cells
NK010 is reportedly the first Chinese trial of its kind to be approved by the FDA.
Gilead's Trodelvy Falls Short of Phase III Trial Primary Endpoint of Improved Overall Survival in NSCLC
The EVOKE-01 trial compared Trodelvy with docetaxel for the treatment of patients with metastatic or advanced non-small cell lung cancer who progressed on or following platinum-based chemotherapy and checkpoint inhibitor therapy.
The Importance of Responsible and Transparent Communications in Pharma Marketing
Pharma marketing strategies that are both socially and ethically responsible can build long term success for the life sciences industry.
Opdivo Plus Yervoy Reduces the Risk of Colorectal Cancer Disease Progression or Death by 79% Versus Chemotherapy
Opdivo plus Yervoy shows promise in treating patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer.
Has Pharma Given Up on Long-Term Adherence?
Will the FDA ultimately step in and mandate a credible effort to eradicate the mindset that long-term adherence is not achievable?
The Evolving Role of PBMs: An Interview with Bill Roth, General Manager, Managing Partner, Blue Fin Group
In an interview with Nicholas Saraceno, Bill Roth, General Manager, Managing Partner, Blue Fin Group, discusses the changing role of PBMs and recent price structure overhauls.
Novartis' Lutathera Shows Significant Survival Benefit as First-Line Treatment for GEP-NETs
Lutathera plus long-acting release octreotide lowered the risk of disease progression or death by 72% in patients with somatostatin receptor-positive well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors.
Making the Case for Early-Stage Commercial Analytics
Analytics capabilities are no longer a nice-to-have, but a necessity to build and maintain a successful business and competitive edge.
FDA Approves Balversa for Locally Advanced, Metastatic Urothelial Carcinoma
Today’s FDA approval amends a previously granted accelerated approval for Balversa (erdafitinib) to treat patients with metastatic urothelial carcinoma whose tumors harbor FGFR3 or FGFR2 alterations following prior platinum-based chemotherapy.
Pusan National University Announces Potential Breakthrough for Muscle Regeneration Using Nanotech
According to the university, new nanotech scaffolding can be used to support tissue growth.
Navigating Success During a Rare Disease Product Launch
Webinar Date/Time: Thu, Feb 15, 2024 11:00 AM EST
Sun Pharma and Taro Reach Definitive Merger Agreement
Sun Pharmaceutical Industries will purchase Taro’s outstanding shares for $43 each, which will total $348 million.
Poll Reveals Only a Small Number of Older Americans Have Used Online Direct-to-Consumer Health Services
Researchers believe low numbers in the use of direct-to-consumer healthcare services could rapidly trend up.
FDA Approves Takeda’s Hyqvia for Maintenance of Chronic Inflammatory Demyelinating Polyneuropathy
Hyqvia is the only subcutaneous immune globulin infusion that can be administered once per month.
Phesi Releases Annual Analysis of Clinical Development for 2023
New analysis for 2023 shows signs of post-pandemic recovery; breast cancer remains most studied disease area.
Arcutis’ Zoryve Shows Progress for Individuals with Atopic, Seborrheic Dermatitis
Company displayed findings at the 2024 Winter Clinical Dermatology Conference in Hawaii demonstrating significant improvements in atopic dermatitis and seborrheic dermatitis.
FDA Clears AnX Robotica’s NaviCam SB for Expanded Indications
The device can produce AI-assisted readings.
Report: Pharmaceutical Contract Manufacturing Market Expected to Hit $140 Billion by 2030
Roots Analysis report suggests increase can be attributed to the growing demand for advanced therapies and biologics.
Department of Defense Awards Emergent BioSolutions With $235.8 Million Contract for Anthrax Vaccine
The BioThrax vaccine is indicated for active immunization to prevent anthrax disease caused by Bacillus anthracis in individuals aged 18 through 65 years.
Mucinex Survey Reveals Americans Only Feel Healthy For Half of Every Month
The survey is part of the brand’s new marketing campaign.
RemeGen's Antibody-Drug Conjugate Gets FDA Fast Track Designation for Ovarian Cancer
RC88 is under evaluation for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.
Will Employers Support Demand for Coverage Expansion of GLP-1 Agonists into Weight Loss?
Although medications such as Mounjaro and Zepbound have shown efficacy in helping individuals lose weight, there are not yet enough results to fully support these claims.
Dexcom Announces Preliminary and Unaudited Revenue For Fourth Quarter and Fiscal Year 2023
The company also announced that it has submitted its new glucose monitoring system to the FDA for approval.
Foundational Questions in Data Reporting, Analytics to Meet Reimbursement-Directed Marketing Goals
Measuring the relationship between a product’s reimbursement position and performance begins with gathering key data points for as many products as possible.
S&P Global Releases Healthcare Industry Outlook for 2024
While the industry as a whole still faces challenges, there are positive trends appearing for pharmaceutical and medical device companies.
FDA Fast Tracks SELLAS Life Sciences' CDK9 Inhibitor for Acute Myeloid Leukemia
SELLAS Life Sciences Group, Inc’s CDK9 inhibitor SLS009 is being evaluated in an ongoing Phase I/II study in combination with Venclexta and Vidaza for patients with relapsed or refractory acute myeloid leukemia.
FDA Accepts New Drug Application for Shorla Oncology’s Novel Treatment for Breast, Ovarian Cancer
SH-105 eliminates the need for powder reconstitution, which Shorla stated will bolster the novel product’s efficiency and lower the risks associated with drug preparation. The FDA has accepted Shorla Oncology’s New Drug Application (NDA) for SH-105 to treat patients with…
Evaluate Acquires J+D Forecasting
Both companies are now under the Norstella umbrella. Evaluate announced the acquisition of J+D Forecasting, a provider of forecasting solutions focused on the pharmaceutical and life sciences industry. The move will bring J+D under the Norstella umbrella, the parent company…
Merck, Johnson & Johnson Announce Acquisitions to Bolster Respective Oncology Pipelines
Merck has acquired Harpoon Therapeutics with its clinical stage T-cell engager, whereas Johnson & Johnson acquired Ambrx Biopharma with its expertise in next generation antibody drug conjugates and targeted oncologic therapies. Both Merck and Johnson & Johnson have announced separate acquisitions…
Zelix Pharmaceuticals Files BLA for PET Imaging Agent for Renal Cell Carcinoma
Trial data show 89Zr-DFO-girentuximab was more effective than traditional PET/CT imaging in identifying malignant renal cell carcinoma lesions. Telix Pharmaceuticals has filed a biologics license application (BLA) to the FDA for the novel positron emission tomography (PET) imaging agent 89Zr-DFO-girentuximab…
IQVIA Responds to FTC’s Block on Acquisition of Propel Media
Proposed acquisition would have given IQVIA a market-leading position in healthcare advertising. Following a review spanning November and December 2023, on December 29, 2023, the US District Court for the Southern District of New York granted the Federal Trade Commission’s…
FDA Grants Fast Track, Breakthrough Designations to CG Oncology Inc’s Cretostimogene Grenadenorepvec
Cretostimogene grenadenorepvec (CG0070) is currently being evaluated for the treatment of patients with high-risk Bacillus Calmette-Guérin–unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors. The FDA granted Fast Track and Breakthrough Therapy designations…
How Bringing Pharmacovigilance In-House Drives Better Oversight and Faster Data Analysis
For companies in the life science industry, managing their processes in house on their own platforms proved beneficial. For many growing biotechs, it can be difficult to choose a safety or pharmacovigilance (PV) operating model that works for their organization’s…
Invivyd Seeks EUA for Monoclonal Antibody Designed to Prevent COVID-19 in Immunocompromised Individuals
VYD222 is a broadly neutralizing, half-life extended monoclonal antibody developed specifically to prevent COVID-19 in immunocompromised adults and adolescents. Invivyd, Inc. has filed a request with the FDA for emergency use authorization (EUA) for VYD222, a broadly neutralizing, half-life extended…
FDA Fast Tracks Candel Therapeutics’ Novel Treatment for Pancreatic Ductal Adenocarcinoma
Study results show an estimated 71.4% survival rate after both 24 and 36 months with aglatimagene besadenovec (CAN-2409) in combination with valacyclovir for the treatment of patients with pancreatic ductal adenocarcinoma compared with 16.7% in the control group. The FDA…
Which Offers the Best Chance for Career Longevity in Biopharma? Q&A with Kerry McKittrick, Co-Director of the Harvard Project on Workforce
Practical recommendations for a path forward for both biopharma C-Suites and their employees. Kerry McKittrick is a co-director of the Harvard Project on Workforce, an interdisciplinary applied research project between the Harvard Kennedy School’s Malcolm Wiener Center for Social Policy,…
Key Challenges in Chemicals and Materials R&D
Companies must address myriad challenges to improve upon issues such as data quality and transparency, process efficiency, and artificial intelligence/machine learning preparedness. The chemical and materials industry contributes roughly $5.7 trillion to global GDP and supports an estimated 120 million…
An Enterprise-Wide Approach to Customer Intelligence
The importance of enabling customer intelligence at scale. Most healthcare professionals (91%) place a high value on scientific exchange1 with medical science liaisons (MSLs) and say that biopharma is underutilizing its MSL workforce. In addition, Veeva Pulse data shows that…
Erasca’s Naporafenib Gets FDA Fast Track Designation for Metastatic Melanoma
Erasca will initiate the pivotal SEACRAFT-2 trial in the first half of 2024 to evaluate naporafenib in combination with trametinib in adults with unresectable or metastatic melanoma with an NRAS mutation. Erasca’s naporafenib (ERAS-254) has been granted FDA Fast Track…