Best practices for defending against lawsuits based on pharmaceutical labeling, including avenues for early resolution of the case and, as necessary, strategies for developing the
Category: Medicine
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
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
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
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
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
Examining the Prevalence of Underinsurance in Children with Special Health Care Needs
JAMA study investigates whether physical or behavioral healthcare needs are associated with the risk of underinsurance across household income levels. In a recently published study
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
Study Highlights Need to Improve Diversity Across Healthcare Professions
Over the past 15 years, on average, racial and ethnic diversity in multiple US regions has increased by 1% to 5%. One concern that has
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
AstraZeneca Bolsters Cellular Therapy Pipeline With Acquisition of Gracell Biotechnologies
Merger agreement includes the Gracell FasTCAR platform, which could significantly improve the efficacy of CAR T-cell therapies. AstraZeneca had a busy holiday season as it
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
Biopharma’s AI revolution is about more than algorithms
Artificial intelligence (AI) has enormous potential in healthcare, but all too often, it gets misunderstood. Especially with the proliferation of AI in other industries and
The Top 5 Q&As of 2023
Pharm Exec spent the year speaking with some of the most interesting professionals from the life sciences industry.
Arcutis Biotherapeutics, Inc’s Zoryve Gets FDA Approval for Seborrheic Dermatitis
Zoryve (roflumilast) topical foam, 0.3% is the first approved treatment for seborrheic dermatitis with a new mechanism of action in more than two decades. The
The Top 5 DE&I Stories in 2023
As companies continued to expand their DE&I efforts, Pharm Exec was there to cover it in 2023. Equity for Women in Healthcare: 131 Years is
Top Marketing Stories of 2023
Pharma marketing teams had to deal with big changes in 2023. Q&A With UCB’s Camille Lee on New Psoriasis Medication Approval The UCB executive speaks
Our Top 5 Podcast Episodes of 2023
Published on: December 27, 2023 Our top five episodes of the year. The Explosive Arrival of Chat GPT and Generative AIFran Pollaro talks with Faruk Capan
Top 5 AI Stories of 2023
As this exciting technology exploded in 2023, Pharm Exec was there to cover it all. The Promise and Challenges of Generative AI in Healthcare Pharma
Top Social Media Trends of 2023
Five trends in pharmaceutical marketing from the past year. Doctors as influencers A recent Hootsuite social trends presentation focused on healthcare revealed that a significant
GSK’s Jemperli Plus Zejula Produces Significant Survival Improvement in Endometrial Cancer
Jemperli plus standard-of-care chemotherapy with carboplatin and paclitaxel, followed by Jemperli plus Zejula as maintenance therapy produced a statistically significant and clinically meaningful benefit in
The Cover Stories of 2023
Enabling Authenticity Natalie Bickford, chief people officer at Sanofi, reveals how she approaches the employee experience, which ultimately influences employee retention, and discusses the importance
Moderna’s Novel mRNA Vaccine Shows Significant Efficacy Against RSV
Pivotal trial findings show favorable clinical safety and efficacy data for mRNA-1345 in lowering the incidence of respiratory syncytial virus-associated lower respiratory tract disease. The
FDA Approves Expanded Indication for LEO Pharma’s Adbry for Pediatric Patients With Atopic Dermatitis
Indication of Adbry (tralokinumab-ldrm) expanded to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with
FDA Approves Filsuvez for Epidermolysis Bullosa
Filsuvez (birch triterpenes) is indicated to treat partial thickness wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa. The FDA has approved Chiesi Global
FDA Accepts Biologics License Application for CSL Behring’s Garadacimab for Hereditary Angioedema
Garadacimab is a novel, first-in-class, recombinant monoclonal antibody for hereditary angioedema that targets activated Factor XII. The FDA has accepted a Biologics License Application (BLA)
Maximizing ROI with Lab Software Solutions
Published on: December 21, 2023 Explore the implementation of enterprise laboratory software and the start of a digital transformation in your lab with an industry expert
The Transformative Potential of AI and Machine Learning in Biomedical Research and Healthcare
In a recent article published by Oxford Academic, authors discussed a number of ways that artificial intelligence (AI) and machine learning (ML) could transform biomedical
Maximizing ROI with Lab Software Solutions (December 2023)
Published on: December 21, 2023 Explore the implementation of enterprise laboratory software and the start of a digital transformation in your lab with an industry expert
79% of Respondents Admit to Neglecting Health Needs During the Holiday Season
American Heart Association survey suggests holiday stress has a major impact on health habits. A recent survey released by the American Heart Association revealed that
Q&A With Christoph Bug, Vice President of Global Medical at Veeva
Data will continue to grow in importance in 2024. Many of the biggest stories in 2023 were related to technological advancements in the life sciences
FDA Grants Priority Review to Genentech’s sBLA for Xolair to Treat Food Allergies
If approved by the FDA, Xolair would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure, including peanut,
Merck’s 21-Valent Pneumococcal Conjugate Vaccine Granted FDA Priority Review
Merck’s Biologics License Application for V116, a novel 21-valent pneumococcal conjugate vaccine has been given a Prescription Drug User Fee Act (PDUFA) date of June
Study Finds Association Between Neighborhood-Level Socioeconomic Status, Medication Nonadherence Among Heart Failure Patients
JAMA study aims to discover whether ignoring medical advice relates to financial status among patients with heart failure. Recently published research points to a need
The Life Sciences Industry in 2023 and a View for 2024
In the coming year, efficiency and automation will take center stage to maximize constrained resources but balancing sensible financial management with strategic investments will be
The Price of Prescriptions: Getting it Right
Drug companies face new hurdles in a rapidly changing marketplace. How do they finance new drug development amid the uncertainty? How much is a prescription
FDA Approves Merck’s Welireg for Advanced Renal Cell Carcinoma
Welireg (belzutifan) approved for the treatment of adults with advanced renal cell carcinoma that progressed after a regimen of a PD-1 or PD-L1 inhibitor and
Moderna and Merck’s Novel Cancer Vaccine, Keytruda Combo Cuts Risk of Skin Cancer Death, Recurrence by Half
Adjuvant treatment with Moderna’s mRNA-4157 (V940) in combination with Merck’s Keytruda lowered the risk of recurrence or death by 49% compared with Keytruda monotherapy. Findings
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
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
FDA Approves Padcev/Keytruda Combo for Locally Advanced, Metastatic Urothelial Cancer
In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally
CDC Raises Urgent Alert for Low Vaccination Coverage for COVID-19, Influenza, RSV
CDC data show hospitalizations among all age groups spiked by 200% for influenza, 51% for COVID-19, and 60% for respiratory syncytial virus over the past
Study Highlights Need for Pharma Industry to Address Stigmatization of Acne
JAMA Network study evaluates current attitudes toward individuals with acne with a call for pharma companies to focus efforts on helping to overcome these stigmas.
FDA Approves First Treatment Indicated to Lower Risk of Relapse in Pediatric Patients With High-Risk Neuroblastoma
Eflornithine (Iwilfin) approved by FDA for adult and pediatric patients with high-risk neuroblastoma who showed at least a partial response to previous multi-agent and multimodality
Pfizer Clears Final Regulatory Hurdles to Acquire Seagen Inc
Pfizer Inc. expects to close its $43 billion acquisition of Seagen Inc., on December 14, 2023. Pfizer Inc. has cleared all regulatory hurdles to complete
MAPS Seeks Approval of First Psychedelic-Assisted Therapy for PTSD
MAPS Public Benefit Corporation filed a new drug application for MDMA (midomafetamine capsules) for use with psychological intervention for the treatment of post-traumatic stress disorder.
AstraZeneca Strengthens Respiratory Illness Pipeline With Acquisition of Icosavax
The deal includes Icosavax’s lead investigational candidate, IVX-A12, a potential first-in-class vaccine being developed for both respiratory syncytial virus and human metapneumovirus. AstraZeneca has announced
Bristol Myers Squibb to Pay Up to $8.4 Billion to Codevelop Antibody-Drug Conjugate With SystImmune
Bristol Myers Squibb will pay $800 million upfront to SystImmune for the rights to codevelop and sell a potentially first-in-class bispecific antibody-drug conjugate that has
Will Calendar Change Bring an End to Run of Volatility in Biotech?
There’s reason to believe that a positive pivot may be in the offing. The XBI, as of late last month, was trading about 15% off
FDA Expands Indication of Cresemba for Use in Children With Invasive Aspergillosis, Invasive Mucormycosis
Cresemba is now the only azole antifungal treatment approved by the FDA for use in pediatric patients as young as 1 year of age with
Q&A With UCB’s Camille Lee on the Bimzelx Navigate Patient Support System
Pharm Exec: In conjunction with Bimzelx, Bimzelx Navigate can be utilized as a “personalized patient support system.” How is it able to be used as
Experimental HIV Vaccine Unlikely to be Effective in Preventing Acquisition
PREPVACC study expected to stop further HIV vaccination attempts after previously enrolling 1,500 participants in East and Southern Africa. PrEPVacc has announced they will be
Meeting Doctors and Patients Where They Are Now
Pharma companies must embrace the future to advance commercialization. Over the course of my career, I have seen significant changes and evolution in the pharmaceutical
Q&A With Seth Farbman, Chairman and Co-Founder of VStock Transfer
Farbman discusses the struggles that pharma companies are facing when trying to raise funds and how this is impacting IPOs. When it comes to the
FDA Approves Two Landmark Cell-Based Gene Therapies for Sickle Cell Disease
FDA approval of bluebird bio’s Lyfgenia and Vertex Pharmaceuticals’ and CRISPR Therapeutics’ Casgevy marks significant milestone in the treatment of sickle cell disease. The FDA
Teva’s Ajovy Shows Similar Efficacy Reducing Migraine Attacks in Patients With Obesity
Migraine with comorbid obesity have been found to cause high levels of disability and are both more common in female patients. A pair of Phase
Prevalence of Eight Chronic Health Conditions Reach Unprecedented Levels in US
Arthritis, asthma, cancer, cardiovascular diseases, chronic kidney disease, COPD, depression, and diabetes reach the highest recorded levels since the America’s Health Rankings Annual Report began
Artificial Intelligence Changing the Landscape for Healthcare Social Media Marketing
Experts from Hootsuite noted that the primary social media ROI concern for healthcare companies is the time and money it takes to maintain a multi-platform
Q&A With UCB’s Camille Lee on New Psoriasis Medication Approval
UCB executive speaks on recent FDA approval of Bimzelx. In an interview with Pharm Exec associate editor Don Tracy, Camille Lee, VP, head of US
Eli Lilly Announces Availability of Obesity Drug Zepbound at US Pharmacies
Patients with obesity are now able to access Zepbound (tirzepatide) with a prescription at retail and mail-order pharmacies across six dose strengths. Eli Lilly and
How Does a ‘Never Enough’ Achievement Culture Impact Your Workforce’s Morale? Planning for 2024 With Journalist and Author Jennifer Breheny Wallace
Jennifer Breheny Wallace, award-winning journalist and author, notes that C-Suite leaders should understand the financial risks of not taking action to address workplace burnout in
Reviewing Consistency and Adequacy of Public vs. Commercial Health Insurance for American Children
New research reveals significant insurance gaps among both publicly insured and commercially insured children. In a study published last month by JAMA Network Open, researchers
The Promise and Challenges of Generative AI in Healthcare
Pharma industry stakeholders must develop actionable roadmaps to prioritize the areas in which the use of generative artificial intelligence can create the greatest benefits. Over
Complete Patient Journeys Outperform Open Claims Data, Surfacing 2.2x More HCPs
Published on: December 1, 2023 Komodo Health Insight into the complete patient journey not only offers new ways to empower field teams, it is also key
FDA Fast Tracks eFFECTOR Therapeutics’ Zotatifin Combo for ER+/HER2– Breast Cancer
FDA to expedite review of zotatifin plus Faslodex (fulvestrant) and Verzenio (abemaciclib) as a second- or third-line treatment for patients with estrogen receptor–positive, human epidermal
FDA Grants Priority Review to Keytruda Plus Padcev for Urothelial Carcinoma
The FDA previously granted accelerated approval to the Keytruda plus Padcev combination for the treatment of patients with locally advanced or metastatic urothelial carcinoma who
Don’t Get Distracted By AI, Instead Focus on Intellectual Property
Artificial intelligence is making it quicker to get drug candidates to the clinic, but it isn’t addressing the fundamental need to marry the right candidate
Keys to Success for Social Media in Healthcare Advertising
How to build a loyal audience of brand evangelists. Today, more than 50% of U.S. adults rely on social media to help them make major
GSK Survey Discovers Extensive Misconceptions About Shingles
Findings show that a considerable number of adults remain uneducated on how herpes zoster is triggered. Data from a recent global survey conducted by GSK
Phase 3 Trial for GSK’s Blenrep Yields Positive Results in Relapsed or Refractory Multiple Myeloma
Blenrep significantly extended the time to disease progression or death against existing care methods as a second-line treatment for relapsed or refractory multiple myeloma. GSK
Building Effective Real World Evidence Studies to Support New Indications for Established Products
The use of real-world evidence can prevent pharma companies from performing studies based on flawed data. In recent years, the healthcare landscape has seen the
Vivos Therapeutics’ Obstructive Sleep Apnea Oral Appliance Gains FDA 510(k) Clearance
Vivos becomes the first company to bring to market an alternative to continuous positive airway pressure (CPAP) or surgical neurostimulation implants for patients with severe
FDA Accepts New Drug Application for Karuna Therapeutics’ Novel Schizophrenia Drug
KarXT (xanomeline-trospium) is currently in development to treat schizophrenia and psychosis related to Alzheimer disease. The FDA has accepted a New Drug Application (NDA) for