Global Launch Strategies in the Current Political Climate

James Foster, CEO and co-founder of Virax Biolabs, discusses how global launches are being impacted by…

FDA Approves Samsung Bioepis Biosimilars Ospomyv and Xbryk

Ospomyv, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of…

Navigating Distrust: Pharma in the Age of Social Media

Ian Baer, Founder and CEO of Sooth, discusses how the growing distrust in social media will…

FDA Approves Sanofi’s Rapid Acting Insulin Biosimilar Merilog for Diabetes

Meilog marks the first rapid-acting insulin biosimilar to gain FDA approval for the treatment of diabetes.

Inclusive Marketing: Engaging with Purpose

How one Big Pharma ad campaign is incorporating diversity as a driving force in improving the…

Limitations of Modern Databases: Q&A with Stavros Papadopoulos

The TileDB CEO discusses how the life sciences can overcome these limitations.

Proactive Engagement: How AI-Driven Alerts are Transforming HCP Outreach

The benefits for brand teams in bolstering their rapid-response capability.

FDA Approves Pfizer’s Adcetris for Relapsed or Refractory Large B-Cell Lymphoma

Approval of Adcetris provides a new treatment option for patients with relapsed or refractory large b-cell…

Navigating an Uncertain Regulatory Landscape

James Foster, CEO and co-founder of Virax Biolabs, discusses how companies can strategize despite hard-to-predict regulatory…

Q&A: Gain Therapeutics CEO Discusses AI-Driven Drug Discovery, Strategic Growth Plans

Gene Mack, Gain Therapeutics CEO, provides a look into the future of the company and the…

Preparing for Potential Vaccine Regulatory Changes

James Foster, CEO and co-founder of Virax Biolabs, discusses how the industry is preparing for potential…

The Shifting Pharmacy Landscape in 2025

Polypharmacy, biosimilars, and GLP-1s among the evolving trends likely to play out in the pharmacy benefits…

Balancing the New Trend in HEOR Organizational Structure and Focus

HEOR requires executive leaders who have both scientific and managerial acumen.

Statistically and Clinically Significant Paths to Value Proposition

Demonstrating clinical benefit is the ultimate gateway to smoother patient access.

Changing Political Winds and the IRA: Q&A with Monica Martin de Bustamante

A change in political power is altering how companies are strategizing around the IRA.

FDA Approves AbbVie’s Emblaveo for Complicated Intra-Abdominal Infections

Emblaveo marks the first and only fixed-dose intravenous monobactam/β-lactamase inhibitor combination antibiotic to be approved by…

The Most Studied Diseases in a Post-Covid World: Q&A with Gen Li

The Phesi CEO discusses his company’s recent analysis of the most studied diseases in the world.

Revolutionizing Patient Adherence: Leveraging AI for Personalized Engagement

Bill Grambley, CEO of AllazoHealth, delves into the potential of AI to revolutionize patient engagement and…

Mim8 Demonstrates Promising Results in Pediatric Patients with Hemophilia A

Data from the Phase III FRONTIER3 trial found that 98% of caregivers prefer Mim8 for hemophilia…

Pharma Pulse 2/7/25: SCOPE Summit 2025 Coverage, Genetic Sensitivity to Stress Possibly Links to Lung Cancer & more

The latest news for pharma industry insiders.

AI Drug Discovery Impact on Pharmaceutical Value Chain

In this Pharmaceutical Executive video interview, Edoardo Madussi, Head of Business Development, Intelligencia AI discusses where…

Finding Underserved Communities: Q&A with Biljana Naumovic of J&J

Biljana Naumovic discusses the importance of finding ways to reach out to underserved communites.

Pfizer Appoints Jeffrey Legos as Chief Oncology Officer

Legos will take over from Roger Dansey, who will begin transitioning to retirement.

FDA Approves Supernus Pharmaceuticals’ Onapgo for Managing Motor Fluctuations in Parkinson Disease

Approval of Onapgo (apomorphine hydrochloride) marks the first and only subcutaneous apomorphine infusion device for managing…

Preventing Silos During Product Launches: Q&A with Dan Rizzo

New technology is creating new opportunities but is also causing new complications.

Merck Launches Phase III Trial Evaluating Zilovertamab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma

The waveLINE-010 trial will compare zilovertamab vedotin, in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone…

AMCP Issues Statement on Tariffs’ Potential Impact on Pharmaceutical Industry

Susan Cantrell responds to the tariffs on China, Canada, and Mexico.

Overall Impact of AI-Driven Discovery Platforms

In this Pharmaceutical Executive video interview, Edoardo Madussi, Head of Business Development, Intelligencia AI compares and…

The Blue Jacket Fashion Show: Q&A with Biljana Naumovic of J&J

Biljana Naumovic of Johnson & Johnson discusses the unique fashion show and how it’s raising awareness…

FDA Approves Roche’s Susvimo Refillable Eye Implant for Diabetic Macular Edema

Roche’s Susvimo, a refillable eye implant for diabetic macular edema, provides continuous delivery of ranibizumab, showing…

Pharma Pulse 2/4/25: Analyzing Supply Chain Complexities, Navigating Medicare Advantage in 2025 & more

The latest news for pharma industry insiders.

Pharma Organizations Respond to Proposed Tariffs

President Trump’s tariffs will include imported pharmaceuticals, among other items that will impact the industry.

Senior Senators Introduce Bill to Force DTC Drug Advertisements to Include List Price

Senators Durbin and Grassley proposed the new regulations for direct-to-consumer pharma advertising.

2025 Pharma Forecast: Four Pivotal Trends Revolutionizing Market Access Strategies

2025 Pharma Forecast: Four Pivotal Trends Revolutionizing Market Access Strategies

Why Frontline Sales Have and Will Continue to be a Foundation for Long-term Career Success

A Harvard Business School Healthcare Alumni Association Q&A with Paul Ollinger, one of Facebook’s first 250…

FDA Approves Vertex Pharmaceuticals’ First-in-Class Non-Opioid Journavx for Moderate-to-Severe Acute Pain

Approval of Journavx for acute pain marks the first new class of acute pain medication approved…

FDA Approves Axsome Therapeutics’ Symbravo for Migraine with or without Aura

Clinical trials demonstrated that a single dose of Symbravo provides rapid migraine relief, sustains efficacy for…

IMU-856 Shows Promise in Celiac Disease: Histologic Protection and Nutrient Absorption Key to Advancing Trials

Daniel Vitt, CEO, Immunic Therapeutics, discusses promising results from the Phase Ib trial of IMU-856 in…

ImmunityBio, BeiGene Strike Deal to Conduct Phase III Trial for Tislelizumab, Anktiva in Advanced or Metastatic Non-Small Cell Lung Cancer

The Phase III trial builds on findings from prior findings that indicated Anktiva can restore T-cell…

Roundup: Top Pharma Companies Report Q4 Earnings, Highlighting Revenue Trends and Market Shifts

Q4 earnings for companies such as Johnson & Johnson, Teva, and Roche highlight the impact of…

Roche Appoints Wafaa Mamilli as Chief Digital Technology Officer

Effective February 10, 2025, Mamilli will assume global responsibility for the Informatics function for the Roche…

ADRIATIC Trial Demonstrates Significant Survival Benefit in LS-SCLC, Potentially Shaping Future Treatment Standards

Nancy Ghattas, VP, US franchise head, imunno-oncology, gastrointestinal tumors, AstraZeneca, discusses the promising results from the…

FDA Approves AstraZeneca, Daiichi Sankyo’s Enhertu for Unresectable or Metastatic Hormone Receptor-Positive, HER2-Low Breast Cancer

Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive,…

New Spravato Indication Offers Greater Flexibility and Personalization for Patients with Treatment-Resistant Depression

Gregory Mattingly, MD, president, Midwest Research Group, founding partner, St. Charles Psychiatric Associates, discusses the approval…

EMA Takes Break From X, Joins Bluesky

The government agency says X no longer suits its communication needs.

FDA Grants Priority Review to Merck’s Welireg for Advanced, Unresectable, or Metastatic Pheochromocytoma, Paraganglioma

Priority review for Welireg is based on data from the Phase II LITESPARK-015 trial, which showed…

The Ups and Downs of AI for Pharma Investors

Ash Shehata from KPMG discusses how artificial technology has a lot to prove, although investors still…

FDA Approves Two Generics from Amneal Pharmaceuticals for Alzheimer and Oncology, with Tentative Approval for Gastrointestinal Disease

As part of the regulatory action, memantine/donepezil extended-release capsules have been granted a 180-day exclusivity in…

Pharma Pulse 1/24/25: Clinical Technology Advancements, Encourage Patient Accountability & more

The latest news for pharma industry insiders.

Using Digital Therapeutics with Abuse-Deterrent Pain Medication

Paul Howe, chief commercial officer at Protega, discusses efforts to combine high tech solutions with pain-management…

Biogen Seeks FDA Approval for a Higher Dosing Regimen of Spinraza for Spinal Muscular Atrophy

Application is supported by results from the DEVOTE study, which suggested that two doses of Spinraza…

AbbVie, Neomorph Strike Deal to Co-Develop Molecular Glue Degraders for Oncology, Immunology

Under terms of the deal, AbbVie will provide Neomorph with an upfront payment and the potential…

Jelmyto Demonstrates Significant Recurrence-Free Survival Rate at Three Years in Patients with Low-Grade Upper Tract Urothelial Cancer

Trial findings show long-term recurrence-free survival in patients with low-grade upper tract urothelial cancer treated with…

Viralgen and Axovia Partner to Manufacture Gene Therapy for Retinal Dystrophy in Bardet-Biedl Syndrome Patients

New partnership hopes to give BSS patients more options for treatment.

Sen-Jam Partners Strikes Deal with 5 Horizons Capital to Support Phase II Trial of SJP-001 for Inflammation, Metabolic Health

The trial, developed in collaboration with Novotech, will specifically target dietary and alcohol-induced overindulgence.

Avalon Healthcare Solutions Teams with Sentara Health Plans to Offer Genetic Testing Management

Expanded GTM services aim to ensure members receive tests at the optimal times while cutting down…

AD04 Advancing to Phase III Amid Promising Results in Alcohol Use Disorder

Cary Claiborne, CEO, Adial Pharmaceuticals, discusses AD04’s development timeline and next steps towards approval for alcohol…

Pharma Pulse 1/21/25: Reaching Diverse Patient Populations With Personalized Treatment Methods, Managing Cancer Treatment Amid a Nationwide IV Fluid Shortage & more

The latest news for pharma industry insiders.

FDA Approves AstraZeneca, Daiichi Sankyo’s Datroway for Previously Untreated Unresectable, Metastatic HR-Positive, HER2-Negative Breast Cancer

Approval is based on results from the TROPION-Breast01 Phase III trial, in which Datroway demonstrated a…

JPM25: Oncology Outlook for 2025

Panel participants share an optimistic outlook for integrating new innovations, tacking community-level challenges, and more.

AD04-13 Study Highlights Consistent Bioavailability and Safety for Alcohol Use Disorder Treatment

Cary Claiborne, CEO, Adial Pharmaceuticals, discusses promising results of the AD04-13 study in patients with Alcohol…

Pharma Pulse 1/17/25: Compounding Pharmacies and Meeting Patient Needs, Survey Shows Gaps in Consumer Awareness & more

The latest news for pharma industry insiders.

Casey McPherson Shares His Journey With Rare Drug Development and Chrysalis Genetics

Casey McPherson, Founder and CEO of Chrysalis Genetics, talks about his daughter’s rare genetic condition, and…

HHS Selects 15 New Drugs for Medicare Part D Price Negotiations

As part of the Inflation Reduction Act, price negotiations with manufacturers will begin this year, with…

FDA Approves AstraZeneca’s Calquence for Previously Untreated Mantle Cell Lymphoma

Approval follows results from the Phase III ECHO trial, which demonstrated that Calquence plus chemotherapy reduced…

The Bottlenecks Blocking Cell and Gene Therapy

Jason Foster, CEO of Ori Biotech, discusses the difficulties preventing more widespread adoption of these advanced…

FDA Approves Incyte and Syndax’s Niktimvo for Chronic Graft-Versus-Host Disease in 9 and 22 mg Vial Sizes

Niktimvo marks the first FDA-approved therapy targeting CSF-1R to address inflammation and fibrosis in chronic graft-versus-host…

Engaging Patients: Why Pharma’s Direct-to-Patient Approach Should Be Applauded

Physicians remain central even as DTP programs are implemented.

Johnson & Johnson Initiates New Drug Application for TAR-200 in BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer

The New Drug Application for TAR-200 is supported by results from the Phase IIb SunRISe-1 study,…

NVIDIA Announces Pharma Partnerships to Expand AI

The company revealed plans to increase the usage of AI in pharma at JP Morgan’s healthcare…

Partnering for Progress: Leveraging Advocacy Groups to Drive Awareness and Participation in IPF Trials

John Hood, CEO, Endeavor BioMedicines discusses partnering with advocacy groups to increase awareness of clinical trials…

Pharma Pulse 1/14/25: Simpler Sample Ordering for HCPs, Smart Money Bets on Value & more

The latest news for pharma industry insiders.

Flurry of Acquisitions and Licensing Deals Come Amid JP Morgan Healthcare Conference 2025

Organizations including Gilead, Eli Lilly, and AbbVie announced a number of deals addressing inflammatory diseases, multiple…

Novo Holdings Invests in Windward Bio

The Swiss company is focused on developing treatments for respiratory conditions, such as asthma and COPD.

Amylyx Names New Chief Commercial Officer Ahead of GLP-1 Commercialization

Dan Monahan will serve in the role as the drug goes through Phase III trials.

Havas Launches GLP-1 Focused Content Platform

‘Shape Shifting’ is a creator-led series that focuses on the scientific and cultural impact of GLP-1s.

FDA Grants Priority Review to Johnson & Johnson’s Nipocalimab for Generalized Myasthenia Gravis

Priority Review was based on results from the Phase III Vivacity-MG3 study of nipocalimab in patients…

Additional Security Measures Taken for J.P. Morgan Healthcare Conference

San Francisco Police cancel time off requests to increase security at the J.P. Morgan Healthcare Conference…

Blue Shield of California Issues Statement Regarding California Wildfires

Company leadership urged members and employees to stay safe and follow evacuation orders.

Bausch + Lomb Launches Second Annual Faces of Glaucoma Campaign

The campaign will include patient stories, education resources, and is being held in partnership with the…

FDA Mandates Updates to Prescribing Information for RSV Vaccines Abrysvo, Arexvy for Increased Guillain-Barré Syndrome Risk

Abrysvo and Arexvy will now be required to come with labeling that includes a warning about…

Swoop Acquires MyHealthTeam

This acquisition will help generate data from over four million members of MyHealthTeams’ opted-in patient universe.

How Are Telehealth and Pharma Partnering to Revolutionize Healthcare?

In this part of his Pharmaceutical Executive video interview, Peter Ax, CEO of UpScriptHealth, explores the…

The Power of AI: Personalized Medicine and Predictive Analytics

In this part of his Pharmaceutical Executive video interview, Peter Ax, CEO of UpScriptHealth, shares some…

Navigating Fertility Misinformation on Social Media

In this part of his Pharmaceutical Executive video interview, Dr. Lawrence B. Werlin, MD, FACOG of…

The Ethical Implications of Sharing Personal & Professional Experiences on Social Media

In this part of his Pharmaceutical Executive video interview, Dr. Lawrence B. Werlin, MD, FACOG of…

2024’s Top DTC Stories

New technologies are creating more efficient ways for pharma companies to work directly with consumers.

Making an Impact in the Era of Disinformation

With increasing cases of disinformation across social media blurring the lines of what’s credible and real,…

Our Top 5 Podcast Episodes of 2024

The top five episodes of our podcast in the year 2024, highlighted.

The Affects of ENV-101 on IPF

John Hood, CEO, Endeavor BioMedicines discusses the key differences between ENV-101 and currently approved IPF treatments.

2024’s Executive Profiles

Pharm Exec covered key players in the industry over the past year.

The Impact of Regulatory Policy on Telehealth Innovation

In this part of his Pharmaceutical Executive video interview, Peter Ax, CEO of UpScriptHealth, discusses regulatory…

Pharma Pulse 12/24/24: Forecasting the 2025 Healthcare Logistics Space, Tech Industry on Cusp of AI Slowdow? & more

The latest news for pharma industry insiders.

FDA Approves Hikma’s Generic GLP-1 Agonist for Type 2 Diabetes

Approval marks the first generic version of liraglutide injection, referencing Victoza, for improving glycemic control in…

كيف يمكن لإدارة التمويل الشخصي أن تساعد في تحسين الاستقرار المالي؟

كيف يمكن لإدارة التمويل الشخصي تتضمن أساسيات إدارة التمويل الشخصي إعداد الميزانية والادخار بانتظام وسداد الديون…

FDA Approves Ionis Pharmaceuticals’ Tryngolza for Familial Chylomicronemia Syndrome

Approval was based on positive results from the Phase III balance study, where Tryngolza demonstrated a…

FDA Grants Accelerated Approval to Pfizer’s Braftovi Combination for Metastatic Colorectal Cancer

Accelerated approval was based on promising results from the ongoing Phase III BREAKWATER trial.

Shuttle Pharmaceuticals, UCFS Strike Sponsored Research Agreement

Collaboration aims to enhance PSMA-B ligand, a novel theranostic molecule in development for the treatment of…

Pharma Pulse 12/20/24: Trends in Enterprise Value Growth and Value-to-Sales Ratios, PPF, Its Risk Factors & more

The latest news for pharma industry insiders.

Peer Exchange: AI’s Data Advantage

In the third part of this roundtable discussion, experts discuss the issues with data that AI…

The Impact of DEA Telehealth Extensions on Patient Access

In this part of his Pharmaceutical Executive video interview, Peter Ax, CEO of UpScriptHealth, discusses the…

Pharma Marketing's Top Movers and Shakers in 2024

These professionals in the healthcare marketing sector have been chosen by their peers for making big…

The Transformative Potential of AI in the Pharmaceutical Industry: Opportunities and Cautions

The technology provides the industry with many opportunities, but it must also navigate a complex regulatory…

FDA Updates Guidelines on Compounding Tirzepatide Injections as GLP-1 Shortage Ends

Amid the end of a national GLP-1 shortage, the FDA will now require all compounding, distributing,…

Merck Obtains Global License for Hansoh’s HS-10535

The molecule is an investigational pre-clinical oral GLP-1 receptor agonist.

FDA Grants Breakthrough Therapy Designation to Gilead’s Trodelvy for Extensive-Stage Small Cell Lung Cancer

Breakthrough Therapy designation for Trodelvy was granted based on promising results from the Phase II TROPiCS-03…

Pharma Pulse 12/18/24: Boosting Patient Support and Engagement, Paxlovid’s Double-Edged Sword & more

The latest news for pharma industry insiders.

Pharma’s ‘Best-Kept Secret’

Margaret Keegan, the new CEO of Precision Medicine Group, is eager to elevate the profile of…

AbbVie Agrees to Acquire Nimble Therapeutics

This will bring Nimble’s psoriasis and inflammatory bowel disease treatment under AbbVie’s pipeline.

FDA Grants Breakthrough Therapy Designation to GSK’s Jemperli for Locally Advanced Mismatch Repair Deficient/Microsatellite Instability-High Rectal Cancer

The Breakthrough Therapy Designation for Jemperli was based on Phase II clinical trial data, showing a…

What Role Can Pharma Play in Achieving Health Equity for All?

In this Pharmaceutical Executive video interview, Angela Tenuta, President, Full Service Agencies, at EVERSANA INTOUCH, provides…

FDA Grants Breakthrough Therapy Designation to Sanofi’s Tolebrutinib for Non-Relapsing Secondary Progressive Multiple Sclerosis

The regulatory action was supported by results from the Phase III HERCULES trial, which demonstrated a…

Pharmaceutical Marketing Challenges & Trends to Expect on 2025: According to KOLs

Industry voices stress importance of a strategic approach to social media marketing, choosing platforms wisely, prioritize…

Gilead Appoints Dietmar Berger as Chief Medical Officer

Berger joins Gilead with over 25 years of global drug development experience and will oversee the…

Pharma Forecasting: Key Markets Investors Can’t Ignore

The importance of expanding your pharma sales forecasting horizon beyond the US. Learn how to effectively…

The Recipe for Relief: Overcoming Industry Pain Points

Why investing in people and training can help drugmakers deal with six pressing challenges in particular…

Peer Exchange: Marketing With AI

In the second part of this roundtable discussion, experts discuss how the industry is handling AI…

Why Healthcare Costs are Surging—And What to Do About it

Identifying the inflators and deflators, and the role all stakeholders play.

How Can We Ensure Ethical Use of AI in Pharma Marketing?

In this Pharmaceutical Executive video interview, Angela Tenuta, President, Full Service Agencies, at EVERSANA INTOUCH, identifies…

Mastering Your AI Budget for 2025 Success

Because the AI space is changing rapidly, it’s essential that companies are budgeting correctly and using…

Klick Health Uses AI to Create Digital Hugs

The videos are designed to help bring people together during the holidays.

How to Build and Maintain Relationships with High-Profile Clients

For pharma manufacturers, the primary requirement for working with high-profile clients is matching their organizational level…

FDA Grants Breakthrough Therapy Designation to Datopotamab Deruxtecan for Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer

Breakthrough designation was based on results from the TROPION-Lung05 Phase II trial with support from the…

Yescarta Demonstrates Promise in Treating Relapsed/Refractory Large B-Cell Lymphoma

Real-world evidence from the largest analysis of second-line treatment with Yescarta in 2022-2023 demonstrated a high…

How Can Pharma Navigate the Regulatory Maze of AI-Powered Interventions?

In this part of his Pharmaceutical Executive video interview, Bill Grambley, CEO of AllazoHealth, discusses how…

Peer Exchange: Embracing AI in Pharma

In this first part of this roundtable discussion, experts discuss the current perception of AI and…

Trinity Life Sciences Releases Annual TGaS Digital Marketing Competency Report

The report gives high rankings to brands from Pfizer and AstraZeneca.

FDA Grants Priority Review to AstraZeneca’s Imfinzi for Muscle-Invasive Bladder Cancer

The FDA based the Priority Review designation on results from the Phase III NIAGARA trial, which…

The Launch of SPIMA Therapeutics

Mohamed Haitham Ayad, CEO, co-founder, SPIMA Therapeutics, discusses the company’s launch and how multiple institutions have…

National Comprehensive Cancer Network Adds Jazz’s Ziihera as a Category 2A Treatment Option for Biliary Tract Cancers

Ziihera’s addition as a category 2A treatment follows the FDA’s accelerated approval of the drug for…

FDA Approves AstraZeneca’s Imfinzi for Limited-Stage Small Cell Lung Cancer

Approval of Imfinzi was based on results from the ADRIATIC Phase III trial, marking the first…

FDA Accepts Roche’s Supplemental Biologics License Application of Columvi for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Acceptance of the application was based on results from the Phase III STARGLO study, which found…

FDA Grants Breakthrough Therapy Designation to Allay’s Therapy for Post-Surgical Pain in Total Knee Arthroplasty

The breakthrough designation is based on Phase II clinical trial data, which demonstrated that ATX101 provides…

Transforming “what if” to “what is” with the Veradigm Network

Our network connects providers, health plans, and life science companies to deliver seamless care that benefits…

Takeda, Novartis, and Gilead Strike Separate Licensing Deals

Licensing deals are expected to enhance the oncology, neuroscience, and antibody drug conjugate pipelines of the…

FDA Grants Breakthrough Therapy Designation to Merck’s Sacituzumab Tirumotecan for Metastatic Nonsquamous Non-Small Cell Lung Cancer

The breakthrough designation is based on data from the expansion cohort of a Phase I/II study…

Roche Inks Deal to Acquire Poseida Therapeutics

Under terms of the deal, Roche will gain access to Poseida’s pipeline, including P-BCMA-ALLO1, an allogeneic…

FDA Accepts GSK’s Biologics License Application of Blenrep for Relapsed or Refractory Multiple Myeloma

Acceptance of the Biologics License Application of Blenrep was based on promising results from the DREAMM-7…

Exact Sciences Enlists Carlos Ponce to Promote Early Cancer Screening

The actor is part of a campaign for early colon cancer screening.

Pharma Pulse 11/25/24: Deepening Patient Relationships, Menopause May Increase Risk of Asthma & more

The latest news for pharma industry insiders.

Pharma Pulse 11/26/24: RFID Technological Obstacles, Self-Care for the Flu & more

The latest news for pharma industry insiders.

Children’s Hospital of Philadelphia Announces New Imaging AI Technology

CelloType produces more accurate results when analyzing high content tissue images.

ReviR Therapeutics Partners with Kennedy’s Disease Association for New Molecule Development

The two companies will work to develop treatments for SBMA.

Pharma Pulse 11/29/24: AI’s Role in Personalizing Life Sciences Digital Experiences & more

The latest news for pharma industry insiders.

Pharma Pulse 11/27/24: Empowering Sites and Patients, Shingles Can Occur in Children & more

The latest news for pharma industry insiders.

Pharma Pulse 11/28/24: Nov. 27 Passed—What Does That Mean for DSCSA? & more

The latest news for pharma industry insiders.

FDA Approves AOP Health’s Rapiblyk for Atrial Fibrillation and Atrial Flutter

Approval was based on the combined results from five studies of adults with supraventricular tachycardia.

Sarepta, Arrowhead Strike Global Collaboration Deal to Develop Treatments for Rare Genetic Diseases Affecting Muscles

Agreement grants Sarepta exclusive rights to several clinical-stage programs for muscular dystrophy, myotonic dystrophy type 1,…

Biohaven’s Taldefgrobep Alfa Fails to Achieve Statistical Significance in Treating Spinal Muscular Atrophy

Results of the RESILIENT SMA study found that while taldefgrobep demonstrated clinically meaningful motor function improvements…

Biden-Harris Administration Proposes Expansion to Medicare and Medicaid to Include Anti-Obesity Medications

The proposal aims to reduce out-of-pocket costs for a number of anti-obesity medications by 95%.

FDA Expands Labelling for Roche’s Pathway Rabbit Monoclonal Primary Antibody in Patients with Biliary Tract Cancer

Pathway is now the first and only FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer…

2024 Pharmaceutical Executive APEX Award Winners

2024 Pharmaceutical Executive APEX Award Winners

FDA Approves HS Treatment Bimzelx

The drug, developed by UCB, is approved to treat adults with the inflammatory skin disease.

Pharma Pulse 11/21/24: A Global Standard for Data Sources, 75% of Adults are Obese & more

The latest news for pharma industry insiders.

Survey Suggests Pharma Industry Still Struggling with Digital Transformation

The results say that the industry still lacks talent and skills in this area.

Pharma Pulse 11/22/24: Challenges Facing the Pharma Industry in 2025 & more

The latest news for pharma industry insiders.

Dexcom Teams with Nick Jonas to Launch Diabetes Treatment Education Campaign

The campaign also includes partnerships with other celebrities, including Lance Bass and Retta.

Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya Regimen for Ulcerative Colitis

Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous…

IDEAYA Names Stu Dorman as New Chief Commercial Officer

Dorman previously served as head of Gilead Sciences’ U.S. Oncology Unit.

FDA Grants Accelerated Approval to Jazz Pharmaceuticals’ Ziihera for HER2-Positive Biliary Tract Cancer

Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii) provides a chemotherapy-free treatment option for patients with HER2-positive biliary tract cancer,…

The Influence of PD-1 Inhibitor Label Restrictions on Future Studies

Ron Lanton, Partner, Lanton Law, ways that the recent FDA PD-1 inhibitor label restrictions could influence…

Pfizer Appoints New Chief Scientific Officer and President, Research and Development

Former Chief Oncology Officer and Executive Vice President, Chris Boshoff, MD, PhD, will assume the role…

FDA Approves Revuforj to Treat R/R Acute Leukemia with KMT2A Translocation

Syndax describes the drug as the first of its kind.

Blue Cross Blue Shield of Massachusetts Announces New Services Focused on Women’s Health

The news is part of the organization’s goal of demonstrating a commitment to women’s health.

Pharma Pulse 11/18/24: An Overview of RFID, Moving More Modifies Mood & more

The latest news for pharma industry insiders.

Rationale Behind the Recent FDA PD-1 Inhibitor Label Restrictions

Ron Lanton, Partner, Lanton Law, discusses why the regulatory body made the decision to place restrictions…

Drilling in on Disease Hallmarks: New Tricks to Solve Age-Old Problems

Ann Beliën, PhD, founder and CEO of Rejuvenate Biomed, discusses how AI is being used to…

FDA Approves PTC Therapeutics’ Kebillidi for Aromatic L-Amino Acid Decarboxylase Deficiency

Kebillidi is the first gene therapy to gain FDA approval for the treatment of aromatic L-amino…

Noam Solomon: Bringing the Human Story to AI

A look at one biotech’s mission to map the immune system using artificial intelligence—and how its…

Pharmaceutical Executive: November 2024 Issue (PDF)

Click the title above for a link to open the Pharmaceutical Executive November 2024 issue in…

FDA Accepts Resubmission of Supplemental Biologics License Application for Dupixent for Chronic Spontaneous Urticaria in Patients Under 12

The resubmission for Dupixent includes new data in pediatric patients with chronic spontaneous urticaria.

AI’s Attention Span

Developments in the world of artificial intelligence continue to accelerate at a rapid pace. Our November…

ROI and Rare Disease: Retooling the ‘Gene’ Value Machine

Framework proposes three strategies designed to address the unique challenges of personalized and genetic therapies for…

Merck Reaches Deal with LaNova Medicines to Develop Novel Treatment for Programmed Cell Death Protein-1 and Vascular Endothelial Growth Factor

Under terms of the collaboration, Merck will lead the development, manufacturing, and commercialization of LM-299, an…

Powering Pipelines Forward: Approach Science Differently

Why tapping the value generated for the next set of therapies is critical.

Koselugo Demonstrates Clinically Meaningful Improvement in Adults with Symptomatic, Inoperable Plexiform Neurofibromas

Results from the Phase III KOMET trial found that Koselugo demonstrated a statistically significant objective response…

AstraZeneca, Daiichi Sankyo Submit Biologics License Application of Datopotamab Deruxtecan for Advanced Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer

Decision to submit the Biologics License Application of datopotamab deruxtecan was based on feedback from a…

Pharma Pulse 11/12/24: Takeaways From Midlife MS Patients, The Power of Simplicity for First-in-Human Studies & more

The latest news for pharma industry insiders.

AbbVie’s Emraclidine Fails to Reduce Schizophrenia Symptoms Compared to Placebo

Results from the Phase II EMPOWER trial found that emraclidine failed to meet its primary endpoint…

NABIP Responds to Aetna and Anthem Changes to Medicare Commission Policy

Agents were informed that they would no longer receive commissions for select signs up as of…

Pharma Pulse 11/8/24: Dusting Off One’s Cost Center Hat, Iron Supplements Benefit Children with HIV & more

The latest news for pharma industry insiders.

Advertising/Marketing Trends to Expect in Q1 of 2025

Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab, identifies advertising/marketing trends he expects in Q1 of…

Vaccines After COVID: Biopharma's Renewed Public Health and Commercial Push

At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed the potential of…

Key Findings of the NIAGARA and HIMALAYA Trials

In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US…

Biotech Investor Sentiment Climbing Steadily, with Growing Enthusiasm Heading into 2025

The sector’s XBI is up 15% year-to-date; rate cuts, election outcome, and M&A are viewed as…

FDA Approves Johnson & Johnson’s Varipulse for Drug-Resistant Paroxysmal Atrial Fibrillation

The Varipulse platform includes a single-device workflow with minimal to zero fluoroscopy requirements, real-time imaging, and…

Financial Times Global Pharma and Biotech Summit: The Impact of the Election

How will President Trump’s return to office impact the pharma industry?

Specialty Value-Based Care is Improving Health Outcomes While Reducing Heath Care Costs

Delivering value-based care is expected to become even more prevalent, driven by factors such as patient…

How to Bring World’s Most Innovative Treatments to Least Wealthy Places

At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed initiatives aimed at…

Pharma Pulse 11/6/24: Enacting Sustainable Practices, Pharmacist Provider Status Is Growing & more

The latest news for pharma industry insiders.

Global Pharma and Biotech Summit: The Impact of Politics on Pharma and Biotech

Amgen CEO Robert A. Bradway discusses the potential impact of the election, and politics in general,…

Balancing Personalized Targeting with Protecting Consumer Privacy

Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab discusses the need to balance personalized targeting with…

Viking Therapeutics Presents Positive Data from VK2735 for Reducing Body Weight Effectively and Safely

Results from the VENTURE Phase II trial and a Phase I oral formulation study found that…

Pharma Pulse 11/4/24: Community Pharmacies in Crisis, Insights Into ADHD Diagnoses in Adult Women & more

The latest news for pharma industry insiders.

Recent Developments in Pharmaceutical Validation

Explore the latest pharmaceutical validation developments with industry experts from Barry-Wehmiller Design Group, Kneat Solutions, and…

Biopharma Needs a Health System Strategy to Secure Optimal Market Access

In 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

The latest news for pharma industry insiders.

Eisai Completes Rolling Biologics License Application to FDA for Subcutaneous Maintenance Dosing Option of Leqembi for Alzheimer Disease

The subcutaneous form of Leqembi was previously granted Fast Track designation by the FDA to treat…

Wegovy Demonstrates Superiority Over Placebo in Patients with Metabolic Dysfunction-Associated Steatohepatitis

Results from Part I of the Phase III ESSENCE trial found that Wegovy 2.4 mg achieved…

Key Benefits of RWD in Privacy and Targeting Effectiveness

Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab discussed how the use of Real-World Data has…