Category: Medicine

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.

Dr. Russo discusses how modern innovations will shape the way hospitals operate in years to come.

The agency recognized the medication as a significant advancement for the treatment of IPF.

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 comes after the FDA seized thousands of counterfeit Ozempic units.

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.

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.

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.

Atypical antidepressant linked to severe adverse effects and death as a result of misuse.

The FDA previously approved Dupixent in May 2022 to treat eosinophilic esophagitis in patients aged 12 years and older.

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…

New FDA guidelines require manufacturers to add boxed warnings to CAR T-cell therapy products.

Embracing new digital-based tools is critical throughout the healthcare landscape to prepare for the rise of telemedicine as a permanent way of life.

NK010 is reportedly the first Chinese trial of its kind to be approved by the FDA.

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.

Pharma marketing strategies that are both socially and ethically responsible can build long term success for the life sciences industry.

Opdivo plus Yervoy shows promise in treating patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer.

Will the FDA ultimately step in and mandate a credible effort to eradicate the mindset that long-term adherence is not achievable?

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.

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.

Analytics capabilities are no longer a nice-to-have, but a necessity to build and maintain a successful business and competitive edge.

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.

According to the university, new nanotech scaffolding can be used to support tissue growth.

Webinar Date/Time: Thu, Feb 15, 2024 11:00 AM EST

Sun Pharmaceutical Industries will purchase Taro’s outstanding shares for $43 each, which will total $348 million.

HyQvia is the only subcutaneous immune globulin infusion that can be administered once per month.

Researchers believe low numbers in the use of direct-to-consumer healthcare services could rapidly trend up.

New analysis for 2023 shows signs of post-pandemic recovery; breast cancer remains most studied disease area.

Company displayed findings at the 2024 Winter Clinical Dermatology Conference in Hawaii demonstrating significant improvements in atopic dermatitis and seborrheic dermatitis.

The device can produce AI-assisted readings.

Roots Analysis report suggests increase can be attributed to the growing demand for advanced therapies and biologics.

The BioThrax vaccine is indicated for active immunization to prevent anthrax disease caused by Bacillus anthracis in individuals aged 18 through 65 years.

Measuring the relationship between a product’s reimbursement position and performance begins with gathering key data points for as many products as possible.

RC88 is under evaluation for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.

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.

The company also announced that it has submitted its new glucose monitoring system to the FDA for approval.

The survey is part of the brand’s new marketing campaign.

While the industry as a whole still faces challenges, there are positive trends appearing for pharmaceutical and medical device companies.

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.

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…

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…

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…

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…

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…

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…

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…

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…

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 been consistently raised in the healthcare professional…

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 reached a definitive agreement to acquire Gracell…

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…

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 chatGPT. And yet, AI offers more promise…

Pharm Exec spent the year speaking with some of the most interesting professionals from the life sciences industry.

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 FDA has approved Arcutis Biotherapeutics, Inc’s Zoryve…

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 Too Long to Wait Closing the gender…

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 on recent FDA approval of Bimzelx. Artificial…

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 is the CEO, EVERSANA INTOUCH & Chief…

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 industry stakeholders must develop actionable roadmaps to…

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 majority of Gen Z use social media…

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 progression-free survival in patients with primary advanced…

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 of a corporate DE&I strategy in those…

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 results of a pivotal Phase III trial…

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 topical prescription therapies or for whom those…

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 Rare Diseases’ topical gel Filsuvez (birch triterpenes)…

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) for CSL Behring’s garadacimab (CSL312), a once-monthly…

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 who discusses maximizing returns on investment, upholding…

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 research and healthcare. This includes enhancing operational…

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 who discusses maximizing returns on investment, upholding…

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 79% of respondents tend to neglect their…

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 industry. These advancements have increased the importance…

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, milk, and egg allergies. The FDA has…

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 17, 2024. The FDA has granted priority…

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 for greater outreach efforts to improve medication…

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 medicine really worth? For patients suffering from…

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 vital. The breakneck pace of digital transformation…

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 a VEGF-TKI. The FDA has approved Merck’s…

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 four weeks, emphasizing the need for improved…

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 from the KEYNOTE-942/mRNA-4157-P201 clinical trial show that…

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…

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 advanced or metastatic urothelial cancer. The FDA…

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…

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. Currently, little is known about the magnitude…

Published on: December 14, 2023 A discussion of the current standard for diabetes care and how the importance of patient centricity, including addressing patient’s mental health, are imperative to the future of the…

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. MAPS Public Benefit Corporation has submitted a…

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 its $43 billion acquisition of Seagen Inc.,…

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 an agreement to acquire Icosavax, Inc, in…

While hurdles remain, home healthcare could deliver better patient-centered cancer care—providing improved outcomes, enhanced quality of life, and reduced strain on resources. Cancer is a life-altering disease, and the pursuit of quality…

Unprecedented policy and access issues threaten R&D momentum. In the 30 years that I have been writing about FDA policy and biopharmaceutical research and drug manufacturing, I have not encountered a time…

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 of its lows back in October and…

Trial of Keytruda (pembrolizumab) plus chemotherapy and maintenance Lynparza (olaparib; AstraZeneca, MSD) for the treatment of metastatic squamous non-small cell lung cancer stopped after data did not show a survival benefit. Merck…

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 a resource for patients on this drug?…

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 shutting down their study of experimental HIV…

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 financial side of the life sciences industry,…

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 has approved a pair of landmark treatments…

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 industry and challenges brought forth by the…

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 tracking them in 1990. The prevalence of…

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 3 studies demonstrated the efficacy of Ajovy…

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 immunology, UCB, speaks about the company’s recent…

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 presence. The dawn of the era of…

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 2024. Jennifer Breheny Wallace is an award-winning…

TAR-200 has a novel targeted releasing system for the treatment of patients with Bacillus Calmette-Guérin-unresponsive high-risk non-muscle-invasive bladder cancer who are ineligible for bladder removal surgery. The FDA has granted Breakthrough Therapy…

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 the past few years, the world of…

Roche announces definitive merger agreement to acquire Carmot Therapeutics, Inc., which has an R&D portfolio that includes clinical stage subcutaneous and oral incretins for the treatment of patients with obesity, both with…

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 to surfacing more HCPs who treat patients…

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 growth factor receptor 2-negative advanced or metastatic…

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 are ineligible for cisplatin-containing chemotherapy. The FDA…

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 decisions about their healthcare. That’s why having…

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 indicates some significant gaps in the understanding…

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 and the right target to the right…

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 rapid generation and accessibility of real-world data…

AbbVie acquiring all outstanding shares of ImmunoGen, Inc. for $31.26 per share, valuing the company at a total equity value of approximately $10.1 billion. AbbVie Inc. has announced the acquisition of ImmunoGen,…

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 Karuna Therapeutics, Inc’s KarXT (xanomeline-trospium) treatment for…

The FDA will investigate all currently approved CAR T-cell treatments, as well as BCMA-directed and CD19-directed genetically modified autologous CAR T-cell therapies, for the risk of secondary T-cell malignancies. The FDA has…

Law aims to mitigate ongoing global drug shortages. US President Joe Biden has announced approximately 30 new actions aimed at strengthening supply chains critical to national interests. According to the White House,…

Kimberlee Heidmann serves as Executive Vice President of Patient Experience and Customer Success as well as the Global Head of Quality and Regulatory Affairs at Scout Clinical. She spoke with Pharmaceutical Executive…

Trial results expected to accelerate the potential of Dupixent to become the first FDA-approved treatment for chronic obstructive pulmonary disease. Regeneron Pharmaceuticals and Sanofi have announced that a Phase 3 trial evaluating…

Shields discusses Ferring’s recent $5 million endowment to the American Society of Reproductive Medicine. Ferring Pharmaceuticals recently announced a $5 million endowment to the American Society of Reproductive Medicine. Jade Shields, vice…

Study emphasizes role in bridging research and development and commercial/marketing functions. According to a study published in Springer Link, the medical affairs (MA) function in pharmaceutical companies creates a unique opportunity to…

Ho discusses how gamma-delta T cells can improve cancer treatments. Pharmaceutical Executive: Can you provide some background on gamma-delta T-Cells? William Ho: I’ve been in the biotech industry for over 22 years,…

Medication focuses on the acute treatment of migraines. AbbVie announced results published in The Lancet evaluating the efficacy, safety, and tolerability of Ubrelvy (ubrogepant) 100 mg for the acute treatment of migraine…

Leuchter discusses FDA’s new pilot program. The FDA recently launched a new pilot program to encourage the development of new drugs for rare diseases. Dr. Bruce Leuchter, CEO of Neurvati, spoke with…

Smalley discusses her work with proactive signal detection. Pharmaceutical Executive: Can you describe your work with signal detection? Elizabeth Smalley: Signal detection is all about finding patterns, correlations, and applying causality. It’s…

IQVIA report explores why these shortages are increasing, and how they can be mitigated. Drug shortages are an issue that continue to grow in news coverage, due to their impact on patient…

Leuchter discusses FDA’s new pilot program. The FDA recently launched a new pilot program to encourage the development of new drugs for rare diseases. Dr. Bruce Leuchter, CEO of Neuvati, spoke with…

Study aims to find ways industry gets involved in the most influential clinical trials, and how transparent these trials are. In a study published earlier this month by JAMA, the authors aimed…