FDA Lifts Clinical Hold on Novavax’s Trials for COVID-19-Influenza Combination, Standalone Influenza Vaccines
The FDA’s clinical hold for the COVID and influenza vaccine trials was a result of a report of a serious
October 23, 2026
The FDA’s clinical hold for the COVID and influenza vaccine trials was a result of a report of a serious
Results from the Phase II EMPOWER trial found that emraclidine failed to meet its primary endpoint of reducing Positive and
The latest news for pharma industry insiders.
Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab, identifies advertising/marketing trends he expects in Q1 of 2025.
At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed the potential of mRNA technology in developing
The Varipulse platform includes a single-device workflow with minimal to zero fluoroscopy requirements, real-time imaging, and lesion tagging for paroxysmal
den Tornado Vape 12000 züge von anderen Vapes RandM Tornado Vape 12000 Puffs ist ein führender Einweg-Vaporizer, der sich von
The sector’s XBI is up 15% year-to-date; rate cuts, election outcome, and M&A are viewed as tailwinds.
In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca,
At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed ways to prepare for the high number
How will President Trump’s return to office impact the pharma industry?
At the Financial Times’ Global Pharma and Biotech Summit 2024, a breakout panel discussed how dealmaking remains vital for biopharma
At the Financial Times’ Global Pharma and Biotech Summit 2024, a panel discussed initiatives aimed at bringing cell and gene
At the Financial Times’ Global Pharma and Biotech Summit 2024, Christophe Weber, president and CEO, Takeda, discusses how trust and
Amgen CEO Robert A. Bradway discusses the potential impact of the election, and politics in general, will have on the
The latest news for pharma industry insiders.
Results from the VENTURE Phase II trial and a Phase I oral formulation study found that VK2735, a novel a
Explore the latest pharmaceutical validation developments with industry experts from Barry-Wehmiller Design Group, Kneat Solutions, and No Deviation. You’ll gain
In today’s pharmaceutical market access landscape, payers are not the sole decision-makers in utilization management development.
The latest news for pharma industry insiders.
Ted Sweetser, VP, Ad Partnerships and Strategy, PurpleLab discussed how the use of Real-World Data has evolved in the healthcare
The subcutaneous form of Leqembi was previously granted Fast Track designation by the FDA to treat mild cognitive impairment or
Results from Part I of the Phase III ESSENCE trial found that Wegovy 2.4 mg achieved a 37% improvement in
The executive director of patient strategies & solutions discusses J&J’s new Guide to Expanded Access.
The deal is expected to leverage EvolveImmune’s T-cell engager EVOLVE platform to develop novel antibody-based therapies for solid and hematologic
Accelerated approval is based on results of the ASC4FIRST Phase III trial, which demonstrated Scemblix’s superior efficacy in achieving major
The trials will investigate datopotamab deruxtecan in combination with treatments including rilvegostomig, osimertinib, and chemotherapy in patients with nonsquamous non-small
CMG1A46 is currently being developed for B cell-driven autoimmune diseases, primarily systemic lupus erythematosus and lupus nephritis.
Roxybond is the and only FDA-approved abuse-deterrent immediate-release 10 mg oxycodone formulation designed to reduce abuse of pain medication via
Acquisition includes Aliada’s lead asset, ALIA-1758, which is being developed for the treatment of Alzheimer disease.
Collaboration seeks to advance the treatment of non-small cell lung cancer by combining Keytruda with Moderna’s novel neoantigen therapy, which
Despite a recent FDA Complete Response Letter issued to Lykos for midomafetamine capsules for the treatment of post-traumatic stress disorder,
In this episode of the Pharmaceutical Executive podcast, UpScriptHealth’s Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer,
The latest news for pharma industry insiders.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, explains how to identify a compound pharmacy versus and illicit actor.
Growth is expected due to increased instances of chronic diseases such as cancer and Alzheimer disease.
Under terms of the deal, Richter will receive an upfront cash payment of $25 million, along with potential future development,
Under terms of the deal, Merck will provide an upfront payment of $30 million, with potential milestone payments of up
Najat Khan, chief R&D officer, chief commercial officer, Recursion, and Fred Hassan, director, Warburg Pincus, discuss how artificial intelligence can
The current phase of the campaign is focused on family conversations during holiday gatherings.
Peter Marks, director, Center for Biologics Evaluation and Research, FDA, presented the keynote presentation on the future of gene therapy
The expanded indication of Selarsdi for the treatment of diseases such as psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn disease
Under terms of the deal, Sanofi would sell a 50% controlling stake in Opella to CD&R, while remaining a significant
In the pharmaceutical industry, patient engagement should be centered in health education, communication, and strategy during drug discovery and throughout
Regulatory action marks the fourth aesthetic indication and the first beyond facial treatments for Botox.
In this part of her video interview, Amanda Powers-Han, Chief Marketing Officer, Greater Than One and Pharmaceutical Executive Advisory Board
The company includes the technology in drug development, improving efficiency, and other areas.
Sun Life U.S. teamed up with several other Florida-based companies to provide needed assistance in areas impacted by the recent
The latest news for pharma industry insiders.
Expanded approval of Lumryz offers a once-nightly treatment option for younger patients, eliminating the need for traditional narcolepsy treatments that
Priority Review status for GSK’s New Drug Application for gepotidacin was based on promising results from the Phase III EAGLE-2
Vyalev is the first and only FDA-approved subcutaneous 24-hour infusion of a levodopa-based therapy for the treatment of motor fluctuations
Partnership is expected to develop radioligand therapies based on lead-212 alpha-emitting isotopes, which offer the opportunity to destroy cancer cells
Results from the Phase III Vivid-1 trial found that more Crohn disease patients treated with mirikizumab achieved histologic response at
Results from the Phase II/III Vibrance-MG study found that patients with generalized myasthenia gravis who were treated with nipocalimab plus
Highlighting two pieces beyond Pharm Exec’s October headliners that draw interesting parallels when it comes to life sciences leadership and
Click the title above for a link to open the Pharmaceutical Executive October 2024 issue in an interactive PDF format.
Rafaat Rahmani, president and founder of Lifescience Dynamics, grew up in abject poverty, but such hardships—and a later violent brush
The Big Pharma commercialization playbook doesn’t work for emerging life sciences companies bootstrapping their way up. Exploring three strategies that
The program will now cover 15 gene and cell therapies.
Laura Johnson, senior director, sales, life sciences, Loftware, discusses integrating digital solutions with traceability and drug administration.
A value deficit and potential consumer value proposition.
Announcements such as Apple’s come with pros and cons for industry.
Approval was based on results from the Phase III INAVO120 trial, which found that Itovebi in combination with palbociclib and
Three key components to scaling quickly—while maintaining purpose.
Healgen’s Rapid Check COVID-19/Flu A&B Antigen Test is the first non-prescription COVID-19/flu combination test to be authorized by the FDA
Data from the Phase III AReSVi-006 clinical trial found that Arexvy offered a cumulative efficacy of 62.9% against lower respiratory
The partnership will provide plan members with access to digital services aimed at older patients.
Felzartamab granted Breakthrough Designation after a clinical trial showed a significant improvement in late antibody-mediated rejection in kidney transplant recipients
Breakthrough Therapy designation for survodutide was based on preliminary clinical data showing potential improvement in patients with non-cirrhotic metabolic dysfunction-associated
Under terms of the deal, Astellas will obtain the license for the global development and commercialization of AVB-101 to treat
Approval was based on results from Phase I clinical safety studies, which demonstrated that using three tubes of Ameluz maintained
Under the agreement, AstraZeneca will be granted access to CSPC’s small molecule candidate, YS2302018, with the goal of treating dyslipidemia
The stop loss is designed to protect against potentially massive costs related to gene therapy treatments.
Dr. Wagner discusses her work with the Bill and Melinda Gates Medical Research Institute.
The campaign is called #BustTheMyth and is aimed at patient education.
The latest news for pharma industry insiders.
Approval for Opdivo was based on results from the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival
Approval of Cologuard Plus follows results from the BLUE-C study, which demonstrated a 95% sensitivity for detecting colorectal cancer.
Under terms of the deal, Philogen will complete clinical trials for Fibromun, seek approval, and handle manufacturing, with Sun Pharma
Indegene Digital Summit 2024 (October 17-18)
New facilities are expected to focus on manufacturing next-generation medicines and biologic medicines.
Marketed as a biosimilar to Stelara, approval of Otulfi was based on clinical data demonstrating comparable efficacy in treating inflammatory
CN201 is currently being evaluated in Phase I and Phase Ib/II clinical trials for relapsed or refractory non-Hodgkin lymphoma and
Partnership is expected to leverage Amneal’s global manufacturing and product development experience and Metsera’s portfolio of ultra-long acting injectables and
Commercialization vs. Launch—What You Need to Know
Flyrcado is the first positron emission tomography myocardial perfusion imaging agent of its kind designed for the detection of coronary
The latest news for pharma industry insiders.
Murphy previously worked at the Biotechnology Innovation Organization as its chief policy officer.
The program, Rx-Performance, will be available starting in January of next year.
A Harvard Business School Healthcare Alumni Association Q&A with Martin Gonzalez, Principal of Org and Leadership Development at Google.
Dupixent was found to significantly reduce the rate of moderate to severe exacerbations of chronic obstructive pulmonary disease, according to
Landmark FDA approval of Cobenfy represents the first new class of drugs indicated to treat schizophrenia in decades.
A new JAMA study indicates that semaglutide produced up to a 68% lower risk of opioid overdose for patients with
Omnichannel marketing can help companies improve HCP engagement to facilitate the delivery of effective treatment to patients who desperately need
In this part of his Pharmaceutical Executive video interview, Jonathan Scheinberg, of the Northeast Science and Technology Center, identifies key
The legal challenges surrounding Biogen’s Aduhelm and Cassava Sciences’ simufilam underscore the ongoing difficulties in Alzheimer’s drug development, leading to
The drug is approved for newly diagnosed patients not eligible for transplant and is to be used in combination with
Max Colao, CEO of OncoVerity, discusses his extensive experience in the biotech industry and shares how his company is harnessing
The latest news for pharma industry insiders.
Bimzelx is the first approved medication for active psoriatic arthritis, non-radiographic axial spondyloarthritis, and ankylosing spondylitis that selectively inhibits IL-17A
Conferences, congresses, and the digital discussions kicked off by those events create a halo effect that amplifies scientific information more
Webinar Date/Time: Wednesday, October 9th, 2024 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
Truxal discusses Exact Science’s first Spanish language TV commercial and campaign for Cologuard.
The program is aimed at raising funds for children with cancer and blood disorders.
The latest news for pharma industry insiders.
Rybrevant is the first targeted second-line regimen to significantly reduce the risk of disease progression by more than 50% in
The service will provide compounding pharmacy services to healthcare providers.
Results of the Phase III HERTHENA-Lung02 trial demonstrated the superiority of patritumab deruxtecan over platinum plus pemetrexed induction chemotherapy in
Approval was based on data from the IND.227/KEYNOTE-483 trial, which demonstrated a 21% reduction in the risk of death when
Approval was based on results from the MANDARA Phase III trial, which demonstrated the superiority of Fansenra over Nucala in
Click the title above for a link to open the Pharmaceutical Executive September 2024 issue in an interactive PDF format.
Jan van de Winkel, PhD, president and CEO of Genmab, the longtime innovation engine in antibody drug development, discusses its
Results from the ADvocate 1, ADvocate 2, and ADhere clinical trials found that patients treated with Ebglyss 38% of patients
The diversification of site-of-care delivery models is accelerating rapidly, creating new go-to-market implications for drug manufacturers—but also new opportunities to
These services will help alleviate the impact of contraceptive deserts in the state.
The industry holds the key to true change to the drug access landscape.
Subcutaneous Tecentriq Hybreza will provide patients and physicians increased flexibility for administration of the immunotherapy across approved indications for Tecentriq,
Landmark results from the Phase III PURPOSE 2 trial found that lenacapavir demonstrated 89% greater efficacy than Truvada in preventing
As the digital medium poses new threats to brand equity and public safety for pharma, what can drugmakers do to
As new litigation looms in the debate over use of copay accumulator programs, a look at potential next moves for
Dupixent displayed a nearly 50% reduction in itch and urticaria activity scores in patients with chronic spontaneous urticaria.
Tremfya is the first and only fully-human, dual-acting monoclonal antibody targeting IL-23 and CD64 to be approved for the treatment
A Harvard Business School Healthcare Alumni Association Q&A with Jeremy Goldberg of Arsenal Capital Partners.
A recent study by Morningstar predicts that 16 new weight-loss drugs could be on the market by 2029.
In this interview, Melissa Krebs, CEO and founder of GelSana, shares her journey in developing cutting-edge biomaterials that could transform
The digital revolution has brought more efficient ways to reach and touch HCPs.
Results of the FENopta study found that after one year of treatment, 96% of patients experienced no relapses of multiple
Filspari is considered the first non-immunosuppressive treatment to significantly slow kidney function decline in adults with IgA nephropathy.
Head of Medical Affairs and Outcomes Research at Organon, Charlotte Owens, MD, FACOG, discusses the most critical changes needed to
Pharma companies are facing a higher number of incredibly destructive cyber-threats than ever before.
The latest news for pharma industry insiders.
Texas Biomed announced that research shows that a certain monoclonal antibody treatment could treat all variants of COVID-19, including past,
Results from the MATINEE trial found that Nucala led to a statistically significant and clinically meaningful reduction in moderate/severe exacerbations
Boruzu is the first ready-to-use version of bortezomib for subcutaneous and intravenous administration in the treatment of multiple myeloma and
Results from the QWINT-1 and QWINT-3 trials found that insulin-naïve patients achieved similar reductions in A1C levels using once-weekly efsitora
A C-suite Q&A with Cristina Ortega Duran, President of Evinova.
Data from the Phase II/III DEVOTE study demonstrated that Spinraza showed significant motor function improvements at six months in infants
The “Do It For You & Them” campaign focuses on the impact that virus has on day-to-day lives.
Results of the RESTORE study revealed that 94% of participants preferred Lumryz over twice nightly oxybate treatments for narcolepsy.
Results from the Phase III EXPLORER-LTE study found that Camzyos maintained effectiveness in treating symptomatic obstructive hypertrophic cardiomyopathy after 3.5
The insurance company is offering the guidance in response to continued popularity of the drugs which are commonly used for
Perspective Therapeutics’ CEO explains how this method can be used to determine how to target cancer cells without damaging other
Pharmaceutical companies are seeing the benefits of being able to outsource entire functions through functional service providers.
Strategies that can help maintain and grow your market share. Plus how to adapt to new competitive pressures and evolving
Ecolab is looking to the future with new opportunities to partner with Pharma for critical solutions to support drug development
The product line includes vaccines, monoclonal antibodies, and antigens.
Submission is supported by results from the Phase III Vivacity-MG3 study, which demonstrated that nipocalimab, combined with standard care, significantly
The latest news for pharma industry insiders.
Submission of a New Drug Application for mirdametinib included data from the Phase IIb ReNeu trial, which evaluated patients with
A Harvard Business School Healthcare Alumni Association Q&A with Dr. Hersh Sagreiya at the Hospital of the University of Pennsylvania.
A new National Institutes of Health grant will advance research into the role of the serotonin 5-HT2A receptor in mitigating
This makes Aetna the first major insurer to cover these types of services.
The new vials of Zepbound are available through a new self-pay pharmacy channel, priced over 50% lower than other incretin
Expanded indication makes Omnipod the first automated insulin delivery system to be approved for the management of both type 1
Results from the Phase III BOREAS and NOTUS trials found that Dupixent reduced moderate-to-severe COPD exacerbations by 31% over 52
The novel lipid-in-oil delivery platform showed positive results across multiple disease states.
The latest news for pharma industry insiders.
The technology has the potential to be implemented across multiple aspects of the industry.
Key industry trends and how the relationships between companies and CDMOs are evolving to better meet the challenges of a
In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer, IMF, discusses challenges of
64Cu-SAR-bisPSMA has demonstrated advantages over current diagnostic tools, such as higher tumor uptake, next-day imaging, and a longer half-life in
The updated formulas should provide better protection against the currently circulating strains.
Findings from a recent study demonstrated that high-dose psilocybin provided a superior reduction in depressive symptoms compared to both placebo
By integrating support directly into existing workflows and focusing on solutions that eliminate “shoulder time,” manufacturers can significantly reduce delays
Acceptance of supplemental Biologics License Application was based on results from the Phase III CheckMate-9DW trial, which demonstrated that the
Manufacturers must navigate complex regulatory landscapes, understand diverse cultural nuances, and prioritize patient access in each region.
The acquisition, valued at $600 million, is expected to integrate V-Wave into Johnson & Johnson MedTech, which could improve the
In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, chief medical officer, IMF, offers a glimpse at
Approval of Niktimvo was based on positive data from the AGAVE-201 study, which demonstrated a 75% response rate in patients
Astellas Pharma’s chief people officer and chief ethics & compliance officer discusses the unique ways he’s brought DE&I to the
Key approval signals progress in addressing immune-mediated inflammatory diseases.
Surviving a long road, novel next-generation treatment offers hope for major depressive disorder.
Pharm Exec’s latest sampling of notable biopharma brand approvals and launches all have unique stories to tell—from the winding journeys
Three pieces of coverage in this month’s issue of Pharmaceutical Executive explore the tipping point that’s seemingly on the cusp
Click the title above for a link to open the Pharmaceutical Executive July/August 2024 issue in an interactive PDF format.
In an interview with Pharm Exec Associate Editor Don Tracy, Joseph Mikhael, MD, chief medical officer, IMF, explains the goals
How drugmakers can reap value from using generative AI in their market-entry strategies and decision-making, including mitigating launch challenges and
To safeguard patient access to life-saving medications, pharma companies must prioritize building robust resilience strategies that encompass IT systems, inventory
Ken Keller, CEO of Daiichi Sankyo’s US business, reflects on the trials, triumphs, and lessons learned in steering the transformation
The latest news for pharma industry insiders.
Why pharma needs to focus on improving—not just extending life.
In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, Head of Medical Affairs, US Oncology Business
In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, Head of Medical Affairs, US Oncology Business
Strategic imperatives for biotech firms in light of the latest market dynamics and investor behaviors.
The latest news for pharma industry insiders.
Lymphir is the first therapy to target the IL-2 receptor in the treatment of relapsed or refractory cutaneous T-cell lymphoma
The data may be a catalyst for sector with a now-likely rate pivot looming.
As part of the acquisition of CN201, Curon is expected to receive an upfront payment of $700 million, with the
Approval of neffy marks a significant advancement in epinephrine delivery, offering a less painful alternative to traditional needle injections.
The Trinity Life Sciences managing director and head of DE&I strategy discusses recent research on the topic.
Accelerated approval of Fabhalta for treating primary IgA nephropathy was based on positive results from the Phase III APPLAUSE-IgAN study.
Independence Blue Cross and Jefferson health published a study detailing the impact of such care.
Partnership with Abbott for Simplera CGM will expand access to the advanced automated insulin delivery.
The foundation donated over $1 million to these programs.
In an interview with Pharm Exec Associate Editor Don Tracy, Carlos Doti, VP, head of medical affairs, US oncology business
The latest news for pharma industry insiders.
Expanded indication makes Fibryga the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate approved for this indication.
The PGDx elio plasma focus Dx offers laboratories testing options for situations where samples are hard to obtain.
In this part of her Pharmaceutical Executive video interview, Charlotte Owens, MD, FACOG, Head of Medical Affairs and Outcomes Research