February 23rd 2024
Results of a study conducted by the National Institutes of Health indicate that the Paxlovid prevented a substantial number of hospitalizations associated with COVID-19.
February 20th 2024
Planning for a post-recession scenario is essential, ensuring companies are prepared to scale up when funding permits.
February 12th 2024
The FDA granted accelerated approval to Elahere in November 2022 for adults with folate receptor-alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Entrenched and emerging hurdles alike are challenging manufacturer pricing and access strategies.
February 9th 2024
Key steps in relationship-building beyond just treatment options.
Escaping the “Valley of Death:” The Funding Process for Biotechnology Companies
Christopher J. Calhoun pulls back the curtain on the mysterious biotech funding process.
Here Come the COVID Treatment Options
On December 22, 2021, FDA authorized emergency use of Pfizer’s oral antiviral drug Paxlovid on December 22, 2021, skipping the advisory committee review to make the drug available as quickly as possible. The following day, FDA provided similar authorization for Merck’s Molnupiravir.
FDA’s Guidance on Using RWD in Evidence Generation Is a Big Step Forward
Practices to ensure accuracy in selected datasets.
In It For the Long-Haul: Planning for the Future of COVID-19
While pharma has reached new heights in vaccine development, many questions remain around the lasting effects of COVID and how future therapies can curb them.
Turning the Corner: A New Era of Pharma Sales Comes Into View
It wasn’t long before sales reps realized they needed a new strategy to keep prospect pools flowing—18 months later, a mix of in-person and virtual meetings with healthcare professionals is emerging as the preferred approach moving forward.
An Industry Under Attack: Pharma Revisits Cybersecurity During COVID-19
Pharma organizations have long been vigilant in protecting their intellectual property and financial information, but the disruption of COVID-19 has seen an expansion of the ‘cyberattack surface.’
The New COVID Workforce: Keeping Pharma Strong Through Adversity
How an increased focus on people has helped companies survive the pandemic.
mRNA Technology: First COVID-19, Now Cancer
Having proved its efficacy against COVID-19, mRNA technology is positioned to combat another insidious human adversary: cancer.
Pandemic Alters FDA Inspection Process and Policies
Changes prompt collaboration and improved quality management.
Q&A: Cathal Friel, Open Orphan
Open Orphan CEO Cathal Friel talks to Pharm Exec about how the company is distinctive from traditional CROs and its role in the UK’s COVID-19 human challenge study.
Protecting Public Health: Lorna Meldrum, Seqirus
Lorna Meldrum, Vice President, Commercial Operations, International Markets & Pandemic at Seqirus, talks about the challenges of the influenza vaccine market and how COVID-19 has highlighted that preventing ’flu is crucial for public health.
Setting Sights on the COVID Vaccine Market: Shankar Musunuri, CEO, Ocugen
Dr. Shankar Musunuri talks about his 25 years’ experience in biotech about his company Ocugen’s latest mission to develop, manufacture, and commercialize Bharat Biotech’s COVID-19 vaccine, COVAXIN, in the North American market.
The Next Big COVID Challenge: Vaccines for Children under 12
If the debate over vaccines for adults and the need for extra booster shots has been heated, FDA will face even more scrutiny over the safety and value of vaccinating children under age 12.
Vaccine Booster Battle Reveals Rifts Among Regulators, Sponsors
FDA’s Vaccines and Related Biological Products Advisory Committee announces its recommendations for the authorization of a third dose of the Pfizer/BioNTech Comirnaty vaccine.
Commercial Models for the Changing Life Sciences Market
Life sciences companies have an opportunity to craft a sales approach that resonates with clients, protects against future disruptions and stands out from the competition.
Biden Bolsters Vaccine Production in Pandemic Preparedness Plan
White House officials recently announced a nearly $3 billion program to ramp up production of vaccines and their components to better serve patients in the U.S. and globally.
How GxP Leaders Can Assess and Approach a Company’s Quality Culture
Using the interview process to ensure high organizational standards.
Harnessing China’s Global Opportunity
Sy Chyi Yeoh looks at some of the practical considerations faced by Chinese firms looking to expand overseas.
Pfizer Vaccine Approval Key to Boosting Vaccination Rates
FDA has granted full approval for the Pfizer/BioNTech anti-COVID 19 vaccine, raising hopes that this action will help overcome the vaccine hesitancy that has plagued efforts to broadly immunize the U.S. population.
Ireland’s Role in the European Union’s Evolving Pharmaceutical Sector
Rory Mullen outlines Ireland’s importance to multinational pharma in the changing EU landscape.
Biosimilars Move to Center Stage
All eyes are watching closely to see how well Viatris and Biocon Biologics’ Semglee, approved by FDA on July 28, competes with Sanofi’s well-established, long-acting insulin analog, Lantus.
Why the Pandemic is Rewriting the Biopharma Rule Book
Changes necessitated by COVID will drive unprecedented transformation of industry.
Primary Care in Crisis: PCP Navigation in a Specialty World
COVID-19 may be the latest challenge to primary care physicians, but it’s just one of many threatening the profession, including the increased focus on specialty drug markets—if PCPs are left out of the equation.
Pharm Exec at 40 (2003-2006)
Looking Back at 2003–2006.
COVID, Post-COVID, and Long-Haul COVID
Still plenty to learn about the virus even after year-plus long pandemic
Has COVID-19 Opened up the Route to Market for Cell and Gene Therapy?
Cliodhna McDonough-Stevens looks at what the COVID-19 pandemic might mean for the future of cell and gene therapy across Europe.
D&I at GSK
GSK‘s President of US Pharmaceuticals, Maya Martinez-Davis, outlines her organization’s evolving diversity and inclusion commitments.
Achieving Diverse Teams for a Diverse World
The benefits of diversity in the workplace are far-reaching — not just for employees, but for a company’s overall health.
Pharm Exec at 40 (2000-2002)
Looking back at 2000-2002.
Recent roundtable highlights need for biopharma to enter ESG conversation.
2 Commerce Drive Cranbury, NJ 08512