Industry Trends

CDER's process for vetting and authorizing important new therapies remained strong and productive last year, despite the need to deal with COVID-19 related approvals and policies.

Applications put on hold as agency limits alternative oversight methods.

Donna L. LaVoie outlines the takeaways of a recent industry webinar discussing global trends on public and private markets, JPM virtual week, and more. 

President Trump finally signs the critical year-end COVID-19 package, appropriating $2.3 trillion to finance the federal government through September 2021 and providing critical support for individuals and entities suffering from the economic crisis wrought by the pandemic.

Jill Wechsler reports on FDA's newly published strategies supporting broader eligibility criteria for Phase III studies.

If the COVID-19 crisis represents an unprecedented opportunity for pharma to strengthen its public reputation, it also poses enormous risks if things go wrong, writes Professor Guido Palazzo.

FDA is poised to approve an Emergency Use Authorization (EUA) for the much anticipated vaccine against COVID-19 developed by Pfizer/BioNTech following a strong vote of support by the Agency's vaccine advisory committee

Data suggest that physician prescribers are just as hesitant as patients when it comes to COVID-19 vaccine safety, distribution, logistics and rollout. Will recent successes turn the tide?

How the pandemic’s impact on physicians and patients has spurred fundamental changes and redefined approaches in areas such as adherence and drug formulation and delivery.

Adoption of digital by biopharma reps has added an element of flexibility to their engagement strategies, resulting in better communications with HCPs.

How the CIO role has transformed and strengthened against the backdrop of COVID-19.

The redirection of healthcare and life sciences resources to COVID-19 has taken focus from other areas of need, including antimicrobial resistance.

2020 has proven to be a year like no other for pharma. Here is a quick look back at some of the trends 2020 created for the industry.

Amid COVID-19, pressure for “socially responsible” pricing could temper investments in future urgent healthcare needs.

In a time of global pandemic, traditional vaccine procurement schemes are not fit for purpose and need to adapt to allow both governments and manufacturers the ability to manage a greater level of risk associated with rapid vaccine development and deployment.

If telehealth is here to stay, how is the industry adjusting?

What the industry has learned navigating the pandemic and what the future holds for field teams.

Cliodhna McDonough and Emily Lockey give a UK perspective on the potential pros and cons of the three leading candidates in the COVID-19 vaccine race.

In unveiling a set of drug price control measures last week, the president displayed his bitterness that vaccine makers failed to announce their success in achieving high efficacy rates for new preventives before the Nov. 3 election.

A brief look into how the Gene Editing Institute researching the diversity of responses in African-American regenerative cells to various forms of CRISPR.

Authorities fear distrust of early preventives and complications for ongoing COVID-19 research.

Must maintain trust in face of customary, non-pandemic challenges.

Lessons to launch by during a pandemic—or otherwise.

President-elect Biden has announced initiatives to combat the widening coronavirus pandemic including a 13-member COVID advisory board.

Lise Stevens explores what difference the ISO IDMP (Identification of Medicinal Products) data standards would have made in a COVID-19 context — in applications ranging from pharmacovigilance adverse event reporting and electronic prescribing to falsified medicines control.

The Medical Affairs Digital Strategy Council's Mary Alice Dwyer and Indegene's Sameer Lal talk to Pharm Exec about how digital solutions can help the Medical Affairs function take a leadership role 
in ensuring fast, efficient, and meaningful responses to all stakeholders at a time of intense pressure.

Amid attention on coronavirus, efforts to address the burden of non-communicable diseases are at a critical juncture.

FDA has published updated Emergency Use Authorization (EUA) requirements for new coronavirus preventives.

Experts fear confusion over allocation process, cold-chain requirements, IT systems.

Assessing the landscape of the pharma industry’s readiness for future pandemics by looking at past pandemics, funding and revenue, and sustainability.