Articles

Explaining Unapproved Drugs to Payors: FDA Guidance Helps Pharma Avoid Pitfalls

The FDA has issued new guidance on how drug manufacturers can communicate information about unapproved drugs to payors, aiming to reduce legal risks. This article explains the key provisions, including what can and cannot be said about study results, and offers strategic insights for pharma teams.

OpenEvidence's Hospital Pitch: A New Era for Pharma Partnerships

OpenEvidence is redefining its approach to hospital engagement, signaling a significant shift in how pharmaceutical companies can forge new partnerships. This strategic pivot emphasizes transparency and collaboration, promising to reshape the dynamics of healthcare innovation and patient care.

AstraZeneca's Camizestrant: Navigating Divergent Regulatory Paths for Breast Cancer Treatment

AstraZeneca's breast cancer drug, camizestrant, faced a significant regulatory divergence with CHMP approval in Europe contrasting with an FDA rejection. This split highlights evolving global regulatory landscapes and presents key considerations for pharmaceutical business development and investment strategies.

Why Optimistic Scientists Are Losing Heart: Insights from MIT

Structured plan for Why Optimistic Scientists Are Losing Heart: Insights from MIT

FDA Approves Generic Eribulin Mesylate for Metastatic Breast Cancer

The U.S. Food and Drug Administration (FDA) has approved an abbreviated new drug application (ANDA) for generic eribulin mesylate injection. This approval offers a new therapeutic option for patients with pretreated metastatic breast cancer and unresectable or metastatic liposarcoma.

House bill aims to crack down on China biotech deals

Structured plan for House bill aims to crack down on China biotech deals

Diversity in Medical Education: Bridging the Gap to a Representative Healthcare Workforce

While medical schools are admitting more diverse students, the number of practicing physicians from underrepresented backgrounds has not kept pace, creating systemic barriers. This gap has significant implications for pharmaceutical companies seeking to serve diverse patient populations.

Impact of CDER Leadership Changes on Pharma Strategy

Recent leadership shifts within the FDA's Center for Drug Evaluation and Research (CDER) signal potential alterations in regulatory priorities and drug approval processes. This analysis explores the strategic implications for pharmaceutical companies, business development teams, and investors.

ASGCT Annual Meeting 2026: Live Event Coverage and Key Insights

The ASGCT Annual Meeting 2026 is set to be the premier event for cell and gene therapy professionals. This live coverage will bring you the most significant advancements and industry insights.

Biotech's Future: Insights from Jeremy Levin

Structured plan for Biotech's Future: Insights from Jeremy Levin

New Hormone Regimen Shows Promise for Prostate Cancer Surgery Patients: Study Insights

Trump's Disloyalty Claims: Implications for Louisiana's Republican Primary

Structured plan for Trump's Disloyalty Claims: Implications for Louisiana's Republican Primary

The Hidden History of BPC-157: Unlocking Pharma Opportunities

Delve into the intriguing history of BPC-157, a peptide with significant regenerative medicine potential, and uncover its implications for pharmaceutical business development and investment strategies. Understand its research trajectory and market impact.

Eisai's Leqembi Sales Forecast: A Turning Point?

Structured plan for Eisai's Leqembi Sales Forecast: A Turning Point?

FDA seeks to cut repeat work for gene therapy developers

Structured plan for FDA seeks to cut repeat work for gene therapy developers

ASCO Summit: Ivonescimab's China Lung Data Shows Promise, But Global Validation Remains Key

Summit Therapeutics' ivonescimab demonstrated a significant survival benefit in a Chinese lung cancer trial presented at ASCO, yet analysts caution that replicating these results in a broader, global population is crucial for its market potential against established therapies like Keytruda.

CG Life Appoints Collette Douaihy Chief Creative Officer to Drive Biopharma Marketing Innovation

CG Life has appointed Collette Douaihy as its new Chief Creative Officer, a move signaling a strategic enhancement of its creative leadership. Douaihy's extensive background in healthcare creative leadership is expected to drive innovation in marketing strategies for biopharma companies.

OpenEvidence's Approach to Hospitals: A New Era in Pharma

Structured plan for OpenEvidence's Approach to Hospitals: A New Era in Pharma

FDA Hold Puts Aardvark Prader-Willi Drug in Limbo: Implications for Pharma BD

The FDA has placed a full clinical hold on Aardvark Therapeutics' investigational drug ARD-101 for Prader-Willi syndrome, halting all ongoing studies. This decision, stemming from heart-related adverse events, creates significant uncertainty for the company and the rare disease landscape.

STAT+ R&D Performance Ranking: Insights for Pharma Companies

Structured plan for STAT+ R&D Performance Ranking: Insights for Pharma Companies