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Regulatory Shock Trades: How FDA Letters Move Billions Before Lunch

CRL Regulatory Shock Trades: How FDA Letters Move Billions Before Lunch No fireworks. A 7:12 a.m. line to the exchange:…

admin October 14, 2025October 15, 2025

Case Files Signals

Data Integrity’s New Price Tag: How Compliance Failures Now Move Stock Prices in Hours

admin October 10, 2025October 10, 2025

Deep Dives Regulatory

Regulatory Pressure & Supply Shock: Why Europe’s Drug Shortages Became Chronic – and What Everyone’s Missing

admin September 20, 2025September 20, 2025

Signals

Nitrosamines 2.0: new AI thresholds, new “casualties,” and finally predictable rules

admin September 10, 2025September 10, 2025

Opinion Deep Dives

Cracking Down on Orphan Drug Abuse: The ORPHAN Cures Act and Its Impact

admin August 23, 2025August 23, 2025

Newswire

Novel Antibody Technologies Expand Potential Cancer Applications

Recent advancements in antibody technologies are significantly enhancing the potential applications of cancer therapies. Since the FDA’s approval of the first monoclonal antibody in 1986, the landscape of antibody-based treatments has evolved, incorporating immune checkpoint inhibitors, antibody-drug conjugates (ADCs), and bispecific antibodies. These innovations are crucial in addressing the complexities of cancer treatment, particularly in […]

October 13, 2025

Newswire

Boehringer Ingelheim Breathes New Life into Lung Fibrosis Field with FDA Approval for Jascayd

Boehringer Ingelheim has received FDA approval for Jascayd, marking the first new drug to enter the idiopathic pulmonary fibrosis (IPF) market in over a decade. This significant milestone follows the success of Ofev, which was launched in 2014 and has since established itself as a cornerstone treatment in this challenging therapeutic area. Jascayd’s approval not […]

October 13, 2025

Newswire

Orally Disintegrating Tablets: A Growing Market with Unique Formulation Challenges

Orally disintegrating tablets (ODTs) are gaining traction in the pharmaceutical market, with projections indicating growth from $11 billion to over $27 billion by 2025. This surge is largely attributed to the needs of pediatric and geriatric populations, as well as patients with dysphagia, who require alternative dosage forms that facilitate easier administration. The United States […]

October 13, 2025

Newswire

Généthon Aims to Reduce CGT Costs Through Innovative Biomanufacturing

Généthon is on a mission to make cell and gene therapies (CGTs) both safe and affordable, addressing a critical barrier for patient access. The exorbitant costs associated with CGTs often deter payers, particularly for rare diseases where commercial viability is limited. As Frédéric Revah, PhD, CEO of Généthon, highlights, approximately 85% of rare diseases are […]

October 13, 2025

Newswire

Quotient Sciences’ Platform Accelerates Development of Poorly Soluble Drugs

Quotient Sciences has unveiled a preclinical screening platform that significantly enhances the development of poorly soluble drugs, addressing a critical barrier in pharmaceutical R&D. With approximately 40% of marketed pharmaceuticals and nearly 90% of investigational compounds suffering from poor aqueous solubility, the implications for bioavailability and therapeutic efficacy are profound. This platform integrates advanced formulation […]

October 13, 2025

Recently Featured

CPHI Frankfurt 2025: A Convergence of Pharma Professionals

October 12, 2025

As the pharmaceutical world gathers once again in Europe for CPHI Frankfurt 2025, we’re reminded of just how global—and interconnected—our industry truly is. Over three days this October, more than 62,000 pharma professionals and 2,000 exhibitors will converge to discuss the trends, technologies, and partnerships shaping the future of drug development and delivery. For Contract…

CDC Amends Covid-19, Chickenpox Immunisation Schedule Amid Vaccine Controversy

October 12, 2025

The Centers for Disease Control and Prevention (CDC) has officially revised its immunisation schedule, no longer recommending routine Covid-19 booster vaccinations or the combined administration of varicella and measles, mumps, and rubella (MMR) vaccines. This decision comes in the wake of ongoing debates surrounding vaccine efficacy and safety, particularly as public health officials reassess the…

MapLight Uses Workaround to Tee Up IPO During Government Shutdown

October 12, 2025

MapLight has set the terms for its initial public offering (IPO) by leveraging a rarely utilized provision of the Securities Act, allowing the offering to automatically price within 20 days. This strategic move comes amid a government shutdown, which has created uncertainties in the regulatory landscape for many companies seeking to go public. In the…

Container Selection is Crucial for Addressing Sterile Fill & Finish Challenges in Biologics

October 12, 2025

The biological drug market is witnessing significant growth, with 18 biologics approved by the US FDA in 2024, compared to just 12 in 2021. This surge is largely driven by a robust pipeline of innovative therapies. Given that biologics are typically administered via injection due to their large molecular size and sensitivity to degradation, it…

Ongoing Cases

Deep Dives Regulatory

505(b)(2): The Fast Track to Innovation in Pharma

August 22, 2025September 20, 2025

Connecting the Past and Future of Drug Development 505(b)(2): Towards the Future, While Reflecting the Past While…

In Focus

Regulatory Shock Trades: How FDA Letters Move Billions Before Lunch

Data Integrity’s New Price Tag: How Compliance Failures Now Move Stock Prices in Hours

Regulatory Pressure & Supply Shock: Why Europe’s Drug Shortages Became Chronic – and What Everyone’s Missing

Nitrosamines 2.0: new AI thresholds, new “casualties,” and finally predictable rules

Cracking Down on Orphan Drug Abuse: The ORPHAN Cures Act and Its Impact

Novel Antibody Technologies Expand Potential Cancer Applications

Boehringer Ingelheim Breathes New Life into Lung Fibrosis Field with FDA Approval for Jascayd

Orally Disintegrating Tablets: A Growing Market with Unique Formulation Challenges

Généthon Aims to Reduce CGT Costs Through Innovative Biomanufacturing

Quotient Sciences’ Platform Accelerates Development of Poorly Soluble Drugs

CPHI Frankfurt 2025: A Convergence of Pharma Professionals

CDC Amends Covid-19, Chickenpox Immunisation Schedule Amid Vaccine Controversy

MapLight Uses Workaround to Tee Up IPO During Government Shutdown

Container Selection is Crucial for Addressing Sterile Fill & Finish Challenges in Biologics

Ongoing Cases

505(b)(2): The Fast Track to Innovation in Pharma

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