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  1. The Coming of Age of Amorphous Solid Dispersions

    Márcio Temtem, Director for Drug Product Development at Hovione, discusses drug formulation using amorphous solid dispersions.

  2. How to Tell If You’re Using a Quality Hard Capsule

    Bahi Mahesan, Regulatory Affairs and Quality Manager for CapsCanada, explains the benefits of using a high-quality supplier for hard-shell capsules.

  3. What is the Most Significant Recent Advancement in Downstream Bioprocessing Technology? Why is it so Important?
    Experts weigh in on our Roundtable question.
  4. Regulatory Spotlight: FDA Delays Enforcement of Serialization Mandate
    In late September, the U.S. Food and Drug Administration (FDA) issued a pair of draft guidances related to the implementation of product identifiers as mandated by the Drug Supply Chain Security Act (DSCSA).
  5. How is the Need to Provide Local Drug-Product Supply in Multiple Regions Around the World Impacting Pharmaceutical Manufacturing Facility and Equipment Design?
    Experts from across the industry lend their thoughts to the Roundtable.
  6. Drug Repositioning: Facilitating Drug Repositioning with Artificial Intelligence
    Repositioning existing drug substances for the treatment of different indications can significantly reduce the cost and time required for the development of new medicines.
  7. Proposed U.S. Rules Would Eliminate Rebate Deals Between Drug Makers and Pharmacy Benefit Managers
    New safe harbor provision will allow drug makers to give discounts directly to consumers.
  8. Johnson & Johnson Announces Agreement to Acquire Auris Health, Inc.

    Auris Health's robotic platform expands Johnson & Johnson's digital surgery portfolio.

  9. Statement from FDA Commissioner Scott Gottlieb, M.D. on New Programs to Promote the Adoption of Innovations in Drug Manufacturing

    Ensuring the safety of our nation's drug supply is a cornerstone of our consumer protection mission. 

  10. Alexion Acquires Minority Stake in Caelum Biosciences

    Alexion will acquire the rest of the company if phase II data for anti-amyloid antibody CAEL-101 are positive.


  11. Creating Comprehensive Solutions through Laboratory Testing

    Xin Zhang, Ph.D., Vice President & Global Head of DMPK, Bioanalysis & Abgent, Eugene Gong, Ph.D., Vice President, Head of Technology Operations & Analytical & Regulatory CMC and Ed Amat, Vice President of International Sales & Marketing for WuXi AppTec discuss the company’s Laboratory Testing Division.

  12. Supporting Patient-Centric Clinical Trials from Point-of-Origin through the Last Mile

    Wes Wheeler, CEO of Marken explains how Direct-to-Patient (DTP) clinical trials are becoming an industry standard.

  13. The Evolution of Pharma Depends on Data Integration and Application

    The pharmaceutical industry must respond to increasing pressure to rapidly develop cost-effective, fairly priced medicines.

  14. Leveraging Lyophilization Development Expertise for Clinical Manufacturing

    By late 2018, AB BioTechnologies, Inc.will be providing cGMP manufacturing of Phase I-III clinical trial material and small-volume commercial products, says Jeff Schwegman, Founder & CEO.

  15. Using a Risk-Based Approach to Manufacturing in a Multi-Product Facility

    Peter Boeddeker, Director of Quality Management at Baxter BioPharma Solutions describes the challenges and advantages of multi-product facilities.

  16. Building a Biologics Business from the Ground Up

    Achieving success requires the right strategy, explains Hannes Teissl, Vice President, Biologics at Polpharma Biologics.

  17. U.S. FDA Approves Botox Competitor

    Evolus has secured approval for Jeuveau. 

  18. BHB Therapeutics Launched to Develop Medicines to Prevent Age-Related Diseases
    Company formed by Juvenescence and the Buck Institute for Research on Aging will develop drugs that induce a state of ketosis. 
  19. FDA Advisory Committee Recommends Approval of SPRAVATO™ (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression

    The committees based their support on the safety and efficacy data from five Phase 3 studies in patients with treatment-resistant depression: three short-term studies; one maintenance of effect study; and one long-term safety study.

  20. Statement from FDA Commissioner Scott Gottlieb, M.D., on Ongoing Efforts to Secure the U.S. Supply Chain and Confront the Opioid Epidemic

    The opioid epidemic continues to be one of the greatest challenges facing this nation and the FDA. 

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Researchers May Have Found Method for Detecting Consciousness

Feb 14, 2019 2:36:28 PM PAO-M02-19-NI-012
Artificial Intelligence

Trump Signs Executive Order Launching the American AI Initiative

Feb 14, 2019 2:32:22 PM PAO-M02-19-NI-012

Putting Mosquitoes on a Diet

Feb 14, 2019 2:21:40 PM PAO-M02-19-NI-011
Oral Insulin

An Innovative Approach to Oral Insulin

Feb 12, 2019 5:38:22 PM PAO-M02-19-NI-010
Drug Pricing

Price Lowered on Cholesterol Drugs

Feb 12, 2019 5:35:16 PM PAO-M02-19-NI-009

Alexion Acquires Minority Stake in Caelum Biosciences

Feb 7, 2019 3:53:28 PM PAO-M02-19-NI-007
Drug Development

BHB Therapeutics Launched to Develop Medicines to Prevent Age-Related Diseases

Feb 7, 2019 3:50:22 PM PAO-M02-19-NI-006
FDA Approval

U.S. FDA Approves Botox Competitor

Feb 7, 2019 3:44:09 PM PAO-M02-19-NI-005

Novo Nordisk to Use Priority Voucher for Diabetes Drug

Feb 6, 2019 4:39:44 PM PAO-M02-19-NI-004
Drug Development

EMA Committee Recommends Approval of Teva’s Anti-CGRP Treatment for Migraines

Feb 6, 2019 4:33:28 PM PAO-M02-19-NI-003

argenx Licenses Halozyme Subcutaneous Delivery Tech

Feb 5, 2019 5:46:36 PM PAO-M02-19-NI-002

EMA Will Soon Operate from Amsterdam

Feb 5, 2019 5:11:25 PM PAO-M02-19-NI-001

Nice Insight Overview

The Evolution of Pharma Depends on Data Integration and Application
New business models must be adopted to leverage the massive amounts of data generated across the pharma/healthcare continuum.


Q: What Innovative Technologies Had the Greatest Impact on your Company this Year? What Were the Impacts?

New Drug News

Regulatory Approval Brings siRNA into the Rare Disease Toolbox
David Alvaro, Ph.D., Scientific Editorial Director, Nice Insight

Regulatory Spotlight

FDA Delays Enforcement of Serialization Mandate

KshitiJ (TJ) Ladage, Market Research Manager, Nice Insight