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  1. 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.

  2. Taking Middle-Market CROs and CDMOs to the Next Level

    Pharmaceutical development is a very attractive area for both strategic and financial investors, says Jeffrey Marlough, Managing Director at Castleford Capital.

  3. Leveraging Hot Melt Extrusion for Solubility and Continuous Manufacturing

    Hot melt extrusion (HME) technology has become a key solution to adding absorption for enhanced solubility, says Tony Listro, Vice President, Technical Business Development at Foster Delivery Science.

  4. Flexible, Mobile, Modular: High-Containment Viral Vector Center of Excellence

    Next-generation viral vector and gene therapy manufacturing facilities must be flexible, says Thomas Page, Ph.D., Vice President of Engineering and Asset Development for Fujifilm Diosynth Biotechnologies.

  5. 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.

  6. State-of-the-Art Biologics Manufacturing in an Unexpected Location

    Vladas Algirdas Bumelis, Chief Executive Officer and Chairman of the Board for Biotechpharma comments on how the company, located in Lithuania is exporting biologic drug substances worldwide.

  7. Unilever’s Indian Subsidiary to Acquire GSK’s Consumer Nutrition Brands in India

    The deal represents India’s largest consumer goods transaction.

  8. FDA Gives Novartis Gene Replacement Therapy Application Priority Review

    Zolgensma (AVXS-101, onasemnogene abeparvovec) is designed to address the genetic cause of spinal muscular atrophy.


  9. Statement from FDA Commissioner Scott Gottlieb, M.D., on New Actions Advancing the Agency's Biosimilars Policy Framework

    Timely and efficient regulatory processes ensure that the U.S. remains a driving force in global biomedical innovation.

  10. Roche to Develop Companion Diagnostic Test to Help Identify Patients Eligible for Anti-PD-1 Therapy Based on Biomarker Expression, Not Location, of Solid Tumors
    Roche will seek FDA approval for biomarker panel expected to provide a standardized predictive testing option for dMMR.
  11. Speeding Development and Reducing Costs with Analytical Quality by Design

    António Ramos, Analytical Chemistry Group Leader, Process Chemistry Development and Rui Loureiro, Director of the R&D Process Chemistry at Hovione outline Quality by Design (QbD) in analytical method development.

  12. Leveraging Offsite Fabrication in the Pharma Industry

    Offsite fabrication of facility components and equipment can help drug manufacturers achieve their goals, says Dennis Kearney, Pharmaceutical Core Team Leader at CRB USA.

  13. Terminal Sterilization for Parenteral Drugs: Finding the Right CDMO Partner

    Lluis Twose, Managing Director for Grifols, discusses terminal sterilization options for parenteral drugs.

  14. Hard-Shell Capsule Solutions for Sensitive Compounds: A Focus on Probiotics

    Eli Elias, Director of Business Development for CapsCanada explains why hard-shell capsules designed to degrade under specific conditions are a better option for probiotics.

  15. Seven Trends Impacting Chemical Process Development

    While greater efficiency and productivity will always be goals in manufacturing, there is currently increased demand to optimize processes in chemical manufacturing, says Justin Kadis, Business Development for Federal Equipment Company.

  16. Facilitating Implementation and Customer Service with Offline Serialization

    Tyler Ewald, Associate Director, Manufacturing and Joseph Quales, Supervisor, Label Control at UPM Pharmaceuticals explain the company’s offline serialization system.

  17. Clinical Study Explores the Efficacy of Numerous Ebola Therapies

    The safety and efficacy of investigational Ebola medicines in multiple countries experiencing outbreaks will be evaluated internationally.

  18. Mallinckrodt Spins off its Generics Business
    The company will split into two divisions.
  19. FDA Approves Roche's Tecentriq in Combination with Avastin and Chemotherapy for the Initial Treatment of People with a Specific Type of Metastatic Lung Cancer

    This approval is based on results from the Phase III IMpower150 study, which showed that Tecentriq in combination with Avastin and chemotherapy helped people live significantly longer.

  20. NYCEDC Grants $1M To Quentis Therapeutics For Expansion of LifeSci Space in West Harlem
    This is the first grant to be distributed from $10M LifeSci NYC Expansion Fund.
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Genentech Receives Additional Approval for Tecentriq

Dec 11, 2018 12:31:18 PM PAO-M12-18-NI-011

Roche Exec Moves to Gilead

Dec 11, 2018 12:26:17 PM PAO-M12-18-NI-010

FDA Issues Draft Guidance for Companion Diagnostics

Dec 11, 2018 12:22:57 PM PAO-M12-18-NI-009
Spin-off Business

Mallinckrodt Spins off its Generics Business

Dec 11, 2018 12:03:11 PM PAO-M12-18-NI-005-11

WuXi AppTec Plans for Growth

Dec 11, 2018 11:59:01 AM PAO-M12-18-NI-005-10

Hard-Shell Capsule Solutions for Sensitive Compounds: A Focus on Probiotics

Dec 6, 2018 2:24:02 PM PAO-M12-18-CL-002

Cutbacks and Divestitures Planned at Bayer

Dec 5, 2018 12:10:34 PM PAO-M12-18-NI-004

FDA Gives Novartis Gene Replacement Therapy Application Priority Review

Dec 5, 2018 12:07:21 PM PAO-M12-18-NI-003

GSK Acquires Oncology Company Tesaro

Dec 5, 2018 12:05:06 PM PAO-M12-18-NI-008

Unilever’s Indian Subsidiary to Acquire GSK’s Consumer Nutrition Brands in India

Dec 5, 2018 11:58:17 AM PAO-M12-18-NI-002
Bispecific Antibody

Regeneron’s Bispecific Antibody Candidate Shows Positive Results in Early Clinical Studies

Dec 5, 2018 11:56:33 AM PAO-M12-18-NI-007
Licensing Agreement

Pfizer to License AbbVie’s Humira IP

Dec 5, 2018 11:56:16 AM PAO-M12-18-NI-006
Collaboration Agreement

Cilag GmbH to Collaborate with argenx on New Treatment for AML, MDS

Dec 5, 2018 11:55:49 AM PAO-M12-18-NI-005

Pfizer’s Rituximab Biosimilar Achieves Positive Study Results

Dec 5, 2018 11:54:25 AM PAO-M12-18-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