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  1. 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.

  2. Mallinckrodt Spins off its Generics Business
    The company will split into two divisions.
  3. 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.

  4. 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.
  5. Steps Ahead: Planning for Future Equipment Surpluses from the Point of Procurement

    There are clear advantages to planning for your facility’s future explains Justin Kadis, Business Development Federal Equipment Company.

  6. Modern OSD Facility Design Considerations for Operational Efficiency and Regulatory Compliance

    When engineering and designing today’s OSD manufacturing facilities, the primary goal is to develop an operation that provides for the highest levels of product quality and operational efficiency, says Dave DiProspero, Associate/Director of Pharmaceutical Process Technology at CRB USA.

  7. Knowledge and Experience Equal Successful Technology Transfer

    Joe Szczesiul, Director of Technical Services at UPM Pharmaceuticals, outlines best practices for effective tech transfer.

  8. From Proof of Concept to Commercialization

    Mark Bamforth, CEO and Richard Snyder, CSO, explain how Brammer Bio is investing to support the commercial development of gene and cell therapies.

  9. 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.

  10. Designing a Better Single-Use Facility

    With the right tool, single-use facility design can benefit from a proactive review of facility, systems, design intent and risk, explains Carl Carlson, Director, Bioprocess Design & Technology of M+W Group. 

  11. Investor Group Purchases 110-Acre Pharmaceutical Campus in Huntsville, Alabama
    Diversified ultra-modern pharmaceutical campus with solid dosage form, liquid manufacturing filling, distribution warehouse, and vault storage. Assets are available for purchase and/or lease.
  12. Histo-Scientific Research Laboratories and Vet Path Services Merge

    Formation of company to meet growing demand for high-quality histopathology services in the research and pre-clinical therapeutics markets includes growth equity investment from Ampersand Capital Partners.

  13. Researchers Discover Potential Cause for Alzheimer’s Disease

    Scientists find that neurons in the brain can modify their own genes.

  14. Pfizer’s Rituximab Biosimilar Achieves Positive Study Results
    A comparative safety and efficacy study meets its primary endpoint.
  15. Product and Service Concepts Driving Speed to Market

    Jonathan Gilinski, Executive Director of CapsCanada explains how to accelerate timelines.

  16. Death to Cleanrooms in Biopharmaceutical Manufacturing

    Marc Pelletier, Ph.D., Director of CRB USA explains the benefits of closed processing.

  17. 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.

  18. Designing Effective Drug Formulations: Keys to Successful Proof of Concept Services

    Ed Scholtz, Ph.D., Vice President of R&D for UPM Pharmaceuticals explains the company's approach to formulations. 

  19. Aligning with Sponsors for Strategic Growth
    Syed T. Husain, Chief Commercial Officer, and Catherine Hanley, Head of Marketing & Corporate Communications, Alcami, discuss the new company sponsorship.
  20. WuXi Biologics Breaks Ground on Innovation Center in China
    Global innovation center will integrate biologics discovery, development and clinical and commercial manufacturing.
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SEARCH COMPANIES
Approval

Genentech Receives Additional Approval for Tecentriq

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

Roche Exec Moves to Gilead

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

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
Growth

WuXi AppTec Plans for Growth

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

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

FDA Gives Novartis Gene Replacement Therapy Application Priority Review

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

GSK Acquires Oncology Company Tesaro

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

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
Biosimilars

Pfizer’s Rituximab Biosimilar Achieves Positive Study Results

Dec 5, 2018 11:54:25 AM PAO-M12-18-NI-001
Columns

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.

Roundtable

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