Top News

Bayer Announces R&D and Manufacturing Cuts

Nov 30, 2018

In a strategic move to strengthen its core life science businesses, Bayer announces 900 R&D and 350 manufacturing job cuts.

WuXi Biologics Begins Construction of Major Biologics Center in China

Nov 27, 2018

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

Cambrex to Acquire Avista Pharma

Nov 20, 2018

With the $252-million acquisition of contract development, manufacturing, and testing organization Avista Pharma Solutions, Cambrex will enter the market for early stage small-molecule development and testing services.

Industry News

Shire Gains EU Approval for its Preventive Treatment of Hereditary Angioedema

Dec 05, 2018

Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.

UK Government Announces Huge Investment Through Second Life-Sciences Sector Deal

Dec 05, 2018

The UK's government has revealed the details of the second Life Sciences sector deal, forming part of the Industrial Strategy.

European Commission Approves First Oral Disease-Modifying Treatment for MS

Dec 05, 2018

Novartis has announced that the European Commission has approved Gilenya (fingolimod) as a treatment for children and adolescents (10–17 years) with relapsing-remitting forms of multiple sclerosis (RRMS).

Supplier News

Shire Gains EU Approval for its Preventive Treatment of Hereditary Angioedema

Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.

European Commission Approves First Oral Disease-Modifying Treatment for MS

Novartis has announced that the European Commission has approved Gilenya (fingolimod) as a treatment for children and adolescents (10–17 years) with relapsing-remitting forms of multiple sclerosis (RRMS).

GSK and TESARO Reach Acquisition Agreement

GSK and TESARO have entered into a definitive agreement concerning GSK's acquisition of TESARO for an aggregate cash consideration worth approximately $5.1 billion.

Bio/Pharma News

Pfizer Gets Global Patent License for AbbVie’s Humira

AbbVie will grant Pfizer license to launch a biosimilar to AbbVie’s Humira worldwide.

Genentech Acquires Jecure Therapeutics

The acquisition will give Genentech full rights to Jecure’s preclinical portfolio of NLRP3 inhibitors.

FDA Approves New Cancer Drugs from Pfizer and Loxo Oncology

The agency has approved two new chemical entities, Daurismo (glasdegib) from Pfizer, and Vitrakvi (larotrectinib) from Loxo Oncology, for treating cancers.

Drug Development

Spray Film Provides Alternative to Patches

Virpax’s Patch-in-a-Can technology delivers pain medication using a metered-dose spray film.

Genentech Acquires Jecure Therapeutics

The acquisition will give Genentech full rights to Jecure’s preclinical portfolio of NLRP3 inhibitors.

QPS Expands US-Based Phase I Clinical Trial Capabilities

The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.

Drug Manufacturing

Manufacturing Considerations for Transdermal Delivery Systems

Drug and adhesive formulation are crucial to the development of microneedle patches for pharmaceutical transdermal delivery systems.

Improving Production: How IT, OT, and Quality Can Collaborate

To improve production in pharmaceutical manufacturing, the IT, OT, and Quality functional groups must work together to get the most value from existing plant data.

Unprocessed Bulk Testing for Biopharmaceuticals

Unprocessed bulk material harvested directly from the bioreactor should be tested for contamination prior to downstream processing.

Best Practices

Simulating Reality in Mock Inspections

Mock inspections—if conducted properly—can prepare a pharma company for the day FDA knocks on the door.

Planning a Successful MES Deployment

Preventing problems in implementing a manufacturing execution system requires upfront analysis and detailed planning.

The Power of In Vitro Assays in Immuno-Oncology

The combination of translatable in-vitro and in-vivo assays, coupled with expertise in immunology and oncology helps facilitate the progression of novel oncology therapeutics from hit identification to investigational new drug submission.

Standards/Regulations

EMA Publishes Revision to Environmental Risk Assessment Guideline

The EMA has published a revision to its guideline on the environmental risk assessment of human medicines.

Disputes Over SPC Waivers

The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.

PDA’s New Technical Report Highlights Data Integrity Management System for Pharma Labs

PDA Technical Report 80 (TR 80): Data Integrity in Laboratory Systems is the first in a series of three technical reports PDA will publish on data integrity.

Sponsored Videos

PharmTech Talk

Opposition Demands Protection for Part D “Protected Classes”

The proposal from the Centers for Medicare and Medicaid Services (CMS) proposes to give plans more flexibility to limit coverage of certain drugs.

Quality Manufacturing Key to Reducing Drug Shortages

Despite ongoing efforts to address the problem, FDA now sees a rise in active shortages and in the duration of supply problems.

Manufacturing Challenges Limit Gene Therapy Development

Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.

Bio/Pharma and Brexit

Prioritizing Pragmatism in Face of a ‘No-Deal’ Brexit

During CPhI Worldwide in Madrid, Lynne Byers, executive director of NSF International detailed the facts about how Brexit can impact the pharmaceutical industry.

Coalition of UK’s Health Sector Request Protection for Public Health Post-Brexit

A coalition group from the UK's health sector has called on both the UK and EU to ensure the protection of patients and public health when considering the future relationship of the regions post-Brexit.

Pharmaceutical Industry Welcomes an Important Step Toward Securing a Brexit Deal, Says ABPI

Pharma industry welcomes announcement of a draft withdrawal agreement, stating it is an important step towards securing a Brexit deal.

PharmTech Europe News

Shire Gains EU Approval for its Preventive Treatment of Hereditary Angioedema

Shire has announced that the European Commission has granted marketing authorisation for Takhzyro (lanadelumab) subcutaneous injection.

UK Government Announces Huge Investment Through Second Life-Sciences Sector Deal

The UK's government has revealed the details of the second Life Sciences sector deal, forming part of the Industrial Strategy.

European Commission Approves First Oral Disease-Modifying Treatment for MS

Novartis has announced that the European Commission has approved Gilenya (fingolimod) as a treatment for children and adolescents (10–17 years) with relapsing-remitting forms of multiple sclerosis (RRMS).

PharmTech eBook Series

 

Laboratory Best Practices 2018 eBook

The editors explore new tools for bio/pharma lab studies—such as robotics, augmented reality, and advanced instrumentation— as well as best practices for method development, multiple attribute monitoring, lab mixers, and raw material testing.

View E-Book

 

Peer-Review Research

Uniformity of Dosage Units, Part 1: Acceptance Value

This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.

Understanding Internal Release Limits

Internal release limits help ensure that a batch of drug product remains within specifications throughout its shelf life. This article explores what internal release limits are and why they are important.

Rethinking Cleaning Validation for API Manufacturing

This article focuses on applying new and traditional techniques to design a cleaning process, ensure the surfaces are clean, and develop rinse solution analysis to continuously monitor cleaning performance.

Sponsored eBooks

 

Strategies for Accelerating Drug and Process Development
This eBook offers several approaches to meet these needs, including how to gauge the level and type of polymorph screening needed to minimize risk and how to implement Quality by Design during process development.

More eBooks

 

CPhI Update

Prioritizing Pragmatism in Face of a ‘No-Deal’ Brexit

During CPhI Worldwide in Madrid, Lynne Byers, executive director of NSF International detailed the facts about how Brexit can impact the pharmaceutical industry.

bioLIVE to Merge with BioProduction Congress for 2019 Event

Bioprocessing and manufacturing events bioLIVE and BioProduction Congress will take place as one event adjacent to CPhI Worldwide in Frankfurt, Germany, on November 5–7, 2019.

CPhI Worldwide Survey Indicates 2019 Should be a Strong Year for Pharma

The latest CPhI Worldwide survey results have revealed a promising outlook for the global pharma economies.

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