Top News

Split Congress to Attack Drug Pricing

Nov 08, 2018

Leaders of the two parties are open to challenging the status quo on drug costs and spending.

Manufacturers’ Brexit Concerns Reflected in Lowest Growth Expectation in Six Years

Nov 01, 2018

The latest Manufacturing Barometer report, published by SWMAS, indicates concern over Brexit by UK manufacturers and an anticipation of lower business growth over the next six months.

FDA Announces Plan to Advance Biotech Innovation

Oct 31, 2018

A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.

Industry News

FDA Modernizes Inspection of Sterile Products

Nov 12, 2018

The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.

Be The Match BioTherapies Launches Program for Faster Cell Facility Onboarding

Nov 09, 2018

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

Survey Predicts Drug Product Formulation Recognition and Increasing Budgets

Nov 08, 2018

Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.

Supplier News

GE Healthcare Manufactures Single-Use Consumables in China

GE Healthcare will collaborate with Wego Pharmaceutical in China for local production and supply of GE Healthcare’s Fortem single-use consumables.

Thermo Fisher Opens Newly Expanded Facility in Maryland

The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.

Survey Predicts Drug Product Formulation Recognition and Increasing Budgets

Formulation issues cause significant drug project delays and project failures, according to a 2018 survey conducted by Informa Pharma Intelligence, Rentschler Biopharma, and LEUKOCARE.

Bio/Pharma News

AbbVie Signs Patent License with Momenta for Humira Biosimilar

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

Sandoz Decides Against Pursuing Biosimilar Rituximab

The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.

Shire Wins ISPE Facility of the Year Award

The International Society for Pharmaceutical Engineering (ISPE) named Shire as the ISPE 2018 Facility of the Year Awards Overall Winner for a facility integration project in Los Angeles, CA.

Drug Development

Ending the Impasse on Drug Pricing

More—and earlier—interaction between R&D and payers will be essential if innovative therapies are to become more accessible for patients, and more profitable for manufacturers, said panelists at the 2018 Galien Foundation Forum.

Sandoz Decides Against Pursuing Biosimilar Rituximab

The decision follows an FDA request for additional information to complement the company’s submission for biosimilar rituximab.

Lilly, NextCure Partner on Immuno-Oncology Medicines

The multi-year collaboration will incorporate NextCure's proprietary FIND-IO platform, a technology designed to identify novel cell-surface molecular interactions that drive functional immune responses in the tumor microenvironment and other disease sites.

Drug Manufacturing

GE Healthcare Manufactures Single-Use Consumables in China

GE Healthcare will collaborate with Wego Pharmaceutical in China for local production and supply of GE Healthcare’s Fortem single-use consumables.

Be The Match BioTherapies Launches Program for Faster Cell Facility Onboarding

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

Thermo Fisher Opens Newly Expanded Facility in Maryland

The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.

Best Practices

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.

Modular Facility Design Maximizes Space Flexibly

Vetter's FOYA award-winning facility is an example of a flexible pharmaceutical and biopharmaceutical modular facility design that allows expansion of space without affecting existing operations.

Standards/Regulations

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.

Pharmaceuticals in the Environment

Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.

Sponsored Videos

PharmTech Talk

Split Congress to Attack Drug Pricing

Leaders of the two parties are open to challenging the status quo on drug costs and spending.

Pharma Unhappy with Trump Reference Pricing Proposal

A new proposal aims to reduce reimbursement for medicines administered to seniors under the Part B benefit to an amount pegged to the average price paid in foreign industrial nations.

FDA Promotes Complex Generics and Combination Products

To achieve a more dynamic marketplace, FDA is issuing guidance documents and targeted advisories to support R&D on complex generics and combination products.

PharmTech Europe News

Medicines Containing Sartan Currently Available in Switzerland are Free of NDMA, Says Swissmedic

Investigatory work arranged by Swissmedic has revealed that sartan-containing medicines on the Swiss market are safe in respect of NDMA.

Medherant Reveals Positive Phase I Results of Transdermal Patch

Medherant has announced positive results from two Phase I trials evaluating its transdermal drug delivery patch loaded with ibuprofen.

New Report Claims that a Few Dollars More Per Person Could Stop AMR

New analysis from the OECD highlights that spending just a couple of dollars per person could help prevent deaths from antimicrobial resistance.

PharmTech eBook Series

 

Biologics and Sterile Drug Manufacturing 2018 eBook

This ebook covers novel technologies for the formulation, manufacture, purification, and delivery of sterile small- and large-molecule drugs, including single-use systems, facilities and equipment, contamination issues, and process analytics.  

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

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.

CMOs to Benefit from Double-Digit Approvals for ADCs, CPhI Reports

According to CPhI’s annual report, the therapeutic antibody drug conjugates (ADC) market is expected to reach $4 billion by 2023.

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