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

Manufacturing Challenges Limit Gene Therapy Development

Nov 16, 2018

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

EMA Suspends Authorizations of Quinolone and Fluoroquinolone Antibiotics

Nov 16, 2018

After a review of serious side effects, the agency decided to suspend marketing authorizations for quinolone and fluoroquinolone antibiotics and restrict use of remaining fluoroquinolone antibiotics.

EMA Recommends Four Medicines for Approval

Nov 16, 2018

The positive opinions included the first oral-only tablet for the treatment of human African trypanosomiasis.

Supplier News

KORSCH America Receives Manufacturing Award

KORSCH America received an award from the Massachusetts Legislative Manufacturing Caucus.

Single-use and IIoT Solutions Expected to Reduce Costs and Enhance Production Efficiency

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

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.

Bio/Pharma News

Amgen And Provention Bio to Develop Celiac Disease Treatment

The companies will develop AMG 714, a novel anti-IL-15 monoclonal antibody, for the treatment of gluten-free diet non-responsive celiac disease in a collaboration worth $170 million.

Sanofi, Denali Therapeutics in $1-Billion Deal for Neurologic Drugs

The companies will develop treatments for a range of neurological and inflammatory diseases.

AbbVie Signs Patent License with Momenta for Humira Biosimilar

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

Drug Development

Single-use and IIoT Solutions Expected to Reduce Costs and Enhance Production Efficiency

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

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.

Drug Manufacturing

AODD Pump Offers Flexible Installation Orientations

Wilden’s new air-operated double-diaphragm pumps can be installed in vertical or horizontal positions with various inlet and discharge options.

Robotic System Loads Trays for Prefilled Syringes

A robotic tray-loading system from ESS Technologies gently handles glass prefilled syringes.

Single-use and IIoT Solutions Expected to Reduce Costs and Enhance Production Efficiency

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

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

Manufacturing Challenges Limit Gene Therapy Development

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

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.

Bio/Pharma and 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.

EMA Gives Update on Brexit Plans

The agency provided an update on its relocation plans and assured that core activities are continuing uninterrupted.

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

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.

PharmTech Europe News

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.

Pharmapack Expects Accelerated Growth in Drug Delivery and Packaging, Mirroring Overall Industry

Pharmapack Europe expects further increases in innovation across packaging and drug delivery to mirror overall industry trends.

EMA Publishes Guidance on Pediatric Drug Safety

The new good pharmacovigilance practice chapter IV on specific considerations for the pediatric population offers a holistic view of pediatric pharmacovigilance and provides guidance on how to address the specific needs and challenges of safety monitoring of medicines used in children.

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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