Top News

EMA Recommends Suspension of 700 Drugs Tested at GVK Site

Jan 23, 2015

EMA Recommends Suspension of 700 Drugs Tested at GVK Site GVK Biosciences argues that EMA’s recommended suspension of 700 drugs is disproportional to reported infractions.

EMA Sets Elemental Impurities Implementation Dates

Jan 23, 2015

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

Giovanni Caforio Named BMS CEO

Jan 21, 2015

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

Industry News

Compounding Committee Meets to Discuss Drugs Approved for Compounding

Jan 23, 2015

FDA’s Pharmacy Compounding Advisory Committee will meet in February to discuss the list of bulk drug substances that may or may not be compounded.

EMA Sets Elemental Impurities Implementation Dates

Jan 23, 2015

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

EMA Recommends Suspension of Medicines Due to Flawed Studies Found at GVK Biosciences’ Hyderabad Site

Jan 22, 2015

The decision came as a result of an inspection that raised concerns on how GVK carried out those studies at the Hyderabad site on behalf of marketing authorization holders.

Supplier News

BASF Announces Plans to Expand PVP Facilities

BASF announced that it would invest $65 million to improve its PVP manufacturing facilities, as well as add production to its Shanghai facility.

Baxter BioPharma Solutions Joins PBOA

Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board.

Industry Veteran Tom Tappen Remembered by Colleagues

Tom Tappen, who passed away Jan. 1, 2015, is remembered for contributions to the pharma industry, customers, and business associates.

Bio/Pharma News

Giovanni Caforio Named BMS CEO

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

Catalent and MGC Pharma Partner for Production of Cell Lines

Catalent announced that it would partner with Mitsubishi Gas Chemical Company, and its subsidiary MGC Pharma, to promote GPEx technology, a high-titer vector for stable mammalian cell lines.

Boehringer Ingelheim Partners with Vanderbilt University to Develop Ras Inhibitors

Boehringer Ingelheim announced that it would partner with Vanderbilt University to research and develop Ras inhibitors for the treatment of cancers affected by Ras mutation.

Peer-Review Research

Effects of 100% Ethylene Oxide Test Gas on the Resistance of Ethylene Oxide Biological Indicators

In anticipation of this mandatory switch from Oxyfume 2000 to 100% EtO for BI testing, comparison studies were performed to determine if the switch from Oxyfume 2000 to 100% EtO would have any impact on BI resistance label claims.

Comparing Manufacturing Process Options

A techno-economic profiling method supports pharmaceutical process development by helping identify the best manufacturing approach.

Considerations in Developing Sublingual Tablets—An Overview

This review highlights relevant physicochemical drug properties and formulation design considerations critical to quality and performance of the sublingual tablets.

Drug Manufacturing

CDC Publishes Information on Reducing Worker Exposure to Hazardous Drugs

A draft NIOSH Current Intelligence Bulletin on recommendations for reducing worker exposure to reproductive risks of drugs is available for public comment.

Filling Pre-sterilized Containers

Pre-sterilized, nested syringes and vials are seeing increased use in sterile filling.

Argos and Saint-Gobain Partner on Single-Use Components for Immunotherapy Manufacturing

Single-use components aid efficiency in automated personalized therapy manufacturing.

Drug Development

EMA Sets Elemental Impurities Implementation Dates

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

Investment into T-Cell Therapies Continues

Syncona and Kite Pharma announced separate investments into T-cell therapies to fight cancerous tumors.

Eli Lilly Enters into Collaborations for Cancer Treatments

Eli Lilly collaborates with Bristol-Myers Squibb and Merck on clinical trials of oncology treatments.

Current Issue

Fill/Finish Capacity Use for Biologics

There are significant differences between small molecules and biologics fill/finish capacity.

Value-Based Healthcare in the: United Kingdom

Bio/pharmaceutical manufacturers in the UK face challenges in proving that their drugs are worth the price.

Great Expectations from New European Commission

The European Commission’s new structure has sparked controversy about its allocation of responsibilities and the impact on the development and approval of new medicines.

PharmTech Talk

FDA Advisors Unanimously Approve Sandoz Biosimilar

An FDA expert committee has recommend approval of Zarizio, the first US biosimilar application from Sandoz, setting a milestone for generic biologic drugs and setting the stage for future approvals.

More New Drugs and Faster Approvals

FDA set several milestones in approving more new, important drugs and biologics in 2014. Breakthrough drug designations went through through the roof, speeding more new therapies for cancer and critical conditions to patients.

Biosimilar Development Moves Forward at FDA

FDA has scheduled a public meeting in early January to assess and weigh data on the first United States application for a biosimilar therapy.

PharmTech Europe

25th Anniversary Issue

Experts review bio/pharma industry growth and future prospects as Pharmaceutical Technology Europe marks its 25th anniversary.

 

 

 

PharmTech Europe Archives

 

Editor's Picks

FDA Realigns Drug Inspection and Manufacturing Oversight

Operational changes at FDA and CDER aim to improve global market monitoring.

Novel Technologies Win CPhI Pharma Awards

On Oct. 7, 2014 at CPhI Worldwide in Paris, France, UBM Live announced the winners of the 11th annual CPhI Pharma Awards.

The Bio/Pharma Working Life

Professionals share the ups and downs of working in the bio/pharma industry.

Eliminating Tablet Spots and Specks

Although the source of spots and specks on tablets is sometimes difficult to identify, following good maintenance and manufacturing practices can help solve or even prevent the problem.

USP Supply Chain Safety Videos

eBook Series

Analytical and Bioanalytical Testing eBook 2014

The editors of Pharmaceutical Technology review best practices and methods for analytical and bioanalytical testing.

Bioprocessing and Sterile Manufacturing

Review emerging trends in the development and manufacturing of parenteral and biologic drugs, including continuous manufacturing, monitoring, sterilization procedures, modular manufacturing, and single-use technologies.

Solid Dosage and Excipients

Review emerging trends in the formulation and manufacture of solid dosage drugs, as well as the role of excipients in enhancing the functionality of these drug forms.