Top News

Pfizer Receives FTC Clearance for Hospira Acquisition

Aug 25, 2015

Pfizer agrees to divest four sterile injectable assets to clear the way to complete acquisition of Hospira.

Mylan Receives FDA Warning Letter for Manufacturing Sites in India

Aug 19, 2015

Mylan received an FDA warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

GSK Factory in Tianjin Affected by Explosion

Aug 18, 2015

GSK reports no employee injuries at the facility and is assessing damage.

Industry News

BIOTECHNICA 2015

Aug 26, 2015

Set to take place in Hannover, Germany from October 6–8, 2015, BIOTECHNICA is one the major events in Europe that brings together players in the biotechnology, life sciences, and lab technology sectors.

Cracked Caps Spark Recall of Merck's Cancer Drug Bottles

Aug 19, 2015

Citing failure to meet child-resistant closure requirement, Merck has advised that all bottles should be examined for cracks and that affected bottles should be kept out of children’s reach.

Novartis Licenses AVEO Oncology’s Antibody to Treat Metabolic Syndrome

Aug 18, 2015

Novartis will develop AVEO’s AV-380, an investigational humanized antibody targeting growth differentiation factor 15.

Supplier News

WuXi PharmaTech Supplies Laboratory Testing Services to Lee's Pharm

WuXi's Laboratory Testing Division will be the exclusive supplier of laboratory testing services for Hong Kong-based Lee's Pharm.

Recipharm to Manufacture RedHill Biopharma’s FDC Therapy for Helicobacter pylori Infection

Recipharm will be responsible for the supply of the remaining clinical-trial material and ongoing future commercial supply of RHB-105, the lead drug candidate developed by RedHill for the treatment of Helicobacter pylori bacterial infection.

Cytovance Biologics Acquired by Hepalink

Cytovance Biologics anticipates continued expansion plans following acquisition by Hepalink USA

Bio/Pharma News

TxCell Consortium Receives EUR 1.28 Million Funding for Immunotherapy Project

The TRUST project will focus on the process development of Col-Treg, which is TxCell’s autologous collagen type II specific Treg immunotherapy product for the treatment of autoimmune uveitis.

Merus Obtains Financing and Progresses in Clinical Trials of Bispecific Antibodies

Merus announced new investors and the sale of $80.5 million in shares to advance its immuno-oncology programs.

Shire to Add Manufacturing Capacity for Cinryze

Shire requests a technical transfer from Sanquin to widen its manufacturer base for the production of Cinryze.

Standards/Regulations

Industry Responds to FDA Metrics Program

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

Reagan-Udall Foundation Builds Portfolio of Drug Regulatory and Safety Projects

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

Mylan Receives FDA Warning Letter for Manufacturing Sites in India

Mylan received an FDA warning letter citing violations at its Agila Specialty Formulation Facility, Sterile Products Division, and Onco Therapies Limited sites in India.

CPhI 2015 Update

2015 CPhI Pharma Awards

The 2015 CPhI Pharma Awards honors innovation in all phases of small-molecule and large-molecule drug development. Deadline: 14 August 2015.

CPhI Adds Expert Panel Members

Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.

USP Stresses Pharmacopeial Standards at CPhI China

The US Pharmacopeial Convention hosts compliance seminar at CPhI China 2015.

Drug Manufacturing

Shire to Add Manufacturing Capacity for Cinryze

Shire requests a technical transfer from Sanquin to widen its manufacturer base for the production of Cinryze.

Recipharm to Manufacture RedHill Biopharma’s FDC Therapy for Helicobacter pylori Infection

Recipharm will be responsible for the supply of the remaining clinical-trial material and ongoing future commercial supply of RHB-105, the lead drug candidate developed by RedHill for the treatment of Helicobacter pylori bacterial infection.

Allergan Recalls Eye Medication Due to Cap Particles

Allergan issued a voluntary nationwide recall in the US of specific lots of ophthalmic ointment after customers complained of black particles, which came from the cap.

Drug Development

Hermes Pharma Expands Formulation Services to US Market

Companies in the US will now have the opportunity to tap into Hermes Pharma’s technical expertise in effervescent and chewable tablets, instant drinks, lozenges, and orally disintegrating granules (ODGs).

arGEN-X Partners with University of Bern to Develop Combination Cancer Therapies

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.

Sanofi and Regeneron Form Immuno-Oncology Pact

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

Current Issue

Black Specks in Tablet Stability Samples

A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.

Getting Comfortable With Lean

Contract research, development, and manufacturing organizations are embracing lean manufacturing, while Big Pharma is applying it, not so much for inventory management, but to improve supply chain visibility and control.

Limiting Risk in Bio/Pharmaceutical Development

Mitigating risk in the bio/pharmaceutical sector demands a holistic approach.

USP Supply Chain Safety Videos

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PharmTech Talk

Industry Responds to FDA Metrics Program

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

Reagan-Udall Foundation Builds Portfolio of Drug Regulatory and Safety Projects

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

Cell Culture, Single Use, and the Evolving Biopharmaceutical Landscape

Andrew Bulpin, executive vice president of EMD Millipore’s Process Solutions Business, speaks to Pharmaceutical Technology about the trends shaping the biopharmaceutical manufacturing industry.

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

 

Peer-Review Research

Black Specks in Tablet Stability Samples

A study of root cause in stability samples suggests the need for tighter control of the sodium lauryl sulfate manufacturing processes.

Beyond the Blink: Using In-Situ Gelling to Optimize Opthalmic Drug Delivery

Delivery systems that allow drugs to be administered as liquids, but to form gel within the eye, promise to improve efficacy and patient compliance.

Using a Dual-Drug Resinate Complex for Taste Masking

Box-Behnken modeling was used to optimize a resinate complex, to mask the taste of levocetirizine dihydrochloride and montelukast sodium in orally disintegrating tablets.

Editor's Picks

CDMOs Cautiously Address Expansion

While all market signs are pointing up, memories of past setbacks may discourage CDMOs from expanding capacity.

Compliance with US and EU Internal Audit Requirements

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to handle internal audit reports during inspections.

Ensuring Correct Tablet Count

Electronic pharmaceutical tablet counters meet demands for accuracy, flexibility, speed, compact size, easy cleanability, and quick changeover.

PharmTech eBooks

 

Bioprocessing and Sterile Manufacturing eBook
The editors examine novel sterile and bioprocessing technologies including single-use systems, aging systems, cleanrooms, and lyophilization.  View eBook

 

More eBooks
Solid Dosage and Excipients
Analytical and Bioanalytical Testing