Top News

Sartorius Stedim Biotech to Supply Membrane Adsorber Technologies to GE Healthcare

Sep 01, 2015

Under the terms of the agreement, Sartorius Stedim Biotech will manufacture membrane adsorber technologies for GE, which will be marketed as part of GE’s ReadyToProcess product offerings.

Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020

Aug 28, 2015

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

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.

Industry News

EMA’s Medical Literature Monitoring Begins

Sep 01, 2015

The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.

FDA Releases Guidance on Biosimilar Nomenclature, Requests Comments on Interchangeable Product Naming

Aug 27, 2015

In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.

USP Partners with USAID to Secure Supply Chain

Sep 01, 2015

USP joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

Supplier News

Microscan Acquires Label Vision Systems

Label Vision Systems (LVS) will be fully integrated into Microscan and the LVS name will become a brand within Microscan’s barcode label verification portfolio.

Sartorius Stedim Biotech to Supply Membrane Adsorber Technologies to GE Healthcare

Under the terms of the agreement, Sartorius Stedim Biotech will manufacture membrane adsorber technologies for GE, which will be marketed as part of GE’s ReadyToProcess product offerings.

Mayne Pharma to Invest $65m in Manufacturing Expansion

Mayne Pharma plans to double oral-dose manufacturing space and expand contract services.

Bio/Pharma News

FDA Approves Amgen’s PCSK9 Inhibitor Repatha

The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.

Novo Nordisk Unveils Plans to Boost Manufacturing Capacity in North Carolina and Denmark

Novo Nordisk plans to invest approximately $2 billion over the next five years in new production facilities in Clayton, North Carolina, US and Måløv, Denmark. The facilities are expected to be operational during 2020.

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.

Standards/Regulations

EMA’s Medical Literature Monitoring Begins

The agency started the full operation of its medical literature monitoring on Sept. 1, 2015.

USP Partners with USAID to Secure Supply Chain

USP joins the Global Health Supply Chain Technical Assistance program to help secure the drug supply chain.

FDA Releases Guidance on Biosimilar Nomenclature, Requests Comments on Interchangeable Product Naming

In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.

CPhI 2015 Update

Worldwide Pharmaceutical Meetings—A Place for Sharing

Worldwide, meetings take place for several reasons, such as to share new findings, learn about novel technologies, discuss international issues, exchange know-hows, and network, to name a few. While each of these reasons has its significant importance, what really matters in scientific inquiry is progress.

Knowledge-Sharing and Networking at the CPhI Pre-Connect Congress

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.

Pharma Moves Towards More User-Friendly Packaging

Ger Standhardt, manager of knowledge development & projects at NVC, shares insights on the role of pharmaceutical packaging and accessible design in patient adherence.

Drug Manufacturing

Mayne Pharma to Invest $65m in Manufacturing Expansion

Mayne Pharma plans to double oral-dose manufacturing space and expand contract services.

Novo Nordisk Unveils Plans to Boost Manufacturing Capacity in North Carolina and Denmark

Novo Nordisk plans to invest approximately $2 billion over the next five years in new production facilities in Clayton, North Carolina, US and Måløv, Denmark. The facilities are expected to be operational during 2020.

Shire to Add Manufacturing Capacity for Cinryze

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

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

Worldwide Pharmaceutical Meetings—A Place for Sharing

Worldwide, meetings take place for several reasons, such as to share new findings, learn about novel technologies, discuss international issues, exchange know-hows, and network, to name a few. While each of these reasons has its significant importance, what really matters in scientific inquiry is progress.

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.

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