Pharmaceutical Technology ePT Weekly
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PharmTech
June 16, 2016
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

in this issue

CPhI Istanbul Discusses MENA Trends
Merck to Acquire Afferent Pharmaceuticals
FDA Finalizes Compounding Guidance

Top Stories

New Aggressive Treatment Shown to Halt Symptoms of Multiple Sclerosis for a Prolonged Period

Results of a Phase II clinical trial reveal that stem-cell transplantation treatment following complete immune system destruction increases the duration of long-term remission in patients with multiple sclerosis.
/ read more /


US and EU Regulators Seek to Reduce Pharma Inspections

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.
/ read more /


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Industry News

Results Released from Ixekizumab Phase III Trials

In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.
/ read more /


CPhI Istanbul Discusses MENA Trends for 2016

At the conference, industry experts discussed regional trends and challenges for the Middle East and North Africa for 2016.
/ read more /


More Industry News

EXPERT INTERVIEW

Pharmaceutical Technology sat down with Mike Valazza, vice-president of business development at Catalent Pharma Solutions, to discuss modified-release formulations.

WATCH NOW

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Supplier News

GE Healthcare Sells Rights for Inactivated Yellow Fever Vaccine to PnuVax

The inactivated vaccine, manufactured with a GE FlexFactory system, could be associated with fewer adverse reactions than the live vaccine option.
/ read more /


Enable Injections Completes its High-Volume Injector Manufacturing Facility

The wearable devices for the delivery of biologic products are now being manufactured and will be tested in clinical trials in the near future, according to the company.
/ read more /


More Supplier News

Bio/Pharma News

Merck to Acquire Afferent Pharmaceuticals

Merck will acquire Afferent Pharmaceuticals for $500 million in cash with the potential for additional payments.
/ read more /


Alvotech Opens mAbs Biosimilar Facility in Iceland

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.
/ read more /


More Bio/Pharma News
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Regulatory News

FDA Finalizes Compounding Guidance

The agency publishes three final guidance documents on drug compounding.
/ read more /


 

FDA Approves Cholera Vaccine

FDA approved Vaxchora intended for travelers who are at risk for the disease.
/ read more /


More Regulatory News
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For the past 25 years, the PDA/FDA Joint Regulatory Conference has provided an exclusive forum in which to hear directly from FDA speakers regarding current Agency efforts that could potentially impact the development of global regulatory strategies. Take advantage of a level of direct exchange with the FDA not found at any other conference.
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FEATURED TOPICS

MANUFACTURING

Indian Pharma Is Committed to the Future, Says Biocon Managing Director

Investment in talent and infrastructure, more quality-by-design skills, and increased communication with global regulators will be needed to combat compliance issues at API and drug manufacturing facilities in India.
/ read more /

ANALYTICS

Improving Pharma Systems with Process Analytical Technology

Pharmaceutical Technology spoke with Melissa Topp, director of Global Marketing at ICONICS, about the latest in process analytical technology (PAT).
/ read more /

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Compliance is Key Solutions to Decrease the Likelihood of Receiving a Form 483
LIVE WEBCAST: Thursday, June 23, 2016 at 11:00 am EDT
Free registration



FORMULATION

Customizing HPMC to Minimize Drug Variability

The authors evaluated the performance and robustness of controlled-release tablets made with HPMC blends of unimodal and bimodal molecular weight distribution.
/ read more /

API SYNTHESIS & MANUFACTURING

Steps Closer to the Adoption of Continuous Processing

Application of flow chemistry for small-molecule API synthesis continues to expand thanks to research efforts.
/ read more /

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Bio/Pharma in China
New Initiatives, New Opportunities

On Demand
Read more



Webcasts

Development Partners for Biopharma: Are you Getting What You Need?

On Demand

Your current contract laboratory and instrument provider may be familiar and comfortable, but, maintaining the status quo doesn't lead to greater rewards. In fact, it often involves putting up with less-than-desired results. Join us in this web seminar to hear how Ajinomoto Althea develops unsurpassed solutions for biopharma companies, and how a team at Thermo Fisher Scientific has challenged the status quo to deliver uncompromised UHPLC.
Sponsored by Thermo Fisher Scientific

Engineering the Mechanical Properties of Amorphous Spray-Dried Dispersions

On Demand
Capsugel Dosage Form Solutions will present a webinar discussing the aspect of engineering spray-dried dispersion properties, with a particular emphasis on the impact of atomization and drying rate on powder mechanical properties.

Sponsored by Capsugel

more webcasts

Events

MES 2016

August 10-11, 2016

Data Integrity Conference

August 17-18, 2016

PDA/FDA Joint Regulatory Conference

September 12-14, 2016

more events

REFERENCE BOOKS

Pharmaceutical Technology Solid Dosage Combo

Increase your knowledge of solid dosage technology and solid dose tablet manufacturing processes. These comprehensive pharmacology reference guides cover a variety of solid-dosage form principles such as oral solid-dosage forms, powders, mixing and blending, excipients, tableting, and coating. Drug delivery system manufacturing professionals can use the solid dosage manufacturing books to stay current with compressed tablet manufacturing processes, solid dosage processing equipment, tablet-pressing processes, and pharmaceutical industry trends in oral solid dosage manufacturing and solid dosage form development.
/ Learn more /

More Reference Library

eBOOKS

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.


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