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PharmTech Europe
9 May 2017

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Top Stories

FDA Warns 14 Companies for Sale of Fraudulent Cancer Treatments

The agency has issued more than 90 warning letters over the past 10 years to companies selling fraudulent cancer treatments.
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United BioPharma Selects GE Healthcare's FlexFactory for Manufacturing Facility in Taiwan

UBP will build a single-use FlexFactory in Taiwan to add capacity for monoclonal antibody treatments.
/ read more /


Transforming Regulatory Data Management

The Identification of Medicinal Products (IDMP) standards requires regulatory teams to efficiently collate data from multiple sources and functions.
/ read more /

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Industry News

Spanish Pharma Market Set to Hit $25 Billion by 2021, Says GlobalData

The pharmaceutical market in Spain is showing signs of stability according to a report by GlobalData.
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Reducing ANDA Approval Timeframes Can Lower Drug Costs, CPhI Expert Says

CPhI expert, Girish Malhotra believes drug costs could be lower if approval timeframes can be cut from 10 to three months.
/ read more /


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Regulatory News

EMA and EU Member States Begin Brexit Discussions

The agency met with EU National Competent Authorities to begin making plans for the distribution of workload because of the UK's departure from the EU.
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Combination Products Raise New Manufacturing Challenges

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.
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Bio/Pharma News

Fresenius Kabi Acquires Merck KGaA's Biosimilars Business and US-Based Akorn

With two acquisitions, German company Fresenius Kabi enters biosimilars market and expands in US.
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FDA Approves Radius Health's Tymlos to Treat Osteoporosis

The drug is approved to treat postmenopausal women with osteoporosis and is the first anabolic bone building agent approved in the US in approximately 15 years.
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Supplier News

EAG Laboratories Expands Cell Bioassay Laboratory

New incubators, instrumentation, and staff will increase cell bioassay capabilities for EAG Laboratories.
/ read more /

Avid Bioservices Adds Single-Use Bioreactors to Expand Manufacturing in California

MilliporeSigma's Mobius 2000-L single-use bioreactors will allow Avid Bioservices to meet increased demand for clinical and commercial manufacturing services at its Myford, CA facility.
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FEATURED TOPICS

FORMULATION

Alternative Routes for Delivering Macromolecules

Transdermal and inhaled/nasal delivery provide alternative routes of administration for macromolecules.
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API SYNTHESIS & MANUFACTURING

Catalysis, Flow Chemistry Impact API Manufacturing

Advances in chemical synthesis are enabling greener, more cost-efficient processes for API manufacturing.
/ read more /

OUTSOURCING

CMOs and CROs Have Different Trajectories

CMOs may be gaining as strategic partners to large bio/pharma companies, but they have a much harder path to navigate.
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PEER-REVIEWED RESEARCH

Comparison of Permitted Daily Exposure with 0.001 Minimal Daily Dose for Cleaning Validation

The authors investigated the relationship between the 0.001 MinDD and the PDE values for 140 drug substances as an attempt to identify high-risk groups of products for patient safety.
/ read more /


Product Profiles

IMA S.p.A. - Active division

CROMA
IMA is world leader in the design and manufacture of automatic machines and complete lines for the processing and packaging of pharmaceutical products.
/ Read more/

Shimadzu

Insights on molecular level
Shimadzu's iMScope TRIO* revolutionary technology combines an optical microscope together with a mass spectrometer. It is applied to cutting-edge R&D and identifies what users see at the molecular level. / Read more/


UPCOMING WEBCASTS

A Complete Guide to USP <232> & <233> Pharmaceutical Elemental Impurities – Implementing Pharmaceutical Elemental Impurity Sample Preparation and Analysis
Live Webcast: Wednesday, May 10 at 11:00am EDT
Register now


Best Practices for Extractables and Leachables Testing for Primary Drug Product Packaging
Live Webcast: Wednesday, May 24 at 11:00am EDT and Wednesday, May 31 at 11:00am CEST
Register now


ON DEMAND WEBCAST

A Complete Guide to USP <232> & <233> Pharmaceutical Elemental Impurities – Understanding Pharmaceutical Elemental Impurity Regulations and Laboratory Considerations
On Demand
Learn more


Events

CPhI North Amercia

Philadelphia, United States

16–18 May 2017

Pharmaceutical Sciences World Congress

Stockholm, Sweden

21–24 May 2017


more events

Reference Library

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.
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More Reference BookS

eBOOKS

Quality Throughout the Supply Chain

Quality issues can appear at any stage of the bio/pharmaceutical development and manufacturing supply chain. Drug companies must monitor raw materials, suppliers, contract service providers, facilities, manufacturing processes, and production workers. In this e-book, the editors examine current quality issues, and how the industry is addressing quality challenges throughout the supply chain.

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