Pharmaceutical Technology ePT Weekly
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PharmTech
March 29, 2018
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In this issue:

Improving Operations in the Lab

Challenges in Bioprocesses Development

Helsinn to Acquire Rights to Skin Cancer Drug


Top Stories

When One Therapy No Longer Fits All

New therapies and tighter budgets challenge bio/pharma to think outside the industry.
/ read more /


GSK Buys Out Novartis’ Share of OTC Business

In a $13-billion transaction, GSK will purchase Novartis' share of the Consumer Healthcare Joint Venture.
/ read more /

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INTERPHEX 2018 Keynote Series

Data Integrity Educational Sessions
Experts at INTERPHEX 2018 will discuss regulatory requirements for data integrity and best practices for data integrity and process security.


LEARN MORE
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Industry News

bioLIVE to Launch Global Biopharma Country Ranking

Major countries will be ranked based on the potential for biopharma market growth, innovation, and competitiveness.
/ read more /


FDA Publishes Compounding Guidance on the Evaluation of Bulk Drug Substances

The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
/ read more /


More Industry News

Supplier News

Thermo Fisher Expands Clinical Distribution in Europe

An expanded pharma services supply chain facility in Germany boosts Thermo Fisher’s Pharma Services footprint in Europe.
/ read more /


Recipharm Completes Blow-Fill-Seal Expansion at Kaysersberg Facility

The CDMO’s new blow-fill-seal machinery at its Kaysersberg site is now operational.
/ read more /


More Supplier News

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BIO International Convention
BIO International Convention is back in Boston, June 4-7, to celebrate history-making innovation. This is the only event where you can access the global biotech and pharma community via Partnering, attend 150 education sessions and network with 16,000+ attendees from 74 countries. Discover the next generation of cutting-edge products, therapies, and cures at events all week long at BIO 2018. Learn more at convention.bio.org.


Bio/Pharma News

Helsinn to Acquire Rights to Skin Cancer Drug

Helsinn will acquire the global rights to Valchlor/Ledaga (mechlorethamine/chlormethine) from Actelion Pharmaceuticals.
/ read more /


Hitachi to Manufacture Regenerative Medicines

Hitachi will manufacture regenerative medicines developed by Daiichi Sankyo and SanBio Group.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Warns of the Potential of Contamination at API Facility

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited for CGMP violations that include the presence of vermin.
/ read more /


EMA Recommends Two Biosimilars, One Orphan Drug, for Approval

The agency's Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.
/ read more /


More Regulatory News

FEATURED TOPICS

ANALYTICS

Improving Operations in the Lab

New and emerging products advance bio/pharma laboratory operations.
/ read more /

OUTSOURCING

Challenges in Bioprocesses Development

Development and adoption of new technologies create challenges that may take years to resolve.
/ read more /

MANUFACTURING

Best Practices for Testing Foreign Particulate Matter in Inhaled Products

Lower costs, fewer opportunities for temperature excursions, and a smaller carbon footprint are making ocean transport more attractive for pharmaceuticals. Poseidon, a new collaborative pharma initiative, seeks to leverage benefits.
/ read more /

FORMULATION

FDA: Early Stage Drug Development Costs Trigger Higher Drug Costs

Drug companies must consider all factors impacting the cost of drugs, including high costs of early development stages.
/ read more /


UPCOMING WEBCASTS

Improve Data Transparency and Collaboration Across your Manufacturing Network
Wednesday, April 25 at 10:00am EDT
Register now


Dose Design: Bridging Early- and Late-Phase Development
Live Webcast: Tuesday, April 24 at 11:00am EDT
Register now


Streamlined Manufacture of Modified Release Matrix Tablets via Direct Compression
Live Webcast: April 10 at 11:00am EDT
Register now


ON DEMAND WEBCASTS

Best Practices for Spray-Dried Dispersion Formulation Selection and Early Development
On Demand
Learn more


Real-Time Process Control for Healthy, High-Purity Water Systems
On Demand
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Successfully Progressing Therapeutic Candidates from Discovery to Development Using Early Developability Assessment Tools
On Demand
Learn more


Top Quality Trends for 2018: Pharma Quality Survey Report
On Demand
Learn more

Events

World Vaccine Congress Washington 2018

April 2–5, 2018

INTERPHEX

April 17–19, 2018

CPhI North America

April 24–26, 2018


more events

eBOOKS

Vaccines Development and Manufacturing 2017

Vaccines—from childhood and influenza immunizations, to epidemic prevention, to cancer and therapeutic treatments—present unique development challenges. In this Vaccine and Manufacturing eBook, the editors explore development and manufacturing options to make vaccines more accessible.

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