Pharmaceutical Technology ePT Weekly
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PharmTech
March 8, 2018
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In this issue:

Avoiding Complete Response Letters

Hospira Recalls Hydromorphone HCl Injection

Colorcon Restores Manufacturing Operations in Puerto Rico

Top Stories

AstraZeneca to Create Independent Biotech Spin-Off

The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.
/ read more /


Prime Minister Wants UK to Remain Part of EMA After Brexit

The government is exploring terms by which the UK could still be part of EMA after its departure from the EU, Theresa May said in a key speech on Brexit.
/ read more /

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Industry News

Hospira Recalls Hydromorphone HCl Injection

The company is recalling three lots of Hydromorphone HCl Injection USP CII 10 mg/mL, 1 mL in 2 mL Single Dose Vials because of possibly empty or cracked vials.
/ read more /


JLL Publishes Report on Trends Shaping the Labs of the Future

JLL, a real estate and investment management firm, recently released a new report on three trends shaping labs for the future of life sciences R&D.
/ read more /


More Industry News

Supplier News

Catalent Expands Clinical Supply Capabilities

Catalent completes $4.6 million expansion at Singapore clinical supply facility and marks 20 years in the region.
/ read more /


Colorcon Restores Manufacturing Operations in Puerto Rico

With minimal damage to its manufacturing plant in Humacao, Puerto Rico, Colorcon has been able to restore full operations.
/ read more /


More Supplier News
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Bio/Pharma News

Novartis, Pear to Develop Digital Therapeutics

The companies will work together to develop prescription digital therapeutics for patients with schizophrenia and multiple sclerosis.
/ read more /


Gilead’s Kite, Sangamo Partner on Cell Therapies

The companies will join forces to develop next-generation ex vivo cell therapies in oncology.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Approves New HIV Treatment

The agency has approved a new HIV treatment for patients with "limited treatment options".
/ read more /


Tackling Medicine Shortages in Europe

The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.
/ read more /


More Regulatory News
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The 2018 PDA Annual Meeting will deliver the same high-quality content attendees expect in a NEW meeting format that starts on Monday afternoon. Delve into the future of bio/pharmaceutical manufacturing with the latest updates on the end user/patient perspective, innovative manufacturing strategies, and disruptive technologies. The industry's increased use of big data, artificial intelligence, and robotics will also be explored. Learn more and register today!

FEATURED TOPICS

Outsourcing

Outsourcing: Does Focus Pay Off?

Research suggests that working with a single contract partner can reduce development time and improve economics.
/ read more /

Analytics

Reducing Development Timelines and Costs

Joe DiMasi, director of economic analysis and research associate professor, Tufts Center for the Study of Drug Development (CSDD), discussed research into the impacts of working with single source contractors with Pharmaceutical Technology.
/ read more /


Standards & Regulations

Avoiding Complete Response Letters

CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.
/ read more /

Manufacturing

Considerations for Seals in Split Butterfly Valves

Materials used in the seals of split butterfly valves for aseptic pharmaceutical manufacturing should be chosen carefully.
/ read more /


UPCOMING WEBCASTS

Best Practices for Spray-Dried Dispersion Formulation Selection and Early Development
Live Webcast: Wednesday, March 28 at 11:00EST
Register now


Real-Time Process Control for Healthy, High-Purity Water Systems
Live Webcast: Thursday, March 15 at 11:00am EDT
Register now


Successfully Progressing Therapeutic Candidates from Discovery to Development Using Early Developability Assessment Tools
Live Webcast: Wednesday, March 14 at 11:00am EDT
Register now


ON DEMAND WEBCASTS

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


Assessing Product Integrity Risk Profiles and Engineering On-Dose Authentication During Drug Development Process
On Demand
Learn more


Events

BIO-Europe Spring 2018

March 12–14, 2018

9th Global Drug Delivery & Formulation Summit

March 12–14, 2018

Making Pharmaceuticals Europe 2018

March 13–14, 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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