Pharmaceutical Technology ePT Weekly
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PharmTech
April 05, 2018
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In this issue:

CoAs Help Secure the Supply Chain

Takeda Confirms Interest in Acquiring Shire

Annex 1 Misses the Mark–Expanded Version


Top Stories

Pfizer Transfers CAR-T Assets to Allogene

Pfizer transfers CAR-T assets to Allogene Therapeutics under a new alliance to further develop immuno-oncology therapeutics.
/ read more /


FDA Gives Update on Benefit-Risk Assessment Program

The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.
/ read more /


INTERPHEX 2018 Keynote Series

Aseptic, Sterile, and Biologics Drug Manufacturing
Industry experts will discuss lyophilization best practices and continuous manufacturing for biopharmaceuticals.


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Industry News

Publication Brings Analytical Science to Cannabis Industry

A new scientific publication examines analytical processes for the emerging legal cannabis industry.
/ read more /


Budget Bill Boosts Funding for Biomedical Research and FDA Programs

Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.
/ read more /


More Industry News

Supplier News

MedPharm Receives Investment from Ampersand Capital Partners

MedPharm has received a multi-million dollar investment by Ampersand Capital Partners to diversify its service offering and regional coverage.
/ read more /


Trutag Technologies Adds New Smart Laminate and Business Unit

The company has developed an intelligent laminate for supply chain security and traceability in addition to a new business unit that develops intelligent hyperspectral imaging solutions.
/ read more /


More Supplier News
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Bio/Pharma News

Takeda Confirms Interest in Acquiring Shire

Takeda is considering approaching Shire with a possible offer.
/ read more /


Novartis Gets Positive EMA Opinion on Biosimilar to J&J’s Remicade

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.
/ read more /


More Bio/Pharma News

Regulatory News

FDA Grants Priority Review to AstraZeneca's Leukemia Biologic

The agency has accepted AstraZeneca's biologics license application for an investigational leukemia drug candidate and granted it priority review.
/ read more /


Amgen, Allergan Score Positive EMA Opinion on Biosimilar to Roche’s Herceptin

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).
/ read more /


More Regulatory News

FEATURED TOPICS

DRUG DELIVERY

Future Therapies Using Implanted Engineered Cells as Protein Factories

Afibromer protein factories represent a flexible and programmable alternative to gene therapies.
/ read more /

QC/QA

Annex 1 Misses the Mark–Expanded Version

A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.
/ read more /

DRUG DEVELOPMENT

Bridging the Gap from Molecule to Drug

Formulation expertise can smooth the transition of a prospective therapy from medicinal chemistry to drug dosage form.
/ read more /

STANDARDS & REGULATIONS

CoAs Help Secure the Supply Chain

Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
/ 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
Learn more


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

INTERPHEX

April 17–19, 2018

CPhI North America

April 24–26, 2018

BIO International Convention

June 4–7, 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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