Pharmaceutical Technology ePT Weekly
Having trouble viewing this e-mail? CLICK HERE
PharmTech
January 26, 2017
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD

In this issue

Data Integrity Problems at Japan Facility

GSK Makes Staff Changes

New Drug Approvals Dip in 2016

Top Stories

Reproducibility Project only Partially Able to Validate Findings of Prominent Cancer Studies

Researchers were not able to replicate all of the findings in five highly-cited cancer biology papers.
/ read more /


FDA Clarifies How It Handles 180-Day Exclusivity

A new document discusses the exclusivity period for authorized generics, but does not tackle the issue of pay-for-delay agreements.
/ read more /

Subscribe

Subscribers can enjoy each full issue of Pharm Tech in print, or via Pharm Tech apps.

subscription offers
subscribe

PODCAST

Laura Bo, advertising and communication manager, Indena S.p.A. discusses the company's Centella asiatica project in Madagascar, the winner of the 2016 CPhI Pharma Award for Corporate Social Responsibility.

WATCH NOW

advertisement

Connect with top suppliers to the pharma and medical device industry at PACK EXPO East in Philadelphia, February 27 to March 1, 2017. You'll discover new solutions for enhancing safety, security and quality from 400 exhibitors. Explore 100,000 nsf of packaging innovations and machinery in action. Exchange ideas with 7,000 peers. And gain insights from the Healthcare Packaging and Processing Conference.
Register today at packexpoeast.com!


Industry News

Pharma Manufacturers Say Supply Chain Stakeholders Now Getting a Bigger Cut

A new report says that failure to account for rebates, discounts, and price concessions leads to an "overstatement of payments realized by manufacturers" in most annual industry drug spend reports.
/ read more /


Data Integrity Problems Found at Japan Facility

FDA cites Sato Yakuhin Kogyo Co., Ltd. with data integrity violations after a June 2016 inspection of its Kashihara City facility.
/ read more /


More Industry News

Supplier News

EAG Laboratories Adds Capabilities in Dermal Absorption Testing

EAG Laboratories offers dermal absorption studies using OECD methods.
/ read more /


Bedrocan's Netherlands Facility Becomes GMP Compliant

The medical cannabis producer has become compliant with EMA's GMP standards.
/ read more /


More Supplier News

advertisement

Pharmaceutical Technology's PharmaMarketplace
Your Connection to Global Pharmaceutical Manufacturing Suppliers
Check it out today!


Bio/Pharma News

Axim Biotechnologies Begins Clinical Trials with CBD Chewing Gum

The company will begin trials with its CBD chewing gum, CanChew Plus, for the treatment of irritable bowel syndrome.
/ read more /


GSK Makes Staff Changes to Global Pharmaceuticals Division

Luke Miels will replace Abbas Hussain as president of GSK's Global Pharmaceutical division later this year.
/ read more /


More Bio/Pharma News

Regulatory News

Report: FDA New Drug Approvals Dip in 2016

A new report from HBM Partners said FDA new molecular entity approvals have dropped to 19 in 2016 from 45 in 2015.
/ read more /


Conditional Marketing Authorization Has Positive Impact in Europe

A study by EMA shows that drugs that received conditional marketing authorization gave patients earlier access to needed medications.
/ read more /


More Regulatory News

FEATURED TOPICS

GLOBAL REPORT

Global Drug Spending: A Look Ahead

Estimates that global medicine spending will reach nearly $1.5 trillion by 2021 and the types of therapies and use of innovator versus generic drugs, will vary by region.
/ read more /

OUTSOURCING

The Tide Stays High

Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.
/ read more /

QUALITY

Drug Quality Key to Innovation and Access

FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
/ read more /

API SYNTHESIS & MANUFACTURING

FDA New Drug Approvals Down Significantly in 2016

As of mid-December, less than half the number of new drug approvals were issued by FDA in 2016 compared with 2015.
/ read more /


On Demand WEBCASTS

Orally Disintegrating Tablets: A Patient-centric Dosage Form
On Demand
Learn more


From Bench to Clinic: Preclinical and First-in-Man Development Strategies
On Demand
Learn more


Events

Pharmapack Europe

February 1–2, 2017

IFPAC Annual Meeting

February 27–March 2, 2017

Pittcon 2017

March 5–9, 2017

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.
/ Click here /

More Reference Library

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.


contribute | contact editors | CONTACT SALES | subscribe | advertise