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PharmTech Europe
31 January 2017

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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.
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Cellectis Describes Novel CAR-T Design in New Paper

Researchers from Cellectis investigate how external signals in the tumor microenvironment could control the cell-surface expression and specificity of engineered CARs.
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J&J to Acquire Actelion for $30 billion

The companies will split Actelion's drug discovery and early-stage clinical development assets into a new Swiss biopharmaceutical company.
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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.

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Industry News

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.
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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.
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Regulatory News

FDA Gives UK Facility Warning Letter

The agency finds repeated CGMP violations at Porton Biopharma, Limited.
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FDA Moves Forward with Inspection Overhaul

FDA's Office of Regional Affairs aims to implement Program Alignment initiative by May 15, 2017.
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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.
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Merck Settles Litigation with Bristol-Myers Squibb on Use of Antibody Targeting PD-1

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.
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Supplier News

Bedrocan's Netherlands Facility Becomes GMP Compliant

The medical cannabis producer has become compliant with EMA's GMP standards.
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WuXi AppTec Acquires HD Biosciences

WuXi AppTec acquired HD Biosciences, a preclinical drug-discovery-focused CRO.
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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.
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QUALITY

Drug Quality Key to Innovation and Access

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

The Tide Stays High

Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.
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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.
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Product/Service Profile

Aptar Pharma

Pharmapack Booth N° F7
Aptar Pharma will showcase eDose Counter for MDIs integrating a proprietary sensing technology, at the Pharmapack Europe conference to be held in Paris, France on February 1-2, 2017.
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SCHOTT AG, Germany

SCHOTT Vials DC
A new series of studies has demonstrated the effectiveness of SCHOTT Vials Delamination Controlled (DC), which can replace existing packaging solutions without re-registration and offers higher product security.
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UPCOMING WEBCAST

Around the World in Clinical Trials: New Regulations and Country Specific Challenges
Live Webinar: Tuesday, February 28 at 11:00am EST
Register now


Events

Pharmapack Europe

1–2 February, 2017

Sartorius Research Xchange Forum 2017

22–23 February, 2017

CPhI Istanbul

8–10 March, 2017


more events

Reference Library

Pharmaceutical Technology Outsourcing Guide

Pharmaceutical Technology Outsourcing Guide provides details behind recent partnerships, strategies for selecting an appropriate CDMO/CMO, and quality by design factors for outsourced operations.
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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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