Breaking News on Contract Research, Manufacturing & Clinical Trials

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Merck & Co. contracts Catalent to make sublingual hayfever drugs

MSD has selected Catalent to manufacture two recently approved sublingual pollen extract drugs using its Zydis formulation platform.

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News in brief

Hospira has announced US recalls for seven lots of its propofol injection and one lot of 1% Lidocaine HCI Injection due to a glass contamination.

As the European Medicines Agency (EMA) announces final consultations on its clinical trial data policy will begin at the start of May, we take a look at the issues surrounding trial transparency in Europe.

CRO Quintiles has signed a five-year agreement to use OmniComm Systems' technology for Phase I clinic automation. 

Global Industry News

Quality of Life shown in robust Q1 for Thermo Fisher from BioPharma-Reporter.com

Q1 revenues for Thermo Fisher’s Life Sciences Solutions business shot up 384% year-over-year in a quarter that saw the integration of Life Technologies.

Epirus hopes to bring its infliximab biosimilar to EU in merger with Zalicus from BioPharma-Reporter.com

Epirus and Zalicus have agreed to merge in order to focus on the development and manufacture of biosimilars.

UK generics makers and MHRA pool manufacturing knowledge from in-PharmaTechnologist.com

The British Generic Manufacturers Association (BGMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) will launch a forum for the generics industry to discuss manufacturing and quality issues.

US FDA offers guidance on when two mAbs should be considered the same from BioPharma-Reporter.com

As the race to develop mAbs (monocolonal antibodies) heats up and companies vie for the elusive seven years exclusivity that comes with an orphan drug designation, the US FDA is now offering guidance on when two mAbs should be viewed as the same.

Novartis scoops GSK’s oncology portfolio, trades away its vaccine division from in-PharmaTechnologist.com

Novartis has agreed to acquire GlaxoSmithKline’s oncology pipeline for as much as $16bn, while GSK will acquire Novartis’ vaccine business, excluding the flu vaccines, for as much as $7bn.

INFOGRAPHIC

AZ for $100bn? Pfizer could buy Azerbaijan and keep the change from in-PharmaTechnologist.com

With Pfizer rumoured to be on the brink of a mega-merger with AstraZeneca, in-Pharmatechnologist.com brings you an interactive view of what £60bn ($101bn) could get.

Spotlight

CROs to 'push' patients into trials using partners, report predicts

CROs to 'push' patients into trials using partners, report predicts

Patient recruitment is “the major bottleneck” in clinical development, an Industry Standard Research report says, but though it predicts...

EU law: public database for trial transparency

EU law: public database for trial transparency

Companies running clinical trials will have to use an online portal to stay on the right side...

Always on my mind or return to vendor? CRO models discussed in Vegas

Always on my mind or return to vendor? CRO models discussed in Vegas

Big Pharma's split opinion on the best way to work with a CRO was in evidence in...

Quality and IP issues driving sponsors away from Indian CMOs, experts say

Quality and IP issues driving sponsors away from Indian CMOs, experts say

Quality and IP issues are driving firms back to the US and Europe for their contract manufacturing...

CROs debate: Can surrogate endpoints speed oncology drugs to market?

CROs debate: Can surrogate endpoints speed oncology drugs to market?

As biopharma companies look to develop cancer therapies more quickly, some are turning to CROs with the...

Consolidation prevalent in industry, says third largest CMO
Dispatches from interphex

Consolidation prevalent in industry, says third largest CMO

Brad Carlson

VP Marketing 7 Sales, Aenova

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