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Breaking News on Global Pharmaceutical Technology & Manufacturing

Regulatory & Safety: Top Headlines

Sagent shifts production in-house after US FDA concerns about CMO Emcure

Sagent takes manufacturing in-house

25-Feb-2015 - Problems at Emcure Pharmaceutical have prompted US customer Sagent Pharmaceuticals to recall two lots of a muscle relaxant made by the CMO and take production in-house.

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News in brief

People on the Move

Who's on the move in pharma?

25-Feb-2015 - Our round-up of the latest people news in big and small pharma - from Bayer to biotech's most recent start-up.

Transcelerate teams to take on investigator selection bias

24-Feb-2015 - A register of clinical investigators can help eliminate bias according to Big Pharma Group Transcelerate, which has teamed with DrugDev to develop such a database.

EMA calls for industry involvement in applying new ISO standards to drugs

23-Feb-2015 - The EMA wants help applying new ID and information standards to medicines sold in Europe and has asked drugmakers to join its implementation taskforce.

Celltrion: Remsima could save UK, Italy and France $336m in five years

20-Feb-2015 - Celltrion has emphasised the savings Remsima ((inflizimab) could offer as partner Napp Pharmaceuticals prepares to extend the roll out of the Remicade biosimilar to the UK. 

Sanofi: deals like Lead Pharma accord not a replacement for in-house R&D

18-Feb-2015 - Sanofi has partnered with Dutch biotechnology spin-out Lead Pharma to discover autoimmune drugs that target ROR gamma t hormone receptors.

More US FDA draft guidance for compounders

16-Feb-2015 - The US FDA has proposed more new rules for compounders three years after a deadly meningitis outbreak was linked to unsafe manufacturing practices at a pharmacy in Massachusetts.

update

Switzerland rejects allegations it offers drug fakers easy route to the EU

12-Feb-2015 - The increase in dodgy erectile dysfunction drugs seized in Switzerland does not mean the country is a weak point for counterfeiters shipping to Europe according to Swissmedic.

Regulatory & Safety: Featured news

Spotlight

Third time's a charm: Pfizer to buy Hospira for $17bn
breaking news

Third time's a charm: Pfizer to buy Hospira for $17bn

Pfizer has entered into a definitive merger agreement to buy Hospira for $17bn.

Vertellus buys antiretroviral API reagent plant from Dow

Vertellus buys antiretroviral API reagent plant from Dow

Specialty chemicals firm Vertellus will continue to supply antiretroviral drugmakers sodium borohydride following its takeover of a...

ScinoPharm: profits fall on higher costs, an idle plant and lower Qsymia sales

ScinoPharm: profits fall on higher costs, an idle plant and lower Qsymia sales

ScinoPharm was hurt by weak US demand for the weight loss pill Qsymia, higher raw material prices...

Analyst: Pfizer's withdrawal from Repligen deal "not smart" amid growing Big Pharma interest in SMA

Analyst: Pfizer's withdrawal from Repligen deal "not smart" amid growing Big Pharma interest in SMA

Pfizer must act fast to convince investors it can compete with Roche and Biogen Idec for a...

MUGAS-funded Tamiflu analysis included fewer studies than Cochrane review

MUGAS-funded Tamiflu analysis included fewer studies than Cochrane review

Researchers claiming Tamiflu cuts flu symptom duration and hospitalisations analysed less than half as many studies as...

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