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Regulatory & Safety: Top Headlines

News in brief

Manufacturers concede on price as drug spending increases

02-May-2016 - Specialty medicine innovation is driving growth, yet advances are being offset by price concessions from manufacturers, according to IMS Health.

Biotrinity 2016

Biopharma 'future is better in Europe,' says UK life science minister

27-Apr-2016 - Britain’s minister for life sciences has called on the country’s £60bn pharma sector to rally together in support of remaining in the European Union.

Controlled substances: fewer CMOs, more regulations

26-Apr-2016 - The manufacture of controlled substances has faced increased scrutiny over the years, and as such, fewer CMOs are in the market.

Almac Group launches new serialization solution

26-Apr-2016 - Almac Group has expanded its serialization capabilities to include its US commercial packaging facility in Audubon, PA.

George Freeman: New meds and delivery methods a regulatory challenge

26-Apr-2016 - George Freeman spoke about #Brexit and the challenge new medicines pose for existing regulatory systems at #Biotrinity2016 in London, UK.

WHO says Semler Research manipulated data and warns repeat studies may needed

25-Apr-2016 - The WHO has accused Semler Research of data fraud and said Mylan, Micro Labs, Lupin and Strides and others may need to repeat bioanalytical trials conducted by the CRO.

Brexit bad for biosimilar developers says new industry group

22-Apr-2016 - Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).

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