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BIO 2016

Commissioner Califf commits to tackling staffing issues at US FDA

Automated systems and reducing hiring time will be crucial in revamping the US FDA’s “antiquated” HR systems, says Commissioner Robert Califf.

India to rewrite 75-year old drug laws with an eye on business, biologics and devices

India has withdrawn a proposed amendment to its drug laws after deciding a more extensive rewrite is needed to allow the effective regulation of biologics, regenerative medicines and clinical trials.

Biogen in negotiations to sell 2,000L stainless steel plant in MA

Biogen will shutter a bioproduction facility in Massachusetts by the end of the year if it fails to find a buyer.

Opko extended-release kidney disease drug approved after Catalent 483 delay

The US FDA has approved Opko Health’s kidney disease drug Rayaldee, delayed by almost three months due to manufacturing concerns at its CMO Catalent.

update

Three drug wholesalers have failed GDP checks according to Czech regulator

Czech regulators say three drug wholesalers have “seriously violated” good distribution practices (GDP) guidelines.

AMRI licenses Teewinot's cannabinoid analytical standard production tech

AMRI has licensed technology needed to make an analytical standard drug firms working with cannabinoids can use for research and quality control.

Juniper invests in tablet technology for UK site

Juniper Pharma Services has invested in a tablet press that can produce 42,000 pills an hour citing customers’ clinical trial supply needs as the driver.

Collegium's OxyContin rival is first drug using Deterx anti-abuse tech launched in US

Collegium Pharmaceutical has launched the first product formulated using its Deterx anti-abuse technology in the US.

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