BC Innovations | Sep 19, 2019
Translation in Brief

Public funding highlights

Public funding highlights Selected developments and initiatives in 2Q19 from major sources of public funding including National Institutes of Health (NIH), the U.K.’s Medical Research Council (MRC), the Innovative Medicines Initiative (IMI), the Canadian Institutes...
BioCentury | Sep 19, 2019
Product Development

Industry seeks ICH revisions to curb influx of irrelevant pharmacovigilance data

The mounds of post-market safety data now being generated through social media and other non-traditional data sources are overwhelming regulators and often hindering pharmacovigilance, not improving it. Industry groups have proposed updates to ICH guidelines...
BC Extra | Apr 11, 2019
Politics & Policy

Regulatory reprieve with Brexit delay

An EU-granted extension for Brexit means short-term clarity for biopharma companies expecting EMA or European Commission decisions before the new Oct. 31 deadline. The U.K. had been scheduled to leave the union Friday. At least...
BC Extra | Mar 22, 2019
Politics & Policy

Brexit delay offers biopharma more time to prepare for a no-deal

Although Europe remains at risk of a drug supply disruption in the event of a no-deal Brexit, Thursday's extension means more time for British biopharma companies to get drug applications approved, and for the U.K....
BC Extra | Jan 15, 2019
Politics & Policy

Pharma group calls for medicines exemptions after U.K. Brexit vote

Biopharma groups reiterated that a no-deal Brexit constitutes a real threat to patient safety and public health after the House of Commons' decisive vote against the Withdrawal Agreement for the U.K.'s exit from the EU....
BC Extra | Nov 19, 2018
Politics & Policy

U.K. groups push for explicit language on medicines regulation post-Brexit

U.K. health and pharma groups are asking their country and the EU to explicitly make cooperation on medicine safety and regulation a priority in the final version of the Political Declaration . The U.K.-EU relationship framework...
BC Extra | Jun 29, 2018
Politics & Policy

No U.K. life sciences deal after EU council meeting

With the EU Council's June meeting now completed, the Association of the British Pharmaceutical Industry (ABPI) and the U.K.'s BioIndustry Association (BIA) said there is still no agreement on a deal for life sciences trade...
BC Innovations | May 17, 2018
Finance

Europe’s piece of the pie

With China’s rising infrastructure for life science innovation and the unabated growth of U.S. science, Europe has two cards to play that can help it compete globally: expertise in key core technologies and its centralized...
BC Extra | May 4, 2018
Politics & Policy

EC proposes to increase research budget

The European Commission outlined its Horizon Europe research and innovation proposal for 2021-27 on Wednesday, which includes a budget increase to €97.9 billion ($118 billion). The €18 billion (23%) increase over the current Horizon 2020...
BioCentury | Apr 27, 2018
Regulation

Independent opportunities

The scenario the U.K. is trying to avoid is a full disconnect from EMA when the Brexit curtain falls. But a clean break from the agency could create opportunities for the U.K.’s Medicines and Healthcare...
Items per page:
1 - 10 of 134
BC Innovations | Sep 19, 2019
Translation in Brief

Public funding highlights

Public funding highlights Selected developments and initiatives in 2Q19 from major sources of public funding including National Institutes of Health (NIH), the U.K.’s Medical Research Council (MRC), the Innovative Medicines Initiative (IMI), the Canadian Institutes...
BioCentury | Sep 19, 2019
Product Development

Industry seeks ICH revisions to curb influx of irrelevant pharmacovigilance data

The mounds of post-market safety data now being generated through social media and other non-traditional data sources are overwhelming regulators and often hindering pharmacovigilance, not improving it. Industry groups have proposed updates to ICH guidelines...
BC Extra | Apr 11, 2019
Politics & Policy

Regulatory reprieve with Brexit delay

An EU-granted extension for Brexit means short-term clarity for biopharma companies expecting EMA or European Commission decisions before the new Oct. 31 deadline. The U.K. had been scheduled to leave the union Friday. At least...
BC Extra | Mar 22, 2019
Politics & Policy

Brexit delay offers biopharma more time to prepare for a no-deal

Although Europe remains at risk of a drug supply disruption in the event of a no-deal Brexit, Thursday's extension means more time for British biopharma companies to get drug applications approved, and for the U.K....
BC Extra | Jan 15, 2019
Politics & Policy

Pharma group calls for medicines exemptions after U.K. Brexit vote

Biopharma groups reiterated that a no-deal Brexit constitutes a real threat to patient safety and public health after the House of Commons' decisive vote against the Withdrawal Agreement for the U.K.'s exit from the EU....
BC Extra | Nov 19, 2018
Politics & Policy

U.K. groups push for explicit language on medicines regulation post-Brexit

U.K. health and pharma groups are asking their country and the EU to explicitly make cooperation on medicine safety and regulation a priority in the final version of the Political Declaration . The U.K.-EU relationship framework...
BC Extra | Jun 29, 2018
Politics & Policy

No U.K. life sciences deal after EU council meeting

With the EU Council's June meeting now completed, the Association of the British Pharmaceutical Industry (ABPI) and the U.K.'s BioIndustry Association (BIA) said there is still no agreement on a deal for life sciences trade...
BC Innovations | May 17, 2018
Finance

Europe’s piece of the pie

With China’s rising infrastructure for life science innovation and the unabated growth of U.S. science, Europe has two cards to play that can help it compete globally: expertise in key core technologies and its centralized...
BC Extra | May 4, 2018
Politics & Policy

EC proposes to increase research budget

The European Commission outlined its Horizon Europe research and innovation proposal for 2021-27 on Wednesday, which includes a budget increase to €97.9 billion ($118 billion). The €18 billion (23%) increase over the current Horizon 2020...
BioCentury | Apr 27, 2018
Regulation

Independent opportunities

The scenario the U.K. is trying to avoid is a full disconnect from EMA when the Brexit curtain falls. But a clean break from the agency could create opportunities for the U.K.’s Medicines and Healthcare...
Items per page:
1 - 10 of 134