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Analysis and opinion covers key topic areas such as:
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From next year, owners of trademarks and other rights in the European Economic Area will be able to prevent the parallel export of medicines from the UK to the EEA. But those owning similar rights in the UK will not be able to stop parallel imports from EEA countries.
Topic EU Pharma-Brexit Brexit
Pink Sheet
England’s health technology appraisal body, NICE, and the UK medicines regulator, the MHRA, are working together to align their process timelines so that access to medicines is “maintained and enhanced.”
Topic Brexit Pharma-Brexit EU
Pink Sheet
Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.
Topic Pharma-Brexit Brexit
Pink Sheet
With still no guarantee of what kind of access the UK will have to the EU’s all-important Article 57 database after the Brexit transition period ends, drug companies will have to provide key information about their pharmacovigilance systems directly to the UK medicines regulator.
Topic Pharma-Brexit Safety Brexit
Pink Sheet
The UK medicines regulator has written to pharmaceutical companies outlining the actions they need to take regarding products with a centralized EU approval that will be converted to Great Britain marketing authorizations next year.
Topic Pharma-Brexit Brexit Approvals
Pink Sheet
Regardless of the outcomes of the US elections, drug pricing is likely to take a back seat to COVID as policy focus. But the pandemic does offer pharma an opportunity for partnerships with payers on health outcomes. Commonwealth Fund’s Liz Fowler, South Capitol’s John O’Brien and ICER’s Steve Pearson discuss where drug pricing stands in public opinion, whether policies embraced by President Trump will have staying power, and the conditions needed in the policy environment for major change.
Pink Sheet
A Biden Administration with near-term priorities other than drug pricing and a Republican-controlled Senate dedicated to blocking any legislation that would enact government price controls is a relatively positive outcome for industry
Topic US Election 2020 Drug Pricing
Pink Sheet
Given the ongoing election challenges in the US, China has yet to officially congratulate Joe Biden as the next US president, although many world leaders are already hailing a reset in US foreign policy. Many are wondering if this and other moves indicate a quiet internal shift for China's high tech and life sciences sectors, just days after Beijing concluded a high-level plenary meeting outlining its priorities for the next five years.
Topic US Election 2020 China
Pink Sheet
Two prominent former US FDA officials are a part of the president-elect’s new COVID-19 advisory board. Biden’s emphasis on scientific independence, including a commitment to publicly release vaccine trial data, could help restore public confidence in the agency and coming COVID-19 vaccines.
Topic US Election 2020 Coronavirus FDA
Pink Sheet
Following a Brexit-induced delay over the summer, England's HTA body NICE has come up with a concrete set of proposals that it says will help it “robustly and efficiently” evaluate innovative technologies such as advanced therapies, histology-independent cancer treatments, and technologies for rare diseases. Industry bodies have welcomed the plans, which have just been put out for consultation.
Pink Sheet
Committee members rebuked FDA for its positive review of Biogen’s Alzheimer’s disease drug, objecting to its ‘terrifically one-sided’ analysis of data, the short shrift given the contrary conclusions of its own statistician, and its interpretation of a dosing study to support the sole positive Phase III study.
Pink Sheet
Germany uses government facilitated price negotiations between publicly funded insurers and manufacturers that are based on an independent assessment of how much added value a drug provides.
Topic US Election 2020 Drug Pricing
Pink Sheet
Commissioners vote 3-2 that Mylan and Pfizer’s Upjohn can combine after divesting seven products; dissenting votes focus on price fixing allegations as commissioners Chopra and Slaughter criticize majority for not addressing government’s case against Pfizer and Mylan. Former FTC attorneys note that if Biden wins the presidential election, he could nominate one of the dissenters to FTC chair and give more traction to their views.
Topic US Election 2020 M A Legal Issues
Pink Sheet
Master the nuances of accelerated approval processes for the US and Europe with coverage from Pink Sheet. Go inside the competitive landscape to learn which drugs are benefitting from such programs – and which are not. Pink Sheet delivers the insider’s view of European fast-track programs like PRIME – plus updates on US FDA expedited reviewal processes – you can use to inform your own regulatory strategy.
Topic Policy & Regulation
Pink Sheet
EUA request for COVID-19 vaccine is unlikely before late November; the CEO’s frequent comments that the timetable isn’t politically motivated are unusual to say the least
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