Interviews
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A selection of in-depth interviews and profiles of policymakers and industry executives.
How The EU & UK’s Contrasting Approaches To AI Regulation Could Impact Pharma
While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.
‘A Maze Of Rules’: EFPIA On EU’s Proposed Health Data Sharing Law
While some progress has been made in strengthening the proposed European Health Data Space during legislative negotiations, further amendments must be made to protect trade secrets and avoid fragmentation, pharma industry federation EFPIA says.
EMA’s Cancer ‘Pathfinder’ Project Targets Conditional Approvals, Endpoints & RWE
This second of a two-part article on the EU’s “Cancer Medicines Pathfinder” initiative looks at the trade-off between the benefits and risks of conditional drug approvals and differing perceptions of progression-free survival as a validated endpoint in cancer drug trials.
Blue Shield Of California’s Pharmacy Benefit Overhaul Could Still See Boost From Transparency Legislation
The payor’s multiyear plan to ditch the traditional PBM model and use multiple vendors has drawn a lot of skepticism from other actors in the health care system, but Blue Shield is hoping that it can help give policymakers some momentum, VP Lum tells the Pink Sheet.
EU Rare Disease Policy Needs To Help Revive Abandoned Candidates & Repurpose Existing Drugs
The EU must adopt a more comprehensive policy on rare diseases to increase the number of orphan drugs and address access challenges, says EURORDIS’ chief executive Yann Le Cam.
‘We Did Too Good Of A Job’ On Lowering Prices: Sandoz’s Haruvi Discusses Generic Sustainability
As Hatch-Waxman celebrates its 40th anniversary, the chair of the US generic trade association talks about striking the right balance on supply and pricing, preventing shortages, and improving Medicare price negotiations.
Creating A ‘Critical Mass’: Outgoing EURORDIS Chief On 25 Years Of EU Orphan Disease Policy
As Yann Le Cam prepares to step down from his role as leader of the EU network of rare disease patient organizations, EURORDIS, he reflects on the organization’s role in almost three decades of major changes to Europe’s orphan disease and drug policy.
Pazdur On Accelerated Approval: FDA Needs To Explain Why It Does Not Always Seek Withdrawal When Trials Fail
Knee-jerk reaction when a confirmatory trial fails is that the drug should be withdrawn, but the agency must undertake a more nuanced evaluation and do a better job explaining it to the public, OCE Director Richard Pazdur says; Pazdur and Project Confirm lead Gautam Mehta spoke with the Pink Sheet about dangling indications, FDORA reforms and the withdrawal process.
Confirmatory Trials: Flexibility In Timing Hinges On Accelerated Approval Indication Size – FDA’s Marks
CBER director suggests more flexibility on confirmatory study timing is warranted for accelerated approvals in rare diseases and even in some more common scenarios such as infectious disease outbreaks, although a ‘relatively stronger approach’ will apply to most large indications.
Janet Woodcock Retires From US FDA: ‘I’m Trying To Tie Up All The Loose Ends’
On the eve of departure after more than 37 years of service to FDA, the agency’s principal deputy commissioner discusses her legacy, issues that others will take up, and preparing the agency for change in a Pink Sheet interview.
Bluebird’s Fast Lyfgenia Launch Was A Year And A Half In The Making; Medicaid Talks Continuing
When Zynteglo was approved for beta-thalassemia, bluebird said launch would lay groundwork for sickle cell gene therapy Lyfgenia. The strategy is paying off so far with a fast ramp-up. Outcomes-based contracts for Lyfgenia give payers rebate based on hospitalizations over a three-year period.
ICER’s New President On What She Wants From Industry – And From Medicare Price Negotiations
In an interview, Sarah Emond talks about why she is ‘worried’ about cell and gene therapy, when ICER might revise its assessment of obesity drugs, and how CMS could build a reliable and transparent Medicare price negotiation program.
How The EU’s Landmark AI Act Could Impact The Pharma Industry
With the EU’s AI Act set to enter into force early this year, a life sciences lawyer tells the Pink Sheet how pharmaceutical firms could be affected by the landmark legislation in areas such as clinical trial recruitment and drug dose personalization.
From Supply Chain To Value Chain: OPPI’s Matai On Moving ‘Up’ Amidst Winds Of Policy Change In India
Incoming director general of the Organisation of Pharmaceutical Producers of India discusses the evolving policy and regulatory landscape in India in areas such as R&D and quality. Stricter adherence to ethical marketing practices could be focus in the coming year, Anil Matai adds.
ICMRA Chief On The Future Of Regulatory Collaboration & The Move Towards Convergence
Artificial intelligence, real world evidence and point of care manufacturing are top priorities for the International Coalition of Medicines Regulatory Authorities, says the coalition’s chair, Emer Cooke.
Departing Teva Exec Issues Warnings On Popular Shortage Solutions
Before leaving her role as US generics COO, Christine Baeder discussed paying for quality, generic confidence, redundancy and predicting shortages in a Pink Sheet interview.
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