Interviews
While both the US and Europe have similar regulatory approaches to advanced therapy manufacturing, it is easier for patients in the US to access “out-of-specification” treatments if they have no other options, a biotech expert says.
Clinigen's CEO and senior executives outline how the services company navigated Japan’s rigorous regulatory framework to secure approval for Prolacta’s human milk–based fortifier as a prescription biological product.
Parexel’s CEO Peyton Howell and India chief Sanjay Vyas talk to the Pink Sheet about clinical trials amid global turmoil, the slowdown in big pharma decision-making and pivot in some cases to the FSP outsourcing model, evolving DCT definitions and India opportunities.
EU regulators must strive to balance scientific rigor with “common sense” when it comes to advanced therapy medicinal products, particularly for patients with no other treatment options, Immatics’ chief medical officer tells the Pink Sheet.
NextGate Partner’s Jay Byun gives a mixed review of South Korea’s recent biopharma policy measures, saying providing government support to all cycles of R&D may lower efficiency.
Data from virtual, artificial intelligence-based labs can help guide the clinical development pathway for pharmaceutical companies. But regulatory involvement will be key to assessing whether a virtual model is accurate, the CEO of Turbine Labs tells the Pink Sheet.
Pharma firms are keen to ensure that artificial intelligence tools used in the earlier stages of drug discovery are excluded from the “onerous scope” of the EU’s AI Act, as this could “defeat” the benefits of using this technology, says Clifford Chance’s Stephen Reese.
If the EU’s controversial Artificial Intelligence Act applies restrictive rules to pharmaceutical research and development activities, the UK could benefit from offering a more favorable regulatory environment, top lawyer Stephen Reese explains.
Using artificial intelligence in drug discovery and development could have huge benefits for companies, but a key challenge will be addressing how data is used to train AI tools and managing intellectual property issues, says Clifford Chance’s Stephen Reese.
Pink Sheet interviews with ex-FDA leaders and agency experts offer guidance for drug developers navigating an agency playing by a different and ever-shifting rulebook.
India’s moves on digital data protection don’t pose a hurdle to patient recruitment, but on the wish list of global innovators is permission for first-in-human (FIH) trials and removal of certain commercialization requirements, says Parexel’s India head
Alternatives to animal testing can replace lengthy, resource-intensive studies for drug developers, helping to lower costs for companies, but a lack of regulatory global alignment can be a barrier to reducing animal testing, an expert says.
The UK medicines regulator, the MHRA, and England’s health technology appraisal (HTA) body, NICE, spoke to the Pink Sheet about the new pathway that aligns the HTA and regulatory processes to cut the time it takes to bring medicines to market.
FDA’s proposed easing of biosimilar pathways is a mixed blessing for CROs even as it, along with tariff threats and funding scarcity, has led to paused clinical studies. Parexel’s India head talks about keeping up with the regulation and other AI-led changes in this interview.
Flu vaccines are specifically mentioned in the CBER director's internal email, but all new and some older vaccines seem to be affected. The impact on development programs is unclear.
While there is a general shift towards alignment and collaboration in health technology assessments in the EU under the new HTA Regulation, member states still have “their own recipe” when it comes to making reimbursement decisions.
While the volume of questions that companies have received from the EU member states under the Health Technology Assessment Regulation has been lower than expected, some firms are struggling with the comparator analysis required to answer some questions, an expert says.
Association for Accessible Medicines CEO John Murphy told the Pink Sheet that the FDA may need to consider phasing in the requirements for the new ANDA priority voucher incentive program if it wants sponsors to apply in the near-term.
In this second of a two-part series, Clifford Chance partner and life sciences legal expert Gunnar Sachs explains how the upcoming EU Biotech Act could place extra strain on SMEs due to overlap with other regulations and how to mitigate this through careful planning.
While industry awaits specific details on the EU Biotech Act, Clifford Chance partner and life sciences legal expert Gunnar Sachs explains the key aims of the new legislation and discusses the potential benefits for biotech firms.