Global Tensions as a Backdrop Uncertainty, not Inflation may direct the Fed's next move. As global markets react to ripples from the Iran conflict, the Fed is expected to keep current interest rates steady. Traditional economic signals are harder to interpret in the wake of geopolitical shocks; reflexive decision making can do more harm than … Continue reading Geopolitics and Monetary Policy: Why Big Pharma Should Wait & See
biotech
Insidious CMC Risks in Regulatory Filings
As the FDA notes, many IND delays can be tied to CMC challenges. Quite often, warning signs are visible - analytical methods that are good enough but hard to scale- process steps that rely on the skills of an operator or one site- issues on stability or delivery that are shelved into future work.Such considerations … Continue reading Insidious CMC Risks in Regulatory Filings
Biotech Sector, Investor confidence, Cautious optimism
After being stagnant since 2022, the Biotech sector now shows renewed growth. Biotech ETF (XBI) has outperformed the S&P 500. So, perhaps it's time for cautious optimism for investors, acquirers, and innovators. Quiet Comeback Biotech ETF has grown 5% in the last month compared to the 0.2% growth of the S&P 500. This might not … Continue reading Biotech Sector, Investor confidence, Cautious optimism
FDA approvals in just 60 days?
The FDA has launched the Commissioner's National Priority Voucher (CNPV) program, offering 1-2 month reviews, so drug developers can get faster market access for products that align with national priorities. Some examples could be:1. Strengthening US employment in development & manufacturing2. Ensuring that clinical trials have robust US patient population3. Affordability of drug products by … Continue reading FDA approvals in just 60 days?
BK talks Biopharm 