The Cyclospora outbreak's latest evidentiary tension: On July 19, the FDA stated that a previously reported Cyclospora result π΄π©π°πΆππ₯ π£π¦ π€π°π―π΄πͺπ₯π¦π³π¦π₯ π’ π§π’ππ΄π¦ π±π°π΄πͺπ΅πͺπ·π¦. This prompts an understandable corporation relief and a renewed skepticism about statements from regulatory agencies. Note: the FDA is still telling consumers, restaurants, and retailers not to touch the recalled lettuce. … Continue reading Public Health Evidence: Strong Enough to Act, Not Clean Enough to Reassure
News & Opinion
Manufacturing is now a Biopharma Strategy
Making a great product once is a magic trick. The product becomes real only when you can make it reliably, over and over again. For the longest time, manufacturing in biopharma was treated like the person in the group project who actually did the work but never made it to the title slide. Discovery got … Continue reading Manufacturing is now a Biopharma Strategy
Is Today’s Biotech Investment Borrowing Growth from the Future?Β
As capital has become more selective, investors have understandably gravitated toward later-stage, de-risked assets. Pharmaceutical companies have responded by allocating more capital toward licensing and acquisitions of those assets because of their higher probability of success, shorter development timelines, and more predictable returns. That is a rational investment strategy for an individual company. Whether it … Continue reading Is Today’s Biotech Investment Borrowing Growth from the Future?Β
Big Pharma Bets for the Next Decade
Follow the spending 2025 R&D Expenditure against 2025 Revenue and 2024 Expenditure Reference: Top 10 pharma R&D budgets in 2025
Geopolitics and Monetary Policy: Why Big Pharma Should Wait & See
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 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 