China's Investigator-Initiated Pathway (IIT) could help accelerated biotech development, but it needs to be approach judiciously. The IIT model allows some early cell and gene therapy studies to begin through hospitals and academic investigators, rather than always starting through the full drug-registration pathway. The Upside - Faster human PoC- Quicker enrollment- More clinician-led exploratio- Earlier … Continue reading Chinaβs Alternative Regulatory Path for Biotech: Faster Learning, Fragile Trust
Public Health Evidence: Strong Enough to Act, Not Clean Enough to Reassure
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
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
Lilly Acquires 4E Tx – Adds to Non-Opioid Pain Management Assets
Eli Lilly acquired 4E Therapeutics this week for an undisclosed amount. 4E Therapeutics is based on Austin, TX, and is dedicated to developing innovative and novel treatments for neuropathic pain. 4E Therapeutics Pipeline CandidateIndicationDevelopment Stage4ET1103Neuropathic PainPhase I4ET2124Migraine PainIND EnablingMNK-EIF4EAcute PainDiscovery Lilly previously paid cash for SiteOne Therapeutics, a South-San-Francisco company developing potent and selective non-opioid … Continue reading Lilly Acquires 4E Tx – Adds to Non-Opioid Pain Management Assets
A Molecule and a Dream: But is it Operational?
What makes a promising scientific asset truly fundable is whether it is operational, whether the path from milestone to milestone is robust. Signs of a Reliable Investment (Image Creation - ChatGPT) Designing Biotech Financial Models for Series B Success from WorldPharmaToday reframes what gets scrutinized in biotech financial models. Here are the key takeaways - … Continue reading A Molecule and a Dream: But is it Operational?
Lilly acquires Ajax Therapeutics for $2.3B cash
Eli Lilly is acquiring Ajax Therapeutics by paying up to $2.3B cash, composed of an upfront and milestone payments. Image Credit: ChatGPT
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
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
BK talks Biopharm 