Biotech CEOs often express surprise when the FDA rejects their drugs. But collaborative interactions between regulators and drug sponsors count for little if the latter fail to adjust their clinical and regulatory efforts accordingly.

The era of follow-on medicinal chemistry has largely been eliminated by more comprehensive patent protection. Nowadays, investors trade on the differences in safety and efficacy for similar molecules.

A drastic risk-off pullback in the public market can close an IPO window while private biotechs aspiring for either a public debut or an acquisition by big pharma may be stymied by their stale valuations.

Oncology drug sales plummeted during the pandemic leading to a backlog of untreated patients that lingered even after the impact of COVID-19 drugs. While Q2 reports suggest this cancer backlog is now being addressed, the contrasting fates of vaccines and treatments for SARS-CoV-2 are actually turning out to be opaquer than expected. 

When a loss-making rare disease biotech company’s product takes on Pfizer in the same indication but without the benefit of superior data, pharmaceutical marketing lessons will be learnt.

Pfizer recorded the largest quarterly sales in its history as its COVID-19 franchise easily outweighed the currency issues that are challenging other companies. But expectations for a quick end to the pandemic have wiped these gains from Pfizer’s stock price.

Roche’s stock price has underperformed in the last nine months in spite of a natural hedge on the strong US dollar that has troubled most other profitable pharma companies. Has Roche become a value stock?

Among equity investors there is concern about the impact of macroeconomic headwinds on second-quarter earnings. The first two big life sciences companies’ reports did nothing to alleviate those concerns.

Antibody-drug conjugates have come a long way in two decades but pricing, defined target expression levels, toxicity and possibly the competition may defuse recent fireworks.

Even with higher interest rates, some debt on the balance sheets of profitable biotechs is healthy. However, among loss-making biotechs and in the current environment, raising new debt has unhealthy connotations.

Most of the money raised by biotech companies to address chronic hepatitis B has resulted in failed programs. But wait, a glimmer of light from yonder pharma breaks.

It takes a lot of negotiation with regulators, advisory boards, and alignment between commercial and portfolio management teams to define and agree a clinical trial protocol. Why on earth would companies change it once a study is underway?