FDA’s OPDP untitled letters show rising scrutiny of DTC ads’ overall impression on consumers and urge companies to balance ...

FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster.

As emerging biotechs scale, procurement is becoming a key lever for patient access, resilience, and long-term commercial ...

Drug and device manufacturers have long sought clearer rules for sharing scientific information about unapproved (off-label) uses of their products with health care providers (“HCPs”). In January 2025 ...

Speed alone no longer guarantees success; here’s what matters most in today’s launch environment. In today’s launch environment, order of entry (OOE) isn’t destiny. Many brands still anchor strategy ...

In the increasingly complex world of artificial intelligence (AI), the concept of "correct outcomes" takes on a profound and sometimes ambiguous meaning. Although efforts are made to create AI that ...

Recently, there has been heightened focus on dual brand approaches in which the same molecule is approved for multiple indications and packaged, priced, and distributed under different brand names.

GLP-1s didn’t just change how patients lose weight. They changed how pharma must sell. GLP-1 receptor agonists were supposed to be a diabetes treatment. Instead, they became the first pharmaceutical ...

Achieving regulatory approval for a new drug is an extraordinary achievement. The bar for success is high. Many companies with breakthrough scientific discoveries and promising clinical data still ...

Spinning off a $4 billion biopharma business is no easy task. Integrated functions need to be separated, governance boards created, leadership teams assembled, and corporate headquarters established.

As the fentanyl epidemic rages on, opioid antagonist rescue agents like Narcan, Kloxxado, and Opvee have become omnipresent. Like defibrillators and EpiPens, advocates insist they should be available ...

Biotech has entered a new era of financial discipline. The days of easy capital, billion-dollar preclinical valuations, and “platform first, data later” investing have largely disappeared. Today, ...