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

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 ...

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, ...

Smart money will find good ideas, and if you follow the money in biotech these days, that means looking to China. From January to mid-May 2025, Chinese biotechnology companies had announced licensing ...

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.

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 ...

Biotechnology is all about scientific breakthroughs that lead to transformative therapies. But despite billions invested and years of R&D, data from Deloitte found that more than half of drug launches ...

Individualized genetic medicine is moving faster than the traditional drug approval model was built to handle. Genome editing, RNA-based medicines, and other targeted therapies can now be designed for ...

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 pharmaceutical manufacturers grow, they often pursue external sources of innovation to supplement their own R&D efforts. A recent study found that 45% of drugs in the pipelines of 20 large ...

Last October, the American Association of Pharmaceutical Scientists (AAPS) released its annual salary survey, which measures the earnings of individuals working in pharmaceutical sciences in the U.S., ...