Reinvention is essential for pharma and biotech companies. Promising molecules fail, clinical hypotheses often don't pan out and patents (eventually) expire.
Successful drugmakers are able to refill pipelines and replace aging blockbusters with new therapies. Past approaches may no longer serve, however — a realization increasingly apparent amid signs of falling R&D productivity and fierce criticism of rising drug prices.
This year in particular has underscored the changes facing the industry's business model, some of which are reflected in our top ten stories for 2018 below.
Drugmakers will enter next year still seeking a solution to resolve the tension between the remarkable technologies developed in recent years with a system built for the therapies of the past century.
We don't promise to have an answer, but perhaps you'll find some inspiration in the following sampling of BioPharma Dive's top stories:
Memorial Sloan Kettering scandal raises questions for pharma's biggest corporate boards
A review of corporate board membership found about two-thirds of the largest drugmakers had at least one director who also had a leadership role in a nonprofit healthcare organization. Read More >>
CAR-T ups challenges in pharma supply chain
New technology made it viable to ship the cell therapies. Now, stakeholders are pushing for more innovation to meet looming commercial demands. Read More >>
Oncology boom spurs DTC advertising, and with it controversy
As the debate for and against direct-to-consumer advertising rages on, cancer drugmakers look poised to pump massive amounts of money into the practice. Read More >>
NASH drugs come into focus as field awaits late-stage data
A second wave of NASH-focused biotechs has emerged behind the four drugmakers currently out in front. Next year will prove a major test. Read More >>
FDA confronts its limits in push on drug pricing
Legally, regulating prices is outside of the FDA's purview. But that hasn't stopped Scott Gottlieb from taking a more vocal approach to the hot-button issue than past FDA chiefs. Read More >>
Seeking to adopt AI, drugmakers search for right mix of talent
AI holds promise as a powerful new tool in the hunt for new drugs. Yet building a team that blends tried-and-true methods with AI remains a challenge. Read More >>
Red pill or blue? It could be a billion-dollar decision
Viagra and Nexium underscore how marketers and manufacturers can use color to make a drug franchise more successful. Read More >>
FDA's Woodcock: 'The clinical trial system is broken'
The CDER director said the current system doesn't serve the interests of patients and noted support for trials capable of answering multiple clinical questions at once. Read More >>
Amgen, Sandoz begin biosimilar trial with top-selling Enbrel at stake
In the still unsettled biosimilar market, the result could hold far-reaching consequences. "You are going to start hearing about this," one top Wall Street analyst predicted. Read More >>
Pharma's slow embrace of continuous manufacturing
On the whole, drugmakers remain wedded to traditional production methods that have served for decades. Some, however, are shifting to newer technology. Read More >>