End­points as­sess­es the big bio­phar­ma sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

 Pres­i­dent Don­ald J. Trump

Whether you love Trump or hate him, and you’ll find few peo­ple in be­tween those two sen­ti­ments, he’s made a huge im­pact on the bio­phar­ma world in the first few days as pres­i­dent. In many ways, it’s been a tox­ic af­fair right from the start.

First, Trump man­aged to raise quite a few bio­phar­ma hack­les with his ear­ly ex­ec­u­tive or­der ban­ning trav­el from 7 pre­dom­i­nant­ly Mus­lim coun­tries. True, none of these coun­tries are like­ly to reg­is­ter as big play­ers in sci­ence and drug de­vel­op­ment. But a poll of our read­ers, along with in­di­vid­ual com­ments from a large slate of ex­ec­u­tives, un­veiled a clear fear on the part of many green card hold­ers that their world could be turned up­side down in a heart­beat.

Fear and un­cer­tain­ty do not mix well with a fun­da­men­tal de­sire to re­cruit the best staff glob­al­ly.

The in­dus­try re­sponse to our sur­vey was ex­tra­or­di­nary, with 87% of more than 1,400 ex­ecs voic­ing their dis­ap­proval. That’s a big thumbs down from biotech.

  You say you want a rev­o­lu­tion?

Then came Trump’s sit-down with some very ap­pre­cia­tive phar­ma CEOs will­ing to nod their ap­proval as the pres­i­dent blast­ed the FDA and promised a whole­sale re­vi­sion of the reg­u­la­tions re­gard­ing drug de­vel­op­ment. No doubt, many crit­ics would have liked to have seen some de­fi­ance. The phar­ma ex­ecs, though, were on a lob­by­ing mis­sion. What they want, clear­ly, is to lim­it Trump’s ap­petite for slash­ing drug prices while gain­ing swift and im­me­di­ate tax re­lief, fat­ten­ing mar­gins and re­gain­ing bil­lions held over­seas for im­me­di­ate repa­tri­a­tion.

That’s all part of their job de­scrip­tion, so you shouldn’t act sur­prised when they go to DC to help make the sale.

As a group of biotech ex­ecs made crys­tal clear to me, though, FDA “re­form” isn’t need­ed or want­ed. Yes, there are con­tin­u­ing ef­forts to stream­line the reg­u­la­to­ry side of the busi­ness in PDU­FA VI, but leg­is­la­tion over the last few years has dra­mat­i­cal­ly al­tered many de­vel­op­ment time­lines. Trump’s loud protests to the con­trary, he’s ad­vo­cat­ing a rad­i­cal re­vi­sion at a time the in­dus­try is quite hap­py with where it is.

Re­form is a cov­er for sim­ply low­er­ing reg­u­la­to­ry stan­dards dra­mat­i­cal­ly. Once you do that, as just about any biotech CEO will tell you, you will cor­rupt a process that has be­come the gold stan­dard for the world. With­out an ob­jec­tive de­ci­sion that a drug’s ben­e­fits out­weigh ever present risks, you have chaos. And no one in this busi­ness with any in­tegri­ty wants to pit their good drugs against a tidal wave of fake cures that can be sold cheap.

 About those phar­ma jobs…

Trump likes to talk about bring­ing over­seas jobs back to the US. And the phar­ma rep­re­sen­ta­tives he met with were quick to oblige with some promis­es of their own. But Trump went look­ing for new jobs in the wrong place. Big Phar­ma has been zeal­ous in hold­ing the line on em­ploy­ment, which has fre­quent­ly called for sig­nif­i­cant cuts in the US.

As a quick re­view of the num­bers re­vealed, Eli Lil­ly, Mer­ck, Am­gen and oth­ers are bet­ter at cut­ting jobs than they are at adding them. And noth­ing Trump does or says is go­ing to get any­one re­al­ly en­thu­si­as­tic about putting the ax aside. Yes, we’ll get some lip ser­vice about man­u­fac­tur­ing and so on, but the new jobs in this in­dus­try are com­ing from biotech com­pa­nies, not Big Phar­ma.

Maybe that’s some­thing the pres­i­dent should think about be­fore he sets out to “help.”

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.