The Trump ef­fect: PwC re­port says the FDA has slammed the brakes on sig­nif­i­cant new drug reg­u­la­tions

Don­ald Trump launched his pres­i­den­cy breath­ing fire on fed­er­al reg­u­la­tions. And the top of­fi­cials at the FDA heard that call loud and clear.

Scott Got­tlieb

A new re­port out from Price­wa­ter­house­C­oop­ers shows that the agency reined in its is­suance of new fed­er­al reg­u­la­tions to a 20-year low in 2017, as the Scott Got­tlieb stepped up to the helm as com­mis­sion­er.

In­stead, the agency has shift­ed to new guid­ances in pref­er­ence to hard­line reg­u­la­tions, says PwC. And that will like­ly come as a wel­come em­pha­sis in the bio­phar­ma in­dus­try, where we’ve seen the FDA re­peat­ed­ly demon­strate its will­ing­ness to re­lax old stan­dards to ac­cel­er­ate new drug de­vel­op­ment.

Over the 4-year run of the Oba­ma ad­min­is­tra­tion, says the re­port, the agency is­sued 132 “eco­nom­i­cal­ly sig­nif­i­cant” reg­u­la­tions for the in­dus­try as a whole — an av­er­age of 33 per year. Un­der Trump and Got­tlieb, that dropped to a low of just 6.

And while the num­ber of new drug ap­provals has soared to a record high, with 53 new ap­provals — a com­bi­na­tion of bi­o­log­ics and new chem­i­cal en­ti­ties — PwC sees the FDA large­ly stay­ing the course on in­dus­try over­sight, in­spec­tions and en­force­ment.

For the phar­ma­ceu­ti­cal in­dus­try, the FDA un­der Got­tlieb’s tenure has been pre­dictable, sta­ble and con­sis­tent, al­low­ing com­pa­nies to con­tin­ue in­vest­ments in­to drug re­search and de­vel­op­ment and ex­ist­ing com­pli­ance pro­grams with­out fear of a ma­jor change in reg­u­la­to­ry ap­proach. While Got­tlieb’s reg­u­la­to­ry phi­los­o­phy is per­haps more in­dus­try-friend­ly than past FDA com­mis­sion­ers, the agency’s broad­er ap­proach from en­force­ment to ap­provals has not been an abrupt de­par­ture from ex­ist­ing trends and norms.

A few oth­er high­lights:

  • Or­phan drug ap­provals rock­et­ed to a new high, with 64 new ap­provals in 2017, un­der­scor­ing a trend dri­ven by small­er clin­i­cal tri­als and steep prices for new roll­outs re­strict­ed to tiny pa­tient pop­u­la­tions.
  • Da­ta in­tegri­ty re­mains a key con­cern. And reg­u­la­tors re­main vig­i­lant about is­su­ing qual­i­ty re­lat­ed warn­ing let­ters.

Will the agency’s move to brake new reg­u­la­tions last through 2018?

Per­haps not, says the PwC re­port. A look at his­tor­i­cal trends show a dra­mat­ic in­crease in the sec­ond year of the George W Bush ad­min­is­tra­tion, with a more mod­est 15.4% in­crease in the sec­ond year of the Oba­ma ad­min­is­tra­tion. And their an­a­lysts flagged a list of sig­nif­i­cant new regs now un­der de­vel­op­ment at the FDA that could have a big im­pact on bio­phar­ma com­pa­nies.

As we re­port­ed re­cent­ly, Scott Got­tlieb and the FDA are held in high re­gard by drug de­vel­op­ers. And the PwC group found that there’s still a big push on for fur­ther eas­ing FDA stan­dards for ap­proval, as well as clin­i­cal and pre­clin­i­cal reg­u­la­tions.

Im­age: Pres­i­dent Don­ald Trump speaks with re­porters in No­vem­ber, 2017. Shut­ter­stock. Charts: PWC

Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a big plan to ex­pand its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 60,200+ biopharma pros reading Endpoints daily — and it's free.

Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.