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

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.

FDA over­rides ad­comm opin­ions a fifth of the time, study finds — but why?

For drugmakers, FDA advisory panels are often an apprehended barometer of regulators’ final decisions. While the experts’ endorsement or criticism often translate directly to final outcomes, the FDA sometimes stun observers by diverging from recommendations.

A new paper out of Milbank Quarterly put a number on that trend by analyzing 376 voting meetings and subsequent actions from 2008 through 2015, confirming the general impression that regulators tend to agree with the adcomms most of the time — with discordances in only 22% of the cases.

Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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John McHutchison in 2012. Getty Images

The $1.1M good­bye: Gilead CSO John McHutchi­son is out as Daniel O’Day shakes up the se­nior team

Just a little more than a year after John McHutchison grabbed a promotion to become CSO at Gilead in the wake of Norbert Bischofberger’s exit, he’s out amid a shakeup of the senior team that is also triggering the departure of two other top execs.

Gilead stated that McHutchison “has decided to step down” from the job as of August 2nd. And their SEC filing notes that he’ll be getting a $1.1 million check to settle up on his contract.

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Thomas Gajewski, David Steinberg. (CRI, Pyxis)

Bay­er, Long­wood back star re­searcher's deep dive in­to the tu­mor mi­croen­vi­ron­ment for new I/O tar­gets

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”