'Right-to-try' bill fails to muster votes, dies in the House (for now)

The con­tro­ver­sial right-to-try bill, a di­vi­sive piece of leg­is­la­tion that would have giv­en ter­mi­nal­ly ill pa­tients ac­cess to ex­per­i­men­tal drugs with­out FDA au­tho­riza­tion, was re­ject­ed by the House Tues­day af­ter fail­ing to get enough back­ers for the vote.

Greg Walden

The bill died on a vote of 259 to 140, short of the nec­es­sary two-thirds sup­port from the cham­ber.

The vote came af­ter a con­tentious de­bate among law­mak­ers and bio­phar­ma alike, cen­ter­ing on the ap­pro­pri­ate bal­ance be­tween a pa­tient’s free­dom of choice and the reg­u­la­to­ry over­sight need­ed for that pa­tient’s safe­ty.

The mea­sure, strong­ly backed by Pres­i­dent Don­ald Trump and VP Mike Pence, was por­trayed by GOP law­mak­ers as a last chance at sur­vival for ter­mi­nal­ly ill pa­tients. De­moc­rats op­pos­ing the bill said it weak­ened FDA pro­tec­tions with­out do­ing much good for ad­dress­ing the re­al ob­sta­cles to ex­per­i­men­tal drugs.

Bio­phar­ma will like­ly have mixed re­ac­tions to the news, as a re­cent End­points sur­vey re­vealed our au­di­ence was rather split on the mat­ter. As of Feb­ru­ary, near­ly 58% of our read­ers dis­ap­proved of right-to-try, while 42% ap­proved of the leg­is­la­tion.

In our sur­vey, those who ap­proved of the bill shared over­whelm­ing­ly con­sis­tent rea­son­ing. Most con­veyed com­pas­sion for ter­mi­nal­ly ill pa­tients who are out of oth­er op­tions for treat­ment.

“(They) should be al­lowed to try a treat­ment or ther­a­py if they think it will ex­tend their life,” said one anony­mous com­menter. “Why should we leg­is­late treat­ments? Shouldn’t some­one be able to make their own de­ci­sion about their health?”

Those read­ers who op­posed the bill ex­pressed deep con­cern for pa­tients’ safe­ty and vul­ner­a­bil­i­ty, go­ing as far as to call right-to-try an av­enue for “snake oil” sales tac­tics from un­trust­wor­thy drug­mak­ers.

“The gen­er­al pub­lic is dra­mat­i­cal­ly mis­in­formed about right to try,” one com­menter wrote. “It comes to a head dur­ing emo­tion­al times. The me­dia sen­sa­tion­al­ism of the sit­u­a­tion doesn’t help. Re­search or­ga­ni­za­tions use the words ‘life sav­ing clin­i­cal tri­al’ like they all work. This too is a dis­ser­vice. That caus­es peo­ple to feel that they are be­ing de­nied some­thing in­stead of be­ing pro­tect­ed from snake oil.”

Michael Burgess

The Re­pub­li­can con­gress­men push­ing the leg­is­la­tion — Com­merce Com­mit­tee Chair­man Greg Walden (R-Ore) and Health Sub­com­mit­tee Chair­man Michael Burgess (R-Tex) — ex­pressed their dis­ap­point­ment in the bill’s fail­ure.

“For months we sought to strike the right bal­ance by al­low­ing pa­tients greater ac­cess to these un­ap­proved treat­ments and ther­a­pies while al­so en­sur­ing prop­er pa­tient pro­tec­tions,” they said in a joint state­ment. “This bill does just that.”

Af­ter the vote, House Ma­jor­i­ty Leader Kevin Mc­Carthy said the cham­ber will try again to pass the bill. A GOP aide said House Re­pub­li­cans are like­ly to bring a Sen­ate ver­sion of the bill to the floor or try to at­tach the bill to a big­ger leg­isla­tive pack­age.

Brent Saunders [Getty Photos]

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Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

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Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

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Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

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An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.