Study: Just half of post­mar­ket­ing com­mit­ment tri­als are pub­lished

A new study pub­lished Mon­day in BMC Med­i­cine finds that on­ly about half of the clin­i­cal tri­als re­quest­ed by the FDA as part of post­mar­ket­ing com­mit­ments for new­ly ap­proved drugs and bi­o­log­ics are pub­lished in peer-re­viewed jour­nals.

The study al­so found that in­for­ma­tion for near­ly half of the post­mar­ket­ing com­mit­ment stud­ies sub­ject to re­port­ing re­quire­ments un­der sec­tion 506B of Fed­er­al Food, Drug, and Cos­met­ic Act (FD­CA) was not up to date.

Con­duct­ed by re­searchers at Yale Uni­ver­si­ty, Uni­ver­si­ty of Con­necti­cut and Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co, the study re­viewed post­mar­ket­ing com­mit­ments for the 110 new drugs and bi­o­log­ics ap­proved from 2009-2012.

Un­like post­mar­ket­ing re­quire­ments, which drug­mak­ers must con­duct as a con­di­tion of ap­proval, post­mar­ket­ing com­mit­ments are agreed to by drug­mak­ers at the time of ap­proval and are not re­quired un­der statute or reg­u­la­tion.

More than half (55.5%) of the 110 ap­provals had one or more post­mar­ket­ing com­mit­ment(s), with 33 re­quir­ing a new clin­i­cal tri­al. Of those, 27 were sub­ject to Sec­tion 506B re­port­ing re­quire­ments.

For the stud­ies sub­ject to re­port­ing re­quire­ments, 12 (44.4%) were nei­ther closed nor had an up-to-date sta­tus in pub­licly avail­able data­bas­es on the FDA’s web­site.

The study did find, how­ev­er, that near­ly all the clin­i­cal tri­als re­quest­ed as part of post­mar­ket­ing com­mit­ments were reg­is­tered on Clin­i­cal­Tri­als.gov (90.3%), most of which were marked as com­plet­ed or ter­mi­nat­ed (82.1%). Of the com­plet­ed or ter­mi­nat­ed stud­ies all but one had re­port­ed re­sults.

How­ev­er, the au­thors found that most of the stud­ies (81.8%) that had re­port­ed re­sults on Clin­i­cal­Tri­als.gov re­port­ed their re­sults af­ter the sched­uled sub­mis­sion dead­line.

On­ly about half of the stud­ies that were el­i­gi­ble for pub­li­ca­tion (i.e. com­plet­ed or ter­mi­nat­ed in Clin­i­cal­Tri­als.gov or sub­mit­ted, ful­filled or re­leased ac­cord­ing to the FDA) were pub­lished in peer-re­viewed jour­nals.

“Among the 29 reg­is­tered or un­reg­is­tered stud­ies for which pub­li­ca­tion would be ex­pect­ed based on the most re­cent sta­tus pro­vid­ed by the FDA, phar­ma­ceu­ti­cal com­pa­nies, or on Clin­i­cal­Tri­als.gov, just un­der half were pub­lished in a peer-re­viewed jour­nal (14 of 29 (48.3%)),” the au­thors write.

And while post­mar­ket­ing com­mit­ments on­ly make up 19% of the postap­proval com­mit­ments and re­quire­ments im­posed by the FDA, the au­thors say the da­ta gen­er­at­ed by post­mar­ket­ing com­mit­ments “may be a po­ten­tial­ly im­por­tant source of in­for­ma­tion about drug and bi­o­log­ic safe­ty and ef­fec­tive­ness af­ter mar­ket ap­proval.”

Study


First pub­lished in Reg­u­la­to­ry Fo­cus™ by the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety, the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care prod­ucts. Click here for more in­for­ma­tion.

So­cial im­age: Shut­ter­stock

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

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Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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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:

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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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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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