FDA (via AP Images)

FDA slams GSK's month­ly HIV in­jectable with CRL, cit­ing man­u­fac­tur­ing is­sues

HIV pa­tients will have to wait a while longer for a long-act­ing vi­ral sup­pres­sion reg­i­men as the FDA has re­ject­ed Vi­iV Health­care’s NDA for the month­ly in­jec­tion of cabote­gravir and rilpivirine.

Reg­u­la­tors hand­ed the GSK sub­sidiary a com­plete re­sponse let­ter days be­fore the orig­i­nal PDU­FA date on De­cem­ber 29. While Vi­iV had been ex­pect­ing a smooth sail to the fin­ish line based on glow­ing clin­i­cal re­sults, the CRL cit­ed con­cerns with chem­istry man­u­fac­tur­ing and con­trols.

“There have been no re­port­ed safe­ty is­sues re­lat­ed to CMC and there is no change to the safe­ty pro­file of the prod­ucts used in clin­i­cal tri­als to date,” Vi­iV added in a short state­ment.

Kim Smith

A de­lay here with the month­ly in­jec­tion of cabote­gravir and rilpivirine al­so means that Vi­iV will have to push back on the planned sN­DA fil­ing for the 2-month­ly reg­i­men, which was slat­ed for the first quar­ter of 2020.

Gilead’s block­buster cock­tails, both dou­blets and triplets, have been im­mense­ly suc­cess­ful at keep­ing HIV to un­de­tectable lev­els, but they have still left pa­tients sad­dled with the bur­den of tak­ing dai­ly pills — which Vi­iV said is not on­ly in­con­ve­nient but al­so car­ries an emo­tion­al bur­den. With their new for­mu­la­tion of their own ex­per­i­men­tal cabote­gravir (in­te­grase in­hibitor) and J&J’s rilpivirine (non-nu­cle­o­side re­verse tran­scrip­tase in­hibitor), Vi­iV was look­ing to shake up the treat­ment land­scape and carve out a big­ger share from the Gilead-dom­i­nat­ed mar­ket.

The long-act­ing reg­i­men is de­signed for pa­tients who are al­ready vi­ro­log­i­cal­ly sup­pressed, have nev­er ex­pe­ri­enced vi­ro­log­i­cal fail­ures, and have not de­vel­oped re­sis­tance to ei­ther of the in­gre­di­ents. Vi­iV head of R&D Kim Smith has es­ti­mat­ed that around 10% to 15% of all pa­tients in the clin­ic would be can­di­dates.

Two late-stage stud­ies in­volv­ing 1180 pa­tients sug­gest­ed that their in­jec­tion was just as ef­fec­tive as stan­dard an­ti­retro­vi­ral ther­a­py in vi­ro­log­ic sup­pres­sion, with sim­i­lar rates of re­sis­tance at 1%. And as they fol­low up on a Phase IIb tri­al, re­searchers found that 83% of pa­tients re­main vi­ral­ly sup­pressed at the three-year mark.

That, along­side sim­i­lar­ly pos­i­tive da­ta for the 2-month­ly reg­i­men, would have made a ground­break­ing treat­ment op­tion. The com­pa­ny said it’s work­ing close­ly with the FDA to fig­ure out the next steps.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.

Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepeneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film Fantastic Voyage, the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his own account, along with some seed cash from friends and family.

UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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UP­DAT­ED: Biotech's shares rout­ed af­ter the FDA de­mands new tri­al, rais­es safe­ty and end­point is­sues in sur­prise CRL

A small biotech that’s been laboring long and hard on an oral chemo program for metastatic breast cancer was slammed hard on Monday morning, losing more than half of its market cap after revealing that the FDA had issued a surprise CRL with some harsh new hurdles in place.

Athenex $ATNX says that regulators stiff-armed its application for oral paclitaxel and encequidar — a marked setback after winning a priority review earlier that should have signified a more positive regulatory frame of mind. And Athenex was clear that any comeback for this program is going to face a high bar at the FDA.

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Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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