Lib­er­tar­i­an ideas on FDA dereg­u­la­tion threat­en biotech; It's time for some re­al pow­er to re­form drug prices, rea­son­ably

Do you sin­cere­ly want to dereg­u­late drug de­vel­op­ment?

Sil­i­con Val­ley’s Bal­a­ji Srini­vasan had quite a habit of tack­ling the FDA on Twit­ter, crit­i­ciz­ing the agency for its slow and back­ward ways. But all that came back to haunt him af­ter re­porters picked up on the news that he and fel­low ‘seast­ead­er’ Jim O’Neill had been in to chat with Don­ald Trump about top jobs at the FDA. Sud­den­ly, that Twit­ter chan­nel van­ished in­to thin air, as we re­port­ed first. But his Tweets were saved, and live on, even as we hear that Srini­vasan may not be in line for that job any more. Trump’s fi­nal pick to run the FDA will have a huge in­flu­ence on how the agency plans to speed drug de­vel­op­ment. And we have a right and a need to suss things out for our­selves. So far, this episode ranks as an­oth­er rea­son to sus­pect that the FDA may soon be head­ed for a wrong turn, es­pe­cial­ly if the new fo­cus is on a sub­stan­tial dereg­u­la­tion of drug de­vel­op­ment born out of a dis­gust for the bu­reau­cra­cy.


Medicare price ne­go­ti­a­tions can ben­e­fit bio­phar­ma too.

Speak­ing of Trump, our new pres­i­dent got the chance to clar­i­fy his think­ing re­gard­ing drug prices in a week­end in­ter­view with The Wash­ing­ton Post. As we sus­pect­ed, his main weapon in the war against list prices will be Medicare ne­go­ti­a­tions — now banned by in­dus­try-friend­ly law­mak­ers. The in­dus­try des­per­ate­ly doesn’t want to see this, but in re­al­i­ty it makes for an ef­fec­tive way to get ac­tu­al dis­count prices on dis­play for all to see. The Amer­i­can pub­lic has a right to see what’s ac­tu­al­ly be­ing paid for ther­a­peu­tics, and this is one way to set a base­line dis­count price that is read­i­ly trans­par­ent. The free ride on ever-ris­ing drug prices is over, and we all know it. The soon­er this hap­pens, the bet­ter for every­one. If a price can’t sur­vive the light of day, it’s too high. In the mean­time, the in­dus­try can move more to­ward a per­for­mance-based pric­ing method.


Mallinck­rodt joins the price goug­ing club, and gets away with “mur­der.”

One of the rea­sons why drug prices are so con­tro­ver­sial is that the fed­er­al gov­ern­ment is vir­tu­al­ly help­less when it comes to pre­vent­ing a com­pa­ny from jack­ing up prices as­tro­nom­i­cal­ly overnight. Quest­cor proved that more than three years ago, when it brazen­ly bought a ri­val to Ac­thar to pre­vent com­pe­ti­tion. And Mallinck­rodt bought in to that rigged game by buy­ing Quest­cor. This week, Mallinck­rodt was cit­ed for il­le­gal­ly block­ing com­pe­ti­tion, but got away with on­ly a $100 mil­lion fine. The com­pa­ny paid for that with the in­creased rev­enue it earned on Ac­thar in just 2015, as its price con­tin­ued to soar. This is what Trump means when he says phar­ma is get­ting away with mur­der. It may take years for a ri­val to get ap­proved and on the mar­ket. And Mallinck­rodt is still free to jack prices. This has to end with some kind of ef­fec­tive le­gal mech­a­nism to pre­vent abus­es. Your next Mar­tin Shkre­li or Mallinck­rodt is sit­ting just around the cor­ner. And the longer we wait, the more like­ly it is that re­form will overzeal­ous­ly dam­age the way in­no­va­tion is fi­nanced in bio­phar­ma.


Our lat­est lists on ven­ture cash un­der­score sol­id fun­da­men­tals for biotech. Let’s not screw it up now.

Biotech is de­pen­dent on the flow of bil­lions of dol­lars in ven­ture cash. And we love noth­ing quite as much as track­ing where the mon­ey is com­ing from as well as what re­gions it is go­ing to. Al­ways enor­mous­ly pop­u­lar with read­ers, this year’s sto­ries paint a sim­ple tale of the dom­i­nant role played by two cru­cial hubs — Boston/Cam­bridge and the Bay Area — as well as a group of savvy in­vestors who are in­stru­men­tal in fos­ter­ing and fund­ing new in­no­va­tion in drug de­vel­op­ment. That ma­chine has been hum­ming along nice­ly now for sev­er­al years, point­ing to the fact that the fun­da­men­tals in pri­vate biotech are strong and durable. That bodes well for the years ahead, as ma­jor re­forms are be­ing planned, which we should all ap­pre­ci­ate. Re­form­ers might like to keep that in mind.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

UP­DAT­ED: Es­ti­mat­ing a US price tag of $5K per course, remde­sivir is set to make bil­lions for Gilead, says key an­a­lyst

Data on remdesivir — the first drug shown to benefit Covid-19 patients in a randomized, controlled trial setting — may be murky, but its maker Gilead could reap billions from the sales of the failed Ebola therapy, according to an estimate by a prominent Wall Street analyst. However, the forecast, which is based on a $5,000-per-course US price tag, triggered the ire of one top drug price expert.

Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Cameron Dur­rant hus­tled his way from the OTC side­lines right in­to the Covid-19 drug race. Death or glo­ry lies straight ahead

Over the past few months, Covid-19 has gone from being a monolithic threat to one of the biggest overnight boons the biopharma industry has ever seen. And amid all the furor over Moderna’s swelling stock price, plenty of chatter over what new drugs and vaccines will cost and investors’ uninhibited zeal for all things related to pandemic products, it’s been one little biotech’s golden ticket back from the land of the living dead.

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Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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