Martin Shkreli (AP Images)

The FDA OKs gener­ic Dara­prim, the Mar­tin Shkre­li ther­a­py that trig­gered an un­end­ing tem­pest over drug pric­ing

The FDA post­ed a new gener­ic drug ap­proval Fri­day af­ter­noon, and this one ar­rived with a lit­tle ex­tra rel­ish added to the cus­tom­ary pro­nounce­ment.

The agency has giv­en Cerovene the green light to sell gener­ic Dara­prim, Mar­tin Shkre­li’s treat­ment for tox­o­plas­mo­sis that det­o­nat­ed a world class brouha­ha over drug pric­ing that has taint­ed the in­dus­try. Shkre­li no soon­er ac­quired the old, once cheap drug than he in­stant­ly raised the price by more than 5,000%, some­thing that the gen­er­al pub­lic — and a big seg­ment of the bio­phar­ma in­dus­try — was pro­found­ly ap­palled by.

It’s tak­en more than 4 years for a gener­ic to come along, and giv­en the way drug pric­ing works in the U.S., there’s a good chance that re­al price re­lief may still be a long way off.

Shkre­li, al­ways ready to play the Jok­er in every phar­ma biopic, blast­ed back against the pub­lic scorn that he stirred, up un­til he was sen­tenced to 7 years for de­fraud­ing in­vestors in the hedge funds he had dri­ven in­to a brick wall be­fore he turned to biotech — fol­low­ing the path of buy­ing drugs and hik­ing the price.

Law­mak­ers put him in the spot­light, but there was no sham­ing Shkre­li. The price stayed high, and the agency even­tu­al­ly wound up us­ing the case to craft new rules that would help pre­vent Shkre­li wannabes from fol­low­ing in his foot­steps.

“Through the FDA’s Drug Com­pe­ti­tion Ac­tion Plan, we’ve worked to re­move bar­ri­ers in gener­ic drug de­vel­op­ment by not on­ly tak­ing ac­tions that im­prove the ef­fi­cien­cy of the de­vel­op­ment, re­view and ap­proval of gener­ic drugs, but al­so by clos­ing loop­holes that al­low brand-name drug com­pa­nies to ‘game’ the rules in ways that de­lay gener­ic com­pe­ti­tion that Con­gress in­tend­ed,” FDA com­mish Stephen Hahn said in a pre­pared state­ment.

Ac­cord­ing to a re­cent fed­er­al law­suit brought by the FTC and the state of New York, Shkre­li en­gaged in just such be­hav­ior, cook­ing up “an elab­o­rate an­ti­com­pet­i­tive scheme to pre­serve a mo­nop­oly” for Dara­prim. The al­leged of­fens­es ranged from keep­ing sam­ples out of reach for gener­ic drug­mak­ers to block­ing ac­cess to sales rev­enue.

There’s no im­me­di­ate word, though, on what Cerovene plans to charge for the drug. And typ­i­cal­ly, it takes sev­er­al gener­ic drug ri­vals to force the price down sharply. No mat­ter what hap­pens to Dara­prim, though, the drug pric­ing de­bate, and the fall­out that Dara­prim helped cre­ate, has be­come a fix­ture of the US po­lit­i­cal scene and the 2020 elec­tion cy­cle. And some of these can­di­dates are af­ter much big­ger fish than the im­pris­oned Shkre­li.

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Stéphane Bancel, Moderna CEO (Steven Ferdman/Getty Images)

Mod­er­na CEO Stéphane Ban­cel out­lines a prospec­tive moth­er­lode of Covid-19 vac­cine rev­enue — will a back­lash fol­low?

Moderna shows no sign of slowing down, or turning charitable when it comes to pricing supplies of its Covid-19 vaccine.

One of the leaders in the Phase III race to get a Covid-19 vaccine across the finish line in record time, Moderna says it’s on track to complete enrollment in one of the most avidly watched studies in the world next month. And the biotech has already banked some $400 million in deposits for vaccine supply as it works through negotiations with countries around the world — as CEO Stéphane Bancel sets out to hire a commercial team.

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My­ovant lands a fresh $200M loan as FDA mar­ket­ing de­ci­sion looms; Amarin goes it alone in Eu­rope

Myovant is getting ready to roll out its commercial operations to back relugolix, now under FDA review for prostate cancer.

The startup has added a fresh $200 million in support from Sumitomo Dainippon Pharma, which controls a majority of the stock $MYOV. Sumitomo is handing the cash over as a loan, bringing its total to $600 million. Myovant — which is gearing up for a showdown with AbbVie — has also filed an NDA to sell relugolix for uterine fibroids and recently posted positive late-stage data for endometriosis.

Covid-19 roundup: J&J and BAR­DA agree to $1 bil­lion for 100 mil­lion dos­es; Plas­ma re­duces mor­tal­i­ty by 50% — re­ports

J&J has become the latest vaccine developer to agree to supply BARDA with doses of their Covid-19 vaccine, signing an agreement that will give the government 100 million doses in exchange for $1 billion in funding.

The agreement, similar to those signed by Novavax, Sanofi and AstraZeneca-Oxford, provides funding not only for individual doses but to help J&J ramp up manufacturing. Pfizer, by contrast, received $1.95 billion for the doses alone. Still, if one looked at each agreement as purchase amounts, J&J’s deal would be $10 per dose, slotting in between Novavax’s $16 per dose and AstraZeneca’s $4 per dose.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Ver­sant de­buts Ridge­line's start­up #4, armed with $30M and al­ter­na­tive TCR cell ther­a­pies for sol­id tu­mors

For all the iterations and advances in TCR therapies for cancer, any experimental treatments involving T cell receptors share one trait: By definition, they only recognize antigens presented as peptides on the major histocompatibility complex (MHC) on cells.

Versant reckons it’s time to expand the arsenal. With $30 million in initial funding, its Ridgeline Discovery Engine in Switzerland has been working on a non-peptidic approach that it says has tumor-agnostic potential, especially in solid tumors. They’ve named it Matterhorn, after a Swiss mountain as they did with the three other companies that have emerged from the Basel-based incubator.

CF Foun­da­tion, Long­wood team on new in­cu­ba­tor for com­pa­nies with cut­ting-edge CF treat­ments

Nine months after launching a $500 million hunt for a cure for cystic fibrosis, the Cystic Fibrosis Foundation said it will use a portion of those funds to do something it has never done before: help launch new companies.

The CF Foundation, whose venture philanthropy efforts helped fund Vertex’s line of powerful CF drugs, is teaming with Longwood Fund to create a CF incubator. The incubator will identify new companies with platforms or technologies that can be applied in the rare genetic condition. The partners can then finance early development in exchange for a commitment from the companies to focus on applications in cystic fibrosis.

Deep tech, round 2: DCVC Bio bags $350M fund to chase the tip of the life sci­ence spear

It took one trip from San Francisco to Vancouver for Kiersten Stead and her DCVC Bio crew to feel confident about throwing their weight — and cash — behind AbCellera.

CEO Carl Hansen’s academic background and the potential of the platform, which combined machine vision and robotics with microfluidics, were promising. But the site visit sealed the Series A deal, where DCVC was the lead and only investor.