Un­want­ed by Ab­b­Vie and In­fin­i­ty, bat­tered Ve­rastem gets an OK for du­velis­ib and a sec­ond shot at suc­cess

Ve­rastem $VSTM is get­ting its prover­bial sec­ond chance.

Once bat­tered, bruised and left on the ropes af­ter the com­plete fail­ure of the ini­tial strat­e­gy mapped by Christoph West­phal, the ex­ec­u­tive team at Ve­rastem snapped up a tar­nished star as In­fin­i­ty hap­pi­ly hand­ed off its per­fect­ly ap­prov­able — but com­mer­cial­ly un­ex­cit­ing — PI3K drug du­velis­ib for ex­act­ly noth­ing up front.

To­day, the FDA did its part, hand­ing over an ac­cel­er­at­ed ap­proval for the drug, which will now be sold as Copik­tra, the on­ly gam­ma/delta in­hibitor on the mar­ket for third-line cas­es of chron­ic lym­pho­cyt­ic leukemia/small lym­pho­cyt­ic lym­phoma. And the agency al­so of­fered up a tan­dem OK as a 3rd-line ther­a­py for fol­lic­u­lar lym­phoma.

Fur­ther ham­per­ing its mar­ket po­ten­tial, the FDA is stamp­ing the la­bel with a black box warn­ing of 4 po­ten­tial­ly lethal tox­i­c­i­ties: in­fec­tions, di­ar­rhea or col­i­tis, cu­ta­neous re­ac­tions, and pneu­moni­tis. 

Robert For­rester, Ve­rastem CEO

On­col­o­gists of­ten call for new ther­a­pies that they can con­sid­er for dy­ing, drug re­sis­tant pa­tients. And now they have an­oth­er one.

At one stage, Ab­b­Vie hand­ed over $275 mil­lion up­front to part­ner on this drug, on­ly to walk away when it proved to be an­oth­er PI3K with se­vere­ly lim­it­ed com­mer­cial po­ten­tial. Ab­b­Vie’s dis­card, though, still looked plen­ty good to Ve­rastem, which re­tains high hopes for mak­ing some­thing re­al out of this.

Ve­rastem has a mar­ket cap of $657 mil­lion.

“Pa­tients liv­ing with CLL/SLL or FL are in need of ad­di­tion­al treat­ment op­tions, and new ther­a­pies such as Copik­tra are cru­cial be­cause each pa­tient’s treat­ment jour­ney is unique,” said Meghan Gutier­rez, the CEO of the Lym­phoma Re­search Foun­da­tion.

Michel Younatsos, Biogen CEO (via YouTube)

Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application.

The big biotech also notes that the “FDA has stated that, if possible, it plans to act early on this application under an expedited review.”

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Covid-19 roundup: No­vavax inks vac­cine deals with Japan and In­dia; As­traZeneca near­ing agree­ments with Japan and Brazil

Following the release this week of promising early data for their Covid-19 vaccine candidate, Novavax has announced collaborations to supply it to two countries — Japan and India.

The Maryland-based biotech announced a deal Friday morning with Takeda to develop and manufacture up to 250 million doses per year of its adjuvanted vaccine. And late Thursday afternoon, Novavax entered into an agreement with the Serum Institute of India to provide up to 1 billion doses to India and low- and middle-income countries.

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In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Donald Trump, AP

Trump reach­es for his pen as long-await­ed ex­ec­u­tive or­der on drug man­u­fac­tur­ing on-shoring fi­nal­ly ar­rives — re­ports

President Trump will sign a long-rumored executive order later today that is designed to spur more made-in-the-USA therapies, according to a slate of new reports out Thursday morning.

Drug manufacturing circles have been buzzing about this EO for months now, wondering how Trump plans to require the on-shoring of certain therapies.

According to the Bloomberg report, White House trade adviser Peter Navarro told reporters that the administration will come up with a list of essential medicines Trump wants to have made inside the US. The order will direct government purchasers to buy these essential meds from US suppliers. The reports add that the order relaxes drug safety and environmental regulations to make it happen.

Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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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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