No­var­tis’s block­buster CDK 4/6 con­tender LEE011 gets a VIP count­down at the FDA

No­var­tis’s LEE011 (ri­bo­ci­clib) is get­ting VIP treat­ment at the FDA. A few weeks af­ter post­ing im­pres­sive late-stage da­ta for its CDK 4/6 drug, the agency has giv­en it a pri­or­i­ty re­view sched­ule, lop­ping four months off the usu­al reg­u­la­to­ry re­view.

No­var­tis adds that the EMA has al­so ac­cept­ed their ap­pli­ca­tion for first-line treat­ment of post­menopausal women with hor­mone-re­cep­tor pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor-2 neg­a­tive ad­vanced or metasta­t­ic breast can­cer in com­bi­na­tion with letro­zole.

Al­ready armed with the FDA’s break­through ther­a­peu­tic des­ig­na­tion, No­var­tis would ap­pear to be on a short path to a near-term ap­proval in ear­ly 2017, set­ting up a show­down with Pfiz­er’s pi­o­neer­ing Ibrance (pal­bo­ci­clib).

The pri­or­i­ty re­view will al­so like­ly get the phar­ma gi­ant’s drug out in­to a mar­ket well ahead of Eli Lil­ly, which is bull­ish about its chances with the ri­val CDK 4/6 drug abe­maci­clib. Last sum­mer Lil­ly was forced to con­cede that it was not able to end its piv­otal study ear­ly, leav­ing a fi­nal read­out in 2017 and pos­si­bly no ap­proval be­fore 2018, giv­ing No­var­tis a clear shot at mak­ing a splash in the mar­ket well ahead of abe­maci­clib’s ar­rival.

The head­line fig­ure from ES­MO, based on a study that was wrapped ear­ly due to its suc­cess, was that ri­bo­ci­clib com­bined with letro­zole re­duced the risk of death or pro­gres­sion by 44% among first-line pa­tients com­pared to letro­zole alone.

That’s all in line with an­a­lysts’ es­ti­mates of peak sales break­ing $2 bil­lion.

Michel Younatsos, Biogen CEO (via YouTube)

UP­DAT­ED: 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.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

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

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

Covid-19 roundup: Pfiz­er teams with Gilead on remde­si­ivr; Japan, Brazil, Switzer­land, In­dia get vac­cines

Pfizer has joined the list companies helping Gilead manufacture remdesivir. The pharma giant announced today they signed a multi-year agreement to provide Gilead with contract manufacturing services at their McPherson, Kansas plant. The deal is part of a broad effort by Gilead to scale up the drug, the only currently authorized therapy for Covid-19, to 2 million doses this year.

That effort now includes 40 different companies on 3 continents, according to a press release the biotech put out yesterday, not including the generic drugmakers the company has allowed to produce the anti-viral for low and middle-income countries. Dozens of state governments, though, have said those efforts have not been extensive enough to keep up with demand and have called upon the federal government to sidestep Gielad’s patents and begin scaling the drug itself.  – Jason Mast

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

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.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 86,700+ biopharma pros reading Endpoints daily — and it's free.