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The Wash­ing­ton Post points the fin­ger at Pfiz­er for stay­ing mum about an Alzheimer’s study. But there’s more to the sto­ry than that

The Washington Post on Tuesday raised some provocative questions about Pfizer’s R&D operations, publishing a story that spotlights their review of research an internal group did that illustrated their blockbuster drug Enbrel could be effective in treating Alzheimer’s — the ultimate Holy Grail in an industry that has lavished billions of dollars on drug programs in search of something that could be used to bat back the disease.

This is a story of a big, bad company and its execs who had their own selfish reasons for not pursuing the research themselves. The drug is headed off-patent, say some unnamed critics, and why would Pfizer care to spend the money needed to test the theory that an anti-inflammatory could reduce risk of Alzheimer’s if it couldn’t stand to profit?

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Let's talk AI: Top R&D ex­ecs tack­le where we are and where we're head­ed with this cru­cial new tech­nol­o­gy

As a biotech exec with a background in computational chemistry, Rosana Kapeller has been watching the hubbub over artificial intelligence and machine learning in biopharma play out with a considerable degree of skepticism.

“People talk about ML and AI without knowing what they are talking about,” the outspoken Nimbus alum told me earlier in the week. And there are some big pitfalls the uninitiated are likely to drop into without warning if they follow the crowd into AI without thinking things through first. 

Alzheimer’s R&D projects side­lined as Bio­gen’s ad­u­canum­ab shock shakes re­searchers to the core of their be­liefs

As Biogen works through the fallout from the stunning implosion of its aducanumab Phase III — and its partners at Eisai bustle ahead with BAN2401 and their BACE program — the shock waves have clearly rippled to the far corners of the Alzheimer’s field. Falling on top of landmark failures for Phase III BACE studies at Merck and Eli Lilly/AstraZeneca, some of the players in Alzheimer’s have already begun to factor in the aducanumab failure on symptomatic patients in making a go/no go decision.

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That feel­ing you get when you hit the fin­ish line, and then set new goals

Self-congratulation is an art form most of us master at an early age. And I’m no different from your average person.

Like everyone, I understand nothing is sweeter than the last step of a 1,000-mile march to the finish line of a big goal. We assume that everyone wants to celebrate with us when we arrive, but that’s not usually the case.

So I’ll keep this short and sweet.

Sometime in the next day or so, Endpoints News will pass the 50,000 mark on subscribers. That is the second of two goals I set out for myself at the beginning — June 20, 2016. The ‘win’ I was looking for (alongside 500,000-plus web traffic and 250,000-plus monthly users, a goal we blew the doors off of months ago). And I’ve devoted a good deal to achieving it.

Ned Sharp­less is not play­ing with the FDA’s gold stan­dard — any more than Scott Got­tlieb did

Ned Sharpless got a chance to outline just what kind of acting FDA chief he’ll be in the wake of Scott Gottlieb’s departure from the agency. And aside from a more conservative selection of socks, he’s clearly planning to adopt the exact same fashions laid down by his predecessor.

In an all-hands-on-deck address to staffers, Sharpless promised to fit the Gottlieb mold perfectly, vowing to maintain the agency’s gold standard on drug approvals while doing what he can to keep the copycats coming to help tamp down on drug costs.
So let me reassure you, I am not planning any radical changes from what the FDA has been trying to accomplish.

SCO­TUS just turned its back on Al­ler­gan’s le­gal ma­neu­ver to take a blow at in­ter partes re­view. What did you ex­pect?

It’s finally over.

From the very beginning, Allergan’s attempt to safeguard its blockbuster Restasis franchise by handing over the patents to a Mohawk tribe in New York looked like a bad parody of a legal loophole maneuver. Now it’s a dead parody, after the Supreme Court on Monday shunned the company’s attempt to take its argument to the highest court in the land with a single line.

The tribe’s immunity would safeguard the patents from the inter partes review process, they reasoned, and they could basically lease back control of the drug while steering clear of a serious threat from generic drugmakers.

Go­ing vi­ral? J&J tries to spark a Twit­ter­storm for the lat­est da­ta on its HIV med

When you set out to make a blockbuster, can a Twitterstorm help?

About 9 months after the FDA OK’d J&J’s 4-in-1 HIV pill Symtuza, the pharma giant rolled out new Phase III data Thursday that demonstrates how newly diagnosed HIV patients are likely to squelch any signs of the virus if they jump on drug within 14 days of diagnosis. And they offered canned tweets in the PR to help spread the word — fast.

An­oth­er play­er in the gene ther­a­py field is gun­ning for the Duchenne MD crown — and here’s what they're bet­ting on

Most of you gene therapy enthusiasts reading this will already know about one program out of Nationwide Children’s Hospital that’s attracted considerable attention in the industry. It’s the micro-dystrophin one at Sarepta, which has snagged a big spotlight for the early — and very exciting — human data that they’ve been rolling out.

Today, a different biotech company you most likely haven’t heard nearly as much about is rolling out a new gene therapy program for Duchenne muscular dystrophy — soon to be tested in humans — that they believe can leapfrog Sarepta straight to patients.

“It’s safer and more effective compared to other approaches, including micro-dystrophin.”

That’s the CEO of Audentes talking. Matt Patterson. He’s the company co-founder who counted himself as employee #1 for the first 6 months, now with a staff of 230 and a market cap of $1.7 billion. Audentes has some early data due out on their lead gene therapy program for AT132 in a few weeks.

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RIP amy­loid be­ta the­o­ry? Nope. Bio­gen part­ner launch­es a new PhI­II be­fore ad­u­canum­ab's corpse turned cold

A day after Biogen rattled the biopharma world with the news that its lead late-stage therapy aducanumab proved worthless in treating Alzheimer’s — a disaster that may drive a stake through the heart of the amyloid beta theory once and for all — the big biotech’s partners at Eisai have come up with their next big move.

Right in the wake of a 35% plunge in their stock value, Eisai $ESALY is starting a Phase III study involving 1,566 Alzheimer’s patients with mild cognitive impairment for the controversial Alzheimer’s drug BAN2401. The anti-amyloid antibody was the center of a firestorm of criticism over a tardy reveal that researchers had pulled high-risk patients out of their last study, potentially warping the positive results that were claimed, leaving that drug under a dark cloud.

How do you re­place a rock star like Scott Got­tlieb at the FDA? Maybe you can't

Anyone looking for a convenient weather vane to determine the reaction to Scott Gottlieb’s abrupt departure from the FDA need go no further than the $XBI. The S&P Biotech ETF took a 4% hit. And it was down another 1.8% ahead of the bell on Thursday.

The market and the industry loved Gottlieb, as we underscored on several occasions with industry surveys highlighting the intense enthusiasm for someone who advocated for collaborating with the drug industry. Biopharma had a partner in Gottlieb, and they all knew it.