Bioregnum channel feed

All of the news, delivered with full-text to your inbox. For professionals discovering, developing, and marketing biopharmaceutical drugs.

SUBSCRIBE NOW
Subscribe to Endpoints News

In­vestors lost big as Alzheimer’s R&D went over the cliff in 2019. Will they ever come back?

Neurotrope this week joined the long line of biopharma companies that have been mauled by clinical failure for Alzheimer’s drugs. But their crushed shares ($NTRP down from more than $8 in June to penny stock range today) represented just a tiny drop in the bucket of red ink that has drained from players which have pursued the greatest of all Holy Grails in drug R&D. Decades of defeat, headlined by the likes of solanezumab at Eli Lilly stretching to the most recent snafu with Biogen’s aducanumab, have forced a slew of players to change course on their R&D strategy — or just leave it in limbo.

Once again No­var­tis’ car­dio team looks to beat the odds us­ing sketchy da­ta and a fa­mil­iar ar­gu­ment

Whenever a clinical trial team starts touting the “totality” of the data, you know they’re in trouble.

For Novartis’ Entresto (sacubitril/valsartan) team, that’s the early go-to position on their latest round of pivotal data for the blockbuster — which the pharma giant believes has megablockbuster potential. We already knew that Novartis’ team plans to field the drug to regulators in search of a label extension — but now we have a better idea of the hurdles it faces. 

Re­mem­ber that post-mar­ket­ing tri­al? New study con­firms many drug­mak­ers don’t do them — half drag their feet

Earlier this month Sarepta confirmed to us that the post-marketing study the FDA required in their controversial OK for the Duchenne MD drug Exondys 51 — now on the market at $1 million a year — was years behind schedule. 

But it’s right in line with the industry norm — which runs from slow to glacial.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

Vas Narasimhan, Getty Images

The FDA’s very pub­lic slap of No­var­tis’ red face is a warn­ing to the en­tire in­dus­try — don’t down­play it

In drug development, there’s an unwritten rule that the FDA can rely on the deep-pocket global players to produce clean data. The results may be positive or negative, and you’re free to interpret as you please, but the data are reliable.

All the data, from humans right down to the mice. 

Trust in the integrity of the people handing over the data is essential for the current emphasis on accelerated approvals. If the top players start gaming the system, everyone can go back to the clinic and plan to plod through each standard phase of clinical trials, with a long, slow regulatory review at the end.

Remember how well that worked?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

Roger Perlmutter, Merck

Do you want to see what win­ning big in the R&D race looks like in the Big Phar­ma league?

Merck $MRK offered a simple lesson in the economics of winning a megablockbuster R&D race today. And it shouldn’t be missed by anyone.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

Hal Barron, GSK

What makes Hal Bar­ron tick? Look at the peo­ple he’s team­ing up with at GSK

GSK R&D chief Hal Barron is all about people: The people who lead his teams, the people on his teams and the people he’s collaborating with.

If you listened closely to Barron’s one-year review of the effort to turn around GSK’s R&D organization in their Q2 update this week, that came through loud and clear as he flagged a series of new hires, new plans to build research teams and a new cell therapy collaboration we haven’t heard of before. 

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Kamala Harris speaking yesterday at the Des Moines Register Iowa Presidential Candidate Forum [via Getty]

Who’s the tough­est on drug prices? A game of po­lit­i­cal one-up­man­ship is dri­ving the pol­i­cy de­bate in Wash­ing­ton

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.

Why would the FDA ap­prove an­oth­er con­tro­ver­sial drug to spur a woman’s li­bido with these da­ta? And why no ex­pert pan­el re­view?

AMAG Pharmaceuticals’ newly approved drug for spurring women’s sexual desire may never make much money, but it’s a big hit at sparking media attention.

The therapy — Vyleesi (bremelanotide) — got the green light from regulators on Friday evening, swiftly lighting up a range of stories around the world, from The New York Times to The Guardian. Several headlines inevitably referred to it as the “female Viagra,” invoking Pfizer’s old erectile dysfunction blockbuster.

But the two drugs have little in common.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

Af­ter watch­ing its share price soar on a Bloomberg re­port and heat­ed ru­mors, Bio­haven stock takes a bil­lion-dol­lar bath

Back in April, Biohaven Pharmaceutical became one hot biotech stock $BHVN based on a report in Bloomberg that some “potential bidders” had been kicking the tires at the biotech, which has a lead drug for migraines. Then the rumor mill really started to smoke when execs canceled a presentation at an investor conference a little more than a week ago.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 67,300+ biopharma pros reading Endpoints daily — and it's free.

Turns out, Rudy Tanzi did­n't see much of a sto­ry about a hid­den link be­tween En­brel and Alzheimer's ei­ther

The Washington Post managed to whip up the quickest industry consensus I’ve ever seen that one of its reporters was purveying overblown nonsense with a story that Pfizer was sitting on data suggesting that Enbrel could be an effective treatment for Alzheimer’s. 

In covering that bit of anti-Big Pharma fantasy — there are lots of reasons to go after pharma, but this piece was ludicrous — I noted comments in the story from some prominent people in the field criticizing Pfizer for not publishing the data. I singled out Rudy Tanzi at Harvard and then applied some added criticism for the things he’s done to hype — in my opinion — highly questionable assumptions. You can see it in the link.