Mer­ck’s snap­shot of pos­i­tive da­ta for front­line lung can­cer niche trig­gers a new scram­ble for quick Keytru­da OK

Mer­ck has caught the big wave on front­line lung can­cer, and it plans to ride an ear­ly pos­i­tive sig­nal straight through to a quick OK for an­oth­er lu­cra­tive mar­ket niche for Keytru­da.

Roger Perl­mut­ter

This morn­ing the phar­ma gi­ant post­ed word that their Keynote-407 tri­al scored a pos­i­tive hit on the over­all re­sponse rate for un­treat­ed metasta­t­ic squa­mous non-small cell lung can­cer in an in­ter­im analy­sis and they’ve al­ready filed for the ap­proval.

That’s a sec­ondary end­point and just a co­hort of pa­tients, but Mer­ck isn’t wait­ing to find out the rest of the da­ta. They want a green light to start mar­ket­ing AS­AP us­ing just a piece of the puz­zle. And at this stage, with reg­u­la­tors speed­ing ap­provals in can­cer, there’s good rea­son to be­lieve that the FDA will give it to them.

Re­searchers are al­so busi­ly gath­er­ing the rest of the da­ta on pri­ma­ry end­points for over­all sur­vival and pro­gres­sion-free sur­vival. Mer­ck adds that it plans for a late-break­ing ses­sion at AS­CO to un­veil more on this study.

Mer­ck shares $MRK are up 2% in pre-mar­ket trad­ing.

In the lat­est quar­ter­ly matchup be­tween Mer­ck and its big ri­val Bris­tol-My­ers Squibb, Mer­ck had inched up to with­in punch­ing dis­tance of push­ing past Bris­tol-My­ers on PD-1 rev­enue. Bris­tol-My­ers pushed out well ahead of Mer­ck ear­ly in this in­tense ri­val­ry, but Roger Perl­mut­ter’s R&D crew have pulled out all the stops.

At last count, Mer­ck had 753 tri­als un­der­way us­ing Keytru­da.

Mer­ck won their lat­est bout in the heavy­weight ri­val­ry at AACR with the de­tails on their front­line win for the Keytru­da-chemo com­bo for lung can­cer. Bris­tol-My­ers tried hard to show that it had the edge in a large group of pa­tients with a high tu­mor mu­ta­tion bur­den, but an­a­lysts over­all were much more im­pressed by Mer­ck’s dom­i­na­tion in a more clas­si­cal­ly de­fined pa­tient group.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus pric­ing just yet

Novo Nordisk’s priority review voucher on oral semaglutide has paid off. The FDA approval for the GLP-1 drug hit late Friday morning, around six months after the NDA filing.

Rybelsus will be the first GLP-1 pill to enter the type 2 diabetes market — a compelling offering that analysts have pegged as a blockbuster drug with sales estimates ranging from $2 billion to $5 billion.

Ozempic, the once-weekly injectable formulation of semaglutide, brought in around $552 million (DKK 3.75 billion) in the first half of 2019.

Oxitec biologist releases genetically modified mosquitoes in Piracicaba, Brazil in 2016 [credit: Getty Images]

In­trex­on unit push­es back against claims its GM mos­qui­toes are mak­ing dis­ease-friend­ly mu­tants

When the hysteria of Zika transmission sprang into the American zeitgeist a few years ago, UK-based Oxitec was already field-testing its male Aedes aegypti mosquito, crafted to possess a gene engineered to obliterate its progeny long before maturation.

But when a group of independent scientists evaluated the impact of the release of these genetically-modified mosquitoes in a trial conducted by Oxitec in Brazil between 2013 and 2015, they found that some of the offspring had managed to survive — prompting them to speculate what impact the survivors could have on disease transmission and/or insecticide resistance.

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[via AP Images]

Pur­due threat­ens to walk away from set­tle­ment, asks to pay em­ploy­ees mil­lions in bonus­es

There are two updates on the lawsuit against Purdue Pharma over its role in fueling the opioid epidemic, as the Sackler family threatens to walk away from their pledge to pay out $3 billion if a bankruptcy judge does not stop outstanding state lawsuits against them. At the same time, the company has asked permission to pay millions in bonuses to select employees.

Purdue filed for chapter 11 bankruptcy this week as part of its signed resolution to over 2,000 lawsuits. The deal would see the Sackler family that owns Purdue give $3 billion from their personal wealth and the company turned into a trust committed to curbing and reversing overdoses.

As Nas­daq en­rolls the fi­nal batch of 2019 IPOs, how have the num­bers com­pared to past years?

IGM Biosciences’ upsized IPO haul, coming after SpringWorks’ sizable public debut, has revved up some momentum for the last rush of biotech IPOs in 2019.

With 39 new listings on the books and roughly two more months to go before winding down, Nasdaq’s head of healthcare listings Jordan Saxe sees the exchange marking 50 to 60 biopharma IPOs for the year.

“December 15 is usually the last possible day that companies will price,” he said, as companies get ready for business talks at the annual JP Morgan Healthcare Conference in January.

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Aerial view of Genentech's campus in South San Francisco [Credit: Getty]

Genen­tech sub­mits a plan to near­ly dou­ble its South San Fran­cis­co foot­print

The sign is still there, a quaint reminder of whitewashed concrete not 5 miles from Genentech’s sprawling, chrome-and-glass campus: South Francisco The Industrial City. 

The city keeps the old sign, first erected in 1923, as a tourist site and a kind of civic memento to the days it packed meat, milled lumber and burned enough steel to earn the moniker “Smokestack of the Peninsula.” But the real indication of where you are and how much has changed both in San Francisco and in the global economy since a couple researchers and investors rented out an empty warehouse 40 years ago comes in a far smaller blue sign, resembling a Rotary Club post, off the highway: South San Francisco, The Birthplace of Biotech.

A fa­vorite in Alex­ion’s C-suite is leav­ing, and some mighty sur­prised an­a­lysts aren’t the least bit hap­py about it

Analysts hate to lose a biotech CFO they’ve come to trust and admire — especially if they’re being blindsided by a surprise exit.

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David Grainger [file photo]

'Dis­con­nect the bas­tard­s' — one biotech's plan to break can­cer cell­s' uni­fied de­fens­es

Chemotherapy and radiotherapy are the current gladiators of cancer treatment, but they come with well-known limitations and side-effects. The emergence of immunotherapy — a ferocious new titan in oncologist’s toolbox — takes the brakes off the immune system to kill cancer cells with remarkable success in some cases, but the approach is not always effective. What makes certain forms of cancer so resilient? Scientists may have finally pieced together a tantalizing piece of the puzzle, and a new biotech is banking on a new approach to fill the gap.

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While No­var­tis ban­ish­es Zol­gens­ma scan­dal scars — Bio­gen goes on a Spin­raza 'of­fen­sive'

While Novartis painstakingly works to mop up the stench of the data manipulation scandal associated with its expensive gene therapy for spinal muscular atrophy (SMA) Zolgensma— rival Biogen is attempting to expand the use of its SMA therapy, Spinraza. 

The US drugmaker $BIIB secured US approval for Spinraza for use in the often fatal genetic disease in 2016. The approval covered a broad range of patients with infantile-onset (most likely to develop Type 1) SMA. 

Jason Kelly. Mike Blake/Reuters via Adobe

Eye­ing big ther­a­peu­tic push, Gink­go bags $290M to build a cell pro­gram­ming em­pire

Ginkgo Bioworks is on a roll. Days after publicizing a plan to nurture new startups via partnerships with accelerators Y Combinator and Petri, the Boston biotech says it has raised another $290 million for its cell programming platform to reach further and wider.

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