Pfiz­er’s block­buster safe­ty is­sue jumps the At­lantic as EMA launch­es its own re­view of Xel­janz

Pfiz­er’s Xel­janz woes have spread to Eu­rope.

Af­ter the FDA an­nounced ear­li­er this week that it is in­ves­ti­gat­ing the in­creased risk of blood clots and death linked to their block­buster JAK in­hibitor seen in a post-mar­ket­ing study, the EMA says they’ll now make their own as­sess­ment on the safe­ty of the drug.

“EMA is as­sess­ing the re­sults of the study and will con­sid­er what reg­u­la­to­ry ac­tion is need­ed,” the agency said in a state­ment sent to End­points News. The EMA added that pa­tients should con­sult a doc­tor if they have any ques­tions.

Eu­ro­pean reg­u­la­tors had proved much tougher than the FDA on Xel­janz, wait­ing un­til 2017 to ap­prove the drug for rheuma­toid arthri­tis af­ter de­lay­ing the roll­out for more safe­ty da­ta — 6 years af­ter the FDA OK.

The drug en­tered the mar­ket with a black box warn­ing of a high­er risk of in­fec­tions, but the phar­ma gi­ant set off alarm bells when re­searchers said they were tak­ing peo­ple off the 10 mg dose used in their as­sess­ment of the drug’s safe­ty among pa­tients with an added car­dio risk af­ter the tri­al mon­i­tors con­clud­ed that the drug was as­so­ci­at­ed with high­er rates of blood clots and death.

Both the FDA and EMA note that the rec­om­mend­ed dose for Xel­janz in RA is 5 mg twice a day, but the drug is ap­proved at 10 mg for ul­cer­a­tive col­i­tis. Eli Lil­ly al­so faced its own chal­lenges af­ter the FDA ini­tial­ly re­ject­ed its JAK in­hibitor baric­i­tinib, fi­nal­ly ap­prov­ing it as Olu­mi­ant last year at a low­er dose than it had sought.

The new safe­ty alert comes at a bad time for Pfiz­er, which is de­pend­ing on ris­ing sales of its block­buster drug at a time when US law­mak­ers have been ham­mer­ing hard against an­nu­al price hikes. Oth­er JAKs are in the late-stage pipeline with their own claims on safe­ty and ef­fi­ca­cy that will now face fur­ther scruti­ny.

On the oth­er hand, any new RA ther­a­py en­ter­ing the field with a bet­ter safe­ty pro­file will be look­ing at a se­ri­ous­ly dis­rupt­ed mar­ket.

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

Genen­tech sub­mits a big plan to ex­pand 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.

Here comes the oral GLP-1 drug for di­a­betes — but No­vo Nordisk is­n't dis­clos­ing Ry­bel­sus price 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.

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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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.

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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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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Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

Over the past 10 years I’ve made a point of getting to know the Golden Triangle and the special role the UK biopharma industry plays there in drug development. The concentration of world class research institutes, some of the most accomplished scientists I’ve ever seen at work and a rising tide of global investment cash leaves an impression that there’s much, much more to come as biotech hubs are birthed and nurtured.