Star drugs like BM­S' Op­di­vo, As­traZeneca's Lyn­parza will get speedy OKs in Chi­na this year, new re­port pre­dicts

Now that Chi­na has re­vamped its drug re­view process to speed things up for de­vel­op­ers, a new re­port pre­dicts that Bris­tol-My­ers Squibb $BMY, As­traZeneca $AZN and Am­gen $AMGN are among the lead­ing multi­na­tion­al phar­ma gi­ants that will win ap­proval for some block­buster hope­fuls. Oth­ers stand to ben­e­fit from mar­ket­ing drugs de­vel­oped by Chi­nese part­ners.

The re­port, pro­duced by Bei­jing-based da­ta provider Pharm­Cube, high­lights 16 prod­ucts Chi­nese reg­u­la­tors are ex­pect­ed to green light in 2018. Over half of them in­volve an over­seas play­er in bio­phar­ma.

The re­port came out just ahead of the CF­DA’s up­dat­ed set of guide­lines for a pri­or­i­ty re­view path­way, con­tin­u­ing an em­pha­sis on speed­ing re­views and new drug ap­provals spot­light­ed through­out last year. Com­pa­nies can now seek pri­or­i­ty re­view of drug can­di­dates that meet one of a list of cri­te­ria, or prove ef­fec­tive in treat­ing sev­er­al ma­jor dis­eases. And a host of key out­fits are rush­ing in to see how they can be­gin to cap­i­tal­ize on the boom­ing Chi­nese health care mar­ket.

On track to be Chi­na’s first PD-1/PD-L1 check­point treat­ment, BMS’ Op­di­vo (nivolum­ab) is high up on the list. The ap­pli­ca­tion was ac­cept­ed in No­vem­ber and grant­ed pri­or­i­ty re­view in De­cem­ber. The hopes for a speedy ap­proval is high giv­en its clin­i­cal ben­e­fits and the at­ten­tion it has gar­nered (not to men­tion that the bi­o­log­ic queue is rel­a­tive­ly short). Con­sid­er­ing As­traZeneca’s lung can­cer drug Tagris­so was OK’d with­in three weeks of get­ting ac­cel­er­at­ed re­view, a Q1 ap­proval does not seem far-fetched.

As­traZeneca is cheer­ing on its own Lyn­parza for ovar­i­an can­cer, which was the first im­port­ed drug to in­clude in­ter­na­tion­al mul­ti­cen­ter da­ta in its ap­pli­ca­tion. Pharm­Cube is look­ing at a Q3 ap­proval for this one, giv­en that it does get fast-tracked.

In the fourth quar­ter there’s Am­gen’s Repatha (evolocum­ab) and No­var­tis’ Zyka­dia (cer­i­tinib) — which low­ers cho­les­terol and treats lung can­cer, re­spec­tive­ly. And if things go smooth­ly, Eli Lil­ly will pock­et a good chunk of rev­enue from mar­ket­ing fruquin­tinib, a prod­uct de­vel­oped by Chi­na’s Hutchi­son MediPhar­ma, which lays claim to be­ing the first true home grown drug to aim at a mar­ket­ing launch. It treats col­orec­tal can­cer, the sec­ond-most preva­lent can­cer in Chi­na.

Here’s the full list:

  1. Fron­tier Biotech: al­bu­ver­tide
  2. Bris­tol My­ers-Squibb: nivolum­ab
  3. Jiang­su Hen­grui Med­i­cine: 19K
  4. CT­TQ: an­lo­tinib hy­drochlo­ride
  5. Jiang­su Hen­grui Med­i­cine: py­ro­tinib
  6. Hutchin­son MediPharm/Eli Lil­ly: fruquin­tinib
  7. As­traZeneca: Lyn­parza  (ola­parib)
  8. Ei­sai: Lenvi­ma (lenva­tinib)
  9. Fi­bro­Gen/AZ: rox­adu­s­tat
  10. Han­soh: PEX168
  11. No­var­tis: Zyka­dia (cer­i­tinib)
  12. Am­gen: Repatha (evolocum­ab)
  13. As­cle­tis: danopre­vir
  14. Gilead: Har­voni (ledi­pasvir/so­fos­bu­vir)
  15. Eli Lil­ly: Trulic­i­ty (du­laglu­tide)
  16. Gilead: Vem­lidy (teno­fovir alafe­namide)


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

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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]

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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

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