Pfiz­er, Astel­las win pri­or­i­ty re­view for Xtan­di sN­DA; Hemi­spherx changes its name

→ The FDA has grant­ed Pfiz­er $PFE and Astel­las pri­or­i­ty re­view for a la­bel ex­pan­sion for Xtan­di, the prostate can­cer drug it grabbed in the $14 bil­lion ac­qui­si­tion of Medi­va­tion. An ap­proval here, for metasta­t­ic hor­mone-sen­si­tive prostate can­cer, would make the drug avail­able to pa­tients ear­li­er in their treat­ment reg­i­men, the com­pa­nies said. In two Phase III stud­ies, the drug was shown to im­prove pro­gres­sion-free sur­vival when used in con­junc­tion with an­dro­gen de­pri­va­tion ther­a­py. 

Hemi­spherx Bio­phar­ma is putting all its eggs in the Ampli­gen bas­ket, and it’s chang­ing its name to re­flect that. The com­pa­ny’s new name, AIM Im­munoTech, stands for “am­pli­fied im­muno­log­i­cal mod­u­la­tion” — the tech­nol­o­gy that its lead drug is based on. Cor­re­spond­ing­ly it will be trad­ing on the NYSE un­der $AIM in­stead of $HEB.

→ Boston biotech HotSpot Ther­a­peu­tics, which is work­ing mol­e­cules to treat se­ri­ous au­toim­mune and meta­bol­ic dis­eases, is buy­ing out its part­ner Macro­ceu­tics. HotSpot’s tech­nol­o­gy is en­gi­neered to iso­late ‘reg­u­la­to­ry hotspots’ — a “fam­i­ly of pock­ets that sit re­mote from the ac­tive site on a pro­tein and are used by na­ture to con­trol pro­tein func­tion,” to de­vel­op med­i­cines. Macro­ceu­tics is provider of DNA-en­cod­ed li­brary (DEL) screen­ing tech­nol­o­gy, which mol­e­cules to be syn­the­sized and screened against a pro­tein of in­ter­est.  “Us­ing the rich struc­tur­al in­for­ma­tion de­liv­ered by our plat­form, we have a roadmap for the de­sign of cus­tomized chem­i­cal scaf­folds. DEL tech­nol­o­gy al­lows us to trans­late these in­sights in­to mil­lions of tai­lored scaf­folds quick­ly, ac­cel­er­at­ing hit ex­pan­sion and lead op­ti­miza­tion ef­forts,” Geral­dine Har­ri­man, co-founder and Chief Sci­en­tif­ic Of­fi­cer of HotSpot Ther­a­peu­tics said in a state­ment. No fi­nan­cial de­tails were dis­closed. 

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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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

A year after taking the reins as CEO of Lundbeck, Deborah Dunsire is making a bold bid to beef up the Danish biotech’s portfolio of drugs in what will likely be a direct leap into an intense rivalry with a group of giants now carving up a growing market for new migraine drugs.

Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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San Diego cou­ple charged with steal­ing trade se­crets, open­ing Chi­nese biotech as DOJ crack­down con­tin­ues

A San Diego couple has been charged with stealing trade secrets from a US hospital and opening a business based off those secrets in China as the controversial industry-wide crackdown on alleged corporate espionage continues. On the same day, the Department of Justice announced they had arrested Beijing representative Zhongsan Liu for allegedly trying to obtain research visas for government recruiters.

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UP­DAT­ED: Bio­gen pulls the plug on prized IPF drug from $562M+ Stromedix buy­out

One of Biogen’s attempts to branch out has flopped as the biotech scraps a mid-stage program for idiopathic pulmonary fibrosis.

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

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.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

Psychedelics have experienced a renaissance in recent years amid a torrent of preclinical and clinical research suggesting it might provide a path to treat mood disorders conventional remedies have only scraped at. Now a preclinical trial from a young biotech suggests at least one psychedelic compound has effects beyond the mind, and — if you believe the still very, very early hype — could provide the first single remedy for some of the main complications of obesity.

Ac­celeron drops a de­vel­op­ment pro­gram as #2 drug fails to spark func­tion­al ben­e­fits in pa­tients with a rare neu­ro­mus­cu­lar ail­ment

Acceleron is scrapping a muscular dystrophy development program underway for its number 2 drug in the pipeline after pouring over some failed mid-stage secondary data.

Gone is the ACE-083 project in patients with facioscapulohumeral muscular dystrophy. Their drug hit the primary endpoint on building muscle but flopped on key secondaries for functional improvements in patients, which execs felt was vital to the drug’s success.