In­ves­ti­ga­tors prep PhI­II in ef­fort to move MD­MA (you know it as ec­sta­sy) off the street and in­to use for PTSD

Over the past few years there has been a grow­ing push to study the ef­fi­ca­cy of il­lic­it drugs for a range of neu­ropsy­chi­atric con­di­tions. And now a group of in­ves­ti­ga­tors are re­port­ed­ly prep­ping a Phase III tri­al of MD­MA, bet­ter known on the street as ec­sta­sy, for post trau­mat­ic-stress dis­or­der.

The Mul­ti­dis­ci­pli­nary As­so­ci­a­tion for Psy­che­del­ic Stud­ies is un­der­tak­ing the study, ac­cord­ing to The New York Times, which did an in-depth fea­ture on the drug and its slow progress in the clin­ic. MAPS, a non­prof­it fu­eled by do­na­tions, has been ad­vo­cat­ing for the clin­i­cal use of a range of psy­che­delics like MD­MA and LSD, as well as mar­i­jua­na, but on­ly af­ter a rig­or­ous sci­en­tif­ic re­view. And it can cite Phase II da­ta that in­di­cate MD­MA can end PTSD symp­toms that af­flict a large per­cent­age of pa­tients.

They’re not alone in this ap­proach.

David Nutt in the UK — for­mer drugs ad­vis­er to the gov­ern­ment — has been ad­vo­cat­ing the same po­si­tion, of­ten quite con­tro­ver­sial­ly, with a new study out ear­li­er this year that looks at the il­lu­mi­nat­ing im­pact of LSD on the brain. Aca­d­e­mics have re­peat­ed­ly looked at the use of ke­t­a­mine, or Spe­cial K, for de­pres­sion and sui­cide. Last sum­mer Robert Malen­ka, a psy­chi­a­trist and neu­ro­sci­en­tist at Stan­ford Uni­ver­si­ty, not­ed that sci­en­tists still have no idea of all the path­ways that MD­MA takes. But it is known that the Sched­ule 1 drug elic­its very strong feel­ings of em­pa­thy, which may make it par­tic­u­lar­ly ef­fec­tive in treat­ing con­di­tions like PTSD.

“Drugs like MD­MA should be the ob­ject of rig­or­ous sci­en­tif­ic study, and should not nec­es­sar­i­ly be de­mo­nized,” Malen­ka not­ed re­cent­ly. But not every­one is hap­py with the idea.

“It sends the mes­sage that this drug will help you solve your prob­lems, when of­ten it just cre­ates prob­lems,” Swansea Uni­ver­si­ty’s An­drew Par­rott told The Times. “This is a messy drug we know can do dam­age.”

MAPS may be in a bet­ter sit­u­a­tion to ad­dress that con­cern af­ter its Phase III. There are no spe­cif­ic time­lines in The New York Times piece, but the writer says that the in­ves­ti­ga­tors are seek­ing a break­through drug des­ig­na­tion to speed a reg­u­la­to­ry re­view. Reg­u­la­tors, though, have a long track record of re­main­ing ex­tra­or­di­nar­i­ly cau­tious in han­dling con­trolled sub­stances. The group tells The Times that they should have a prod­uct ready by 2021.

Five years to fin­ish a Phase III with 230 pa­tients and a BTD fits no known de­vel­op­ment out­line I’m fa­mil­iar with, un­less they’re plan­ning a se­ries of stud­ies to con­vince skep­tics. In this field, though, re­searchers are blaz­ing a com­plete­ly unique, and very dif­fi­cult, clin­i­cal trail.

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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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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UP­DAT­ED: Speak­er Nan­cy Pelosi to un­veil bill for fed­er­al­ly ne­go­ti­at­ed drug prices

After months of buzz from both sides of the aisle, Speaker Nancy Pelosi will today introduce her plan to allow the federal government to negotiate prices for 250 prescription drugs, setting up a showdown with a pharmaceutical industry working overtime to prevent it.

The need to limit drug prices is a rare point of agreement between President Trump and Democrats, although the president has yet to comment on the proposal and will likely face pressure to back a more conservative option or no bill at all. Republican Senator Chuck Grassley is reportedly lobbying his fellow party members on a more modest proposal he negotiated with Democratic Senator Ron Wyden in July.