Ko­re­an bio­phar­ma ex­ec­u­tive in­dict­ed for al­leged­ly con­duct­ing il­le­gal tri­als on com­pa­ny re­searchers

Ko­re­an news out­lets are re­port­ing that an ex­ec­u­tive at a ma­jor Ko­re­an phar­ma­ceu­ti­cal com­pa­ny has been ar­rest­ed for con­duct­ing il­le­gal clin­i­cal tests on com­pa­ny re­searchers.

Cit­ing the Seoul West­ern Dis­trict Pros­e­cu­tors’ Of­fice and oth­er of­fi­cials, The Ko­rea Times re­port­ed that Auh Jin of Ahn-Gook Phar­ma­ceu­ti­cal was ar­rest­ed for car­ry­ing out il­le­gal tests on the com­pa­ny’s own re­searchers in vi­o­la­tion of the coun­try’s phar­ma­cy law. The Ko­rea Her­ald sim­i­lar­ly re­port­ed that Jin had been ar­rest­ed.

The news came as a ma­jor blow to a com­pa­ny that has al­ready seen its share of bad head­lines and to a Ko­re­an sec­tor that has seen both le­gal con­tro­ver­sy and ma­jor re­search fail­ures in re­cent months. Last week, Ko­re­an au­thor­i­ties re­port­ed­ly raid­ed the of­fices of biotech Sil­la­Jen on sus­pi­cion of in­sid­er trad­ing (ex­ec­u­tives had ap­par­ent­ly sold some or all of their shares di­rect­ly be­fore news broke that a Phase III tri­al for a ma­jor on­colyt­ic had failed and the com­pa­ny’s stock pum­meled). Be­fore that J&J, Boehringer and Eli Lil­ly walked away from ma­jor deals with Han­mi, shock­ing the stock price, and Sam­sung Bi­o­log­ic’s stock was sus­pend­ed over vi­o­la­tions re­lat­ed to its 2016 IPO.

Ac­cord­ing to The Ko­rea Times, Ahn-Gook ad­min­is­tered sev­er­al med­i­cines to re­searchers, in­clud­ing an­ti­hy­per­ten­sive and an­ti­co­ag­u­lant agents, as it test­ed in­cre­men­tal­ly mod­i­fied drugs. Due to a risk of in­ter­nal bleed­ing, these drugs re­quire pre­scrip­tions and con­stant mon­i­tor­ing, none of which were pro­vid­ed, The Ko­rea Times re­port­ed. The re­searchers al­so al­leged­ly did not sign con­sent forms and did not re­ceive check­ups.

The op­er­a­tion was re­port­ed­ly un­cov­ered when a Na­tion­al Foren­sic Ser­vice analy­sis found the com­pa­ny was us­ing hu­man blood for tests, as op­posed to the bea­gle blood they list­ed in re­ports.

Ahn-Gook said the tests were ful­ly vol­un­tary and done with re­searcher con­sent, ac­cord­ing to The Ko­rea Times.

For Ahn-Gook, this news comes af­ter the com­pa­ny faced al­le­ga­tions of giv­ing kick­backs to physi­cians in both 2009 and 2014 – a charge that has reap­peared. The Ko­rea Times re­ports that in Ju­ly, Jin and oth­er ex­ec­u­tives were al­so in­dict­ed for brib­ing 85 doc­tors to pre­scribe their prod­ucts, giv­ing out near­ly $7.5 mil­lion. The doc­tors were al­so re­port­ed­ly in­dict­ed.

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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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.

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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Jeff Kindler's Cen­trex­ion re­news bid to make pub­lic de­but

Jeffrey Kindler’s plan to take his biotech — which is developing a slate of non-opioid painkillers — public, is back on.

The Boston based company, led by former Pfizer $PFE chief Kindler, originally contemplated a $70 million to $80 million IPO last year— but eventually postponed that strategy. On Wednesday, the company revived its bid to make a public debut in a filing with the SEC — although no pricing details were disclosed.

Zachary Hornby. Boundless

'A fourth rev­o­lu­tion in can­cer ther­a­pies': ARCH-backed Bound­less Bio flash­es big check, makes big­ger promis­es in de­but

It was the cellular equivalent of opening your car door and finding an active, roaring engine in the driver seat.

Scientists learned strands of DNA could occasionally appear outside of its traditional home in the nucleus in the 1970s, when they appeared as little, innocuous circles on microscopes; inexplicable but apparently innate. But not until UC San Diego’s Paul Mischel published his first study in Science in 2014 did researchers realize these circles were not only active but potentially overactive and driving some cancer tumors’ superhuman growth.

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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Mer­ck helps bankroll new part­ner Themis' game plan to fin­ish the chikun­gun­ya race and be­gin on­colyt­ic virus quest

As Themis gears up for a Phase III trial of its chikungunya vaccine, the Vienna-based biotech has closed out €40 million ($44 million) to foot the clinical and manufacturing bills.

Its heavyweight partners at Merck — which signed a pact around a mysterious “blockbuster indication” last month — jumped into the Series D, led by new investors Farallon Capital and Hadean Ventures. Adjuvant Capital also joined, as did current investors Global Health Investment Fund, aws Gruenderfonds, Omnes Capital, Ventech and Wellington Partners Life Sciences.