Mark Ahn (via PR Newswire)

For­mer Gale­na chief Mark Ahn back in hot wa­ter as DOJ lev­els in­sid­er trad­ing charges for con­sul­tant work

When Mark Ahn de­part­ed trou­bled Gale­na Phar­ma­ceu­ti­cals back in 2014, he told in­vestors he look­ing to pur­sue oth­er “long-held” goals. Turns out one of those goals may al­leged­ly have been ped­dling stock based on in­sid­er in­fo.

The DOJ on Mon­day charged Ahn, Gale­na’s for­mer CEO, with two counts of se­cu­ri­ties fraud af­ter he al­leged­ly bought a biotech’s stock based on non­pub­lic in­for­ma­tion about the com­pa­ny’s in­tent to sell, which he ac­quired as a con­sul­tant.

Ahn al­so faces a civ­il in­ves­ti­ga­tion from the SEC on claims he prof­it­ed on in­sid­er knowl­edge of Cam­bridge, Mass­a­chu­setts-based Di­men­sion Ther­a­peu­tics’ be­hind-the-scenes work to sell back in 2017. Di­men­sion was suc­cess­ful in that at­tempt, sell­ing to Cal­i­for­nia ul­tra-rare dis­ease drug­mak­er Ul­tragenyx for $151 mil­lion in Oc­to­ber of that year.

At the time, Ahn worked as a con­sul­tant for New York’s Abeona Phar­ma­ceu­ti­cals, which was piec­ing to­geth­er a buy­out of­fer for Di­men­sion their team dubbed “Pro­ject Di­a­mond,” ac­cord­ing to charg­ing doc­u­ments. Ahn was al­leged­ly made aware by Abeona’s CEO that Di­men­sion was in­ter­est­ed in sell­ing and be­gin buy­ing shares of the biotech in mid-2017

Once Di­men­sion an­nounced it would sell in Au­gust, the biotech’s stock sky­rock­et­ed 262% in a sin­gle day, net­ting Ahn a ma­jor re­turn on the rough­ly 28,000 shares he had pur­chased, the feds al­lege.

Ahn will face up to 25 years in prison and five years of su­per­vised re­lease along with a $250,000 fine, the DOJ said.

Ahn’s name will ring a bell with those who fol­lowed the Gale­na de­ba­cle back in 2014, when the SEC launched an in­ves­ti­ga­tion over an il­le­gal pro­mo­tion­al scheme that even­tu­al­ly led to Ahn’s jet­ti­son from the com­pa­ny. Gale­na al­leged­ly hired an in­vestor re­la­tions firm to draft and post es­says on­line that pur­port­ed to be ob­jec­tive analy­ses of the com­pa­ny’s se­cu­ri­ties but was ac­tu­al­ly paid for by Gale­na. The drug­mak­er then failed to dis­close that fi­nan­cial arrange­ment, putting it in the SEC’s crosshairs.

Ahn stepped down in late 2014, cit­ing the need to pur­sue oth­er op­por­tu­ni­ties, and was stripped of his sev­er­ance pay on the way out the door. Ahn was among a group of com­pa­ny in­sid­ers who sold stock dur­ing the pro­mo­tion­al scheme and was be­ing watched by Gale­na’s board amid the SEC in­ves­ti­ga­tion.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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