Robert Coughlin, MassBio

Mass­Bio head Cough­lin set to step down af­ter over­see­ing mas­sive bio­phar­ma ex­pan­sion in the state dur­ing 13-year tenure

The past decade has been good to bio­phar­ma, nowhere more so than the bustling and ever-ex­pand­ing life sci­ences hub in and around Boston. At the tip of the spear of that ex­pan­sion is non­prof­it trade as­so­ci­a­tion Mass­Bio and its long-tenured CEO Robert Cough­lin.

Now, Cough­lin is step­ping aside as the hub con­tin­ues to bloom.

In an open let­ter an­nounc­ing his de­par­ture ear­ly next year, Cough­lin tout­ed the work Mass­Bio has done in his 13 years at the non­prof­it amid an in­dus­try­wide boom that has brought 18 of the top 20 bio­phar­ma play­ers to the greater Boston area, he said.

In all, Mass­Bio’s 140 mem­bers have added 16.5 mil­lion square feet of com­mer­cial lab space and 38,000 new jobs in the past 10 years, spurred by a rush of in­vestor mon­ey in­to the space, Cough­lin wrote. The in­dus­try over­all has seen 94% growth in 15 years, Cough­lin not­ed, ic­ing Boston’s po­si­tion as one of the ma­jor cen­ters for med­ical in­no­va­tion in the world.

Kendalle Burlin O’Con­nell

“The Mass­a­chu­setts life sci­ences clus­ter has gone from one of the best places in the world for our in­dus­try to the best be­cause of our unique part­ner­ship be­tween in­dus­try, acad­e­mia, and gov­ern­ment,” Cough­lin wrote.

As Mass­Bio looks for its next CEO, the non­prof­it will be led in the in­ter­im by chief op­er­at­ing of­fi­cer Kendalle Burlin O’Con­nell, who has been pro­mot­ed to pres­i­dent and will keep her cur­rent role; Zach Stan­ley, Mass­Bio’s VP of pub­lic af­fairs, who has been pro­mot­ed to ex­ec­u­tive VP; and Kris­tine Kel­ly, VP of ad­min­is­tra­tion and fi­nance. Cough­lin said he left the or­ga­ni­za­tion “well-po­si­tioned to suc­ceed” in his stead.

Cough­lin’s long run at the helm wasn’t on­ly a ma­jor suc­cess for the Boston life sci­ences hub but one that struck a per­son­al note for him, he wrote in the let­ter. When Cough­lin be­gan his tenure, his then-5-year-old son was pre­vi­ous­ly di­ag­nosed with cys­tic fi­bro­sis, which at the time had no ap­proved ther­a­pies. More than a decade lat­er, Cough­lin wrote, a “Mass­a­chu­setts com­pa­ny” — Boston-based Ver­tex — has scored FDA ap­provals for a suite of CF drugs that could vast­ly ex­tend his son’s life.

“To­day, I can con­fi­dent­ly say that he’ll out­live me,” Cough­lin wrote. “This was not some­thing I could have said a few years ago.”

Af­ter more than a decade of rapid growth, bio­phar­ma in­vest­ment in the Boston area hub doesn’t ap­pear to be slow­ing much as Mass­Bio looks to the fu­ture. On top of the seem­ing­ly end­less stream of star­tups and ear­ly- to mid-stage biotechs at work, ma­jor phar­ma­ceu­ti­cal com­pa­nies are al­so mak­ing big moves to ex­pand their pres­ence.

In Sep­tem­ber, Take­da an­nounced the open­ing of a 24,000 square-foot cell ther­a­py man­u­fac­tur­ing fa­cil­i­ty at its R&D head­quar­ters in Boston. Take­da tout­ed the new fa­cil­i­ty’s prox­im­i­ty to its ex­ist­ing work­force in Boston as a key ben­e­fit for its newest team, which is de­signed to pro­duce clin­i­cal-grade ma­te­r­i­al from dis­cov­ery through piv­otal Phase IIb tri­als.

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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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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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.

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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Michael Shpigelmacher

Khosla joins bet on un­con­ven­tion­al start­up look­ing to send drug de­liv­er­ing ro­bots in­to the brain

When Michael Shpigelmacher started the project, he knew he’d have to fund it himself. Every other effort of its kind was academic, rejected as too risky by investors.

Shpigelmacher, a robotics geek and entrepreneur who had drifted into consulting for pharma, wanted to build the real-life equivalent of technology from the 1960s film “Fantastic Voyage,” the one where a submarine crew is shrunk to “about the size of a microbe” and sent on a mission to repair a scientist’s brain. He scanned the literature, found the lab that was working on the most advanced project — at the Max Planck Institute in Germany, it turned out — and started funding them with money from his and his co-founders’ own accounts, along with some seed cash from friends and family.

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.