Eye drop de­vel­op­er Oculis show­cas­es pos­i­tive PhII da­ta; Aque­s­tive hunts for an­oth­er FDA OK

→ Oph­thal­mol­o­gy-fo­cused Swiss drug de­vel­op­er Oculis has rolled out pos­i­tive da­ta from their Phase II study of OCS-01 — an eye drop for­mu­la­tion of dex­am­etha­sone for the treat­ment of di­a­bet­ic mac­u­lar ede­ma (DME). The study met its pre-de­fined ef­fi­ca­cy end­points and showed that OCS-01 eye drops were more ef­fec­tive than the ve­hi­cle in di­min­ish­ing cen­tral mac­u­lar thick­ness and im­prov­ing acu­ity in pa­tients with DME.

→ Af­ter re­ceiv­ing the green light from the FDA to mar­ket Exser­van, oral film ver­sion of a gener­ic ALS drug last No­vem­ber, Aque­s­tive Ther­a­peu­tics an­nounced that the FDA has ac­cept­ed the com­pa­ny’s NDA for Liber­vant (di­azepam) buc­cal film for the man­age­ment of seizure clus­ters. A PDU­FA date has been set for Sep­tem­ber 27, 2020.

David Mor­ris En­ter­prise

→ Res­pi­ra­to­ry dis­ease-fo­cused En­ter­prise Ther­a­peu­tics has tapped David Mor­ris as CMO. In his new role, Mor­ris will lead the clin­i­cal de­vel­op­ment for ETD002 and ETD001 — ther­a­pies aimed at treat­ing cys­tic fi­bro­sis pa­tients. Mor­ris joins the com­pa­ny from No­var­tis Ven­ture Fund, where he cur­rent­ly serves as a man­ag­ing di­rec­tor and will con­tin­ue as op­er­at­ing part­ner. Pri­or to that, Mor­ris worked with No­var­tis and Roche.

→ Af­ter win­ning a la­bel ex­ten­sion from the FDA for their block­buster Ozem­pic, No­vo Nordisk is drop­ping DKK 800 mil­lion in up­grad­ing and ex­pand­ing fa­cil­i­ties at the com­pa­ny’s pro­duc­tion site in Kalund­borg, Den­mark. The in­jec­tion of cash will boost its ca­pac­i­ty to pro­duce di­a­betes treat­ments — and the ex­pan­sion is ex­pect­ed to be com­plet­ed by 2022.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Cameron Durrant, Humanigen CEO (Columbia University Technology Ventures via YouTube)

Cameron Dur­rant hus­tled his way from the OTC side­lines right in­to the Covid-19 drug race. Death or glo­ry lies straight ahead

Over the past few months, Covid-19 has gone from being a monolithic threat to one of the biggest overnight boons the biopharma industry has ever seen. And amid all the furor over Moderna’s swelling stock price, plenty of chatter over what new drugs and vaccines will cost and investors’ uninhibited zeal for all things related to pandemic products, it’s been one little biotech’s golden ticket back from the land of the living dead.

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Credit: AP Images

Covid-19 roundup: BAR­DA sup­ports Op­er­a­tion Warp Speed with big $628M con­tract to ser­vice Amer­i­ca's vac­cine pro­duc­tion needs

Another BARDA contract designed to service America’s Covid-19 vaccine needs has been deployed.

The White House-led initiative designed to bankroll development to bring a vaccine to the American public by this fall — Operation Warp Speed — has via BARDA handed a meaty contract to the maker of an FDA-licensed anthrax vaccine to open up its manufacturing apparatus to shore up production of Covid-19 vaccines.

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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Adam Keeney (NodThera)

As NL­RP3 play­ers head for first clin­i­cal face-off, No­vo, Sanofi fu­el trans-At­lantic con­tender with $55M

In the relative short history of inflammasome research, Adam Keeney sees two time points marking major breakthroughs: the early 2000s, when the role of inflammasomes as a major innate immunity node was elucidated; and 2015, when Pfizer found out a compound it thought was targeting IL-1 actually blocks NLRP3. Keeney’s biotech, NodThera, was founded the year after alongside several others to create its own superior small molecule drugs.

Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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