House ap­proves $3.2 bil­lion FDA bud­get

The House of Rep­re­sen­ta­tives passed a four-bill ap­pro­pri­a­tions minibus for fis­cal year 2021 that in­cludes an amend­ment giv­ing the FDA the au­thor­i­ty to re­call drugs. The agency’s pro­posed bud­get al­so in­cludes tar­get­ed boosts to spend­ing for med­ical prod­uct and food safe­ty ac­tiv­i­ties and in­fluen­za vac­cine man­u­fac­tur­ing tech­nolo­gies.

Oth­er tar­get­ed ini­tia­tives in­clude cross-de­part­men­tal ini­tia­tives de­signed to en­hance food and med­ical prod­uct safe­ty; ad­di­tion­al­ly, “[T]he bill in­cludes a strong fo­cus on con­tin­u­ing FDA’s ef­forts to en­able faster re­spons­es to food­borne ill­ness out­breaks and in­crease the safe­ty and cy­ber­se­cu­ri­ty of med­ical de­vices,” ac­cord­ing to the House Ap­pro­pri­a­tions Com­mit­tee’s sum­ma­ry of the minibus.

Ad­di­tion­al funds are tar­get­ed to de­vel­op a cannabid­i­ol reg­u­la­tion frame­work, and med­ical prod­uct de­vel­op­ment would re­ceive a $70 mil­lion ap­pro­pri­a­tion, as pro­vid­ed by the 21st Cen­tu­ry Cures Act.

The bill in­cludes lan­guage pro­vid­ing FDA, for the first time, with manda­to­ry re­call au­thor­i­ty for pre­scrip­tion and over-the-counter drugs,” ac­cord­ing to the minibus sum­ma­ry. Ad­di­tion­al­ly, “The bill in­cludes lan­guage di­rect­ing the FDA to de­vel­op a plan to iden­ti­fy, de­tain, and refuse the im­port of FDA-reg­u­lat­ed prod­ucts from a for­eign es­tab­lish­ment that did not al­low phys­i­cal ac­cess to FDA in­ves­ti­ga­tors.”

A to­tal of $3.212 bil­lion is slat­ed for FDA in HR 7608, $40.8 mil­lion more than the 2020 en­act­ed lev­el. The $259.5 bil­lion minibus pack­age in­cludes ap­pro­pri­a­tions for State-For­eign Op­er­a­tions, In­te­ri­or-En­vi­ron­ment and Mil­i­tary Con­struc­tion and Vet­er­ans Af­fairs in ad­di­tion to the Agri­cul­ture-Rur­al De­vel­op­ment-FDA ap­pro­pri­a­tions.

The pri­or­i­ties and bud­get for FDA in the minibus are un­changed from the bill ap­proved by the House Ap­pro­pri­a­tions Com­mit­tee on 9 Ju­ly. At that time, the Al­liance for a Stronger FDA thanked the House Ap­pro­pri­a­tions Agri­cul­ture/FDA sub­com­mit­tee in a blog post, while call­ing for in­creased lev­els of sup­port for FDA: “We view the pro­posed $41 mil­lion in­crease in FY 21 as a vote of con­fi­dence in the agency, giv­en the se­vere bud­getary con­straints for all fed­er­al pro­grams. We be­lieve the FDA will still need more re­sources in the com­ing fis­cal year to ful­fill its mis­sion and we will con­tin­ue to work with Con­gress to achieve that end,” said the Al­liance.

Ac­tion on the FY 2021 FDA bud­get next comes from the Sen­ate; it is un­cer­tain whether a bud­get will be fi­nal­ized be­fore the be­gin­ning of the next fis­cal year on 20 Oc­to­ber 2020, or whether the agency will need to start fis­cal year (FY) 2021 with fund­ing from a Con­tin­u­ing Res­o­lu­tion (CR).

Steven Gross­man, deputy ex­ec­u­tive di­rec­tor of the Al­liance for a Stronger FDA, stat­ed that “The con­se­quences of a CR are se­vere, even though they may be tem­po­rary. The FDA would need to car­ry out its pro­grams us­ing the FY 20 (pri­or year) fund­ing lev­els, with­out the in­creased monies pro­posed for FY 21 by the House.”

“Fur­ther,” said Gross­man, “FDA would be lim­it­ed in its abil­i­ty to start new ini­tia­tives (var­i­ous­ly de­fined) for as long as it is on CR fund­ing. Last (but hard­ly least), CRs cre­ate un­cer­tain­ty, which makes pro­gram and per­son­nel plan­ning dif­fi­cult.”


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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Vi­da Ven­tures co-leads Dyne's $115M megaround for next-gen oli­go ther­a­pies aimed square­ly at mus­cles

Dyne Therapeutics started out last April with a modest $50 million to mine targeted muscle disease therapies from its in-house conjugate technology. The biotech has now convinced more investors that it’s got gems on its hands, closing $115 million in fresh financing to push its next-gen oligonucleotide drugs into the clinic.

Vida Ventures and Surveyor Capital led the round, joined by a group of other new backers including Wellington Management Company, Logos Capital and Franklin Templeton.

Eli Lil­ly teams with Pieris on HER2+ tu­mors; Op­di­vo + Yer­voy best chemo in mesothe­lioma

Despite the FDA putting a partial clinical hold on its lead program only a few weeks ago, Boston-based Pieris Pharmaceuticals is plowing forward with a new collaboration.

Pieris will work with Eli Lilly to further advance studies on PRS-343, a 4-1BB/HER2 bispecific for HER2-positive tumors, in combination with the latter’s ramucirumab and paclitaxel for the second-line treatment of patients with HER2-positive gastric cancer in a single-arm, Phase II study.

In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Gallia Levy, Spark CMO (Roche)

Spark Ther­a­peu­tics nabs new CMO from Genen­tech, fill­ing a ma­jor post-merg­er de­par­ture

Spark Therapeutics is getting a new CMO from their new owners.

The gene therapy company-turned-subsidiary has named Gallia Levy, who had been running rare blood disorders — including clinical development for their blockbuster-potential hemophilia antibody Hemlibra for Roche’s big biotech sub Genentech — to run medical affairs.

The appointment is a fitting one. Roche spent $4.8 billion to acquire Spark last year in large part to get their hands on their hemophilia gene therapy, SPK-8011, and expand the toe-hold Hemlibra gave them in an crowded hemophilia space.  It’s also a somewhat ironic appointment: The FTC held up the Spark acquistions for nearly a year, reportedly over concerns about the anti-trust implications of Roche owning both a top chronic treatment in Hemlibra and a top one-time treatment in Spark’s gene therapy.

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