Last-minute US spend­ing bill fea­tures a be­gin­ning for ARPA-H, and half of what Biden re­quest­ed for Covid-19

The House and Sen­ate are again rac­ing against the clock to pass an an­nu­al $1.5 tril­lion gov­ern­ment spend­ing bill, with a tight dead­line Fri­day that may have to be briefly ex­tend­ed to ear­ly next week.

Un­der the 2,700+ page bill for 2022, re­leased just af­ter mid­night on Wednes­day, fund­ing for Covid-re­lat­ed pro­vi­sions will on­ly hit $15.6 bil­lion af­ter the Biden ad­min­is­tra­tion pre­vi­ous­ly re­quest­ed about $30 bil­lion to help pre­pare for the next wave of cas­es.

That to­tal in­cludes al­most $10 bil­lion for BAR­DA to buy more oral Covid-19 an­tivi­rals, mon­o­clon­al an­ti­bod­ies and vac­cines, which will be cru­cial to ramp up sup­plies, par­tic­u­lar­ly for Pfiz­er’s pill. Al­though the US has pur­chased a to­tal of 10 mil­lion cours­es of Pfiz­er’s an­tivi­ral Paxlovid, on­ly about 690,000 cours­es have al­ready been dis­trib­uted, and on­ly about 100,000 more cours­es have so far been pro­cured to date.

An ad­di­tion­al $750 mil­lion in 2022 funds will go to­ward de­vel­op­ing vac­cines that pro­tect against fu­ture vari­ants. Who will re­ceive those funds re­mains un­known. And an­oth­er near­ly $4.5 bil­lion will go to an ini­tia­tive to in­crease glob­al vac­ci­na­tions over­seas, with an aim for a 70% vac­ci­na­tion rate in every coun­try.

Mean­while, the spend­ing bill, which is ex­pect­ed to clear Con­gress and be signed by Biden, al­so in­cludes $1 bil­lion to kick-start Biden’s new­ly pro­posed Ad­vanced Re­search Pro­jects Agency for Health or ARPA-H. Biden had ini­tial­ly re­quest­ed $6.5 bil­lion for the NIH-housed re­search out­fit, which is go­ing to mir­ror DARPA with risky, ground­break­ing in­vest­ments.

ARPA-H’s in­vest­ments in­to var­i­ous re­search en­deav­ors may in­clude can­cer vac­cine de­vel­op­ment, or even ways to make man­u­fac­tur­ing process­es for pa­tient-spe­cif­ic T cells cheap­er and eas­i­er.

Mean­while, the De­part­ment of De­fense is al­so dol­ing out $577.5 mil­lion for can­cer re­search in 2022, on top of the Na­tion­al Can­cer In­sti­tute’s $6.7 bil­lion bud­get. The DoD funds in­clude $150 mil­lion for breast can­cer re­search and $110 mil­lion for prostate can­cer re­search.

The FDA will re­ceive a to­tal of $3.3 bil­lion in dis­cre­tionary fund­ing from the bill for 2022, which is a slight in­crease of $102 mil­lion above the FY 2021 en­act­ed lev­el. But the ap­pro­pri­a­tions from Con­gress make up a lit­tle more than half of all to­tal fund­ing for FDA, which al­so gets $2.9 bil­lion in in­dus­try user fees next year.

With­in this 2022 to­tal, the House Ap­pro­pri­a­tions Com­mit­tee pro­vides a tar­get­ed in­crease of $29 mil­lion at FDA to ad­dress the opi­oid cri­sis, med­ical sup­ply chain sur­veil­lance, rare can­cers, and in­creas­ing and strength­en­ing in-per­son in­spec­tions of for­eign drug man­u­fac­tur­ers, the ap­pro­pri­a­tions com­mit­tee said.

No less than $8.5 mil­lion is set aside in the FDA’s bud­get for pi­lot projects to in­crease unan­nounced for­eign drug in­spec­tions.

Mem­bers on both sides of the aisle have crit­i­cized the FDA for not con­duct­ing more unan­nounced in­spec­tions over­seas (where­as FDA of­ten in­spects do­mes­tic fa­cil­i­ties unan­nounced) al­though FDA of­fi­cials have ex­plained that if the ap­pro­pri­ate of­fi­cials are not at the for­eign site when the FDA in­spec­tors show up unan­nounced, the agency can waste re­sources on or­ga­niz­ing such in­spec­tions.

The bill al­so ap­pro­pri­ates $50 mil­lion to ac­cel­er­ate med­ical prod­uct de­vel­op­ment as au­tho­rized in the 21st Cen­tu­ry Cures Act.

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FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Merck closes in on a potential $40 billion buyout of Seagen, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Benjamin Oakes, Scribe Therapeutics CEO

CEO of Doud­na spin­out: With­in five years, genome ed­i­tors will have a 're­al­ly big im­pact' on pa­tients' lives

“CRISPR-by-design” is the idea behind Scribe Therapeutics, a company spun out from Jennifer Doudna’s Nobel-winning lab that’s competing in a closely-tracked field of genome editor companies just starting to make their way to the clinic.

After nabbing $100 million last March for its Series B funding round, Scribe is taking a different tack from some of its competitors, crafting a new enzyme isolated from bacteria called CasX, which has now been tweaked extensively and may be targeted to a range of genome-related diseases, offering a plethora of therapeutic options.

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