Rep. Anna Eshoo (D-CA) (Graeme Sloan/AP Images)

Fight over where to house ARPA-H still brews with House bil­l's pas­sage

The Biden ad­min­is­tra­tion isn’t back­ing down from its de­sire to keep a new drug ac­cel­er­a­tor, known as ARPA-H, in­side the Na­tion­al In­sti­tutes of Health.

But the House on Wednes­day passed a bill by an over­whelm­ing bi­par­ti­san ma­jor­i­ty (336 to 85) to make this new ac­cel­er­a­tor a stand­alone agency.

An­na Es­hoo (D-CA), the au­thor of the House bill, made clear that the sep­a­ra­tion from NIH is in­ten­tion­al, say­ing in a state­ment that “the House passed my ARPA-H leg­is­la­tion to cre­ate a new agency with the au­thor­i­ties and au­ton­o­my it needs to be suc­cess­ful and en­sur­ing it will be a nim­ble, dy­nam­ic, and in­de­pen­dent agency.”

Biden of­fi­cials, mean­while, re­main sup­port­ive of the bill in gen­er­al but are still push­ing for a tweak to put ARPA-H un­der the NIH um­brel­la, say­ing in a state­ment:

In or­der to suc­cess­ful­ly con­duct im­pact­ful re­search on dis­eases like can­cer or men­tal health con­di­tions, it is crit­i­cal that ARPA-H is stood up in a time­ly and ef­fi­cient man­ner. At the same time, we need to al­low this nascent agency to be nim­ble, dy­nam­ic, and adap­tive. To that end, the Ad­min­is­tra­tion sup­ports an ap­proach that pro­vides the agency with flex­i­bil­i­ty to adapt to un­fore­seen cir­cum­stances and be­lieves that lever­ag­ing the Na­tion­al In­sti­tutes of Health’s ex­ist­ing in­fra­struc­ture would pro­vide for the most ef­fi­cient ad­min­is­tra­tion of the pro­gram’s goals. The Ad­min­is­tra­tion is con­cerned by the pro­vi­sion that would en­able ARPA-H to by­pass the process for en­sur­ing that com­mu­ni­ca­tions with Con­gress are ac­cu­rate and re­flect the views of the Ex­ec­u­tive Branch.

But law­mak­ers are al­ready plot­ting ARPA-H’s au­tonomous fu­ture, with or with­out the White House’s sup­port, with 2023 fund­ing plans for $2.75 bil­lion for the ac­cel­er­a­tor, an in­crease of $1.75 bil­lion above the ini­tial $1 bil­lion, which ap­pro­pri­a­tors said will go “to ac­cel­er­ate the pace of sci­en­tif­ic break­throughs” for dis­eases like ALS, Alzheimer’s dis­ease, di­a­betes and can­cer.

Biden had ini­tial­ly re­quest­ed $6.5 bil­lion for this cur­rent­ly NIH-housed re­search out­fit, which is go­ing to mir­ror DARPA with risky in­vest­ments.

Rep. Fred Up­ton (R-MI) and oth­er Re­pub­li­cans stood be­hind the House bill too, with Up­ton say­ing, “ARPA-H can pro­vide the break­through to in­deed find cures for all these dis­eases. The pres­i­dent has signed fund­ing for this agency in­to law, now we need the bi­par­ti­san au­tho­riza­tion so the re­searchers can get to work.”

Adam Rus­sell

HHS Sec­re­tary Xavier Be­cer­ra late last month, how­ev­er, sought to for­mal­ly an­nounce the es­tab­lish­ment of the ARPA-H, known for­mal­ly as the Ad­vanced Re­search Project Agency for Health, as an en­ti­ty with­in the NIH, al­though HHS had pre­vi­ous­ly sought to keep the new re­search arm some­what in­de­pen­dent, stip­u­lat­ing that “NIH may not sub­ject ARPA-H to NIH poli­cies.”

Be­cer­ra al­so an­nounced the ap­point­ment of ARPA-H’s in­au­gur­al em­ploy­ee, Adam Rus­sell, who will serve as act­ing deputy di­rec­tor. Rus­sell, a for­mer DARPA man­ag­er and a Rhodes Schol­ar at Ox­ford, will be­gin to con­struct a new agency that has eyed big, trans­for­ma­tive work in the life sci­ences space from the be­gin­ning, con­tin­u­al­ly promis­ing “high-risk, high-re­ward re­search” on hard-to- or ex­pen­sive-to-treat dis­eases, with promis­es of “bio­med­ical and health break­throughs.”

With this new fund­ing, the Biden team still has to come up with the first di­rec­tor of ARPA-H, and where its head­quar­ters will be lo­cat­ed.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Albert Bourla, Pfizer CEO (Michel Euler/AP Images, Pool)

FDA ap­proves Pfiz­er’s RSV shot for old­er adults, tee­ing up a com­pet­i­tive $17B vac­cine mar­ket

The FDA approved Pfizer’s RSV vaccine called Abrysvo for older adults on Wednesday, placing another Big Pharma onto the commercial stage ahead of the next RSV season.

Pfizer’s approval comes weeks after GSK won approval for its rival shot, Arexvy. Those two vaccines are both approved for use in adults 60 years and older and will be reviewed by a CDC panel in June before they’re expected to commercially launch this fall. Wall Street analysts see RSV as the next multibillion-dollar vaccine market, with Jefferies analysts recently forecasting the RSV market will grow to $17 billion over the next decade.

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Richard Pazdur, FDA's OCE director (Flatiron Health via YouTube)

FDA's can­cer chief weighs in on com­mon chemo short­ages — re­port

Richard Pazdur, director of the FDA’s Oncology Center of Excellence, attributes the current shortage of two cancer drugs to drug companies that haven’t invested in building out their production capacity.

In an interview with The Cancer Letter, a weekly cancer publication, Pazdur said that the current shortages of cisplatin and carboplatin, a pair of drugs used to treat a wide range of cancer patients, are the result of two problems: manufacturers not investing in enhancing production capacity, and drug companies being dependent on one supplier of raw ingredients. The cisplatin shortage followed an inspection that revealed quality issues at a manufacturing facility, which then led to the shutdown of production. This led to a surge in carboplatin demand, creating a secondary shortage.

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Photo: Ida Marie Odgaard/Ritzau Scanpix/Sipa USA/Sipa via AP Images

FDA warns about com­pound­ed semaglu­tide-based drugs

The FDA has warned the public that compounded versions of popular GLP-1 drugs Ozempic and Wegovy may not include the same ingredients as the prescription medications, and that has raised questions about their safety and effectiveness.

The regulator said Tuesday it has received reports of adverse events related to compounded versions of semaglutide, the active ingredient in Ozempic and Wegovy. Some products being marketed as semaglutide contain the salt formation of semaglutide, which is not considered safe or effective.

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Denny Lanfear, Coherus BioSciences CEO

FDA in­spec­tion of Chi­na-based site mak­ing Co­herus' po­ten­tial new can­cer drug ends with three ob­ser­va­tions

After Covid-related delays that forced the FDA to delay its China-based inspections, Coherus BioSciences said today that its China-based partner Junshi Biosciences has now successfully completed the required pre-approval inspection for its PD-1 toripalimab, which is being made at a site in China, with three observations.

“The Company believes that the three observations received at the close of the FDA inspection are readily addressable and, together with Junshi Biosciences, plans to submit the response to the FDA in early June,” Coherus said in an SEC filing. The company did not disclose the observations, but Coherus’ stock price $CHRS fell by almost 8% on Wednesday.

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Eu­ro­pean Par­lia­ment calls mem­ber states to ac­tion on an­timi­cro­bial re­sis­tance

Members of the European Parliament have called on EU countries to develop national action plans against antimicrobial resistance (AMR), calling it a top-three priority health threat.

Parliament on Thursday announced recommendations for the fight against AMR, including national action plans that must be updated at least every two years, an EU-level database tracking AMR and antimicrobial use and increased partnership between the pharma industry, patient groups and academia.

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Roche plans to di­vest from lega­cy Genen­tech man­u­fac­tur­ing fa­cil­i­ty in Cal­i­for­nia

Roche is planning to make some changes to its subsidiary’s manufacturing network in California.

The Swiss pharma announced Wednesday that it plans to divest from Genentech’s manufacturing facility in Vacaville, CA, around 58 miles northeast of San Francisco. According to a statement from Roche, the move is part of a “broader strategy” to bring its manufacturing capabilities in line with its future pipeline. Roche is starting the process of finding a buyer for the site but has not named any candidates yet.

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FDA lifts hold on Mol­e­c­u­lar Tem­plates’ mul­ti­ple myelo­ma tri­al af­ter less than two months

The FDA has lifted a partial clinical hold on Molecular Templates’ early-stage trial for a multiple myeloma drug, the biotech company announced Thursday morning.

Regulators had put the trial on partial hold in early April, pausing patient enrollment, following two adverse heart-related events in patients who received the highest dose of Molecular Templates’ treatment MT-0169 last year. One patient had asymptomatic grade 2 myocarditis, or heart muscle inflammation, while the other had a grade 3 cardiomyopathy. Both recovered within two months.

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

Eikon Therapeutics announced three business development deals on Thursday, effectively dropping in a pipeline of cancer drugs alongside more than $100 million in fresh funding.

The Hayward, CA-based company has become one of biotech’s richest startups since its 2019 founding, having raised nearly $775 million. It’s developing a massive, automated research approach built around Nobel Prize-winning microscope science to peer inside cells and watch proteins in action. After its Series B last year, PitchBook reported a $3.02 billion valuation. And while CEO Roger Perlmutter declined to comment on that figure, he said its first tranche of nearly $106 million in Series C funding is a “meaningful step-up to our Series B valuation.”

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