Con­gress ap­proves gov­ern­ment spend­ing bill with in­creased FDA fund­ing

The Sen­ate ear­ly Fri­day fol­lowed the House’s lead ear­ly Fri­day to pass the $1.3 tril­lion spend­ing bill to fund the gov­ern­ment through 30 Sep­tem­ber.

The White House had in­di­cat­ed that Pres­i­dent Don­ald Trump sup­ports the bill, but he doesn’t seem so cer­tain:

The om­nibus bill would bring the FDA bud­get to a to­tal of $2.9 bil­lion in dis­cre­tionary fund­ing (mean­ing not user fees), $135 mil­lion above the 2017 en­act­ed lev­el, ac­cord­ing to the House Ap­pro­pri­a­tions Com­mit­tee.

Ac­cord­ing to the Al­liance for a Stronger FDA, com­pared to the last FY 2018 con­tin­u­ing res­o­lu­tion, the om­nibus would add $41 mil­lion in ad­di­tion­al dis­cre­tionary fund­ing.

Of the new funds, $15 mil­lion will go to­ward FDA’s new On­col­o­gy Cen­ter of Ex­cel­lence, while the bill al­so ap­pro­pri­ates $60 mil­lion to ac­cel­er­ate med­ical prod­uct de­vel­op­ment as au­tho­rized in the 21st Cen­tu­ry Cures Act, which is an in­crease of $40 mil­lion avail­able un­der the Act from 2017.

In ad­di­tion, a one-time fund­ing of $94 mil­lion will help ex­pand FDA’s ef­forts at In­ter­na­tion­al Mail Fa­cil­i­ties to ad­dress the opi­oid cri­sis.

For the NIH and the CDC, the spend­ing bill would pro­vide ad­di­tion­al funds as well.

Ac­cord­ing to the House Ap­pro­pri­a­tions Com­mit­tee, the bill pro­vides a to­tal of $37 bil­lion for NIH, an in­crease of $3 bil­lion above the FY 2017 en­act­ed lev­el.

The bill al­so in­creas­es fund­ing for sev­er­al re­search ini­tia­tives, in­clud­ing:

  • $1.8 bil­lion (+$414 mil­lion) for Alzheimer’s dis­ease re­search
  • $400 mil­lion (+$140 mil­lion) for the Brain Re­search through Ap­pli­ca­tion of In­no­v­a­tive Neu­rotech­nolo­gies (BRAIN) ini­tia­tive
  • $290 mil­lion (+$60 mil­lion) for the All of Us re­search ini­tia­tive (for­mer­ly called the Pre­ci­sion Med­i­cine Ini­tia­tive)
  • $10 mil­lion (+$8 mil­lion) for re­gen­er­a­tive med­i­cine re­search
  • $100 mil­lion (+$40 mil­lion) for uni­ver­sal flu vac­cine re­search
  • $351 mil­lion (+17 mil­lion) for re­search on com­bat­ing an­tibi­ot­ic-re­sis­tant bac­te­ria
  • $543 mil­lion (+27 mil­lion) for Clin­i­cal and Trans­la­tion­al Sci­ence Awards
  • $351 mil­lion (+$17 mil­lion) for In­sti­tu­tion­al De­vel­op­ment Awards (IDeA).

First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email for more in­for­ma­tion.

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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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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance Chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

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.

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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.

Pharma brands are trying to figure out new ways to better reach patients and doctors, but also measure results. (Credit: Shutterstock)

Do phar­ma TV and so­cial ads work? Phar­ma mar­ket­ing agen­cies adopt­ing new tech so­lu­tions to find out

It’s a timeworn advertising question — is my ad campaign working? In pharma, that can be an especially difficult question to answer in part because of privacy regulations, but also because the brands spend a lot of money on TV commercials where viewers can’t directly click on an ad.

Healthcare marketing services companies like Lasso and CMI Media Group are trying to change that with new measurement methods and partnerships that aim to get closer to patients’ and physicians’ actions.

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Corey McCann, Pear Therapeutics CEO

Pear Ther­a­peu­tics touts Q2 growth while scal­ing back full-year goals and chop­ping 9% of staff

Pear Therapeutics set some ambitious goals back in March, predicting a five-fold boost in revenue and a surge in new prescriptions for its digital therapeutics. Now the company is scaling back those estimates and chopping 9% of its workforce — an all-too-common occurrence in biotech lately.

CEO Corey McCann unveiled Pear’s Q2 numbers on Thursday, touting a 20% quarter-over-quarter revenue growth totaling $3.3 million. That’s more than double what the company made in Q2 2021, and McCann thinks the team could see a nearly four-fold jump in revenue this year, falling in the range of $14 million to $16 million.

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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 Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, 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.

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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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