BIO files amicus brief in suit challenging IRA price controls

We have details on BIO’s amicus brief in a suit challenging the Inflation Reduction Act price controls, the latest on updated COVID-19 vaccines, plus more news you need to know. (769 words, 3 minutes, 50 seconds)

BIO files amicus brief in suit challenging IRA price controls

The Inflation Reduction Act (IRA) drug price controls involve unconstitutional coercion and will destroy innovation that saves patients’ lives, BIO argues in a recent amicus brief.

The case: The suit from Bristol Myers Squibb (BMS) and Janssen says the IRA drug price program violates the Fifth Amendment by forcing drug makers to agree to sell their products at below-market prices. BIO’s amicus brief agrees, saying the IRA involves illegal coercion and harms innovation.

‘No choice at all’: “Manufacturers must either ‘voluntarily’ participate in the Program’s ‘negotiations’ or withdraw entirely from Medicare. That is no choice at all,” says BIO’s brief. “Medicare is the 10,000-pound gorilla in the pharmaceutical market,” and no drug maker can afford to withdraw.

The IRA ignores R&D costs and drug development challenges: “Each drug that makes it to market stands on the shoulders of nine or ten other drugs that never make it out of clinical trials.”

The impact on innovation: BIO cites research showing 78% of manufacturers are planning to cancel early-stage projects, which “no longer make sense given the short timelines before medicines could be subject to government price setting.”

The impact on patients: The IRA disincentivizes R&D into rare disease treatments—and drug innovation in general—meaning fewer drugs will reach the market or patients, BIO explains.

What’s next: The briefing before the U.S. Court of Appeals for the Third Circuit should be completed by the end of August. The timing is difficult to predict, though prior Third Circuit cases suggest that the court could issue a decision as soon as early 2025.

Read more at Bio.News.

FDA approves updated COVID mRNA vaccines

Food and Drug Administration (FDA) approval of updated COVID-19 mRNA vaccines came earlier than expected this year, giving us a new weapon against the worst summer COVID surge since 2022.

The news: On Aug. 22, the FDA approved Moderna’s and Pfizer’s updated mRNA COVID-19 vaccines targeting the KP.2 strain for individuals 12 years and older and granted emergency use authorization for six months through 11 years.

Why it matters: By acting now, the FDA can facilitate vaccination while wastewater measurements from the Centers for Disease Control and Prevention (CDC) show we are in the middle of a surge close to the summer peak of 2022.

Ready to roll: Moderna and Pfizer said their new vaccines could be ready to ship within days of the announcement. FDA approval is expected soon for another vaccine, the updated version of Novavax’s protein-based vaccine.

The big picture: On Aug. 19, the CDC declared KP.3.1.1 the predominant variant, but it is not a major mutation, and the new vaccines are expected to be highly effective against KP.3.1.1.

The bottom line: Get vaccinated. CDC urges everyone six months and older to get the approved and authorized vaccines, as vaccination is the best defense against COVID-19. 

Read more at Bio.News.

What Else to Know This Week

Mpox vaccines heading to the Democratic Republic of Congo (DRC). Bavarian Nordic is ramping up production of its Jynneos mpox vaccines, which are expected to be distributed this week in the DRC—ground zero for the current mpox global health emergency. The DRC requested the shots two years ago, but the World Health Organization (WHO)—which acts as the only drug regulator in many lower-income countries—had not yet approved the vaccines, even though the U.S. Food and Drug Administration and European Medicines Agency cleared Jynneos for use against mpox.

Australian SAF plant eyes waste-to-fuel solution. Australia’s Wagner Sustainable Fuel plans to equip its new sustainable aviation fuel (SAF) refinery with a joint solution from LanzaTech and LanzaJet that turns municipal and industrial waste into jet-ready fuel. LanzaTech uses fermentation technology to convert all kinds of waste to make CarbonSmart™ ethanol and converts the ethanol into drop-in SAF.

New progress against lung cancer. Johnson & Johnson recently announced FDA approval of RYBREVANT plus LAZCLUZE™ for “first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.” The combination therapy proved superior to the existing therapy for the condition, Johnson & Johnson said. Meanwhile, patients in the UK began clinical trials to test a vaccine given to lung cancer patients to help their immune system target cancer cells, reports the BBC.

Beltway Report: What's Ahead in Washington

Following a week’s vacation outside of public view in California, President Joe Biden is heading to the family vacation home in Delaware today. Former President Donald Trump and Vice President Kamala Harris are set to campaign in battleground states this week, with Harris and her running mate visiting Georgia and Trump and his running mate going to Michigan and Pennsylvania. On Capitol Hill, Congress’s summer recess continues this week and next.