Biden calls on Con­gress to al­low Medicare drug price ne­go­ti­a­tions

Over­shad­owed by Pres­i­dent Biden’s vac­cine man­date an­nounce­ment, the ad­min­is­tra­tion ear­li­er in the day re­leased its top pri­or­i­ties for drug pric­ing re­forms mak­ing their way through Con­gress.

The re­forms are slat­ed to save the gov­ern­ment hun­dreds of bil­lions to off­set oth­er spend­ing pri­or­i­ties.

The 29-page HHS re­port makes clear the ad­min­is­tra­tion’s strong de­sire for any leg­is­la­tion to in­clude Medicare drug price ne­go­ti­a­tions — an idea the phar­ma­ceu­ti­cal in­dus­try strong­ly op­pos­es — as well as mea­sures to slow price in­creas­es over time on ex­ist­ing drugs.

“A pro­vi­sion in the law that es­tab­lished the Medicare Part D pro­gram specif­i­cal­ly pro­hibits the HHS Sec­re­tary from in­ter­fer­ing with the ne­go­ti­a­tions be­tween drug man­u­fac­tur­ers and phar­ma­cies and plan spon­sors, re­quir­ing a par­tic­u­lar for­mu­la­ry, or in­sti­tut­ing a price struc­ture for the re­im­burse­ment of cov­ered Part D drugs,” the re­port says. “This re­stric­tion is unique to Part D and con­trasts with how drug prices are de­ter­mined in oth­er fed­er­al pro­grams, such as the use of ceil­ing prices in the VA and manda­to­ry re­bates in Med­ic­aid—both of which re­sult in low­er brand drug prices than in Medicare Part D.”

Peg­ging Medicare prices to what drug­mak­ers of­fer the VA is one of the top ideas be­ing float­ed by the Sen­ate Fi­nance Com­mit­tee, ac­cord­ing to a Stat News re­port. Sen­ate fi­nance chair Ron Wyden (D-OR) is ex­pect­ed to of­fer up a bill in the com­ing days that could set the course for what Con­gress ul­ti­mate­ly adopts when it comes to drug pric­ing re­forms.

Wyden has pre­vi­ous­ly em­pha­sized his de­sire to al­low Medicare to ne­go­ti­ate, al­though it re­mains un­known if all 50 Sen­ate De­moc­rats, all of whom will like­ly be need­ed for the bill’s pas­sage, are will­ing to back such an idea. Sens. Bob Menen­dez of New Jer­sey and Kyrsten Sine­ma of Ari­zona have pre­vi­ous­ly ex­pressed doubts.

SVBLeerink an­a­lyst Ge­off Porges said in a note this morn­ing, “from an in­dus­try point of view this pro­pos­al is an ex­is­ten­tial threat, and is like­ly to be fought tooth and nail. Giv­en the ten­u­ous ma­jor­i­ty for De­moc­rats in the House and Sen­ate, and the pri­or op­po­si­tion in the House to HR3, we be­lieve there is next to no chance that this ma­jor pil­lar of the plan gets through Con­gress.”

In the House, the En­er­gy & Com­merce com­mit­tee on Mon­day will be­gin mark­ing up its own drug pric­ing bill. That cur­rent­ly in­cludes Speak­er Nan­cy Pelosi’s HR 3, which the CBO has warned could put a damper on new drug de­vel­op­ment. But those pro­vi­sions could change de­pend­ing on the Sen­ate.

In con­junc­tion with Medicare ne­go­ti­a­tions, the ad­min­is­tra­tion en­cour­ages Con­gress to im­pose an ex­cise tax when man­u­fac­tur­ers raise the price of their prod­ucts faster than the rate of in­fla­tion, the HHS re­port adds, not­ing that Amer­i­cans spend more than $1,500 per per­son on av­er­age for pre­scrip­tion drugs and “pay prices that are far high­er than any com­pa­ra­ble na­tion.”

Oth­er pro­vi­sions from the re­port, such as in­creas­ing gener­ic drug and biosim­i­lar com­pe­ti­tion with fast FDA ap­provals, have been float­ed for years by mem­bers of Con­gress on both sides of the aisle.

But the ad­min­is­tra­tion al­so pledged its sup­port for so-called “skin­ny” la­bels, which have come un­der fire from courts re­cent­ly, and can al­low for gener­ic com­pe­ti­tion to come to mar­ket for some of the in­di­ca­tions of an ap­proved ref­er­ence prod­uct that aren’t un­der patent pro­tec­tion.

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.

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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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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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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Can­cer as­so­ci­a­tion says na­tion­al bud­get deal threat­ens re­search fund­ing

As the US House of Representatives is expected to vote this evening on a deal that would raise the nation’s debt ceiling, some biopharma industry advocates worry about how proposed budget restrictions could affect drug research.

The proposed budget deal includes relatively flat funding for non-defense spending over the next fiscal year, and a 1% increase in fiscal year 2025, which the Association for Clinical Oncology said on Wednesday would “considerably restrict potential resources for the National Institutes of Health (NIH) and National Cancer Institute (NCI) at a time when scientists are on the cusp of so many promising cancer discoveries.”

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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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Ky­owa Kirin re­news sup­port for foun­da­tion that ful­fills wish­es for ter­mi­nal­ly ill adults

Although not as well-known as the pediatric-focused Make-A-Wish organization, the Dream Foundation has been making wishes come true for adults diagnosed with a terminal illness for decades. Kyowa Kirin began supporting the group six years ago, and now is doubling down on its commitment and extending its pledge through next year.

The financial support of Kyowa Kirin and on-the-ground work by its employees have directly led to 100 final dreams for people across the US and Puerto Rico. The Dream Foundation overall grants 2,500 requests each year to people who have a prognosis of 12 months or less to live. The wishes fulfilled range from family trips to places such as Disneyland or beach destinations to professional sports games to meet a sports hero.

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San­doz plans to stay lo­cal af­ter No­var­tis sep­a­ra­tion, se­lect­ing new HQ in Basel

Sandoz, a generics maker that Novartis plans to spin off later this year, has picked its new headquarters — and it’s only 2.4 miles away from its current digs on the Novartis campus.

The Novartis unit said Thursday that it plans to move to an office building in Basel called Elsässertor sometime in mid-2024.

Sandoz CEO Richard Saynor said in a news release that the location in the heart of Basel “will allow us to create a working environment that meets our business needs,” citing the talent pool in the Swiss city. Sandoz added that the workspace is designed to allow for “closer collaboration and teamwork.”

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