Trump slams Pfiz­er’s drug price hikes, promis­es to re­tal­i­ate — but how?

Pfiz­er’s re­cent round of drug price hikes in the wake of Pres­i­dent Don­ald Trump’s promise of cas­cad­ing costs has drawn the at­ten­tion of the com­man­der-in-chief.

The Fi­nan­cial Times first re­port­ed that Pfiz­er had hiked prices on 100 prod­ucts at right around 9% for most, fit­ting un­der a 10% cap that most man­u­fac­tur­ers are hap­py to com­ply with. Just a few weeks ago, though, Trump caught the at­ten­tion of the in­dus­try when he promised that phar­ma com­pa­nies were about to de­liv­er “vol­un­tary mas­sive drops in prices.”

Turns out, the in­dus­try hadn’t been alert­ed, and HHS Sec­re­tary Alex Azar was left with the task to ex­plain that deep price cuts weren’t re­al­ly in the cards. Te­va and Roche al­so raised prices re­cent­ly, ac­cord­ing to a re­port from Reuters.

Pfiz­er CEO Ian Read is prob­a­bly the last chief in Big Phar­ma to suc­cumb to pres­sure from the gov­ern­ment on pric­ing. Near­ing the end of his reign, he’s been out­spo­ken about boost­ing prices as need­ed for his busi­ness and re­quired a change in tax pol­i­cy from the Oba­ma ad­min­is­tra­tion to stop a planned M&A deal to shift his tax base to a more ap­peal­ing en­vi­ron­ment — like what the UK has to of­fer.

In­ter­est­ing­ly, Bern­stein’s Ron­ny Gal put out a note ear­li­er to­day that says Azar has been look­ing for some cov­er on pric­ing — with­out tam­per­ing with the bot­tom line.

We learned from in­dus­try con­tacts that Trump’s promise for ma­jor price cuts has blind­sided HHS. In re­sponse, HHS in­vit­ed mul­ti­ple in­dus­try com­pa­nies to meet­ings over the past two weeks ask­ing them to re­duce list prices ma­te­ri­al­ly, clar­i­fy­ing the agency does not ex­pect re­duc­tion in net prices or in pa­tient out of pock­et costs. BERN: this da­ta point rais­es our con­fi­dence this ad­min­is­tra­tion will not in­tro­duce poli­cies that will ma­te­ri­al­ly neg­a­tive­ly im­pact the drug in­dus­try. It sug­gests that the cur­rent fo­cus is on po­lit­i­cal­ly-vis­i­ble ‘points’ rather than ad­dress­ing drug costs (we strug­gled for a bit with find­ing ways to say this po­lite­ly 🙂 ). We ex­pect the drug in­dus­try to look for ways to ac­com­mo­date the ad­min­is­tra­tion (per­haps with PBM help – they are al­so look­ing for ways out of the cross-fire).

These an­nu­al price hikes have be­come stan­dard op­er­at­ing pro­ce­dure in Big Phar­ma, par­tic­u­lar­ly at Pfiz­er. But in re­sponse to the pres­i­dent’s Tweet, Pfiz­er had this to say in its de­fense:

The list price re­mains un­changed for the ma­jor­i­ty of our med­i­cines. Our port­fo­lio in­cludes more than 400 med­i­cines and vac­cines; we are mod­i­fy­ing prices for ap­prox­i­mate­ly 10% of these, in­clud­ing some in­stances where we’re de­creas­ing the price. Im­por­tant­ly, list prices do not re­flect what most pa­tients or in­sur­ance com­pa­nies pay.  In the first quar­ter of 2018 the net sell­ing price in­crease was 0% due to the grow­ing amount of re­bates paid back to stake­hold­ers in the bio­phar­ma­ceu­ti­cal sup­ply chain.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

Amid mon­key­pox fears, biotechs spring to ac­tion; Mod­er­na’s CFO trou­ble; Cuts, cuts every­where; Craft­ing the right pro­teins; and more

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It’s always a bittersweet moment saying goodbye, but as Josh Sullivan goes off to new adventures we are grateful for the way he’s built up the Endpoints Manufacturing section — which the rest of the team will now carry forward. If you’re not already, this may be a good time to sign up for your weekly dose of drug manufacturing news. Thank you for reading and wish you a restful weekend.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Sanofi and Re­gen­eron clear the fin­ish line in an in­flam­ma­to­ry esoph­a­gus dis­ease, leav­ing Take­da in the dust

With atopic dermatitis rivals breathing down Dupixent’s neck, Sanofi and Regeneron on Friday secured a first win in new territory in what Sanofi’s head of immunology and inflammation Naimish Patel called the fastest approval he’s ever seen.

The FDA approved Dupixent on Friday to treat patients 12 years and older with eosinophilic esophagitis (EoE), an inflammatory condition that causes swelling and scarring of the esophagus. The approval came just a couple months after regulators granted Dupixent priority review, and months ahead of its PDUFA date on Aug. 3.

Fu­ji­film con­tin­ues its biotech build­ing spree with new fa­cil­i­ty in Chi­na

A Japanese conglomerate is making a big play in China with the opening of a new facility, as it continues to expand.

Fujifilm Irvine Scientific has opened its new Innovation and Collaboration Center in Suzhou New District, China, an area in Jiangsu province specifically designated for technological and industrial development.

According to Fujifilm, the 12,000-square-foot site will be responsible for the company’s cell culture media optimization, analysis and design services. Cell culture media itself often requires customization of formulas and protocols to achieve the desired quantity and quality of therapeutic desired. Fujifilm Irvine Scientific is offering these services from its headquarters in California and Japan to its customers globally, as well as in China now.

Rob Etherington, Clene CEO

Mary­land of­fers loan to Clene de­spite ALS tri­al bumps

Even after Utah-based Clene failed to hit its primary endpoints for its ALS drug last year, the state of Maryland is putting its money at least behind Clene’s manufacturing facility.

The Maryland Board of Public Works has finalized a $3 million, 60-month loan facility with Clene Nanomedicine. The loan was provided by the state’s Neighborhood BusinessWorks program within the Maryland Department of Housing and Community Development.

Armon Sharei, SQZ founder and CEO

SQZ's out­side-the-box man­u­fac­tur­ing method slash­es pro­duc­tion time in ear­ly in study

At ASCO 2021 in June of last year, SQZ Biotech showcased a glimpse of its unorthodox cell therapy manufacturing tech. And on Wednesday, the Watertown, MA, company announced that its first-generation system showed comparable or better performance than a conventional clean-room-based manufacturing process.

The study was non-clinical. Clinical trials are expected by the first half of 2023.

SQZ’s device opens up a temporary window by cell-squeezing to deliver cargoes into cells. Its average processing time was less than six hours per batch, which is more than half the time than conventional methods. The company is planning to use the technology in its first red blood cell derived program for celiac disease. That IND is set to be submitted in the first half of 2023, the company said.

Bobby Sheng, Bora Pharmaceuticals CEO

With new ac­qui­si­tion, Bo­ra to ven­ture in­to bi­o­log­ics

Last week, Taiwan-based CDMO Bora Pharmaceuticals announced that it acquired Eden Biologics. Now, it says that purchase has helped established Bora Biologics, expanding into the biopharmaceutical market.

The acquisition of the company’s assets, which are located in the Hsinchu Biomedical Science Park in Taiwan, is helping Bora build its presence in the biopharma world by expanding production capacity of cell lines for the production of protein drugs. It will also improve the quality control and inspection specifications, as well as cell bank generation. The facility has four 500-liter bioreactors that have been approved by European and Taiwanese regulators.

Paul Chaplin, Bavarian Nordic president and CEO

With mon­key­pox cas­es ris­ing, one Eu­ro­pean coun­try is lock­ing down a small­pox vac­cine con­tract

As the global number of confirmed and suspected monkeypox cases continues to slowly climb, one country is trying to get a head start on potential vaccine stocking.

Bavarian Nordic signed a contract with an undisclosed European nation to supply its smallpox vaccine in response to new cases this month, the company announced Thursday morning. The continent saw its first monkeypox case confirmed about two weeks ago, with both the UK and Portugal seeing cases, according to the Washington Post.

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