Joe Biden on the North Lawn of the White House, April 27, 2020 (Evan Vucci/AP Images)

Opin­ion: Mean­ing­ful drug pric­ing re­forms are head­ed nowhere fast

Pres­i­dent Biden is tak­ing a page out of for­mer Pres­i­dent Trump’s drug pric­ing play­book: of­fer big promis­es around tough ne­go­ti­a­tions with drug­mak­ers, but fail to of­fer a vi­able path for get­ting it done.

Warn­ing signs that drug pric­ing would no longer be a pri­or­i­ty for the pres­i­dent’s mar­quee leg­is­la­tion came over the past week from the Wash­ing­ton Post and Wall Street Jour­nal. To the cha­grin of House Speak­er Nan­cy Pelosi (D-CA) and oth­er De­moc­rats, Pres­i­dent Biden’s mas­sive, $1.8 tril­lion so­cial safe­ty net plan to help Amer­i­can fam­i­lies, de­tails of which were un­veiled Wednes­day morn­ing, does not in­clude a ma­jor push to cur­tail drug prices.

Al­though Biden is sup­posed to of­fer more specifics in his speech to Con­gress tonight, in­clud­ing a de­mand for leg­is­la­tion on price ne­go­ti­a­tions this year, stand­alone leg­is­la­tion on ne­go­ti­a­tions is not like­ly to make head­way in the dead­locked Sen­ate, es­pe­cial­ly if it needs 60 votes for pas­sage.

Biden whiffed on an op­por­tu­ni­ty to spell out what he wants in writ­ing.

“Pres­i­dent Biden has a plan to build on the Af­ford­able Care Act and low­er pre­scrip­tion drug costs for every­one by let­ting Medicare ne­go­ti­ate prices,” the White House said Wednes­day. That was the on­ly men­tion of drug prices in the White House fact sheet on the safe­ty net over­haul.

Se­nior Biden of­fi­cials tried to down­play this gap­ing hole where Biden should ex­plain what he wants on drug prices, telling re­porters on a call on Tues­day evening that Biden “has been very, very clear that he re­mains ful­ly com­mit­ted to ne­go­ti­a­tions to re­duce pre­scrip­tion drug prices — that, you will hear him re­it­er­ate as a very top pri­or­i­ty and some­thing he deems ur­gent.”

But the broad­er nar­ra­tive is that drug pric­ing as a pri­or­i­ty is slip­ping, and no one knows why ex­act­ly, con­sid­er­ing the sup­port from House and Sen­ate De­moc­rats and even some Re­pub­li­cans. Per­haps the phar­ma­ceu­ti­cal lob­by has al­ready got­ten to Biden? Per­haps the Biden team doesn’t want to pun­ish drug­mak­ers af­ter how quick­ly they were able to de­vel­op Covid vac­cines?

What­ev­er the rea­son, those as­sur­ances from se­nior staffers mean very lit­tle as the House and Sen­ate re­main di­vid­ed on how to pur­sue drug prices. House De­moc­rats last week rein­tro­duced their land­mark (or dead in the wa­ter, de­pend­ing on which par­ty you lis­ten to) drug pric­ing bill, HR 3, which passed along par­ty lines in the House in De­cem­ber 2019 but was nev­er con­sid­ered by the Sen­ate.

At­tempts to re­vive that bill and oth­ers will be­gin in earnest next week at a House En­er­gy & Com­merce Com­mit­tee hear­ing. But if drug pric­ing leg­is­la­tion is re­al­ly go­ing to make head­way, the Sen­ate will need to weigh in.

Some Sen­ate Re­pub­li­cans have al­ready raised red flags about gov­ern­ment price ne­go­ti­a­tions (even as the US is the on­ly coun­try in the world to not ne­go­ti­ate) and fo­cused their plans in­stead on low­er­ing out-of-pock­et costs.

How the leg­is­la­tion makes it across the fin­ish line re­mains murky, but the need for such leg­is­la­tion is as clear as ever.

A new GAO analy­sis on Wednes­day found that for 20 brand-name drugs in 2020, es­ti­mat­ed US prices paid at the re­tail lev­el by con­sumers and oth­er pay­ers (such as in­sur­ers) were more than two to four times high­er than prices in Aus­tralia, Cana­da and France.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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FDA grants or­phan drug des­ig­na­tion to Al­ger­non's ifen­prodil, while ex­clu­siv­i­ty re­mains un­clear

As the FDA remains silent on orphan drug exclusivity in the wake of a controversial court case, the agency continues to hand out new designations. The latest: Algernon Pharmaceuticals’ experimental lung disease drug ifenprodil.

The Vancouver-based company announced on Monday that ifenprodil received orphan designation in idiopathic pulmonary fibrosis (IPF), a chronic lung condition that results in scarring of the lungs.  Most IPF patients suffer with a dry cough, and breathing can become difficult.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Yuling Li, Innoforce CEO

In­no­force opens new man­u­fac­tur­ing site in Chi­na

Innoforce is off to the races at its new site in the city of Hangzhou, China.

The Chinese CDMO announced last week that it has started manufacturing at the new facility, which was built to offer process development and manufacturing operations for RNA, plasmid DNA, viral vectors and other cell therapeutics. It will also serve as Innoforce’s corporate HQ.

The company said it’s investing more than $200 million in the 550,000-square-foot manufacturing base for advanced therapies. The GMP manufacturing facility features space for producing plasmids with three 30-liter bioreactors. For viral vector manufacturing, Innoforce also has 200- and 500-liter bioreactors at its disposal, along with eight suites to make cell therapies. The site also includes several labs and warehouse spaces.

‘Catchy’ de­sign tops big ad buys on­line for grab­bing on­col­o­gists’ at­ten­tion — sur­vey

The cancer drug ads that get oncologists’ attention online are informative and use clear, eye-catching designs. That’s ZoomRx’s assessment in its most recent tracking survey, and while not necessarily surprising, the details in the research do break a few common misconceptions.

One of those is frequency, also known as the number of impressions an ad gets. No matter how many times oncologists saw a particular cancer drug ad, effectiveness prevailed in the survey across five drug brands. ZoomRx measured effectiveness as a combination of most attention-getting, relevant information and improved perception as reported by the doctors.

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Tim Walbert, Horizon Therapeutics CEO (via YouTube)

And then there were two: Janssen bows out of Hori­zon takeover ne­go­ti­a­tions

Horizon Therapeutics announced last week that it was in talks with three pharmaceutical giants that could take over the company. You can now remove one of them from the equation.

J&J’s Janssen, after Horizon reported its initial involvement in early discussions to acquire the rare disease biotech, issued a statement Saturday that said Janssen “does not intend to make an offer for Horizon,” and that Janssen is bound by restrictions set in Rule 2.8 of the Irish Takeover Rules. These rules are in place for any company interested in taking over Irish companies, with Horizon Therapeutics currently based in Dublin.

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Sekar Kathiresan, Verve Therapeutics CEO

Verve re­veals let­ter from FDA that lays out con­di­tions to lift base edit­ing tri­al hold

We now know why Verve’s lead candidate was placed on hold last month by US regulators.

In an SEC filing, Verve laid out the FDA’s conditions for lifting the hold on its lead therapy, VERVE-101. That includes submitting preclinical data about potency differences in human versus non-human cells, risks of gene editing germline cells, and off-target analyses in non-hepatocyte cell types.

The FDA also wants clinical data from the ongoing Heart-1 trial, and to modify the trial protocol in the US to add additional contraceptive measures and increase the length of a staggering interval between the dosing of participants.