President Biden (AP Images)

Biden sets a 45-day count­down for 'com­pre­hen­sive' plan to tack­le drug pric­ing — while cham­pi­oning some fa­mil­iar poli­cies

Should the phar­ma in­dus­try be brac­ing for new bat­tles on drug pric­ing?

In an ex­ec­u­tive or­der that might serve as a pre­lude for what’s to come, Pres­i­dent Joe Biden spot­light­ed some fa­mil­iar pol­i­cy pro­pos­als while di­rect­ing the HHS to “is­sue a com­pre­hen­sive plan with­in 45 days to com­bat high pre­scrip­tion drug prices and price goug­ing.”

The EO an­nounce­ment comes on the heels of a call by House Speak­er Nan­cy Pelosi to at­tach drug pric­ing re­form to the cur­rent bud­get bill. The cen­tral fig­ure be­hind a sweep­ing bill to tack­le drug prices that’s passed the House, Pelosi pub­licly re­ject­ed the in­dus­try’s ar­gu­ment that low­er­ing prices would harm in­no­va­tion.

Biden’s pre­lim­i­nary plan, re­leased Fri­day af­ter­noon, was paint­ed in much broad­er strokes, and no­tably ex­clud­ed the most rad­i­cal ideas, such as em­pow­er­ing Medicare to di­rect­ly ne­go­ti­ate prices or peg­ging US list prices to an in­ter­na­tion­al in­dex.

Rather, fram­ing the main is­sue as a lack of com­pe­ti­tion, Biden fo­cused on three spe­cif­ic mea­sures en­gag­ing a trio of gov­ern­ment agen­cies: The FDA shall work with states and tribes to safe­ly im­port drugs from Cana­da; the HHS shall in­crease sup­port for gener­ics and biosim­i­lars; and the FTC shall ban “pay for de­lay” or sim­i­lar types of arrange­ments de­signed to sti­fle new mar­ket en­trants.

From the White House:

One strat­e­gy that drug man­u­fac­tur­ers have used to avoid com­pet­ing is ‘pay for de­lay’ agree­ments, in which brand-name drug man­u­fac­tur­ers pay gener­ic man­u­fac­tur­ers to stay out of the mar­ket. That has raised drug prices by $3.5 bil­lion per year, and re­search al­so shows that ‘pay for de­lay’ and sim­i­lar deals be­tween gener­ic and brand name man­u­fac­tur­ers re­duce in­no­va­tion — re­duc­ing new drug tri­als and R&D ex­pen­di­tures.

All three di­rec­tives echo poli­cies or ap­proach­es that have been cham­pi­oned by his pre­de­ces­sor Don­ald Trump or oth­er politi­cians across the aisles.

With the ex­cep­tion of his con­tro­ver­sial en­dorse­ment of a Covid-19 vac­cine IP waiv­er, Biden has been seen as cor­dial to the bio­phar­ma in­dus­try, es­pe­cial­ly in con­trast with Trump’s of­ten con­fronta­tion­al style. The gov­ern­ment spent the past few months main­ly ty­ing ad­min­is­tra­tive loose ends — his HHS with­drew two re­quests for pro­pos­als days ago on the reim­por­ta­tion of in­sulin and per­son­al im­por­ta­tion of pre­scrip­tion drugs, cit­ing a dearth of re­sponse — leav­ing Con­gress to sort out pol­i­cy po­si­tions.

That could well change in 45 days when the HHS lays out its plan. Or not.

The largest phar­ma play­ers, a fact sheet on the new EO states, reaps av­er­age an­nu­al prof­its of 15% to 20%, much high­er than the 4% to 9% re­port­ed by the largest non-drug com­pa­nies.

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.

Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Enhertu researcher Ian Krop speaks during Wednesday's SABCS press conference (MedMeetingImages/Todd Buchanan via SABCS)

SABCS roundup: No­var­tis shows two-year PFS in breast can­cer sub­groups; As­traZeneca re­veals more En­her­tu da­ta

The San Antonio Breast Cancer Symposium is taking place this week, and so far, some of the Big Pharmas are turning out new trial data about some of the biggest drugs in the space.

First off, Novartis announced that its drug, Kisqali, showed about a year of progression-free survival in patients with different types of first-line metastatic breast cancer. The CDK 4/6 drug was first approved by the FDA in 2017, setting it up in direct competition against Pfizer’s Ibrance.

Big Phar­mas team up with lo­cal Sin­ga­pore or­ga­ni­za­tions to boost man­u­fac­tur­ing

Singapore has long established itself as a major hub for pharma manufacturing, and now several big players are looking to further cement their presence in the Lion City.

Takeda, Sanofi and GSK are forming a partnership with the Singapore-based Agency for Science, Technology and Research (A*STAR) and several local academic institutions, including the National University of Singapore, Nanyang Technological University, Singapore, its enterprise company called NTUitive and Singapore Institute of Technology to provide a greater boost to the manufacturing of biologics.

Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.