What’s in a (drug) name? FDA to study how they af­fect ef­fi­ca­cy per­cep­tions

When it comes to pro­pri­etary drug names over­stat­ing their ef­fi­ca­cy, taint­ed sex­u­al en­hance­ment prod­ucts dis­guised as sup­ple­ments may take the cake (see: “2 Own The Knight” or “XXXPlo­sion Ul­tra”).

For the le­git­i­mate phar­ma­ceu­ti­cal world, the FDA wants to take a clos­er look at how cer­tain brand names af­fect con­sumer and health care providers’ per­cep­tions about ef­fi­ca­cy and the med­ical con­di­tions for which they’re in­di­cat­ed.

The agency is prepar­ing to con­duct what it says is the first wide­spread study in­to pro­pri­etary pre­scrip­tion drug names. The plan is to look at the per­cep­tions of 500 con­sumers and 500 health care providers on cer­tain fic­tion­al names for two med­ical con­di­tions — high cho­les­terol and gas­troe­sophageal re­flux dis­ease.

The study will com­pare five tar­get names that may just sug­gest a med­ical con­di­tion or vary in terms of how the name por­trays a drug’s ef­fi­ca­cy, with one name that ex­plic­it­ly sug­gests strong ef­fi­ca­cy (Cures­Flux) and one that is more neu­tral (Zer­pex­in).

Par­tic­i­pants will an­swer ques­tions about the names, be­fore and af­ter they have been told what each drug’s in­di­ca­tion is. “Tar­get names will vary such that some ef­fi­ca­cy im­pli­ca­tions are more ap­par­ent than oth­ers, and some will more clear­ly im­ply the med­ical con­di­tion for which a drug is in­di­cat­ed than oth­ers,” FDA said.

Al­ready the agency has signed off on such pro­pri­etary names that sug­gest the med­ical con­di­tion (e.g. As­traZeneca’s HER2-pos­i­tive breast can­cer treat­ment En­her­tu) or may not seem as ran­dom as oth­ers (e.g. Pro­tein Sci­ences’ flu vac­cine Flublok or Gilead’s CAR-T ther­a­py Yescar­ta).

The agency on Mon­day of­fered more de­tail and re­spond­ed to com­ments on how its study, first pre­viewed in Jan­u­ary 2020, will be con­duct­ed and why it’s look­ing in­to this is­sue.

“The pur­pose of the cur­rent study is to de­ter­mine whether a pro­pri­etary name it­self could play a role in in­flu­enc­ing con­sumer and HCP [health care provider] per­cep­tions of drug risks or ben­e­fits by sug­gest­ing the med­ical con­di­tion for which the drug is in­di­cat­ed or by sug­gest­ing an over­state­ment of the ef­fi­ca­cy of the drug,” FDA said.

The agency fur­ther clar­i­fied that the pur­pose of in­clud­ing this “ex­treme” name, Cures­Flux, is not to have da­ta on names that won’t be used in the re­al world, but to have some­thing against which to com­pare the tar­get names, which are sim­i­lar to the kind of names that would be sub­mit­ted to FDA for ap­proval.

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.

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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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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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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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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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.

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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Mark McKenna, Prometheus Biosciences chairman & CEO

With clear PhII win in IBD, Prometheus thwarts Pfiz­er com­par­isons as it fol­lows Hu­mi­ra 'play­book'

Prometheus Biosciences reported a clear Phase II win in two inflammatory bowel disease conditions in a clinical development race with Pfizer, planting the biotech’s flag in a field of antibodies attempting to go against black box-cornered JAK inhibitors and AbbVie’s Humira.

Shares $RXDX have soared since the summer — a small dip last week notwithstanding when rival Pfizer teamed up with Roivant on a new company for their competing anti-TL1A monoclonal antibody. And they skyrocketed once again Wednesday morning, climbing from $36 apiece to more than $100 on the back of two Phase II studies: one placebo-controlled in ulcerative colitis and the other an open-label trial in patients with Crohn’s disease.

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