President Biden (Patrick Semansky/AP Images)

US gov­ern­ment pledges $2B for new ini­tia­tive on bio­man­u­fac­tur­ing

Over the past few days, the Biden ad­min­is­tra­tion has been fo­cused on new sci­ence ef­forts, par­tic­u­lar­ly around can­cer, and grow­ing bio­man­u­fac­tur­ing in the US.

On Wednes­day, the White House held a sum­mit on biotech and bio­man­u­fac­tur­ing, re­veal­ing what it will spend to boost these ef­forts.

Bri­an Deese, di­rec­tor of the Na­tion­al Eco­nom­ic Coun­cil, said that the ad­min­is­tra­tion has been fo­cused on a mod­ern in­dus­tri­al strat­e­gy by plac­ing pub­lic funds in ef­forts that in­vest in in­fra­struc­ture and se­cure sup­ply chains. He al­so said that the fo­cus of the ini­tia­tive is to in­crease the do­mes­tic man­u­fac­tur­ing of APIs to lim­it the de­pen­dence on for­eign sup­pli­ers as well as in­crease the do­mes­tic man­u­fac­tur­ing ca­pac­i­ty in gen­er­al and cre­ate jobs.

The ad­min­is­tra­tion re­vealed that it will in­vest over $2 bil­lion in­to biotech and bio­man­u­fac­tur­ing ef­forts, with $1 bil­lion specif­i­cal­ly go­ing to man­u­fac­tur­ing in­fra­struc­ture in the US pro­vid­ed by the De­part­ment of De­fense. The funds will go to­ward both pri­vate and pub­lic ini­tia­tives to ex­pand man­u­fac­tur­ing ca­pac­i­ty as well as sup­ply chain boost­ing ef­forts. Around $200 mil­lion will al­so be geared to­ward cy­ber­se­cu­ri­ty for these fa­cil­i­ties.

The DOD will al­so be launch­ing a pro­gram to ac­cel­er­ate re­search for new prod­ucts as well as sup­port the cre­ation of bio-based ma­te­ri­als for de­fense sup­ply chains. This ef­fort will re­ceive $270 mil­lion over the next five years.

HHS al­so re­ceived $40 mil­lion to ex­pand do­mes­tic API, an­tibi­ot­ic man­u­fac­tur­ing and the pro­duc­tion of ma­te­ri­als re­lat­ed to med­ica­tions and pan­dem­ic re­sponse.

Ac­cord­ing to a state­ment from HHS, fur­ther ini­tia­tives stem­ming from Biden’s ex­ec­u­tive or­der in­clude the de­vel­op­ment of FDA re­search pro­grams for more ad­vanced man­u­fac­tur­ing tech­nolo­gies and sup­port­ing the de­vel­op­ment of an “Ad­vanced Man­u­fac­tur­ing In­no­va­tion Hub” at the FDA.

Sup­port will al­so go to the de­vel­op­ment of the FDA’s Cen­ter for Ad­vance­ment of Man­u­fac­tur­ing Phar­ma­ceu­ti­cals and Bio­phar­ma­ceu­ti­cals to cre­ate more sci­ence and reg­u­la­to­ry poli­cies. HHS will al­so con­tin­ue fund­ing sev­er­al pro­grams re­lat­ed to gene and cell ther­a­py man­u­fac­tur­ing.

While the gov­ern­ment is putting more fo­cus on bio­man­u­fac­tur­ing, it’s al­ready been in­vest­ing in US-based man­u­fac­tur­ing. Last month, BAR­DA grant­ed $11 mil­lion to CD­MO Grand Riv­er Asep­tic Man­u­fac­tur­ing to boost the do­mes­tic pro­duc­tion of a vac­cine for mon­key­pox amidst a wide range of grants be­ing dis­trib­uted.

Last week, the De­part­ment of Com­merce al­so gave over $52 mil­lion in grants to boost API man­u­fac­tur­ing in cen­tral Vir­ginia.

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.

Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.

EMA rec­om­mends re­vok­ing au­tho­riza­tion of No­var­tis' sick­le cell drug

The European Medicines Agency’s committee for medicinal products for human use (CHMP) on Friday recommended revoking the marketing authorization for Novartis’ treatment for a painful complication related to sickle cell, after a recent study did not confirm its clinical benefit.

CHMP’s review looked at results of the STAND study, finding that Adakveo (crizanlizumab) did not reduce the number of painful crises leading to a healthcare visit, and patients treated with Adakveo had slightly more painful crises on average, with a subsequent healthcare visit, over the first year of treatment, compared with those on placebo.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 170,300+ biopharma pros reading Endpoints daily — and it's free.