As­traZeneca R&D leader Pan­ga­los warns of a post-Brex­it UK re­search re­treat with­out re­im­burse­ment re­form

As­traZeneca’s in­flu­en­tial R&D leader Mene Pan­ga­los has blast­ed the UK gov­ern­ment’s drug watch­dog NICE for keep­ing the price of new drugs at low lev­els, say­ing that reg­u­la­tors are threat­en­ing the in­dus­try’s sub­stan­tial R&D pres­ence in the coun­try in a post-Brex­it world.

Mene Pan­ga­los

“To con­tin­ue to get the re­search and in­vest­ment here, you have to pay for the drugs,” Pan­ga­los told The Tele­graph in an in­ter­view. “Re­search and adop­tion of clin­i­cal in­no­va­tion go hand in hand and the Gov­ern­ment has to be pre­pared to pay for treat­ments that work.”

World-class aca­d­e­m­ic re­search in the UK’s Gold­en Tri­an­gle or Lon­don, Ox­ford and Cam­bridge com­bined with an at­trac­tive tax en­vi­ron­ment has played to the coun­try’s ad­van­tage so far, he adds, but Brex­it could change that equa­tion with­out a bet­ter ap­proach to re­im­burse­ment that rec­og­nizes the val­ue of new meds.

Added Pan­ga­los:

The UK is not a big enough mar­ket to be a pri­or­i­ty. As a drugs mar­ket it is more im­por­tant for us to launch in France, Ger­many and Swe­den than in the UK be­cause they adopt and pay for the drugs. The UK is a chal­lenge now but with­out the EU the UK will get left be­hind if it doesn’t start to change the way it re­im­burs­es drugs.

As­traZeneca $AZN has re­lied heav­i­ly on its pres­ence in the UK to weath­er a va­ri­ety of storms in re­cent years. CEO Pas­cal So­ri­ot raised the prospect of an R&D Ar­maged­don if Pfiz­er —  known for its will­ing­ness to pil­lage re­search as a way to pay for M&A — was al­lowed to fol­low through on its pro­posed takeover. And ear­ly on So­ri­ot hit hard on the com­pa­ny’s base in the UK with his com­mit­ment to build a half-bil­lion dol­lar HQ and re­search hub in Cam­bridge as he set out to re­or­ga­nize the com­pa­ny’s hap­less R&D op­er­a­tions four years ago.

He’s had mixed suc­cess on that score so far, gain­ing a cou­ple of sig­nif­i­cant ad­vances in on­col­o­gy with new drugs like Lyn­parza and Tagris­so. The phar­ma gi­ant al­so has a late-stage check­point in­hibitor in a slate of com­bi­na­tion stud­ies, though one pro­gram for head and neck can­cer was placed on a par­tial hold due to safe­ty fears. A string of oth­er set­backs have al­so tak­en a toll.

It’s not un­com­mon for drug com­pa­nies to ham­mer British reg­u­la­tors for the way NICE man­ages drug costs to their dis­ad­van­tage. But it is rare for a se­nior re­search ex­ec like Pan­ga­los to spear­head a di­rect as­sault like this by threat­en­ing the coun­try’s Achilles heel: hit­ting on re­search em­ploy­ment, which dis­tin­guish­es the coun­try from much of the rest of Eu­rope. That sig­nals their be­lief that the UK gov­ern­ment is feel­ing par­tic­u­lar­ly vul­ner­a­ble in the wake of the stun­ning Brex­it vote, and may fi­nal­ly be will­ing to do more to cater to Big Phar­ma now.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Jean Bennett (Brent N. Clarke/Invision/AP Images)

Lux­tur­na in­ven­tor Jean Ben­nett starts a new gene ther­a­py com­pa­ny to tack­le rare dis­eases left be­hind by phar­ma, VCs

A few years ago Jean Bennett found herself in a surprising place for a woman who invented the first gene therapy ever approved in the United States: No one, it seemed, wanted her work.

Bennett, who designed and co-developed Luxturna, approved in 2018 for a rare form of blindness, had kept building new gene therapies for eye diseases at her University of Pennsylvania lab. But although the results in animals looked promising, pharma companies and investors kept turning down the pedigreed ophthalmology professor.

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Maureen Hillenmeyer, Hexagon Bio CEO

Hexa­gon Bio rais­es $61M to con­tin­ue ef­forts to turn fun­gi in­to drugs

A year after raising a $47 million launch round, the fungi-loving drug hunters at Hexagon Bio have more than doubled their coffers.

Hexagon announced today that it raised another $61 million for its efforts to design cancer and infectious disease drugs based on insights mined from the DNA in millions of species of fungi. The new financing brings Hexagon’s committed funding to over $108 million.

Blue­bird sends blood dis­or­der drug to FDA for ap­proval; CG On­col­o­gy en­ters col­lab­o­ra­tion with Roche for Tecen­triq

Bluebird bio announced it completed the rolling submission of its BLA to the FDA for betibeglogene autotemcel gene therapy.

The therapy, designed for patients with beta-thalassemia who require regular red blood cell transfusions, was previously granted breakthrough therapy designation for treating transfusion-dependent beta-thalassemia (TDT). If approved, beti-cel will be the first hematopoietic stem cell ex-vivo gene therapy for patients in the US.