Chancellor of the Exchequer Jeremy Hunt (AP Photo/Kirsty Wigglesworth)

UK R&D cred­it in­crease, faster drug ap­provals promised in bud­get speech

When Chan­cel­lor of the Ex­che­quer Je­re­my Hunt an­nounced that he had plans to scale back R&D tax cred­its in No­vem­ber, it sparked back­lash in a coun­try that has seen a de­cline in clin­i­cal tri­als and drug pric­ing ques­tion marks.

But Hunt, the for­mer UK health sec­re­tary, said to­day in his Spring 2023 bud­get speech that he had re­turned with a “more ro­bust” R&D tax cred­it scheme.

Part of that is an “en­hanced cred­it” for qual­i­fy­ing small- or medi­um-sized bio­phar­ma busi­ness­es. If a com­pa­ny spends 40% or more of its to­tal ex­pen­di­ture on R&D, it can claim a cred­it worth £27 for every £100 they spend, as well as a £1.8 bil­lion sup­port pack­age for 20,000 com­pa­nies.

“That means an el­i­gi­ble can­cer drug com­pa­ny spend­ing £2 mil­lion on re­search and de­vel­op­ment will re­ceive over £500,000 to help them de­vel­op break­through treat­ments,” Hunt said.

The chan­cel­lor al­so turned to drug reg­u­la­tion re­form.

Start­ing in 2024, the Med­i­cines and Health­care prod­ucts Reg­u­la­to­ry Agency (MHRA) will get an ex­tra £10 mil­lion in fund­ing over the next two years and be able to have “rapid, of­ten near au­to­mat­ic sign off” for med­i­cines al­ready OK’d by reg­u­la­tors in the US, Eu­rope or Japan. The reg­u­la­tor hint­ed at such a move last month, say­ing rec­i­p­ro­cal ap­provals with the FDA, EMA and PM­DA could be­gin next year, al­though some crit­ics have warned of a race to the bot­tom.

“We are proud of our life sci­ences sec­tor, which re­ceived more in­ward in­vest­ment than any in Eu­rope last year,” Hunt added. “To­day’s change will make the UK an even more ex­cit­ing place to in­vest — as well as speed­ing up ac­cess for NHS pa­tients to the very newest drugs.”

Richard Tor­bett

It’s a turn for the bet­ter, ABPI chief ex­ec­u­tive Richard Tor­bett said in a state­ment.

The as­so­ci­a­tion has point­ed out that the UK is falling be­hind in med­i­cine in­no­va­tion af­ter a de­crease in clin­i­cal tri­als; the num­ber of tri­als fell by 41% be­tween 2017 and 2021. Can­cer tri­als fell by the same mar­gin. The UK al­so took a ma­jor hit in the over­all phar­ma­ceu­ti­cal trade bal­ance, go­ing from fourth to 98th place since 2010.

“It is al­so right that the Gov­ern­ment wants the most at­trac­tive pos­si­ble en­vi­ron­ment for in­vest­ment,” Tor­bett said. “Boost­ing in­cen­tives for R&D fo­cused SMEs, along­side the in­tro­duc­tion of ‘full ex­pens­ing’ and a com­pre­hen­sive R&D tax cred­it of­fer, will help achieve this goal for UK life sci­ences.”

Tor­bett ref­er­enced what the as­so­ci­a­tion and Big Phar­ma see as an in­com­ing li­a­bil­i­ty — the pro­posed rev­enue claw­back rate com­ing in April.

Gener­ic drug­mak­er Vi­a­tris said it would stop sell­ing cer­tain drugs in the UK that are in short sup­ply if the vol­un­tary scheme op­tion wasn’t changed. Ear­li­er this year, Eli Lil­ly and Ab­b­Vie ex­it­ed the NHS’ vol­un­tary med­i­cine pric­ing agree­ment af­ter the gov­ern­ment said com­pa­nies with brand­ed med­i­cines un­der the vol­un­tary agree­ment would have to re­turn al­most £3.3 bil­lion in sales rev­enue to the gov­ern­ment.

“But to fur­ther un­lock this po­ten­tial, it is es­sen­tial that a new Vol­un­tary Scheme is agreed be­tween in­dus­try and Gov­ern­ment, which will help build on the Chan­cel­lor’s vi­sion for a glob­al­ly com­pet­i­tive, high growth UK,” Tor­bett added.

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Feng Zhang (Susan Walsh/AP Images)

In search of new way to de­liv­er gene ed­i­tors, CRISPR pi­o­neer turns to mol­e­c­u­lar sy­ringes

Bug bacteria are ruthless.

Some soil bacteria have evolved tiny, but deadly injection systems that attach to insect cells, perforate them and release toxins inside — killing a bug in just a few days’ time. Scientists, on the other hand, want to leverage that system to deliver medicines.

In a paper published Wednesday in Nature, MIT CRISPR researcher Feng Zhang and his lab describe how they engineered these syringes made by bacteria to deliver potential therapies like toxins that kill cancer cells and gene editors. With the help of an AI program, they developed syringes that can load proteins of their choice and selectively target human cells.

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Luke Miels, GSK chief commercial officer

GSK picks up Scynex­is' FDA-ap­proved an­ti­fun­gal drug for $90M up­front

Editor’s note: This is a live story and will be updated.

GSK is dishing out $90 million cash to add an antifungal drug to its commercial portfolio, in a deal spotlighting the pharma giant’s growing focus on infectious diseases.

The upfront will lock in an exclusive license to Scynexis’ Brexafemme, which was approved in 2021 to treat a yeast infection known as vulvovaginal candidiasis, except in China and certain other countries where Scynexis already out-licensed the drug.

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See­los Ther­a­peu­tics 'tem­porar­i­ly' stops study in rare neu­ro dis­or­der for busi­ness rea­sons

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Alec­tor cuts 11% of work­force as it dou­bles down on late-stage neu­ro pro­grams part­nered with GSK, Ab­b­Vie

A month after revealing plans to concentrate on its late-stage immuno-neurology pipeline, Alector is trimming its headcount by 11%.

The layoffs will impact around 30 employees across the organization, the company disclosed in an SEC filing, adding that the plan will “better align the company’s resources” with the new strategy. With $712.9 million in cash, cash equivalents and investments as of the end of 2022, Alector believes the reserves will now get it through 2025.

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Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Hugo Peris, Spiral Therapeutics CEO

Hear­ing-fo­cused biotech grabs trio of pro­grams from Oton­o­my's fire sale

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Commissioner Robert Califf joined industry, academic and regulatory representatives in Washington to discuss why more drugs weren’t in development for cardiovascular diseases, the leading US cause of death and once a mainstay of pharmaceutical industry blockbusters.

The group pointed to many reasons. Clinical trials could take years and testing was expensive. Wide availability of generic drugs made the commercial prospects uncertain. Their paper title summed up the mood: “Cardiovascular Drug Development: Is it Dead or Just Hibernating?”

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