British CRO wins con­tract for Covid-19 chal­lenge virus; Dutch agency aims to slash Zol­gens­ma prices in half

Ef­forts are un­der­way to de­vel­op a new chal­lenge virus for SARS-CoV-2, and a British CRO is mak­ing its case.

Open Or­phan said Mon­day that its sub­sidiary hVI­VO signed a con­tract with Im­pe­r­i­al Col­lege Lon­don to man­u­fac­ture such a chal­lenge virus. The con­tract is worth £3 mil­lion and hVI­VO will de­vel­op the virus based on new emerg­ing Covid-19 vari­ants of con­cern. The com­pa­ny hopes to then use the virus in fu­ture chal­lenge stud­ies.

Open Or­phan added the project will be­gin im­me­di­ate­ly, and man­u­fac­tur­ing is ex­pect­ed to be com­plete by the end of the year.

The CRO feels hVI­VO is well-suit­ed to the task be­cause of its past ex­pe­ri­ence work­ing on chal­lenge virus­es for the flu, RSV and the com­mon cold, in ad­di­tion to an ear­li­er ver­sion of SARS-CoV-2. That orig­i­nal Covid-19 strain is be­ing used in a chal­lenge study in col­lab­o­ra­tion with the UK gov­ern­ment.

“The avail­abil­i­ty of a vari­ant SARS-CoV-2 virus will great­ly ex­pand the util­i­ty of the SARS-CoV-2 chal­lenge mod­el and al­low us to an­swer a wider range of im­por­tant sci­en­tif­ic ques­tions to aid con­trol of the pan­dem­ic as well as fa­cil­i­tate fur­ther test­ing of vac­cines de­signed against Covid-19,” — hVI­VO CSO An­drew Catch­pole said in a state­ment.

Dutch agency says Zol­gens­ma price should be cut in half

No­var­tis’ Zol­gens­ma drug for spinal mus­cu­lar at­ro­phy is no­to­ri­ous for be­ing the most ex­pen­sive med­i­cine in the world at about $2.1 mil­lion. But the Dutch are try­ing to change that.

The Zor­gin­sti­tu­ut, the na­tion­al health care in­sti­tute of The Nether­lands, is push­ing to slash Zol­gens­ma’s price in half, per a state­ment re­leased Mon­day. The in­sti­tute not­ed that the price point does not re­flect the drug’s ef­fec­tive­ness, say­ing there is too lit­tle ev­i­dence the drug works to cost its cur­rent price.

It has rec­om­mend­ed that the Dutch gov­ern­ment not cov­er the costs of the med­i­cine un­less this price cut is met.

“The Zor­gin­sti­tu­ut en­sures that our care is and re­mains good and af­ford­able, all this to on­ly spend our mon­ey for health­care on valu­able treat­ments that are known to ac­tu­al­ly work,” the agency said in a state­ment. “We ul­ti­mate­ly make these com­pli­cat­ed but nec­es­sary choic­es for and on be­half of 17 mil­lion Dutch peo­ple, so that every­one con­tin­ues to have ac­cess to good and af­ford­able care in the fu­ture.”

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.