Way over bud­get and years late — As­traZeneca’s mas­sive HQ project of­fers a trou­bling sym­bol

As­traZeneca CEO Pas­cal So­ri­ot

When Pas­cal So­ri­ot took the helm at a deeply trou­bled As­traZeneca five years ago, one of his first acts was to slash staff and bold­ly blue­print a large new head­quar­ters fa­cil­i­ty in Cam­bridge in the UK, where com­pa­ny sci­en­tists and top aca­d­e­mics could brush shoul­ders and spark fresh in­no­va­tion. And he planned to move in last year.

On Tues­day, though, the CEO turned out at a cer­e­mo­ny to make the com­ple­tion of just one stage of con­struc­tion. And So­ri­ot had to con­cede that the build­ing — in­tend­ed to sym­bol­ize the phar­ma gi­ant’s em­brace of the lat­est tech­nolo­gies and sci­en­tif­ic in­sights on drug R&D — had al­so come to rep­re­sent the com­pa­ny’s in­abil­i­ty to stay on sched­ule with its turn­around plan.

In­stead of com­plet­ing the job in 2016 as ini­tial­ly planned, So­ri­ot told Reuters, the BBC and oth­ers that the 2,000 staffers in the area wouldn’t ac­tu­al­ly start mov­ing in un­til 2018. The build­ing is now three years be­hind sched­ule for wrap­ping up work.

De­sign of As­traZeneca’s Cam­bridge Bio­med­ical Cam­pus

The cost, which was orig­i­nal­ly slat­ed at £330 mil­lion, has now bro­ken the £500 mil­lion mark (that’s $640 mil­lion-plus at to­day’s ex­change rate).

So­ri­ot hasn’t been able to slow the avalanche of gener­ics that have been wip­ing out key drug fran­chis­es at As­traZeneca. And some of his bold­est pre­dic­tions, like ex­pand­ing the Bril­in­ta fran­chise, have failed bad­ly. So­ri­ot arranged to buy ZS-9, sup­pos­ed­ly near the mar­ket, and has been hand­ed back-to-back re­jec­tions based on man­u­fac­tur­ing prob­lems. And once top pro­grams like bro­dalum­ab have been sold off to dis­count buy­ers af­ter dis­ap­point­ing re­searchers in the clin­ic.

One area where As­traZeneca can’t af­ford any slip­page is on its piv­otal MYS­TIC study for a com­bi­na­tion of dur­val­um­ab and treme­li­mum­ab, their PD-L1/CT­LA-4 com­bo for front­line lung can­cer. As­traZeneca opt­ed to push back their ini­tial fil­ing plans for their big check­point dur­val­um­ab — now slat­ed to fill the fifth slot be­hind Mer­ck, Bris­tol-My­ers, Roche and Pfiz­er/Mer­ck KGaA — so they could shoot at a big tar­get that might give them a big en­try in­to the field.

That da­ta is now due in the sum­mer, and fail­ure — or even a slight dis­ap­point­ment — is not an op­tion.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Ron DePinho (file photo)

A 'fly­over' biotech launch­es in Texas with four Ron De­Pin­ho-found­ed com­pa­nies un­der its belt

In his 13 years at Genzyme, Michael Wyzga noticed something about East Coast drugmakers. Execs would often jet from Boston or New York to San Francisco to find more assets, and completely miss the work being done in flyover states, like Texas or Wisconsin.

“If it doesn’t come out of MGH or MIT or Harvard, probably not that interesting,” he said of the mindset.

Now, he and some well-known industry players are looking to change that, and they’ve reeled in just over $38 million to do it.

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Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.

Biden ad­min­is­tra­tion backs a po­lar­iz­ing pro­pos­al to waive IP for all Covid-19 vac­cines

In a surprise U-turn, the Biden administration said Wednesday that it will support a proposal at the World Trade Organization to temporarily waive intellectual property protections on Covid-19 vaccines.

The proposal, backed by South Africa and India at the WTO, seeks to help developing countries with limited vaccine supplies. The US and Europe historically opposed the proposal, saying IP should be protected because it incentivizes new drug and vaccine development.

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FDA ex­tends re­search agree­ment with MIT-li­censed or­gan-on-chip sys­tems

The FDA on Wednesday extended its four-year agreement with CN Bio, a developer of single- and multi-organ-on-chip systems used for drug discovery, for another three years.

CN Bio said the scope of the research performed by the FDA’s Center for Drug Evaluation and Research has expanded to include the exploration of the company’s lung-on-a-chip system to help with the agency’s evaluation of inhaled drugs, in addition to the agency’s work on its liver model.

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In quest to meet user fee goals, FDA’s per­for­mance con­tin­ues down­ward trend

A recent update to the FDA’s running tally of how it’s meeting its user fee-related performance goals during the pandemic shows an agency that is not out of the woods yet.

The latest numbers reveal that for a second straight quarter in 2021, the FDA has met its user fee goal dates for 93% of original new drug applications, which compares with 94% and 98% for the previous two quarters in 2020, respectively.

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