As­traZeneca looks to re­bound from pro­duc­tion de­lays for its Covid-19 vac­cine with new fill-fin­ish deal

The re­la­tion­ship be­tween As­traZeneca and the EU has been on edge in re­cent weeks af­ter pro­duc­tion de­lays have scut­tled roll­out plans for the British drug­mak­er’s Covid-19 vac­cine. Now, look­ing to squash wor­ries its pro­duc­tion can’t keep up with de­mand, As­traZeneca is bring­ing on a new part­ner it hopes can right the ship.

As­traZeneca has tapped Ger­many’s IDT Bi­ologi­ka to ramp up im­me­di­ate pro­duc­tion of its ade­n­ovirus-based Covid-19 vac­cine, dubbed “Covid-19 Vac­cine As­traZeneca,” and build long-term ca­pac­i­ty to han­dle fill-fin­ish work for the shot, the British drug­mak­er said Wednes­day.

The part­ners are look­ing at “op­tions to ac­cel­er­ate out­put” of As­traZeneca’s vac­cine as soon as next quar­ter, hop­ing to quick­ly fill its 300-mil­lion-dose or­der for the EU. The com­pa­ny be­gan ship­ping out dos­es late last week with the goal of dis­trib­ut­ing an ini­tial 17 mil­lion dos­es be­fore March.

The newest pact un­der­scores As­traZeneca isn’t mov­ing fast enough in sup­port­ing its EU or­der — and that doesn’t be­gin to ad­dress a po­ten­tial fu­ture OK in the US or oth­er parts of the world.

Even so, As­traZeneca is al­so tak­ing the long view with its part­ner­ship with IDT, pledg­ing to build long-term ca­pac­i­ty at the man­u­fac­tur­er’s Dessau site for fu­ture pan­demics. De­tails are still in the works, both com­pa­nies said, but As­traZeneca hopes to in­stall five 2,000-liter re­ac­tors at the site by the end of 2022 — enough ca­pac­i­ty to make “tens of mil­lions” of dos­es of the Covid-19 shot per month.

As­traZeneca and the EU have squab­bled for weeks over sup­ply con­straints for the vac­cine, with the EU at one point ac­cus­ing the British drug­mak­er of duck­ing a plan­ning meet­ing. As­traZeneca de­nied those claims, but did ad­mit that pro­duc­tion lags set back plans to meet their dis­tri­b­u­tion tar­gets.

As­traZeneca may have rea­son to dodge EU reg­u­la­tors af­ter the bloc pub­lished a heav­i­ly redact­ed ver­sion of the com­pa­ny’s con­tract with redac­tions over cost fig­ures that were eas­i­ly re­moved by in­ter­net sleuths. Among the most note­wor­thy find­ings was that the con­tract it­self was worth £870 mil­lion, or about $1.19 bil­lion for 300 mil­lion dos­es, in­clud­ing all di­rect and in­di­rect costs.

The drug­mak­er and its ade­n­ovirus vac­cine car­ry­ing the SARS-CoV-2 spike pro­tein pay­load have al­so fall­en be­hind the curve in terms of ef­fi­ca­cy com­pared with Pfiz­er and Bion­Tech and Mod­er­na, drug­mak­ers with mR­NA-based vac­c­cines that have hit the 90% ef­fi­ca­cy mark and high­er in pre­vent­ing se­vere dis­ease.

Just last week, As­traZeneca rolled out new da­ta for a two-shot reg­i­men show­ing 82.4% ef­fi­ca­cy in pre­vent­ing symp­to­matic dis­ease when giv­en giv­en 12 weeks apart, but months af­ter the FDA gave its emer­gency use nod to Pfiz­er and Mod­er­na, those re­sults and some squishy ear­li­er da­ta may not be enough to con­vince US reg­u­la­tors.

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.

Stéphane Bancel, Getty

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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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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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

UP­DAT­ED: EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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As­traZeneca caps PD-L1/CT­LA-4/chemo com­bo come­back with OS win. Is treme­li­mum­ab fi­nal­ly ready for ap­proval?

AstraZeneca’s closely-watched POSEIDON study continues to be the rare bright spot in its push for an in-house PD-L1/CTLA-4 combo.

Combining Imfinzi and tremelimumab with physicians’ choice of chemotherapy helped patients with stage IV non-small cell lung cancer live longer, the company reported — marking the first time the still-experimental tremelimumab has demonstrated an OS benefit.

For AstraZeneca and CEO Pascal Soriot, the positive readout — which is devoid of numbers — offers much-needed validation for the big bet they made on Imfinzi plus tremelimumab, after the PD-L1/CTLA-4 regimen failed multiple trials in head and neck cancer as well as lung cancer.

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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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Aindrea Campbell, Zymergen

Q&A: Ain­drea Camp­bell goes small, step­ping away from Ap­ple to head man­u­fac­tur­ing at Zymer­gen — where am­bi­tions are big

Over the past 22 years, Aindrea Campbell has worked with just two corporate giants, Ford Motor Company and Apple, with generations of experience between them. But in her new role as Zymergen’s chief manufacturing officer, Campbell comes to a company with years — eight — of history, not decades.

This month, Campbell joined synthetic biology player Zymergen to lead manufacturing for the company’s “biofacturing” process, which ferments genetically engineered molecules to create products that can be used in a range of potential applications, including electronics, consumer health and agriculture, just to name a few. The process, Zymergen says, obviates the need for toxic chemicals and huge infrastructure demands in traditional manufacturing, potentially cutting costs by 90% in half the time.

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Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.