As it expands its footprint, Moderna reaches deal to commercialize Covid-19 vaccine doses in Middle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to commercialize its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

Saudi Arabia has vaccinated just 6% of its population. The country has had a steady number of around 1,000 cases per day since May 20. Since the start of the pandemic, 7,503 Saudi Arabians have died from the virus, while 461,000 people have tested positive.

“As part of our role and mission in Tabuk to deliver unique health solutions and preserve lives for the people of Saudi Arabia and countries we operate in especially during the current pandemic, our partnership with Moderna comes in as an evident choice to further support our mission in line with Saudi vision 2030 regarding biotechnology in association with such a distinguished & renowned company as Moderna,” said Mohammed Alhagbani, the president of Astra Industrial Group, which owns Tabuk.

Moderna has been busy. The company announced a plan to produce as many as 3 billion doses of its vaccine per year, in a move that CEO Stéphane Bancel said in an interview with Endpoints News was driven by the company’s sense of obligation in helping the rest of the world with vaccines. At the start of May, though it was late to the party, Moderna pledged 500 million doses to Gavi, the vaccine alliance.

Since then, it’s announced partnerships to manufacture vaccines in Spain, South Korea, Australia and Switzerland, as well as bolstered its US operations with expansions in Massachusetts. Just Thursday, Moderna filed for emergency use authorization to get its vaccine in the arms of teens between the ages of 12 and 17. Earlier that week, it filed for authorization with EU and Canadian regulators as well.

The company announced in May that its Phase II/III study of the vaccine in adolescents met the primary endpoints in nearly 2,500 patients and showed an efficacy of 100% against severe symptomatic Covid-19. The trial also looked at milder cases than were examined in the adult study, since children are less likely to develop serious side effects. The study found that the vaccine was 93% effective at stopping mild cases 14 days after patients were dosed with their first shot.

A previous version of this story stated that Moderna and Magenta had reached a deal to manufacture vaccines in Saudi Arabia. That has been corrected.

Adaptive Design Methods Offer Rapid, Seamless Transition Between Study Phases in Rare Cancer Trials

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UPDATED: Roivant bumps stake in Immunovant with a $200M deal. But with M&A off the table, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Sanofi preps a multibillion-dollar buyout of an mRNA pioneer after falling behind in the race for a Covid-19 jab — report

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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UPDATED: Watch out GlaxoSmithKline: AstraZeneca's once-failed lupus drug is now approved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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Covid-19 roundup: Regeneron's mAB gets expanded EUA; mRNA drugmakers spike price of vaccines in EU supply deal

The FDA has expanded the authorization for Regeneron’s Covid-19 treatment Regen-Cov in an announcement Friday.

The authorization now covers post-exposure prophylaxis for those exposed to an infected person or who are at high risk of exposure “in an institutional setting” like a nursing home or a prison, and are not fully vaccinated or expected to provide a sufficient immune response.

Regeneron experts predict that 3% of the US population may not be able to fully respond to Covid-19 vaccinations.

Not all mRNA vaccines are created equal. Does it matter?; Neuro is back; Private M&A affair; and more

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As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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Bristol Myers pulls lymphoma indication for Istodax after confirmatory trial falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

Rick Pazdur (via AACR)

FDA's oncology head Rick Pazdur defends the accelerated approval pathway, claiming it is 'under attack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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FTC pulls remaining case against AbbVie; New EU clinical trials system coming in 2022; Abingworth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.