The FDA may soon sign off on two new pills from Merck and Pfizer to help treat Covid-19 before those infected end up in the hospital, according to a Bloomberg report.
An announcement from the agency may come as early as Wednesday, according to three Bloomberg sources, which would create more options for those who are unvaccinated and need quick and early treatment.
Most recently, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the Merck pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms. But Merck offered little explanation for why its potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, and mutagenesis concerns remain.
But Pfizer’s pill held up with nearly 90% efficacy in a full analysis of its trial data, and the FDA has not set up an adcomm to review the pill, likely signaling an OK. — Zachary Brennan
Broad Institute finds rise of Omicron via CRISPR
As Omicron spreads across the US, the Massachusetts public health department has teamed up with the Broad Institute to use CRISPR to take a look at the rise for public health’s sake.
The Broad is using a platform it calls mCARMEN to test Covid-19 specimens across the Bay State, allowing researchers to analyze variants faster. About 45% of the 1,108 specimen tested by Dec. 16 showed strong evidence of the Omicron variant. That’s a 40% increase in Omicron cases since about Dec. 10.
The CDC meanwhile, said late Monday, that Omicron accounted for 73% of new Covid cases nationwide – a stunning rise over last week’s figures.
mCARMEN stands for Combinatorial Arrayed Reactions for Multiplexed Evaluation of Nucleic acids. The technology scales up CRISPR-based diagnostics, using microfluidic chips to run several tests at the same time. The platform was first developed in 2020, and the Broad Institute has been partnering with the CDC to conduct what it calls ‘large-scale viral sequencing to support Covid-19 genomic surveillance’ since March.
The Broad Institute says it scaled up its ability to sequence Covid-19 samples and projects it will be able to process 8,000 samples a week by the start of 2022. On Dec. 4, the first significant percentage of US Covid-19 cases were marked as the Omicron variant, as Broad detected about 15%.
The Broad’s works comes nearly two years after scientists first began repurposing genome-editing tool CRISPR as a diagnostic. Despite early hype and a couple FDA authorizations, though, the impact of such tests has been limited. — Josh Sullivan
Veklury gets expanded OK in Europe for patients who don’t need oxygen
Patients not requiring supplemental oxygen have been added to the conditional marketing authorization for Gilead’s Covid-19 treatment Veklury in Europe. The addition comes as the Omicron variant has brought new fears of how to best treat patients.
The determination comes after a Phase III trial found that Veklury reduced the risk of Covid-19 hospitalizations and deaths by 87% compared with the placebo.
‘We can now use Veklury to help prevent high-risk patients from progressing to more severe disease, even when they do not require oxygen, as well as continue to utilize Veklury as a key tool in the treatment of severe disease. This latest approval will also help to relieve some of the pressure on healthcare systems that are already under significant strain from the burden of Covid-19,’ said Roger Paredes, of Spain’s infectious disease department.
The most common side effects of the treatment include nausea and headaches. — Josh Sullivan
Preclinical mAb cocktail may be effective against Omicron
A California biotech announced its monoclonal antibody cocktail, which is currently in preclinical study, may be effective against the Omicron variant of Covid-19.
The cocktail is also reactive against SARS, MERS and the common cold, the company, known as Aridis Pharmaceuticals, said.
AR-701 is expected to provide protection from viruses for up to a year, the company said. The cocktail is made up of AR-703 and AR-720, which block viral binding to the human ACE2 receptor. AR-703 binds to the ‘S2′ stalk region of spike proteins from virus variants, including Beta, Gamma, Delta, and Epsilon, and bind to the Omicron variant with no loss in protection, compared to the original strain.
‘To our knowledge AR-701 is the only Covid-19 therapy that targets two distinct viral mechanisms of action, making it much harder for the virus to generate resistance, and exhibits an unmatched combination of broad reactivity and high efficacy,’ Aridis CEO Vu Truong said in a statement. — Josh Sullivan
CALQUENCE is a registered trademark of the AstraZeneca group of companies.
At the 2021 American Society of Hematology (ASH) Annual Meeting & Exposition, blood cancer researchers from around the world gathered virtually to discuss the progress that has been made in the field of hematology. Over the past decade, that progress has been tremendous. We’ve seen not only breakthrough approaches to care, but also significant improvement upon existing novel treatments and exploring combinations within those medicines.1 These advances have transformed expectations of what a blood cancer diagnosis now means for patients. While we’ve come a long way, I believe the most exciting scientific discovery is yet to come, and that future advances will truly transform patient care.
Alzheimer’s disease researchers along with medical professors from Harvard and Johns Hopkins issued a formal statement Monday asking the FDA to quickly pull Biogen’s Aduhelm from the market.
‘An accelerated withdrawal would mitigate some of the harm of its unwarranted accelerated approval,’ they wrote to FDA, explaining how Aduhelm ‘did not meet the FDA’s own criteria for accelerated approval based on surrogate markers because amyloid plaque does not correlate well with symptoms, severity of disease or progression.’
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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)
In a surprise move, Biogen announced Monday that it will cut the price of its controversial Alzheimer’s drug Aduhelm in half, slashing the cost from $56,000 to $28,000.
The sudden discount marks a sudden turnaround for the big biotech as it struggles to turn around a drug whose stuck-in-the-mud sales and political ramifications have sent the company into turmoil and triggered the ousting of its longtime chief scientist. Biogen’s leadership had resisted calls since June to reduce the price of the drug.
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Angie You and Volker Schellenberger, Amunix
Sanofi is crashing the year-end M&A party with a deal of its own.
Immuno-oncology is the name of the game as it swallows Mountain View, CA-based Amunix for $1 billion upfront and up to $225 million in biobucks, tagging a suite of T cell engagers and cytokine therapies as well as a tech platform for making ‘conditionally activated biologics.’
‘The Amunix technology platform utilizes a next generation smart biologics approach to precisely tailor-deliver medicines to become active only in tumor tissues while sparing normal tissues,’ said Sanofi R&D chief John Reed, ‘thus bringing the promise of more effective and safer treatment options for cancer patients.’
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New research from Johns Hopkins shows convalescent plasma may work in the outpatient space, which could be key as the Omicron variant has extinguished several monoclonal antibody treatments.
The results of this placebo-controlled, multicenter trial led by Hopkins researchers showed that convalescent plasma reduced the need for hospitalization among more than 1,000 outpatients with Covid-19 who participated.
Right as the new Omicron variant is poised to increase rapidly across the US, the federal government has effectively run out of the only monoclonal antibody treatment that works against it, and at least one major hospital system is now halting all mAb infusions.
Late last month, the federal government paused shipments of GlaxoSmithKline and Vir’s mAb treatment sotrovimab in order to conserve supplies of the only treatment that might work against the Omicron variant. Last week, however, HHS told Endpoints News that the move to hold back sotrovimab was unrelated to Omicron, and due to a surplus of Eli Lilly mAbs, which aren’t effective against Omicron.
Graphic: Alexander Lefterov for Endpoints News
Drug pricing reform has been a political football for years, with both Donald Trump and Joe Biden championing changes during their presidencies. Little has moved the needle on Capitol Hill, however, thanks in part to the drug industry’s powerful lobbyists.
In the most recent example, Democrats tried to allow Medicare to negotiate drug prices — an immediate non-starter for biopharma proponents. After months of negotiation, the measure fell apart in favor of provisions on a small subset of drugs that passed the House but marked a far cry from Biden’s promises and what many activists had hoped for. The bill, included as part of Biden’s broad social policy agenda, now appears dead after Democrats failed to secure 50 votes in the Senate.
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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)
Just 6 days after Eli Lilly execs ID’d its $1.1 billion atopic dermatitis drug lebrikizumab as one of its top late-stage drug candidates, the pharma giant has followed up with another round of positive late-stage data as it paves the way to planned regulatory filings in 2022.
The Christmas week statement from Lilly included little by way of hard data — the big outfit typically reserves that for its science conferences — but researchers touted a clean sweep of the primary and all secondaries in its 3rd round of late-stage results.
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Bob Duggan, Summit CEO (via Summit Investments)
Bob Duggan — the billionaire investor famous for turning Pharmacyclics from a penny stock to a $20 billion company — placed a handsome bet on the company’s new antibiotic for C. difficile infection last year, scooping up a majority stake and naming himself CEO in hopes of turning a profit in a field largely abandoned by Big Pharma.
But on Monday, a Phase III failure sent the company’s stock spiraling in premarket trading — and now, Duggan says he’s looking to raise more cash.
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