Eli Lilly: As donanemab filing approaches, execs 'even more confident' in data package
Kyle Blankenship
Managing Editor
Eli Lilly had a strong Q2, but unsurprisingly analysts don’t want to talk much about drugs already approved — their eyes are set firmly on Alzheimer’s hopeful donanemab, a potential blockbuster in the making.
Lilly CEO David Ricks faced a wall of questions Tuesday from analysts on the drugmaker’s Q2 earnings call looking to paint a picture of Lilly’s hand as it prepares to file a BLA for donanemab later this year.
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October 11, 2021 06:00 AM EDT
Biotech Halftime Report: After a bumpy year, is biotech ready to rebound?
Brian Abrahams
Co-Head of Biotechnology Research
The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.
RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.
How to collect and submit RWD to win approval for a new drug indication: FDA spells it out in a long-awaited guidance
Zachary Brennan
Senior Editor
Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.
While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.
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Pfizer throws its weight behind LNP player eyeing mRNA treatments for CF, PCD
Amber Tong
Senior Editor
David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.
Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.
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Bristol Myers pledges to sell its Acceleron shares as activist investors circle Merck's $11.5B buyout — report
Amber Tong
Senior Editor
Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.
The pharma giant is planning to tender its Acceleron shares, Bloombergreported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.
To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.
Novo CEO Lars Fruergaard Jørgensen on R&D risk, the deal strategy and targets for gender diversity
John Carroll
Editor & Founder
I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.
John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?
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UPDATED: FDA slaps AstraZeneca's MCL-1 cancer drug with a hold after safety issue — 2 years after Amgen axed a troubled rival
John Carroll
Editor & Founder
There are new questions being posed about a class of cancer drugs in the wake of the second FDA-enforced clinical hold in the field.
Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca says that regulators hit them with a hold on their rival therapy of the same class.
The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.”
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Some cancer patients now have to find other options as Bristol Myers' Abraxane falls into shortage from manufacturing woes
Zachary Brennan
Senior Editor
When Beth Hogan, a metastatic pancreatic cancer patient, showed up for her infusion at Yale’s Smilow Cancer Hospital in New Haven, CT on Oct. 11, she said she was informed that day that she would not be receiving Bristol Myers Squibb’s Abraxane, part of her combo treatment, because of a shortage.
“I was told we don’t know when you can have it,” she told Endpoints News via email, adding that she doesn’t expect to receive any Abraxane this coming Monday at her treatment appointment either, and she doesn’t know when things will change.
Surgeons successfully attach pig kidney to a human for the first time, using tech from United's Revivicor
Max Gelman
Editor
In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.
Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.
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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)
Updated: Biogen sells just $300K worth of Aduhelm in Q3, as questions on long-term viability remain
Zachary Brennan
Senior Editor
Barely anyone is accessing Biogen’s controversial Alzheimer’s treatment, with the company reporting just $0.3 million in Aduhelm sales in the third quarter. Although investors will be looking to the longer term, when CMS may decide to cover the drug and open the floodgates for more reimbursement, use of the drug is currently stalled.
Since June, when the FDA first signed off on the drug under its accelerated pathway, Biogen said Wednesday that it’s sold a total of $2 million worth of Aduhelm. That’s a far cry from the peak Wall Street sales estimate of about $9 billion in annual sales, and even a ways away from the sell-side consensus of about $17 million in Q3 sales.
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