Jacob Van Naarden, Senior VP, CEO of Loxo Oncology at Lilly; President, Lilly Oncology

Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?

The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

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.

With hun­dreds of mil­lions spent on failed ac­cel­er­at­ed ap­provals, re­searchers call for faster FDA with­drawals

Between 2017 and 2019, Medicare spent more than $220 million on cancer drugs for which the indications were either voluntarily pulled by their applicants or FDA’s oncology adcomm had recommended their withdrawal.

That kind of massive spending on cancer drugs lacking overall survival benefit is wasteful and risks harming people’s health, a research letter published in JAMA Internal Medicine on Monday said. The researchers from Harvard and the London School of Economics called on the FDA to move faster in both requiring timely postmarketing trials and accelerating the speed in pulling these dangling approvals when the confirmatory studies fail.

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UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

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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Jon Cole, emergency doc at Minneapolis' Hennepin County Medical Center

FDA warns Min­neso­ta doc for run­ning two ke­t­a­mine tri­als with­out INDs, and with chil­dren and a preg­nant woman

The FDA on Tuesday released a warning letter sent to a Minnesota physician who failed to exclude vulnerable populations from two clinical trials comparing the anesthetic ketamine with haloperidol and midazolam as potential severe agitation treatments.

The letter makes clear that not only did Jon Cole, emergency doc at Minneapolis’ Hennepin County Medical Center, never file INDs for the trials with the FDA, as required by law, he also didn’t write appropriate protocols to ensure that children and pregnant women weren’t enrolled, and didn’t exclude those who were under the influence of intoxicants, in whom the use of ketamine is cautioned.

Francis Collins (Michael Reynolds/Pool via AP Images)

Sen­ate spend­ing bill slash­es funds for Biden's planned break­through drug ac­cel­er­a­tor at NIH

With the announcement that Francis Collins, the NIH’s longtime head, is leaving at the end of the year, a flashy new idea from President Joe Biden to accelerate more cancer, diabetes and Alzheimer’s drugs at the NIH appears to have lost steam.

The Senate Appropriations Committee on Monday unveiled its proposal for the NIH’s spending bill, which proposes just $2.4 billion for this Biden project, to be known as the Advanced Research Projects Agency for Health or ARPA-H. Biden had initially requested $6.5 billion, and the House Appropriations Committee signed off on $3 billion earlier this summer.

Jean-Pierre Sommadossi, Atea CEO

Roche-Atea’s Covid-19 pill fails mid-stage tri­al, cloud­ing fu­ture for close­ly watched pro­gram

When Merck announced this month that its Covid-19 pill cut newly diagnosed patients’ risk of being hospitalized by 50%, researchers and analysts hoped that other pills would soon prove similarly effective. They paid particular attention to two drugs from Pfizer and Roche.

But on Tuesday, Roche and its biotech partner, Atea, announced that their antiviral had failed a key interim test.

In a Phase II trial, AT-527 didn’t reduce the amount of virus in mild to moderate Covid-19 patients any more than a placebo pill did. That was true for both the patients who received a high dose and those who received the low dose.

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Antoine Papiernik (Sofinnova)

UP­DAT­ED: Sofinno­va hauls in $548M to build and scale star­tups — as Eu­ro­pean VCs step up their bio­phar­ma game

When Sofinnova Partners unveiled its $540 million crossover fund earlier this year, the Paris-based power VC player touted its leading role in providing late-stage capital to high-growth startups in Europe and beyond.

But that doesn’t mean it’s forgetting its roots in early-stage healthcare investing.

In fact, the Sofinnova crew was already talking to investors behind the scenes for what would become the largest iteration yet of its flagship fund. At $548 million (€472 million), Sofinnova Capital X is almost $50 million bigger than its predecessor and brings its total assets under management to more than €2.5 billion.

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