In a first, Re­gen­eron's an­ti­body cock­tail re­duces deaths for a sub­group of hos­pi­tal­ized Covid-19 pa­tients

Sci­en­tists have come up with the first ev­i­dence that Re­gen­eron’s an­ti­body cock­tail, which has so far on­ly been au­tho­rized for the out­pa­tient set­ting, may re­duce deaths of hos­pi­tal­ized Covid-19 pa­tients — al­beit on­ly a sub­set.

The com­bi­na­tion of casiriv­imab and imde­vimab is the sub­ject of the lat­est da­ta cut from RE­COV­ERY, the large-scale UK-based tri­al test­ing a va­ri­ety of po­ten­tial treat­ments. In to­tal, 9,785 pa­tients hos­pi­tal­ized with Covid-19 were en­rolled in this arm of the study and were ran­dom­ly as­signed to re­ceive ei­ther usu­al care plus the in­tra­venous com­bo or usu­al care alone.

Al­though Re­gen­eron has bur­nished the pro­file of its drugs with new da­ta against new vari­ants, like Eli Lil­ly, its suc­cess has been lim­it­ed to mild to mod­er­ate cas­es or as a pro­phy­lax­is. De­spite an ear­ly set­back among the most se­vere pa­tients, the biotech is still run­ning a tri­al in­volv­ing pa­tients who are hos­pi­tal­ized but re­quire no or lit­tle oxy­gen (with ini­tial da­ta in­di­cat­ing an an­tivi­ral ef­fect) — as the search for ther­a­pies that can help the sick­est pa­tients goes on.

The new re­sults are thus “very ex­cit­ing,” said joint chief in­ves­ti­ga­tor Pe­ter Hor­by.

In par­tic­u­lar, the com­bo ap­pears to keep cer­tain pa­tients who were seroneg­a­tive at base­line — mean­ing they had not mount­ed an an­ti­body re­sponse against the virus — from dy­ing. About one-third of the over­all group were seroneg­a­tive.

Fo­cus­ing on this co­hort for the pri­ma­ry analy­sis, in­ves­ti­ga­tors found that the an­ti­body treat­ment re­duced the 28-day mor­tal­i­ty by 20% over usu­al care: 24% of the seroneg­a­tive pa­tients in the an­ti­body group died ver­sus 30% of the usu­al care arm (95% con­fi­dence in­ter­val 0·70–0·91; p=0·001). In oth­er words, they wrote, “for every 100 such pa­tients treat­ed with the an­ti­body com­bi­na­tion, there would be six few­er deaths.”

The same ef­fect was not seen in seropos­i­tive pa­tients. When pool­ing da­ta from this larg­er group as well as those with un­known sta­tus with the seroneg­a­tive pa­tients, no sig­nif­i­cant ef­fect was re­port­ed in re­duc­ing deaths. Over­all, 20% of all pa­tients in the an­ti­body group died com­pared to 21% of those who re­ceived usu­al care (p=0.17).

It was im­por­tant to make the dif­fer­en­ti­a­tion, said Fiona Watt — ex­ec­u­tive chair of the Med­ical Re­search Coun­cil, which fund­ed the tri­al — “giv­en the cost of drugs.”

Nonethe­less, the find­ing that the an­ti­body cock­tail worked in any group at all was “ex­cel­lent news,” ac­cord­ing to joint chief in­ves­ti­ga­tor Mar­tin Lan­dray.

“Peo­ple have been very, very skep­ti­cal, that any treat­ment against this par­tic­u­lar virus would work by the time peo­ple get in hos­pi­tal,” he said in a me­dia brief­ing, as re­port­ed by Reuters. “If you haven’t raised an­ti­bod­ies of your own, you re­al­ly would ben­e­fit from get­ting some.”

On top of a low­er death rate, seroneg­a­tive pa­tients al­so got out of the hos­pi­tal soon­er, with a four-day dif­fer­ence in me­di­an du­ra­tion of hos­pi­tal stay (13 days ver­sus 17 days for usu­al care group) — and 64% of them were dis­charged alive by day 28, com­pared to 58%. The num­bers al­so sug­gest that if they were not on in­va­sive me­chan­i­cal ven­ti­la­tion at base­line, they were at low­er risk of pro­gress­ing to that point or dy­ing.

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.

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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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.

Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.

Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

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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Bill Gates at the Global Investment Summit in London, Oct. 19, 2021 (Leon Neal/Pool via AP Images)

Gates Foun­da­tion pledges $120M to ramp up gener­ic sup­ply of Mer­ck­'s Covid-19 pill while ac­tivists blast Pfiz­er's dis­pro­por­tion­ate pow­er

Merck’s molnupiravir may not be officially authorized anywhere in the world yet, but who will get access to it has shaped up to be a huge issue. The Bill & Melinda Gates Foundation is now stepping up to ensure lower-income countries won’t be left behind — and calling on others to follow its lead.

The oral antiviral pill, which was shown to dramatically cut the risk of severe Covid-19 disease and death in a Phase III study, is the latest rallying symbol in the battle against not just the coronavirus but the inequality it’s exposed.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

Break­ing: Bio­gen sells just $300K worth of Aduhelm in Q3, as ques­tions on long-term vi­a­bil­i­ty re­main

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.

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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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Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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