Dan Skovronsky, Eli Lilly CSO (Purdue University)

Eli Lil­ly racks up EUA for an­ti­body cock­tail — but the big­ger chal­lenge is still ahead

Eli Lilly has become the first drugmaker to have three Covid-19 treatments authorized for emergency use by the FDA, racking up an EUA for the use of its two-drug antibody cocktail to treat recently diagnosed patients with mild to moderate disease.

The regulatory clearance comes just two weeks after Lilly released a large batch of data from the BLAZE-1 trial showing that the combo of bamlanivimab and etesevimab reduced deaths and hospitalizations by 70% among 1,000 patients. But it arrives much later than the pharma giant had hoped: As early as October, following initial results around viral load, ER visits and hospitalization rate, Lilly said it had applied for an EUA.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Demis Hassabis, DeepMind CEO (Qianlong/Imaginechina via AP Images)

Google's Deep­Mind opens its pro­tein data­base to sci­ence — po­ten­tial­ly crack­ing drug R&D wide open

Nearly a year ago, Google’s AI outfit DeepMind announced they had cracked one of the oldest problems in biology: predicting a protein’s structure from its sequence alone. Now they’ve turned that software on nearly every human protein and hundreds of thousands of additional proteins from organisms important to medical research, such as fruit flies, mice and malaria parasite.

The new database of roughly 350,000 protein sequences and structures represents a potentially monumental achievement for the life sciences, one that could hasten new biological insights and the development of new drugs. DeepMind said it will be free and accessible to all researchers and companies.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

EMA re­jects FDA-ap­proved Parkin­son's drug, signs off on Mod­er­na vac­cine use in ado­les­cents ahead of FDA

The European Medicines Agency on Friday rejected Kyowa Kirin’s Parkinson’s disease drug Nouryant (istradefylline), which the US FDA approved in 2019 under the brand name Nourianz.

EMA said it considered that the results of the clinical studies used to support the application “were inconsistent and did not satisfactorily show that Nouryant was effective at reducing the ‘off’ time. Only four out of the eight studies showed a reduction in ‘off’ time, and the effect did not increase with an increased dose of Nouryant.”

In­side Bio­gen's scram­ble to sell Aduhelm: Pro­ject 'Javelin' and pres­sure to ID as many pa­tients as pos­si­ble

In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.

The program identified about 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Vas Narasimhan, Novartis CEO (Jason Alden/Bloomberg via Getty Images)

No­var­tis dis­cards one of its ‘wild card’ drugs af­ter it flops in key study. But it takes one more for the hand

Always remember just how risky it is to gamble big on small studies.

A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.

By last fall, the program had risen up to become one of CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, Pfizer CEO (Evan Vucci/AP Images)

Covid-19 roundup: Pfiz­er to sup­ply US with 200M more vac­cines as UK study finds high­er an­ti­bod­ies in 8-10 week in­ter­vals

The US government has purchased 200 million more doses of the Pfizer/BioNTech vaccine, the companies announced Friday morning.

Pfizer and BioNTech expect to deliver 110 million of the additional doses by Dec. 31, with the remaining 90 million doses to be delivered no later than April 30, 2022. The price was not disclosed, and the US government has the option to acquire an updated version of the vaccine to address potential variants, as well as new formulations of the vaccine, if available and authorized.

6 top drug­mak­ers of­fer per­spec­tives on FDA's new co­vari­ates in RCTs guid­ance

Back in May, the FDA revised and expanded a 2019 draft guidance that spells out how to adjust for covariates in the statistical analysis of randomized controlled trials.

Building on the ICH’s E9 guideline on the statistical principles for clinical trials, the 3-page draft was transformed into an 8-page draft, with more detailed recommendations on linear and nonlinear models to analyze the efficacy endpoints in RCTs.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Severin Schwan (AP Images)

Roche CEO Schwan puts 3-time Alzheimer's los­er gan­tenerum­ab back in the spot­light as FDA's con­tro­ver­sial Aduhelm OK in­spires block­buster fore­casts

Four years after Roche opted to resurrect its late-stage effort on their Alzheimer’s program for gantenerumab following a clear failure, Roche CEO Severin Schwan is signaling some fresh enthusiasm for its blockbuster prospects in the wake of the controversial Aduhelm OK.

Schwan told reporters that company execs are engaged in ongoing talks with the FDA as speculation continues to percolate around its chances based on biomarker data alone, now that regulators have established a precedent using an accelerated approval pathway process with no convincing evidence of efficacy in helping patients retain their cognitive skills. In Aduhelm’s case, the drug reduced the amount of amyloid in the brain and Biogen was able to win the accelerated approval on what the FDA called a reasonable expectation of success.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 112,600+ biopharma pros reading Endpoints daily — and it's free.

Mol­e­c­u­lar Di­ag­nos­tics Can Trans­form Can­cer Care. Let’s Make It Hap­pen.

Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.