US paus­es use of Eli Lil­ly Covid-19 mAb com­bo in six more states due to vari­ants from Brazil, In­dia

As the com­bined fre­quen­cy of the Covid-19 vari­ants first iden­ti­fied in Brazil and South Africa now ex­ceeds 10% in Ari­zona, Cal­i­for­nia, Flori­da, In­di­ana, Ore­gon and Wash­ing­ton, the US said Wednes­day that it’s halt­ing all ship­ments to those states of Eli Lil­ly’s mAb com­bo to treat Covid-19 pri­or to hos­pi­tal­iza­tions.

The FDA rec­om­mends that health care providers in those six states use Re­gen­eron’s mAb cock­tail as an al­ter­na­tive au­tho­rized mon­o­clon­al an­ti­body ther­a­py be­cause it’s more ef­fec­tive against the vari­ants than the Lil­ly treat­ment.

“RE­GEN-COV is like­ly to re­tain ac­tiv­i­ty against the P.1 and B.1.351 vari­ants,” the As­sis­tant Sec­re­tary for Pre­pared­ness and Re­sponse and FDA said in a state­ment.

Pre­vi­ous­ly, the US halt­ed ship­ments of the Lil­ly com­bo of bam­lanivimab and ete­se­vimab to Illi­nois and Mass­a­chu­setts be­cause of the vari­ant first iden­ti­fied in Brazil. FDA al­so re­voked the EUA for bam­lanivimab alone last month be­cause it was no longer as ef­fec­tive as a com­bo ther­a­py.

The con­tin­u­al­ly shift­ing land­scape of mAbs to treat Covid-19 al­so saw the ad­di­tion of an EUA for an­oth­er mAb treat­ment from Vir and Glax­o­SmithK­line on Wednes­day. Vir says their sin­gle an­ti­body can neu­tral­ize each of the vari­ants sci­en­tists sus­pect are pro­lif­er­at­ing, al­though it’s still un­known how many dos­es of the new mAb will be avail­able.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

Andrew Schiermeier, Intellia

Black­stone throws $250M be­hind In­tel­lia-Cellex quest to com­bine CRISPR and con­trol­lable CAR-Ts

So here’s how Blackstone is spending its $4.6 billion biopharma pot.

The private equity firm announced Tuesday they were teaming with the CRISPR biotech Intellia and the little-known German CAR-T startup GEMoaB to launch a new — and so far unnamed — CAR-T company. Blackstone, the sole investor, will pour $250 million into the joint venture and take a third ownership. Intellia and Cellex, GEMoaB’s parent company, will each take another third.

Con­sor­tium of 5 drug reg­u­la­tors plot path to in­crease har­mo­niza­tion through 2024

A group of drug regulators from Australia, Canada, Singapore, Switzerland and the UK on Tuesday unveiled their strategic plans for the next three years, laying out how they’ll work together on reviewing new drugs to reduce duplication across borders.

While understanding that the biopharma industry is truly global, the group, known collectively as the Access Consortium, seeks to better align their respective regulatory and policy approaches for pharmaceuticals, with an aim to facilitate faster access to high quality, safe and effective health products.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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