Covid-19 Roundup: Cancer Biotech To Submit EUA For Covid Drug; FDA OKs Eli Lilly JAK Inhibitor – Endpoints News

May 11, 2022 10:06 AM EDT

As vac­cine talk wanes, re-pur­posed treat­ments take cen­ter stage for Covid-19.

Veru, which start­ed out as a can­cer out­fit, plans to re­quest an EUA for its drug sabiz­ab­u­lin as a Covid-19 treat­ment for pa­tients at high risk for acute res­pi­ra­to­ry dis­tress syn­drome (ARDS), it an­nounced to­day.

Last month, Veru said its Phase III study for its Covid-19 treat­ment was shut down by an in­de­pen­dent da­ta mon­i­tor­ing com­mit­tee due to the drug’s “over­whelm­ing ef­fi­ca­cy.” Ac­cord­ing to the com­pa­ny, sabiz­ab­u­lin re­duced deaths by 55% com­pared to the stan­dard of care group, which re­ceived remde­sivir, dex­am­etha­sone, an­ti­bod­ies, and JAK in­hibitors.

To­day, the biotech said that in a pre-EUA meet­ing with the FDA, the reg­u­la­to­ry agency agreed that it has enough da­ta to sup­port both an EUA and NDA sub­mis­sion for sabiz­ab­u­lin, which is al­so cur­rent­ly in clin­i­cal tri­als for breast and prostate can­cer.

Veru said it plans to sub­mit an EUA in the sec­ond quar­ter of 2022.

Eli Lil­ly gets ap­proval for Olu­mi­ant

The FDA has ap­proved Eli Lil­ly and In­cyte’s JAK in­hibitor ​​baric­i­tinib, mar­ket­ed as Olu­mi­ant, for adults with Covid-19 who need sup­ple­men­tal oxy­gen, ven­ti­la­tion or EC­MO, the agency an­nounced yes­ter­day.

Olu­mi­ant has al­ready been in use un­der an EUA as a stand­alone treat­ment for Covid-19 since Ju­ly 2021, af­ter it was ini­tial­ly giv­en an EUA in 2020 as part of a com­bo treat­ment with Gilead’s Vek­lury (remde­sivir). With this ap­proval, Olu­mi­ant be­comes the first ap­proved im­munomod­u­la­to­ry treat­ment for Covid-19, the FDA not­ed in its press re­lease.

How­ev­er, it has not been ap­proved for pe­di­atric Covid-19 pa­tients and re­mains un­der EUA there, the reg­u­la­to­ry agency said.

In its own press re­lease, Eli Lil­ly said the ap­proval was sup­port­ed by two Phase III clin­i­cal tri­als — one of which was for the com­bo treat­ment of Olu­mi­ant and Vek­lury, and the oth­er of which com­pared Olu­mi­ant alone to stan­dard of care, but did not reach its pri­ma­ry end­point. The FDA had giv­en Olu­mi­ant its so­lo EUA based on the re­sults from the sec­ond study, say­ing the da­ta did show the treat­ment re­duced the pro­por­tion of pa­tients who died com­pared to stan­dard of care.

In the first quar­ter of 2022, Eli Lil­ly made $255.6 mil­lion from Olu­mi­ant sales.

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May 9, 2022 06:00 AM EDT

How are top investors navigating the longest biotech bear market in almost 20 years? RBC Capital Markets Healthcare Desk Sector Strategist Chris McCarthy discusses key fundamentals, macro-awareness and the continued impact of COVID with HealthCor’s Ben Snedeker and Omega Funds founder Otello Stampacchia.

Picking biotech winners

Biotech indexes may be down, but both Snedeker and Otello Stampacchia, Ph.D., Founder and Managing Director of Omega Funds, see opportunities in the market. In Snedeker’s opinion, investors need to seek out companies with the potential for meaningful revenue growth, particularly those that are mispriced in the current bear market.

May 10, 2022 06:31 AM EDT

Novo Nordisk established its R&D rep around its in-house expertise that ultimately birthed the GLP-1 blockbuster semaglutide and pushed it to major-market franchise status. But its top execs have been crystal clear that the path to the future of R&D — moving past semaglutide on to the next big thing — points to more external alliances, marrying its global research arms in and out of Copenhagen with outside groups sparking headlines around their discovery work.

May 11, 2022 11:12 AM EDT

Arrowhead Pharmaceuticals is getting a leg up from Wisconsin officials on a new building project.

The company has outlined a set of incentives that have become quite common as states look to compete for new manufacturing facilities and the jobs they can create.

Arrowhead is building a new drug manufacturing facility in Verona, WI, roughly 10 miles from Madison, that will have 125,000 square foot laboratory and office facilities to support process development and analytical activities. It will also contain 160,000 square feet of manufacturing space. Arrowhead is no stranger to the Madison area as it currently has operations around in the state’s capital.

May 11, 2022 03:19 AM EDTUpdated 03:32 AM

Roche has racked up its second straight Phase III fail for its TIGIT tiragolumab, flagging a flop on the progression-free survival co-primary endpoint for the drug combined with Tecentriq as a first-line treatment for PD-L1 high patients suffering from non-small cell lung cancer.

The other co-primary endpoint in the SKYSCRAPER-01 study on overall survival hasn’t reached the readout phase yet. But this time around Roche execs are waiting to see if it just might hit positive after seeing numerical gains for both endpoints.

May 10, 2022 12:20 PM EDT

GlaxoSmithKline is teaming up with “Beverly Hills 90210” star Jennie Garth around its anti-inflammatory med Voltaren.

Garth, who has osteoarthritis and uses the over-the-counter gel Voltaren, is also a caregiver. She’s partnering with GSK to launch the CareWalks video series where she hosts a walk and talk with other caregivers to discuss their experiences and challenges – and their joint pain.

May 11, 2022 10:31 AM EDT

Just as quickly as he started, the new CFO at Moderna has been shown the door after a single day on the job.

Jorge Gomez was out in a day after his former employer, Dentsply Sirona, said it was in an ongoing internal investigation by the audit committee, according to an SEC filing. The audit is investigating Dentsply Sirona’s “use of incentives to sell products to distributors in the third and fourth quarters of 2021, and whether those incentives were appropriately accounted for and the impact of those sales was adequately disclosed in the Company’s periodic reports filed with the Securities and Exchange Commission.”

May 11, 2022 10:07 AM EDT

The first time Roche reported a failure for its sweeping Phase III program for the TIGIT contender tiragolumab a couple of months ago, quite a few analysts were willing to give the drug — and the class — a pass.

But when the Swiss giant flagged the collapse of the PFS endpoint in SKYSCRAPER-01 in the wee hours of the American market today, there was no mistaking the dark cloud that took shape over the field as the analyst crew shook their heads over the prospects for what had been the latest, greatest hope for immuno-oncology 2.0.

May 10, 2022 07:10 AM EDTUpdated 10:30 AM

Pfizer has found a use for a chunk of its Covid windfall, agreeing to buy Biohaven and its migraine drug Nurtec for $11.6 billion.

The move to acquire the biotech at $148.50 a share — a 33% premium over a 3-month average of the share price — hands Pfizer boasting rights to the lead migraine drug in the US. And it follows on Pfizer’s $500 million deal to bag ex-US rights to the drug, when the pharma giant acquired a small, 2.6% stake in the biotech at $173 a share.

May 10, 2022 01:28 PM EDT

The Institute for Clinical and Economic Review, a pharma drug pricing watchdog, recently dug into the data on three Covid-19 therapeutics, voting 11-2 that there is not enough evidence to demonstrate a “net health benefit” for Merck’s pill molnupiravir over symptomatic care of Covid-19 alone. But Pfizer’s Paxlovid and the repurposed generic drug fluvoxamine received more favorable votes.