The FDA’s ad­comm of out­side vac­cine ex­perts will meet to­mor­row to dis­cuss how to pro­tect the US from a like­ly com­ing wave of Omi­cron cas­es in the fall and win­ter, and whether to de­ploy vac­cines that specif­i­cal­ly tar­get the Omi­cron vari­ant.

While the da­ta so far are lim­it­ed, the FDA sound­ed an up­beat tone in the brief­ing doc­u­ments on Pfiz­er/BioN­Tech’s can­di­dates, re­leased this week­end ahead of the VRB­PAC meet­ing.

“The cur­rent epi­demi­ol­o­gy of SARS-CoV-2, the ev­i­dence of wan­ing im­mu­ni­ty elicit­ed by cur­rent COVID-19 vac­cines, and the avail­able im­muno­genic­i­ty da­ta gen­er­at­ed from a lim­it­ed num­ber of vari­ant-spe­cif­ic vac­cine can­di­dates sug­gest that an up­dat­ed vac­cine com­po­si­tion may pro­vide added ben­e­fit against cur­rent­ly cir­cu­lat­ing virus vari­ants,” the FDA said in its brief­ing doc­u­ments, adding:

This may be par­tic­u­lar­ly im­por­tant as the 2022-2023 win­ter sea­son pro­gress­es and the risk of an­oth­er ma­jor COVID-19 out­break in­creas­es due to the com­bi­na­tion of wan­ing im­mu­ni­ty, fur­ther evo­lu­tion of vari­ants, and in­creased in­door ac­tiv­i­ty. Nev­er­the­less, as not­ed above, un­cer­tain­ties re­main, and there are po­ten­tial trade-offs as­so­ci­at­ed with var­i­ous op­tions for mod­i­fy­ing the com­po­si­tion of cur­rent vac­cines

How­ev­er, the po­ten­tial ben­e­fits of this up­dat­ed vac­cine will have to be weighed by the ad­comm against mul­ti­ple un­cer­tain­ties, in­clud­ing un­known fu­ture vari­ants, the dearth of clin­i­cal ef­fi­ca­cy da­ta for these boost­ers com­pared to the pro­to­type vac­cines, and po­ten­tial man­u­fac­tur­ing is­sues that might arise re­lat­ed to pro­duc­ing an up­dat­ed vac­cine for­mu­la­tion, FDA said.

Pfiz­er said on Fri­day that its Omi­cron-adapt­ed mono­va­lent can­di­date giv­en as a fourth boost­er dose elicit­ed a 13.5 and 19.6-fold in­crease in neu­tral­iz­ing geo­met­ric titers against Omi­cron BA. 1, while its bi­va­lent vac­cine can­di­date ex­hib­it­ed a 9.1 and 10.9-fold in­crease against Omi­cron.

“Based on these da­ta, we be­lieve we have two very strong Omi­cron-adapt­ed can­di­dates that elic­it a sub­stan­tial­ly high­er im­mune re­sponse against Omi­cron than we’ve seen to date. We look for­ward to dis­cussing these da­ta with the sci­en­tif­ic com­mu­ni­ty and health au­thor­i­ties so we may rapid­ly in­tro­duce an Omi­cron-adapt­ed boost­er as soon as pos­si­ble if au­tho­rized by reg­u­la­tors,” Pfiz­er CEO Al­bert Bourla said in a state­ment.

The agency of­fers the com­mit­tee six op­tions for mak­ing a strain rec­om­men­da­tion:

The vot­ing ques­tion al­so seems to steer the pan­elists to not just weigh in on the Pfiz­er vac­cine specif­i­cal­ly, but to think about this sit­u­a­tion holis­ti­cal­ly. The vot­ing ques­tion is, “Does the com­mit­tee rec­om­mend in­clu­sion of a SARS-CoV-2 Omi­cron com­po­nent for COVID-19 boost­er vac­cines in the Unit­ed States?”

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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