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Thursday, September 30, 2021

AstraZeneca COVID-19 Jab Shows 74% Efficacy In US Trial


  • Reuters reported that large U.S. trial results of AstraZeneca Plc's  (Get Free Alerts for AZN) COVID-19 vaccine demonstrated 74% efficacy at preventing symptomatic disease.
  • In people aged 65 and older, the efficacy increased to 83.5%
  • Overall efficacy of 74% was lower than the interim 79% reported in March, a result AstraZeneca revised days later to 76% after a rare public rebuke from health officials that the figure was based on "outdated information."
  • The study included data from more than 26,000 volunteers in the United States, Chile, and Peru.
  • There were no cases of severe or critical symptomatic COVID-19 among the more than 17,600 participants who got the vaccine, compared with 8 cases among the 8,500 volunteers on placebo. 
  • There were also two deaths in the placebo group but none among those who received the vaccine.
  • "I was pleasantly surprised," Dr. Anna Durbin, a vaccine researcher at Johns Hopkins University and one of the study's investigators, said of the overall result. "It was also highly protective against severe disease and hospitalization," she said.
  • No blood clotting side effects linked to the vaccine were observed during the study.
  • AstraZeneca said it plans to file for full approval with the FDA rather than seek emergency use authorization. 

How nanomaterial aids antibody response

 Researchers explain how nanomaterial aids antibody response, study it as antibody factory

Illustration shows how a nanomaterial links with receptors on the immune system's B cells and helps them initiate antibody production. The top two panels show anti-immunoglobulin antibody fragments (brown) binding to immune system B cell receptors (blue). Micelles (spheres) don't interact with B cell receptors without these fragments (bottom left panel). In the presence of the fragments, the micelles link the fragments and B cell receptors (bottom right panel), boosting antibody production. Credit: Nanovaccine Institute

The researchers' original task was to figure out how certain polymer nanomaterials provided for a low-inflammatory immune response and yet were able to boost antibody production as part of a single dose of vaccine.

Once they learned how these nanomaterials just 20 to 30 billionths of a meter in size acted as vaccine-aiding adjuvants, they decided to take the next scientific step.

Could these same tiny adjuvants carry real-world antigens to the immune system's B cells and turn them into antibody-secreting factories? In addition, could this be an alternative way to produce laboratory  for diagnostic and therapeutic applications?

The answers were yes. Cell-culture experiments with the technique produced antibodies against key antigens from the coronavirus that causes COVID-19 and the bacterium that causes pneumonic plague.

The initial observation and subsequent discovery show how researchers affiliated with the Nanovaccine Institute based at Iowa State University look at their research from many perspectives:

"This is a great example of the healthy tug of war between a basic research finding about the mechanism of antibody production and a translational benefit that we may have invented a new antibody-production platform," said Balaji Narasimhan, the director of the Nanovaccine Institute, an Iowa State Anson Marston Distinguished Professor in Engineering and the Vlasta Klima Balloun Faculty Chair. "The Nanovaccine Institute is burning both sides of that candle."

The journal Science Advances recently published the researchers' findings. First author is Sujata Senapati, a former Iowa State doctoral student in chemical and biological engineering. Corresponding authors are Narasimhan and Surya Mallapragada, an Iowa State Anson Marston Distinguished Professor in Engineering, an associate vice president for research and the Carol Vohs Johnson Chair in Chemical and Biological Engineering. (See sidebar for the full research team.)

Grants from the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health, supported the researchers' work.

It's like a ladder

It was clear to the researchers that these nanomaterials—"pentablock copolymer micelles," according to the researchers' paper—helped B cells initiate antibody production. (Micelles are structures that self-assemble in water or oils as their molecules align because of their water-loving or water-hating properties.)

"From our studies, we understood very early on that these self-assembling micelles are different from the other types of adjuvants out there," Senapati said. "What we didn't know was the reason behind this unique type of immune response generated by them and that to me was the most intriguing part of this project."

Mallapragada said the researchers were able to tailor the chemistry of the nanomaterials, creating "micelles with added functionality."

One of those functions is the ability of positively charged micelles to associate with multiple antigens and directly interact with receptors on B cells, according to the paper. This cross-linking of the B cell receptors led to better antibody production and an enhanced immune response to a vaccine.

"These micelles act like a scaffold to cross-link two receptors," said Michael Wannemuehler, an associate director of the Nanovaccine Institute and an Iowa State professor of veterinary microbiology and preventive medicine.

He said the cross-link is strong and stable, like a ladder hooked at both ends, and is effective at stimulating  by the B cells.

That cellular activation came without the inflammatory response that accompanies other vaccine adjuvants, potentially producing a "'just right' immune response" that could be "critical in the rational design of vaccines for older adults" who often suffer from chronic inflammation, according to the paper.

Making lab antibodies

Now that the researchers understood the "behind-the-scenes" mechanism of the micelles' antibody boost, Senapati said they wanted to see what else they could find.

"The next obvious step then was to test our hypothesis with antigens from some real-world pathogens and see if these micelles could be potentially used to produce antibodies against them," she said.

They used the micelle scaffolds to present antigens for SARS-CoV-2, the virus that causes COVID-19, and Yersinia pestis, the bacterium that causes pneumonic plague, to B cells in culture.

Those cells began generating "laboratory-scale quantities of therapeutic antibodies" against the two antigens, "further expanding the value of these nanomaterials to rapidly develop countermeasures against infectious diseases," according to the paper.

Those antibodies could potentially be used for diagnostic test kits or for treatments such as the monoclonal antibodies that have been developed to treat COVID-19, Wannemuehler said.

"There are different ways to produce antibodies," Narasimhan said. "The method we found is an alternative that could be quite powerful if it's generalized to other diseases. It could be a plug-and-play platform."

Because it's an effective vaccine adjuvant and antibody producer, the paper says the nanomaterial platform developed by the study team is "a highly versatile tool in the development of multiple countermeasures against emerging and reemerging infectious diseases."

Explore further

Antibodies from original strain COVID-19 infection don't bind to variants

More information: Sujata Senapati et al, Self-assembling synthetic nanoadjuvant scaffolds cross-link B cell receptors and represent new platform technology for therapeutic antibody production, Science Advances (2021). DOI: 10.1126/sciadv.abj1691

Why some people are less naturally resistant to COVID-19

 A large team of researchers affiliated with a host of institutions in the U.K. and Brazil has partially solved the mystery of why some people are less naturally resistant to COVID-19 than others. In their paper published in the journal Science, the group describes their study of the interferon system and the role it plays in combating the SARS-CoV-2 virus.

As the global pandemic has unfolded, it has become clear that some people have much more serious symptoms when contracting COVID-19 than others. Indeed, some people have been found to exhibit no symptoms at all, while others become so sick that they die. In this new effort, the researchers conducted extensive interferon-stimulated  screening to isolate possible enzymes involved in alerting the immune system to an infection. Interferons are signaling proteins that alert the body when invasive entities such as bacteria and viruses are detected.

The work by the researchers led them to OAS1, an enzyme that reacts to interferon signaling by calling for an immune response when the SARS-CoV-2  is detected. Prior research has shown that OAS1 attaches to membranes using a prenyl group as part of the signaling process. Prior research has also shown that this signaling can inhibit replication of the SARS-CoV-2 virus. Noting its value in protecting people against COVID-19, the researchers looked at the transcriptomes of 500 COVID-19 patients who had experienced a wide range of symptoms and found that those who did not have prenylated OAS1 experienced much more severe symptoms. Why some people are born without the enzyme is still a mystery, but the work by the team could help lead to new types of vaccines against COVID-19 and other types of infections.

Intrigued by their findings, the researchers turned their attention to another mammal possibly involved in the pandemic—the . They found it did not possess the form of prenylated OAS1 that protects humans from the virus, helping to explain why the virus is so deadly to that species. The finding could also help explain why the bats are such prolific hosts to a variety of viruses.

Explore further

Sensor spies hideouts for ​virus replication inside cell membranes

More information: Arthur Wickenhagen et al, A prenylated dsRNA sensor protects against severe COVID-19, Science (2021). DOI: 10.1126/science.abj3624

DHS concerned about potential border surge if COVID-19 restriction is partially lifted

 The Department of Homeland Security (DHS) is reportedly concerned about a potential increase in migrants trying to enter the U.S. if COVID-19 restrictions are partially lifted on Thursday.

NBC News reported on Thursday that Secretary Alejandro Mayorkas, during a phone call with senior DHS officials this week, asked if the department was ready for a potential surge of migrants attempting to cross the border in October, according to two DHS officials familiar with the conversation.

Personnel at the department is reportedly concerned about a possible influx of migrants if Title 42 — the policy the Biden administration has used amid the pandemic to return border crossers without giving them an opportunity to apply for asylum — is lifted, according to the DHS officials.

Federal District Judge Emmet Sullivan earlier this month ordered that the Biden administration stop using Title 42 to drive out families with children who cross the U.S.-Mexico border.

The ruling was handed down after families filed a class-action lawsuit arguing that the policy, which was crafted under the Trump administration, wrongly barred them from seeking humanitarian protections.

Sullivan’s ruling, which only applies to families, is set to take effect on Thursday, though the Biden administration has appealed the decision. More than 16,000 “individuals in a family unit” were expelled in August.

The Biden administration previously weighed nixing the measure by the end of July, according to NBC News, but ultimately decided against such a move. Officials were reportedly concerned that lifting it would cause a “catastrophic” migrant surge.

Two DHS officials told NBC News that the department is concerned that migrants may view the lifting of Title 42 as a green light to cross the border, and that they will be permitted to remain in the U.S. despite rulings on their asylum cases.

The concern within the department comes after the administration last week dealt with an unexpected influx of more than 25,000 Haitian migrants in Texas.

The camp where the migrants were staying has since been cleared, but photos circulated amid the chaos that depicted border officers on horseback trying to disperse the migrants.

Mayorkas said an investigation into the situation is underway.

1/3 of parents want to vaccinate 5- to 11-year-olds 'right away'

 One-third of parents want to vaccinate their 5- to 11-year-olds “right away” when the coronavirus vaccine is approved for their age group, according to a new report from the Kaiser Family Foundation

The report found that 34 percent of parents polled will get their 5- to 11-year old children vaccinated immediately, with most of the interviews conducted before Pfizer released their clinical trial results for the age group in September. 

Thirty-two percent of respondents say they would want to “wait and see” before getting young children vaccinated, 7 percent would do so if it was required and 24 percent would “definitely not” get their kids vaccinated.

The percentage of those who would get their children vaccinated right away has gone up from a July survey by Kaiser, when 26 percent of parents said they would get their 5- to 11-year olds vaccinated right away when the vaccine was approved. 

The Pfizer vaccine is only authorized for those 12 and older. Forty-eight percent of those surveyed said they have had their 12- to 17-year old children vaccinated. 

The results follow a previous poll from Axios-Ipsos Coronavirus Index that showed parents are split on whether to get their young children vaccinated once it is approved for the age group.

The poll found 44 percent of respondents with kids ages five to 11 would get their children vaccinated while 42 percent would not. 

The Kaiser Family Foundation survey was conducted between Sept. 13 and Sept. 22. The group surveyed 1,519 people and reports a margin of error of plus or minus 3 percentage points.

Troops move to block Pentagon vaccine requirement in court

 Two service members filed a potential class action lawsuit against Defense Secretary Lloyd Austin to attempt to block him from requiring all troops receive a COVID-19 vaccine.  

Army Staff Sgt. Dan Robert and Marine Corps Staff Sgt. Hollie Mulvihill, who filed the complaint Aug. 17 in the U.S. District Court of Colorado, also want the Pentagon to create a vaccine exemption for those previously infected with the coronavirus as they already have “natural immunity.”

The two, who are both based in North Carolina, argue that the Defense Department’s vaccine mandate “is in open violation” of the rights of service members and is unconstitutional.

Austin is named as a defendant in the lawsuit as are Health and Human Services Secretary Xavier Becerra and Janet Woodcock, acting commissioner of the Food and Drug Administration (FDA).

The Pentagon chief in late August ordered service members to “immediately begin” receiving the COVID-19 vaccine, with the military services setting the deadlines for the requirement.

The Pentagon has also made clear it would only require a COVID-19 vaccine that had full FDA approval, which the Pfizer shot received on Aug. 23.

But Robert and Mulvihill, who filed their complaint days prior to the FDA decision, base their argument on the Pfizer vaccine’s previous emergency-use authorization standing.

They also say they should be exempt from the mandate because they already caught and recovered from COVID-19.

More than 372,000 coronavirus cases — 244,300 of which were service members — have been reported among U.S. military personnel, with 5,274 hospitalizations and 515 deaths, according to Defense data.

As of Wednesday, 58 troops, sailors and airmen have died from the illness.

NYC teachers ask Supreme Court to block vaccine mandate

 A group of New York City public school teachers who refuse COVID-19 inoculation have asked the Supreme Court to block a vaccine mandate set to take effect Friday.

The teachers, who expressed various reasons for refusing to vaccinate, are united in their view that New York City’s public health measure runs afoul of the law. 

“Thousands of school teachers will lose their livelihoods if they are without pay and cannot work anywhere else, their ability to serve the children of New York City, and, of course, their ranking as teachers,” their lawyer Vinoo Varghese told The Hill. 

The teachers’ request was submitted to Justice Sonia Sotomayor, who handles emergency matters arising from New York, after their legal bid was rebuffed by lower federal courts over the past week.

The dispute arose after New York City officials in August announced that public school employees would be required to get vaccinated against the coronavirus in the interest of protecting the health of those who populate America’s largest school system.

The policy initially provided teachers the ability to opt-out of the vaccine requirement by agreeing instead to undergo weekly COVID-19 screenings. That option was later withdrawn for teachers, however, even as firefighters and police officers continue to be able to opt-out of receiving jabs.  

Part of the teachers’ legal complaint is that school employees are being treated differently than other city workers. 

“There is no rational and non-discriminatory basis for treating applicants differently than other municipal workers,” the teachers wrote in their Supreme Court filing. 

The New York-based challenge follows a recent legal fight over another mandatory school vaccine policy. 

In that case, a group of Indiana University students sought to block the school’s requirement that students be vaccinated against COVID-19 before attending classes this fall. Justice Amy Coney Barrett, who handles emergency matters from Indiana, denied their request without comment.

Gilead's Kite Applies to FDA for Earlier Use of Yescarta in Large B-cell Lymphoma

 Kite, a Gilead Company (Nasdaq: GILD), today announced that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Yescarta® (axicabtagene ciloleucel) to expand its current indication to include the treatment of adults with relapsed or refractory large B-cell lymphoma (LBCL) in the second-line setting.

The sBLA filing is based on data from the ZUMA-7 study with the longest follow-up – over two years – of any Phase 3 CAR T-cell therapy trial. Top-line results from the primary analysis of ZUMA-7 were recently reported and showed superiority of Yescarta compared to standard of care (SOC) in second-line relapsed or refractory LBCL. With a median follow-up of two years, the study met the primary endpoint of event-free survival (EFS; hazard ratio 0.398, p <0.0001). This represents a clinically meaningful 60% reduction in risk of EFS events versus standard of care. The study also met the key secondary endpoint of objective response rate (ORR). The interim analysis of overall survival (OS) showed a trend favoring Yescarta; however, the data are immature at this time, and further analyses are planned for the future.

FDA posts guidance on mining real-world data from health records

 There is a lot of discussion about the power of drawing out insights from information hidden within electronic health records and insurance claims, but little regulatory guidance on how that should be undertaken.

Now, the FDA has published its first take on sourcing real-world data (RWD) from EHRs and medical claims, setting out its thinking on the approach that should be used to support regulatory filings for medicines.

The new guidance is the first of a series that have been promised by the US regulator to develop a framework for regulating RWD, which is increasingly being used by pharma companies to investigate how their medicines perform beyond the controlled environment of clinical trials.

The plan is in response to new legislation requiring the FDA to create a framework for evaluating real-world evidence (RWE) to support the approval of a new indication for an already-approved drug, or other post-approval study requirements, for example to provide confirmatory data after an accelerated approval.

In some respects the agency is playing catch-up in this area, as it has already approved the first new indication for a drug based on real-world evidence (RWE) alone – a filing to expand the breast cancer indication for Pfizer’s Ibrance (palbociclib) to include men in 2019.

It is becoming increasingly common for pharma companies to include some element of RWE in their marketing applications to back up clinical trial results.

The new guidance – entitled Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products – covers three key issues related to the use of RWD from EHRs and medical claims data.

First up is advice on how to select and validate data sources that appropriately address the study question in terms of study populations, exposure, outcomes of interest, and other factors.

It also focuses on the development and validation of definitions for study design elements, and maintaining the provenance and quality of data during  “accrual, curation, and transformation into the final study-specific dataset. ”

The guidance does not provide recommendations on study designs or statistical analyses, or any particular type of data source or study methodology, but instead seeks to set out general principles on RWD use.

“For all study designs, it is important to ensure the reliability and relevance of the data used to help support a regulatory decision, ” says the regulator.

The FDA stresses it is a preliminary document and is encouraging comments, which can be filed up to 60 days after publication.

Glaxo $4.2B bet on Merck KGaA cancer drug goes up in smoke after series of flops

 Merck KGaA and GlaxoSmithKline are ending a partnership for the oncology asset bintrafusp alfa which could have netted billions for the German pharma if successful.

But the data just didn’t pan out that way in multiple tests, most recently a phase 2 clinical trial in locally advanced or metastatic biliary tract cancer that was discontinued due to futility.

The companies announced their mutual parting effective today, September 30. Merck said the decision was “based on the clinical trial data generated to date,” specifically results from the INTR@PID Lung 037 study that failed to show the effect seen in earlier tests.

GSK did not pay out any milestone payments through the deal and will not do so in the future, either. Merck collected €300 million upfront in 2019 through the pact, with an additional €500 million in milestones and €2.9 billion in sales possible down the line.

So what does Merck do with bintrafusp alfa now? The therapy was once heralded as a future competitor to the mega-blockbuster Keytruda sold by U.S. competitor Merck & Co.

Merck KGaA said the company will use “advanced analytics” to comb through the vast data collected through the INTR@PID clinical program and better understand what happened—and how learnings can be applied to the field of immunotherapy.

The drug is a bifunctional immunotherapy designed to combine a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein. In plain English, bintrafusp alfa was supposed to control tumor growth by enhancing or restoring anti-tumor responses in the immune system. Merck and GSK hoped it could become a targeted treatment for difficult-to-treat cancers.

Merck and GSK had an expansive clinical program for bintrafusp alfa, including indications in non-small cell lung cancer, biliary tract cancer, cervical cancer, breast cancer and urothelial cancer.

Regeneron's Covid-19 antibody gets an in-patient boost

 Regeneron’s latest trial of its antibody cocktail Regen-Cov was intended to broaden the use of the treatment to patients hospitalised with Covid-19. And it looks to have succeeded, at least in some patients. In a phase 2/3 trial the combination of casirivimab and imdevimab met the primary endpoint of significantly reducing viral load within seven days of treatment. More importantly, it reduced the risk of death by 36% compared with placebo at day 29 for hospitalised Covid-19 patients not requiring high-flow oxygen or mechanical ventilation. However, this was not significant, as the trial was stopped early because of slow enrolment. And in an echo of the much larger Recovery trial, the greatest benefit was in seronegative patients – those who fail to mount an adequate response to infection – with the risk reduction here rising to 56%. Regen-Cov is not yet authorised for hospitalised patients, but the latest data could help support a nod here, at least in a seronegative population. This should give a much-needed option for in patients, but serostatus testing will have to become routine. 

Editas falls well short of Brilliance

 Editas kept investors waiting for years for the first data from one of its Crispr-based gene editing projects. Yesterday, its big reveal disappointed.

The group claimed hints of efficacy with EDIT-101, which is being developed for the rare inherited eye disorder Leber congenital amaurosis, but these are hard to see. More troubling are reports of retinal tears and haemorrhage. Editas plans to push the dose of EDIT-101 higher, but the latest data suggest that finding a therapeutic window might be difficult.

Despite its positive spin on the results, which came from the phase 1/2 Brilliance trial, Editas’s stock sank 19% yesterday. But the company is still worth nearly $3bn, which seems hard to credit given its very early-stage pipeline.

Unmet need

True, there is an unmet need in Leber congenital amaurosis type 10 (LCA10), the disease subtype Editas is targeting, caused by mutations in the CEP290 gene. EDIT-101, which is injected subretinally, is designed to delete the mutation in question, c.2991+1655A>G, using Crispr-Cas9 in vivo gene editing.

The jury is still out on the effectiveness of this strategy. The results released yesterday came from two patients in the low-dose and three in the mid-dose cohort of Brilliance, testing 6x1011vg/ml and 1.1x1012vg/ml respectively.

According to Editas, two subjects in the mid-dose group showed signs of efficacy after three to six months of follow-up. For one of these patients that interpretation is debatable, given no improvement in best-corrected visual acuity with the EDIT-101-treated eye versus the patient’s untreated eye, which acted as a control.

For the best-performing patient, a 0.7logMAR improvement in BCVA versus control eye looks more clear-cut. The lead investigator of Brilliance, Dr Eric Pierce of the Massachusetts Eye and Ear hospital, noted during an Editas conference call yesterday that a 0.3logMAR improvement here was considered clinically meaningful.

However, this improvement was seen in only one patient out of five. Furthermore, Evercore ISI’s Liisa Bayko noted that in this subject BCVA had been measured using the Berkeley rudimentary visual test, which is not as well validated and reproducible as the more standard letter chart known as the early treatment diabetic retinopathy study.

Source: Compant presentation

It is difficult to conclude much about the efficacy of EDIT-101 on the available evidence. Perhaps things will become clearer next spring with longer-term results from the low and mid-dose cohorts, as well as data from the high-dose arm, testing 3x1012vg/ml. Editas is also starting a mid-dose paediatric cohort.

Toxicity might prove a stumbling block at a higher dose, though. Editas said in its press release and slides that no serious adverse events had been seen in Brilliance, highlighting a lack of treatment-related cataracts, oedema or retinal thinning.

However, a presentation yesterday at the International Symposium on Retinal Degeneration detailed one case of hypotony among two low-dose patients, and two retinal tears and one retinal haemorrhage among four mid-dose subjects.

Neutralising antibodies to AAV5, the viral vector used to deliver EDIT-101, were also seen in three patients, a fact omitted from Editas’s slide deck. When questioned about this on the conference call, company execs said that in patients who did have neutralising antibodies the levels were low.

Antisense contender

Perhaps patients would be willing to risk these adverse events with no other options available. But another LCA10 therapy is on the horizon: Proqr’s sepofarsen, an antisense project that binds to CEP290 RNA to enable correct splicing and production of the CEP290 protein. 

EDIT-101 might hold the promise of a once-and-done therapy, but sepofarsen is given every six months, still a relatively convenient schedule compared with some eye drugs.

And so far sepofarsen looks like a better bet, although patient numbers are admittedly small. In a phase 1/2 trial 11 sepofarsen-treated patients showed a 0.5.5logMAR improvement in BCVA.

Proqr is set to report data from the pivotal sham-controlled Illuminate trial next year, and all eyes will now be on this update.

AngioDynamics Reports Fiscal 2022 Q1 Results; Updates Guidance

 Fiscal 2022 First Quarter Highlights

  • Net sales of $77.0 million increased 9.6% compared to the prior-year quarter

  • Gross margin of 52.1% increased 120 basis points year over year

  • GAAP loss per share of $0.18, and adjusted loss per share of $0.02

  • The Company commenced a Limited Market Release of its AlphaVac Mechanical Thrombectomy device in September

Updating Fiscal Year 2022 Financial Guidance

The Company now expects its fiscal year 2022 net sales to be in the range of $310 to $315 million, an increase from its prior guidance of $305 to $310 million. The Company expects gross margin to be approximately 55.0% and adjusted earnings per share in the range of $0.00 to $0.05 as it continues to invest in new product launches to drive future growth.

Conference Call

The Company's management will host a conference call today at 8:00 a.m. ET to discuss its first quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13723182.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, September 30, 2021, until 11:59 p.m. ET on Thursday, October 7, 2021. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13723182.

Alzamend Neuro: Positive Pre-IND FDA Response for Alzheimer's Candidate

 FDA Agrees to Alzamend’s Plan to Conduct a Combined Phase 1 and 2 Clinical Trial for AL002

Alzamend Neuro, Inc. (Nasdaq: ALZN) ("Alzamend"), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received a written response to its meeting request relating to its Type B Pre‑Investigational New Drug ("IND") application from the U.S. Food and Drug Administration (the "FDA") providing a path for Alzamend’s planned clinical development of AL002. AL002 is a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s.

Based on the FDA’s written feedback, Alzamend anticipates filing the IND by the end of November 2021 and initiating the clinical trial of AL002 in the first quarter of 2022.

Perrigo Stock Soars After Settling Irish Tax Dispute

 Perrigo  (PRGO) - Get Perrigo Co. Plc Report shares jumped on Thursday after the drugmaker said it had settled a dispute with Irish tax officials for about $344 million.

At last check shares of the Dublin company were up nearly 15% to $49.89.

Perrigo, formerly known as Elan, said in a statement that it had settled with the Irish Office of the Revenue Commissioners regarding an amended assessment from Nov. 29, 2018. That assessment claimed income tax of 1.6 billion euros, or roughly $1.9 billion, not including penalties or interest.

Irish Revenue Commissioners had charged that intellectual property sales by Elan Pharma, including the multiple-sclerosis drug Tysabri, were taxed as trading income at 12.5%, when they should have been treated as a chargeable gain at a rate of 33%.

In July, the company said, tax officials said they did not have all the relevant facts when the notice was issued and allowed adjustments that cut about $764 million from the original amount.

Perrigo said that while it believed that its tax position was correct and would have been confirmed on appeal, it agreed to settle "given the risks inherent in any litigation, as well as the ongoing costs of what could have been years of litigation and the uncertainty that would create."

The company agreed to pay 297 million euros, or $344 million, as a full and final settlement of all liabilities arising from the sale of the Tysabri patents. And it agreed to be taxed in periods from fiscal 2013 to fiscal 2021 inclusive.

In addition, Irish Revenue will give Perrigo credit for certain taxes already paid and for certain unused R&D credits, all of which will be applied against the 297 million euros.

So the total cash payment that Perrigo makes as part of the settlement will be 266.1 million, or about $308.1 million.

No interest is due and no penalties apply, the company said, and Irish Revenue will take no further action in relation to the amendment or any Tysabri-related income or transactions.

Earlier this month, Perrigo said it had agreed to acquire peer Héra SAS for 1.8 billion euros, or about $2.1 billion, cash.

OptimizeRx Set to Join S&P SmallCap 600

 OptimizeRx Corp. (NASD:OPRX) will replace Lydall Inc. (NYSE:LDL) in the S&P SmallCap 600 effective prior to the opening of trading on Monday, October 4. Clearlake Capital Group is acquiring Lydall in a deal that is expected to close on or about October 1.

Following is a summary of the changes that will take place prior to the open of trading on the effective date:

Effective Date

Index Name


Company Name


GICS Sector

October 4, 2021

S&P SmallCap 600




Health Care

S&P SmallCap 600





For more information about S&P Dow Jones Indices, please visit

DiaMedica Fast Tracked for the Treatment of Acute Ischemic Strok

 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation to the Company’s lead candidate DM199 for the treatment of acute ischemic stroke (AIS) where tissue plasminogen activator and/or mechanical thrombectomy are not indicated or medically appropriate.

Lilly, Incyte : Olumiant Superior to Placebo in Scalp Hair Regrowth as Early as 24 Weeks

 Eli Lilly & Co. and Incyte Corp. on Thursday said a pair of Phase 3 studies showed that once-daily four-milligram doses of their arthritis drug Olumiant was superior to placebo in achieving significant scalp hair regrowth as early as 24 weeks in adults with severe alopecia areata.

The companies earlier this year had reported that the studies showed significant improvements in scalp hair regrowth compared with placebo at 36 weeks for patients taking 2- and 4-milligram doses.

Eli Lilly said it plans to file for U.S. Food and Drug Administration approval for Olumiant in alopecia areata by the end of the year. There are currently no FDA-approved treatments for the autoimmune disorder, which can cause unpredictable hair loss on the scalp, face and other areas of the body.

Olumiant is approved in dozens of countries around the world for adults with moderate to severe rheumatoid arthritis and for adults with moderate to severe atopic dermatitis who are candidates for systemic therapy. The drug is also approved for the treatment of hospitalized patients with Covid-19 in several countries, including Japan and Switzerland.

Indianapolis-based Eli Lilly signed an exclusive world-wide license and collaboration agreement with Incyte, a Wilmington, Del., biopharmaceutical company, in late 2009 to develop and commercialize Olumiant and other compounds for inflammatory and autoimmune diseases.