Athira Pharma’s stock falls 39% after placing its CEO on leave

The Bothell, Wash.–based clinical-stage biopharma Athira Pharma (NSDQ:ATHA) is in a tailspin after the company’s board put Leen Kawas, the firm’s CEO, on temporary leave.

The company’s stock closed the day at an all-time low of $11.15. The stock was valued as high as $34.25 on Dec. 31, 2020.

Washington State University has launched an independent review of Kawas’s doctoral research in molecular pharmacology and toxicology, which she completed a decade ago.

The university is investigating reports that Kawas authored several papers with altered images.

Several papers Kawas had co-authored now appear on PubPeer, which cites possible problems with published research. PubPeer authors have pointed out that specific images in those papers appear to have duplicated portions and other irregularities. Some of the anomalies could have led to incorrect research findings or at least the interpretability of those findings.

In the interim, the company has…

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Moderna to expand its Massachusetts manufacturing capabilities 

Cambridge, Mass.–headquartered Moderna (NSDQ:MRNA) will hire at least 155 new manufacturing employees for manufacturing jobs at its plant in Norwood, Mass.

A $2.33 million tax incentive from the Massachusetts Life Sciences Center helped bankroll the expansion. The investment will enable the company to double the size of its manufacturing site in Norwood, Mass., which became operational in 2018.

With limited manufacturing capability, Moderna has had to rely on partners with contract manufacturers such as Lonza(SWX:LONN), Catalent (NYSE: CTLT), Baxter BioPharma Solutions (NYSE: BAX), Recipharm and Laboratorios Farmacéuticos Rovi (BME:ROVI).

Get the full story from our sister site, Pharmaceutical Processing World. 

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mRNA vaccines do not negatively affect sperm county, study finds

One of the many urban legends related to COVID-19 vaccines is that they cause infertility. Researchers at the University of Miami set out to disprove that claim with a recent single-center prospective study. Unsurprisingly, the study that indicated the mRNA vaccines have no negative impact on male fertility. In fact, the researchers found that after the second vaccine dose, participants exhibited a significant increase in median sperm concentration and sperm motility.

In the study published in JAMA, the researchers stopped short of claiming that mRNA COVID-19 vaccines could boost fertility in men. “While these results showed statistically significant increases in all sperm parameters, the magnitude of change is within normal individual variation,” the study authors concluded.

The study only evaluated the BNT162b2 and mRNA-1273 vaccines from Pfizer-BioNTech and Moderna, respectively.

The study tracked participants approximately 70 days after administering…

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CureVac marches on after announced disappointing study results

After CureVac (NSDQ:CVAC) revealed that its first-generation vaccine candidate has an interim efficacy of 47% in a pivotal trial, its stock lost about half its value. The company, however, is undeterred.

Speaking in a call with investors and analysts, CureVac CEO Franz-Werner Haas said the company would continue to seek the authorization of its CVnCoV vaccine and continue developing its next-generation CV2CoV vaccine.

One difference between the vaccine from CureVac and those from Moderna and Pfizer-BioNTech lies in the dose of mRNA. The CureVac vaccine contains 12 µg of mRNA per dose. The Pfizer-BioNTech vaccine uses 30 µg per shot, while the Moderna vaccine contains 100 µg.

Haas, however, stressed the role of virus variants in the 47% interim efficacy figure. The Phase 2b/3 study “provides important insights into a dramatically transformed variant environment, suggesting that we are virtually fighting a different virus — a different pandemic” than six m…

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U.S. buys 200 million more Moderna vaccine doses for potential boosters and use in children

Health experts remain divided over the need for COVID-19 vaccine boosters in the coming months, but the U.S. government is preparing for that possibility by purchasing 200 million additional doses of the COVID-19 vaccine from Moderna (NSDQ:MRNA).

The purchase of additional doses will also enable the U.S. government to inoculate children aged 12 to 17 in coming months, assuming FDA authorizes that use. Two doses of the vaccine were 100% effective in that age group, according to a recent Phase 2/3 trial.

In May, FDA amended its EUA for the Pfizer-BioNTech vaccine to include adolescents aged 12 to 15.

The U.S. has committed to buying 500 million doses of Moderna’s vaccine to date. The company expects to deliver 110 million doses in the fourth quarter of 2021 and another 90 million in the first quarter of 2022.

To date, Moderna has provided 217 million doses to the U.S.

The NIH has launched a clinical trial involving fully vaccinated participan…

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Biogen’s gosuranemab fails in Phase 2 study

Biogen (NSDQ: BIIB) has scrapped its development plans for gosuranemab (BIIB092) after the drug candidate failed to hit the primary endpoint in a Phase 2 trial. 

Biogen’s aducanumab made waves recently, becoming the first Alzheimer’s drug to win FDA approval in recent memory. Not all, however, are happy with that fact. 

Aducanumab is an amyloid beta-protein inhibitor while gosuranemab was an anti-tau antibody. 

In the TANGO Study, gosuranemab did not appear to have a treatment benefit in several measures in the 78-week study. Such measures included the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog 13), the Alzheimer Disease Cooperative Study Activity of Daily Living (ADCS-ADL), the Mini-Mental State Examination (MMSE) and the Functional Assessment Questionnaire (FAQ). 

Biogen will present the findings from the gosuranemab study at an upcoming medical congress.

The biotech iPierian first developed the antibody, whic…

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Biden administration invests $3B to accelerate development of next-gen COVID-19 treatments

[Image courtesy of Biden for President]

President Joe Biden’s administration will spend $3 billion in American Rescue Plan money to accelerate the discovery, development and manufacturing of antiviral medicines against COVID-19, HHS announced today.

Not only will the  Antiviral Program for Pandemics seek to boost the availability of medicines to prevent serious COVID-19 illness and save lives, but it will pursue sustainable discovery and development platforms that could produce antivirals against future viruses that threaten to spark pandemics.

The program is a collaboration within the U.S. Department of Health and Human Services (HHS) that includes the National Institutes of Health (NIH) and its National Institute of Allergy and Infectious Diseases (NIAID) — and the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness …

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Public Citizen demands FDA resignations after aducanumab approval 

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

The Alzheimer’s Association had backed the FDA approval, but many experts had concluded there was insufficient evidence to merit even conditional approval of the drug. Three members of an FDA advisory committee who had recommended against aducanumab’s approval recently resigned.

In its letter, Public…

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CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

CureVac’s stock dropped 3.47% to $94.79 per share after the company announced the news.

The company anticipates that a final analysis will be ready in a matter of weeks. Based on available data, the vaccine appears to have a favorable safety profile.

CureVac is partnering with GSK (NYSE:GSK) to develop a next-gen COVID-19 vaccine. That vaccine could potentially protect against multipl…

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Moderna vaccine highly effective two weeks after first dose

A study published in JAMA involving healthcare workers found that the first dose of Moderna’s (NSDQ:MRNA) COVID-19 vaccine was highly effective at reducing the risk of COVID-19 infections.

In the study, participants received two doses of the vaccine at the recommended 28-day interval. Clinical effectiveness reached 95% for days 15 through 42 of the study. But constraining the window to days 15 to 28 resulted in similar results.

The findings suggest that the vaccine can rapidly reduce the incidence of vaccine-sensitive SARS-CoV-2 infection in healthcare workers.

Even eight days after administration of the first dose, the vaccine yielded greater than 70% efficacy.

The study authors concluded that their findings were in line with aggregated data for the Pfizer-BioNTech BNT162b2 and Moderna’s mRNA-1273 vaccines.

The 42-day study began on Dec. 22, 2020. It involved 4,028 participants.

A number of healthcare workers have made headlines rec…

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Why community-based clinical trials in oncology are on the rise

Photo by Andrea Piacquadio from Pexels

Community-based clinical trials are growing more common in oncology for several reasons.

First, drug developers are looking to boost recruitment efforts and address traditional ethnic and economic health disparities in such studies. Second, community hospitals are growing better equipped to participate in such trials. And finally, drug developers are working on expanding the pool of patients they can recruit in such studies.

Traditionally, community cancer centers have sat on the sidelines in terms of clinical trials. Notable academic medical centers such as Massachusetts General Hospital, Dana-Farber Cancer Institute, Memorial Sloan Kettering and MD Anderson have played a vital role in oncology clinical trials. But the situation is beginning to change for the following reason.

Community hospitals can help address health disparities

Many pharmaceutical and…

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Unraveling aducanumab’s impact on pharma remains a challenge

The FDA’s conditional approval of Biogen’s (NSDQ:BIIB) and Eisai’s (OTCMKTS:ESALY) Alzheimer’s drug aducanumab (Aduhelm) may have been controversial, but the decision will likely have a significant financial impact. There are six million Alzheimer’s people in the U.S. alone, according to Alzheimer’s Association estimates. Approximately half of those patients have mild symptoms, which is the group most likely to be prescribed the drug.

A significant number of physicians are considering prescribing the intravenous drug for approximately one-third of Alzheimer’s patients with mild cognitive impairment, according to an analysis from Jefferies.

The survey bodes well for the early uptake of the drug, according to Jefferies. But the continued success of aducanumab will require winning over skeptical neurologists and psychiatrists. Several physicians have penned op-ed’s voicing their resistance to the drug in outlets ranting from STAT to the Baltimore Sun. Last Novembe…

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