U.S. purchases more monkeypox vaccine doses from Bavarian Nordic

Bavarian Nordic A/S (OMX:BAVA) has announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has ordered an additional 2.5 million doses of liquid-frozen Jynneos vaccine.

FDA first approved Jynneos, a non-replicating smallpox and monkeypox vaccine, in 2019.

It continues to be the only FDA-approved vaccine indicated for monkeypox.

The company will begin deliveries in the recent contract in the fourth quarter of 2022 and continue into early 2023.

In May, Bavarian Nordic announced that it had secured a separate BARDA contract worth $119 million to convert bulk vaccine into freeze-dried doses of Jynneos vaccine.

In all, the company will supply a total of 4.4 million doses to the U.S. in 2022 and 2023.

The company’s share price increased 3.89% to 243.00 Danish Krone.

Earlier this week, the U.S. Department of Health and Human Services (HHS) announced an updated nationwide monkeypox vaccination strategy t…

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Takeda’s Takhzyro fares well in pediatric hereditary angioedema study

Takeda (NYSE:TAK) has announced that in the open-label Phase 3 SPRING study, children aged 2 to <12 had 94.8% fewer hereditary angioedema (HAE) attacks during treatment with Takhzyro (lanadelumab-flyo) over 52 weeks compared to baseline.

The Osaka, Japan–based company plans on presenting the data at the European Academy of Allergy and Clinical

The SPRING study also had positive, clinically meaningful results in children under 6. Children in that age bracket currently have no approved long-term prophylaxis treatment (LTP).

The SPRING study’s findings align with prior studies focused on adults and adolescents.

Takeda aims to submit global regulatory filings later this year.

The primary objective of the SPRING study was to investigate the safety and pharmacokinetics of Takhzyro in patients aged 2 to <12 years with HAE. The prevention of HAE attacks was a secondary outcome measure.

“HAE is a rare condition where unpredi…

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Novartis announces tislelizumab helped extend median overall survival in first-line advanced esophageal cancer 

Novartis (NYSE:NVS) has announced that chemotherapy plus tislelizumab, a humanized monoclonal antibody directed against PD-1, improved overall survival as a first-line treatment for adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) in the Phase 3 RATIONALE 306 study.

The survival benefits were seen in patients regardless of PD-L1 status.

The benefits were consistent across patient subgroups in the study.

In the study, the combination of tislelizumab and chemotherapy resulted in median overall survival of 17.2 months compared to 10.6 months in patients receiving chemotherapy plus placebo.

Investigators concluded that the combination of chemotherapy and tislelizumab cut the risk of death by 34%.

Tislelizumab was first developed by BeiGene. Novartis paid $650 million for rights to the drug. The company also stands to pay up to $1.55 billion in potential milestone payments.


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FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

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The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

In particular, the agency recommends that vaccine makers develop bivalent COVID-19 vaccines with an omicron BA.4/5 spike protein component combined with the current vaccine composition.

FDA expects the updated vaccines to be used as a booster in “early to mid-fall 2022,” but the current formulation of vaccines for use as a primary series will remain unchanged.

Moderna and Pfizer have already shared data from c…

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Pfizer and BioNTech forge new COVID-19 vaccine deal with U.S. government

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) profited handsomely from COVID-19 vaccine sales in 2021. The firms raked in more than $59 billion in combined sales of the Comirnaty vaccine. 

The two companies have now announced a new vaccine supply agreement with the U.S. government worth $3.2 billion. Under the terms of the agreement, the government will receive 105 million additional doses of the vaccine at the 30 µg, 10 µg and 3 µg dose levels. 

The deal could include an omicron-adapted COVID-19 vaccine, assuming FDA authorizes an updated booster. 

Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to back the use of omicron-containing boosters.

Pfizer announced that it could begin shipping doses for the deal as soon as the late summer and continue into the fourth quarter of 2022. 

The U.S. government also has the option to buy up to 195 million additional doses for a total of 300…

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Novartis to cut up to 8,000 positions

AG (NYSE:NVS) has announced a restructuring plan that will result in up to 8,000 layoffs internationally, including 1,400 in Switzerland. The cuts would equate to 7.4% of its workforce.

Novartis currently has approximately 108,000 employees.

The Basel, Switzerland–based company aims to save approximately $1 billion in operating expenses by 2024.

In April, Novartis hinted that such a change was coming with the description of a “new organizational structure” that would “accelerate growth, strengthen pipeline and increase productivity.”

The restructuring could hit the company’s Basel operations the hardest, according to the German language paper Tages-Anzeiger.

The restructuring initiative also will integrate the company’s pharmaceuticals and oncology business divisions into an Innovative Medicines (IM) business.

Furthermore, the company intends to decouple its U.S. operations from international comme…

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Icosavax shares positive early results for VLP vaccine candidate against RSV

The biopharma Icosavax (Nasdaq:ICVX) has announced positive topline interim results from its Phase 1/1b clinical trial of IVX-121, a vaccine candidate with a prefusion stabilized Respiratory Syncytial Virus (RSV) F antigen.

The Phase 1 portion of the study enrolled 90 healthy young adults between 18 and 45. The Phase 1b portion included 130 healthy adults aged 60 to 75.

IVX-121 had a robust immunologic response to RSV. In addition, Icosovax noted that the vaccine candidate achieved comparable Geometric Mean Titer (GMT) levels at Day 28 in both age groups.

Seattle-based Icosavax noted that the vaccine candidate had a favorable tolerability profile with no vaccine-related serious adverse events.

“Importantly, we believe these Phase 1/1b data provide initial validation of our underlying VLP technology. They also reaffirm our strategy to combine multiple pathogen targets in one vaccine,” said Adam Simpson, CEO of Icosavax, in a news release. “As plann…

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VRBPAC backs adding omicron-component to COVID-19 boosters

FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted today to recommend the use of variant-specific boosters.

Out of 21 voting members, 19 supported the use of a SARS-CoV-2 omicron component for COVID-19 booster vaccines.

“I want to be clear that this doesn’t mean that we are saying that there will be boosters recommended for everyone in the fall, but my belief is that this gives us the right vaccine in preparation for the potential need for boosters in the fall,” said VRBPAC member Dr. Amanda Cohn, chief medical officer at the National Center for Immunizations and Respiratory Diseases at CDC.

“Over the coming months, I think we’ll get a sense, and there’ll be plenty of time for debate over who is most appropriate for boosters,” said CBER director Dr. Peter Marks.

Omicron and its subvariants such as BA.2, BA.4 and BA.4 continue to drive the bulk of COVID-19 infections.

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How Cybin aims to maximize the potential of two classical psychedelics 

Classical psychedelics can be agents of chaos. In sufficient doses, they can trigger experiences of ego death or dissolution, as researchers have noted since the 1960s. Psychedelics can also help promote neural plasticity and uproot negative patterns to treat challenging-to-treat mental health disorders. FDA has acknowledged the potential of psilocybin for mental health by twice granting Breakthrough Therapy Designation status to the compound as a potential therapy for serious depression. 

The startup Cybin (Toronto, Canada) aims to harness the therapeutic potential of psychedelics while minimizing possible adverse side effects. 

Cybin’s deuterated psilocybin analog CYB003 could treat major depressive disorder (MDD) and alcohol use disorder (AUD) while potentially being better tolerated than traditional psilocybin. 

CYB003 is the company’s first focus as psilocybin is the most studied psychedelic molecule in academic studies “with decad…

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Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir

Gilead Sciences (Nasdaq: GILD) has asked FDA for the second time in a year to approve the capsid protein inhibitor lenacapavir.

The drug won Breakthrough Therapy Designation from FDA in 2019 for HIV-1-infected individuals who are heavily treatment-experienced and have resistance to multiple drugs. The designation covered the potential use in tandem with other antiretroviral drugs.

In February, the FDA denied the approval of lenacapavir after concluding that the borosilicate glass vials containing the drug were incompatible with the medication as they could result in contamination with “sub-visible” glass particles.

Late last year, FDA placed a clinical hold on the use of the drug candidate in borosilicate vials for ongoing studies.

Foster City, California-based Gilead has also studied oral formulations of the drug.

Gilead included data on the drug used in vials made from aluminosilicate glass in its most recent new drug applicat…

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FDA places clinical hold on Astellas clinical trial focused on Pompe disease

Astellas Pharma (TSE:4503) has revealed that the FDA has slapped a clinical hold on its Phase 1/2 FORTIS Pompe disease study after observing a serious adverse event (SAE) — peripheral sensory neuropathy — in a trial participant.

Peripheral sensory neuropathy results from damage to nerves outside of the central nervous system. The condition can lead to pain, numbness and weakness.

The FORTIS study had focused on the experimental adeno-associated virus gene replacement therapy AT845 in adults with late-onset Pompe disease.

Pompe disease is a rare genetic disorder associated with the buildup of glycogen in cells. The disease can lead to progressive muscle weakness and reduced life expectancy. Disease progression is associated with the age of onset.

Classic infantile-onset Pompe disease occurs in the first few months of life. Non-classic infantile-onset manifests around 1 year of age while late-onset appears after that — often in adolescence or adulth…

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How the pandemic and George Floyd made clinical trial diversity a priority

[Image courtesy of Chad Davis via Flickr]

Where would clinical trial diversity be without the COVID-19 pandemic and the death of George Floyd on May 25, 2020? It likely wouldn’t be the priority it is today across the industry, according to Ariel Katz, CEO and co-founder of H1, a New York–based healthcare and data analytics platform firm.

After the death of George Floyd, scores of pharma companies created or beefed up departments related to diversity and inclusion. “Basically, every pharma company and biotech is now doing something around diversity and inclusion and social determinants of health,” Katz said.

On Google, interest in the search phrase ‘clinical trial diversity’ surged from July 2020 to July 2021. Interest in the phrase continues to remain strong but has dipped from its peak.

Things have changed considerably during the pandemic.

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