Shionogi’s antiviral ensitrelvir could shorten COVID-19 symptoms by about a day

The investigational antiviral ensitrelvir promises to accelerate recovery from mild to moderate COVID-19.

Investigators concluded that patients who received the investigational drug recovered from COVID-19 symptoms about 24 hours earlier than those in the control group. Additionally, participants in the ensiltrelvir group tested negative for SARS-CoV-2 about 29 hours earlier.

The drug, developed by Shionogi (TYO:4507), also promises to accelerate recovery from long COVID. However, some researchers stress that more data are needed to substantiate that claim.

Dr. Eric Topol, director of the Scripps Research Translational Institute in San Diego, told Nature that it is unclear whether Shionogi defined long COVID before the Phase 2/3 study began. Because Shionogi established the long COVID focus in the study’s exploratory phase, it is impossible to draw firm conclusions, Topol noted.

Two antivirals, Paxlovid (nirmatrelvir/ritonavir) and molnupira…

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Biofourmis and Chugai Pharma partner to develop an objective measure of pain

Chugai Pharma (TYO:4519) and privately-held remote patient monitoring firm Biofourmis are continuing a collaboration to develop digital technologies to objectively measure and manage pain in endometriosis patients.

In endometriosis, the lining of a uterus grows outside the womb. The condition can also affect the ovaries and fallopian tubes. The disease affects approximately 10% of women of reproductive age. Stabbing pelvic pain is a common endometriosis symptom.

In general, physicians have traditionally relied on subjective measures to gauge pain. One common system, for instance, asks patients to rate their pain on a scale from 0 to 10. The Wong-Baker Faces Pain Rating Scale is similar, including pain scales using even numbers but also incorporating smiling and frowning faces.

While such scales are valuable, they are highly subjective, and patients’ personal experience and cu…

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Reata sets $370,000 annual cost for new nerve disorder drug

The Plano, Texas-based Reata Pharmaceuticals has won FDA approval for Skyclarys (omaveloxolone), the first therapy specifically indicated to treat Friedreich’s ataxia. The drug is approved for use in adults and adolescents aged 16 years and older. The approval also comes with a rare pediatric disease priority review voucher.

Friedreich’s ataxia is a genetic disease that affects the nervous system, causing a gradual decline in coordination, muscle strength, and energy. This can lead to difficulty with movement and reliance on a wheelchair for people in their teens or early twenties. About 5,000 people in the U.S. are diagnosed with this condition annually.

A silencing of frataxin, a protein encoded by the FXN gene, is responsible for the disease.

$370,000 launch price

Reata announced that Skyclarys would have a wholesale acquisition price of $370,000 annually.

In a company presentation, the company said not Friedreich’s ataxia pat…

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AbbVie’s partnership with Dare to Dream Project focuses on pediatric leukemia

AbbVie Oncology (NYSE:ABBV) recently joined the Dare to Dream Project, an initiative of the Leukemia & Lymphoma Society (LLS) focused on improving the treatment of cancer patients. The initiative is designed to accelerate the development of novel treatments for pediatric blood cancers.

In the interview, Pooja Hingorani, the medical director of oncology early development at AbbVie, discusses the challenges and opportunities in early drug development for pediatric oncology.

Gauri Sunkersett, the associate medical director of pediatric oncology clinical development, discusses later-stage development. She emphasizes the need for innovative trial designs.

The responses have been lightly edited.

How would you characterize the Dare to Dream Project?

Gauri Sunkersett

Gauri Sunkersett: I think the perfect word to describe the Dare to Dream Project by LLS is “rewarding.” The projec…

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How automation is changing the face of pharmacovigilance

White pills close-up on a blue-white background. close-up, pharmacovigilance, safety quality control

The ever-growing volume of data from clinical trials, drug use and other sources presents both opportunities and challenges for pharmacovigilance. COVID-19 has presented an array of possibilities for pharmacovigilance service providers. Detecting and evaluating potential safety signals is essential to maintain the safety of drugs and other therapeutic products.

Companies are constantly challenged to keep costs down to optimize their investment, focus on patient safety and undertake benefit/risk analysis of products. The hard truth is that pharmacovigilance is an additional cost that doesn’t draw revenue but is an essential requirement to do business. The pharmaceutical industry has learned that pharmacovigilance is more than a business necessity. Pharmacovigilance can be an asset as it can inform discov…

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An executive’s journey from clinical trial manager to marketing director at Biomerica

The in vitro diagnostics company Biomerica has a diversified portfolio, including tests for lab, point-of-care and at-home settings. The company has a particular focus on addressing the treatment of gastrointestinal and inflammatory diseases.

We recently spoke with Hamburg, Germany–based Astrid Starke, Biomerica’s marketing director, to learn more about her experience in the life sciences industry. Starting off as a Ph.D. researcher at the University of Zurich, Stark has held positions related to organ transplantation, allergy diagnostics and laboratory diagnostics. In this interview, she discusses topics such as gender equity in the workplace, the importance of clear communication in the workplace and mentorship programs for women.

The responses have been lightly edited.

What are the main focus areas of Biomerica’s product portfolio?

Astrid Starke

Astrid Starke: Biomerica is a biomedical…

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25 novel therapies set to shape the landscape of medicine in 2023

[Image courtesy of kwanchaift/Adobe Stock]

The year 2023 is poised to bring about an array of novel therapies that could significantly impact the treatment of several diseases. This article considers just over two dozen promising novel therapies that could generate significant sales for the industry. From hypertension to cancer, Alzheimer’s to hemophilia, these drugs could potentially change the lives of millions worldwide.

1. Aprocitentan

Indication: Difficult-to-treat hypertension Estimated peak sales: $2.5 billion The investigational hypertension drug aprocitentan from Idorsia Pharmaceuticals (SWX:IDIA) is a dual endothelin receptor antagonist. By blocking the peptide endothelin, the drug can block the constriction of blood vessels, thereby lowering blood pressure.

In late January, Idorsia submitted for European authorization to market aprocitentan for treatment-resistant hypertension. The compan…

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CMS continues to restrict coverage of amyloid-targeting antibodies for Alzheimer’s

[Image courtesy of CMS]

CMS has denied the Alzheimer’s Association’s request asking for broader reimbursement support for FDA-approved monoclonal antibodies targeting amyloid.

In April 2022, CMS decided to limit coverage of such antibodies for Alzheimer’s to clinical trial volunteers. At that time, aducanumab from Biogen (Nasdaq: BIIB) and Eisai (TYO:4523) was the only FDA-approved antibody for the neurodegenerative condition.

CMS noted in an announcement that its latest decision rests on the current lack of evidence that amyloid-targeting antibodies are effective against Alzheimer’s.

Amyloid-targeting antibodies intend to treat Alzheimer’s by targeting and removing amyloid beta, a protein that accumulates in Alzheimer’s patients’ brains. The protein deposits eventually result in plaques that interfere with normal brain function.

Alzheimer’s organ…
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Kendall Square-based LabCentral gaining traction with biotech startups

LabCentral facility at MIT [Image courtesy of LabCentral]

LabCentral is a 501(c)3 nonprofit that serves as a springboard for life sciences and biotech startups. The model makes it easier for creative academics to transform an idea into a profitable business by addressing the initial need to invest in lab equipment and space.

“Biotech startups have historically had to spend all of this money upfront,” said Dr. Johannes Fruehauf, co-founder and president of LabCentral. “And it is the most expensive money they will ever spend.”

Startups in the LabCentral network can accelerate the timeline to verify their scientific hypotheses without needing to own a lab. Once they have confirmed their research ideas, they can more easily attract venture funding. In fact, LabCentral companies has secured a quarter of all early-stage (seed and Series A) bio-pharma financing in 2021 in Massachusetts. I…

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AbbVie and Capsida join forces to target serious eye diseases

AbbVie (NYSE:ABBV) will work with the gene therapy platform company Capsida Biotherapeutics (Thousand Oaks, California) to develop serious eye diseases with few treatment options. The partnership will unite AbbVie’s development and commercialization capabilities with Capsida’s adeno-associated virus (AAV) engineering platform. AbbVie will also help explore therapeutic cargo approaches. The companies plan on identifying and advancing three programs.

The collaboration will center around Capsida’s AAV engineering platform and manufacturing capabilities to develop novel ophthalmological therapies.

Under the terms of the agreement, AbbVie will pay Capsida an upfront payment of $70 million. In addition, AbbVie could also make potential equity investments in the expanded agreement.

Capsida is also eligible for up to $595 million in option fees and R&D milestones if the company reaches commercial milestones. It could also receive mid-to-hig…

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Pfizer’s elranatamab wins priority review from FDA for multiple myeloma

FDA has granted priority review to Pfizer’s (NYSE:PFE) bispecific antibody elranatamab for patients with relapsed or refractory multiple myeloma (RRMM).

Also known as PF-06863135, the immunotherapy won breakthrough therapy designation from the FDA for RRMM in November 2022.

The FDA has also accepted elranatamab’s Biologics License Application (BLA) while the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA).

Pfizer anticipates that it will commercialize elranatamab later this year.

The company estimates that elranatamab could generate $4 billion in peak sales. Pfizer anticipates that the drug candidate could capture between 40% and 80% of market share.

Elranatamab targets B-cell maturation antigen (BCMA) on the myeloma cell while binding to the CD3 protein present on the surface of T-cells. The drug candidate can thus unite myeloma cells and T-cells. That action activates the T-cells, ena…

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The psoriasis medication apremilast could hold promise in alcohol use disorder

[Image courtesy of PubChem]

In two animal models, researchers found animals predisposed to mild-to-heavy alcohol use dropped their alcohol intake after taking apremilast, a phosphodiesterase 4 (PDE4) inhibitor. The scientists also tested apremilast in a Phase 2a study involving 51 subjects with moderate-to-severe alcohol use disorder. The subjects reduced their alcohol consumption from an average of five drinks per day to two.

PDE4 is tied to both alcohol and nicotine dependence.

“I’ve never seen anything like that before,” noted co-senior author and Oregon Health & Science University (OHSU) professor Angela Ozburn, in a news release.

The drug was also generally well tolerated in the study.

The researchers note that apremilast is better tolerated than than older PDE4 inhibitors such as rolipram and ibudilast, which can cause nausea and vomiting.

The Journal of Clinical Investigati…

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