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Key Healthcare and Biotech Developments: FDA Approvals, Investment Insights, and Global Expansions

21 Stocks to Play a ‘Magical Moment’ in Healthcare


Summary:

Barron’s discusses insights from a healthcare and biotech roundtable, focusing on stocks and investment opportunities within the biotech, pharmaceutical, and healthcare sectors. Industry experts weigh in on trends driving growth in these markets, such as advancements in precision medicine, gene therapies, and artificial intelligence (AI) in drug discovery. They highlight how innovations in biotech are opening up new investment opportunities, despite market volatility.

The roundtable emphasizes the potential for growth in companies developing breakthrough treatments in areas like oncology, rare diseases, and chronic conditions. The discussion also touches on regulatory changes, FDA approvals, and how global healthcare needs are influencing biotech strategies.

AstraZeneca’s Fasenra has received FDA approval

Summary: AstraZeneca’s Fasenra to challenge GSK’s Nucala in rare vasculitis after FDA nod
Before the FDA approved AstraZeneca’s Fasenra, Nucala was the only therapy for treating eosinophilic granulomatosis with polyangiitis. 

AstraZeneca‘s Fasenra (bevacizumab) is set to challenge GSK’s Nucala (mepolizumab) in eosinophilic granulomatosis with polyangiitis (EGPA) as the US Food and Drug Administration (FDA) approved the former. 

The approval was based on a non-inferiority Phase III MANDARA trial (NCT04157348) comparing Fasenra to Nucala in patients with EGPA. GSK’s Nucala was first approved by the FDA in 2015, and it has since been the only FDA-approved biologic therapy, along with corticosteroids, for EGPA.

Fasenra is a monoclonal antibody that inhibits IL-5 alpha on eosinophils, a type of white blood cell, to induce cell death. The drug was first developed by Japanese company BioWa and has since been licensed to AstraZeneca.

Ginkgo Bioworks lands in Brazil through partnerships


Summary: The company, known for its advancements in synthetic biology, plans to use its platform to support the development of bio-based products and solutions in various industries, such as agriculture, food, and health. This move reflects Ginkgo’s strategy to expand globally and leverage Brazil’s significant biodiversity and agricultural industry.

The partnership aims to explore biological alternatives to traditional products, emphasizing sustainable and efficient solutions. Ginkgo’s platform offers tools to design custom microbes that can help produce useful compounds or develop more efficient biological processes. With its entry into Brazil, the company will collaborate with local companies and institutions to further the development of biotech applications.

Covaxin Side-Effects Study Retracted

Summary: The study, which was previously published in the journal Nature Scientific Reports, was retracted because the editors expressed “no confidence in the conclusions” of the paper. The study had reported side effects associated with the Covaxin vaccine, but after review, the journal found issues with the scientific validity of the conclusions drawn, leading to its retraction. The paper’s retraction raises concerns about the transparency and accuracy of the reporting of vaccine-related side effects.




FDA Approves Merck’s Keytruda for First-Line Treatment of Pleural Mesothelioma

Summary: The FDA on Wednesday approved a new indication for Merck’s blockbuster cancer therapy Keytruda (pembrolizumab), adding pleural mesothelioma to the already-extensive list of malignancies that the PD-1 inhibitor can be used for. Wednesday’s label expansion covers the use of Keytruda with pemetrexed and platinum chemotherapy to treat adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, a type of cancer that originates in the linings of the chest and the lungs. The Keytruda-based regimen can be used in the frontline setting in this indication. “We’re pleased to offer a new first-line treatment option for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma, a disease where prognoses are generally poor,” Gregory Lubiniecki, vice president of oncology clinical research at Merck Research Laboratories said in a statement.