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Home » Newsletters » BioWorld

BioWorld

Aug. 19, 2024

View Archived Issues
Heart and lungs

Tentative approval of Yutrepia still leaves Liquidia adrift

Despite the U.S. FDA’s tentative approval of Liquidia Corp.’s Yutrepia (treprostinil) for treating pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease, the company is stuck in the starting gate. Liquidia said it disagrees with the agency’s stance of simultaneously granting regulatory exclusivity in both indications to United Therapeutics Corp.’s powdered formulation of treprostinil, branded Tyvaso, until May 23, 2025. That means full approval for the inhalation powder won’t come until after that date and neither will a Yutrepia launch. Read More

Alzamend phase II with ‘new’ lithium: PTSD near critical Mass?

A week after the U.S. FDA spurned Lykos Therapeutics Inc.’s bid for approval of a therapy in post-traumatic stress disorder (PTSD), shares of Alzamend Neuro Inc. (NASDQ:ALZN) zoomed upward on more news in the indication with a next-generation, cocrystal lithium compound AL-001. Atlanta-based Alzamend’s stock closed Aug. 19 at $5.85, up $3.82, or 188%. Read More
Australia flag with microscope, test tubes

Pfizer urges Australia to establish clear vision for life sciences

Pfizer Inc. is calling on the Australian government to establish priorities for the life sciences sector to attract more investment into research, clinical trials and manufacturing in Australia. The new report recommends that the government issue a life sciences vision akin to the one issued by the U.K. in 2021 to make the country more competitive to attract investment. Read More

Stocks rise along with concerns of global mpox outbreak

Following the World Health Organization’s escalation of mpox to a public health emergency of international concern on Aug. 14 and the emergence of what appears to be a more severe strain of the orthopoxvirus, the spotlight has focused on a handful of companies working on vaccines and antivirals. Shares of Geovax Labs Inc., Emergent Biosolutions Inc. and Tonix Pharmaceuticals Inc. were all trading up Aug. 19. Read More
Global handshake silhouette

Huadong gets China rights to Imbiologics’ Oxtima program for ₩430B

Imbiologics Inc. scored a potential ₩430 billion (US$315.5 million) deal with China’s Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd. for Oxtima, an autoimmune disease program with two assets co-developed by Seoul, South Korea-based HK Inno.N Corp. Read More

ICYMI: Week in review, Aug. 12-16, 2024

A quick look back at top stories. Read More

Biggest gainers and losers for Aug. 12-16, 2024

The top 10 biopharma stock gainers and losers for the week. Read More

Appointments and advancements for Aug. 19, 2024

New hires and promotions in the biopharma industry, including: Adicet, Fulcrum, Moonwalk, Tiziana. Read More

Financings for Aug. 19, 2024

Biopharmas raising money in public or private financings, including: Moleculin. Read More

In the clinic for Aug. 19, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biontech, Incyte, Pfizer. Read More

Other news to note for Aug. 19, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alera Pharma, Biomotion, Boston Immune, Eli Lilly, Lobe Sciences, Lykos, Moringa, Morphic, Otsuka, Silexion. Read More

Regulatory actions for Aug. 19, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Astrazeneca, Bavarian Nordic, Deciphera, Mediwound, Ono, Theramex. Read More

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