The vagaries of the COVID-19 market and the uncertainties of pandemic fatigue are hitting some biopharma companies in the pocketbook, at least for now. Due to lower-than-expected revenues from its COVID-19 Comirnaty vaccine and antiviral Paxlovid (nirmatrelvir/ritonavir), Pfizer Inc. reduced its 2023 revenue guidance by $9 billion after hours Oct. 13, saying it now anticipates full-year 2023 revenues to range from $58 billion to $61 billion – down from its previous guidance range of $67 billion to $70 billion. Read More
The EMA is standing firm on its refusal to recommend approval of the amyotrophic lateral sclerosis (ALS) treatment Albrioza in Europe after re-examining Amylyx Pharmaceuticals Inc.’s marketing authorization application and remaining unconvinced that the main study demonstrated the drug effectively slows disease progression. Read More
Omeros Corp.’s phase III stumble in the busy immunoglobulin A nephropathy (IgAN) space put a sizeable dent in the stock (NASDAQ:OMER) and caused the Seattle-based firm to end the experiment with narsoplimab. Shares closed Oct. 16 at $1.54, down 73 cents, or 32%, after Omeros reported the interim analysis outcome of the trial called Artemis-IgAN. Read More
Investors awaiting the announcement of a partnering deal for RASP modulator reproxalap ahead of the drug’s Nov. 23 PDUFA date were in for a rude awakening, as Aldeyra Therapeutics Inc. disclosed that the U.S. FDA had raised issues with the NDA, putting its imminent approval in dry eye disease in doubt. The update, disclosed in an SEC filing, sent shares (NASDAQ:ALDX) sinking 66%, or $3.60, to close Oct. 16 at $1.83. Read More
China is pushing to increase biopharma investment to woo foreign investors, and the State Council laid out policy areas to further incentivize foreign companies to expand their operations in the country. Among those policies are guaranteeing equal treatment of foreign-invested enterprises and domestic enterprises, particularly in government procurement activities. Read More
Cancer treatments for targeting tumor amplifications lag behind those targeting point mutations – and part of the reason may be that amplifications often reside on extrachromosomal DNA (ecDNA). Since ecDNA was first described back in 1965 as minute chromatin bodies in brain cancer cells, the use of large-scale DNA sequencing techniques has revealed the presence of ecDNA across a wide range of cancer types. “The circular structure of ecDNA is associated with increased proto-oncogenic capacity in comparison to linear amplifications. Another key feature is that ecDNA does not contain centromeres,” Roel Verhaak, from Yale School of Medicine, told the audience in a session at the 2023 AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics in Boston. Read More
In a study published in Nature on Oct. 11, coinciding with the beginning of IDWeek 2023 in Boston, researchers from Harvard Medical School described EVEscape, a method for anticipating the movements of SARS‑CoV‑2 by predicting potential mutations likely to escape current vaccines and treatments. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antiverse, Cimeio, Concentra, Fortress, Globalbio, Glycotope, Helocyte, Hudson, KBP, Legochem, Lonza, Novo Nordisk, Rain, Shaperon, Sotio, Synaffix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Ascentage, Astellas, Catalyst, Cidara, Intellia, Merck, Pfizer, Santhera, Yiling. Read More
