BioSpace News Archive

Novartis released promising interim Phase II data of iptacopan in C3 glomerulopathy (C3G). The analysis was presented at the virtual American Society of Nephrology (ASN) 2020 Annual Meeting.

Only a fraction of intravenous antibody treatments will make their way to the lungs of COVID-19 patients, which is where the infection is primarily located. Aridis Chief Executive Officer Vu Truong believes his company has a better solution – an inhaled antibody.

Treatment with FORMA Therapeutics’ investigational agent olutasidenib has shown promising efficacy and safety in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and mutations in isocitrate dehydrogenase 1 (IDH1m).

Bayer is paying $2 billion upfront for AskBio’s AAV-based gene therapy pipeline of treatments for Pompe disease, among others, and could pay an additional $2 billion in potential milestones.

While pre-license inspections of manufacturing sites are typically done following the acceptance of a BLA filing, due to the public health emergency of COVID-19, the FDA is instead requiring a quality control unit to be established by each manufacturer with detailed report submissions about their manufacturing processes.

FibroGen presented data from two pooled analyses from its roxadustat global Phase III development program this weekend at the American Society of Nephrology Kidney Week 2020 Reimagined conference.

Days after the U.S. FDA greenlit the restart of AstraZeneca’s Phase III COVID-19 vaccine trial, the company said the preventative medication boosts immune responses in older and younger adults against the novel coronavirus.

“We are actively working with the FDA to find a way to expedite the plant inspection,” said Joe Turgeon, president and CEO of Spectrum Pharmaceuticals. “The manufacturing facility is ready for inspection and we are eager to assist the FDA in completing their assessment as soon as possible.”

InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV) today announced the closing of its previously announced public offering of 18,750,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof), together with warrants to purchase up to 18,750,000 shares of common stock at a combined effective price to the public of $0.80 per share (or pre-funded warrant) and associated warrant. The gro

Mirati Therapeutics, Inc. announced that it intends to offer and sell in an underwritten public offering $700.0 million of shares of its common stock and a selling stockholder intends to offer 375,000 shares in the offering.