BioCentury | Nov 17, 2020
Regulation

Alkermes expects quick resolution to FDA setback for antipsychotic

Alkermes expects a swift resolution to a manufacturing issue that led to FDA’s issuance of a complete response letter for ALKS 3831, but the company isn’t yet committing to a launch timeline for the antipsychotic...
BioCentury | Nov 11, 2020
Product Development

Nov. 10 Quick Takes: Tezepelumab meets in asthma Phase III; plus a call for speedy trial results, updates on COVID vaccines from Sinovac, CureVac and more

AZ, Amgen rise on asthma dataTezepelumab from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Amgen Inc. (NASDAQ:AMGN) met the primary endpoint of a statistically significant reduction in annualized asthma exacerbation...
BioCentury | Nov 10, 2020
Regulation

Label expansions coming at a rapid clip for Foundation’s blood-based companion cancer diagnostic

In the past three weeks, FDA has added four companion diagnostic indications to the label of Foundation Medicine’s liquid biopsy test, growing the number of genetic biomarkers indicated for matching patients to targeted therapies. The...
BioCentury | Oct 12, 2020
Finance

Priothera raises €30 million to develop onetime Novartis candidate in AML transplantation setting

A VC syndicate is backing Priothera with a €30 million ($35.5 million) series A round to develop a clinical S1PR modulator for acute myelogenous leukemia patients undergoing hematopoietic stem cell transplantation. The group believes mocravimod,...
BioCentury | Oct 10, 2020
Product Development

Oct. 9 Quick Takes: Sobi’s Phase III miss; plus Alkermes, COVAX, Warp Speed-AZ, Lilly-Gates, Pfizer, Everest and Affamed-Kissei

Sobi’s avatrombopag misses in Phase III for chemotherapy-induced thrombocytopenia Swedish Orphan Biovitrum AB (SSE:SOBI) sank 18% on Friday, shedding $1.3 billion in market cap, after CD110 agonist Doptelet avatrombopag missed the composite primary endpoint in a...
BioCentury | Oct 8, 2020
Product Development

COVAX nears $2B fund-raising goal for equitable vaccine distribution; plus Novartis-Merck KGaA, 10x Genomics, Alkermes, UCB-Aetion, Janpix, BeiGene-BioAtla, Phenomic AI

COVAX nearing $2B fund-raising goal for equitable vaccine distributionThe U.K., Canada, Germany, Italy and Sweden pledged $958 million to Gavi’s COVID-19 Vaccines Advance Market Commitment (COVAX AMC), which seeks to ensure equitable access to COVID-19...
BioCentury | Sep 20, 2020
Product Development

Amgen highlights durability, seeks biomarkers as response rates slip for KRAS inhibitor AMG 510

Amgen’s leading KRAS inhibitor hasn’t maintained the exceptionally high response rates seen in its earliest readouts, but the first longer-term data for AMG 510 start to answer one of the biggest questions...
BioCentury | Sep 19, 2020
Product Development

Sept. 18 ESMO roundup: data from Incyte, Autolus, Merck, Alkermes and Daiichi

Incyte moving into Phase III with PD-1 inhibitor retifanlimab for SCACIncyte Corp. (NASDAQ:INCY) reported its PD-1 inhibitor retifanlimab led to an objective response rate of 14% and a disease control rate of 49% in the...
BioCentury | Sep 3, 2020
Product Development

BIO leaders urge industry to hew to norms for COVID-19 candidates

Against a backdrop of questions about FDA’s independence, eight past and present members of BIO’s leadership team have written an open letter calling on industry to hold fast to its principles. The letter,...
BioCentury | Aug 29, 2020
Product Development

Next-wave Th1 cytokine cancer therapies aim for more precise targeting

A growing list of cytokine therapies have been designed to boost cytotoxic immune responses against cancer while sidestepping the limitations of past candidates by controlling where the molecules do and...
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