Small-molecule mRNA translation expert Anima Biotech Inc. has landed a significant new preclinical research deal with Takeda Pharmaceutical Co. Ltd., covering as many as six programs for genetically defined neurological diseases. The deal starts with $120 million in up-front and preclinical research milestone payments for Anima, but altogether the two-part collaboration could hold as much as $2.3 billion in clinical and commercial milestone payouts for the company, providing substantial support for its internal pipeline, Anima co-founder and CEO Yochi Slonim told BioWorld. Read More
Shares of mRNA therapeutics specialist Translate Bio Inc. (NASDAQ:TBIO) fell 30.9% to $17.76 on March 18 over concerns about a new interim analysis of phase I/II data for its cystic fibrosis (CF) candidate, MRT-5005. Several dosing regimens of the inhaled candidate failed to improve a key measure of lung function vs. placebo, in contrast to an earlier readout on other doses tested in the ongoing study, called Restore-CF. Read More
Aktis Oncology Inc. raised $72 million in a series A round and set out its stall as another contender with big ambitions in the rapidly developing field of targeted radiopharmaceuticals for solid tumor indications. Read More
Although U.S. President Joe Biden has yet to nominate his choice to lead the FDA, his nomination of Xavier Becerra as the next Health and Human Services (HHS) secretary – and Becerra’s Senate confirmation March 18 – could signal a shift to a more conservative approach at the FDA when it comes to approving new drugs and devices. Read More
LONDON – Astrazeneca plc’s COVID-19 vaccine is safe and effective and the benefits well outweigh any risks, according to a review carried out by the EMA, following reports of blood clots in people who received the vaccine. Read More
A U.S. Senate committee met March 18 to review the federal government’s response to the COVID-19 pandemic, during which former FDA commissioner David Kessler said the Trump administration’s vaccine contracts were expensive, but effective in ensuring a robust supply. Nonetheless, Sen. Chris Murphy (D-Conn.) said one vaccine manufacturer had recently voiced an interest in charging more on a per-dose basis for its vaccine, and suggested that the cost of booster shots should perhaps be examined anew by the Biden administration. Read More
Combining research on emerging technologies with an accelerator program and a dedicated equity fund, the European Commission (EC) launched the European Innovation Council March 18 to invest in promising research and to scale up innovative startups and small- and medium-size businesses. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: CDER makes COVID-19 EUA data easier to find; NICE recommends use of CLL drug. Read More
Biopharmas raising money in public or private financings, including: Boston Immune, Contrafect, Curi, Gain, Instil, Lava, Phasebio, Solid, Urogen. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Antion, Astrazeneca, Biontech, Boston Pharma, Can-Fite, CR20, Dyadic, Exelixis, Gilead, GSK, Hoth, Indivumed, ITM, Ix, Matrisys, Merck & Co., Merck KGaA, Novamind, Novo Nordisk, Onk, Pfizer, Pyxis, Selexis, Spybiotech, Telix, University of Oxford, Veraxa, Xlife. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Celularity, Chinese Academy, Peptomyc, Precigen, Sangamo. Read More
