LONDON – The EMA has concluded that the rare cases of serious blood clots with low platelet counts seen after administration of Astrazeneca plc’s COVID-19 vaccine are caused by the vaccine, but said the benefits of its use still well outweigh the risks.

Artios, Novartis combining DDR approach with radioligands in three-year, $1.3B deal

LONDON – DNA damage response (DDR) specialist Artios Pharma Ltd. has signed a potential $1.3 billion deal to apply its technology to discover drugs that will work in combination with Novartis AG’s radioligand therapies. The aim is to prevent tumors developing resistance to the effects of the double strand DNA breaks that are induced by targeted radioligands. Under the three-year agreement, Artios and Novartis will do target discovery and validation, with Novartis selecting up to three DDR targets, which it will have exclusive rights to use with its expanding portfolio of radioligand therapies.

Let’s try that again: Fibrogen clarifies phase III analysis for CKD

Fibrogen Inc. said senior management’s prep for an upcoming FDA advisory committee meeting included a surprise. The internal review unearthed a primary cardiovascular safety analyses of roxadustat for treating anemia of chronic kidney disease (CKD) that included post-hoc changes to the phase III study’s stratification factors. An analysis with prespecified stratification factors resulted in higher hazard ratios but that did not alter Fibrogen’s stance on the underlying data, to the efficacy analyses or the company’s confidence in roxadustat’s benefit-risk profile. July 15 is the tentative date for Fibrogen to appear before the FDA’s cardiovascular and renal drug advisory committee to review roxadustat’s NDA for treating anemia of CKD in dialysis-dependent and non-dialysis-dependent patients. The San Francisco-based company’s stock (NASDAQ:FGEN) had lost about 40% of its value in midday trading, with shares going for about $20.90 each.

Biopharmas raise record $37B in first quarter

The biopharmaceutical sector is showing no signs of slowing the pace of attracting capital. After coming off a record year, global private and public companies collectively raised $37 billion in the first quarter, indicating that it could be another bumper year for financings. According to BioWorld data, the total generated in the period was 123% greater than the amount raised in the first quarter last year and 60% higher than the existing 2018 1Q record of $23 billion.

Shoreline Biosciences raises $43M to advance allogenic NK and macrophage cell therapies

Shoreline Biosciences Inc., a San Diego-based company developing allogenic natural killer and macrophage cellular therapies for cancer and other diseases, has raised $43 million in a financing led by Boxer Capital. The funds will help it advance candidates derived from its induced pluripotent stem cell platform, while also supporting research efforts to create NK cell-specific chimeric antigen receptors (CARs), switchable CAR-NK cell engagers and macrophage-specific CARs, it said.

Agios, Rocket trying allosteric, gene therapy approaches in PKD

Cambridge, Mass.-based Agios Therapeutics Inc. favorable phase III data from a pair of trials with allosteric activator mitapivat in adults with pyruvate kinase deficiency (PKD) who were not regularly transfused and those who get transfusion has brought renewed attention to the disorder. A genetic blood disorder, PKD leads to hemolytic anemia because red blood cells need the enzyme in order to function properly. Drawing particular interest in the space is Rocket Pharmaceuticals Inc., of Cranbury, N.J., with gene therapy RP-L301 at the phase I stage.

Record deal volume in Q1, but M&A values hit five-year low

With less uncertainty surrounding the pandemic, the biopharma industry appears on track to shift efforts back to its internal programs and possibly meet, if not exceed, the record-breaking deal level of 2020. Strong financial markets, however, may continue to hold M&As down.

Also in the news

Abbvie, Achilles, ACM, Aikido, Aim, Akili, Alkermes, Applied Molecular Transport, Arcellx, AVM, Biogen, Bioinvent, Bluerock, Bridge, Chinook, Covimro, Cytodyn, Daiichi Sankyo, Delta 4, Endevica, ERC-USA, Evgen, Fibrogen, Homology, Horizon, Humanigen, Icosavax, IMV, Incyte, Intravacc, Ionis, Kamada, Lilly, Luca, Merck, Metagenomi, Mydecine, Pfizer, Protokinetix, Psioxus, Recognify, Rigel, Shanghai Genchem, Silo, Soligenix, Stealth, Vitro, Xoma