Product Development

April 16 COVID-19 Quick Takes: ACIP to reconvene over J&J’s vaccine on April 23; plus Gilead, Lilly-AbCellera and Sputnik V

The CDC’s Advisory Committee on Immunization Practices will hold a virtual emergency meeting on April 23 to discuss the use of Johnson & Johnson’s vaccine. The committee may issue updated recommendations for the vaccine’s use...

How COVID vaccines might be causing blood clots with low platelets

Rare cases of severe blood clotting combined with low platelet count, dubbed thrombotic thrombocytopenia, reported for two adenoviral vector COVID vaccines have raised questions about whether the...

Merck’s COVID-19 arsenal continues to dwindle as pharma scraps fusion protein from OncoImmune takeout

Merck’s roster of COVID-19 countermeasures gained via deals continued to shrink Thursday, when the pharma said it would terminate one therapeutic program and end development of another in hospitalized patients with the disease. The pharma...

Next-generation DNA damage response programs at AACR

Clinical readouts for WEE1 inhibitors, next-generation compounds against PARP and a pair of agents targeting CDC7 were among the DNA damage response programs featured at AACR this year. This year’s virtual meeting of the American...

Adenoviral vector vaccines in development for COVID: Data Byte

The future of adenoviral vector vaccines for COVID-19 has been further clouded after rare blood clotting events were associated with two of the four authorized adenovirus vaccines. At least a dozen other...

Novocure’s valuation tops $20B as it eyes shortened path to Optune’s label expansion in NSCLC

A DMC’s recommendation could shorten the path to a label expansion that would add a lung cancer indication for Novocure’s electric field therapy, which is already approved as Optune for two smaller indications. The news...

FDA’s ‘pause’ could lead to narrowed indication for J&J COVID-19 vaccine

FDA’s non-binding decision to recommend a “pause” in the use of Johnson & Johnson’s COVID-19 vaccine was among the least strenuous measures it could have taken in response to adverse event reports. The action, which...

AACR Quick Takes: Guardant, Gracell, iTeos, Zentalis, ImCheck, PureTech

A study from Guardant Health Inc. (NASDAQ:GH), Amgen Inc. (NASDAQ:AMGN) and academic collaborators showed Guardant’s plasma cell-free DNA (cfDNA)-based Guardant360 CDx test had an 81.5% positive percent agreement and 100% negative percent agreement with a...

FDA requests more data from Provention; plus Iterum, Seagen-Genmab, Pfizer and Gilead

Shares of Provention Bio Inc. (NASDAQ:PRVB) regained a small bit of the ground they lost Friday, when the stock tumbled 18% to $8 after the company revealed FDA wants more data on its BLA for...

COVID Quick Takes: subcutaneous Regeneron mAbs prevent symptomatic COVID; plus Pfizer-BionTech, J&J, Akili and Kiniksa

Regeneron reported Phase III data Monday showing subcutaneous REGEN-COV met the primary endpoint of preventing symptomatic COVID-19 in the study’s two populations, and the company plans to request an EUA...

AACR data suggest Agenus’ next-generation CTLA-4 blocker may expand responding patient group

Agenus’ latest clinical data for AGEN1181 support the idea that Fc engineering can expand the population of patients who respond to checkpoint inhibitors.  While many companies are searching for the...

Carisma adds support for CAR macrophage platform with preclinical data

Carisma is boosting confidence in its CAR macrophage platform ahead of its first clinical readout with preclinical data supporting the cell therapy’s differentiated activity against solid tumors. ...

Sanofi sees early signs that its Synthorx acquisition could pay off with IL-2 data

Sanofi took another step in its oncology pipeline rebuild with the first clinical evidence that a cornerstone program of its oncology pipeline — precision engineered IL-2 therapy THOR-717 -- may be...

Baricitinib improves on SOC survival benefit in hospitalized COVID patients

Lilly and Incyte believe the latest data for baricitinib underscore how the JAK inhibitor can build upon standard of care’s ability to reduce COVID-related death among hospitalized patients even as...

Bispecific constructs move beyond T cell engagers at AACR

T cell engagers have dominated the bispecific antibody scene for the past five years, but the industry is starting to branch out into next-generation structures that offer new functions and potential improvements over first-generation compounds. ...