Lexington, Mass.-based Aldeyra Therapeutics Inc.’s phase III win in the study called Invigorate with reproxalap for allergic conjunctivitis (AC) restarted speculation about odds of the drug, a small-molecule, immune-modulating covalent inhibitor of reactive aldehyde species (RASP), to treat dry eye disease (DED). “I do think there is potential read-through,” CEO Todd Brady said, especially with regard to the redness endpoint. A six-week safety study necessary before going to the FDA has not yet started, he told investors during a conference call. “That will require some discussions with the FDA, but I do not think, given the length of the trial, the safety study would impair our guidance of potentially filing NDAs by the end of this year.” Read More
Being in a crowded space doesn’t bother recently installed Arch Oncology Inc. CEO Laurence Blumberg. As a matter of fact, he’s reassured by it. “There’s a lot of competition in CD47, that’s correct,” Blumberg told BioWorld. “But having been in industry for a long time, competition and the magnitude of that competition in pursuit of a target usually means there’s a good reason for that interest and that there’s compelling evidence it has utility.” Read More
In a virtual meeting fraught with technical difficulties, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 7-2 April 27 that the accelerated approval for Tecentriq (atezolizumab) in combination with nab-paclitaxel as a treatment for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) in adults with PD-L1+ tumors should continue as additional trials are conducted or completed. Read More
Astrazeneca plc’s saga of its COVID-19 vaccine continued this week with the European Commission (EC) deciding to begin legal action against the Cambridge, U.K.-based company, claiming it has failed to deliver doses in line with its contract. Read More
Stuart Therapeutics Inc., a company developing peptide therapeutics for ophthalmic disease, has completed an $11 million series A financing led by Infocus Capital Partners, an ophthalmology-focused life sciences venture capital fund, with significant participation by the Wisconsin Alumni Research Foundation, Mimo Capital and Biobrit. Read More
About a year and a half after Enzyvant Inc.'s tissue-based therapy for children born without a thymus met with a complete response letter over chemistry, manufacturing and controls concerns, its BLA is once again on track for FDA review, the company told BioWorld. Following a resubmission intended to fully address the agency's concerns, the application has a new PDUFA date of Oct. 8. Read More
The volume of phase I-III clinical trial data so far in 2021 is a full 26% more than it was by this point last year, yet the proportion of news focused on the COVID-19 pandemic continues at much the same rate. Read More
New hires and promotions in the biopharma industry, including: Antios, Cohbar, Finch, Immuneering, Modra, Oasmia, Q-State, Repertoire, Stridebio, Surface. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aim, Aldeyra, Alkermes, Ampio, Aravive, Brickell, Discgenics, Fosun, Gila, Logicbio, Lumos, Noxopharm, Obseva, Protagonist, Reithera, Revance, Sifi, Verona. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ampio, Cyclo, Eledon, Enzyvant, Hillhurst, Instil, Krystal, RDIF, Reata, Revive, Rockwell Medical, Sol-Gel Technologies. Read More
