Clade Therapeutics Inc., which launched with an $87 million series A round, may have what sounds like an ambitious goal: to create scalable, off-the-shelf stem cell-based medicines that can be as accessible to patients as antibody therapies are today. But the startup, backed by more than two decades of advances in the area of induced pluripotent stem cells, is within sight of developing a cell therapy to take into clinical testing. Read More
A few hours after the U.S. CDC Advisory Committee on Immunization Practices’ Nov. 2 recommendation to allow children ages 5 through 11 to be administered Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), the agency’s director, Rochelle Walensky, endorsed the recommendation. The recommendation came as the World Health Organization (WHO) expanded the COVID-19 vaccines it recommends in the fight against the pandemic by endorsing Bharat Biotech International Ltd.’s Covaxin. Read More
Antios Therapeutics Inc. followed up its $96 million series B financing in April with another $75 million series B-1 round that reflects faith in the potential of lead candidate ATI-2173, bound for phase IIb investigation as the backbone of a once-daily, curative regimen in chronic hepatitis B virus (HBV) infection. Read More
Eli Lilly and Co. has withdrawn a filing for its COVID-19 antibody cocktail in Europe after health authorities backed rivals – the day after a $1.29 billion purchase of the same medicines from the U.S. government. Indianapolis-based Lilly began filing data from the combination of bamlanivimab and etesevimab in March to enable a fast authorization by the European Medicines Agency. Read More
Although the BioWorld Biopharmaceutical Index has recovered slightly within the last month, it is showing only a small gain since the start of the year. Up by 2.82%, it is somewhat in line with the Nasdaq Biotechnology Index gain of 4.83%, but significantly beneath the broader markets. The Dow Jones Industrial Average, for example, was up by 17.03% at the end of October. Read More
The FDA has one question for its Psychopharmacologic Drugs Advisory Committee when it meets Nov. 4: Has Levo Therapeutics Inc. provided substantial evidence that the company’s carbetocin nasal spray is effective in treating hyperphagia associated with Prader-Willi syndrome? Read More
It looks like direct Medicare drug price negotiations are back in the U.S. fiscal 2022 budget bill.
Nearly a week after President Joe Biden dropped drug pricing reforms from his Build Back Better budget framework, congressional Democrats came together on a scaled-back version of the pricing provisions originally included in H.R. 3. Read More
Four years after an initial investment, Takeda Pharmaceutical Co. Ltd. exercised its option to acquire Gammadelta Therapeutics Ltd. to develop gamma delta T-cell therapies for solid tumors and hematologic malignancies. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bridge, Cytodyn, Innovation, Ionis, Kintor, Macrogenics, Minoryx, Mycovia, Oncolytic, Phasebio, Pieris, RDIF, Rigel, Sage, Sumitomo, Xencor. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Autobahn, Biomunex, Cytovant, Defence, Eisbach, Flagship Pioneering, Gb, Medigene, Pharmather, Reithera, Resverlogix, Revive, Roivant, Tessera. Read More
