The FDA’s Vaccines and Related Biological Products Advisory Committee considering an sBLA for a third, booster dose of Comirnaty from Pfizer Inc.-Biontech SE for people ages 16 and over approximately six months after a second dose began daylong deliberations the morning of Sept. 17. Pfizer-Biontech reps presented data in the morning session showing that vaccine effectiveness waned over time, more than five months, against infections but not against hospitalizations. They also presented data showing a booster restored and could perhaps improve protection against Delta variant. The advisory committee’s vote is expected to take place sometime mid- to late-afternoon Eastern time in the U.S.

FDA puts Protagonist blood drug on clinical hold after mice develop tumors

Shares of Protagonist Therapeutics Inc. (NASDAQ:PTGX) fell 64% by midday after it reported finding malignant skin tumors in a mouse model test of its most advanced candidate, rusfertide for blood disorders. After notifying the FDA, the regulator put the program on a clinical hold, and dosing of patients in all ongoing trials of rusfertide has been halted. The development could impact Protagonist's ability to start phase III testing of the candidate in polycythemia vera (PV) early in 2022, as well as efforts to expand its development to a third indication beyond PV and hereditary hemochromatosis by the end of this year, as it has planned.

Citing safety worries, EU regulators reject Pfizer’s tanezumab for osteoarthritis pain

European regulators have rejected Pfizer Inc.’s tanezumab, casting further doubts on whether the FDA will okay the troubled drug that is intended as a non-opioid alternative for osteoarthritis pain. The EMA’s Committee for Medicinal Products for Human Use’s scientific committee gave a negative opinion, saying the safety problems that have caused problems throughout development of tanezumab outweighed its modest benefits as a painkiller. Branded as Raylumis, tanezumab was intended to treat moderate to severe chronic pain of the hip or knee in adults with osteoarthritis, when nonsteroidal anti-inflammatory drugs or opioid painkillers are not working.

Treefrog Therapeutics takes a big leap with $75M series B round

DUBLIN – Treefrog Therapeutics SA closed a $75 million series B round this week, which will help to increase its reach and its profile, as it pursues its highly ambitious objective to drive the adoption of a new way of making induced pluripotent stem cells (iPSCs) at scale. The Bordeaux, France-based firm is not a CDMO in any sense, however. It is a fully fledged biotech, with early stage iPSC-based programs in Parkinson’s disease, cardiovascular disease (CVD) and bone marrow transplant, among others. It’s just that it is also attempting to revolutionize how these cells are cultivated before it administers them as therapies.

Entrepreneur Paul Hopper launches Radiopharm Theranostics following AU$20M series A

PERTH, Australia – After raising AU$20 million (US$14.62 million) in a series A round, serial entrepreneur Paul Hopper is unveiling his newest venture, Radiopharm Theranostics Ltd., which is developing a platform of radiopharmaceutical and nuclear medicine products for both diagnostic and therapeutic uses. Radiopharmaceuticals are radioactive drugs that can either act as a diagnostic, allowing physicians to see and to measure disease within the body, or as a therapeutic where high energy particles are emitted to treat malignant cancers and other diseases. The new company already has five phase I trials and three phase II trials underway.

Rune Labs’ $22.8M in series A financing symbolizes confidence in its brain data platform

Rune Labs Inc. is on a mission to make the mysteries of the brain easier to read for both clinicians and biopharma companies. Having a fresh $22.8 million in a series A financing on the books will no doubt make the goal easier to reach.

As overall activity slows, pandemic clinical data rebound

Nearly 18% of clinical data reported in August was focused on the COVID-19 pandemic, representing the highest percentage for any single month this year. During the month, as the Delta variant took hold throughout the U.S., news of COVID-19 efforts spiked, doubling the amounts seen in both June and July, in which about 9% of the news was pandemic-related, and up significantly from 10% in May. More activity was seen in March (17%) and April (16.5%). Overall, however, the amount of clinical news reported in August is the lowest for any month this year.

Also in the news

AB Science, Abcellera, Agenus, Alpha Cancer Technologies, Alvotech, Appili, Arctic Vision, Astrazeneca, Avalo, Basilea, Beigene, Bio Elpida, Biogen, Biomea Fusion, Biontech, Biovaxys, Boehringer Ingelheim, Bridge, Bristol Myers Squibb, Calliditas, Celsion, Clene, Coherus, Corcept, Daiichi Sankyo, Deciphera, Derm-Biome, Eli Lilly, Elucida Oncology, Enveric, Eqrx, Everest Medicines, Galapagos, Gilead, Gritstone, Hainan Poly, Henlius, Imcheck, Immix, Innate, Innocare, Innovent, Intravacc, Janssen, Junshi, Keymed, Luye, Merck, Moderna, Novartis, Novavax, Ose Immunotherapeutics, Pfizer, Protagonist, Roche, Rottapharm, Sciclone, Sinomab, Sinovent, Tachyon, Takis, Tarveda, TCR2, Tilt, VBL, Vicore, Virpax