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Home » Newsletters » BioWorld

BioWorld

March 30, 2022

View Archived Issues
Kidneys

Akebia draws CRL for vadadustat in CKD anemia

Opinion on Wall Street said the matter could have gone either way, but in the end Akebia Therapeutics Inc.’s vadadustat, a HIF prolyl-hydroxylase inhibitor for anemia caused by chronic kidney disease (CKD), garnered a complete response letter (CRL) instead of approval from the FDA. The news slammed Akebia shares (NASDAQ:AKBA), which closed at 82 cents, down $1.61, or 66%. Specifically, the agency said that the data in the NDA do not support a favorable benefit-risk assessment of vadadustat in dialysis-dependent (DD) and non-DDs patients. Read More

ALS hope could be delayed following negative adcom vote for Amylyx

Unless the U.S. FDA once again overrides its Peripheral and Central Nervous System Drugs Advisory Committee, it looks like the ALS community will have a longer wait for an additional tool against the fatal, degenerative disease. After hearing from both Amylyx Pharmaceuticals Inc. and FDA reviewers, along with 26 people testifying during the open public hearing, the committee voted March 30 against approval of AMX-0035, a fixed-dose combination of sodium phenylbutyrate and taurursodiol, as a much-needed treatment for amyotrophic lateral sclerosis (ALS). Read More
cancer-cell-light.png

Roche’s TIGIT drug fails in phase III trial in aggressive lung cancer

Roche Holding AG’s attempt to find a next-generation cancer immunotherapy has suffered a setback after the first phase III readout for an anti-TIGIT drug, tiragolumab, turned out negative. With big pharma investing heavily in TIGIT (T-cell immunoreceptor with immunoglobulin and ITIM domains), results from the company’s Skyscraper-02 trial were closely watched. Read More

Rejuvenate gains clearance for ‘groundbreaking’ sarcopenia trial

In a first of its kind phase I trial, Rejuvenate Biomed NV has secured ethical clearance to induce acute sarcopenia in 42 healthy subjects, aged 65 to 75 years old. That will be achieved by placing a cast on one leg to induce sarcopenia through muscle disuse. The volunteers in the double-blind trial will then receive either RJx-01, an oral small molecule for treating sarcopenia, or placebo. Read More
Nasal spray

Phase IIb Revelation with flu drug takes Toll on Street

Results from the phase IIb challenge study with its intranasal immunomodulator for influenza A, REVTx-99a, in healthy volunteers sent Revelation Biosciences Inc. shares (NASDAQ:REVB) into a tailspin, and the stock closed at $1.32, down 82 cents, or 38.3%. Read More

Adagio MAb posts strong data, supporting planned EUA filing

Adagio Therapeutics Inc. plans to file for emergency use authorization in the second quarter of 2022 for its lead candidate, a monoclonal antibody (MAb) for preventing and treating COVID-19. With plenty of competing vaccines around, the company now thinks it has found the right group to receive it: the immunocompromised. Read More
Illustration of DNA, magnifying glass

All about genetics: Neuron23 adds $100M in series C financing to fuel clinical pursuits

Neuron23 Inc. came out of stealth mode in late 2020 with a $113.5 million combined series A and B round to support its AI-enabled drug discovery effort aimed at bringing a precision medicine approach to neuroimmunology. Now it has added another $100 million in a series C financing as it gears up to move into clinical testing with lead programs targeting LRRK2 and TYK2. Read More
Illustration of pill being analyzed

Elix and Shionogi partner to validate retrosynthetic analysis model to discover drugs

Elix Inc. has teamed up with Shionogi & Co. Ltd. to validate a retrosynthetic analysis model for drug discovery that will employ chemical reaction data from Shionogi to explore various routes to synthesizing new molecules. Read More

Appointments and advancements for March 30, 2022

New hires and promotions in the biopharma industry, including: Alector, Coya, Greenlight, Heparegenix, Omega, Pathalys, Pepgen, Pharnext, Scisparc, TFF, Zealand. Read More

Financings for March 30, 2022

Biopharmas raising money in public or private financings, including: Aravive, Argenx, Calithera, Geron, IGM, Vectivbio. Read More

In the clinic for March 30, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Albireo, Aldeyra, Angiocrine, Antios, Aptevo, Bio-Thera, Cullinan, Curevac, Design, Diamond, Galecto, Glaxosmithkline, HDT, Innovent, Krystal, Lannett, Maat, Neuronascent, Neuroplast, Ocuphire, Pfizer, Recce, Recordati, Rejuvenate, Revive, Ribon, Sangamo, Saniona, Scancell, Sumitomo Dainippon, Synthetic, Valbiotis, Vectivbio. Read More

Other news to note for March 30, 2022

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AB, Acelrx, Adocia, Alpha Cognition, Asahi Kasei, Athos, Biosion, Biovaxys, Bone Therapeutics, Brii, Collegium, Cybin, Diurnal, Elicio, Formycon, Graybug, Orchard, Organo, Partner, Polpharma, Pyxis, Qpex, Rainbio, Redx, Scenic, Sinopharm, Sterotherapeutics, Teva, TSB, Vectivbio, Vector, Vyant and Vyne. Read More

Regulatory actions for March 30, 2022

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Antares, Astrazeneca, BMS, Canbridge, CSL, Daewoong, Enanta, Immunogen, Mitsubishi Tanabe, Neurocrine, Novo Nordisk, Noxopharm, Reveragen, Santhera, Takeda, Urogen, Telix. Read More

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