Entries by BioSpace

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BioNTech Forges Ahead in Oncology, Infectious Disease

BioNTech continues to build on the success of the company’s mRNA COVID-19 vaccine co-developed with Pfizer, rapidly expanding its investigational pipeline to include additional infectious diseases and oncology with a first-in-class CAR-T program in solid tumors.

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LogicBio cleared to continue dosing in pediatric MMA trial

LogicBio Therapeutics was granted the green light to continue dosing participants in the company’s Phase I/II Sunrise trial investigating the safety of LB-001 in patients with methylmalonic acidemia (MMA), characterized by methylmalonyl-CoA mutase (MMUT) gene mutations.

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Moderna urges court to dismiss ongoing vaccine patent issues

Moderna is still fending off patent challenges over the lipid nanoparticle delivery system used in the company’s COVID-19 vaccine, Spikevax.

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Like COVID, Life Science Industry Finances Gain and Lose Strength

Although 2020 was a tough year for the biopharma industry — and most other industries as well — it appeared to rebound significantly in mid-2021. However, biotech stocks are generally getting hammered during 2022, although to be fair, the entire stock market is down.

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Biogen licensing deal is sweet music for bolstering MS portfolio

Biogen is bolstering the company’s multiple sclerosis pipeline through a licensing agreement with Maine-based MedRhythms for its investigational digital therapeutic MR-004, which is being assessed for the potential treatment of gait deficits in MS.

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FDA Refutes Pfizer CEO’s Recommendation of Second Paxlovid Round Upon Rebound

The U.S. Food and Drug Administration indirectly refuted Pfizer’s recommendation that it’s all right for COVID-19 patients to take another round of Paxlovid if they experience a rebound after completing the first course.

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AstraZeneca and Daiichi Sankyo move into earlier treatment space with Enhertu

AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval from the U.S. Food and Drug Administration. Enhertu was approved for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

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AstraZeneca, Argenx Score Phase III Wins in Autoimmune Space

Two biologic therapeutic candidates met their primary endpoints in separate Phase III trials: AstraZeneca’s Ultomiris and Argenx’s Vyvgart.