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Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
FEATURED STORIES
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Ionis announced that the FDA has accepted its NDA for tofersen for SOD1-ALS. The application has been given the priority review designation and an action date of January 25, 2023.
BridgeBio announces positive Phase II trial results for achondroplasia, Astellas-Seagen announces promising outcomes from Padcev Plus Keytruda Trial and Kelun-Biotech’s exclusive MSD deal.
The company is readjusting its strategy as it seeks ways to preserve share value. The goal to preserve as much as the $60 million it has in cash and cash equivalents as of the year’s second quarter.
WHO declared the monkeypox outbreak a “public health emergency of international concern [PHEIC].” As COVID-19 wanes, Tonix, SIGA, Emergent Bio and others are now targeting monkeypox.
The U.S. Attorney’s Office was busy indicting nine people for charges related to insider trading. Some charges were unrelated, but three were specific to the biopharma industry.
The biotech industry is facing what some consider the worst times since its inception. Several market analysts recently shared their thoughts.
Here’s a look at global biopharma company news stories including Rona Therapeutics, Genuine Bio and NEOsphere Bio.
The transaction, Ginkgo’s largest acquisition to date, is expected to close by the first quarter of 2023, subject to regulatory approval and other closing conditions.
The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.
Daiichi-Sankyo and AstraZeneca’s sBLA for HER2 directed Enhertu accepted by FDA. Novartis gets BLA acceptance for MS biosimilar. HOOKIPA’s IND for prostate cancer immunotherapy candidate accepted