The FDA expanded Enhertu’s approval to encompass advanced solid tumors positive for the HER2 cancer protein, regardless of tumor type. Analysts say the regulatory decision paves the way for similar broader approvals of other medications in the ADC cancer drug class.
The FDA approved AstraZeneca drug Voydeya as an add-on to standard therapies for paroxysmal nocturnal hemoglobinuria, a rare blood disorder. Alexion, now AstraZeneca’s rare disease subsidiary, added the small molecule to its pipeline via a 2019 acquisition.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
AstraZeneca’s Fusion Pharmaceuticals acquisition is the latest in a wave of M&A activity that includes recent deals by Eli Lilly and Bristol Myers Squibb. The lead Fusion program is in mid-stage clinical development for treating advanced prostate cancer.
AstraZeneca is acquiring Amolyt Pharma to get eneboparatide, a drug in Phase 3 development for treating hypoparathyroidism. Takeda Pharmaceutical markets the only FDA-approved treatment for this rare disease, but the Japanese pharmaceutical giant plans to stop making the drug.
A federal judge disagreed with AstraZeneca’s claims that the Inflation Reduction Act causes harm by disincentivizing innovation and violates its constitutional rights to due process. Blockbuster AstraZeneca drug Farxiga is one of 10 medications selected for the Medicare drug price negotiation program created by the law.
AstraZeneca is paying $1 billion up front to acquire Gracell Biotechnologies, a clinical-stage cell therapy developer. The deal is the latest in a series of AstraZeneca moves intended to expand its presence in the burgeoning cell therapy field.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
AstraZeneca is acquiring Icosavax, which has technology well-suited for multivalent vaccines. Icosavax's pipeline includes a Phase 3-ready program that protects against two pathogens that cause severe respiratory infections in older adults.
The FDA approved AstraZeneca’s Truqap as a new treatment for advanced cases of breast cancer. The drug is the first in a new class of therapies addressing AKT genetic alterations.
AstraZeneca gains global rights to an oral GLP-1 agonist on track to reach Phase 2 testing in 2024. Under China-based Eccogene, the small molecule’s Phase 1 data show reductions in glucose and body weight.
The Federal Trade Commission says more than 100 patents from 10 biopharma companies are improperly listed in the FDA’s official publication of approved products. Such listings delay generic competition, which reduces consumer choice and keeps prices high, the regulator said.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
AstraZeneca starts the Cellectis partnership with $105 million in upfront cash and an equity investment. The pharmaceutical giant will also cover research costs for up to 10 cell therapy programs in oncology, immunology, and rare diseases.
AstraZeneca and Sanofi drug Beyfortus is now FDA approved for preventing respiratory problems from RSV infection in infants and toddlers. Antibody engineering enables the drug to last longer in the body, providing protective effects for potentially the entire RSV season.
An AstraZeneca and Daiichi Sankyo cancer drug achieved one of the main goals of a Phase 3 study in non-small cell lung cancer. But patient deaths were also reported in the study, and the companies disclosed few details about them.
AstraZeneca is paying $85 million to kick off an alliance with Quell Therapeutics focused on developing new cell therapies for autoimmune diseases. Type 1 diabetes and inflammatory bowel disease are the focus of the research collaboration.
An FDA advisory committee voted in favor of supporting a respiratory syncytial virus therapy designed to protect newborns and infants. The antibody drug developed by partners Sanofi and AstraZeneca is currently under regulatory review.