FDA wants more data on AZ’s motavizumab

The FDA has asked AstraZeneca's (NYSE: AZN) MedImmune for more data on motavizumab, a monoclonal antibody being considered to help prevent serious respiratory syncytial virus. The disease is a major cause of lower respiratory tract infection and hospital visits in infants and children. In the complete response letter, the agency said it would need data from an additional trial of the drug to support a satisfactory risk/benefit profile for which the prophylaxis indication is being...

AZ’s blockbuster Brilinta wins landslide FDA panel vote

AstraZeneca scored a big win in front of an FDA advisory panel on Wednesday afternoon, gaining solid support for its blockbuster blood thinner Brilinta in a seven-to-one vote in favor of approval. AstraZeneca's biggest obstacle was the relatively small contingent of 1,413 American patients in a large international Phase III who failed to benefit from the drug. But the 17,000 patients who participated in the study in 42 other countries demonstrated a sharp drop in deaths and heart attacks,...

AZ’s Brilinta garners favorable reviews from FDA staffers

Shares of AstraZeneca inched up after the FDA released some generally positive reviews about Brilinta, the experimental blood thinner that goes before an FDA advisory committee tomorrow. The consensus view was that the therapy is approvable provided the agency requires a post-approval efficacy study once it hits the market. Reuters highlights the remarks of one FDA reviewer who is skeptical about AZ's explanation for a lack of efficacy data among the small group of Americans included in the...

TheStreet tracks the top 10 clinical trials to watch

TheStreet's top biotech stock ace, Adam Feuerstein, has culled through a mountain of releases and reports to come up with the 10 most closely-watched trial announcements expected in the second half of the year. His list includes: Ariad's Phase III data for the sarcoma drug ridaforolimus, which Merck licensed; AstraZeneca's zibotentan, which hopes to answer the question about who has the next Provenge to offer the market; as well as mid-stage data on BioMarin's Peg-Pal for phenylketonuria,...

AZ will open compound library to malaria researchers

The non-profit Medicines for Malaria Venture has just landed another Big Pharma backer. AstraZeneca says that it will open up the books on some 500,000 chemical compounds to help researchers track down new therapies to treat malaria--including some hard-to-treat strains of the disease. "Our experience with infection research, and indeed with all of our R&D efforts, has taught us that we will only find solutions to today's global health challenges through collaborative efforts,"...

New diabetes data highlights promising drug class

Aside from the closely-watched taspoglutide data, a slew of new reports came out of the ADA meeting on experimental diabetes drugs. Here's a sampling of the top news stories: Boehringer Ingelheim laid out data from five trials of its diabetes drug linagliptin, demonstrating lowered blood glucose compared to a placebo. Boehringer is hopeful that the therapy can compete against Januvia and Onglyza after proving that the DPP-4 inhibitor works effectively without having to adjust the dose to...

FDA delays decision on AZ’s motavizumab

AstraZeneca's (NYSE: AZN) MedImmune unit has received word from the FDA has delayed decision date for its review of motavizumab, an investigational monoclonal antibody being considered to help prevent serious respiratory syncytial virus, from June 24 to Aug. 27. AZ is hoping that the experimental drug, which had been in MedImmune's pipeline as a successor to Synagis, wins approval. But these hopes may be dashed, especially after a 14 to 3 vote by an FDA...

FDA panel rejects AZ’s new RSV drug in key setback

AstraZeneca's (NYSE: AZN) attempt to come up with a successor to its blockbuster RSV drug Synagis has run into some heavy flak, with an FDA panel turning their thumbs down on motavizumab in a lopsided vote. The experimental drug had been in MedImmune's pipeline as a successor to Synagis when AstraZeneca bought up the Maryland biotech three years ago. But by a vote of 14 to 3 the FDA experts raised a red flag on data linking motavizumab to a higher number of allergic reactions while criticizing...

FDA rejects AstraZeneca’s Axanum

The FDA has declined to approve AstraZeneca's (NYSE: AZN) Axanum, a combination of aspirin and esomeprazole, the main ingredient in the blockbuster drug Nexium. The drug is an experimental treatment for the prevention of ulcers. Additionally, the FDA issued a complete response letter for Nexium for reducing the risk of low-dose aspirin-associated peptic ulcers. It's a setback for AstraZeneca, which is attempting to extend Nexium's usage before the $5 billion-a-year drug...

AZ colon cancer drug is a bust in PhIII

AstraZeneca (NYSE: AZN) has been handed another setback in its quest to come up with some major new products quickly. Researchers say that their latest Phase III clinical trial of Recentin as a first-line therapy for colon cancer was a bust, with the therapy proving no more effective than the chemo drugs currently available for improving the overall survival rate of patients. The drug did meet the co-primary endpoint of progression-free survival, but that wasn't enough to convince the company...