News
Aiming to compete in the lucrative weight-loss drug market, Zealand Pharma on Thursday posted topline results showing its dapiglutide led to only a slight weight reduction in low doses.
FEATURED STORIES
Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
As big pharmas including Takeda and Novo Nordisk flee the cell therapy space and smaller biotechs shutter their operations, these players are sticking around to take the modality as far as it can go.
This year has seen the approval of several first-in-class therapies for HAE, but in a fragmented space, experts question whether they will be enough to net their developers a significant share of the entrenched market.
Job Trends
Moderna, Inc. announced that the first participant has been dosed in the Phase 2 study of the Company’s Omicron-specific bivalent booster candidate, which combines Moderna’s Omicron-specific booster candidate and the Moderna COVID-19 vaccine.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
THE LATEST
The regulator Monday approved the companies’ supplemental Biologics License Applications for their respective mRNA shots formulated to more closely target currently circulating variants.
The collaboration, which includes an upfront payment of $120 million to Immatics, pairs Moderna’s mRNA technology with Immatics’ T-cell receptor platform for cancer treatment.
Following a Phase II review, Novartis has cut the development of a gene therapy candidate for geographic atrophy. In June, the company sold a dry eye disease drug to Bauch + Lomb for $1.75 billion.
The California pharma is building up to its first-ever approval with promising late-stage data for its once-daily investigational acromegaly pill paltusotine, an alternative to the injectable standard of care.
The first-in-class antibody-drug conjugate—in combination with Merck’s Keytruda—has shown promising results in a Phase II study of patients with metastatic non-small cell lung cancer.
After its prostate cancer therapy was not included in Medicare’s initial drug price negotiation list, Astellas dismissed its Inflation Reduction Act lawsuit this week, while Illumina got new leadership.
With a potential combined market value of $30 billion, BioSpace takes a deep dive into the Phase III data supporting Eisai and Biogen’s Leqembi and Eli Lilly’s investigational donanemab.
Seeking to deepen its neurology and rare disease pipelines, AstraZeneca’s Alexion has joined forces with Verge Genomics to leverage its artificial intelligence platform in drug discovery and development.
The companies have started a collaboration worth up to $3.4 billion to develop a portfolio of degrader-antibody conjugates, a potentially new class of antibodies that selectively kill cancer cells.
To build its ophthalmology portfolio, Japan’s Otsuka Pharmaceuticals has teamed with RNA editing biotech Shape Therapeutics to develop adeno-associated virus gene therapies for ocular diseases.