A partial clinical trial hold has been lifted from cancer drug emavusertib and Curis has selected a dose to use in Phase 2 testing. The small molecule is being developed as a potential treatment for blood cancers.
Frequency Therapeutics said its hearing loss drug candidate failed to beat a placebo in its second mid-stage clinical trial. The biotech is now focusing its regenerative medicine platform on the development of a multiple sclerosis drug not expected to reach the clinic until next year.
At the Payer Insights sessions on Day 1 of ViVE 2024, a panel on prior authorization offered compelling insights from speakers who shared the positive developments in this area after years of mounting frustration. Speakers also shared challenges as they work with providers to figure out how policy developments and technology will work in practice.
Sun Pharmaceuticals is acquiring Concert Pharmaceuticals, a biotech whose lead program has positive data from two late-stage clinical trials in alopecia areata. The deal gives Sun Pharma a drug candidate that could match up against hair loss drugs from two big pharmaceutical companies.
AstraZeneca’s LogicBio acquisition comes at a critical time for the biotech. Though LogicBio has encouraging early clinical data for its lead gene-editing therapeutic candidate, the company’s cash woes include a flagging stock price that is set to lose its listing on the Nasdaq.
While the lymphoma study is now clear to resume enrolling patients, the status of a partial hold on a separate leukemia study remains unchanged so far. The partial holds were placed on both studies of the Curis cancer drug after a patient death in the leukemia trial.
Kaleido Biosciences, formed by Flagship Pioneering as part of a wave of biotech companies developing microbiome therapies, has laid off its entire workforce and is winding down operations. The shutdown follows a strategic review that failed to turn up any deals to support its clinical-stage pipeline.
The TSX Venture Exchange has a strong history of helping early-stage health and life sciences companies raise patient capital for research and development.
The FDA placed a partial hold on a Curis drug in development for treating leukemia after a patient treated in a clinical trial died. The biotech company said the patient experienced a complication that is a known risk of the small molecule drug.
The acquisition agreement comes exactly two years after the two companies began a wide-ranging alliance focused on developing RNA interference drug for metabolic disorders. The most advanced therapy from that alliance is on track to reach the clinic in 2022.
The FDA issued a warning letter to Kaleido Biosciences alleging the company tested its experimental microbiome product in Covid-19 patients without submitting a formal clinical trial application. Kaleido claims the filing was not required because the product is a medical food, but the regulator doesn’t buy that argument.
Sanofi is acquiring Translate Bio, its messenger RNA R&D partner for the past three years, in a $3.2 billion deal. The pharmaceutical and vaccines giant said the acquisition will speed up development of partnered vaccine programs and spark work on new ones in areas such as cancer, immunology, and rare diseases.
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Bristol Myers Squibb already has a cancer program targeting the TIGIT protein, but in acquiring rights to Agenus’s drug, the pharma giant adds a bispecific antibody that preclinical research suggests has the potential to be the best in this drug class. BMS agreed to pay $200 million up front for global rights.
Seasonal allergy sufferers have a plethora of choices for treating the itching and redness affecting their eyes. An experimental Aldeyra Therapeutics drug that takes a new approach to blocking inflammation triggered by allergens has met the goals of a pivotal study and the biotech now plans to discuss the data with the FDA.
Translate Bio and Sanofi's vaccines business unit are expanding on a vaccine-development partnership they formed in 2018. The companies announced plans to develop an mRNA vaccine for Covid-19 in March.
Experts weighed in on how the move could change the way drugmakers raise money for development programs. But as digital securities as a financial instrument gain traction, they could carry potential risks too.
The drugmaker called its offering, scheduled for next month and meant to finance development of the drug AGEN2034, a first in healthcare and said it expects others to use the same means to raise capital.