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In the CRL, the FDA indicated that the single registrational trial (106 Phase III) did not provide sufficient proof of efficacy to demonstrate benefit.
Research continues to reveal how COVID-19 affects different people with different health issues, both short-term and long-term.
With this new collaboration, Astellas will take advantage of Dynos’ next-gen AAV vectors to deliver its gene therapy.
The Phase III DISCREET study evaluated the efficacy of Otezla in adults who have been diagnosed with moderate to severe plaque psoriasis and genital psoriasis.
The approval was based on Phase II data from the PLEIADES study that showed patients treated with the combination therapy generated an overall response rate of 84.8%.
The radiopharmaceuticals being developed by Curie are composed of rationally designed conjugates in contrast to delicately chosen biological targets.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
The FDA’s decision is based on positive results from two Phase III trials, the PROTECT and CONSTANT, on the drug’s efficacy.
The 12-month data showed that 50 mg of zuranolone was well-tolerated among adults with MDD.
23andMe raised $592 million in proceeds from the IPO and, as of September 30, had about $700 million. With that cash in hand, it plans to push faster and deeper into drug development.
The company plans to move it into Phase III studies in APOL1-mediated kidney disease, including FSGS, in the first quarter of 2022.
In open court, the prosecution examined hundreds of text messages sent between Holmes and Balwani, honing in on the romantic exchange between the two.
The takeover is part of the French biotech giant’s “Play to Win” strategy of growing its global vaccines pipeline through the acquisition of promising projects and companies.
Are you looking for effective ways to combat workplace stress? Here are 10 ways that can help you improve and increase the productivity of your day at work.
It may take two to four weeks before experts have enough data to know whether Omicron is a bigger threat than Delta. Much of what is known is based on lab tests and models of the virus’ spike protein mutations.
Parkinson’s disease has been immensely challenging for biotech companies. A high rate of late-stage attrition in trials has led to a lack of approved therapies for the disease.
The FDA’s Antimicrobial Drugs Advisory Committee voted 13 to 10 to recommend emergency authorization of molnupiravir. Read more about the authorization here.
ImmunoGen shares positive results from its Phase III SORAYA trial, which is evaluating the use of mirvetuximab soravtansine for treating ovarian cancer.
The pharmaceutical industry is full of job opportunities for people in various fields. Read on to find out more information about high-paying pharma industry jobs.
Genoskin’s solution is to develop the technologies to replace animals and humans in clinical studies with virtual models, steadily pushing living creatures further and further from testing.