Inovio Pharmaceuticals Inc. said the company’s Covid-19 vaccine candidate was safe, well-tolerated and produced immune response against the new coronavirus in a mid-stage clinical trial, sending the drug developer’s shares up over 3 percent.
The U.S. Food and Drug Administration approved Merck’s Keytruda in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. Keytruda is the first anti-PD-1 therapy approved in combination with anti-HER2 therapy and chemotherapy as a first-line treatment for these patients.
Germany’s CureVac is on track to file for European approval of the company’s Covid-19 vaccine as early as this month because high infection rates among trial participants are bringing a read-out on efficacy within closer reach. The group’s late-stage trial involves more than 37,000 volunteers in Europe and Latin America, half of whom are receiving a placebo.
Pfizer reported first-quarter 2021 revenue of $14.6 billion, an impressive 42 percent operational growth. The company’s Covid-19 vaccine revenue accounted for $3.5 billion of the total.
One year after Astellas and California-based Cytokinetics extended an agreement to develop Skeletal Sarcomere Activators, the Japanese pharma company is walking away from the deal.
An investigational Alzheimer’s disease (AD) drug from Tetra Therapeutics appeared to improve language ability and learning in adults with Fragile X Syndrome, according to a new study reported in Nature Medicine.
The submission of U.S. approval for AstraZeneca’s Covid-19 vaccine was pushed back to mid-May, with the company citing the massive dataset as the cause.
After filing plans for an initial public offering earlier in April, U.K.-based Vaccitech raised $110.5 million in the company’s IPO and on April 30 announced the pricing of 6.5 million American Depositary Shares at $17 per share.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee did not agree in a meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.
The European Medicines Agency will conduct an accelerated review of Eli Lilly and Co.’s rheumatoid arthritis drug Olumiant for hospitalized Covid-19 patients getting oxygen, the EU agency said on April 29, as the search for treatment options continues.
