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The FDA has issued a Complete Response Letter (CRL) to Gilead Sciences for its new drug application (NDA) for lenacapavir, an HIV-1 capsid inhibitor for patients with HIV who are heavily treated and multidrug-resistant. Read More
The Cambridge, Mass., drugmaker earned $18.5 billion in total revenue for 2021, almost all of which was from sales of its coronavirus vaccine. Read More
Viatris, formerly Mylan, has agreed to a $264 million settlement to resolve a class-action lawsuit alleging that the company, along with Pfizer, had taken part in a scheme to delay generic competition to its EpiPen allergy treatment, used to quickly administer epinephrine to treat potentially fatal allergic reactions. Read More
A biologics-focused subsidiary of Bangalore, India-based Biocon is buying the biosimilars portfolio of Pittsburgh, Pa.-based Viatris for up to $3.3 billion. Read More
The FDA outlined its latest thinking on patient-focused drug development in a final guidance released on Friday, including ways to gather information that can be used for trial design. Read More
Johnson & Johnson (J&J) and three drug wholesalers have reached a deal to pay out $26 billion to settle thousands of lawsuits over their business practices, which plaintiffs claim fueled the deadly opioid crisis over the past two decades. Read More
The FDA “has concerns about the integrity of the data generated from the nonclinical toxicity studies conducted at your testing facility,” said the warning letter. Read More
The CDC stressed that a shorter period between a first and second shot is recommended for those who are immune-compromised, adults who are 65 years old and up and those who are at greater risk of severe disease or who require immediate protection because of where they work. Read More