Policy
In his annual letter, Flagship Pioneering’s Noubar Afeyan lays out a choice between near-term “human-made miracles” and a reversion to the pain and suffering of past diseases due to “growing contempt” in the U.S. for the scientific method.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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The probe will be led by investigators experienced in determining whether or not entities have defrauded consumers, investors or government agencies.
Pfizer and BioNTech initiated a Phase II trial of an enhanced COVID-19 vaccine while fending off lawsuits against CureVac and Alnylam over their technology.
Teva expects to finalize and complete the documentation needed in the coming weeks, followed by a nationwide sign-on process for states, subdivisions and Native American tribes.
Martin Shkreli, commonly known as the “Pharma Bro,” announced Monday he has cofounded Druglike, a Web3 drug discovery software platform, despite a lifetime ban from the pharma industry.
WHO declared the monkeypox outbreak a “public health emergency of international concern [PHEIC].” As COVID-19 wanes, Tonix, SIGA, Emergent Bio and others are now targeting monkeypox.
The U.S. Attorney’s Office was busy indicting nine people for charges related to insider trading. Some charges were unrelated, but three were specific to the biopharma industry.
The complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.
The announcement signals that the WHO now views the outbreak as significant enough that a coordinated global response is necessary to control it.
FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.
Pfizer and Flynn Pharma are under the scrutiny of British watchdogs once again, after officials said the companies have been overcharging for an anti-epilepsy medication in the U.K. for over four years.