FDA, malaria and BioNTech

BioNTech SE's RNA-based vaccine for malaria placed on clinical hold by FDA
BioNTech SE (NASDAQ:BNTX) said on Tuesday, that the U.S. Food and Drug Administration informed of a clinical hold on the company's Investigational New Drug application and mid-stage trial evaluating its vaccine for prevention of P.
FDA Places Clinical Hold On BioNTech's Early-Phase Trial For RNA-Based Malaria Vaccine
BioNTech's malaria vaccine trial faces an FDA clinical hold. The company is addressing concerns and collaborating with regulators on next steps.
FDA Pauses Study of BioNTech’s Malaria Shot as Problems for Vaccine Space Mount
The vaccine space has been battered by strong headwinds in recent weeks, including high-level disruptions to FDA and CDC advisory committee meetings.
BioNTech's RNA malaria vaccine trial hit by FDA hold
The FDA has placed a hold on BioNTech’s phase 1/2a trial, pausing the company’s efforts to develop a RNA-based vaccine for malaria prevention. | The FDA has placed a hold on BioNTech’s phase 1/2a trial,
BioNTech reports FDA clinical hold on Phase I/IIa trial of BNT165e
In a regulatory filing, BioNTech (BNTX) disclosed that the U.S. Food and Drug Administration has informed BioNTech SE that it has placed a
BioNTech malaria vaccine study placed on clinical hold by USFDA
BioNTech's early-to-mid stage trial of an experimental malaria vaccine has been put on a clinical hold by the U.S. Food and Drug Administration (USFDA), the drugmaker said in a filing.The trial
US FDA places BioNTech's malaria vaccine study on clinical hold
The trial was to evaluate the safety and efficacy of the RNA-based vaccine called BNT165e for prevention of malaria caused by the P. falciparum parasite in healthy adults who have never had malaria before.
BioNTech stock falls after FDA clinical hold on malaria vaccine trial
The FDA’s clinical hold has prompted a cautious response from investors, reflecting the heightened regulatory scrutiny that BioNTech now faces. The company’s immediate focus will be on resolving the FDA’s concerns to resume the trial, which is a crucial step in the vaccine’s development process.
Health Rounds: Roche/BioNTech experimental vaccine shows early promise in pancreatic cancer
Half of the patients who received an experimental vaccine for pancreas cancer being developed by Roche and BioNTech following ...
Pfizer and BioNTech COVID vaccine broke patent: German court
A German court found Wednesday that American pharmaceutical giant Pfizer and German firm BioNTech violated a patent to make ...
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HHS review of a vaccine contract sparks worries about preparedness for a potential bird flu pandemic
HHS is re-evaluating a nearly $600 million contract with Moderna to develop and test vaccines against flu viruses that could ...
Berenberg Bank Sticks to Its Buy Rating for BioNTech SE (BNTX)
In a report released yesterday, Harry Gillis from Berenberg Bank maintained a Buy rating on BioNTech SE (BNTX – Research Report), with a price ...