Pharma News - Chemdiv

FDA Delays sNDA Decision for Pfizer-Myovant Endometriosis Pain Drug Myfembree

The FDA has pushed back its decision date on Pfizer’s and Myovant Sciences’ supplemental New Drug Application (sNDA) for Myfembree (relugolix, estradiol and norethindrone acetate) from May 6 t...

New discovery to improve malaria elimination strategies

WEHI researchers have made a crucial discovery about how asymptomatic malaria infections impact the body, informing potential strategies to control transmission and improve treatment outcomes. ...

WHO recommends Veklury for high-risk patients

The World Health Organisation (WHO) has recommended Veklury (remdesivir) for the treatment of patients with non-severe COVID-19 who are at the highest risk of hospitalisation. ...

Quantum mechanics could explain why DNA can spontaneously mutate

The molecules of life, DNA, replicate with astounding precision, yet this process is not immune to mistakes and can lead to mutations.

Virus found in pig heart used in human transplant

Researchers trying to learn what killed the first person to receive a heart transplant from a pig have discovered the organ harbored an animal virus but cannot yet say if it played any role in the ...

CordenPharma, part of Germany's mRNA contingency plan, sold to private equity outfit Astorg

Contract manufacturer CordenPharma, recently tapped in a German push to earmark mRNA vaccine capacity, is getting a new owner.

Biogen sends CEO to the exit, abandons Aduhelm sales team in $1B overhaul

Biogen’s yearlong struggle with the controversial FDA approval and launch of Aduhelm has culminated in a deep overhaul reaching all the way to the CEO.

Anticipating FDA Rejection, Spero Cuts 75% Of Workforce

Spero Therapeutics is laying off approximately 75% of its workforce as part of a restructuring operation in light of the U.S. Food and Drug Administration's expected rejection of its New Drug Appl...

Washington State Settles With Three Drug Distributors for $518 Million

Drug distributors McKesson, Cardinal Health and Amerisource Bergen have agreed to pay the state of Washington a total of $518 million to settle litigation over their alleged roles in fueling the op...

FDA Accepts Bayer's Application to Expand Nubeqa into New Prostate Cancer Indication

Bayer announced Tuesday that The U.S. Food and Drug Administration accepted its supplemental New Drug Application (sNDA) for Nubeqa as a potential treatment for metastatic hormone-sensitive prosta...

Phathom Wins Approvals Against Antibiotic Resistance in H. pylori

Phathom Pharmaceuticals is having a good week as the U.S. Food and Drug Administration approved two of its products for bacterial illnesses in adults. ...

European Commission Greenlights Idorsia’s Insomnia Drug Quviviq

The European Commission has granted marketing authorization for Idorsia’s Quviviq (daridorexant) for the treatment of adult patients with chronic insomnia disorder. ...