Biopharma

Corcept’s investigational oral therapy cuts ovarian cancer progression by 30%, teeing up FDA filing

Corcept’s investigational oral therapy cuts ovarian can...

Mar 31, 2025 0

Corcept Therapeutics’ oral antiglucocorticoid plus chemotherapy slashed risk of ...

Concept paper on the revision of the guideline on the S...

Mar 31, 2025 0

Concept paper on the revision of the guideline on the Scientific Data Requiremen...

Scientific data requirements for plasma master file - Scientific guideline

Scientific data requirements for plasma master file - S...

Mar 31, 2025 0

Scientific data requirements for plasma master file - Scientific guideline

Apollomics hands Asia rights to its lead c-MET inhibitor to Taiwan’s LaunXP in $60M deal

Apollomics hands Asia rights to its lead c-MET inhibito...

Mar 31, 2025 0

Apollomics has sold the rights to its lead c-MET inhibitor in Asia, excluding Gr...

Development of a guideline on the quality aspects of mRNA vaccines - Scientific guideline

Development of a guideline on the quality aspects of mR...

Mar 31, 2025 0

Development of a guideline on the quality aspects of mRNA vaccines - Scientific ...

Draft guideline on the quality aspects of mRNA vaccines

Mar 31, 2025 0

Draft guideline on the quality aspects of mRNA vaccines

Alphabet's AI biotech Isomorphic Labs hauls in $600M to power next-gen drug design model

Alphabet's AI biotech Isomorphic Labs hauls in $600M to...

Mar 31, 2025 0

AI drug discovery firm Isomorphic Labs has completed the company’s first externa...

Draft Reflection paper on linking to electronic product...

Mar 31, 2025 0

Draft Reflection paper on linking to electronic product information (ePI) from E...

Electronic product information (ePI)

Electronic product information (ePI)

Mar 31, 2025 0

Electronic product information (ePI)

Human medicines European public assessment report (EPAR): Enhertu, trastuzumab deruxtecan, Date of authorisation: 18/01/2021, Revision: 17, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): Enhertu, trastuzumab d...

'It's just ugly': Federal funding cuts to Columbia University leave chronic fatigue syndrome research in limbo

'It's just ugly': Federal funding cuts to Columbia Univ...

Mar 31, 2025 0

Earlier this month, Ian Lipkin, M.D., and his team at Columbia University submit...

Human medicines European public assessment report (EPAR): Amgevita, adalimumab, Date of authorisation: 21/03/2017, Revision: 14, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): Amgevita, adalimumab, ...

Merck's Winrevair slashes mortality-morbidity risk by 76%

Merck's Winrevair slashes mortality-morbidity risk by 76%

Mar 31, 2025 0

Merck revealed data from a phase 3 study of pulmonary arterial hypertension drug...

Human medicines European public assessment report (EPAR): MicardisPlus, Date of authorisation: 19/04/2002, Revision: 37, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): MicardisPlus, Date of ...

Human medicines European public assessment report (EPAR): Nplate, romiplostim, Date of authorisation: 04/02/2009, Revision: 29, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): Nplate, romiplostim, D...

Emotional whiplash for PTC Therapeutics

Emotional whiplash for PTC Therapeutics

Mar 31, 2025 0

And other biotech news updates, brought to you by The Readout.

STAT+: Pfizer accused of major tax-dodging scheme

STAT+: Pfizer accused of major tax-dodging scheme

Mar 31, 2025 0

Want to stay on top of the science and politics driving biotech today? Sign up t...

STAT+: Pharmalittle: We’re reading about fallout over ousted FDA official, a Colorado pharma setback, and more

STAT+: Pharmalittle: We’re reading about fallout over o...

Mar 31, 2025 0

The ouster of Peter Marks, the FDA official who oversaw vaccines, gene therapies...

STAT+: It’s RFK Jr.’s FDA now

STAT+: It’s RFK Jr.’s FDA now

Mar 31, 2025 0

Why the ouster of Peter Marks, a senior FDA official, is a huge deal, whether yo...

Texas measles cases jump 20%

Texas measles cases jump 20%

Mar 31, 2025 0

The health news stories you need to read this morning.

BiomX's bacteria-killing virus reduces diabetic bone ulcers in midstage test

BiomX's bacteria-killing virus reduces diabetic bone ul...

Mar 31, 2025 0

BiomX’s acquisition of Adaptive Phage Therapeutics is looking like a good bet no...

Human medicines European public assessment report (EPAR): Efmody, hydrocortisone, Date of authorisation: 27/05/2021, Revision: 6, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): Efmody, hydrocortisone...

Transcend rises above threshold for success, linking MDMA analog to PTSD improvements in phase 2

Transcend rises above threshold for success, linking MD...

Mar 31, 2025 0

Transcend Therapeutics has glided over the bar for success, linking its MDMA ana...

Human medicines European public assessment report (EPAR): Heplisav B, hepatitis B surface antigen, Date of authorisation: 18/02/2021, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR...

Mar 31, 2025 0

Human medicines European public assessment report (EPAR): Heplisav B, hepatitis ...

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