Tag: David M. Reese
Amgen, Generate Biomedicines sign $1.9bn worth research collaboration deal
Amgen has signed a research collaboration deal worth up to $1.9 billion with Cambridge-based Generate Biomedicines for the discovery and development of protein therapeutics for ... Read More
LUMAKRAS FDA approval : Amgen bags approval in KRAS G12C-mutated NSCLC
LUMAKRAS FDA approval : Amgen has bagged accelerated approval from the US Food and Drug Administration (FDA) for LUMAKRAS (sotorasib) for the treatment of a ... Read More
Amgen gets breakthrough therapy status for sotorasib in China
Amgen said that sotorasib, an investigational KRASG12C inhibitor, has been given breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National ... Read More
Janssen, Amgen secure FDA approval for DKd regiment in multiple myeloma
DKd regiment FDA approval for multiple myeloma : Janssen Pharmaceutical Companies of Johnson & Johnson and Amgen have been granted an expanded approval from the ... Read More
Amgen, Allergan file BLA to FDA for Rituxan biosimilar ABP 798
Rituxan biosimilar ABP 798 : US biopharma company Amgen and Irish pharma company Allergan have submitted a Biologics License Application (BLA) to the US Food ... Read More
CANDOR clinical trial results : Amgen’s Kyprolis extends PFS in multiple myeloma patients
CANDOR clinical trial results : Amgen said that a phase 3 study assessing Kyprolis (carfilzomib) in combination with dexamethasone and Johnson & Johnson's Darzalex (daratumumab) ... Read More
Amgen seeks FDA approval for infliximab biosimilar ABP 710
Amgen has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to Johnson & ... Read More
FDA approves new dosing option for Amgen blood cancer drug Kyprolis
The US Food and Drug Administration (FDA) has approved a weekly once dosing option for Amgen blood cancer drug Kyprolis (carfilzomib) in combination with dexamethasone ... Read More
AstraZeneca, Amgen asthma drug tezepelumab secures FDA breakthrough designation
UK biopharma company AstraZeneca and Amgen have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for their asthma drug tezepelumab. The ... Read More
Amgen blood cancer drug BLINCYTO scores EC approval in pediatric patients
The European Commission (EC) has approved an expanded indication for Amgen blood cancer drug BLINCYTO (blinatumomab) as monotherapy for the treatment of certain form of ... Read More