Regulation

Zymeworks gets EC’s orphan drug designation for zanidatamab in patients with gastric cancer

Zymeworks announced that the European Commission (EC) has granted Orphan Drug designation for zanidatamab, the company’s investigational HER2-targeted bispecific antibody, in patients with gastric cancer.

Eli Lilly, Incyte get FDA EUA status for baricitinib plus remdesivir to treat Covid-19

Eli Lilly and Incyte have secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for baricitinib plus remdesivir to treat hospitalised patients with Covid-19.

FDA clears expanded access IND for APT’s PhageBank therapy for Covid-19-related bacterial infections

Adaptive Phage Therapeutics (APT) announced clearance by the U.S. Food and Drug Administration (FDA) of the company’s Expanded Access IND for PhageBank treatment for pneumonia or bacteremia/septicemia due to Acinetobacter baumannii, Pseudomonas aeruginosa or Staphylococcus aureus in COVID-19 patients.

ViiV Healthcare gets FDA breakthrough therapy status for HIV prevention drug cabotegravir

Specialist HIV company ViiV Healthcare has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its long-acting and injectable cabotegravir to treat HIV pre-exposure prophylaxis (PrEP).

Amylyx announces FDA granted orphan drug designation for AMX0035 to treat Wolfram syndrome

Amylyx Pharmaceuticals, a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035 for the treatment of Wolfram syndrome.

Merck gets first FDA nod for Keytruda in breast cancer setting

Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda plus chemotherapy to treat patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumours express PD-L1 (combined positive score [CPS] ≥10) as determined by an FDA-approved test.

Forma Therapeutics gets European orphan drug status for FT-4202 to treat sickle cell disease

Forma Therapeutics has secured orphan drug status from the European Commission (EC) for its FT-4202 to treat sickle cell disease (SCD).

ImmunityBio, NantKwest announce positive interim phase 1 safety data of hAd5 Covid-19 vaccine dose study

ImmunityBio, a privately-held immunotherapy company, and NantKwest, a clinical-stage, natural killer cell-based therapeutics company, today announced they have administered their second-generation bivalent, human adenovirus (hAd5) Covid-19 vaccine candidate in a Phase 1 trial with no serious adverse events (SAE) reported in the low dose cohort, safety is ongoing for the high dose cohort.

Eli Lilly gets FDA EUA status for bamlanivimab to treat Covid-19

Eli Lilly has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its investigational neutralizing antibody bamlanivimab (LY-CoV555) to treat recently diagnosed Covid-19 patients.