Top Pharma Rep Focus FDA Pharma Content for Week of Mar 16

Fierce Pharma Asia—Plant expansions at Novo, Novartis, Merck KGaA; Kyowa Kirin's pricing record; BeiGene's PD-1 nod

Fierce Pharma

MARCH 21, 2024

Three large pharma companies plan to expand their manufacturing footprints. Three large pharma companies plan to expand their manufacturing footprints. BeiGene’s PD-1 inhibitor finally crossed the FDA finish line after a 20-month delay. Kyowa Kirin’s $4.25 million gene therapy set a new world pricing record. Kyowa Kirin’s $4.25

Pharma

Pharma Manufacturing FDA

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

MedCity News

MARCH 22, 2024

FDA approval of Italfarmaco’s Duvyzat is the first nonsteroidal drug to pass the agency’s regulatory bar for treating this rare disease. Corticosteroids are a standard first-line treatment for Duchenne muscular dystrophy, but these drugs have many side effects.

Side effects

Side effects FDA Patients Biopharma

Gene Therapy Is Now First FDA-Approved Treatment for Rare & Fatal CNS Disorder

MedCity News

MARCH 18, 2024

Orchard Therapeutics gene therapy Lenmeldy won FDA approval for treating the rare enzyme deficiency metachromatic leukodystrophy. In January, Kyowa Kirin completed its acquisition of Orchard, which now operates as a subsidiary of the Japanese drugmaker.

FDA

FDA Biopharma Pharma

Pharma Rep Focus

Sat.Mar 16, 2024 - Fri.Mar 22, 2024

Fierce Pharma Asia—Plant expansions at Novo, Novartis, Merck KGaA; Kyowa Kirin's pricing record; BeiGene's PD-1 nod

FDA Nod in Duchenne Helps Wider Swath of Patients With the Rare Muscle Disease

Gene Therapy Is Now First FDA-Approved Treatment for Rare & Fatal CNS Disorder

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