2022 Drug Development Pharmaceutical Manufacturing 
Drug Patent Watch
DECEMBER 30, 2024
The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. New Drug Application (NDA) : Needed for marketing approval of new drugs. Abbreviated New Drug Application (ANDA) : Required for marketing approval of generic drugs.
Express Pharma
APRIL 8, 2025
To address growing demand from the pharmaceutical industry, Asahi Kasei has launched a new division, Asahi Kasei Life Science, effective from 1 April 2025. The new structure is designed to unify its bioprocess businesses and streamline services offered to pharmaceutical partners across drug development and manufacturing.
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Express Pharma
JANUARY 17, 2025
Carbon contributing factors: The mitigating factors throughout the drug development process The carbon-contributing factors in the production and distribution of Capsugel capsules at Lonza can be categorised into three main areas: upstream, operational, and downstream activities.
Pharmacy Times
JUNE 23, 2025
CMS is issuing unique J-codes for 505(b)(2) drugs, classifying them as sole-source products if not therapeutically equivalent. This pathway reduces submission denial risk, accelerates drug development, and offers potential market exclusivity for up to 7 years. If it’s a sole-source drug, it gets its own unique J-code.
FDA Law Blog: Biosimilars
JANUARY 16, 2025
Richardson, who focuses her practice on state and federal regulatory strategy and compliance, primarily for pharmaceutical manufacturers and wholesale distributors, has been with the firm 7 years and has proven herself invaluable to colleagues and clients alike. Kalie is the quintessential HPM lawyer.
pharmaphorum
AUGUST 6, 2025
Skip to main content Wednesday 6 August 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views (..)
Pharmaceutical Technology
DECEMBER 6, 2022
Despite the current emphasis on biologic medicines, small molecule drugs still dominate the pharmaceutical manufacturing world. Within the small molecule landscape, several trends are shaping the industry’s future, one of the most notable being the rise of high-potency active pharmaceutical ingredients (HPAPIs).
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