HDA calls for withdrawal of FDA’s latest DSCSA guidance on the ‘enhanced drug distribution system’
FDA’s recommended guidance is for a system that ‘does not exist, cannot be built by 2023, and poses unacceptable security and compliance risks,’ says alliance
Report: BioNTech to seek vaccine approval for 5 to 11-year-olds over the ‘next few weeks’
Biotech firm to file regulatory dossier with officials around the world
Olon to expand Settimo Torinese location, as company adds protein production to repertoire
CDMO’s objective is to cater to various market segments in order to meet microbial bio-manufactured compound demand
Adaptimmune Therapeutics, Genentech partner up to support allogeneic cell therapy development and commercialization
Collaboration earns Adaptimmune an initial payday of $150 million
USAntibiotics reopens Tennessee production facility
After previously going bankrupt, center is now under US ownership for the first time
Japan to purchase 150 million doses of Novavax’s Covid vaccine
Supply deal with Takeda to begin distribution in early 2022, pending shot approval
AstraZeneca, EU reach Covid vaccine supply settlement
Drug maker to supply European Union with 60 million doses by end of Q3
IQVIA unveils contact center powered by AI
Objective is to provide efficiency for analytics company’s medical information department
New CDMO, ten23 health, joins the biopharma industry
Swiss organization will take patient-centric approach towards developing injectables
BioNTech plans to launch mRNA vaccine manufacturing in Africa
Company’s prospective malaria and tuberculosis doses will be developed in Rwanda, Senegal
BioDuro-Sundia acquires drug product manufacturing facility
Irvine, CA, location will house 40,000 square feet of oral solid dosage forms
Cipla, Kemwell ink biosimilars joint venture
Agreement will focus on developing, manufacturing and commercializing biosimilars in the respiratory space
SkyCell expands customer base, partners with Japan's All Nippon Airways
Meeting future expectations in pharmaceutical sustainability a key component of shipping collaboration
Quotient Sciences invests in new drug substance manufacturing facility
Project will center on equipment and technology improvements, says UK R&D and manufacturing accelerator
Indegene boosts its pricing, reimbursement and access foothold
Healthcare tech company acquires Medical Marketing Economics, a provider of value-based strategy support
People spotlight — August 2021
The latest people news happenings over the past month
Roche, Shape Therapeutics ink RNA-editing pact
Gene therapy tech collaboration will target treatment development for Alzheimer's, Parkinson's and rare diseases
Cardinal Health partners with NRx for distribution of Covid therapy
Wholesaler's 3PL arm to provide logistics and distribution support to potential emergency use drug for patients with critical Covid with respiratory failure
UPS Flight Forward forges ahead with drone delivery of Covid-19 vaccine
Program expands an ongoing effort at Wake Forest
Lonza adding new fill-finish line at its biologics manufacturing site in China
Swiss CDMO’s expansion at recently opened Guangzhou plant expected to be ready by next year
Evaluate Pharma predicts a $981-billion global pharma market for 2021, up 14.3%
CAGR growth through 2026 will be 6.4% per year
Pack4U acquires virtual pharmacist services firm
Deal for CHC Health adds depth, scale and expanded clinical expertise in health outcomes pursuits
AGC Biologics begins construction of new facility in Denmark
Venture anticipated to more than double single-use bioreactor mammalian cell-culture capacity on site
FDA officially approves nation’s first Covid-19 vaccine
Agency hopes Pfizer-BioNTech jab approval will convince some in public to get vaccinated
Curia to bolster local commercial manufacturing capabilities
CDMO's expansion of Rensselaer, NY, facility will help grow its API division
AmerisourceBergen expands manufacturer rolodex, purchases FirstView Financial
Acquisition addresses the need for meeting healthcare sector’s patient support demand
Amid mRNA raw materials bottleneck, Biotage opens new UK production facility
Cardiff center will help produce lipids that are necessary for mRNA Covid vaccines
Syngene grows biopharma manufacturing capabilities
Developments include the creation of a new microbial facility, expansion of mammalian center
Recro lands IRISYS in CDMO acquisition
Deal allows for bicoastal expansion of pharmaceutical services
Biden highlights drug pricing reforms to advance legislative agenda
Plan aims to offset costs associated with proposed social and health initiatives
