Contract Manufacturing FDA Approval Regulation Sales 
pharmaphorum
DECEMBER 18, 2020
GlaxoSmithKline’s Benlysta has been on the market for almost a decade, but it still has some tricks up its sleeve – it’s just become the first and only FDA-approved treatment for lupus nephritis. Approval in lupus nephritis is expected to push the product above the $1 billion threshold and into blockbuster sales territory.
pharmaphorum
NOVEMBER 18, 2022
At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.
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pharmaphorum
JUNE 2, 2021
Capacity to supply Moderna’s COVID-19 vaccine in Europe could be swelled by round 300 million doses a year, following an agreement to set up a new production line at contract manufacturer Lonza. Full approval means it could be used routinely in future as an annual booster, much like the seasonal influenza vaccine.
Pharmaceutical Technology
JULY 4, 2022
Companies that own Russian pharma contract manufacturing or supply chain sites include Novo Nordisk (Bagsvaerd, Denmark); UPS (Atlanta, Georgia, US) subsidiary Marken (London, UK); Thermo Fisher Scientific (Waltham, Massachusetts) subsidiary Patheon (Durham, North Carolina); Servier (Paris, France); and Takeda (Tokyo, Japan).
Camargo
FEBRUARY 4, 2021
Pfizer’s Xalkori (crizotinib) was approved in 2011 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer that is anaplastic lymphoma kinase (ALK)-positive. Report Shows that Most Drugs Fall Short of Sales Forecasts. Camargo has extensive experience in assisting clients navigate these challenges.
The Pharma Data
JANUARY 5, 2021
In addition, Radius may pay sales-based milestone payments and a tiered, high single-digit effective royalty. based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C.
pharmaphorum
APRIL 6, 2021
The mix-up at the facility operated by contract manufacturer Emergent BioSolutions resulted in ingredients destined for AZ’s AZD1222 jab being mixed into vials of the J&J product , rendering them unusable, according to media reports. The US has had more than 31 million cases of COVID-19, with deaths approaching 570,000.
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