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President Trump mentioned that the White House was writing an executive order to require pharma companies to offer the U.S. government lower prices — but did not elaborate on details.
There is a flourishing biosimilar industry in Latin America, with its own research, development, production and commercialization capacity.
Amicus Therapeutics has found CDMO partners to manufacture its gene therapies.
According to the Competition Commission in South Africa, the deal was not likely to reduce competition.
The drugs is the only prescription treatment approved by the FDA for both signs and symptoms of dry eye disease, with a mechanism of action that targets inflammation.
A wave of incoming anti-inflammatories and gene therapies that could make it big
It’s important to consider how product drift will impact biosimilars
Lonza has been looking for a way to more efficiently fill-and-finish its injectable drugs and has found a solution by buying a Novartis bottling plant.
Pfizer has announced the successful completion of its acquisition of the privately held clinical-stage biotechnology company, Therachon Holding.
UBiome’s interim CEO, John Rakow, who took over in the wake of a Federal Bureau of Investigation's search of the startup’s San Francisco offices in late April, has left the company.
FDA looks to improve transparency and predictability for generic drug applicants.
Quality & Compliance: “Flawless” may not exist on the plant floor, but reviewing your quality process can save money and lives.
Amgen and Belgian partners at UCB announced that the EMA has adopted a negative opinion on Evenity, for the treatment of osteoporosis in men and in postmenopausal women at increased risk of fracture.
Automation & Control: Single-use technologies offer multiple benefits for those who can overcome instrumentation challenges.
Biosimilar commercialization challenges, real-world tips for updating aging facilities and a deep dive into interchangeability guidance.
How those in the outsourcing sector can be more prepared to meet shifting customer demands as the industry continues to evolve.
Critics have taken aim at Novartis for its ties to a company that bought APIs in Syria that could have been used to make chemical weapons.
The FDA has given Dupixent the go-ahead as a treatment for nasal polyps.
A Q&A about the FDA DSCSA Pilot Program Pilot
The newly combined company will be led by Abbvie chairman and CEO Richard Gonzalez.
The warning letter is the result of an inspection of the company’s Somerset, New Jersey-based plant in July and August 2018.
CPhI N. America's keynote speaker explains what bipartisan bickering means for pharma
Eliminating siloed systems in favor of streamlined applications allows for greater agility and stronger collaboration, enabling pharma to meet the new quality management demands
Shared pursuits might lead to bigger rewards