The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations
Aiming to encourage entry of generic drugs on the market, the US FDA published a finalized guidance that regulates processes for relevant designations and expedited approvals.
Amneal announces acquisition of 65.1% majority interest of generics distributing company, AvKARE, boosting its presence in the generics and federal healthcare market.
US FDA updates Mylan’s ANDA to commercialize a generic of Lilly’s Alimta with a tentative approval, putting the company on course to enter the market in 2022.
'Oncology Repurposing Engine' uses artificial intelligence to identify potential drug candidates among generics and off-patent drugs that may be repurposed as cancer therapies.
Xellia will move US production from its North Carolina manufacturing facility to its site in Ohio to bolster workforce and manufacture generic IV antibiotics.
As generic competition looms, Gilead donates 2.4 million bottles of Truvada to the CDC to aid in the center’s fight against the HIV epidemic in the US.
US FDA issues draft guidance for its competitive generic therapies pathway, providing drugmakers with clarity on the designation and calling on the industry for more generic competition.
Clinigen’s newly announced business, Clinical Trial Service, will establish an on-demand supply chain for clinical trials and extends agreement with its partner Accord.
In Novartis’ latest restructuring move for 2018, the pharma giant announced plans to sell US generic oral solids and dermatology businesses to Aurobindo Pharma US.
Many generic drugs are not truly bioequivalent to the original medicines they copy and switching to them can lead to worse patient outcomes, according to US researchers.
A study in the Journal of the American Medical Association (JAMA) claiming there is no evidence that brandname cardiovascular drugs are superior to their generic counterparts, despite claims to the contrary.
The Food and Drug Administration are set to introduce a series of
measures that will accelerate the review process for generic drugs,
placing a priority on therapies that would address a public health
emergency or nationwide shortage.
US consumers could have saved $20 billion (€16.6 billion) in 2004
and even more could be saved in future years by using more generic
drugs, according to a new report by Express Scripts.
The pharmaceutical industry is facing the possibility of earlier
generic competition for its branded products from 18 August, when
new legislation in the USA comes into effect.
