Dosage Forms

Articles

C-Bridge Capital will form a new biopharmaceutical company, AffaMed Therapeutics, which will collaborate with Samsung Bioepis to accelerate clinical development and registration of Samsung Bioepis’ next-generation biosimilars in China.

Samsung Bioepis and C-Bridge Capital to Commercialize Biosimilars in China

The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs. 

USP’s Generics Access Plan to Encourage Competition

In a statement, FDA Commissioner Scott Gottlieb announced the agency’s plans to publish guidance to promote the development of complex generic drugs. 

FDA Looks to Advance Complex Generics

The US and pharmerging markets will drive growth in drug spending; number of approvals to increase.

Global Medicine Spending to Top $1.5 Trillion by 2023

Teva Pharmaceuticals and Neos Therapeutics entered into a settlement and licensing agreement to resolve all ongoing litigation involving Neos' patents protecting its Cotempla (methylphenidate) extended-release orally disintegrating tablets.

Neos Therapeutics, Teva Settle on Patent Litigation for ADHD Drug

FDA has withdrawn the proposed rule that would have allowed generic-drug makers to independently update and distribute new safety information in drug labels.

FDA Looks to Modernize Generic Drug Labels

Permission from the United Kingdom's Supreme Court has been granted to the UK BioIndustry Association, allowing it to intervene in a dosage regimen patent case.

UK Supreme Court Grants Permission to UK BioIndustry Association to Intervene in Case

Irish manufacturer of generic medicines for both human and animal health, Chanelle Pharma, has been named as Pharma Industry Company of the Year 2018.

Chanelle Pharma Named as Pharma Industry Company of the Year 2018

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

FDA Promotes Complex Generics and Combination Products

Cambrex will create a new center of excellence for API process development and clinical supply at its High Point, NC facility and expand its API manufacturing facility in Italy. 

Generic Drugs