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After years of fighting and securing treatment for her daughter, cystic fibrosis campaigner Gayle Pledger could not leave other patients behind. This is a story of families coming together and finding a generic drug manufacturer in order to save their children.
The US FDA’s approval of the first generic rival to Mayne Pharma’s Imvexxy (estradiol) comes days after the agency released product-specific guidance, which was demanded by the originator through citizen petitions.
CDER Office of Generic Drugs publishes MaPP for prescription-to-nonprescription switches and ANDAs to explain regulatory responsibilities for makers of generic copies of reference listed drugs approved for OTC switch.
Responding to the newly-agreed EU pharma package, Medicines for Europe said the deal was a limited political compromise that could have been more ambitious – particularly when it comes to access – but nevertheless represented “an important step forward” and “progress” for the EU pharma sector.
The US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.
With Richard Pazdur’s abrupt exit marking the fifth CDER leadership change in a year, the AAM is urging continuity and stability amid the ongoing turbulence.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
Cuban argues that user fees under the GDUFA program are deterring domestic production of generics, according to reports.
The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
Teva sees olanzapine LAI as key to building a schizophrenia franchise worth up to $2bn annually, following its earlier risperidone launch.
Zydus inks a new 505(b)(2) oncology deal, taking over the commercialization of RK Pharma’s undisclosed sterile injectable in the US.
European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.
“Section viii cannot function as Congress intended,” if a Federal Circuit ruling stands, the US solicitor general has argued as he urged the Supreme Court to review and reverse the closely-watched Hikma skinny-label Vascepa case.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
Delaware district court refuses to shorten 30-month stay, leaving Hopewell unable to launch its generic Mavenclad product.
A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.
