Generics

Lupin has agreed a “long-term strategic alliance” with CDMO PolyPeptide that the firm says will bolster its supply chain for peptide APIs.

The UK generics market risks becoming unsustainable as prices hit “rock bottom,” the House of Lords has been warned in a letter signed by multiple stakeholder associations including Medicines UK.

Generics Bulletin reviews global regulatory developments across the world.

Unified Patent Court ruling removes legal overhang on cabazitaxel generics already on the European market.

UK liquids specialist Rosemont Pharmaceuticals has named industry veteran Alok Sonig as its new CEO, as the firm continues to set its sights on the US market. Meanwhile, Rosemont has also appointed Gavin Wood as chief financial officer.

Civica has been cleared to supply essential generic medicines across the US veterans health system under a federal supply schedule agreement.

After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.

After multiple warning letter campaigns, the US FTC has claimed a win as Teva’s request to remove hundreds of Orange Book patent listings will pave a generic competition path for more than 30 products.

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.

“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 US FDA has delivered its December batch of product-specific guidances for generic development, marking only the second timely release of the year.

Delaware district court refuses to shorten 30-month stay, leaving Hopewell unable to launch its generic Mavenclad product.

Cuban argues that user fees under the GDUFA program are deterring domestic production of generics, according to reports.

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.

A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.

The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.

EPO Appeal Board overturns earlier ruling and invalidates Biogen’s 480mg Tecfidera patent, clearing the way for broader dimethyl fumarate competition in Europe.

ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.