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Value-Added Medicines

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Entry Deadline Looms For GGB Awards

There is now just one week to go until the 19 August deadline for companies to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

Generic Drugs Biosimilars

What’s Next? Five Things To Look Out For In August

A busy August brings patent expiries, biosimilar target action dates and the potential for a major change to biosimilar prescribing guidelines in Germany.

Biosimilars Generic Drugs

One Month Remains To Enter GGB Awards

Just one month remains until the 19 August deadline for companies to submit entries for the Global Generics & Biosimilars Awards 2022, which returns to Frankfurt this November.

Generic Drugs Biosimilars

Following Positive IIb Study Data, Can 180 Life Sciences Clear The Next Regulatory Hurdle?

180 Life Sciences has found that adalimumab can effectively treat nodule hardness and size in Dupuytren’s disease during a Phase IIb study. But, the company’s CEO Jim Woody tells Generics Bulletin, regulators in the UK and US have requested more information before they will press on with authorization.

Regulation Biosimilars

FDA Asks Hyloris For More Data On Maxigesic IV

Hyloris has received a complete response letter from the US FDA asking for more information on its 505(b)(2) hybrid application for its Maxigesic IV intravenous analgesic for treating post-operative pain.

Value-Added Medicines United States

180 Life Sciences Adalimumab Study Publishes Positive IIb Dupuytren’s Disease Data

Adalimumab could find itself with a tenth official indication, after 180 Life Sciences found that it was able to effectively treat nodule hardness and size in Dupuytren’s disease during a phase IIb study.

Biosimilars Value-Added Medicines

What’s Next? Five Things To Look Out For In June

In June, Medicines for Europe will host its annual and legal affairs conferences in Barcelona, while on the commercial side Hikma’s CEO Siggi Olafsson is to resign from the London-listed company.

Biosimilars Generic Drugs

Stada And Calliditas Celebrate European Nod For Budesonide Hybrid

The EMA’s CHMP has issued a positive opinion for the Kinpeygo budesonide 4mg modified-release hard capsules hybrid medicine developed by Calliditas that will be marketed in Europe by Stada. Meanwhile, four generics from Accord, Fresenius Kabi, Gedeon Richter and Sun have also been endorsed by the committee.

Europe Regulation

ANI ‘On The Cusp Of A Transformation’ Following Cortrophin Launch

ANI Pharmaceuticals appeared confident about its Cortrophin gel launch and integration of Novitium Pharma as it rounded up its Q1 results, but net losses have dampened the company’s share value.

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