Zydus is looking to launch a Revlimid generic in the second wave while an opportunity might soon emerge from Takeda’s Pentasa. It is also pivoting to a multivariant version of its plasmid DNA vaccine against COVID-19, ZyCoV-D, after the original didn’t receive an encouraging response.

Centrient has celebrated passing a “significant milestone in the clean production of antibiotics” after meeting Predicted No Effect Concentration discharge targets set by the AMR Industry Alliance across its entire oral antibiotics product range.

Amneal has celebrated its third US biosimilar approval of 2022 with an FDA nod for its Fylnetra (pegfilgrastim-pbbk) rival to Neulasta, as the firm makes launch preparations for all three products across the second half of the year.

Teva has struck a further cash-and-medicines settlement agreement to resolve opioid-related claims in the US. A bench trial had been due to start in West Virginia by the end of this month, where Teva is to pay $75m over 15 years plus generic Narcan.

Italy’s Olon has announced a €10m investment in a new R&D hub in Rodano, Milan, that the active pharmaceutical ingredient specialist says will help to consolidate its expertise and connect its worldwide network of 11 facilities.

Chinese player Shanghai Henlius Biotech has out licensed semi-exclusive rights to some of its biosimilars in Brazil again, shortly after signing a major deal covering 16 Latin American countries.

The EMA’s CHMP has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

Pharmacy benefit managers often fail to encourage the use of generic and biosimilar medications and in fact undermine patient access to these more affordable drugs, the Association for Accessible Medicines has told the US Federal Trade Commission.

French off-patent industry association Gemme has welcomed the entry into force of biosimilar substitution – but has protested against recent and ongoing price cuts for small-molecule generics in the context of unprecedented cost pressures.

ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.

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.

The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.

One Copaxone (glatiramer acetate) ANDA sponsor is suing another for alleged patent infringement, with Momenta filing a lawsuit against Viatris and its partners in a US district court.

The EMA’s CHMP has recommended the suspension of marketing authorizations for around 100 generics after identifying “irregularities” in how bioequivalence studies were conducted by Synchron Research Services.

Pharmacy benefit managers often fail to encourage the use of generic and biosimilar medications and in fact undermine patient access to these more affordable drugs, the Association for Accessible Medicines has told the US Federal Trade Commission.

Amneal has celebrated its third US biosimilar approval of 2022 with an FDA nod for its Fylnetra (pegfilgrastim-pbbk) rival to Neulasta, as the firm makes launch preparations for all three products across the second half of the year.

Pharmacy benefit managers often fail to encourage the use of generic and biosimilar medications and in fact undermine patient access to these more affordable drugs, the Association for Accessible Medicines has told the US Federal Trade Commission.

Chinese player Shanghai Henlius Biotech has out licensed semi-exclusive rights to some of its biosimilars in Brazil again, shortly after signing a major deal covering 16 Latin American countries.

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.

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.

Accord Healthcare has struck a European licensing deal with Myovant Sciences for its Orgovyx (relugolix) treatment for advanced hormone-sensitive prostate cancer. The move comes shortly after sister company Accord Biopharma launched the Camcevi (leuprolide) prostate cancer treatment in the US.