All news

FDA unanimously shuts down Nektar’s opioid painkiller

16-Jan-2020 By Ben Hargreaves

The US FDA’s advisory committee voted 27-0 against recommending approval of oxycodegol, with Nektar deciding to withdraw its application as a result.

PharmaMar to supply Jazz with drug product under $1bn deal

16-Jan-2020 By Nick Taylor

PharmaMar set to supply Jazz Pharmaceuticals with cancer drug from two sites under terms of $1bn deal.

Sterling expects further HPAPI demand, looks for buy-out opportunities

15-Jan-2020 By Vassia Barba

Sterling continues expansion and lines up further acquisitions, as the HPAPI market continues to see increasing demand, a company executive says.

Alcami sells Dutch API facility to MercachemSyncom

14-Jan-2020 By Ben Hargreaves

Alcami downsizes in Europe through the sale of its API facility to MercachemSyncom, as it expands its presence in North America.

ANI picks up US generics portfolio of Amerigen

13-Jan-2020 By Ben Hargreaves

ANI acquires the 23 generic products from Amerigen to expand its commercial offering in the US.

Lab urges FDA to suspend ranitidine sales due to degradation risk

13-Jan-2020 By Nick Taylor

Emery Pharma files citizen petition arguing data on the degradation of ranitidine supports suspension of the medicine.

Hikma, Arecor partner on Arestat formulation technology

13-Jan-2020 By Vassia Barba

Hikma taps Arestat, a formulation technology for protein- and peptide-based drugs, to develop an injectable medicine, ahead of filing for US FDA approval.

One in, one out: Esteve pivots to specialty products

09-Jan-2020 By Ben Hargreaves

Esteve announces that it will acquire Riemser, two weeks after it revealed that it would be divesting its generics division.

Mylan recalls close-to-expiration nizatidine capsules over NDMA impurity

09-Jan-2020 By Ben Hargreaves

The recall of products due to NDMA contamination continues, with a new medication, nizatidine, now thought to be affected by the probable carcinogen.

Prices of nearly 500 drugs increased in 2020

08-Jan-2020 By Vassia Barba

Nearly 500 prescription drugs will become more costly in 2020, as drugmakers proceed with prices increases averaging 5%, 3 Axis Advisors says.

NEWS IN BRIEF

Aurobindo recalls depression treatment over mislabeled strength

06-Jan-2020 By Ben Hargreaves

Aurobindo announces a voluntary recall of mirtazapine tablets after bottles of tablets marked as 7.5mg were found to potentially contain 15mg tablets.

FDA greenlights first generics of blood thinner

06-Jan-2020 By Vassia Barba

Mylan and Micro Labs receive US FDA approval for two generic versions of Pfizer and BMS’ Eliquis, marking the first generic approvals of direct oral anticoagulants.

FDA rejects ViiV HIV drug on CMC grounds

06-Jan-2020 By Nick Taylor

GSK and Pfizer joint venture suffers regulatory rejection after US FDA finds fault with filing.

FDA blames fall in foreign inspections on investigator shortage

18-Dec-2019 By Nick Taylor

The US FDA attributes decline in foreign inspections from 2016 to 2018 to inability to fill vacancies.

Catalent to formulate CBD multiple sclerosis treatment with Zydis

16-Dec-2019 By Vassia Barba

Catalent enters partnership with Ethicann on Zydis technology to formulate CBD and THC combination treatment for muscular spasticity.