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Sun says US FDA has issued an EIR for Dadra API plant

Sun Pharmaceutical Industries Ltd says the US FDA has issued it with an enforcement inspection report (EIR) for its facility in Dadra.

Ex-Hurricane Ophelia & Ireland-based manufacturing: Pfizer, Roche & Takeda update

Storm Ophelia hit the Green Isle this week, forcing the closure of schools, public institutions, and a number of drug manufacturing sites across the country.

Little impact on pharma biz, says hurricane hit J&J

Back-up generators and secondary manufacturing sites limited the supply and financial impact of Hurricane Maria across J&J’s Puerto Rican pharma facilities, the firm says.

'Luxturna' recommendation good for all AAV based gene therapies says advocacy group

The US approval recommendation for Spark Therapeutics’ blindness gene therapy voretigene neparvovec is also an endorsement of AAV delivery technologies according to the Alliance for Regenerative Medicine.

450 jobs to go as pricing pressures push Novartis to close CO generics plant

Around half the products made at the Broomfield facility will be discontinued or divested says Novartis, blaming increased US generics competition and customer consolidation for the closure.

BTG’s x-ray vision: Microscopic beads to target liver cancer

BTG plc is investigating the use of pre-loaded microscopic beads, which it says can be visualised on x-rays and CT scans, to treat patients with liver cancer.

Grace licenses Formac's bioavailability enhancement tech

WR Grace & Co has licensed rights to a bioavailability enhancement technology from Formac Pharmaceuticals NV.

GT Biopharma starts making carbamazepine tabets for planned trials

GT Biopharma Inc. has started making a non-opioid pain drug that uses a formulation technology licensed from Accu-Break Pharmaceuticals Inc.

EMA says impending EudraVigilance launch benefits MAHs

The European Medicines Agency (EMA) has announced it will launch an updated version of information system EudraVigilance to better monitor suspected adverse reactions to medicines.