Medicare’s current approach to inpatient CAR-T reimbursement in 2019 would lead to an $186,500 shortfall for providers per patient, stakeholders estimate.

Agency seeks input on types of investigations that would involve minimal risk, exclusion of waiver to research involving identifiable private information.

Gilead’s authorized generics for Epclusa and Harvoni will be first alternatives to benefit from preferred coverage on the pharmacy benefit manager's National Preferred Flex Formulary.

The Scottish Medicines Consortium has recommended EUSA’s ultra-orphan neuroblastoma treatment Qarziba.

Public session to gather input on taxonomy and scientific criteria for qualifying animal models, biomarkers and clinical outcome assessments is early step toward satisfying 21st Century Cures Act requirements and PDUFA VI commitments.

Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.

Company needs to get beyond a supply problem for products including iconic Bayer Aspirin brand and heat up Coppertone sun care and sunscreen product sales with line extensions to help drive the consumer health business to heights envisioned as part of an expansion a few years ago.

Prestige Consumer's sales in its latest quarter were lifted by gas relief and ear wax products, but the gains were offset "revenue recognition" accounting changes and slower sales of BC and Goody's as supplies of the analgesics transitioned to new packaging.

AstraZeneca’s Lokelma and Vifor’s Veltassa will be subject to a final review by the England and Wales health technology appraisal body in December following draft guidance not recommending their use in the National Health Service to treat hyperkalemia.

US FDA official advises that to avoid the “brick wall” of BLA rejection, manufacturers should characterize their cell and gene therapy products and develop potency assays as early as possible.

US FDA expects the New Inspection Protocol Project (NIPP) it launched Nov. 9 to increase the consistency of its sterile manufacturing inspections – and the ability of those inspections to catch quality problems before they could lead to drug shortages.

Australian and Canadian drug regulators have extended their mutual recognition agreement on good manufacturing practice inspection and certification to include active pharmaceutical ingredients.

Company needs to get beyond a supply problem for products including iconic Bayer Aspirin brand and heat up Coppertone sun care and sunscreen product sales with line extensions to help drive the consumer health business to heights envisioned as part of an expansion a few years ago.

Amphastar has initial inventory on hand of epinephrine inhalation aerosol reformulated with hydrofluoroalkane as a propellant, and expects "almost no costs" for sales of first several hundred thousand units. After two NDAs and two CRLs, firm convinces US FDA consumers can use the product without doctor or pharmacist guidance and understand it is not for ongoing asthma treatment.

Providing self-care products "opens this organization up to massive opportunity" which Perrigo will identify in early 2019, says new CEO Murray Kessler. It remains committed to selling or spinning off its Rx unit, though it's "just a few FDA approvals away from significantly" growing, he says as firm reports $68m net loss in its latest quarter.