pharmaphorum

APRIL 20, 2021

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year. billion by 2028.

Hospitals 111

Hospitals Documentation 111

pharmaphorum

AUGUST 17, 2020

In this article Joanna Carlish, managing director of financial services at Tag Americas , and Robb DeFilippis, Tag Americas’ managing director, life sciences, go head-to-head to discuss marketing within a regulated industry. How are regulated industries approaching the personalisation, or even hyper-personalisation, of content?

Communication 84

Communication Packaging Pharmaceutical Companies Pharmaceutical Companies 84

pharmaphorum

MAY 17, 2021

There had been speculation that the FDA might approve Empaveli (pegcetacoplan) only as a backup option for patients who don’t see a sufficient benefit with Alexion’s Soliris (eculizumab) or Ultomiris (ravulizumab), but the regulator opted for a broad indication that included first-line treatment for PNH. billion and $1.1

Labelling 52

Labelling Vaccines 52

pharmaphorum

JUNE 2, 2022

R&D into orphan drugs is growing alongside the number of approved treatments, providing treatments for rare diseases that previously did not have any. This is why the action by the US in 1983 and subsequently the European Commission Regulation No. It is estimated that between 3.5 The price is right.

Compounding 52

Compounding Pharmaceutical Companies Pharmaceutical Companies Drug Pricing 52

pharmaphorum

SEPTEMBER 15, 2020

Pharma’s go-to-market strategies have tended to be more traditional than those seen in non-regulated sectors, but there are some signs this is changing, with an acceleration in the pace of change forced by the COVID-19 pandemic that is allowing the industry to close its gap with faster, more nimble consumer brands. Jeremy Richter, Tag.

Communication 111

Communication Documentation Labelling Vaccines 111

RX Note

NOVEMBER 13, 2023

Regulated by Companies Commission of Malaysia ("Suruhanjaya Syarikat Malaysia", SSM). Name tag with the word "Pharmacist". A separate, safe and locked cabinet should be used for storage of psychotropic substances and dangerous drugs. Non-pharmacy products, e.g. gift items, cards and drinks should be minimised.

Community Pharmacies 52

Community Pharmacies Health and Personal Care Stores Documentation Independent Pharmacies 52

Pharmaceutical Technology

APRIL 5, 2023

More than a decade after the first patient was treated with a CAR-T therapy, six therapies relying on the same principles have been approved by the US Food and Drug Administration (FDA) and marketed to thousands of patients. AZ: How can regulators ensure that they nurture future innovations in the field? One challenge is in potency.

Immunity 59

Immunity Immunization 59

pharmaphorum

AUGUST 26, 2022

BioMarin will no doubt have an eye on the earlier experience of bluebird bio, which secured EU approval for rare disease gene therapy Zynteglo (betibeglogene autotemcel) in 2019 for beta thalassaemia with a price tag of around €1.6 million spread over five years.

111

111

European Pharmaceutical Review

MAY 11, 2023

Three SMN-enhancing treatments for the condition are approved by the US Food and Drug Administration (FDA) 2 , however there is no cure for SMA at present. 1 This is assuming a $1M price tag for all gene therapies. This is often called an ‘SMN-based’ or ‘SMN-enhancing’ approach. Stakeholder education is critical to achieving this.

Drug Development 70

Drug Development 70

Viseven

SEPTEMBER 14, 2023

The procurement cycle presupposes all decisions related to selecting suppliers and monitoring drug delivery and distribution. It typically falls into the following steps: Reviewing drug selections. Determining drug quantities. Receiving and checking drugs. Aligning needs with the budget. Selecting a procurement method.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Dosage 52

pharmaphorum

SEPTEMBER 30, 2022

The traceability of components is critical for authoring structured content correctly, especially when it comes to fulfilling compliance regulations. While a single document might only be re-used a couple of times, if at all, components of that document might be re-used a hundred times across multiple applications.

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies Pharmaceutical Manufacturing 52

Express Pharma

SEPTEMBER 11, 2023

This is shown recently when the National Medical Commission decided to put on hold its August 8 rule mandating doctors to prescribe only generic drugs. Though these one-sided pro-industry policies led to the creation of a strong base of around 11,000 pharma units in the country, it happened at the cost of lax regulation on the industry.

Generic Medicine 69

Generic Medicine Diabetes Immunity Immunization 69

European Pharmaceutical Review

DECEMBER 27, 2023

Chimeric antigen receptor (CAR) T cells are the first example of a “living drug”. Being a cellular therapy that involves cell manipulation and molecular transfection – and above all, being a living drug – makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture in‑house. US Food and Drug Administration.

Adverse Reactions 83

Adverse Reactions Immunity Immunization Medical Schools 83