pharmaphorum

OCTOBER 26, 2022

The first patient has already been enrolled into its FIBRONEER phase 3 programme for BI 1015550, which already has a breakthrough designation from the FDA after a positive phase 2 trial showed improved lung function in patients with IPF over a 12-week period.

Recruitment 92

Recruitment Prospecting Marketing Patients 92

pharmaphorum

OCTOBER 3, 2022

One of a group of muscular dystrophies, DMD leads to a gradual loss of muscle function, often with children having to use a wheelchair by their early adolescence. Translarna has had European approval for usage since 2014 and has also been available under terms similar to the MAA to DMD patients in Scotland since 2021.

Patients 80

Patients Medicine FDA Management 80

Pharmaceutical Technology

JANUARY 23, 2023

However, this progress is not reflected with respect to approved treatments for paediatric IBD patients. Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients.

Medical 59

Medical Ethics Specialization Physicians 59

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. What are the most promising microbiome therapeutics in clinical development?

Food and Drug Administration 96

Food and Drug Administration Manufacturing Medicine Pharma 96

Pharmaceutical Technology

SEPTEMBER 5, 2022

On 23 August, at a Reuters Newsmakers online forum, Soriot announced his interest in increasing AstraZeneca’s portfolio of bolt-on acquisitions leading up to 2025. The FDA has granted the drug an orphan drug designation, and Phase III trials with eplontersen were completed In June. In 2019, AstraZeneca entered a $6.9

FDA 114

FDA Pharmaceutical Biopharma Pharma 114

European Pharmaceutical Review

JULY 13, 2023

1,2 Moreover, except for countries such as Czechia, Denmark and Germany, the cost of these medications is borne by the patient, rather than national insurance or healthcare systems. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).

Medical 83

Medical Food and Drug Administration Pharmacology Medicine 83

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. ng/day, compared to EMA which is 18 ng/day.

Pharmaceutical 94

Pharmaceutical Food and Drug Administration Medicine FDA 94

pharmaphorum

AUGUST 19, 2022

The study met its primary and secondary efficacy objectives, according to CSL’s head of R&D Dr Bill Mezzanotte, who said the “underscore our belief that garadacimab has the potential to become a transformative first-in-class therapy for people living with HAE, a patient group that CSL has been serving for many years.”

Sales 52

Sales Pharma Patients Medicine 52

pharmaphorum

NOVEMBER 16, 2022

has announced that its platinum-resistant ovarian cancer drug ELAHERE (mirvetuximab soravtansine-gynx) has been granted FDA accelerated approval. RxDx Assay – Roche’s immunohistochemistry (IHC) companion diagnostic for identifying ovarian patients eligible for ELAHERE – has been contemporaneously approved by the FDA.

FDA 67

FDA Patients Safety Medicine 67

Pharmaceutical Technology

NOVEMBER 22, 2022

The company began formulating ERVEBO™ in 2014 while the Ebola Virus Disease (EVD) epidemic raged in West Africa. The live attenuated vaccine was authorized by the EMA and FDA five years later in 2019 — half the time than normal. Before COVID-19, Merck held the record for the fastest modern vaccine ever developed.

Manufacturing 52

Manufacturing Government FDA Safety 52

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. We can see a future where millions of patients no longer carry the burden of regular injections.”

Food and Drug Administration 87

Food and Drug Administration Manufacturing Safety Pharmaceutical 87

Evolve Your Success

JANUARY 23, 2024

In the changing balance between innovation and tradition, medical sales succeeds with personal connection, persistence, and the commitment to link technology and patient care. That’s what they sold to that patient and committed to. Honestly, as a patient myself, that’s a good thing. It’s the reproducibility.

Medical sales 52

Medical sales Medical Sales Physicians 52

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Previously, the standard of care for obesity consisted of holistic changes to diet, exercise, and bariatric surgery for eligible patients. Novo Nordisk is another company leading the charge in this field.

Medical 105

Medical Manufacturing Insurance Side effects 105

Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. Previously, the standard of care for obesity consisted of holistic changes to diet, exercise, and bariatric surgery for eligible patients. Novo Nordisk is another company leading the charge in this field.

Medical 98

Medical Manufacturing Insurance Side effects 98

Pharmaceutical Technology

FEBRUARY 6, 2023

Leading up to 2023, experts have said a company’s financial wellbeing may depend on its economic position when the market shifted. The FDA approved both drugs in 2014. On February 2, the FDA cleared an Investigational New Drug Application for PLN-101095. Bexotegrast is an oral small molecule that inhibits αvβ6/αvβ1.

Marketing 59

Marketing Pharmaceutical FDA Prospecting 59