European Pharmaceutical Review

AUGUST 8, 2023

Tom Keith-Roach, President of AstraZeneca UK announced: “We are pleased that the SMC has now accepted Forxiga (dapagliflozin) for use in patients with chronic heart failure with preserved or mildly reduced ejection fraction and Tezspire (tezepelumab) has been accepted for restricted use in severe asthma within NHS Scotland.”

Medicine 85

Medicine Patients Pharmaceutical 85

Pharmacy Times

MARCH 15, 2024

The study showed no clinical differences for remission or asthma at age 28 years based on lung function, body mass index, daily smoking, exposure to parental tobacco smoke, or house dampness.

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pharmaphorum

AUGUST 12, 2022

Patient recruitment specialist Clariness will deploy an app aimed at helping asthma patients monitor environment triggers and report symptoms in the clinical trials its support, thanks to a partnership with digital health firm DailyBreath.

Recruitment 52

Recruitment Patients Doctors Medical 52

Pharmaceutical Technology

JUNE 9, 2023

Clinical-stage biotech company Upstream Bio has raised $200m in a Series B financing round to advance its UPB-101 to treat allergic and inflammatory diseases. Upstream Bio will use the funds to advance its UPB-101 into Phase II trials to treat asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).

Healthcare 59

Healthcare Healthcare FDA Management 59

pharmaphorum

JANUARY 12, 2023

Airsupra (PT027), a new asthma rescue treatment developed by AstraZeneca (AZ) and development partner Avillion, has been approved by the US Food and Drug Administration (FDA). An estimated 136 million asthma exacerbations occur globally each year, 10 million of those in the US.

FDA 52

FDA Food and Drug Administration Medical Patients 52

European Pharmaceutical Review

NOVEMBER 21, 2023

If successful this could lead to regulatory submissions in 2025, supporting the health of asthma and COPD patients and making a significant positive impact on our transition to a more environmentally sustainable future,” GSK’s Chief Executive Officer, Emma Walmsley commented.

Manufacturing 109

Manufacturing Patients Pharma Leads 109

pharmaphorum

NOVEMBER 16, 2022

There’s plenty in the pipeline to entice a potential buyer, however, including several mid-stage clinical candidates, such as EPO inhibitor LKA651 for diabetic retinopathy, Factor B inhibitor iptacopan for AMD, and gene therapy PPY988 for geographic atrophy. Novartis has said it will not comment on market speculation.

Sales 117

Sales Prescription Medicine Media 117

Pharmaceutical Technology

NOVEMBER 18, 2023

Rilzabrutinib is under clinical development by Principia Biopharma and currently in Phase II for Asthma.

Biopharma 40

Biopharma 40

pharmaphorum

NOVEMBER 9, 2022

AstraZeneca has moved a step closer to bringing a first-in-class drug to market in the US that can be used to reduce severe asthma attacks, after an FDA advisory committee voted in favour of approval. The post FDA panel backs AZ’s PT027 asthma rescue drug, but in adults only appeared first on.

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FDA Patients Marketing Sales 59

Pharmaceutical Technology

FEBRUARY 24, 2023

Amlitelimab is under clinical development by Kymab and currently in Phase II for Asthma. According to GlobalData, Phase II drugs for Asthma have a 27% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. It is administered through intravenous and subcutaneous routes as an infusion.

Pharmaceutical 40

Pharmaceutical 40

Pharmaceutical Technology

SEPTEMBER 5, 2022

An example of AstraZeneca’s deals in the cardiovascular disease clinical landscape is its agreement with US-based Dogma Therapeutics. The company currently has five Phase III clinical trials in progress for respiratory diseases that aim to target conditions such as asthma and COPD.

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FDA Pharmaceutical Biopharma Pharma 114

pharmaphorum

NOVEMBER 25, 2022

Case study: severe asthma. Some years ago, as new biologic treatments for severe, uncontrolled asthma were in development, and specific patient groups were being proposed for these treatments based upon blood eosinophil (EOS) counts. Therefore, start at the point the data allows – usually, prevalence per 100,000.

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Marketing Consulting Patients Sales 114

European Pharmaceutical Review

DECEMBER 20, 2023

FDA’s priory review was based on positive results from an ongoing Phase III trial, sponsored by the US National Institutes of Health (NIH)” FDA’s priory review was based on positive results from an ongoing Phase III clinical trial, OUtMATCH, sponsored by the US National Institutes of Health (NIH).

Food 96

Food Food and Drug Administration FDA Patients 96

pharmaphorum

NOVEMBER 14, 2022

Dupixent was cleared by the US FDA for adults with PN in September, making it an option for an estimated 75,000 patients with the condition, and adding to the drug’s earlier approvals in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic oesophagitis. Sales of Dupixent rocketed 45% to around $2.4

Sales 95

Sales Medicine Patients Leads 95

pharmaphorum

DECEMBER 19, 2022

It would provide an alternative to standard breathing exercises for patients with conditions that affect breathing, including long-term respiratory diseases like asthma, chronic obstructive pulmonary disorder (COPD) and cystic fibrosis, which can be resource-intensive as they require patients to be overseen by a healthcare worker.

Patients 138

Patients Engineering Government Education 138

Pharmaceutical Technology

APRIL 11, 2023

Under the FDA’s drug safety Sentinel Initiative, the partnership will develop AI tools to collect key information from clinical notes within electronic health records (EHR). During the two-year project, the companies will assess the mental health side effects of the asthma drug, montelukast.

Safety 59

Safety Food and Drug Administration FDA Side effects 59

European Pharmaceutical Review

JANUARY 31, 2023

It is the “… first and only targeted treatment option clinically proven to reduce both oesophageal inflammation and damage,” explained Dr Naimish Patel, Head of Global Development, Immunology and Inflammation at Sanofi. More than 500,000 patients have been treated with Dupixent globally.

Medicine 89

Medicine Safety Patients Pharmaceutical 89

Clarivate

AUGUST 17, 2022

In our latest podcast, Ideas to Innovation, we speak with Dr. Grace Lomax, the clinical director at Patient Connect, part of Clarivate. Dr. Grace Lomax, who co-founded Patient Connect with her sister in 2008, came up with the idea for the solution when she started asking patients in her clinic what information they wanted when and how.

Healthcare 52

Healthcare Healthcare Patients Physicians 52

pharmaphorum

OCTOBER 26, 2022

Boehringer Ingelheim has moved one of its top pipeline prospects – oral phosphodiesterase 4B (PDE4B) inhibitor BI 1015550 – into late-stage clinical testing for idiopathic pulmonary fibrosis and other interstitial lung diseases (ILDs). ” The post Seeking Ofev successor, Boehringer takes PDE4B drug into phase 3 appeared first on.

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Recruitment Prospecting Marketing Patients 90

Pharmaceutical Technology

JANUARY 30, 2023

It has already been approved in many countries worldwide for patients in different age groups with CRSwNP, atopic dermatitis, asthma, EoE or prurigo nodularis. The fully human monoclonal antibody Dupixent has been designed to block the signalling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways.

Medicine 64

Medicine Food Pharmaceutical Patients 64

Legacy MEDSearch

SEPTEMBER 7, 2023

Anil Kukreja, VP of Medical Affairs and Regulatory at AstraZeneca Pharma India, praised the FDA clearance as a milestone, highlighting alveofit’s role in optimized diagnosis and management of lung disorders such as asthma and COPD. Earlier this year, to cater to the growing U.S. market, alveofit® inaugurated its office in New York.

FDA 52

FDA Recruitment Distribution Healthcare 52

pharmaphorum

SEPTEMBER 20, 2022

According to CytoReason its platform “turns biological disease models into actionable insights that enable biotech and pharma companies to shorten clinical trial phases, reduce drug development costs, identify new opportunities and increase the likelihood of FDA drug approval.”

Pharma 52

Pharma Engineering Patients FDA 52

Pharmaceutical Technology

JULY 18, 2022

These include the ongoing clinical development of AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’ icenticaftor (QBW251). receptor antagonist indicated for the treatment of severe eosinophilic asthma, is currently being investigated in the Phase III MAHALE trial (NCT05006573).

Marketing 59

Marketing Safety Management Patients 59

Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

Side effects 64

Side effects Food and Drug Administration Safety Physicians 64

pharmaphorum

AUGUST 4, 2022

Amgen sells a biosimilar version of rituximab so Tavneos slots in alongside that therapy, and the company also gets three early clinical-stage pipeline candidates, namely an oral PD-1/PD-L1 inhibitor and two CC chemokine receptor-targeting drugs for inflammatory diseases.

Side effects 78

Side effects Pharma Sales Competition 78

Clarify Health

APRIL 1, 2021

Many healthcare and life sciences organizations recognize the impact of top social determinants of health on outcomes and cost, prompting them to invest in programs to address the non-clinical factors in patients’ lives. That is why Clarify Health has spent years creating the most SDoH-decorated dataset in the industry.

Healthcare 52

Healthcare Healthcare Transportation Patients 52

pharmaphorum

JULY 28, 2022

billion ($2 billion) – ahead of analyst expectations – driven by buoyant demand in its atopic dermatitis and severe asthma indications fuelled by approvals in earlier age groups. Sales of Dupixent (dupilumab) rocketed 43% to €1.96 The post Dupixent drives Sanofi to hike its full-year profit forecasts appeared first on.

Sales 59

Sales FDA Medicine Leads 59

Medgadget

MAY 30, 2023

Researchers at UMass Chan Medical School have developed a small interfering RNA (siRNA) technology that is stable enough for inhalation into the lungs, where it can potentially treat diseases as diverse as asthma, pulmonary fibrosis, and viral infections such as COVID-19.

Distribution 73

Distribution Recruitment Medical Medicine 73

pharmaphorum

OCTOBER 27, 2022

The Swiss biotech is seeking a priority review for vamorolone, which was licensed from US biotech ReveraGen BioPharma in 2020 after Santhera its former DMD therapy candidate idebenone failed clinical testing and was abandoned. The post Santhera seeks speedy FDA review of Duchenne drug vamorolone appeared first on.

FDA 82

FDA Side effects Biopharma Marketing 82

Legacy MEDSearch

JULY 18, 2023

“ReddyPort’s patented elbow is central to the eco-system we are building to help mitigate clinical obstacles tied to NIV therapy from dry-mouth, oral biofilm accumulation to speech recognition,” says Tony Lair, ReddyPort CEO. 7 In addition, NIV is utilized to wean patients off mechanical ventilation.

FDA 52

FDA Food and Drug Administration Recruitment Patients 52

pharmaphorum

JANUARY 24, 2023

The partnership between Sanofi and CytoReason – for an undisclosed, multimillion dollar amount – forms part of an ongoing collaboration begun in 2021, which originally focused on obtaining advanced mechanistic insights for asthma endotypes. CytoReason develops computational disease models.

Medicine 52

Medicine Media Leads Patients 52

pharmaphorum

SEPTEMBER 15, 2022

The Clinical Data Interchange Standards Consortium (CDISC) is dedicated to the improvement of medical research through data standardization. This enables regulatory reviewers to evaluate and process clinical trials more effectively. In this blog, we provide an overview of the CDISC standards used in clinical research.

Food and Drug Administration 52

Food and Drug Administration Electronics FDA Food 52

Pharmaceutical Technology

JULY 21, 2022

This includes 600,000 packs of antibiotics, painkillers, cardiovascular, and oncology treatments from Novartis, and antibiotics, asthma medication, painkillers, and essential childhood vaccines from GSK. Drug pricing and gouging.

Government 52

Government Healthcare Healthcare Pharma 52

Pharmaceutical Technology

DECEMBER 12, 2022

The successful implementation of these contracts is necessary to ensure that a newly approved drug or an investigational therapy that is ready to advance to the next pivotal stage of clinical evaluation is manufactured in a timely manner. Regulatory decisions and clinical trial news.

Manufacturing 59

Manufacturing Biopharma Pharmaceutical Pharma 59

pharmaphorum

JULY 25, 2022

Vabysmo still has a mountain to climb to catch Eylea, but Roche continues to build the clinical case for its drug reporting two-year results with the drug in wet AMD earlier this month which suggested it continued to be effective whilst cutting the number of injections into the eye needed by patients.

Medicine 71

Medicine Pharma Marketing Distribution 71

European Pharmaceutical Review

JULY 26, 2022

The CHMP gave a positive opinion for Tezspire (Tezepelumab), intended as an add-on treatment in adult and adolescent patients with severe asthma. Hybrid medicines rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

Medicine 90

Medicine Marketing Patients Safety 90

PM360

SEPTEMBER 21, 2023

COPD symptoms vary from patient to patient, Dr. Feigler says, and therefore doctors should continue to ask about each patient’s activities and lifestyle in addition to typical clinical measures to better understand if their COPD is progressing.

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Doctors Patients Education Physicians 104