European Pharmaceutical Review

FEBRUARY 8, 2024

Vertex scores European cystic fibrosis medicine approval Efficacy of the vanzacaftor/tezacaftor/deutivacaftor (vanza triple) Vertex also shared that in the SKYLINE 102 and SKYLINE 103 , head-to-head against TRIKAFTA, for first key secondary endpoint, the vanza triple was found to be superior in reducing sweat chloride (SwCl) levels.

Food and Drug Administration 88

Food and Drug Administration Medicine Medical Consulting 88

European Pharmaceutical Review

SEPTEMBER 28, 2023

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), more than 600 essential medicines are at risk if a proposed restriction on the use of fluorinated substances, per- and polyfluoroalkyl substances (PFAS) across pharmaceutical manufacturing in the EEA, is implemented.

Pharmaceutical manufacturing 95

Pharmaceutical manufacturing Manufacturing Pharmaceutical Medicine 95

Medico Reach

DECEMBER 2, 2022

To bring effective medicines and Innovations in healthcare industry , a Clinical Research Organization or Contract Research Organization (CRO) are a must for the Biotech, Medtech, and pharma industries. Moreover, it works hard to speed up medicine development operations to introduce better and more effective medicine sooner in the market.

Consulting 98

Consulting Specialization Medicine Medical 98

European Pharmaceutical Review

JULY 21, 2023

European Medicines Agency (EMA) has published a draft reflection paper on using artificial intelligence (AI) to support the safe and effective development, regulation and use of medicines. How can AI and ML support development and regulation of medicines?

Food and Drug Administration 81

Food and Drug Administration Medicine Ethics Consulting 81

European Pharmaceutical Review

DECEMBER 12, 2022

The Scottish Medicines Consortium (SMC) has accepted Utrogestan, the only adjunctive micronised progesterone available as hormone replacement therapy (HRT) for use alongside any oestrogen-only HRT for women with an intact uterus. Adjunctive micronised progesterone – a menopause milestone for Scottish women.

Medicine 105

Medicine Doctors Consulting Healthcare 105

PM360

FEBRUARY 23, 2024

The campaign highlighted BeiGene’s commitment to high-quality, accessible medicines, as well as its robust clinical trial program, oncology products, and pipeline. An omnichannel mix of promotions enhanced BeiGene’s reputation and gave account directors effective communication tools.

Pharma 52

Pharma Consulting Management Marketing 52

pharmaphorum

NOVEMBER 23, 2022

Harking back to the Reuters Pharma 2022 event, held at the Nice Acropolis convention centre on France’s South Coast back in October, pharmaphorum had a chance to drop by the booth of EY and discuss not only its consulting operations, but the company’s Smart Reviewer, and their own assessment of the industry event itself.

Pharma 96

Pharma Consulting Marketing Patients 96

European Pharmaceutical Review

DECEMBER 12, 2022

The Scottish Medicines Consortium (SMC) has approved Utrogestan, the only adjunctive micronised progesterone available as hormone replacement therapy (HRT) for use alongside any oestrogen-only HRT for women with an intact uterus. Adjunctive micronised progesterone – a menopause milestone for Scottish women.

Medicine 96

Medicine Doctors Consulting Healthcare 96

European Pharmaceutical Review

MARCH 24, 2023

The European Medicines Agency (EMA) has published a report summarising the mid-point achievements of its Regulatory Science Strategy (RSS) to 2025. Regulatory science refers to the scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products.

Medicine 73

Medicine Consulting Networking Safety 73

European Pharmaceutical Review

NOVEMBER 6, 2023

A new medicine to treat adults with non-small cell lung cancer (NSCLC) with a rare mutation called KRAS G12C has been authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA). According to the MHRA, Mirati Therapeutics B.V.’s

Medicine 87

Medicine Consulting Patients Medical 87

Pharmacy Times

NOVEMBER 14, 2022

When it comes to individualized treatment, “we can do better,” said John Edwards, vice president of Healthcare Solutions Consulting at SoftServe.

Healthcare 40

Healthcare Healthcare Medicine Consulting 40

European Pharmaceutical Review

DECEMBER 13, 2022

David Elder (David P Elder Consultancy). Clinical innovation: using digital solutions to deliver the next wave of medicines. Included in this issue of European Pharmaceutical Review : . The lingering menace of diethylene glycol / ethylene glycol adulteration. SUSTAINABILITY. Stefan Koenig, Martin Olbrich and Jan Backmann, Roche.

Pharmaceutical 84

Pharmaceutical Biopharma Consulting Manufacturing 84

Clarivate

FEBRUARY 5, 2024

Here are some key takeaways: AI and machine learning will have applications throughout every phase and aspect of drug development and will open up previously unreachable frontiers of medicine. “AI Payers, too, will be challenged by AI- and machine learning-enabled advances in medicine. s Artificial Intelligence Act and the U.S.

Ethics 52

Ethics Government Consulting Medicine 52

Pharmaceutical Technology

FEBRUARY 23, 2023

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. GenScript ProBio CEO Dr Brian Min said: “We are delighted to enter into this strategic partnership with RVAC Medicines.

Manufacturing 115

Manufacturing Medicine Consulting Pharmaceutical 115

European Pharmaceutical Review

MAY 18, 2023

Hepcludex ® (bulevirtide) is the first medicine to be conditionally licensed for chronic hepatitis delta virus (HDV) infection in Great Britain” The National Institute for Health and Care Excellence (NICE) has recommended NHS use of Hepcludex ® (bulevirtide).

Medicine 84

Medicine Consulting Safety Medical 84

Pharmaceutical Technology

JUNE 1, 2023

NICE medicines evaluation director Helen Knight said: “Each year, the lives of millions of people in England are blighted by migraine attacks. They can be extremely debilitating and can significantly affect a person’s quality of life. “In

Side effects 98

Side effects Consulting Education Medicine 98

PharmaTimes

DECEMBER 18, 2023

David Lowe, professor of health and innovation, University of Glasgow and emergency medicine consultation, NHSGGC, said: “If we can spot cancer earlier… we can improve time [for] further imaging, and subsequent treatment… [which] will help orchestrate benefits for the whole patient care pathway.”

Medicine 60

Medicine Government Consulting Patients 60

European Pharmaceutical Review

NOVEMBER 27, 2023

According to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) , Kanuma is approved as an LAL-D treatment in countries such as the US, EU, Japan, Canada and other countries. Evidence of successful long-term management of the disease was reported in a case study published last year in the Canadian Liver Journal.

Food and Drug Administration 94

Food and Drug Administration Consulting Food Medicine 94

European Pharmaceutical Review

MARCH 17, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for VYVGART ® (efgartigimod alfa-fcab). It is the first neonatal Fc receptor (FcRn) blocker to be approved in the UK for adults with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

Medicine 91

Medicine Safety Consulting Patients 91

European Pharmaceutical Review

NOVEMBER 14, 2023

to continue expanding its business of “helping innovators manufacture much needed genetic medicines” Miller added that the acquisition will help to advance its mission into the next global stage of development to expand its capabilities.

Manufacturing 89

Manufacturing Consulting Pharma Medicine 89

Pharmaceutical Technology

NOVEMBER 20, 2022

This news came as many organisations and patient advocacy groups have been campaigning for the adoption of some of the rejected drugs for several months, amidst concerns about access to medicines in the UK. At the time Amanda Pritchard, chief executive of NHS England, doubled down on the issue of medicine access. “If

Government 111

Government Medicine Pharmaceutical Consulting 111

European Pharmaceutical Review

AUGUST 25, 2022

For both the Innovative Medicines and Sandoz businesses, the spin-off would enable enhanced focus and the ability to pursue independent growth strategies. Meanwhile, Novartis aims to become a focused innovative medicines company with a stronger financial profile and improved return on capital. Additional transaction details.

Medicine 86

Medicine Distribution Consulting Management 86

MedCity News

NOVEMBER 7, 2022

Just 29% of employers and 34% of payers and benefits consultants said that virtual care will drastically change the way healthcare is provided and outcomes are achieved.

Insurance 96

Insurance Consulting Healthcare Healthcare 96

European Pharmaceutical Review

JANUARY 13, 2023

According to the European Pharmacopoeia Commission, the approach was defined based on: Comments received during the last round of public consultation in Pharmeuropa. Recent feedback from Heads of Medicines Agency (HMA), and European Medicines Agency (EMA), groups and from the national competent authorities of non-EU Ph.

Manufacturing 93

Manufacturing Medicine Pharmaceutical Consulting 93

European Pharmaceutical Review

OCTOBER 12, 2023

A new scheme from the Medicines and Healthcare products Regulatory Agency (MHRA) is set to cut the approval time for the lowest-risk clinical trials in the UK by over half. The new Notification Scheme is based on that outlined in the MHRA’s clinical trials consultation, which was endorsed by 74 percent of those who responded.

Ethics 92

Ethics Safety Medicine Consulting 92

Impetus Digital

SEPTEMBER 22, 2022

The reality is that about 3% of healthcare encounters or healthcare consultations in 2019 took place through telehealth/telemedicine. And so overnight, healthcare consultations became remote. People were doing telehealth consults on Zoom. You can have a telemedicine consult like this, and you can have a conversation.

Patients 52

Patients Medical Consulting Doctors 52

European Pharmaceutical Review

DECEMBER 20, 2023

The proposed changes to EU pharmaceutical legislation broadly aim to: Support innovation and boost attractiveness of EU market Ensure timely and equitable access to medicines for patients across the EU Address other ongoing issues, including antimicrobial resistance and environmental impact of medicines. analysis (Source: L.E.K)

Biopharma 82

Biopharma Pharmaceutical Medicine Manufacturing 82

European Pharmaceutical Review

FEBRUARY 3, 2023

A key consultation by the Department of Health and Social Care (DHSC) is underway on plans to raise the statutory revenue clawback rate paid by companies subject to the Statutory Scheme for branded medicines from 24.4 Between 2019 and 2023, there will have been a 12 percent real terms decline in medicines spending.

Government 59

Government Medicine Pharmaceutical Consulting 59

pharmaphorum

JANUARY 24, 2023

Given the funding environment for innovative medicines that is faced by all pharma, large or small, once assets are approved, however, this 2023 reset seems a necessary response. Medicines manufacturing is energy intensive. Medicines distribution and supply is also an energy intensive and regulated business.

Medicine 90

Medicine Healthcare Healthcare Pharma 90

European Pharmaceutical Review

FEBRUARY 2, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved RINVOQ ® ▼ (upadacitinib), the first oral advanced therapy for adults with moderately to severely active Crohn’s disease (CD). This medicine is subject to additional monitoring.

Safety 68

Safety Medicine Consulting Patients 68

pharmaphorum

NOVEMBER 27, 2022

The approval comes after presentation of data from the ARASENS phase 3 clinical trial at the 2022 ASCO GU Cancers Symposium in February 2022, together with simultaneous publication of the results in The New England Journal of Medicine. reduced risk of death.

Food and Drug Administration 83

Food and Drug Administration Medicine Consulting Patients 83

European Pharmaceutical Review

AUGUST 17, 2022

Results from the Phase III VISION study have shown the significance of this precision medicine for patients with advanced prostate cancer and it is encouraging to see such innovations being recognised by the MHRA with this licensing authorisation.”. This new approach is very welcome.”.

Medicine 111

Medicine Patients Consulting Marketing 111

European Pharmaceutical Review

NOVEMBER 2, 2022

The Phase I trial, published in Science Translational Medicine , involved building and applying a new generation of universal genome-edited T cells, a better solution to current chimeric antigen receptors (CAR) T- cell therapies which rely on collecting and engineering a patient’s own cells, an expensive and lengthy process.

Side effects 127

Side effects Engineering Consulting Manufacturing 127

PM360

MAY 10, 2024

Zara Baker, Chief Digital Innovation Officer Before joining VUE Health, Zara advised several pre-commercial biotechnology startups and healthcare consulting agencies in a fractional Chief Digital Officer (CDO) capacity. VUE Health is also certified as a Women’s Business Enterprise (WBE) by WBENC.

Healthcare 52

Healthcare Healthcare Biopharma Engineering 52

pharmaphorum

JANUARY 16, 2023

Two top pharma companies have exited the UK’s voluntary medicines pricing agreement in protest at what the industry has said is a “punitive” system of revenue clawbacks, casting doubt on the future of the scheme in its present form.

Government 67

Government Medicine Consulting Management 67

Pharma Marketing Network

JUNE 23, 2021

He has worked within life sciences organizations, leading publishers, consultancies, agencies, digital health, and technology solutions support our journeys through illness and to wellness. He often speaks and writes about his passion, EaaM – Experience as a Medicine.

Consulting 52

Consulting Media Networking Leads 52

MedCity News

JULY 27, 2023

However, one-size-fits-all solutions have disadvantages in medicine today. Current applications Today, there is an escalated appetite to address emerging procedures because they offer an opportunity for device makers – and physicians like me who are interested in cutting-edge technology – to influence new areas of medicine.

Specialization 67

Specialization Medical Medicine Leads 67