European Pharmaceutical Review

DECEMBER 13, 2022

North American psychedelic drug developers Mindset, PharmAla, Mydecine and Psyence have signed with clinical research organisation (CRO) Clerkenwell Health to trial therapies for mental health conditions, in London, UK, to benefit from the country’s swift drug regulatory process.

Medicine 104

Medicine Food and Drug Administration Ethics Government 104

World of DTC Marketing

APRIL 7, 2021

American healthcare is in trouble. I have to laugh when I hear that a pharma company is patient-centric because that’s become a slogan to make employees feel good about themselves while the costs of prescription drugs increase every year. Highest-paid CEOs in 2019: Who made the list from healthcare. This has to end.

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Healthcare Healthcare Food and Drug Administration Pharma 162

European Pharmaceutical Review

OCTOBER 14, 2022

Amgen’s 2022 market report has detailed how competition has driven savings across healthcare, estimating that a considerable number of biologics will be in competition with biosimilars in five to 10 years. In Q2, savings in drug spend due to biosimilar availability is estimated to be a substantial $3.2

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European Pharmaceutical Review

MARCH 27, 2024

The authors highlighted the variations in methods advised in guidelines from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) were a contributing factor. As such, this “could impact the need for rigorous quality control measures, such as pyrogen testing”.

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Safety Marketing Food and Drug Administration Pharmaceutical 78

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. Some, 250,000 child deaths per year can be attributed to counterfeit malaria and pneumonia medicines.

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Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 96

European Pharmaceutical Review

AUGUST 29, 2023

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes.

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Food and Drug Administration Safety Medicine Food 92

European Pharmaceutical Review

MARCH 27, 2024

The US Food and Drug Administration (FDA) has approved WINREVAIR ( sotatercept -csrk) for subcutaneous injection (45mg, 60mg) for adults with pulmonary arterial hypertension (PAH, World Health Organization [WHO] Group 1). Merck/MSD stated that WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.

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Food and Drug Administration FDA Healthcare Provider Food 91

World of DTC Marketing

NOVEMBER 24, 2021

needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… From 2009-10 to 2018-19, the lowest average monthly costs for new cancer drugs approved by the U.S. SUMMARY: The U.S.

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Pharmaceutical Technology

JUNE 20, 2023

The investigational drug candidate vamorolone has a mode of action based on binding to the same receptor as glucocorticoids while changing its downstream activity. In the US and Europe, the drug has received orphan drug status to treat Duchenne muscular dystrophy (DMD).

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Food and Drug Administration FDA Prescription Medicine 98

Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. N) = number of approvals.

Medicine 98

Medicine Food and Drug Administration FDA Healthcare 98

European Pharmaceutical Review

APRIL 17, 2024

Roche multiple sclerosis subcutaneous injection: late-breaking data “Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” shared Scott Newsome , DO, lead author, Johns Hopkins University School of Medicine.

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Food and Drug Administration Safety Medicine Food 75

European Pharmaceutical Review

MARCH 4, 2024

As a cornerstone of advanced therapeutics in modern medicine, biologics command significant attention in the search for effective treatments for human diseases. 1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. percent through 2027.

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European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades. .

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Food and Drug Administration Medicine Food Government 115

European Pharmaceutical Review

AUGUST 11, 2023

The European Commission has revoked the conditional marketing authorisation (MA) for Novartis’ sickle cell medicine crizanlizumab in the European Union (EU) and EEA. The decision follows a May recommendation from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).

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Marketing Food and Drug Administration Medicine FDA 92

European Pharmaceutical Review

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) created live biotherapeutic products (LBP) as a new category in the 2012 guidelines. 1 It defined LBPs as drug products containing live microorganism(s) to be used to prevent, treat or cure a disease or condition in human beings.

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Food and Drug Administration FDA Medicine Government 108

Pharmaceutical Technology

OCTOBER 7, 2022

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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European Pharmaceutical Review

NOVEMBER 3, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older. A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose.

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European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

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Pharmaceutical Technology

APRIL 17, 2023

Health Canada has accepted Pfizer Canada’s new drug submission for a bivalent respiratory syncytial virus (RSV) vaccine for review. The company announced that Health Canada’s acceptance follows the acceptance by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

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European Pharmaceutical Review

OCTOBER 25, 2023

Three key medicine regulatory bodies from the UK, US and Canada have collaborated to publish five guiding principles for machine learning-enabled medical devices MLMDs. Since medical devices using machine-learning and artificial intelligence (AI) can require frequent updates, and therefore potentially lengthy reassessment for each change.

Medical 99

Medical Food and Drug Administration Manufacturing Safety 99

pharmaphorum

JANUARY 24, 2023

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates.

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Food and Drug Administration Pharma Medicine Healthcare 78

Pharmaceutical Technology

MAY 26, 2023

The European Medicines Agency (EMA) has accepted two marketing authorisation applications (MAA) from Sandoz for the proposed biosimilar denosumab. The MAAs include all indications covered by the Xgeva (denosumab) and Prolia (denosumab) reference medicines to treat conditions such as osteoporosis in postmenopausal women.

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European Pharmaceutical Review

NOVEMBER 7, 2022

has announced its B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb) elranatamab for relapsed or refractory multiple myeloma (RRMM) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). Pfizer Inc.

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Food and Drug Administration Medicine Safety FDA 102

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. It is coordinated by the US Food and Drug Administration (FDA). reduced risk of death.

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European Pharmaceutical Review

DECEMBER 7, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Comirnaty ® , the Pfizer/BioNTech COVID-19 vaccine for infants and children aged six months to four years in Great Britain. Additional authorisations and recommendations of Comirnaty ®.

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Food and Drug Administration Patients Side effects Medicine 92

Pharmaceutical Technology

MAY 22, 2023

Biogen and Eisai have submitted a marketing authorisation application (MAA) to the UK’s medicines and healthcare products regulatory agency (MHRA) for lecanemab to treat early Alzheimer’s disease (AD). Eisai and Biogen recently announced that Health Canada has accepted a new drug submission for lecanemab to treat early AD.

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Food and Drug Administration Marketing Food Medicine 52

Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. It is specialised in innovative processes for producing difficult-to-manufacture speciality and generic drugs.

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Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

Clarivate

JUNE 26, 2023

Obtaining the preferences of patients and their caregivers is not a new concept in healthcare. Increasingly, however, industry guidance documents utilize the term ‘patient preference’ in relation to new drug development and benefit-risk assessment. These differentiators can inform commercial strategies.

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Food and Drug Administration Patients Side effects Medicine 52

Pharmaceutical Technology

MAY 12, 2023

In partnership with SERB Pharmaceuticals, the company will also file a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year. SFJ Pharmaceuticals will lead the ongoing clinical trial of bentracimab.

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PM360

MAY 2, 2023

Ardelis Health , a healthcare strategic marketing agency and consulting firm partnering with innovators that discover, differentiate, and launch important therapies, today announced the appointment of industry veteran Timmy Garde as Chief Growth Officer. “We We are thrilled to welcome Timmy to the Ardelis leadership team.

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Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.

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Manufacturing Food and Drug Administration FDA Pharma 52

Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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Safety Food and Drug Administration Pharmaceutical Marketing 52

Pharmaceutical Technology

APRIL 25, 2023

The US Food and Drug Administration (FDA) approved Imcivree to offer chronic weight management in adult and paediatric patients aged six years and above living with monogenic or syndromic obesity caused by deficiency of pro-opiomelanocortin (POMC), leptin receptor (LEPR) or proprotein convertase subtilisin/kexin type 1 (PCSK1).

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European Pharmaceutical Review

OCTOBER 19, 2022

The US Food and Drug Administration (FDA) has awarded a total of $38 million in the form of 19 new grants and two new contracts, to facilitate the upcoming four years of clinical trials and regulatory tools for rare diseases. which give patients the ability to interact with their families and healthcare professionals.

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Food and Drug Administration FDA Food Healthcare 97

Pharmaceutical Technology

FEBRUARY 7, 2023

The US Food and Drug Administration (FDA) has accepted Sandoz’s biologics license application (BLA) for its proposed biosimilar denosumab. The BLA covers all indications which are covered by Prolia (denosumab) and Xgeva (denosumab) reference medicines.

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Food and Drug Administration FDA Medicine Food 52

Pharmaceutical Technology

APRIL 17, 2023

QPS is preparing the pre-investigational new drug applications to be submitted to the US Food and Drug Administration (FDA) and the EU’s European Medicines Agency (EMA) for the CannQuit and ReneCann products.

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European Pharmaceutical Review

APRIL 3, 2023

Results of the NANT trial Around 30 percent of patients under the age of 18 responded to the drug. Quickly moving this drug on for the subset of patients with ALK alterations is an opportunity to go after a main driver of the disease to prevent relapse, state the researchers.

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