Pharmaceutical Technology

NOVEMBER 1, 2022

Intrinsic Medicine has signed a definitive business combination agreement with special purpose acquisition (SPAC) firm Phoenix Biotech Acquisition to create a public company. To be named Intrinsic Medicine following closing, the combined company will be led by current Intrinsic CEO Alexander Martinez and president and COO Jason Ferrone.

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European Pharmaceutical Review

JUNE 29, 2022

How does that impact the safety of the biologics? Safety is key to the development of any medicine, but the safety considerations linked to bioproduction are more complex because biologics are more sophisticated medicines than small molecules. This could lead to false positives or, even worse, false negatives!

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European Pharmaceutical Review

FEBRUARY 27, 2024

The Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dame June Raine, will step down in the Autumn following five years in the role. While she is stepping down from her current role, Dame June shared that she still hopes to contribute “to patient safety and public health in other ways.”

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European Pharmaceutical Review

DECEMBER 22, 2022

Advances in mRNA technologies and cellular delivery systems coupled with their cost effectiveness, manufacturing simplicity and ability to target previously-undruggable pathways has limitless potential that could revolutionise medicine. Manufacturing time for mRNA therapeutics is also fast compared to antibodies or protein-based drugs.

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Pharmaceutical Technology

MAY 17, 2023

Under the deal, Prevail obtains exclusive rights to use Scribe’s CRISPR X-Editing (XE) technologies to develop the medicines. The deal will see the integration of Scribe’s new CRISPR by Design approach and Prevail’s expertise in developing genetic medicines for neurological disorders for specific genetic targets.

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Healthcare Success

MAY 9, 2022

In this blog post, you’ll learn: Why QR codes have made a comeback, When to use them, And, 8 ways to improve the patient experience and drive leads with QR codes. . Suddenly the safety of contactless, hygienic interactions became a necessity. 8 Ways to Improve the Patient Experience & Drive Leads with QR Codes.

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European Pharmaceutical Review

JUNE 13, 2024

Tell us about Ocugen’s lead programme, OCU400. Shortly thereafter, the European Medicines Agency (EMA) reviewed the study design, endpoints, and planned statistical analysis, and deemed the US-based trial acceptable for a Marketing Authorisation Application (MAA). What’s the latest and what’s next?

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Pharmaceutical Technology

SEPTEMBER 8, 2022

The expert services rendered by them help in improving patient outcomes, minimising costs of the healthcare system, improving medicinal adherence and persistency and saving clinicians’ time. Patient monitoring for safety and efficacy. The post Leading speciality pharmacies in pharma appeared first on Pharmaceutical Technology.

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Pharmaceutical Technology

SEPTEMBER 15, 2022

Packaging plays a vital role in maintaining the quality, safety, user-friendliness and marketability of drugs and other pharmaceutical products. Pharmaceutical Technology has listed some of the leading contract commercial packaging companies, based on its intel, insights and decades-long experience in the sector.

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Pharmaceutical Technology

FEBRUARY 3, 2023

The field of genomic medicine has reached a true turning point. After years of safety-related setbacks and development challenges, recent progress in gene therapy is especially exciting. More efficient, suspension-based cell culture processes are urgently needed in the now fast-developing genomic medicine space.

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Medicine Manufacturing Safety Management 97

Pharmaceutical Technology

SEPTEMBER 20, 2022

Pharmaceutical Technology has listed the leading commercial dose non-sterile companies in contract marketing based on its intel, insights, and decades of experience in the sector. Newly emerging technologies have helped in improving the effectiveness and safety of non-sterile commercial dose products.

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Leads Marketing Retail Distribution 52

European Pharmaceutical Review

SEPTEMBER 20, 2022

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have announced that biosimilar medicines authorised in the European Union (EU) can now be interchanged with their reference medicine or an equivalent biosimilar product. New regulatory guidance could lead to UK biosimilar boom.

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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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European Pharmaceutical Review

MAY 29, 2023

A neurosteroid drug was one of two medicines recommended for approval at the Committee for Medicinal Products for Human Use (CHMP) ’s May 2023 meeting. This medicinal product has potential to diagnose this cancer in high risk patients in early stages and for patients with suspected recurrence.

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Medicine Marketing Leads Safety 98

Pharmaceutical Technology

SEPTEMBER 20, 2022

Clinical packaging and labelling follow stringently controlled procedures and high-standard quality control measures to assure the safety and functionality of investigational medicinal products, during their storage, distribution, and use.

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European Pharmaceutical Review

JANUARY 25, 2024

Within the EU, patient information leaflets (PILs) are not merely a regulatory requirement but a cornerstone of patient safety. They are vital to ensuring the safe and effective use of medicines, making them an integral part of healthcare in Europe. percent as EU average with some Member States as high as 25 percent).

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European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 6 Thus, it is critical to ensure the consistency of therapeutic effect across batches (see box).

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European Pharmaceutical Review

OCTOBER 20, 2022

Apogenix’s lead immunotherapy candidate, asunercept is a fully human fusion protein, consisting of the CD95 receptor and an IgG1 antibody. The Phase II trial investigated efficacy and safety of asunercept in 435 patients with moderate to severe COVID-19 disease.

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Pharmaceutical Technology

JUNE 2, 2023

Although health officials from the European Medicines Agency believe portfolio diversification is crucial to hedge against any resurgence of the virus and the emergence of newer variants, the prevention of Covid-19 in the EU is at high risk of being dominated by only one product—at least until the end of 2026.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

Victoza, Copaxone, Lupron, Zoladex, Sandostatin, and Somatuline are some of the popularly marketed peptide API therapeutic drugs while more than 600 peptide-based pharmacological leads are being investigated worldwide, across various phases of development. Discover the top API protein and peptide companies in contract marketing.

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European Pharmaceutical Review

OCTOBER 20, 2023

This cytokine drives the type-2 inflammatory loop in the skin, which leads to skin barrier dysfunction, itch, skin thickening and infection. The safety profile of lebrikizumab in ADjoin was found to be consistent with previous lebrikizumab studies in patients with moderate-to-severe atopic dermatitis.

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Safety Pharmaceutical Patients Medicine 105

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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European Pharmaceutical Review

JANUARY 5, 2024

These results should lead to expediting the conduct of a placebo-controlled international trial to replicate these results,” Professor John Kane, Professor of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine, Hempstead New York noted.

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European Pharmaceutical Review

JANUARY 27, 2023

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

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European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. There were 381 Parkinson’s patients enrolled in the trial. and Joan A.

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Pharmaceutical Technology

APRIL 3, 2023

Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa. Its reference medicine, Humira, initially received approval with an adalimumab 50 mg/mL concentration.

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Marketing Food and Drug Administration Medicine Food 105

Healthcare Success

MAY 9, 2022

In this blog post, you’ll learn: Why QR codes have made a comeback, When to use them, And, 8 ways to improve the patient experience and drive leads with QR codes. . Suddenly the safety of contactless, hygienic interactions became a necessity. 8 Ways to Improve the Patient Experience & Drive Leads with QR Codes.

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Leads Patients Healthcare Provider Healthcare 52

European Pharmaceutical Review

DECEMBER 12, 2023

In recent years, nitrosamines have been detected in various medicines, leading to voluntary product recalls from the market. Nitrosamines analysis is, thus, key to ensuring safety and quality in the pharmaceutical industry.

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European Pharmaceutical Review

AUGUST 24, 2023

Therefore “This could improve the overall safety and tolerability of risvodetinib.” “… compared to the capsules currently in use in the 201 clinical trial, the smaller tablets may overcome challenges patients have swallowing oral medication as a result of their disease.

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European Pharmaceutical Review

DECEMBER 14, 2023

Decisions to remove medicines from market are not taken lightly and are often based upon all evidence available to inform a benefit/risk balance. Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe.

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European Pharmaceutical Review

AUGUST 29, 2023

Experts at the European Medicines Agency (EMA) have provided a regulatory perspective on risk factors and mitigation strategies for nitrosamine impurities in human drug products. The paper highlighted an Article 31 referral into medicine safety which began in the EU in September 2019. Cioc et al.

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European Pharmaceutical Review

OCTOBER 7, 2024

New results from a first-of-its-kind study reports that a CAR-T cell therapy provided similar efficacy and safety to relapsed or refractory multiple myeloma patients administered with the treatment in clinical trials.

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European Pharmaceutical Review

OCTOBER 26, 2023

PharmaKure has filed a Clinical Trial Application (CTA) with the UK’s Medicines and Healthcare Regulatory Agency (MHRA) to evaluate PK051, a combination drug targeting disaggregates of amyloid-β proteins. The submission includes comprehensive data from pre-clinical studies and thorough safety assessments, PharmaKure noted.

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European Pharmaceutical Review

MAY 15, 2023

HARMONIE investigated the efficacy and safety of a single intramuscular dose of nirsevimab. Agreed in March 2017, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialisation activities. The mAb demonstrated a reduction of 58.04 Participant follow-up will conclude at 12 months.

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European Pharmaceutical Review

JANUARY 17, 2023

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation for Ximluci ® (ranibizumab), a biosimilar referencing Lucentis®, to help treat a leading cause of blindness globally. First bispecific antibody approved in EU to combat leading causes of vision loss.

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European Pharmaceutical Review

OCTOBER 5, 2022

An industry that is among the world’s biggest polluters is caught in a balancing act between satisfying the health and safety demands of industry regulators and meeting the needs of modern eco-conscious consumers. However, when it comes to pharmaceutical products, health and safety remains the primary consideration.

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European Pharmaceutical Review

JUNE 16, 2023

According to Maximize Market Research , new technologies are expected to boost the clinical trials market between 2022 to 2029, especially as the industry and patients are shifting towards digitalisation approaches and personalised medicines. As the data landscape evolves, what is the most exciting innovation in clinical data management.

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