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. Clear regulatory expectations and allowing easier product development.

Manufacturing 83

Manufacturing Medicine Consulting Engineering 83

European Pharmaceutical Review

FEBRUARY 21, 2023

Crucially, January 2023 marked a key moment: the Medicines and Healthcare products Regulatory Agency (MHRA) granted Celadon Pharmaceuticals the first good manufacturing practice (GMP) registration since legalisation in 2018 for high Δ9-tetrahydrocannabinol (THC) cannabis active pharmaceutical ingredient (API).

Medicine 126

Medicine Manufacturing Specialization Pharmaceutical 126

European Pharmaceutical Review

DECEMBER 4, 2023

To address these issues, companies should adopt more advanced production strategies such as continuous flow chemistry, as they can shorten manufacturing processes, increase productivity and throughput. Simultaneously, there is increasing need for stringent quality control and traceability throughout the supply chain to ensure patient safety.

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Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharmaceutical products 86

European Pharmaceutical Review

NOVEMBER 16, 2022

As the emphasis of new drug development gravitates towards new, ground-breaking therapies and vaccines, the requirements of manufacturing sites, equipment and processes need to be appropriate for this new environment. That is because of the relative expense of emerging therapies and the pressure on pricing for continuing product lines.

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Manufacturing Pharma Biopharma Management 108

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. We now have GMP manufacturing sites and partners across more than 10 countries.

Ethics 80

Ethics Safety Manufacturing Medicine 80

Impetus Digital

JANUARY 30, 2023

Medications and supplies must be handled with the utmost care, often needing to comply with strict temperature regulations and changing demands from patients and providers that vary depending on the country. Add this to infrastructure challenges like cold storage or delays, and it’s no wonder patient needs are not always put first.

Pharmaceutical 69

Pharmaceutical Patients Safety Distribution 69

eMediWrite

JULY 13, 2023

They play a crucial role in assuring the efficacy and safety of products given to patients. Capable of integrating multiple functions and processes, these systems reduce reliance on off-line methods and manual transcription for managing, tracking and applying the large volume of data generated as part of manufacturing processes.

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Pharmaceutical products Safety Pharmaceutical Pharmaceutical manufacturing 52

European Pharmaceutical Review

AUGUST 16, 2022

The Phase III RATIONALE 301 study evaluated the efficacy and safety of tislelizumab versus sorafenib as a first-line systemic treatment in participants with unresectable hepatocellular carcinoma. . The RATIONALE 301 Phase III randomised, open-label study included more than 600 patients in the US, Europe and Asia.

Patients 96

Patients Food and Drug Administration Safety Food 96

PharmaTech

APRIL 25, 2024

While compliance means manufacturers demonstrate they meet regulatory requirements, quality is foundational to patients’ confidence in the safety and effectiveness of their medications. Compliance and quality are not the same thing.

Safety 52

Safety Manufacturing Medical Patients 52

PharmaTech

NOVEMBER 8, 2022

When looking to scale-up monoclonal antibody (mAb) manufacturing, a crucial challenge can be delivering sustained or improved product quality with productivity enhancements. Having consistent product quality is essential to ensure patient safety and product efficacy.

Manufacturing 40

Manufacturing Safety Patients 40

Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label. The regulator has issued a complete response letter.

Food and Drug Administration 52

Food and Drug Administration Manufacturing FDA Medicine 52

Curzon Consulting

NOVEMBER 15, 2021

If hip and knee implant manufacturers want to stay relevant, and “move the needle” on value creation, they need to play big or go home! Implant manufacturers need to provide additional services along the value chain, especially as health systems move towards value-based care models. 15th November 2021 1 Minutes.

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Manufacturing Consulting Healthcare Healthcare 52

European Pharmaceutical Review

OCTOBER 25, 2023

The aim is to remove the regulatory burden of reassessment following certain changes and updates to a medical device by a manufacturer. The device may be reassessed to ensure the performance and safety of the device is negatively impacted. However, each regulator will have specific national guidance which manufacturers must follow.

Medical 87

Medical Food and Drug Administration Manufacturing Safety 87

European Pharmaceutical Review

DECEMBER 19, 2023

Gene therapy manufacturing processes produce low yields, particularly in early product development stages. Often, if gene therapy manufacturers were to adhere to current release requirements, the outcome would be little, if any, remaining product for the clinic or patients who often have no other treatment options.

Manufacturing 76

Manufacturing Safety Pharma Pharmaceutical 76

Pharmaceutical Technology

SEPTEMBER 7, 2022

Failing to adhere to prescribed medication regimens is one of the prime reasons for poor patient health outcomes. Pharmaceutical and healthcare companies are working continuously to improve patient adherence, which also impacts disease control and pharmaceutical industry revenues directly. Patient adherence.

Leads 52

Leads Pharmaceutical Patients Pharmaceutical manufacturing 52

European Pharmaceutical Review

AUGUST 31, 2023

Cancer patients critically depend on accurate diagnosis and disease treatment. By reaching cancer cells that have already spread throughout the body, a targeted radiopharmaceutical treatment offers an alternative for patients with advanced cancer when standard lines of treatment, such as chemotherapy, have failed.

Food and Drug Administration 75

Food and Drug Administration Manufacturing Safety Transportation 75

World of DTC Marketing

APRIL 12, 2021

QUICK READ: Pharma supply chain issues are a concern for us all but especially patients. Patients should be scared. We need a 21st-century approach that puts patient safety first. The adulterated product was found to have caused nine patient deaths and 574 serious adverse events (SAEs).

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Food and Drug Administration Prescription Pharma Manufacturing 187

European Pharmaceutical Review

MAY 22, 2024

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

Medicine 65

Medicine Leads Food and Drug Administration Safety 65

European Pharmaceutical Review

JUNE 5, 2024

These findings from GSK reflect outcomes from 42 patients with mismatch repair deficient (dMMR) locally advanced rectal cancer who finished the treatment. GSK highlighted that the first 24 patients demonstrated “a sustained clinical complete response, with a median follow-up of 26.3 months was observed”.

Safety 83

Safety Patients Manufacturing Medicine 83

Healthcare Success

MAY 9, 2022

The QR code allows hospitals and healthcare providers to satisfy this need with immediate physician-patient interaction and engagement – all through smartphones and tablets. . 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. .

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Leads Patients Healthcare Provider Healthcare 107

European Pharmaceutical Review

NOVEMBER 15, 2022

As ISPE GAMP 5 Second Edition notes in the preface “Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.” Takeaways from ISPE’s GAMP 5 Second Edition update.

Manufacturing 81

Manufacturing Pharma Food and Drug Administration Safety 81

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs).

Patients 71

Patients Food and Drug Administration Side effects Food 71

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Marketing 52

PharmaTech

SEPTEMBER 7, 2023

Implementing a proper contamination control strategy (CCS) helps ensure product quality and patient safety. Additionally, it is a core element of good manufacturing practices.

Safety 52

Safety Manufacturing Patients 52

European Pharmaceutical Review

APRIL 11, 2024

Expirations of biologic patents has enabled manufacturers to enter the market and offer lower-cost alternatives of these drugs, according to the report. In-house manufacturing has become “increasingly popular” with biosimilar companies, according to the report. million by 2032, at 17.6 percent CAGR between 2023 and 2032.

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Marketing Competition Manufacturing Medicine 90

European Pharmaceutical Review

NOVEMBER 16, 2023

It has been conditionally authorised by the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a gene-editing therapy for certain patients 12 years old and over with sickle-cell disease and transfusion-dependent β-thalassemia. No significant safety concerns were identified during the trials.

Safety 90

Safety Side effects Medicine Patients 90

European Pharmaceutical Review

JANUARY 18, 2024

US researchers have reported promising outcomes from a Phase I/II trial in cancer patients treated with cord blood-derived CD19-targeted chimeric antigen receptor (CAR) natural killer (NK) cell therapy. At 30 days post treatment, the overall response rate was 100 percent for patients with low-grade non-Hodgkin lymphoma (NHL).

Manufacturing 73

Manufacturing Patients Safety Medicine 73

European Pharmaceutical Review

OCTOBER 23, 2023

The arrangement includes the development, manufacturing and commercialisation rights in the US and Japan for Telavant’s potential first-in-class agent RVT-3101. Clinical evidence for RVT-3101 RVT-3101 has been investigated in the TUSCANY-2 Phase IIb study in patients with moderate to severe ulcerative colitis. and Pfizer Inc for $7.1

Safety 80

Safety Manufacturing Patients Medical 80

PM360

SEPTEMBER 15, 2022

The term “patient centricity” has been around for over a decade, and since its first utterance the buzzword has been praised, dissected, criticized, and everything in between. The concept has always been worthwhile, but people within and outside of the industry have wondered whether the industry was truly becoming more patient centric?

Patients 98

Patients Healthcare Healthcare Marketing 98

European Pharmaceutical Review

SEPTEMBER 25, 2023

ERP systems and drug serialisation As the scale of generating serialising products is minimal, small manufacturers can alter or improve their current Base ERP system and develop an internal serialisation process. This can be measured by success factors of systems that have been successfully implemented and their interactions.”

Pharmaceutical 89

Pharmaceutical Pharmacology Safety Manufacturing 89

European Pharmaceutical Review

MARCH 8, 2024

defined GAMP as ‘good automated manufacturing practices’, with GAMP 5 being “a widely used framework for validating automated systems that establishes quality assurance practices. GAMP 5 update: computerized system expectations for pharma manufacturers Benefits of Pharma 4.0 Pedro et al. The authors asserted that Pharma 4.0 “has

Pharmaceutical 79

Pharmaceutical Pharma Safety Manufacturing 79

European Pharmaceutical Review

FEBRUARY 19, 2024

Dr Peter Marks, PhD, Director of the FDA’s Center for Biologics Evaluation and Research (CBER) stated that Amtagvi is a novel T cell immunotherapy for patients with limited treatment options. So far, we haven’t seen great success from CAR-T or other cell therapies in treating patients with solid tumours. percent, including three (4.1

Food and Drug Administration 68

Food and Drug Administration FDA Manufacturing Food 68

pharmaphorum

OCTOBER 26, 2022

And just as a family business thrives on its connection to the community, Chiesi is committed to connecting to the global patient community. We try to have a very long-term orientation because we believe that aligns our objectives very well with the objectives of society and the patients we serve, and it makes us a stable business.”.

Patients 75

Patients Pharma Consulting Transportation 75

European Pharmaceutical Review

SEPTEMBER 25, 2023

Moreover, the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC. BeiGene will continue to work with Novartis on development, regulatory and manufacturing priorities.

Food and Drug Administration 85

Food and Drug Administration Manufacturing Safety Medicine 85

European Pharmaceutical Review

MAY 2, 2023

3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients. However, access to these medicines is not close to meeting patient demand, creating inequalities in the health prospects of those diagnosed with cancer. 1,2 In the EU, an estimated 2.7

Patients 97

Patients Medicine Marketing Medical 97

European Pharmaceutical Review

DECEMBER 13, 2023

SystImmune, through its affiliates, will develop, commercialise and manufacture of BL-B01D1 in Mainland China. The company will also be responsible for manufacturing certain drug supplies for use outside of Mainland China. Data from earlier studies also indicates promising anti-tumour activity in patients with breast cancer.

Manufacturing 68

Manufacturing Safety Medical Medicine 68

Pharmaceutical Technology

OCTOBER 17, 2022

The UK Government has announced funding worth more than $894.6m (£800m) to back research into ground-breaking, experimental therapies and progress the response of the country to patient safety challenges. These research centres comprise a new facility in Exeter. The post UK to offer $894.6m

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Safety Government Competition Patients 52