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 85

Manufacturing Medicine Consulting Engineering 85

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.

Pharmaceutical manufacturing 88

Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharmaceutical products 88

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 127

Medicine Manufacturing Specialization Pharmaceutical 127

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.

Manufacturing 109

Manufacturing Pharma Biopharma Management 109

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

pharmaphorum

OCTOBER 14, 2022

DiCE includes 20 organisations from nine countries, representing the manufacturing industry, research, and recycling sectors. The post Janssen leads effort to cut waste in digital health devices appeared first on. Great to have you on board @ForumWeee , we look forward to the next four years of collaboration!

Leads 116

Leads Electronics Ethics Healthcare 116

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!

Ethics 81

Ethics Safety Manufacturing Medicine 81

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.

Pharmaceutical products 52

Pharmaceutical products Safety Pharmaceutical Pharmaceutical manufacturing 52

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. .

Leads 52

Leads Patients Healthcare Provider Healthcare 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

Speciality pharmacies play a crucial role in medication dosing, disease and side effects management, and patient care. 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.

Specialization 45

Specialization Leads Pharma Side effects 45

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 84

Safety Patients Manufacturing Medicine 84

Pharmaceutical Technology

SEPTEMBER 6, 2022

The pharmaceutical supply chain is a global and complex network that includes a wide range of stakeholders such as pharmaceutical manufacturers, wholesale distributors, and pharmacy benefit managers (PBM), to ensure efficient and timely delivery of medications to the patients.

Pharmaceutical 59

Pharmaceutical Leads Pharma Transportation 59

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.

Manufacturing 52

Manufacturing Consulting Healthcare Healthcare 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 76

Food and Drug Administration Manufacturing Safety Transportation 76

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 83

Manufacturing Pharma Food and Drug Administration Safety 83

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 72

Patients Food and Drug Administration Side effects Food 72

Pharmaceutical Technology

SEPTEMBER 15, 2022

Generic injectables firms are also growing significantly due to the extensive use of generic injectables in the treatment of a wide range of chronic diseases while providing the same efficacy and safety as the reference injectables. Discover the top commercial dose injectables companies in contract marketing.

Leads 52

Leads Marketing Retail Sales Management 52

Pharmaceutical Technology

FEBRUARY 2, 2023

The deal builds on the existing partnership with WuXi XDC for chemistry, manufacturing, and controls (CMC) development and GMP manufacturing services for the CD388 influenza drug-Fc conjugate (DFC) programme of Cidara. The post Cidara Therapeutics expands partnership with WuXi XDC appeared first on Pharmaceutical Technology.

Manufacturing 59

Manufacturing Leads Safety Pharmaceutical 59

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 87

Food and Drug Administration Manufacturing Safety Medicine 87

World of DTC Marketing

APRIL 15, 2021

In some instances, vaccine-hesitant activists are manufacturing stories of deaths related to the vaccine that never happened. While patients have the right to full disclosure, misinformation and scare tactics could lead to more deaths from COVID. People who point to deficiencies in COVID vaccines are risking patients lives.

Food and Drug Administration 203

Food and Drug Administration Government Safety Manufacturing 203

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

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 72

Patients Pharma Consulting Transportation 72

European Pharmaceutical Review

APRIL 2, 2024

At Roche, we see it as our ethical and environmental responsibility to support the use of alternative methods that prioritise animal welfare while ensuring the safety of our patients and the quality of our products. However, for companies that manufacture globally marketed products, the journey towards implementing rFC is a slow one.

Ethics 86

Ethics Manufacturing Marketing Networking 86

European Pharmaceutical Review

MAY 2, 2023

Cancer remains a global threat with around 10 million people dying from the disease each year worldwide, making it the second leading cause of death. 3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients. 1,2 In the EU, an estimated 2.7

Patients 98

Patients Medicine Marketing Medical 98

pharmaphorum

NOVEMBER 27, 2022

Supply chain challenges take many forms in pharma – from capacity issues, to managing excess safety stock, and ensuring accurate supplier communication. These shocks can lead to unpredictable or even absent shipments, meaning drug production labs often aren’t dealing with a stable and regular volume of raw materials.

Pharma 98

Pharma Safety Pharmaceutical Manufacturing 98

World of DTC Marketing

AUGUST 12, 2022

In the past 12 months, PhRMA and closely allied groups spent at least $57 million — $19 million of it since July — on TV , cable , radio , and social media ads opposing price negotiations, according to monitoring by the advocacy group Patients for Affordable Drugs. First, let’s clarify how the bill saves taxpayers billions.

Pharma 255

Pharma Retail Pharmaceutical Pharmaceutical manufacturing 255

Pharma Leaders

MAY 26, 2023

Biotechnology company VarmX has raised an additional €30m in a Series B2 financing round to obtain investigational new drug (IND) approval for its lead compound VMX-C001. VarmX also intends to use the financing to complete preparations for the pivotal clinical trial including large scale manufacturing.

Safety 52

Safety Leads Manufacturing Patients 52

Pharmaceutical Technology

AUGUST 17, 2022

RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The company is ranked in the 2022 Excellence Rankings in the INNOVATION , PRODUCT LAUNCH and SAFETY categories. has been manufacturing, designing, and innovating since 1984. The Verdict. Northgate Technologies Inc.

Training 98

Training Safety Medical Media 98

PM360

JUNE 26, 2023

Patients struggle to get the necessary treatments, in some cases resulting in increased hospitalization and death. The end-to-end supply chain comprises material procurement, manufacturing, transportation, warehousing, and distribution. drug manufacturers to continue producing generic drugs. Over 300 drugs in the U.S.

Manufacturing 97

Manufacturing Pharmaceutical manufacturing Pharma Management 97

European Pharmaceutical Review

APRIL 18, 2024

While pharmaceutical manufacturing’s overall contribution is small compared to patient use and inappropriate disposal of pharmaceuticals, inadequately managed manufacturing emissions can impact local environments and receiving waters.

Pharmaceutical 74

Pharmaceutical Manufacturing Management Doctors 74

Clarivate

MARCH 14, 2024

1] To mitigate the potential presence of nitrosamine impurities in pharmaceuticals, manufacturers are now facing impending regulatory requirements in various markets – in the European Union, for example, they were obligated to submit reformulation strategies and mitigation plans in late 2022. [2].

Pharmaceutical 52

Pharmaceutical Manufacturing Food Healthcare Provider 52

Clarivate

MAY 1, 2024

GLP-1s will offer an attractive option to patients hesitant to undergo an invasive surgical procedure, and manufacturers like Medtronic and Johnson & Johnson anticipate a temporary dip in surgery volumes. Ultimately, all this points toward a shift in market dynamics rather than all-loss situation for medtech players.”

Side effects 59

Side effects Physicians Medical Patients 59

European Pharmaceutical Review

JUNE 29, 2023

New drug mirikizumab doubled remission rates up to 50 percent in certain patient groups in two ulcerative colitis (UC) Phase III trials. In LUCENT-1 , patients received 300mg mirikizumab or placebo (in a 3:1 ratio) through an infusion every four weeks for 12 weeks in total. How effective was mirikizumab?

Medicine 84

Medicine Patients Safety Manufacturing 84

European Pharmaceutical Review

JULY 4, 2023

These include: Quality of starting materials Upstream manufacturing (thaw, expansion, harvest) Downstream processing (purification, filtration, sterilisation, filling) Contamination prevention Scalability Aseptic sampling practices Potency Purity Safety Data integrity Evolving regulatory authority expectations.

Food and Drug Administration 78

Food and Drug Administration Manufacturing Management Safety 78

Pharmaceutical Technology

NOVEMBER 14, 2022

In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells. All five patients achieved remission after three months.

Side effects 144

Side effects Patients Manufacturing Safety 144

European Pharmaceutical Review

NOVEMBER 9, 2023

Positively, Brager shared that in clinical trials , the company’s lead clinical candidate has demonstrated ability to cross the blood-brain barrier and to “not cause serious side effects common with traditional immunosuppressive therapies that treat inflammation.” To date, there are no oral TNF-a inhibitor drugs available on the market.

Food and Drug Administration 102

Food and Drug Administration Side effects Pharmaceutical Leads 102

Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. The core objective of the collaboration is to make the therapies affordable and accessible to patients.

Manufacturing 52

Manufacturing Government Safety Pharmaceutical 52