European Pharmaceutical Review

JANUARY 19, 2023

The final appraisal document (FAD) recommended the triple regimen as an option for adult patients who have received two or three lines of therapy. It evaluated 722 patients given ixazomib in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone with placebo (control arm).

Consulting 96

Consulting Safety Patients Pharmaceutical 96

pharmaphorum

AUGUST 23, 2022

France’s BrainVectis, a subsidiary of Bayer’s Asklepios BioPharma (AskBio) unit, has been given the green light by regulators in France to start dosing patients with its gene therapy candidate for devastating neurodegenerative disorder Huntington’s disease.

Safety 105

Safety Biopharma Patients 105

European Pharmaceutical Review

JUNE 12, 2024

The study included 92 adult patients with confirmed CDI. The main objective was to evaluate the efficacy and safety of MBK-01 compared to fidaxomicin, providing significant insights into the potential of MBK-01 as a treatment for primary or recurrent CDI and contributing to the advancement of microbiome-based therapies.

Safety 111

Safety Side effects Patients Healthcare 111

European Pharmaceutical Review

DECEMBER 1, 2022

The report noted that regulations affecting mRNA therapies are focusing on achieving better patient access and increased reviews of drugs that improve treatment, diagnosis, or prevention of serious conditions. Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing.

Medicine 98

Medicine Marketing Safety Pharmaceutical 98

European Pharmaceutical Review

JULY 20, 2022

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. Monitoring and studying the side effects of licensed medicines is an essential part of drug development to ensure public safety. Six products were withdrawn or revoked for safety reasons during the study period.

Medicine 97

Medicine Safety Side effects Electronics 97

Pharmaceutical Technology

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

Food and Drug Administration 52

Food and Drug Administration FDA Physicians Food 52

Referral MD

MAY 19, 2023

Blockchain may help organizations securely share healthcare data while protecting patient privacy. The health system is also moving towards a patient-centered approach prioritizing accessible services and adequate healthcare resources. Blockchain improves healthcare organizations’ patient care and facilities.

Healthcare 84

Healthcare Healthcare Medical Distribution 84

European Pharmaceutical Review

JUNE 13, 2023

According to the CEO of Novartis, Dr Vas Narasimhan, the company is excited by the potential for bringing “additional much-needed treatment options to patients”. In addition, atrasentan revealed a significant reduction in proteinuria versus baseline in a Phase II study, with good tolerability, including liver safety profile.

Biopharma 52

Biopharma Safety Leads Pharmaceutical 52

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) granted Eli Lilly’s Lartruvo (olaratumab) accelerated approval in 2016 for soft tissue sarcoma (STS). External beam radiation is often given to STS patients, making the condition a suitable clinical target for novel radionuclide therapy. After this, Telix licenced the drug for $5m.

Food and Drug Administration 52

Food and Drug Administration Food Safety FDA 52

Pharmaceutical Technology

MARCH 24, 2023

However, it has taken over six years for Amjevita to launch, after first being FDA-approved in 2016. Many other biosimilars have also been FDA-approved since 2016. Further, there remains scepticism on the efficacy and safety of biosimilars. Sometimes the settlement of a patent dispute involves agreeing to defer entry.

Competition 59

Competition Marketing FDA Physicians 59

European Pharmaceutical Review

DECEMBER 20, 2022

An ongoing Phase I/II clinical trial by Sanofi is evaluating IPH6101/SAR’579 (SAR443579), the first NKp46/CD16-based CD123-targeted ANKET TM NK cell engager, in patients with relapsed or refractory acute myeloid leukaemia (R/R AML), B-cell acute lymphoblastic leukaemia (B-ALL) or high-risk myelodysplastic syndrome (HR-MDS).

Pharma 98

Pharma Manufacturing Sales Safety 98

European Pharmaceutical Review

OCTOBER 27, 2023

Benefits of The Future Clinical Trials Bill Chiefly, the Bill’s goal is to increase patient participation and overall, ensure clinical trials have the highest levels of safety while enabling greater regulatory pragmatism, the author explained. This is according to a 2016 paper published in Clinical and Translational Oncology.

Ethics 105

Ethics Medicine Education Competition 105

Pharma Marketing Network

MAY 15, 2023

One of the biggest opportunities presented by big data in the pharmaceutical industry is the ability to gain insights into patient needs and preferences. One of the biggest challenges is ensuring that patient privacy is protected. 1 (2016) 3. 8 (2018) 2. Hardoon and Susan E.

Pharmaceutical 59

Pharmaceutical Marketing Electronics Media 59

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. Mainland China has taken significant steps toward improving access to treatment for its estimated 20 million rare disease patients in recent years. [1]

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

Medgadget

MAY 2, 2023

The system uses the patient’s EEG data to calculate a value for the amygdala-derived-EFP biomarker, and meanwhile the patient tries various mental strategies that may help to reduce the value. These treatments at times come with a long list of side effects, leaving many patients in search of an effective long-term solution.

Side effects 86

Side effects Prescription Healthcare Healthcare 86

Pharma Marketing Network

MARCH 23, 2023

One of the biggest opportunities presented by big data in the pharmaceutical industry is the ability to gain insights into patient needs and preferences. One of the biggest challenges is ensuring that patient privacy is protected. 1 (2016) 3. 8 (2018) 2. Hardoon and Susan E.

Pharmaceutical 52

Pharmaceutical Marketing Electronics Media 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Targeting toxic species of Abeta, such as multimers (with aducanumab and lecanemab) or pyroglutamate Abeta3-42 (with donanemab), induced significant removal of Abeta plaque load in the brains of Alzheimer’s patients, leading to the delay in cognitive decline. Treatment with the mAbs delayed cognitive decline by 2.6 months for lecanemab and 5.5

Food and Drug Administration 97

Food and Drug Administration Safety Patients Leads 97

Medgadget

NOVEMBER 8, 2022

The procedure requires only local anesthetic and is intended to be less distressing for pediatric patients than the conventional approach, which requires general anesthesia. Conn Hastings, Medgadget: Please give us some background on fluid build-up and infections in the middle ear, and their consequences for pediatric patients.

FDA 94

FDA Medical Media Patients 94

Pharmaceutical Technology

JULY 25, 2022

Digitalization is now in full swing as medical care integrates with ICT to take the patient experience to the next level. There are already opportunities for patients to track their health through smart medical devices sending reports directly to their healthcare provider.

Pharmaceutical 114

Pharmaceutical Engineering Healthcare Provider Healthcare 114

World of DTC Marketing

DECEMBER 10, 2020

SUMMARY: (JAMA) The median drug wholesale list price (as defined by Average Wholesale Price) increased by 129% from 2010-2016, while median patient out-of-pocket costs increased by 53% and median insurance payments after rebates and discounts increased by 64%. Say goodbye to all the supposed goodwill.

Insurance 181

Insurance Pharma Manufacturing Retail 181

pharmaphorum

AUGUST 11, 2022

In 2016, the estimated annual cost of drug-related morbidity and mortality resulting from non-optimised medication therapy was $528.4 There have been great strides made in genomics to refine tools that determine the safest, most effective course of treatments for patients across a number of disease states.

Side effects 87

Side effects Medical Prescription Patients 87

European Pharmaceutical Review

MAY 26, 2023

For clinical trials, this is obviously even more complicated with the need for extra safety data. The systems we have in place were not developed with advanced therapies in mind that go from the patients, are adapted and then returned to the patient. But for this, we are more prepared and supported by the trial sponsors.

Safety 98

Safety Management Patients Manufacturing 98

PM360

JUNE 26, 2023

For example, the Access Accelerated initiative was launched by 22 pharmaceutical companies in 2016 to help improve access to non-communicable disease medicines in emerging markets. For instance, emerging market branding is an effective strategy that can benefit both patients and pharmaceutical companies.

Medicine 98

Medicine Marketing Pharma Manufacturing 98

European Pharmaceutical Review

JULY 27, 2023

Pharmacological therapies mainly address symptoms and unfortunately a significant number of patients do not respond adequately, progressing to congestive heart failure and eventually needing a heart transplant. Despite these trials varying in design, they confirmed the feasibility and safety of the procedure.

Pharmacology 98

Pharmacology Manufacturing Leads Patients 98

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. We can see a future where millions of patients no longer carry the burden of regular injections.”

Food and Drug Administration 105

Food and Drug Administration Manufacturing Safety Pharmaceutical 105

PM360

DECEMBER 14, 2023

They’ve disabled health systems’ ability to care for their patients. Combined, they are having a lasting effect on the reputation of the healthcare sector and the safety and durability of its products and services. The ethical standard of putting patients first urges a more prompt and immediate disclosure. References: 1.

Healthcare 52

Healthcare Healthcare Marketing Ethics 52

PM360

MAY 15, 2023

The companies will also use generative AI to design mRNA medicines with optimal “safety and performance.” Both companies hope that the partnership will enable them to make significant advancements in drug discovery and ultimately improve patient outcomes.

Safety 52

Safety Healthcare Healthcare Electronics 52

Clarify Health

MARCH 1, 2023

1] In a separate, controlled study, 80 percent of primary care physicians receiving micro-incentives referred patients to higher-value specialists they had never used before — representing a significant reduction in the total cost of care. Healthcare (2016), [link] [2] Parikh, R. million on orthopedic MS-DRGs.[1]

Physicians 52

Physicians Prescription Medicine Healthcare 52

pharmaphorum

JANUARY 4, 2023

The intention is to streamline the process for patients wishing to access their medical records via electronic health record systems (“EHR systems”) and to facilitate the ability for researchers, innovators, and policy makers to use the data in a trusted and secure way that preserves privacy. General Data Protection Regulation 2016/679.

Pharmaceutical 89

Pharmaceutical Electronics Healthcare Healthcare 89

Pharmaceutical Technology

FEBRUARY 3, 2023

Once a patient is infected with HIV, they are infected for life, except for a few rare cases, he says. Starting in 2016, the South African Uhambo HVTN 702 study, studied the ALVAC vaccine followed by a different booster , but the trial was unsuccessful. The third cohort features the highest studied dose.

Medicine 117

Medicine Prospecting Safety Manufacturing 117

PharmaKinnex

AUGUST 23, 2022

The pharmaceutical industry of 2022 is very different from the space that we all knew in 2012, 2016, or even 2020. From new legislation to functional shifts in marketing and advertising, the pharma industry works hard every day to keep up with new regulatory requirements and the constantly evolving expectations of prescribers and patients.

Pharma 52

Pharma Sales Sales Strategy Marketing 52

European Pharmaceutical Review

DECEMBER 19, 2023

A requisite cold chain has been designed and implemented to be uninterrupted from factory to patient. About 800 million humans are injected with vaccines every year” Most vaccines in use today are relatively cheap to make and are injected into patients with mass‑produced and inexpensive (five-cent) disposable syringes.

Distribution 111

Distribution Manufacturing Food Pharmaceutical 111

PM360

APRIL 25, 2023

Although AbbVie’s patent for Humira officially expired in 2016, the legal and regulatory delays paused competition for Humira until 2023. since the first biosimilar launched in 2016, with more than a dozen branded drugs now with biosimilar competitors. pharmaceutical industry. pharmaceutical industry.

Marketing 97

Marketing Competition Government Manufacturing 97

Clarify Health

MAY 27, 2022

The plan should define enrollment goals for underrepresented racial and ethnic participants, indicate the potential safety or efficacy differences among these participants, and outline the plan to collect data and explore differences between subgroups.

FDA 52

FDA Food and Drug Administration Recruitment Transportation 52

Clarify Health

MAY 27, 2022

The plan should define enrollment goals for underrepresented racial and ethnic participants, indicate the potential safety or efficacy differences among these participants, and outline the plan to collect data and explore differences between subgroups. Leveraging real-world data to develop the clinical trials diversity plan.

FDA 52

FDA Food and Drug Administration Recruitment Transportation 52

European Pharmaceutical Review

DECEMBER 1, 2022

Between 2016 and 2019, DNDi and its partners led an open-label, Phase II/III study to assess the safety and efficacy of acoziborole in patients with early- and late-stage g-HAT. 208 patients were recruited at 10 hospitals in the Democratic Republic of the Congo (DRC) and Guinea. About the Phase II/III study.

Safety 98

Safety Doctors Recruitment Food 98

World of DTC Marketing

MARCH 23, 2021

percent of total health-care spending—in 2016, the last year for which there are definitive data. About 40 percent of drugs fail in preliminary Phase I studies, which assess a drug’s safety in humans and typically cost just $25 million a drug. After all, 90 percent of all drugs that enter human testing fail.

Distribution 187

Distribution Prescription FDA Pharma 187