Pharma Marketing Network

APRIL 27, 2021

Head of the Discovery Technology Center in Cambridge, Massachusetts, Head of Discovery Research in Ann Arbor, Michigan, and Head of Drug Safety R&D. The post Dr. Rod MacKenzie, 2020-2021 HBA Honorable Mentor appeared first on Pharma Marketing Network. HBA Honorable Mentor 2020-21, Dr. Rod MacKenzie.

Medicine 52

Medicine Networking Safety Marketing 52

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012. Do patients care?

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Patients FDA Doctors Physicians 200

World of DTC Marketing

AUGUST 12, 2022

In 2021 alone, the top U.S. The bill does not affect the list prices companies charge for new drugs, which increased from a median price of $2,115 in 2008 to a staggering $180,007 in 2021, according to recent research. He leads the Program on Regulation, Therapeutics, and Law at Brigham and Women’s Hospital in Boston.

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Pharma Retail Pharmaceutical manufacturing Pharmaceutical 255

European Pharmaceutical Review

FEBRUARY 2, 2024

ADUHELM received accelerated approval from the US FDA in June 2021, Biogen confirmed. However, Biogen noted that while the move is not a result of safety or efficacy concerns, a “large portion” of the resources will be diverted in Biogen’s Alzheimer’s disease franchise.

Food and Drug Administration 75

Food and Drug Administration FDA Food Marketing 75

European Pharmaceutical Review

JULY 28, 2023

Publication of results of the Phase III SKYLARK study “is a pinnacle moment in treating postpartum depression ( PDD ),” stated Dr Kristina M Deligiannidis, Professor at the Institute of Behavioral Science at the Feinstein Institutes, the trial’s principal investigator, lead author of the paper.

Food and Drug Administration 88

Food and Drug Administration Food Safety FDA 88

European Pharmaceutical Review

OCTOBER 9, 2023

A new approach to potassium-channel openers for epilepsy Critically, XEN1101 combines the effectiveness of potassium-channel openers with the safety of more traditional drugs, stated study lead author and neurologist Dr Jacqueline French. It ran between January 2019 and September 2021.

Side effects 93

Side effects Recruitment Safety Medicine 93

Pharmaceutical Technology

APRIL 14, 2023

The World Health Organization (WHO) says that in 2021, children under five years accounted for approximately 80% of malaria deaths in Africa, a continent disproportionately affected by the disease. Serum Institute of India (SIIPL), manufacturer and licence holder of the vaccine, has been notified of the registration by Ghana’s FDA.

Manufacturing 111

Manufacturing FDA Food Safety 111

European Pharmaceutical Review

APRIL 27, 2023

“This is the first time that we tested blinatumomab as a first-line treatment, and for the first time in such young children,” stated Dr Inge van der Sluis, study lead and paediatric oncologist and clinical pharmacologist at the Princess Máxima Center for paediatric oncology in the Netherlands.

Safety 97

Safety Medicine Leads Pharmaceutical 97

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 103

Pharma Safety Pharmaceutical Manufacturing 103

Clarivate

JULY 31, 2023

Following the acquisition of Dialog Solutions as part of the ProQuest M&A in December 2021, Dialog Solutions products and services will be folded into the Clarivate portfolio of offerings for Life Sciences & Healthcare. Today, the Dialog Solutions brand has been integrated into Clarivate.

Healthcare 52

Healthcare Healthcare Safety Competition 52

Legacy MEDSearch

DECEMBER 6, 2022

With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety. “As We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety.

Food and Drug Administration 98

Food and Drug Administration Safety Recruitment Medical 98

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. We note the Commission has not conducted an assessment on the impact of removing paper leaflets on patient safety. percent as EU average with some Member States as high as 25 percent).

Healthcare 82

Healthcare Healthcare Electronics Safety 82

pharmaphorum

AUGUST 19, 2022

The endorsement of the drug’s efficacy and safety comes at a good time for the Swedish biotech, just a month before the drug, known as Pepaxto in the US, will have its safety reviewed by an FDA advisory committee after being withdrawn from sale there last year.

FDA 52

FDA Safety Sales Marketing 52

Pharmaceutical Technology

APRIL 28, 2023

This funding will enable us to accelerate the development of our lead antibody programme targeting inflammatory fibrin in neurodegenerative and retinal diseases. “We We look forward to advancing our first candidate, THN391, into clinical trials, and expect to announce key safety and proof of mechanism clinical data by the end of 2024.”

Safety 52

Safety Medicine Leads 52

pharmaphorum

NOVEMBER 1, 2022

The results were based on pre-specified interim analysis conducted through an independent review committee and safety results were consistent with the safety profile previously demonstrated by Reblozyl in the MEDALIST study (NCT02631070). This can lead to anaemia and frequent or severe infections. in November 2021.

Safety 52

Safety Patients Pharma Leads 52

pharmaphorum

JANUARY 27, 2023

The decision comes after Ipsen was forced to withdraw its marketing application for palovarotene in the US in 2021, which delayed regulatory filings elsewhere, although the French pharma company has picked up an approval for the drug in Canada, where it is sold as Sohonos.

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FDA Marketing Medicine Prospecting 92

European Pharmaceutical Review

NOVEMBER 1, 2023

It is one of the leading causes of death associated with AMR globally. Using this approach, our lead programme – RVX 001, a protein-based vaccine against invasive pneumococcal disease – has been designed with antigens common to all pneumococcus serotypes. Bacterial vaccines in clinical and preclinical development 2021 [Internet].

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Safety Marketing Manufacturing Government 98

Curzon Consulting

NOVEMBER 15, 2021

15th November 2021 1 Minutes. Chetan Trivedi I lead Healthcare at Curzon Consulting. I am deeply passionate about improving health outcomes, safety and quality of life for patients. 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!

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Manufacturing Consulting Healthcare Healthcare 52

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 4, 5 Why was the data presented at ELCC 2023 on the bispecific monoclonal antibody significant?

Food and Drug Administration 91

Food and Drug Administration Safety Medicine Patients 91

pharmaphorum

NOVEMBER 24, 2022

The opportunity is open to academic, government, and industry organisations anywhere in the world, with a lead partner based in the UK. Dr Catherine Kettleborough, lead of the LifeArc Chronic Respiratory Infection Translational Challenge, said: “Repurposing an existing drug or compound is a faster way of getting new treatments to patients.

Government 57

Government Leads Safety Medical 57

Pharmaceutical Technology

NOVEMBER 14, 2022

Such developments, including a 2021 approval of AstraZeneca’s Saphnelo (anifrolumab) , prompted The Lancet Rheumatology to posit that 2022 could be a “banner year” for the condition. Saphnelo is also being studied in a Phase III trial in lupus nephritis, where a person’s immune system targets the kidneys, eventually leading to kidney failure.

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Side effects Patients Manufacturing Safety 144

pharmaphorum

JANUARY 17, 2023

Angion Biomedica ended 2022 in the midst of a strategic review after its lead drug for kidney diseases flamed out, and it has now charted a path forward – a reverse merger with clinical-stage biotech Elicio Therapeutics.

Pharmacology 72

Pharmacology Engineering Consulting Leads 72

European Pharmaceutical Review

AUGUST 31, 2023

Overcoming challenges in patient safety, manufacturing and supply of radiopharmaceuticals As clinical trials progress and the first results are published, companies’ best candidates will emerge in the next five years. Hospital staff must also be protected from radiation while handling the agent. Through its longer half-life of 12.7

Food and Drug Administration 78

Food and Drug Administration Manufacturing Safety Transportation 78

European Pharmaceutical Review

DECEMBER 19, 2022

1 However, as most biosimilars are developed by means of a complex biotechnological process in living organisms, this inevitably leads to differences between the biosimilar and the reference product. Marie Manley leads Sidley’s Life Sciences team in London and is a distinguished thought leader and adviser on EU and UK regulatory law.

Medicine 52

Medicine Biopharma Safety Food 52

PM360

OCTOBER 24, 2022

A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world with its medicines, and is developing a pipeline of innovative medicines. Amgen also offers a training curriculum to prepare new managers to lead and inspire their teams.

Pharma 40

Pharma Medicine Education Manufacturing 40

European Pharmaceutical Review

OCTOBER 24, 2023

However, it also leads to a decline in the quality of life and the condition can be fatal. Therefore, the development of a drug that has a safety profile and can target the underlying causes of AD pathology to achieve a cure for AD has been an ongoing pursuit of researchers in this field. The process of Aβ aggregation.

Leads 80

Leads Patients Networking Safety 80

European Pharmaceutical Review

JUNE 27, 2023

Hervé Affagard (HA): Developing microbiome therapeutics as well as every other new therapeutic modality comes with several challenges that need to be addressed carefully to ensure patient safety and maximise the potential benefits of these treatments. However, we observed dose-dependent colonisation across Phase I studies and in Phase II.

Food and Drug Administration 98

Food and Drug Administration Manufacturing Medicine Pharma 98

European Pharmaceutical Review

JULY 13, 2023

While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. This could lead to significant research waste. 2021 Jul;11(4):395-403. References Attwood D, Curley A, Keenan E, Murphy S. Mechoulam R.

Medical 85

Medical Food and Drug Administration Pharmacology Medicine 85

Pharmaceutical Technology

NOVEMBER 24, 2022

Gaming and social media companies are at the vanguard of metaverse development, but enterprises will lead the charge in the next three years. Metaverse safety. Safety is a critical concern in the metaverse. Sexual harassment in Meta’s Horizon Venues was reported during trials in 2021.

Retail 52

Retail Media Safety Professional Services 52

Pharmaceutical Technology

APRIL 28, 2023

Furthermore, although higher salaries are a deterrent against reshoring API manufacturing to Europe, rather than Asia, future technology will lead to an increase in automation and robotisation, and this might result in a need for fewer production employees. The company reported revenues of €981m ($1bn) for FY2022, an increase of 9.9%

Government 52

Government Transportation Manufacturing Pharmaceutical 52

Pharmaceutical Technology

APRIL 25, 2023

The application includes efficacy results from the Phase I/II HGB-206 and Phase III HGB-210 trials, alongside safety data from 50 patients treated with the therapy from the broader lovo-cel program. The BLA specifically targets sickle cell disease patients who are ages 12 years and above and have a history of vaso-occlusive events.

Food and Drug Administration 52

Food and Drug Administration Patients Pharmaceutical Food 52

Pharmaceutical Technology

JUNE 23, 2022

Gaming and social media companies are at the vanguard of metaverse development, but enterprises will lead the charge in the next three years. Metaverse safety. Safety is a critical concern in the metaverse. Sexual harassment in Meta’s Horizon Venues was reported during trials in 2021.

Retail 52

Retail Media Safety Professional Services 52

Clarivate

MARCH 14, 2024

Research is raising concerns about PFAS use Similarly, PFAS (per- and polyfluoroalkyl substances) in pharmaceutical packaging have recently come under scrutiny, leading to significant regulatory changes. With Europe taking the lead in introducing draft regulations on PFAS, will other countries and regions implement their own regulations?

Pharmaceutical 52

Pharmaceutical Manufacturing Food Healthcare Provider 52

European Pharmaceutical Review

MARCH 4, 2024

Therefore, biologics identification and characterisation poses unparalleled challenges, as does their manufacturing processes and routes of administration while maintaining patient safety and clinical efficacy. A Robotic Pill for Oral Delivery of Biotherapeutics: Safety, Tolerability, and Performance in Healthy Subjects. 2023; 13(3).

Food and Drug Administration 88

Food and Drug Administration Transportation FDA Medical 88

Salesforce

SEPTEMBER 9, 2021

Heading into the 2021 holiday season, retail and consumer goods brands must once again prepare for peak demand. Frustrating out-of-stocks, inaccurate inventory counts, and faulty orders — all leading to upset customers. In 2021, there are 900 million more digital buyers than there were in 2020. The result?

Management 95

Management Retail Sales Distribution 95

European Pharmaceutical Review

DECEMBER 22, 2022

1,2 In 2021, ASO-based therapy casimersen was approved for Duchenne muscular dystrophy and inclisiran, a siRNA-based drug, was approved for familial hypercholesterolemia, a rare cardiovascular disease. Carsten Rudolph, PhD is the Chief Executive Officer and co‑founder of Ethris and the lead inventor of its SNIM® RNA Technology.

Medicine 105

Medicine Food and Drug Administration Transportation Distribution 105

PM360

JULY 13, 2023

Launched in 2021, Adheris Health’s intelligent patient platform, THRiV, translates these patient insights into actions. com An estimated 50% of patients with a prescription for a chronic condition stop taking it within the first year, leading to worse outcomes and nearly $250 billion lost revenue annually for the pharmaceutical industry.

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Education Medical Media Patients 89