European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. Counterfeit drugs: fighting illegal supply chains: Subcommittee on oversight and investigations of the committee on energy and commerce house of representatives; 2014.

Medicine 92

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 92

Legacy MEDSearch

JUNE 27, 2022

“We are excited about the potential for IOPS® solution to transform the imaging framework to improve safety, quality and cost of minimally-invasive vascular procedures while reducing radiation exposure of caregivers and patients during critical life-saving procedures” said Todd Schwarzinger, GM Cleveland Clinic Innovations. .

Recruitment 52

Recruitment Healthcare Healthcare Safety 52

pharmaphorum

JANUARY 13, 2023

The new draft guidance introduces some flexibility into the assessments that doctors currently use to decide whether a statin should be prescribed, based on new data reinforcing the safety of the widely-used drug class, which are known to reduce the risk of cardiovascular disease when used for primary prevention.

Side effects 52

Side effects Patients Doctors Medical 52

pharmaphorum

SEPTEMBER 30, 2022

” However, it added that the limited efficacy of the two approved therapies for ALS – Radicava and oral riluzole – plus the apparent safety of Relyvrio means that “this level of uncertainty is acceptable in this instance and consideration of these results in the context of regulatory flexibility is appropriate.”

FDA 75

FDA Doctors Patients Prescription 75

European Pharmaceutical Review

JANUARY 29, 2024

4 The use of CPCA assessments allows for the assignment of scientifically justifiable higher acceptable intakes (AIs), without impacting patient safety. 16 Hydrazoic acid is a toxic, explosive gas and presents a significant worker-safety risk during manufacture of valsartan drug substance. However, there were some notable differences.

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Medicine FDA 98

European Pharmaceutical Review

DECEMBER 19, 2022

3 Under this pathway, comparability studies are required to substantiate the similar nature, in terms of safety and efficacy, of the biosimilar and the reference product. EMA Guideline on Similar Biological Medicinal Products, 23 October 2014, CHMP/437/04 Rev 1. Directive 2001/83 (as amended). EMA Biosimilars Q&A.

Medicine 52

Medicine Biopharma Safety Food 52

European Pharmaceutical Review

DECEMBER 21, 2022

Despite the tidal wave of renewed interest in psychedelic therapies, there is still much to be learned about them, including their precise mechanisms of action, their long- and short-term safety profiles, the durability of their effect, and their adverse effects—which can be severe. Authorisation under exceptional circumstances.

Food and Drug Administration 109

Food and Drug Administration Medicine Food Government 109

pharmaphorum

SEPTEMBER 11, 2022

It had been approved since 2014 for moderate to severe cases only. Last December, it secured FDA approval for the treatment of adult patients with plaque psoriasis, regardless of the severity of their symptoms, making it an option for all the estimated eight million people with the skin disorder in the US.

FDA 52

FDA Marketing Sales Patients 52

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. An observational study of safety and clinical outcome measures across patient groups in the United Kingdom Medical Cannabis Registry.

Medical 87

Medical Food and Drug Administration Pharmacology Medicine 87

pharmaphorum

DECEMBER 14, 2022

Tentative approval means Lumryz has satisfied all the FDA requirements for efficacy, safety, and quality standards, but it can’t be fully approved until a patent or other exclusivity expires. Furthermore, Molina stated Jazz “suppressed generic competition and raised the price of Xyrem 841% between 2007 and 2014.”

Competition 85

Competition FDA Pharmaceutical Marketing 85

Legacy MEDSearch

AUGUST 11, 2022

These implants were designed to achieve unrivaled strength and unmatched safety using their proprietary OSSIOfiber Intelligent Bone Regeneration Technology that leaves nothing permanent behind. For more information on OSSIOfiber implants, please visit www.ossio.io. About OSSIO.

Recruitment 52

Recruitment Marketing Safety Medicine 52

pharmaphorum

DECEMBER 14, 2022

Researchers cautioned that these are early results, and more follow-up is needed to determine the long-term safety and efficacy, but the data could spell trouble for AZ and Alexion’s C5 franchise, which brought in more than $4 billion in sales in the first nine months of this year.

Side effects 52

Side effects Patients Sales Safety 52

Celeritas

DECEMBER 30, 2022

On this basis, let us inspect the pillars that shall concretize a hydrogen-fueled future: infrastructure and safety regulations. Safety and Regulation. The first priority is addressing the safety concerns and threats posed by hydrogen transport and distribution. IoT Monitoring.

Engineering 52

Engineering Distribution Transportation Safety 52

European Pharmaceutical Review

JULY 5, 2022

7 In addition, the study supported the safety, tolerability and convenience of frequent low dosing, showing that Oncoral was well-tolerated and that the reported haematological toxicities were only mild to moderate (grade 1 or grade 2). accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf [Accessed 25.01.22]. Oncotarget.

Patients 85

Patients Food and Drug Administration Side effects Safety 85

pharmaphorum

NOVEMBER 29, 2022

At NeoImmuneTech, a Biotech company founded in Maryland, US, in 2014, the answer to this question looks straightforward: “We believe in incremental progress”, says Dr Se Hwan Yang, president and chief executive officer of the company. NT-I7 exhibits reliable Pharmacokinetic (PK) and safety profiles, making it an ideal combination partner.

Safety 104

Safety Patients Engineering Recruitment 104

pharmaphorum

NOVEMBER 9, 2022

The keynote address of the event entire came from Stella Kyriakides, commissioner for health and food safety at the European Commission. Originating from the European Cancer Patient Bill of Rights, The Code was launched in European Parliament on World Cancer Day 2014, winning the prestigious European Health Award four years later.

Insurance 81

Insurance Patients Healthcare Healthcare 81

European Pharmaceutical Review

DECEMBER 19, 2023

Injection Safety Fact Sheet. Available from: [link] q=US10821210B2. Heatstable vaccines urgently needed to reach the one in five children missed by immunisation worldwide. Internet] Médecins Sans Frontières. cited 2023July]. Available from: [link] reach-one-five-children-missed-immunisation-worldwide. Lee B, Wedlock PT, Haidari LA, et al.

Distribution 101

Distribution Manufacturing Food Specialization 101

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. For the past 15 years, Hervé has been an intra/entrepreneur in the healthcare industry.

Food and Drug Administration 100

Food and Drug Administration Manufacturing Medicine Pharma 100

European Pharmaceutical Review

JUNE 8, 2023

1 In the EU, the Tobacco Products Directive (2014/40/EU) governs “the manufacture, presentation and sale of tobacco and related products”. He is currently a CMC consultant with an interest in impurities and safety‑based limits. The harmful effects of smoking are well known, causing more avoidable deaths than any other single cause.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Law & Regulation 59

pharmaphorum

OCTOBER 26, 2022

There are many challenges in the development of therapies for rare diseases due to several unique factors, including small target patient populations, lack of long-term safety and efficacy data or natural history data, and often complex administration, dosing, and patient monitoring requirements,” Chiesi says.

Patients 69

Patients Pharma Consulting Transportation 69

European Pharmaceutical Review

FEBRUARY 28, 2023

He is currently a CMC consultant with an interest in impurities and safety‑based limits. About the author Dave Elder, PhD has worked in the pharmaceutical industry for 45 years for GSK, Syntex and Sterling. Toxicol Rep. 2022; 9: 250–255. Internet] EMA. cited 2023Jan] Available from: [link] 21. Trejo-Martin A, Bercu JP, Thresher A, et al.

Food and Drug Administration 89

Food and Drug Administration Pharmaceutical FDA Medicine 89

European Pharmaceutical Review

FEBRUARY 7, 2023

Regulation of clinical trials Eight years following its adoption in 2014, the Clinical Trials Regulation 536/2014 (CTR) entered into application on 31 January 2022. In addition, the devices must not present an unacceptable risk to patient and user health and safety as established in Articles 94 and 95 of the MDR.

Government 96

Government Medical Medicine Marketing 96

pharmaphorum

JANUARY 3, 2023

Key secondary endpoints demonstrated a 78% reduction in treated ABR and a 92% reduction in annualised infusion rate, and SPK-9001 was generally well-tolerated, its safety profile consistent with phase 1 and phase 2 results. This resulted in a 71% reduction in ABR after a single dose of 5e11 vg/kg of fidanacogene elaparvovec.

Medicine 90

Medicine Engineering Safety FDA 90

European Pharmaceutical Review

SEPTEMBER 20, 2023

The growing presence of these unintended amino acid sequences in recombinant proteins is a top concern for regulators and drug manufacturers due to the ability of these mutations to cause higher order structural problems, potentially affecting efficacy and safety. While SVs are typically present at less than 0.1

Patients 83

Patients Manufacturing Leads Safety 83

pharmaphorum

NOVEMBER 16, 2022

The drug’s safety has been evaluated from a pooled analysis of three studies among a total of 464 patients with (FR?)-positive, Given there have been no new therapies approved by the FDA for this indication since 2014, ELAHERE’s accelerated approval is a tremendous advance in the ovarian cancer treatment paradigm.”.

FDA 67

FDA Patients Safety Medicine 67

Evolve Your Success

FEBRUARY 6, 2024

I left them in 2014 to start our own thing. We bring products to them that make them faster, more efficient, lower cost, and higher productivity without ever jeopardizing patient safety because that’s what we all do, everybody, you, and me. Patient safety is to do no harm. Probably right around it.

Medical sales 59

Medical sales Medical Sales Doctors 59

European Pharmaceutical Review

FEBRUARY 22, 2023

The study evaluated, among other things, the safety and tolerability of once‑daily administration of RT‑102 containing 20μg of PTH taken repeatedly for seven consecutive days in 10 healthy female volunteers (five of whom were post-menopausal). “The PTH is typically administered by self-injection. Diabetes Therapy. 2019;10(2):437–49.

Food and Drug Administration 91

Food and Drug Administration Manufacturing Safety Pharmaceutical 91

Pharmaceutical Technology

SEPTEMBER 26, 2022

Given the conflict present in the eastern part of Ukraine from 2014, sponsors, investigators and logistics providers were prepared for potential disruption. By August, 28 foreign-sponsored, multi-country trials were affected, almost half with sites in Ukraine and Russia. [1].

Transportation 52

Transportation Law & Regulation Key account management Management 52

Pharmaceutical Technology

NOVEMBER 22, 2022

The company began formulating ERVEBO™ in 2014 while the Ebola Virus Disease (EVD) epidemic raged in West Africa. This approach to vaccination offers many advantages to developers, including quick development, high potency, a favorable safety profile, and the potential for cost-effective manufacturing.

Manufacturing 52

Manufacturing Government FDA Safety 52

Cadensee

JULY 26, 2021

Until back in 2014, I met the team at Schneider Children's Medical Center of Israel. And it also goes to safety, which not surprisingly, was the number one concern with parents. So also want to make sure that our branding and our packaging really communicates the safety of the product. We need to build the trust.

Retail 52

Retail Marketing Doctors Food 52

European Pharmaceutical Review

JULY 1, 2022

Health and safety – the COVID-19 pandemic has thrown into sharp relief the significance of safe working environments, including the importance of employee mental health and wellbeing. Highs and lows of DEI representation in the biotech industry… Changing regulatory expectations.

Government 88

Government Pharmaceutical Safety Consulting 88

Evolve Your Success

MAY 10, 2022

I was done clinical nursing in 2014. Patient safety and probably the medical system when they know that they can demand better staff ratios, “I’m not bringing my mom here. I spit myself out of the hospital system in 2011. That’s when my practice became full-time for me. Private patient advocacy. Are you kidding?

Education 52

Education Patients Medical sales reps Medical sales 52

Clarify Health

MARCH 15, 2023

And frankly, if you’re paying a provider 57% of the 2014 CMS schedule, they’re not going to be terribly excited about you putting this bonus program in front of them when they’re concentrating on that. We have safety net practices, which is a federally qualified health center, so FQHCs.

Management 52

Management Patients Physicians Government 52

Pharmaceutical Technology

JUNE 21, 2023

The FDA first approved Jardiance to help control blood sugar in adults with T2D in 2014. This latest approval is based on results from the Phase III DINAMO trial (NCT03429543) that investigated the safety and efficacy of both drugs. reduction in haemoglobin A1c compared to an average increase of 0.7% in the placebo group.

Medicine 59

Medicine FDA Food and Drug Administration Sales 59

Pharmaceutical Technology

FEBRUARY 6, 2023

The FDA approved both drugs in 2014. In an email , a Pliant spokesperson told Pharmaceutical Technology , “As currently approved therapies are not well tolerated, a new agent with a favorable safety profile and demonstrated efficacy would be a welcome addition to the IPF treatment armamentarium”.

Marketing 59

Marketing Pharmaceutical FDA Prospecting 59

World of DTC Marketing

MAY 6, 2021

Data were mainly accessible for smaller firms, products in certain therapeutic areas, orphan drugs, first-in-class drugs, therapeutic agents that received accelerated approval, and products approved between 2014 and 2018. Pharmaceutical companies often claim that the research costs of unsuccessful drugs also have to be taken into account.

Pharma 185

Pharma Food and Drug Administration Government Insurance 185