European Pharmaceutical Review

JULY 4, 2024

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 10,12 The THR scheme is also limited to products used for oral or external use and/or inhalation.

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

Pharmaceutical Technology

JULY 8, 2022

In December 2014, Amgen’s landmark FDA approval saw Blincyto (blinatumomab) approved for relapsed/refractory (R/R) B-cell progenitor acute lymphoblastic leukaemia (B-ALL), at the time being the only marketed BiTE. months vs. 4.0

Safety 59

Safety Sales Marketing Patients 59

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.

Medical 117

Medical Government Marketing Medicine 117

Pharmaceutical Technology

JANUARY 23, 2023

Out of the seven biologics approved to treat moderate to severe CD in adults, only the anti-TNFαs, Remicade (infliximab), and Humira (adalimumab), have been approved for paediatric patients, with Humira receiving the most recent approval in 2014.

Medical 59

Medical Ethics Specialization Physicians 59

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 98

Medical Food and Drug Administration Pharmacology Medicine 98

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 105

Food and Drug Administration Manufacturing Safety Pharmaceutical 105

pharmaphorum

JANUARY 23, 2023

Morphic had previously also entered into a research collaboration with AbbVie focusing on alpha V beta 6 integrin inhibitors, but rights to that was returned to the biotech after a safety signal emerged in the preclinical testing stage. The post Morphic loses second partner as J&J exits integrin alliance appeared first on.

Safety 52

Safety FDA Pharma 52

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

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 98

Patients Manufacturing Leads Safety 98

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 98

Insurance Patients Healthcare Healthcare 98

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

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

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 Key account management Law & Regulation Management 52

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 96

Patients Pharma Consulting Transportation 96

Clarivate

MAY 13, 2024

Insurance exchanges underwent their largest single-year enrollment growth since their inception in 2014, pushing exchange enrollment to yet another all-time high. Reconnection to coverage is also variable by state, with some states forcing families to re-apply for coverage, a process that can take weeks.

Insurance 52

Insurance Marketing Healthcare Healthcare 52

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 98

Food and Drug Administration Pharmaceutical FDA Medicine 98

European Pharmaceutical Review

JULY 22, 2024

It is not accurate to use ‘sterile’ to describe surfaces, methodologies, or environments such as biological safety cabinets and isolators. This term is best applied to drug substance or product, or items rendered sterile using a validated process such as sterile filtration. The term ‘sterile’ is not to be used casually.

Manufacturing 52

Manufacturing Medicine Management Pharmaceutical 52

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

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 98

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 98

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 104

Patients Food and Drug Administration Side effects Safety 104

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

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 105

Food and Drug Administration Manufacturing Medicine Pharma 105

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 98

Government Pharmaceutical Safety Consulting 98

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 98

FDA Doctors Patients Prescription 98

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 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

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 147

Medical sales Medical Sales Doctors 147

pharmaphorum

JANUARY 3, 2023

After passing on the reins of NICE, he was appointed chair of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), heading up the agency for two 3-year terms between 2014 and 2020. ” The post Tributes as former NICE, MHRA chair Sir Mike Rawlins dies appeared first on.

Medicine 52

Medicine Side effects Safety Healthcare 52

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 69

FDA Patients Safety Medicine 69

European Pharmaceutical Review

AUGUST 15, 2024

BTKis, oral drugs given as continuous monotherapy, have revolutionised the treatment of CLL, with the first generation BTKi ibrutinib receiving European Medicines Agency (EMA) approval in 2014; however, side-effects (such as cardiovascular toxicities 2 ) have limited its suitability. for all-comers; HR=0.52

Safety 52

Safety Patients Medical 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 Marketing 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

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 111

Distribution Manufacturing Food Pharmaceutical 111

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 Medical 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

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 130

Education Patients Medical sales reps Medical sales 130

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

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 40

Management Patients Physicians Government 40