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. Cutting down on safety stock. Here’s how applying automaton in pharmaceutical labs can help address these. Reducing capacity issues. Better communication with traceable data.

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pharmaphorum

JANUARY 3, 2023

” Rawlins was knighted in the 1999 Queen’s New Year Honours for services to the improvement of patient protection from the side effects of medicines, and in 2017 was appointed Knight Grand Cross of the Order of the British Empire (GBE) for services to the safety of medicines, healthcare, and innovation.

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World of DTC Marketing

AUGUST 12, 2022

Meanwhile, the top 25 pharmaceutical companies reported a “healthy average operating margin of 22 percent” at the end of 2017, according to an analysis by GlobalData. 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.

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pharmaphorum

JANUARY 3, 2023

Side-effect data from the open-label studies was also encouraging, helping to downplay concerns abut evenamide’s cardiovascular and central nervous system safety that emerged in 2019. ” The new data could accelerate partnering efforts of the drug this year.

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Side effects Biopharma Patients Competition 100

pharmaphorum

DECEMBER 20, 2022

There were some safety issues to consider, notably that around a third of patients developed fluid retention (oedema) at least once during the study, although Idorsia maintains that almost all (95%) of those cases were mild to moderate and occurred in the first month of treatment. .

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Sales FDA Patients Safety 86

pharmaphorum

SEPTEMBER 14, 2022

SparingVision’s lead candidates are both targeting inherited retinal diseases (IRDs), a group which already has a gene therapy on the market in Novartis’ Luxturna (voretigene neparvovec), which was approved by the FDA in 2017 for biallelic RPE65 mutation-associated retinal dystrophy, a group which includes a small group of RP patients.

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PM360

JUNE 26, 2023

In 2017, Algeria imposed importation restrictions on medicinal products that could be manufactured domestically, forcing manufacturers to establish local manufacturing facilities or to work with a contract manufacturing organization (CMO). To illustrate, let’s take the example of protectionist policies. References: 1.

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Medicine Marketing Pharma Manufacturing 98

World of DTC Marketing

MAY 19, 2021

According to CNBC “AbbVie workers say they worry that the company is putting profits ahead of safety and the health of its U.S. The increase followed total Humira price hikes of 19 percent during 2017 and 2018. employees and their families at risk.

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Pharmaceutical Technology

JANUARY 27, 2023

Briumvi is the third approved injectable MS treatment directed against CD20 antigen expressed on B cells, with the other therapies being Kesimpta (ofatumumab, approved in 2020) and Ocrevus (ocrelizumab, approved in 2017). All three treatments are monoclonal antibodies.

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European Pharmaceutical Review

OCTOBER 21, 2022

At week 28, the study assessed the vaccine’s safety and levels of anti-HBV surface antibodies (HBsAbs). A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017. All participants all were on antiretroviral therapy and received a 0.5ml intramuscularly injected dose of the HEPLISAV-B vaccine.

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Patients Food and Drug Administration Side effects Food 76

pharmaphorum

AUGUST 18, 2022

Treatment with VMS currently relies on hormonal replacement therapy (HRT) as well as less commonly other drugs like selective serotonin reuptake inhibitor (SSRI) antidepressants, which all have trade-offs between safety and efficacy. It acquired elinzanetant as part of its takeover of UK biotech KaNDy Therapeutics in 2020. .

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Pharmaceutical Technology

MARCH 23, 2023

Between 2017 and 2021, the number of industry-led Phase III trials initiated fell by 48%, as per the report. He said, “It’s great to see the MHRA taking forward these important changes to UK clinical trials regulation centred on patient safety and the benefits of participating in research”.

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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). 2017; 8(43): 75712–26. Oral Presentation JGN-75414. Nan X, Xie C, Yu X, Liu J. Oncotarget.

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European Pharmaceutical Review

AUGUST 22, 2022

This motivated the biopharma sector to devise smart approaches to develop and manufacture vaccines without compromising on their safety and efficacy. This can drive informed decisions and strategies to enhance the safety, quality and efficiency of the manufacturing process. Novel biotechnology platforms for vaccine development.

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Manufacturing Biopharma Engineering Safety 90

Pharmaceutical Technology

JANUARY 23, 2023

The few approvals within paediatrics can be seen to be contributing to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs.

Medical 59

Medical Ethics Specialization Physicians 59

pharmaphorum

JANUARY 5, 2023

In 2017, reSET became the first FDA-approved DTx with both a safety and efficacy label, after the US regulator licensed it for substance use disorders involving alcohol, cocaine, marijuana, and stimulants. Pear secured approval for reSET-O in the following year.

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Prescription Specialization FDA Networking 52

pharmaphorum

JANUARY 18, 2023

Recently-listed NewAmsterdam is trying to succeed where a number of much larger drugmakers have failed – including Merck & Co , Pfizer, Eli Lilly, and Roche – which have all scrapped CETP development programmes following safety or efficacy issues. Amgen licensed the rights to NewAmsterdam in 2020.

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Pharma Prospecting Patients Safety 57

Clarivate

NOVEMBER 10, 2022

The purpose of clinical trials is to understand the efficacy and safety of treatments for the patients who need them. In 2017, the Clarivate COA team began working with a sponsor to develop COAs for evaluating key clinical trial endpoints in alopecia areata clinical trials. The regulatory landscape around COAs is fast evolving.

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Patients Food and Drug Administration FDA Safety 52

Pharmaceutical Technology

FEBRUARY 10, 2023

Access to oncology medicines varies across countries, and their cost against safety/efficacy is generally perceived as being low, such as in the US. The three agreed on a confidential price, and the TLV determined whether the drug was cost effective for the eligible patient population.

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European Pharmaceutical Review

DECEMBER 12, 2023

A favorable safety profile was also observed. Beyond Sezary Syndrome, lacutamab showed also preliminary safety and efficacy in TELLOMAK on the first 21 patients having KIR3DL2-expressing Mycosis fungoides with an encouraging global response rate of 28.6 An ORR of 46.4 percent has been also reported in the skin and 48.2

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Pharma Engineering Safety Patients 108

pharmaphorum

OCTOBER 18, 2022

In January, for example, they started enrolment in the open-label, phase 2 PAVO trial of GSK’s PARP inhibitor Zejula (niraparib) that is investigating the drug’s safety and efficacy in patients with cancers which carry PALB2 mutations.

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Pharma Recruitment Patients Networking 52

pharmaphorum

SEPTEMBER 11, 2022

.” He added that the “consistently positive data generated across progression-free survival, objective response rate, and patient-reported outcomes, coupled with a safety profile that is suitable for long-term dosing, support the potential for nirogacestat to become an important and much needed treatment.”

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Side effects Leads Safety Patients 52

pharmaphorum

JULY 26, 2022

Merck’s exit came after other companies including Pfizer, Eli Lilly and Roche all scrapped CETP development programmes following safety or efficacy issues. Others were let down not by safety but efficacy, with anacetrapib coming closest to showing value in a phase 3 trial. Amgen licensed the rights to NewAmsterdam in 2020.

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Side effects Safety Pharma Patients 52

PM360

DECEMBER 20, 2023

From 2017 to 2022, the Chinese market witnessed a growth rate of 5.3%, compared to the average market growth of 6.6% Between 2017 and 2021, the median time difference between the first global approval and the approval in China was five years 1. Long Way to Go: Progress of Orphan Drug Accessibility in China from 2017 to 2022.”

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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. 2017; 106(5): 1302-1309. J Pharm Sci.

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Pharmaceutical Food and Drug Administration Medicine FDA 98

Clarivate

MAY 11, 2023

To address this pain point, the Center for Drug Evaluation (CDE) announced in 2017 that it would accept marketing applications based on clinical evidence generated in multicenter studies conducted overseas [1]. However, to gain approval for a new drug or label expansion, developers needed to meet specific requirements laid out by the CDE.

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Marketing Patients Management Insurance 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.

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Food and Drug Administration Medicine Food Government 109

pharmaphorum

SEPTEMBER 30, 2022

The approval makes Relyvrio (sodium phenylbutyrate and taurursodiol) the first new therapy option for ALS – also known as motor neuron disease (MND) – since Mitsubishi Tanabe Pharma’s intravenous Radicava (edaravone) was cleared by the FDA in 2017. An oral version of edaravone was cleared this year.

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pharmaphorum

MARCH 10, 2017

2017 is once again a year of significant change for pharma market access in Europe, with affordability on the agenda for almost every country in the region.

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Marketing Competition Safety Pharma 52

Pharma Marketing Network

MARCH 25, 2022

Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Connect at linkedin.com/in/sunnywhite/ .

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Legacy MEDSearch

AUGUST 25, 2022

The primary safety endpoint is a performance goal for device and procedure related adverse events at 30 days. The FDA-approved randomized IDE trial has been designed to validate the safety and effectiveness of PiCSO.” Major adverse cardiac events and heart failure endpoints will be captured acutely and for up to 3 years.

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Medical FDA Recruitment Pharmacology 52

pharmaphorum

SEPTEMBER 16, 2022

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. Despite this, there are still remaining unmet needs in moderate to severe AD, mainly around getting robust efficacy over time without safety tradeoffs and better convenience regimens.”.

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Management Side effects Patients Safety 71

European Pharmaceutical Review

MARCH 11, 2024

With therapeutic expertise in HIV, hepatology and rare diseases, Sherene has additional expertise in clinical pharmacology and drug safety. Internet] 2017. Sherene has worked in the healthcare sector for more than 20 years, including in several leadership roles at GSK. Lancet HIV. 2023;10(5):e295-e307.

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Medicine Pharmacology Healthcare Healthcare 92

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). 2017; 8(23):38022-38043. Cancer Chemother Pharmacol. 2019; 83(1):169-178. Oncotarget.

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Patients Food and Drug Administration Side effects Safety 85

pharmaphorum

AUGUST 4, 2022

AR has developed enormously over the last few years, meaning that highly visual step-by-step guidance and training procedures can be delivered to employees to ensure they follow safety protocols without being exposed to actual real-life risks in the manufacturing facility. She joined NSF in 2017. appeared first on.

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Recruitment Pharma Training Pharmaceutical manufacturing 86

Contrarian Sales Techniques

FEBRUARY 26, 2023

The paper was presented at the International Conference on Pharmaceutical Research and Development (IPRDC) in Kuala Lumpur, Malaysia, in June 2017. There are some countries in the world that do not require waiting for patent expiration to produce a generic version of a drug.

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Pharmaceutical Medicine Government Side effects 52

PM360

SEPTEMBER 15, 2022

In many of the states where abortion is banned, strictly regulated, or soon to be restricted, the procedure is legal only in instances of a life-threatening situation, but no regulations define what such a situation may be, leaving 70% of physicians unclear about when to intervene for maternal safety.

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