Pharmaceutical Technology

JANUARY 18, 2023

In September 2018, the US Food and Drug Administration (FDA) approved Galcanezumab as the preventive treatment of migraine in adults. The double-blind, randomised, placebo-controlled pivotal trial evaluated Galcanezumab’s safety and efficacy in episodic migraine patients from India, China, and Russia.

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pharmaphorum

NOVEMBER 3, 2022

Regeneron’s main rival was Pfizer with tanezumab , which got as far as marketing applications in the US and EU for osteoarthritis-related pain before being shot down by regulators on safety grounds. Faced with the regulatory resistance, Pfizer gave up on tanezumab shortly afterwards.

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World of DTC Marketing

FEBRUARY 4, 2021

Amgen CEO Bob Bradway racked up a 2018 pay package of $18.6 The company decided there were too few reports of serious depression and suicidal behavior and not enough specifics about those cases to warrant more than “routine” monitoring of safety data. She recovered very nicely and is now in charge of a team at Amazon.com.

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pharmaphorum

DECEMBER 22, 2022

Prediction 1: the FDA will become more directive and collaborative on guidelines for DCTs. The risk of not having these discussions is to conduct expensive trials only to discover too late that they were measuring the wrong endpoint, in the wrong way, or with a tool or technology the FDA does not accept.

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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.

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European Pharmaceutical Review

JUNE 29, 2023

A reduced global inspections rate in a post-pandemic world further augment the challenge; in 2022 the US Food and Drug Administration (FDA) inspected only six percent of approximately 2,800 overseas manufacturers. But with the spate of recalls, the FDA developed a Guidance for Industry on Control of Nitrosamine Impurities in Human Drugs.

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Food and Drug Administration Manufacturing Food Medicine 85

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.

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European Pharmaceutical Review

MARCH 6, 2023

On 6 January, a milestone was achieved—lecanemab gained US Food and Drug Administration (FDA) approval via the Accelerated Approval pathway. In clinical trials, we targeted the early AD population with confirmed amyloid in the brain and found the right optimal dose that balanced efficacy and safety in the large Phase II dose-ranging study.

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Food and Drug Administration Safety Medicine FDA 73

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. FDA Update. Drug Approvals.

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PM360

OCTOBER 28, 2022

Likewise, it enables them to predict the effect of the compound on the target and the compound’s safety risks. Clinical trials: Evaluating the safety and efficacy of new drugs consumes up to half of the total cost of the drug development process. According to a Deloitte report , pharmaceutical investment ROI has declined from 10.1%

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Pharmaceutical Technology

JANUARY 8, 2023

Since then, the US FDA, EMA, and other agencies have approved several biologic antibodies targeting the inflammatory cytokines IL-4, IL-13, IL-5, and others for asthma. In 2018, the FDA rejected the approval application for GSK’s Nucala (mepolizumab) in COPD. Still, patients require an individual-led approach.

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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. The US Food and Drug Administration (FDA) further estimates that 97 percent of online pharmacies are operating illegally. 2019; Available from: [link]. Available from: [link].

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Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 90

Clarivate

MAY 24, 2022

6] [7] However, in May 2018, the National Health Commission of China (NHC), together with four other national agencies, formulated China’s First List of Rare Diseases (CRDL) to provide a foundation for policymaking around rare disease treatments. 3] Rare Diseases at FDA [online]. [4] 2018; 40:432-434. (in 10] [11] [12].

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pharmaphorum

SEPTEMBER 16, 2022

The week 16 data of lebrikizumab […] points towards a drug with robust efficacy with hardly any safety trade-offs. The FDA granted lebrikizumab Fast Track designation in December 2019. He explained just how promising the recent trial’s maintenance data compared to short-term data results are. About the interviewee.

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Management Side effects Patients Safety 83

Clarivate

MARCH 17, 2022

How feasible is it to establish a drug’s safety for use in a population that may be unwilling or unable to participate in clinical trials? Experts at a November 2021 Food and Drug Administration (FDA) meeting also wrestled with this theme of clinical trials and pregnancy. Medicine use during pregnancy: balancing risks.

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Food and Drug Administration Safety FDA Ethics 10

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. Science 2018 Available from: [link] Davar D. Internet] European Commission.

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pharmaphorum

SEPTEMBER 8, 2022

This year, Novartis’ deal-making in the area paid off when it received US FDA approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for previously-treated patients with PSMA-positive metastatic castration-resistant prostate cancer. The drug was added to Novartis’ portfolio through a $2.1

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Manufacturing Pharma Side effects Patients 101

PM360

JULY 26, 2023

Even top AI developers from Google and OpenAI co-signed a statement at the end of May from non-profit the Center for AI Safety that said, “Mitigating the risk of extinction from AI should be a global priority alongside other societal-scale risks such as pandemics and nuclear war.”

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Clarify Health

JULY 13, 2020

Approvals have spiked in recent years, with 59 new drugs approved in 2018. They narrowed the eligibility criteria, much beyond what was approved by the FDA. Despite their efficacy and safety, the high cost and lifetime use made payers put up barriers to exclude the drug on formulary. With a record-setting price of $2.1

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Pharmaceutical Pharma Patients Marketing 52

European Pharmaceutical Review

SEPTEMBER 21, 2023

Considerable progress has been made in other areas including enhancing safety, improving treatment administration and patient monitoring systems and implementing innovative pricing strategies – all with the goal of providing timely access to eligible patients who can benefit from these treatments. Internet] FDA. Annu Rev Med.

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pharmaphorum

NOVEMBER 4, 2022

Pfizer and BioNTech will share the development costs in what is the fourth collaboration between the companies in the infectious diseases field, after an influenza vaccine collaboration initiated in 2018, the COVID-19 vaccine collaboration begun in 2020, and the shingles vaccine collaboration of this year.

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Pharmaceutical Technology

SEPTEMBER 14, 2022

In 2018, the World Health Organisation (WHO) reported that 570,000 women were diagnosed with cervical cancer, of which 311,000 died of the disease. Opdivo is a programmed cell death receptor-1 (PD-1) inhibitor approved by the US Food and Drug Administration (FDA) for the treatment of several cancers.

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Food and Drug Administration Patients FDA Pharmaceutical 59

PM360

DECEMBER 14, 2022

As of yet, the FDA has only approved medical cannabis in the form of CBD products used for treating epilepsy seizures and nausea caused by chemotherapy, though it is prepared to review studies for several other indications currently in trials.

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Pharmaceutical Technology

DECEMBER 21, 2022

According to a cross-sectorial survey by the consulting firm Mckinsey & Company , 52% of respondents reported investing in AI this year compared to 40% in 2018. This could spell high-stake consequences for consumers whose privacy and safety could be at risk if AI models are not regulated. FDA and EMA action.

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Medgadget

MARCH 2, 2023

Moreover, due to the different nature of healthy and cancerous tissue, alpha radiation produced by Alpha DaRT sources diffuses about a millimeter into healthy tissue while penetrating at a diameter up to about five millimeters into tumors, providing an automatic safety mechanism. Results from initial clinical trials were quite impressive.

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Pharmaceutical Technology

JANUARY 22, 2023

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. The company plans to submit an MAA to the EMA in H1 this year.

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Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

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pharmaphorum

OCTOBER 31, 2022

It is the first FDA-approved treatment for Zaire ebolavirus. Yancopoulos continued: “Our scientists realised that the science demanded they adapt these technologies to deliver the first FDA-approved recombinant monoclonal antibody treatment for any viral disease, and they picked one of the most challenging ones in Ebola.”.

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Pharmaceutical Technology

FEBRUARY 6, 2023

According to 2018 data, IPF occurs in less than five individuals per 100,000 per year. The FDA approved both drugs in 2014. On February 2, the FDA cleared an Investigational New Drug Application for PLN-101095. The company has attributed the success of the follow-on offering to the strength of Phase IIa INTEGRIS-IPF trial data.

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Marketing Pharmaceutical FDA Prospecting 59

World of DTC Marketing

MAY 6, 2021

A study published in JAMA Internal Medicine examined the costs of developing 10 cancer drugs approved by the FDA from 2006 to 2015 and provided a strong contrast to the Tufts study from a year before. years to win FDA approval, at a median cost of $648 million. Big Pharma’s Go-To Defense of Soaring Drug Prices Doesn’t Add Up.

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