Pharmaceutical Technology

FEBRUARY 8, 2023

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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Pharmaceutical Technology

JULY 26, 2022

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) of Novartis subsidiary Sandoz for natalizumab, a proposed first-ever multiple sclerosis (MS) biosimilar to reference medicine Tysabri. In 2019, Sandoz and Polpharma Biologics signed an international commercialisation agreement for natalizumab.

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European Pharmaceutical Review

FEBRUARY 22, 2023

1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. He is currently a CMC consultant with an interest in impurities and safety‑based limits. 2019; 116(3): 168-169. 2019; 116(3): 168-169.

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European Pharmaceutical Review

DECEMBER 13, 2022

The following year, the US Congress passed the 1938 Federal Food, Drug and Cosmetic (FD&C) Act, which mandated safety assessments prior to the release of any new drug. There is now global awareness of this issue and FDA issued a guidance note on the problem in 2007. Pharmacopoeia guidance on DEG and EG. 05 October 2022.

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European Pharmaceutical Review

JANUARY 26, 2023

These concentration measurements are used as part of regulatory decisions regarding the safety and efficacy of medicinal products. The US Food and Drug Administration (FDA) implementation date was 7 November 2022. The draft ICH M10 guideline was published for comments in 2019.

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pharmaphorum

DECEMBER 14, 2022

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. In 2020, the FDA-approved indication was expanded to include those patients who suffer from cataplexy.

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pharmaphorum

AUGUST 11, 2022

Sanofi had rights to the OTC version of the drug that was recalled in 2019 over possible contamination with the suspected carcinogen N-nitrosodimethylamine (NDMA), with the FDA banning sales the following year. Some voluntarily took their products off the market as soon as the NDMA finding was reported by the FDA.

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pharmaphorum

OCTOBER 25, 2022

Astellas has been having some safety-related issues with its gene therapy programmes of late, but it shows no signs of lessened enthusiasm for the category – as a new alliance with US biotech Taysha demonstrates.

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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. During August 2023 the FDA also updated its guidance for NDSRIs 7 and it was closely aligned (but not identical) to EMA’s evolving guidance. ng/day, compared to EMA which is 18 ng/day.

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pharmaphorum

DECEMBER 5, 2022

That sets up a rolling Biologics License Application (BLA) with the FDA by the end of the year, setting Valneva on course to bring the first chikungunya vaccine to market anywhere in the world. Valneva estimates that the global market for vaccines against chikungunya could exceed $500 million annually by 2032.

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Pharma Marketing Network

MARCH 25, 2022

2 In 2019, there were 7 potential family caregivers per older adult. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic.

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Legacy MEDSearch

SEPTEMBER 26, 2023

Food and Drug Administration (FDA) has approved MRI conditional labeling for the Evoke ® System, the first and only precision, dose-control spinal cord stimulation (SCS) therapy powered by SmartLoop technology. Specific scan conditions and safety information are provided in the Evoke ® SCS System MRI Guidelines manual. Are you hiring?

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Legacy MEDSearch

AUGUST 25, 2022

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical. Are you hiring?

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European Pharmaceutical Review

AUGUST 9, 2022

percent of recalls recorded by the US Food and Drug Administration (FDA) between 2012 and 2019. As a result of the rate of contamination events, simple and rapid detection of BCC in non-sterile pharmaceutical products is critical to ensure consumer safety.

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European Pharmaceutical Review

NOVEMBER 15, 2022

The validation of computerized systems should be focused on ‘intended use’ and scaled commensurate with the risks to patient safety, product quality and data integrity” The focus until now has too often been on compliance and not on quality. Takeaways from ISPE’s GAMP 5 Second Edition update.

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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. 2019; 70:273–288. Internet] FDA.

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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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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]. References.

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Pharmaceutical Technology

DECEMBER 5, 2022

Notably, Lupkynis is the first oral therapy approved by the US Food and Drug Administration (FDA) and EC for the treatment of active LN. Overall, Aurinia’s Lupkynis is expected to face tough competition from Benlysta in LN, which received FDA approval in December 2020 and EMA approval in May 2021.

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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.

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European Pharmaceutical Review

SEPTEMBER 26, 2023

This recent decision by the EC follows approval of Tyruko ® (natalizumab) by the US Food and Drug Administration (FDA) last month for the same indication. Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Tysabri ® is a registered trademark of Biogen MA, Inc.

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pharmaphorum

DECEMBER 7, 2022

Sanofi had rights to the OTC version of the drug that was recalled in 2019 over possible contamination with the suspected carcinogen N-nitrosodimethylamine (NDMA), with the FDA banning sales the following year.

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European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Importantly, we believe the safety, reliability, and pharmacokinetic data that we collected through both parts of the Phase I study support the initiation of a Phase II trial of RT-102 in osteoporosis,” Hashim said.

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pharmaphorum

SEPTEMBER 11, 2022

Bristol-Myers Squibb’s deucravacitinib– one of the main pipeline assets in its $74 billion takeover of Celgene in 2019 – has been approved in its first market as a treatment for moderate-to-severe plaque psoriasis. billion oral psoriasis therapy Otezla (apremilast). Otezla was acquired by Amgen for $13.4

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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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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 regulator also granted approval for Galcanezumab to treat episodic cluster headaches in adults in June 2019. The monoclonal antibody selectively attaches to calcitonin gene-related peptide (CGRP).

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Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) granted Eli Lilly’s Lartruvo (olaratumab) accelerated approval in 2016 for soft tissue sarcoma (STS). It is estimated that STS causes approximately 5,000 deaths in the US per year with 13,000 new cases in 2019. Olaratumab will be denoted as TLX300 in Telix’s development pipeline.

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European Pharmaceutical Review

SEPTEMBER 22, 2023

Limitations of monoclonal antibody therapies Regulatory approvals from the US Food and Drug Administration (FDA) for aducanumab and lecanemab – and likely very soon for donanemab also – opened a route for different therapeutic modalities and other relevant disease targets, such as tau.

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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.

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pharmaphorum

NOVEMBER 4, 2022

Galapagos is in the roll-out phase for its first commercial products – JAK1 inhibitor Jyseleca (filgotinib) for rheumatoid arthritis – which has been approved in Europe and Japan but fell foul of FDA concerns about the class’s safety and was rejected in the US. Jyseleca has made €60.5

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European Pharmaceutical Review

JULY 13, 2023

IL-2 therapy is associated with safety concerns, namely the adverse event capillary leak syndrome, which often leads to hospitalisations and thus limits its clinical use. 2019; 1(1): 100001. Although IL-2 was recognised as an efficacious treatment, clinical use was limited by toxicity issues. Mol Cancer. 2022; 21(1). Tang A, Harding F.

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pharmaphorum

JANUARY 23, 2023

Morphic Therapeutic has lost Johnson & Johnson’s Janssen Pharma as a partner, following the termination of an alliance to develop drugs targeting integrins first agreed in 2019. In a filing with the Securities and Exchange Commission (SEC). ” It was modified again in the middle of 2021.

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Pharmaceutical Technology

JANUARY 10, 2023

Many of the current existing therapies are often viewed by physicians as not optimal to addressing the needs of patients, and challenges remain such as improving patient compliance, safety profile, and addressing comorbidities of T2D. billion in sales in 2019, increasing to $136.2

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Medgadget

MAY 2, 2023

Throughout 2016 and until mid-2019 we conducted a deep technology due diligence, as well as market research, and met and spoke with dozens of mental healthcare providers. During this time, two additional studies ended successfully and were published, further validating the clinical safety and effectiveness.

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Pharmaceutical Technology

AUGUST 16, 2022

In 2019, Daiichi Sankyo entered a global development and commercialisation agreement with AstraZeneca for Daiichi Sankyo’s lead antibody-drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), in a deal worth $6.9bn. overall response rate (ORR), with a median duration of response (DOR) of 8.7

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Clarivate

OCTOBER 7, 2021

What’s new from ESMO: Interim efficacy and safety analysis from the randomized KEYNOTE-716 study showed that the trial met its primary endpoint of RFS, with patients receiving Keytruda presenting an RFS of 90.5% Context: In August 2021, Merck & Co. at 12-months compared to 83.1% in the placebo group.

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European Pharmaceutical Review

FEBRUARY 28, 2023

The US Food and Drug Administration (FDA) subsequently developed a liquid chromatography – high resolution mass spectroscopy (LC-HRMS) method for the determination of NDMA in ranitidine. FDA assigned a provisional AI of 26.5 10 It is not clear whether FDA will adopt a similar t-AI. 2019; 103: 325–329. J Pharm Sci.

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