Pharmaceutical Technology

OCTOBER 1, 2022

The US Food and Drug Administration (FDA) has granted approval for Amylyx Pharmaceuticals’ Relyvrio (sodium phenylbutyrate and taurursodiol) to treat adult patients with amyotrophic lateral sclerosis (ALS). Additionally, treatment with Relyvrio substantially reduced physical function loss in ALS patients.

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Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

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European Pharmaceutical Review

DECEMBER 6, 2023

The US Food and Drug Administration (FDA) has approved the first oral monotherapy treatment for adults with paroxysmal nocturnal haemoglobinuria (PNH). The first, the Phase III APPLY-PNH trial evaluated patients with residual anaemia (haemoglobin < 10 g/dL) despite prior anti-C5 treatment who switched to Fabhalta.

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Pharmaceutical Technology

MAY 5, 2023

The US Food and Drug Administration (FDA) has accepted Optinose’s supplemental new drug application (sNDA) for Xhance (fluticasone propionate) to treat chronic rhinosinusitis, which is now under review. The regulator has set 16 December 2023 as a prescription drug user fee act (PDUFA) target goal date.

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Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. The pharmacist can then review their medical history to make sure there are no concerns of drug-drug interactions with Paxlovid.

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Pharmaceutical Technology

NOVEMBER 10, 2022

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for Swedish Orphan Biovitrum AB ’s (Sobi) Kineret (anakinra) to treat Covid-19 in adult patients who are hospitalised with pneumonia. Additionally, the benefits offered by Kineret were found to last long. “The

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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. Key opinion leaders (KOLs) interviewed by GlobalData believe this may have significant impact on patients as the less-invasive route of administration will be preferred by many.

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Pharmaceutical Technology

FEBRUARY 9, 2023

The US Food and Drug Administration (FDA) has granted approval for Regeneron Pharmaceuticals’ Eylea (aflibercept) injection to treat the retinopathy of prematurity (ROP) in preterm infants. A VEGF inhibitor, Eylea is jointly developed by Bayer and Regeneron Pharmaceuticals.

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Pharmaceutical Technology

AUGUST 12, 2022

In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses.

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European Pharmaceutical Review

JANUARY 19, 2023

The contribution will enable the programme to reach additional physicians and medical students, further expanding the initiative that aims to extend the reach of clinical trials in underserved patient populations in US communities. The Winn Award Program has so far trained 114 early-stage investigator physicians.

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Pharmaceutical Technology

MAY 18, 2023

The US Food and Drug Administration (FDA) has accepted Ardelyx’s resubmission of a new drug application (NDA) for XPHOZAH (tenapanor) to control serum phosphate in adults with chronic kidney disease on dialysis who have had insufficient response or intolerance to a phosphate binder treatment.

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Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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Pharmaceutical Technology

FEBRUARY 24, 2023

Sanofi has received approval from the US Food and Drug Administration (FDA) for its Altuviiio [Antihemophilic Factor (Recombinant) , Fc-VWF-XTEN Fusion Protein-ehtl], to treat a type of inherited bleeding disorder known as haemophilia A. It is expected to be available commercially in April in the US. median ABR.

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Pharmaceutical Technology

OCTOBER 26, 2022

The US Food and Drug Administration (FDA) has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson ’s (J&J) Tecvayli (teclistamab-cqyv) to treat relapsed or refractory multiple myeloma in adults. Tecvayli treatment offered an overall response rate (ORR) of 61.8%, with 28.2%

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Pharmaceutical Technology

NOVEMBER 3, 2022

The US Food and Drug Administration (FDA) has granted approval for the supplemental new drug application (sNDA) of Gilead Sciences ’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

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Pharmaceutical Technology

JANUARY 12, 2023

The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma. Airsupra has been approved for the as-needed treatment or prevention of bronchoconstriction and for reducing the exacerbations risk in asthma patients aged 18 years and above.

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European Pharmaceutical Review

AUGUST 30, 2022

The European Commission has granted conditional marketing authorization to BioMarin’s ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe haemophilia A in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5).

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European Pharmaceutical Review

AUGUST 14, 2023

The US Food and Drug Administration (FDA) has approved Janssen’s Akeega (niraparib and abiraterone acetate), for the treatment of adult patients BRCA-positive metastatic castration-resistant prostate cancer (mCRPC). The FDA approval was based on positive results from the multi-centre Phase III MAGNITUDE study.

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Pharmaceutical Technology

DECEMBER 7, 2022

On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps.

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Pharmaceutical Technology

JUNE 14, 2023

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). More than 90% of patients who received treatment with odevixibat were pruritus responders.

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Pharmaceutical Representative Training

DECEMBER 28, 2021

Before 2020, the landscape of drug marketing involved following drug approvals by the Food and Drug Administration ( FDA ), finding which patient population would benefit from therapy, and visiting specialized doctors in-person to advertise its advantages compared to current guidelines.

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Pharmaceutical Technology

AUGUST 2, 2022

The US Food and Drug Administration (FDA) has granted approval for the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) ’s Stelara (ustekinumab) to treat paediatric patients aged six years and above with active psoriatic arthritis (PsA).

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European Pharmaceutical Review

JULY 13, 2023

In many European countries physicians can now prescribe medical cannabis for an array of chronic health conditions, including chronic pain, mental health disorders and neurological conditions. 3 With established drug development pathways, we are accustomed to a rigid structure of translation from bench to bedside.

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Pharma Marketing Network

JULY 10, 2023

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. It can be a complex and challenging process, as pharmaceutical companies must adhere to strict regulations while also developing creative and effective marketing campaigns.

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Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The first AdCom was critical of the study’s robustness. The FDA’s action plan.

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Legacy MEDSearch

AUGUST 23, 2023

Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee met to discuss the pre-market approval application (PMA) for the Paradise Ultrasound Renal Denervation (RDN) system, indicated to reduce blood pressure in patients with hypertension.

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Pharmaceutical Technology

SEPTEMBER 2, 2022

This is a result of intensive research efforts that have produced regimens that have prolonged patient survival, most of which are a combination of a proteasome inhibitor + an immunomodulatory drug (ie. The post An increasing impact of BCMA-targeting biologics in multiple myeloma appeared first on Pharmaceutical Technology.

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European Pharmaceutical Review

NOVEMBER 8, 2022

In the current US Congressional session, Congress has focused heavily on legislation directed at reducing prescription drug prices. The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. Kyle advises investors, academic medical centres, physician practices, and consultants on a range of business, legal, and regulatory issues affecting the telemedicine industry. If so, developers must develop and execute on a regulatory strategy.

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Evolve Your Success

MAY 17, 2022

Antra and Karen started a company and have a podcast where they speak about patient advocacy, impacting how nurses receive an education. Private Patient Advocacy: The Medical Sales Rep’s Role In The Nursing World With Antra Boyd And Karen DiMarco, Part 2. — There is a medical device pharmaceutical rep to get to know the nurses.

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European Pharmaceutical Review

MARCH 8, 2023

Now working as a woman in pharma, Dr Ekaterina Malievskaia highlighted her female inspirations in the industry, two of which have held leading roles at Bristol Myers Squibb and the US Food and Drug Administration (FDA). What made you decide to start working in the pharmaceutical industry?

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European Pharmaceutical Review

SEPTEMBER 21, 2023

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. billion by 2030. How has the gene therapy landscape evolved over the last several years?

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European Pharmaceutical Review

JANUARY 13, 2023

AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use auto-injector (AI) pen for severe asthma patients over 12 years. Trial results on the biologic for severe asthma . Regulatory decisions for Tezspire.

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European Pharmaceutical Review

OCTOBER 25, 2022

AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) combination therapy has been approved in the US for adult patients with unresectable hepatocellular carcinoma (HCC). Phase III trial results found that three years post-treatment, 31 percent of patients given the drug combination were still alive.

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European Pharmaceutical Review

SEPTEMBER 28, 2023

The US Food and Drug Administration (FDA) has approved Takeda’s single-dose pre-filled pen for ENTYVIO ® (vedolizumab) as a treatment for the chronic inflammatory disease ulcerative colitis. The biologic is approved for intravenous (IV) and subcutaneous (SC) administration.

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Pharmaceutical Technology

APRIL 4, 2023

Vertex Pharmaceuticals and CRISPR Therapeutics have completed the rolling submission of biologics licence applications (BLAs) to the US Food and Drug Administration (FDA) for exagamglogene autotemcel (exa-cel) to treat sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT).

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Pharmaceutical Technology

FEBRUARY 5, 2023

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients.

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