Pharma Marketing Network

MAY 3, 2023

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

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World of DTC Marketing

JUNE 22, 2022

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). The FDA’s stamp of approval for the Fitbit sensor is a big deal. Then there is the cost of generic drugs.

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Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has accepted Accord BioPharma’s Biologics Licence Application (BLA) for HLX02 (a proposed trastuzumab biosimilar) to treat HER2 cancer types. Accord BioPharma is the US specialty division of Intas Pharmaceuticals.

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Pharmaceutical Technology

FEBRUARY 21, 2023

The US Food and Drug Administration (FDA) has accepted a priority review of the biologics license application (BLA) for Regeneron Pharmaceuticals ’ pozelimab to treat children and adults with ultra-rare CHAPLE disease. It was also granted Orphan Drug Designation during the same time.

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Pharmaceutical Technology

MAY 24, 2023

Inovio has received orphan drug designation for INO-3107 from the European Commission (EC) to treat recurrent respiratory papillomatosis (RRP). In July 2020, the US Food and Drug Administration (FDA) also granted orphan drug designation to INO-3107.

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Legacy MEDSearch

FEBRUARY 13, 2023

the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of the company’s upgraded AI-powered software.

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Pharmaceutical Technology

MAY 10, 2023

The US Food and Drug Administration (FDA) has granted approval for AstraZeneca ’s Farxiga (dapagliflozin) to reduce the risks of cardiovascular (CV) death, hospitalisation for heart failure (hHF) and urgent heart failure (HF) emergency care visits in HF adult patients.

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World of DTC Marketing

SEPTEMBER 7, 2022

In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. They relied so much on a new drug that they tried to market a product with bad science behind it. The pharma industry is a giant behemoth that needs new drugs to survive and grow.

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Pharmaceutical Technology

JUNE 12, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has unanimously voted in support of Eisai and Biogen’s Leqembi and its clinical benefit in patients with early Alzheimer’s disease , raising the drug’s full approval prospects.

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European Pharmaceutical Review

AUGUST 11, 2022

Hospitalised patients on high-flow oxygen for severe COVID-19 pneumonia were nearly 50 percent less likely to die when treated with antiviral remdesivir in combination with steroid dexamethasone and baricitinib, according to research from Rutgers Ernest Mario School of Pharmacy in the US.

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Pharma Leaders

JUNE 27, 2023

An oral inhibitor of hypoxia-inducible factor prolyl hydroxylase, daprodustat is intended for usage in adult patients who are on chronic maintenance dialysis. The company is developing the therapy as an oral treatment option for CKD patients with anaemia. CKD is characterised by gradual kidney function loss.

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Food and Drug Administration Medicine Food Safety 52

European Pharmaceutical Review

AUGUST 11, 2023

Crizanlizumab is a once-a-month, humanised monoclonal antibody infusion, indicated for the prevention of recurrent vaso‑occlusive crises (pain crises) in sickle cell disease patients aged 16 years and above. Adakveo (crizanlizumab) received conditional authorisation by the EC in October 2020.

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European Pharmaceutical Review

JANUARY 29, 2024

In reviewing both the revised ISO standard and FDA study discussed, it is clear robust evaluation of toxicological substances such as extractables and leachables remain a key part of device-drug combination product and medical device safety assessments.

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Legacy MEDSearch

OCTOBER 19, 2023

Food and Drug Administration (FDA) 510(k) clearance for the ACES Automatic Continuous Effusion Shunt System. ACES focuses on patient-centered outcomes, potentially eliminating the need for a long hospital stay and chronic drainage at home. This is a potentially perfect solution,” said David Feller-Kopman, M.D.,

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pharmaphorum

NOVEMBER 2, 2022

In many ways, medicine has advanced rapidly and in myriad ways over the last few decades, and yet the opioid epidemic in the US proved that the challenge of helping patients in pain remains a difficult one to address. The study lasted one year and assessed patients with back pain who had received traditional treatments prior to using Jogo-Gx.

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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

JUNE 29, 2023

Based on scientific knowledge and process understanding, manufacturers of drugs and drug substances have a broad awareness of potential impurities – including nitrosamine impurities – that could form during manufacturing or degradation. 1 Nitrosamines are not new or unknown impurities.

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European Pharmaceutical Review

JANUARY 29, 2024

1 Some five years after the initial NDMA (N-nitrosodimethylamine) contamination issue 2 initially affecting valsartan drug substance, then other active pharmaceutical ingredients (APIs), eg, sartans, ranitidine, metformin, etc; the toxic short alkyl chain N-nitrosamine issue appears, if not resolved, then well on the way to resolution.

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Pharmaceutical Technology

JANUARY 23, 2023

The China National Medical Products Administration (NMPA) approved fruquintinib for marketing in September 2018. Takeda Global Oncology Business Unit president Teresa Bitetti said: “Fruquintinib has the potential to change the treatment landscape for patients with refractory metastatic CRC who are in need of additional treatment options. “We

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Food and Drug Administration Medicine FDA Sales 52

Legacy MEDSearch

JULY 6, 2023

Food and Drug Administration (FDA). The InTandem name reflects both the synchronization inherent in the device’s mechanism of action and the partnership formed between patient and device. The burden on patient functioning is also profound. MedRhythms also unveiled the brand name for MR-001: InTandem.

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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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pharmaphorum

NOVEMBER 27, 2022

Based on results from 1,305 patients who participated in the ARASENS randomised, phase 3, multi-centre, double-blind, placebo-controlled clinical trial, the approval was given after the study showed that the combination treatment led to a statistically significant 32.5% It is coordinated by the US Food and Drug Administration (FDA).

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Pharmaceutical Technology

APRIL 26, 2023

Patients will receive the digital therapy through their mobile phone applications over a 12-week period, and its efficacy will be evaluated based on the difference in the number of monthly migraine days. Click teamed up with Boehringer Ingelheim in September 2020 to develop and commercialise a digital therapeutic to treat schizophrenia.

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PM360

MARCH 22, 2024

Amor Vegas stated, “T cells have the ability to develop memory and persist in your body for really long periods, which is very different from a chemical drug. Think about patients who need treatment multiple times per day versus you get an infusion and then you’re good to go for multiple years.” was approved by the U.S.

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Pharmaceutical Technology

JUNE 27, 2022

Currently, the drug is indicated to treat metastatic or locally advanced epithelioid sarcoma in adults and paediatric patients aged 16 years and above who are not eligible for complete resection and adult patients with relapsed or refractory follicular lymphoma (FL) without any alternative treatment options.

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Legacy MEDSearch

JUNE 22, 2023

Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras. ” This latest FDA clearance for the EyeArt v2.2.0

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European Pharmaceutical Review

AUGUST 1, 2022

The goal is to “ensure all patient groups are reflective of the real-world population and aligned with the epidemiology of the disease studies,” a statement said. The DDiCT project will be co-led by Bristol Myers Squibb (BMS)’s Disability Advancement Workplace Network (DAWN) and the Global Drug Development Team.

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Clarivate

AUGUST 2, 2022

Increased collaboration between regulatory agencies also appears to be having a positive impact on the roll out of new drugs. The following blog post summarizes key findings from the latest CIRS R&D Briefing, New drug approvals in six major authorities 2012-2021. FDA continues to approve the most NASs.

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Legacy MEDSearch

AUGUST 30, 2023

Food and Drug Administration (FDA) 510(k) exemption registration for Bio Leg ; its robotic prosthetic knee. This milestone of achieving our FDA registration underscores our dedication to developing state-of-the-art prosthetic solutions that have the potential to revolutionize mobility of people who have limb loss.”

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Clarivate

NOVEMBER 14, 2023

Well, it is, but only if it benefits patients. 2] Advances in blood glucose monitoring and in the delivery of insulin through insulin pens and, more recently, pumps have also helped to make diabetes management easier for patients. 6] GLP-1 RAs provide another example of the benefits that incremental innovation can bring to patients.

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Legacy MEDSearch

MAY 10, 2023

Food and Drug Administration (FDA) for continuous neonatal and infant monitoring for babies born of any gestational age to infants of 2 years at the International Maternal Newborn Health Conference in Cape Town, South Africa. . We know that going wireless will have the greatest impact for our littlest patients.

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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. lenalidomide) + a steroid ± an anti-CD38 antibody. Does Blenrep have an efficacy advantage over Tecvayli?

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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. Citizen Petitions before the FDA. Senate Bill 562 (S.

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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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Legacy MEDSearch

AUGUST 8, 2022

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. NaviBot is subsidiary of MicroPort MedBot. About MicroPort MedBot Shanghai MicroPort MedBot (Group) Co.,

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European Pharmaceutical Review

OCTOBER 19, 2022

1 However, patent protection for pharmaceutical products is an economic trade-off between providing monopoly rights that incentivise development of future products and permitting higher drug prices to recoup the investment. 4 The initial patents are usually filed during drug discovery. The patent will typically expire after 20 years.

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Pharmaceutical Technology

MAY 16, 2023

In June 2020, CSL Behring announced plans to acquire exclusive global rights for the development and commercialisation of Hemgenix from UniQure. billion in milestone payments, per the June 2020 announcement. The standard of care involved factor replacement therapy where patients receive infusions that replenish their Factor IX levels.

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