World of DTC Marketing

OCTOBER 6, 2021

to produce, according to a report issued last week by drug pricing experts at the Harvard School of Public Health and King’s College Hospital in London. Remdesivir was the first drug approved by the Food and Drug Administration to treat COVID-19. And while it costs $17.74 Merck charges the U.S.

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European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few?

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Pharmaceutical Technology

JUNE 5, 2023

The US Food and Drug Administration (FDA) granted final approval to the therapy in May 2023. The regulatory approval was based on the findings from the pivotal Phase III REST-ON clinical trial completed in March 2020. LUMRYZ is an extended-release formulation of sodium oxybate, indicated to be taken once at bedtime.

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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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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). Then there is the cost of generic drugs. bil­lion in 2020 if it had pur­chased 77 of 89 drugs from Cuban’s firm.

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Pharmaceutical Technology

JANUARY 22, 2023

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

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European Pharmaceutical Review

OCTOBER 9, 2022

QBiotics, a biotech firm in Australia, initially identified tigilanol tiglate as potentially useful for drug development. To develop the drug, researchers used a Chinese herbal medicine called Croton tiglium (purging croton), which has an active pharmaceutical ingredient (API) called phorbol.

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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

JUNE 24, 2022

RECENTLY, there has been a spate of withdrawals caused by nitrosamine drug substance-related impurities (NDSRIs). These NDSRIs can form during manufacturing or subsequent storage of the drug product. It has also outlined the various issues impacting on the drug product.

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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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Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). dL) for the patients.

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Food and Drug Administration FDA Safety Food 105

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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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

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. Notably, an FDA AdCom voted largely against Aduhelm in November 2020.

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European Pharmaceutical Review

AUGUST 11, 2023

Adakveo (crizanlizumab) received conditional authorisation by the EC in October 2020. Crizanlizumab is approved for use by the United States Food and Drug Administration (FDA). Conditional marketing authorisation is a pragmatic tool for the fast-track approval of a medicine that fulfils an unmet medical need.

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World of DTC Marketing

APRIL 7, 2021

million compensation package in 2020, a slight increase from his $19.6 Pfizer CEO Bourla’s Pay Climbed 17% to $21 Million in 2020 and Gilead Sciences CEO Daniel O’Day earned a $19 million take home. drug spending by 9 percent” What about taxpayers? Bob Bradway of Amgen bagged a $20.1 This has to end.

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European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. AML makes up 23.1%

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Pharmaceutical Technology

MAY 5, 2023

In July 2020, the European Commission (EC) granted conditional marketing authorisation to bulevirtide for urgent access to HDV treatment. It has also received breakthrough therapy and orphan drug designations from the US Food and Drug Administration.

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Pharmaceutical Technology

JANUARY 16, 2023

In October last year, CARsgen submitted a new drug application (NDA) for CT053 to China’s National Medical Products Administration (NMPA). The US Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug designations to the company’s zevor-cel in 2019.

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Pharma Leaders

JUNE 27, 2023

Jesduvroq (daprodustat) tablets received approval from the US Food and Drug Administration (FDA) in February this year to treat CKD-caused anaemia in adults on dialysis for a minimum of four months.

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Food and Drug Administration Medicine Food Safety 52

European Pharmaceutical Review

MAY 2, 2023

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. This draft guidance builds on recommendations published by the agency in 2020.

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Pharmaceutical Technology

JUNE 19, 2023

In 2020, both companies initially collaborated for Biomm’s distribution and marketing of Bio-Thera’s bevacizumab biosimilar, BAT1706, in Brazil. It plans to seek regulatory approval from the European Medicines Agency, the China National Medical Products Administration and the US Food and Drug Administration.

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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. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

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Pharmaceutical Technology

MAY 2, 2023

Avadel Pharmaceuticals has received final approval from the US Food and Drug Administration (FDA) for LUMRYZ to treat cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy. It has also secured orphan drug exclusivity from the FDA until 1 May 2030.

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European Pharmaceutical Review

APRIL 4, 2023

Reducing severity of COVID-19 with monoclonal antibodies Between 2020 and 2022, the US Food and Drug Administration (FDA) granted emergency use authorisation to five different COVID-19 monoclonal antibody treatments. The findings showed that the overall risk for hospitalisation or death at 28 days was 4.6

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pharmaphorum

JANUARY 24, 2023

Drug development has long been an issue for the pharma industry, due to the expense and the high failure rate of potential treatments. Ben Hargreaves finds that the vast amount of genetic data that exists today could help provide a faster, more targeted way of developing new drug candidates. appeared first on.

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Pharmaceutical Technology

MAY 5, 2023

The sale of an illegally imported supplement being marketed as a weight-gain enhancer has been associated with cases of dizziness, cognitive impairment, and sedation, according to the US Food and Drug Administration (FDA).

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Pharmaceutical Technology

JULY 14, 2022

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes.

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European Pharmaceutical Review

AUGUST 11, 2022

The study compared outcomes for 110 patients treated with remdesivir and dexamethasone and 81 treated with both those medications plus baricitinib at Saint Peter’s University Hospital in New Jersey, USA, between June 2020 and June 2021. .

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Pharmaceutical Technology

FEBRUARY 6, 2023

The first-in-class orally available investigational drug, Telacebec blocks Mycobacterium tuberculosis growth by inhibiting cytochrome bc1 complex. In preclinical and clinical studies, the drug showed potent efficacy against drug-sensitive and drug-resistant TB.

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Pharmaceutical Technology

MAY 3, 2023

Lupkynis has also received orphan drug designation in Switzerland. It is claimed to be the first oral medicine to receive approval from the US Food and Drug Administration and the European Commission to treat active LN in adults. This promotes podocyte stability in the kidneys.

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Pharmaceutical Technology

MAY 4, 2023

The US Food and Drug Administration (FDA) approved Kamada’s application to manufacture Cytogam (cytomegalovirus immune globulin intravenous [human]) at its facility located in Beit Kama, Israel.

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European Pharmaceutical Review

NOVEMBER 10, 2023

The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ ® , the first chikungunya vaccine to be authorised in the world. The vaccine was granted PRIority MEdicine (PRIME) designation by the EMA in 2020. Valneva declared it plans to begin commercialisation of IXCHIQ in the US in early 2024.

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European Pharmaceutical Review

AUGUST 16, 2022

HCC accounted for more approximately 85 percent of the 900,000 new liver cancer cases in 2020, according to the Globocan 2020 database. . Following this trial, in September 2021 the US Food and Drug Administration accepted a Biologics License Application (BLA) from BeiGene on behalf of Novartis in the US.

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Pharmaceutical Technology

MAY 30, 2023

The US Food and Drug Administration (FDA) is currently reviewing a biologic licence application (BLA) for the vaccine candidate under priority review. The vaccine candidate also received a priority medicine (PRIME) designation from the European Medicines Agency in 2020.

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Pharmaceutical Technology

SEPTEMBER 6, 2022

The China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted priority review for InnoCare Pharma ’s orelabrutinib to treat relapsed or refractory marginal zone lymphoma (R/R MZL). The therapy obtained conditional approval from the NMPA for two indications in December 2020.

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