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% of total leukaemia cases globally.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

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The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. This draft guidance builds on recommendations published by the agency in 2020.

FDA 98

FDA Food and Drug Administration Medical Food 98

Legacy MEDSearch

NOVEMBER 7, 2022

a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. “Surgeons are constantly learning new techniques, either robotics or laparoscopic, and safety is always front and center.

Medical 95

Medical FDA Safety Recruitment 95

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.

FDA 105

FDA Patients Pharmacology Pharmaceutical 105

World of DTC Marketing

FEBRUARY 4, 2021

million in 2020, more than double the number in 2015, according to health data company IQVIA. 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. Annual U.S.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

European Pharmaceutical Review

MAY 4, 2023

Adjuvanted vaccine Arexvy has been approved by the US Food and Drug Administration (FDA). Approval of GSK’s RSV vaccine The FDA granted approval of Arexvy to GlaxoSmithKline Biologicals. Now, the FDA has granted this milestone to GSK’s Arexvy. Could GSK offer the first RSV older adult vaccine?

Food and Drug Administration 98

Food and Drug Administration Safety FDA Food 98

Pharma Marketing Network

MAY 3, 2023

In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

pharmaphorum

SEPTEMBER 27, 2022

It comes after Johnson & Johnson’s Janssen Biotech division signed up to access the bispecific antibody technology in 2020, without revealing any financial details. The biotech said earlier it planned to seek FDA approval to start clinical trials towards the end of 2022. 2 T cells, which have potent tumour-killing activity.

Safety 111

Safety Sales FDA Leads 111

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.

Competition 116

Competition FDA Pharmaceutical Marketing 116

European Pharmaceutical Review

AUGUST 11, 2023

Adakveo (crizanlizumab) received conditional authorisation by the EC in October 2020. However, the STAND results did not suggest new safety concerns with crizanlizumab. Crizanlizumab is approved for use by the United States Food and Drug Administration (FDA).

Marketing 98

Marketing Food and Drug Administration Medicine FDA 98

European Pharmaceutical Review

JANUARY 29, 2024

Overall, the authors summarised that the enhanced sensitivity improves safety assessments for volatiles in medical devices. The paper discussed the detection of volatile extractables released during the clinical use of medical devices.

Food and Drug Administration 98

Food and Drug Administration Medical Safety Food 98

Pharmaceutical Technology

APRIL 3, 2023

Treatment is then conducted as a clinical trial by the National Cancer Center Hospital to confirm its safety and efficacy. Under this system, patients can request the government for access to medical treatment using unapproved drugs not covered by insurance.

Insurance 98

Insurance Government Safety Patients 98

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? 3 Is two too few?

Marketing 103

Marketing Food and Drug Administration Medicine Prescription 103

pharmaphorum

AUGUST 24, 2022

Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion’s blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The safety and immunogenicity profile of the biosimilar was also comparable to Alexion’s drug, said Amgen.

Safety 98

Safety Sales Patients FDA 98

Pharmaceutical Technology

FEBRUARY 26, 2023

This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. with placebo.

Safety 111

Safety FDA Medicine Side effects 111

pharmaphorum

JANUARY 27, 2023

It refiled in the US, but got a complete response from the FDA in December with a request for more clinical information that has delayed the programme even further, and the CHMP’s decision will further undermine confidence in the drug’s prospects.

FDA 98

FDA Marketing Medicine Prospecting 98

Pharmaceutical Technology

NOVEMBER 9, 2022

A previous October 2020 report concluded that longer-term safety and efficacy were needed to update health-benefit price benchmarks. The program was put on hold in December 2020 following a patient report, but this was lifted in April 2021. million, the think tank concluded in its updated evaluation. million ($1.8

Safety 111

Safety Pharmaceutical Patients Medicine 111

pharmaphorum

JANUARY 25, 2023

An FDA advisory committee has recommended approval of Cidara Therapeutics’ once-weekly antifungal therapy rezafungin, setting it up to become the first new option for severe infections caused by Candida species in a decade. Melinta is privately-owned, after emerging from bankruptcy protection in 2020.

FDA 52

FDA Safety Marketing Patients 52

pharmaphorum

NOVEMBER 22, 2022

The company said it has started the processing for withdrawing the marketing authorisation for Blenrep (belantamab mafodotin) at the request of the FDA. “We will continue the DREAMM clinical trial programme and work with the US FDA on a path forward for this important treatment option for patients with multiple myeloma.”

Marketing 105

Marketing FDA Patients Sales 105

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.

Pharmaceutical 111

Pharmaceutical Food and Drug Administration Medicine FDA 111

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. The post US FDA accepts Regeneron’s pozelimab BLA for priority review appeared first on Pharmaceutical Technology.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

pharmaphorum

AUGUST 11, 2022

GSK, its consumer health spin-off Haleon and Sanofi could be on the hook for billions of dollars in potential damages over Zantac, a gastrointestinal drug pulled from the market in 2020 after it was linked to cases of cancer. Some voluntarily took their products off the market as soon as the NDMA finding was reported by the FDA.

Sales 105

Sales Prescription FDA Marketing 105

pharmaphorum

AUGUST 31, 2022

In recent years, gene therapy has transitioned from a promising idea to a reality for patients, with many of the severe safety issues that emerged in early iterations of the technology being overcome. FDA backing. from 2021 to 2029.

FDA 98

FDA Marketing Safety Patients 98

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.

Safety 98

Safety Marketing Patients FDA 98

European Pharmaceutical Review

MAY 8, 2024

2 Driven by the success of FMTs with clinical efficacy in several indications 3-6 and the first two FDA-approved donor-derived products on the market for recurrent Clostridioides difficile infections, 7,8 a new and promising trend is emerging that combines the ‘whole ecosystem’ of FMTs with rational consortia design. Microbiome.

Manufacturing 98

Manufacturing Safety FDA Patients 98

Pharmaceutical Technology

MARCH 22, 2023

Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. The US Food and Drug Administration (FDA) has provided guidance for the use of RFID in the drug supply chain and to standardise the data format.

Food and Drug Administration 105

Food and Drug Administration Electronics Pharma Pharmaceutical products 105

Pharmaceutical Technology

JUNE 1, 2023

Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug. Additionally, when asked whether the FDA should consider a potential accelerated approval, panellists voted 15 to one against that regulatory pathway for the drug.

FDA 52

FDA Side effects Prescription Patients 52

European Pharmaceutical Review

MAY 4, 2023

Data announced at the European Lung Cancer Congress (ELCC) earlier this month revealed the long-term efficacy and safety of RYBREVANT ® (amivantamab) in patients with post-platinum EGFR Ex20ins-mutated advanced non-small cell lung cancer (NSCLC). 2020; 19(10): 2044–56. Personalized medicine at FDA. References 1. Garrido P et al.

Food and Drug Administration 98

Food and Drug Administration Safety Patients Medicine 98

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. 2020 [cited 2023Jan]. 2020; 22(4): 89.

Food and Drug Administration 98

Food and Drug Administration Pharmaceutical FDA Medicine 98

pharmaphorum

OCTOBER 26, 2022

Less than a week before Ipsen’s palovarotene was due to go in front of an FDA advisory committee, the meeting has been called off following a request by the regulator for more data. The drug failed a futility test in a pivotal trial and was also placed under a partial clinical hold by the FDA while it probed the drug’s safety.

FDA 59

FDA Marketing Safety Pharma 59

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. The SkyWalker System has the technical advantages of precise operation and efficient coordination, while prioritizing safety.

Food and Drug Administration 98

Food and Drug Administration Recruitment Medical Food 98

European Pharmaceutical Review

JANUARY 16, 2023

This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry. This places a continued reliance upon plate reading and the limitations of human vision.

Pharmaceutical 128

Pharmaceutical Food and Drug Administration Manufacturing Medicine 128

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?

Medical 52

Medical FDA Recruitment Pharmacology 52

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.

Food and Drug Administration 10

Food and Drug Administration Safety FDA Ethics 10

European Pharmaceutical Review

SEPTEMBER 2, 2022

To ensure the safety of medicines post-regulatory approval, a risk management plan (RMP) is established. As does the US Food and Drug Administration (FDA): REMS Assessment: Planning and Reporting Guidance for Industry Draft Guidance. What are risk minimisation methods? Before that she has been an independent scientific advisor.

Food and Drug Administration 96

Food and Drug Administration Medicine Safety Food 96

pharmaphorum

NOVEMBER 3, 2022

If approved, gepotidacin (GSK2140944) could become the first drug in a new class of oral antibiotics for uncomplicated urinary tract infections (UTIs) in more than 20 years, according to the pharma group, which plans to submit the data to the FDA in the first half of next year.

Pharma 98

Pharma Government Patients Safety 98

European Pharmaceutical Review

JUNE 8, 2023

2 The US Food and Drug Administration (FDA) has recently announced that it will control the quality of tobacco products, particularly e-cigarettes, more closely, to prevent avoidable contamination and help address “inconsistencies between product labelling and actual concentrations” in these products, potentially misleading customers.

Food and Drug Administration 59

Food and Drug Administration FDA Manufacturing Law & Regulation 59