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

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

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

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 81

Food and Drug Administration Medical Safety Food 81

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

World of DTC Marketing

JANUARY 8, 2021

Moderna, maker of one of only two vaccines granted emergency authorizations to prevent COVID-19 in the US, has been shamed with a 2020 “Shkreli Award” by the Lown Institute, a healthcare think tank. Can the FDA really control the quality of vaccine orders this big? However, in vaccines, cut corners could compromise patient safety.

Government 266

Government Safety FDA Pharma 266

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 84

Marketing Food and Drug Administration Medicine FDA 84

World of DTC Marketing

DECEMBER 23, 2020

During the first quarter of 2020, the number of telehealth visits increased by 50%, compared with the same period in 2019, with a 154% increase in visits noted in surveillance week 13 in 2020, compared with the same period in 2019. The FDA can be myopic when researching how consumers view and react to DTC.

Prescription 249

Prescription Doctors Side effects Marketing 249

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

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 97

Pharmaceutical Food and Drug Administration Medicine FDA 97

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

Pharma Leaders

JUNE 27, 2023

The trials analysed the safety and efficacy of daprodustat to treat anaemia of CKD in more than 8,000 patients who received the treatment for up to 4.26 Based on findings from three international Phase III clinical trials in patients from the ASCEND trial programme, the agency issued a positive opinion for the therapy.

Food and Drug Administration 52

Food and Drug Administration Medicine Food Safety 52

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 93

FDA Marketing Medicine Prospecting 93

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 58

FDA Safety Marketing Pharma 58

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 90

Safety Sales Patients FDA 90

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 98

Competition FDA Pharmaceutical Marketing 98

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 Safety 105

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

AUGUST 18, 2022

Astellas remains on course to be the first drugmaker to bring a new non-hormonal therapy for symptoms of menopause to market, after the FDA started a review of its orally-active neurokinin-3 (NK3) receptor antagonist fezolinetant. It acquired elinzanetant as part of its takeover of UK biotech KaNDy Therapeutics in 2020.

FDA 52

FDA Safety Marketing Pharma 52

Pharmaceutical Technology

MAY 22, 2023

Intercept Pharmaceuticals faced a setback after a US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) meeting on the prospective use of its drug Ocaliva in pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) did not go in its favour.

Medicine 59

Medicine FDA Prospecting Food 59

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.

Food and Drug Administration 59

Food and Drug Administration Physicians Competition FDA 59

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

Pharmaceutical Technology

MARCH 20, 2023

The FDA accepted Intercept’s resubmitted NDA on 19 January 2023 and set a PDUFA of 22 June 2023. However, it appears the race may be closer than anticipated earlier, with the FDA recently announcing plans to hold an advisory committee (AdCom) meeting to review Intercept’s re-submitted NDA on Friday, May 19, 2023.

Marketing 52

Marketing FDA Leads Safety 52

pharmaphorum

JANUARY 23, 2023

Morphic said it had received notice that Janssen had decided to pull out of the agreement, which initially focused on two targets but was revised at the end of 2020 to with the additional programme covering “antibody activators for an undisclosed integrin target.” In a filing with the Securities and Exchange Commission (SEC).

Safety 52

Safety FDA Pharma 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 101

Sales Prescription FDA Marketing 101

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 91

Food and Drug Administration Safety Medicine Patients 91

pharmaphorum

SEPTEMBER 14, 2022

The French biotech said the cash injection – which follows a €45 million Series A in 2020 – will also help it bring forward the first development candidate in a collaboration signed with gene-editing specialist Intellia Therapeutics last year, currently in the early-discovery stage.

Safety 52

Safety Leads Patients FDA 52

Pharmaceutical Technology

JANUARY 27, 2023

The FDA’s recent approval of TG Therapeutics’s Briumvi (ublituximab) against relapsing forms of multiple sclerosis (MS) is welcome news for the company after suffering a major setback in 2022 when the FDA extended its review of Briumvi by three months. All three treatments are monoclonal antibodies.

Marketing 52

Marketing Side effects Safety Patients 52

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 88

Food and Drug Administration Pharmaceutical FDA Medicine 88

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

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.

Food and Drug Administration 86

Food and Drug Administration Manufacturing Food Medicine 86

European Pharmaceutical Review

DECEMBER 28, 2023

We received encouraging feedback from the US Food and Drug Administration (FDA) on the trial design and potential for accelerated approval. These efficacy results, combined with the safety profile that allows patients to complete their treatment regimen, are extremely encouraging.

Food and Drug Administration 84

Food and Drug Administration Patients Safety Medical science 84

European Pharmaceutical Review

NOVEMBER 8, 2022

There are also several pending bills that seek to lower drug costs by means other than price regulations, including: 1) deterring the delay in FDA approval of drug applications caused by sham ‘Citizen Petitions’. Citizen Petitions before the FDA. 562 would permit the FDA to deny the petition if either of these factors were satisfied.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

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

pharmaphorum

DECEMBER 22, 2022

The FDA and EMA have formally started their review of the drug, which analysts have suggested could become a $3 billion blockbuster for Pfizer if it reaches the market for UC and other immuno-inflammatory diseases. “We believe that etrasimod, if approved, has the potential to be a best-in-class, first-line advanced therapy.”

Pharmacology 52

Pharmacology Safety Patients Marketing 52

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.

Manufacturing 85

Manufacturing Pharma Food and Drug Administration Safety 85

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 75

Food and Drug Administration Medicine Safety Food 75