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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European Pharmaceutical Review

APRIL 27, 2023

Solving this issue will improve industry best practice, increase public confidence and create a more efficient pathway to patients; but it necessitates enhanced collaboration between companies.

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Manufacturing Food and Drug Administration Pharmaceutical products Food 97

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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Food and Drug Administration Food Patients FDA 130

European Pharmaceutical Review

JULY 5, 2022

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects.

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Patients Food and Drug Administration Side effects Safety 104

Pharmaceutical Technology

JUNE 7, 2023

The US Food and Drug Administration (FDA) has granted approval for a new indication for Merck’s PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. The latest move follows a priority review of a supplemental new drug application (sNDA) for the therapy.

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Food and Drug Administration FDA Food Medicine 52

Clarivate

NOVEMBER 10, 2022

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. Patient focused drug development in alopecia areata clinical trials.

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Patients Food and Drug Administration FDA Safety 52

pharmaphorum

JUNE 27, 2022

7008), which allows manufacturers to share vital information with healthcare payers and plans while treatments are pending Food and Drug Administration (FDA) approval, was passed by the House of Representatives and is awaiting approval in the Senate. Affecting patient care. The AMCP backed bill (H.R. The history of PIE.

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European Pharmaceutical Review

DECEMBER 21, 2023

This NICE recommendation is based on data from the PROpel Phase III clinical trial, which enrolled 700 patients globally. Up to a fifth of patients with prostate cancer will develop castration-resistant prostate cancer (CRPC) within five years.

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Food and Drug Administration Food Patients FDA 98

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades. .

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European Pharmaceutical Review

JANUARY 3, 2023

Sensorion, a biotechnology company has announced that the first patient has been enrolled in its NOTOXIS Phase IIa proof of concept clinical trial of SENS-401 (Arazasetron) in cancer patients experiencing cisplatin-induced ototoxicity (permanent hearing loss), a serious side effect of key chemotherapeutic agent cisplatin.

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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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Pharmaceutical Technology

DECEMBER 21, 2022

The US Food and Drug Administration (FDA) has granted approval for Radius Health ’s Tymlos (abaloparatide) to boost bone density in men with osteoporosis at increased fracture risk. The treatment is also indicated for patients who have failed or are not tolerant to other osteoporosis treatments available at present.

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Food and Drug Administration FDA Food Safety 52

Pharmaceutical Technology

MARCH 30, 2023

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. On the same day, researchers presented new interim data from the Phase III RUBY trial of GSK’s PD-1 antibody Jemperli (dostarlimab) in patients with primary advanced or recurrent endometrial cancer. billion in its FY 2022 results. billion in 2028.

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Food and Drug Administration FDA Sales Food 52

Legacy MEDSearch

OCTOBER 17, 2023

Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. FloBio’s test determines blood clotting status and whether a patient is on popular blood thinners called Direct Oral Anticoagulants (DOACs).

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Pharmaceutical Technology

JUNE 9, 2023

A US Food and Drug Administration (FDA) Advisory Committee (AdCom) has voted unanimously in favour of AstraZeneca’s and Sanofi’s respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) prophylactic nirsevimab for use in newborns and infants entering their first RSV season. However, Dr.

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FDA Food and Drug Administration Patients Food 59

Pharmaceutical Technology

JULY 11, 2022

La Jolla focuses on marketing innovative treatments that can enhance outcomes in patients with life-threatening diseases. The lead product of the company, Giapreza (angiotensin II) obtained the Food and Drug Administration (FDA) approval in December 2017.

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European Pharmaceutical Review

OCTOBER 19, 2023

These diagnostics have significantly progressed based on rigorous Phase III trial designs and because of the impact these diagnostics have had on patient management. These diagnostics are also paired with therapeutics and act as an imaging biomarker to identify patients who may benefit from the paired therapies.

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Food and Drug Administration Manufacturing Side effects Doctors 105

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. N) = number of approvals.

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Medicine Food and Drug Administration FDA Healthcare 98

Legacy MEDSearch

JANUARY 4, 2023

Food and Drug Administration (FDA) 510(k) clearance of the BiWaze ® Clear System. This new airway clearance system helps patients clear their airways as well as prevent or treat atelectasis by using Oscillating Lung Expansion (OLE) therapy. We are proud to introduce this innovative OLE therapy system.”

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Pharmaceutical Technology

APRIL 18, 2023

Members of the FDA’s Antimicrobial Drugs AdCom voted 12-0 for the drug’s potential approval based on a positive benefit-risk assessment. The agency accepted the drug’s new drug application (NDA) for priority review in November 2022. The application’s PDUFA date was set to 29 May 2023. Entasis is a subsidiary of Innoviva.

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Food and Drug Administration FDA Safety Food 52

Pharmaceutical Technology

APRIL 24, 2023

There, the data shows that patients on this regimen live longer lives along with having a greater period of time before disease progression, than with other treatments. CLL is regarded as the most common type of leukaemia in England where 3,157 patients were diagnosed with the disease in 2017, based on the institute’s announcement.

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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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Legacy MEDSearch

MARCH 1, 2023

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced Food and Drug Administration (FDA) 510(k) clearance of their flagship intravascular imaging system, HyperVue. SpectraWAVE, Inc., Chief Executive Officer of SpectraWAVE.

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Food and Drug Administration Physicians Recruitment Medical 97

Legacy MEDSearch

FEBRUARY 21, 2023

Food and Drug Administration (FDA) 510(k) clearance for DiLumen EZ¹, a single-use, disposable endotherapy device for endoscopic mucosal resections (EMR) and difficult colonoscopies. Since 2017, clinicians in the U.S., Connecticut-based medical device innovator Lumendi, LLC announced that it has received U.S.

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Food and Drug Administration Recruitment Medical Distribution 98

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). Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication?

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Food and Drug Administration Safety Patients Medicine 98

European Pharmaceutical Review

DECEMBER 15, 2022

12 In addition, over 40 percent of patients who did not respond to between three and four conventional antidepressants within their current depressive episode continued to be managed sub‑optimally through subsequent cycles of ineffective monotherapy. Additionally, the Phase IIb trial found that outcome was associated with dose.

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Food and Drug Administration Healthcare Healthcare Food 69

MedCity News

JUNE 12, 2023

The goal was simple: provide access and focused support to patients remotely while simultaneously relieving overtaxed healthcare facilities. Combined, DTx and DCTs improve patient recruitment, retention, and access, allowing researchers to pull from underserved communities, including rural populations.

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Food and Drug Administration Prescription Government FDA 93

Legacy MEDSearch

AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). per eligible Medicare patient case. ClarityPro is now the only FDA-indicated device for the diagnosis of ESE in adult patients over the age of 18. Ceribell, Inc. NTAP reimbursement of up to $913.90

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European Pharmaceutical Review

JUNE 28, 2022

The approvals of empagliflozin were based on data from two pivotal, placebo controlled trials – the EMPEROR-Preserved and EMPEROR-Reduced studies, involving 5,988 and 3,730 patients, respectively. percent of patients taking placebo. Of the patients taking empagliflozin for around 23 months in the EMPEROR-Preserved trial, 13.8

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Food and Drug Administration Medicine Patients FDA 98

Legacy MEDSearch

SEPTEMBER 20, 2023

a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue Imaging System. SpectraWAVE, Inc., Shlofmitz, M.D., Chairman of Cardiology of the St.

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Food and Drug Administration Recruitment Physicians Patients 52

Pharmaceutical Technology

JUNE 30, 2022

The country also offers timely patient recruitment due to a population of nearly 4 million, many of whom are treatment-naïve. This will put up a barrier to the traditional system where the drugs are shipped on a direct-to-site basis straight away from the manufacturing facilities to a Georgia storage facility within the location.”.

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World of DTC Marketing

MARCH 17, 2022

What treatment works in one patient may not work in another but we have to keep trying to beat cancer anyway we can. In recent years, early detection and treatment improvements have helped boost the 3-year survival rate for lung cancer from 21% in 2004 to 31% in 2015 through 2017. In 2018 cancer patients in the U.S.

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Food and Drug Administration Medical Patients Ethics 255

Evolve Your Success

FEBRUARY 7, 2023

In a sense, although I started a surgery center company from scratch in 2017 and we sold that. The patients like that their copay is lower. Patients have a lower copay. The foods are put on the trays, then go up to the person who has a diabetic diet. It’s the first drug-eluting heart stent in the world.

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Sales Medical Medical sales Doctors 52

Pharmaceutical Technology

AUGUST 8, 2022

In 2017, the US Food and Drug Administration (FDA) broke ground by approving the first drug with an embedded biosensor to track its use. Proteus Health’s Abilify MyCite had an ingestible sensor that could track if a patient consumed the drug. But researchers hope that this may soon change.

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Food and Drug Administration FDA Medicine Patients 122

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. First generics are the first opportunity manufacturers have to market new generic drug products in the US.

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Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. ABC consists of four species of bacteria in the Acinetobacter family.

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FDA Food and Drug Administration Patients Prospecting 52

Pharmaceutical Technology

APRIL 20, 2023

Following a tumultuous development cycle, DBV Technologies will now have to conduct an additional safety study of its peanut allergy Viaskin patch in toddlers ages 1–3 years, based on written correspondence from the US Food and Drug Administration (FDA). DBV expects to share topline data from the study in H1 2025.

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