pharmaphorum

NOVEMBER 2, 2022

The most common solutions today for pain relief are non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, meaning that standard treatments have not changed for a number of years. RelieVRx became the first FDA-authorised treatment for pain delivered at the patient’s home through virtual reality (VR) in November 2021.

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European Pharmaceutical Review

APRIL 27, 2023

Growth has been rapid since Europe’s first gene therapy approval in 2012, 2 and the first US Food and Drug Administration (FDA) approval of a gene therapy in 2017.

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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.

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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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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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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). Novartis’ Factor B inhibitor, Fabhalta ® (iptacopan) provides comprehensive control of red blood cell (RBC) destruction, according to the company.

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European Pharmaceutical Review

DECEMBER 21, 2023

The Lynparza combination is also approved in the EU for advanced prostate cancer , and by the US Food and Drug Administration (FDA). The post NICE recommends combination therapy for prostate cancer appeared first on European Pharmaceutical Review.

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Food and Drug Administration Food Patients FDA 83

Legacy MEDSearch

OCTOBER 17, 2023

Food and Drug Administration has granted Breakthrough Device Designation for its rapid bleeding risk diagnostic test. The FDA recognizes that the device will provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

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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

AUGUST 16, 2023

Food and Drug Administration (FDA) for the indication of diagnosing Electrographic Status Epilepticus (ESE). The clearance follows prior receipt of Breakthrough Device Designation from FDA. Subsequent to receiving Breakthrough Device Designation and 510(k) clearance from FDA, the U.S. Are you hiring?

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Pharmaceutical Technology

JULY 11, 2022

The lead product of the company, Giapreza (angiotensin II) obtained the Food and Drug Administration (FDA) approval in December 2017. Xerava (eravacycline), another FDA-approved asset of La Jolla, is intended to treat complicated intra-abdominal infections (cIAIs) in individuals of the age 18 years and above.

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pharmaphorum

JUNE 27, 2022

Jennifer Mathieu, director of government relations at the Academy of Managed Care Pharmacy (AMCP), tells us why the organisation backed the pre-approval information exchange (PIE) Act of 2022 and how the legislation will empower companies to share information with healthcare payers and plans during the FDA approval process. .

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Food and Drug Administration Medical Patients FDA 78

European Pharmaceutical Review

OCTOBER 21, 2022

A two-dose version of the vaccine was approved by the US Food and Drug Administration (FDA) in 2017. The product will be given to HIV patients whose previous HBV vaccination failed to prevent against the virus. The clinical trial is estimated to be completed in March 2023.

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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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Pharmaceutical Technology

APRIL 24, 2023

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. Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. billion in 2029, while Calquence is expected to make $5.31

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European Pharmaceutical Review

MAY 4, 2023

Why are bispecific monoclonal antibody drugs such as amivantamab promising for this indication? They are not US Food and Drug Administration (FDA)-approved for these patients due to the lack of benefit. 2017; 8(43): 75712–26. Personalized medicine at FDA. Oral Presentation JGN-75414. Oncotarget.

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Food and Drug Administration Safety Medicine Patients 90

Legacy MEDSearch

SEPTEMBER 20, 2023

Food and Drug Administration (FDA) 510(k) clearance for product enhancements to the HyperVue Imaging System. is a privately held medical device company founded in 2017 to provide unrivaled optical and computational insights to improve the treatment and outcomes for patients with coronary artery disease (CAD).

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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.

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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 post US FDA grants approval for Radius’ Tymlos for osteoporosis in men appeared first on Pharmaceutical Technology.

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Food and Drug Administration FDA Food Safety 52

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. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

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Pharmaceutical Technology

MAY 15, 2023

Nirsevimab is still undergoing regulatory review in the US, with the US Food and Drug Administration (FDA) accepting the Biologics License Application (BLA) for nirsevimab in January 2023. Nirsevimab is a long-acting antibody being jointly developed by Sanofi and AstraZeneca as per an agreement made in 2017.

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World of DTC Marketing

MARCH 17, 2022

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. Medicare spent nearly $600 million over three years to pay for cancer care involving four drugs later found to provide no clinical benefit for some forms of the disease.

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Pharmaceutical Technology

MARCH 30, 2023

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. The drug is approved in several indications, including advanced melanoma, metastatic non-small cell lung cancer (NSCLC), and relapsed classical Hodgkin lymphoma (cHL). In 2022, the company reported Keytuda sales of $20.9 billion in 2028.

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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.

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Food and Drug Administration FDA Manufacturing Law & Regulation 59

MedCity News

JUNE 12, 2023

Bringing the very first prescription digital therapeutic (PDT) to market in 2017, Pear Therapeutics went above and beyond to follow suggested regulatory guidelines, obtained Food & Drug Administration (FDA) clearance, and provided solid clinical study evidence.

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European Pharmaceutical Review

OCTOBER 19, 2023

One of the aspects of radiopharmaceuticals that is often overlooked is how complicated it is to develop a new agent, in terms of the complexity of drug design to realise a therapeutic candidate and the implementation of the clinical evaluations. This is not an effective strategy.

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Food and Drug Administration Side effects Manufacturing Doctors 87

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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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., About SpectraWAVE, Inc.

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Food and Drug Administration Physicians Recruitment Medical 97

European Pharmaceutical Review

JUNE 28, 2022

This theory has been supported by the clinical results of drugs such as empagliflozin, the SGLT2 inhibitor, across several of these conditions. The drug advanced through to Phase II trials in adults living with obesity and also those with NASH in 2021. This programme has received FDA Fast Track designation.

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Food and Drug Administration Medicine Patients FDA 91

European Pharmaceutical Review

DECEMBER 15, 2022

Compared to conventional antidepressant therapy that consists of daily oral administration, psilocybin therapy acts through a single-dose capsule, with repeated administration being investigated in COMPASS’ larger Phase III study. Additionally, the Phase IIb trial found that outcome was associated with dose. Available from: [link].

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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. Not even three years later, Proteus filed for bankruptcy.

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Food and Drug Administration FDA Medicine Patients 122

European Pharmaceutical Review

JANUARY 3, 2023

In a preclinical model of cisplatin-induced ototoxicity (Petremann et al, 2017), SENS-401 demonstrated an ability to significantly reduce hearing loss. Prior study results assessing SENS-401 for cisplatin-induced ototoxicity. 70 percent of the Intent to Treat population). Previous approvals for SENS-401.

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Pharmaceutical Technology

JUNE 30, 2022

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.”. In 2017 Oximio began providing dedicated local clinical trial support from its depot in Tbilisi as well as its courier fleet.

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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. from 2001 to 2022.”

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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. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046).

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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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