European Pharmaceutical Review

JULY 13, 2023

In many European countries physicians can now prescribe medical cannabis for an array of chronic health conditions, including chronic pain, mental health disorders and neurological conditions. 1 In many countries, medical cannabis is only utilised as a therapy when licensed medications have proven ineffective.

Medical 85

Medical Food and Drug Administration Pharmacology Medicine 85

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.

Food and Drug Administration 81

Food and Drug Administration Medical Patients FDA 81

European Pharmaceutical Review

APRIL 29, 2024

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. This authorisation of BEQVEZ is based on results from the pivotal Phase III BENEGENE-2 study.

Food and Drug Administration 74

Food and Drug Administration Medicine FDA Food 74

European Pharmaceutical Review

MARCH 18, 2024

A Phase III trial has shown that compared oral drug delivery, administering levodopa through an infusion pump led to nearly two hours of day (1.72) of additional time in which the medicine reduced symptoms in Parkinson’s patients. There were 381 Parkinson’s patients enrolled in the trial. and Joan A.

Food and Drug Administration 90

Food and Drug Administration Medicine Physicians Food 90

European Pharmaceutical Review

JANUARY 10, 2023

Clarivate Plc has released its Drugs to Watch 2023 report — among 70 of the drugs highlighted, including potential blockbuster drugs, the majority were revealed to be personalised medicines. The report offers predictive analysis of drugs entering the market or launching key indications in 2023.

Food and Drug Administration 88

Food and Drug Administration FDA Food Medicine 88

Pharmaceutical Technology

MAY 18, 2023

HLB subsidiary Elevar Therapeutics has submitted a new drug application to the US Food and Drug Administration for its rivoceranib drug candidate plus camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC), which is the most common type of liver cancer.

Food and Drug Administration 59

Food and Drug Administration Food Patients Medical 59

Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. In March 2022, the US Food and Drug Administration approved the IND application for SM17 to treat asthma.

Food and Drug Administration 109

Food and Drug Administration Food Safety Medical 109

Legacy MEDSearch

AUGUST 23, 2023

Recor Medical, Inc. (“Recor”) and its parent company, Otsuka Medical Devices Co., Otsuka Medical Devices”) announce the U.S. The overall vote from the committee was favorable that there was sufficient data to support the use of the device in patients with uncontrolled hypertension. About Recor Medical, Inc.

Medical 52

Medical Food and Drug Administration FDA Recruitment 52

LEVO Health

OCTOBER 26, 2022

The medical device market is more saturated than you might think. With seemingly countless treatment options on the table, how can your device cut through the clutter and get in front of the right patients at just the right time? You need a marketing strategy that sets your medical device apart from the competition.

Medical 52

Medical Marketing Patients Food and Drug Administration 52

European Pharmaceutical Review

DECEMBER 1, 2023

During CPHI Barcelona, EPR Editor Caroline Peachey asked Anil Kane, Global Head of Technical & Scientific Affairs, Pharma Services, at Thermo Fisher Scientific about the dynamic landscape of pharmaceutical drug development. What are the trends affecting drug development today? Prefilled syringes bring a range of benefits.

Food and Drug Administration 84

Food and Drug Administration Manufacturing Pharma Patients 84

World of DTC Marketing

DECEMBER 2, 2021

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Presenting quantitative information increased participants’ gist and verbatim recall of drug efficacy. ” Uh…no.

Food and Drug Administration 185

Food and Drug Administration Side effects FDA Prescription 185

Pharmaceutical Technology

AUGUST 23, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Ocelot Bio’s OCE-205 to treat hepatorenal syndrome. It will analyse the safety and efficacy of OCE-205 in adult HRS-AKI patients having cirrhosis with ascites. A lead candidate of the company, OCE-205 is a peptide therapeutic.

Food and Drug Administration 52

Food and Drug Administration FDA Food Safety 52

European Pharmaceutical Review

MARCH 4, 2024

1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5

Food and Drug Administration 89

Food and Drug Administration Transportation FDA Medical 89

European Pharmaceutical Review

FEBRUARY 22, 2023

The hurdles encountered in development and approval of a new drug can be overwhelming. 1 Consequently, the US Food and Drug Administration (FDA) and other agencies are keen to see “accelerated development” programmes in areas where there is a significant unmet clinical need. billion, and rising.

Food and Drug Administration 77

Food and Drug Administration FDA Safety Food 77

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. However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

Pharmaceutical Technology

SEPTEMBER 8, 2022

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to AceLink Therapeutics’ AL01211 to treat Fabry disease. A glucosylceramide synthase (GCS) inhibitor, AL01211 has high potency, increased selectivity and other beneficial drug properties that support once-a-day oral dosing.

Food and Drug Administration 52

Food and Drug Administration FDA Food Medical 52

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). The new initiative, Care Studio, aims at doctors rather than patients. Then there is the cost of generic drugs.

Healthcare 227

Healthcare Healthcare Food and Drug Administration FDA 227

Pharmaceutical Technology

JUNE 9, 2023

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% It has been designed to address the unmet needs of patients and to provide quick action and well-tolerated dry eye drug therapy.

Food and Drug Administration 98

Food and Drug Administration FDA Medical science Food 98

Legacy MEDSearch

OCTOBER 25, 2022

EndoStim , a medical device company developing and commercializing a first-in-class implantable neurostimulation treatment for drug refractory gastroesophageal reflux disease (GERD), announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the Company’s EndoStim System.

Food and Drug Administration 98

Food and Drug Administration FDA Side effects Recruitment 98

European Pharmaceutical Review

FEBRUARY 9, 2023

To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder. If progress continues in a Phase III clinical trial, this medication would be the first FDA-approved drug specifically for people with notalgia paresthetica. points for patients receiving placebo.

Food and Drug Administration 78

Food and Drug Administration FDA Side effects Medicine 78

Legacy MEDSearch

MARCH 1, 2024

Boston Scientific’s AGENT Drug-Coated Balloon (DCB) has been granted approval by the U.S. Food and Drug Administration (FDA) for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. physicians the opportunity to treat their patients with this novel device.”

Food and Drug Administration 52

Food and Drug Administration FDA Recruitment Physicians 52

Pharmaceutical Technology

APRIL 17, 2023

US-based development-stage biopharmaceutical firm Satsuma Pharmaceuticals is developing STS101, a unique nasal powder formulation of the anti-migraine drug dihydroergotamine mesylate, for the treatment of acute migraine. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA).

Food and Drug Administration 59

Food and Drug Administration FDA Food Pharmaceutical 59

Legacy MEDSearch

SEPTEMBER 26, 2023

Saluda Medical, Inc. (“Saluda Medical”), a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced that the U.S. IDE study with 300 patients enrolled. head and extremity and 1.5T

Medical 52

Medical FDA Food and Drug Administration Safety 52

Pharmaceutical Technology

MAY 26, 2023

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. The new drug application (NDA) included data from the Phase III FRESCO-2 and FRESCO trials conducted in China.

Food and Drug Administration 105

Food and Drug Administration FDA Prescription Food 105

European Pharmaceutical Review

AUGUST 16, 2022

Despite improvements in screening, surveillance rules, and imaging, more than two-thirds of patients with HCC present with advanced disease at diagnosis, BeiGene said. Currently there are few treatment options if patients cannot tolerate [tyrosine kinase inhibitor] TKI therapy or if their condition progresses,” he added.

Food and Drug Administration 97

Food and Drug Administration Patients Safety Food 97

Pharmaceutical Technology

MARCH 2, 2023

The US Food and Drug Administration (FDA) has approved Reata Pharmaceuticals ’ oral, once-daily medication SKYCLARYS (omaveloxolone) to treat Friedreich’s ataxia patients. SKYCLARYS is the first approved treatment in Friedrich’s Ataxia and marks a milestone for drug development in this complex disease.

Food and Drug Administration 105

Food and Drug Administration Pharmaceutical FDA Food 105

PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

European Pharmaceutical Review

NOVEMBER 9, 2023

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders.

Food and Drug Administration 105

Food and Drug Administration Side effects Pharmaceutical Leads 105

Pharmaceutical Technology

APRIL 26, 2023

The US Food and Drug Administration (FDA) has granted orphan drug designation to IN8bio’s INB-400 and INB-410 to treat a range of malignant gliomas, including newly diagnosed glioblastoma multiforme (GBM). We eagerly anticipate enrolling our first Phase II patients for INB-400 later this year.”

Food and Drug Administration 52

Food and Drug Administration FDA Engineering Food 52

European Pharmaceutical Review

AUGUST 29, 2023

The Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised the first subcutaneous formulation of an anti-PD-(L)1 cancer immunotherapy to be made available to patients in Great Britain. Administration of Roche’s Tecentriq ® SC (atezolizumab) takes approximately seven minutes.

Food and Drug Administration 84

Food and Drug Administration Safety Medicine Food 84

Pharmaceutical Technology

MAY 24, 2023

Inovio has received orphan drug designation for INO-3107 from the European Commission (EC) to treat recurrent respiratory papillomatosis (RRP). In July 2020, the US Food and Drug Administration (FDA) also granted orphan drug designation to INO-3107.

Food and Drug Administration 52

Food and Drug Administration Medicine Food Marketing 52

Pharmaceutical Technology

JUNE 6, 2023

American Regent and Daiichi Sankyo have announced that the INJECTAFER (ferric carboxymaltose injection) has received approval from the US Food and Drug Administration (FDA) to treat iron deficiency in adult patients with heart failure. Approximately 2.8

Food and Drug Administration 52

Food and Drug Administration Patients FDA Food 52

European Pharmaceutical Review

AUGUST 23, 2022

A study led by Boston University School of Public Health (BUSPH) and the White River Junction Veterans Affairs Medical Center in Vermont has completed a rigorous analysis to compare the effectiveness of direct acting antivirals on improving symptoms of posttraumatic stress disorder (PTSD). . About PTSD.

Food and Drug Administration 70

Food and Drug Administration Pharmacology Prospecting Medical 70

European Pharmaceutical Review

DECEMBER 22, 2023

Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024. The drug is also undergoing trials both for adjunctive therapy to existing standard of care agents in schizophrenia and for the treatment of psychosis in patients with Alzheimer’s disease.

Food and Drug Administration 94

Food and Drug Administration Side effects Safety Food 94

Legacy MEDSearch

DECEMBER 7, 2022

Medical device and technology company Lazurite has received recognition from Medical Device Network Excellence Awards & Rankings, one of the largest, most prestigious, and widely recognized programs in the industry. All Commended companies will be entered into the Medical Device Network Awards at the end of the year.

Networking 98

Networking Medical Food and Drug Administration Recruitment 98

Pharmaceutical Technology

APRIL 28, 2023

Ocugen has received orphan drug designation from the US Food and Drug Administration for its OCU410ST (AAV5-hRORA) to treat ABCA4 – linked retinopathies. Ocugen intends to file an investigational new drug application in the second quarter of 2023, with the aim of commencing a Phase I/II clinical study.

Food and Drug Administration 52

Food and Drug Administration Transportation FDA Food 52

Pharmaceutical Technology

MAY 29, 2023

Lexicon Pharmaceuticals (Lexicon) has received approval from the US Food and Drug Administration (FDA) for its Inpefa drug to treat heart failure. The SOLOIST-WHF (worsening heart failure) and SCORED trials together assessed around 12,000 patients.

Food and Drug Administration 98

Food and Drug Administration FDA Transportation Physicians 98