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. The research paper comparing the two drug delivery methods was published in The Lancet Neurology.

Food and Drug Administration 95

Food and Drug Administration Medicine Physicians Food 95

European Pharmaceutical Review

DECEMBER 22, 2022

The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category” The term ‘mRNA’ has become commonplace globally. The success of mRNA vaccines against SARS-CoV-2 has quickly catapulted mRNA therapeutics as a disruptive, expanding drug category.

Medicine 112

Medicine Food and Drug Administration Transportation Distribution 112

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. 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.

Safety 52

Safety Food and Drug Administration Pharmaceutical Marketing 52

European Pharmaceutical Review

AUGUST 23, 2022

FAKE MEDICINES are not a new problem, and pose a tremendous threat to patient safety and public health in society regardless of a country’s economic status. The prevalence of fake drugs is a continually growing problem worldwide. 1 Simply, pharmaceutical products are the most vulnerable to counterfeiting.

Medicine 96

Medicine Food and Drug Administration Pharmaceutical products Pharmaceutical 96

European Pharmaceutical Review

APRIL 17, 2024

Roche multiple sclerosis subcutaneous injection: late-breaking data “Updated results from OCARINA II further underline the potential benefits of subcutaneous OCREVUS for patients with both relapsing and progressive forms of MS,” shared Scott Newsome , DO, lead author, Johns Hopkins University School of Medicine.

Food and Drug Administration 75

Food and Drug Administration Safety Medicine Food 75

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 94

Food and Drug Administration FDA Food Medicine 94

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 92

Food and Drug Administration Safety Medicine Food 92

Pharmaceutical Technology

MAY 4, 2023

Vertex Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for KALYDECO (ivacaftor) to treat children with cystic fibrosis (CF) aged between one and four months. This cohort showed a safety profile identical to that found in older children and adults.

Food and Drug Administration 98

Food and Drug Administration FDA Safety Medicine 98

Pharmaceutical Technology

APRIL 14, 2023

The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label.

Food and Drug Administration 52

Food and Drug Administration Manufacturing FDA Medicine 52

European Pharmaceutical Review

FEBRUARY 9, 2023

Oral difelikefalin could potentially relieve the moderate-to-severe itching associated with notalgia paresthetica, according to a study published in the New England Journal of Medicine. To date, there are no US Food and Drug Administration (FDA)-approved treatments specifically targeting this disorder.

Food and Drug Administration 86

Food and Drug Administration FDA Side effects Medicine 86

European Pharmaceutical Review

JUNE 26, 2023

US Food and Drug Administration (FDA) has published its first draft guidance presenting considerations to the pharmaceutical industry for designing clinical trials for psychedelic drugs. What recommendations are included in the draft guidance on psychedelic drugs? However, these are still investigational products.

Food and Drug Administration 91

Food and Drug Administration FDA Safety Food 91

European Pharmaceutical Review

APRIL 16, 2024

In December 2023, the US Food and Drug Administration (FDA) approved the treatment for adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH). Our renal pipeline includes medicines with a variety of mechanisms which may allow them to be targeted to patients based on their clinical characteristics.”

Food and Drug Administration 88

Food and Drug Administration Food Safety Medicine 88

European Pharmaceutical Review

MARCH 4, 2024

As a cornerstone of advanced therapeutics in modern medicine, biologics command significant attention in the search for effective treatments for human diseases. 1 However, the entry of biologics into the pharmaceutical market is not without unique challenges, particularly when compared to small molecule drugs. percent through 2027.

Food and Drug Administration 95

Food and Drug Administration Transportation FDA Medical 95

European Pharmaceutical Review

FEBRUARY 8, 2024

RIDGELINE 105, evaluated the safety and efficacy of the vanza triple in children with cystic fibrosis between six and 11 years old with at least one mutation responsive to triple combination CFTRm. A third Phase III study was also part of the programme. Treatment with the vanza triple was well tolerated in all three studies.

Food and Drug Administration 95

Food and Drug Administration Medicine Medical Consulting 95

Pharmaceutical Technology

MAY 2, 2023

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS).

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 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.

Food and Drug Administration 115

Food and Drug Administration Medicine Food Government 115

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 112

Food and Drug Administration Side effects Pharmaceutical Leads 112

Pharmaceutical Technology

APRIL 3, 2023

Hyrimoz has been approved for use in all the indications covered by the reference medicine Humira, including plaque psoriasis, rheumatic diseases, ulcerative colitis, Crohn’s disease, uveitis and hidradenitis suppurativa. Its reference medicine, Humira, initially received approval with an adalimumab 50 mg/mL concentration.

Marketing 105

Marketing Food and Drug Administration Medicine Food 105

Pharmaceutical Technology

NOVEMBER 25, 2022

The latest development was based on the findings from the international, head-to-head, open-label, randomised Phase III DESTINY-Breast03 trial which analysed the efficacy and safety of Enhertu versus trastuzumab emtansine (T-DM1). In subjects who received Enhertu, the median progression-free survival (PFS) was not attained versus 6.8

Food and Drug Administration 105

Food and Drug Administration Safety Food Medicine 105

European Pharmaceutical Review

JANUARY 9, 2024

Safety of TALZENNA plus XTANDI in the TALAPRO-2 trial was found to be generally consistent with the known safety profile of each medicine. While a key secondary endpoint, favouring TALZENNA plus XTANDI was also observed, these data are immature, Pfizer noted.

Food and Drug Administration 92

Food and Drug Administration Safety Food Patients 92

European Pharmaceutical Review

OCTOBER 25, 2023

Three key medicine regulatory bodies from the UK, US and Canada have collaborated to publish five guiding principles for machine learning-enabled medical devices MLMDs. The device may be reassessed to ensure the performance and safety of the device is negatively impacted.

Medical 99

Medical Food and Drug Administration Manufacturing Safety 99

European Pharmaceutical Review

JANUARY 20, 2023

The US Food and Drug Administration (FDA) has issued a complete response letter for the accelerated approval submission of donanemab for early Alzheimer’s, Eli Lilly and Company revealed. In some cases, this occurred in less than 12 months, which is why fewer patients stayed on the drug for a full year.”

FDA 93

FDA Food and Drug Administration Safety Medicine 93

European Pharmaceutical Review

AUGUST 11, 2023

The European Commission has revoked the conditional marketing authorisation (MA) for Novartis’ sickle cell medicine crizanlizumab in the European Union (EU) and EEA. The decision follows a May recommendation from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).

Marketing 92

Marketing Food and Drug Administration Medicine FDA 92

Pharmaceutical Technology

FEBRUARY 2, 2023

The US Food and Drug Administration (FDA) has approved GlaxoSmithKline ’s (GSK) Jesduvroq (daprodustat) to treat anaemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months. Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).

Food and Drug Administration 105

Food and Drug Administration FDA Safety Food 105

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

European Pharmaceutical Review

JULY 4, 2023

As drug development professionals know, global health crises like the COVID-19 pandemic provide the public with valuable insights into how clinical research and regulatory processes work. What are Antibody Drug Conjugates and Multispecific Antibody Therapeutics?

Food and Drug Administration 89

Food and Drug Administration Manufacturing Management Safety 89

European Pharmaceutical Review

JUNE 27, 2023

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease.

Food and Drug Administration 100

Food and Drug Administration Safety FDA Food 100

European Pharmaceutical Review

NOVEMBER 7, 2022

has announced its B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb) elranatamab for relapsed or refractory multiple myeloma (RRMM) has received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA). The investigation noted elranatamab delivered a manageable safety profile.

Food and Drug Administration 102

Food and Drug Administration Medicine Safety FDA 102

European Pharmaceutical Review

DECEMBER 5, 2022

GSK has announced that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for momelotinib, a new oral treatment for myelofibrosis, which, if approved, could be the only medicine available to address myelofibrosis, including anaemia, symptoms, and splenomegaly.

Food and Drug Administration 85

Food and Drug Administration Marketing Food Medicine 85

Pharmaceutical Technology

APRIL 6, 2023

The Singapore Health Sciences Authority (HSA) has accepted Everest Medicines’ new drug application (NDA) for Nefecon to treat adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Nefecon represents the first non-oncology medicine to gain breakthrough therapy designation in China.

Food and Drug Administration 52

Food and Drug Administration Food Medicine Safety 52

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. Quizartinib had a 11.3%

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

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.

Pharmaceutical 105

Pharmaceutical Food and Drug Administration Medicine FDA 105

Pharmaceutical Technology

NOVEMBER 11, 2022

The latest development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on vaccine use. In all these trials, the vaccine was found to be well-tolerated with a favourable safety profile.

Food and Drug Administration 98

Food and Drug Administration Medicine Food Safety 98

Pharmaceutical Technology

MAY 5, 2023

The European Medicines Agency’s (EMA) committee for medicinal products for human use (CHMP) has recommended full marketing authorisation (MA) for Gilead Sciences ’ Hepcludex (bulevirtide) to treat chronic hepatitis delta virus (HDV) and compensated liver disease in adult patients.

Food and Drug Administration 59

Food and Drug Administration Marketing Medicine Food 59

European Pharmaceutical Review

SEPTEMBER 29, 2023

The US Food and Drug Administration (FDA) has approved Exxua (gepirone hydrochloride extended-release tablets) for adults with major depressive disorder ( MDD ). According to the company’s website, the medicine offers the first truly novel mechanism for MDD in over 30 years.

FDA 97

FDA Food and Drug Administration Medicine Food 97

Pharma Leaders

JUNE 27, 2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion recommending authorisation of GlaxoSmithKline’s (GSK) daprodustat for symptomatic anaemia linked to chronic kidney disease (CKD).

Food and Drug Administration 52

Food and Drug Administration Medicine Food Safety 52