European Pharmaceutical Review

JANUARY 16, 2023

In 2019, there were 40 million individuals with bipolar disorder worldwide. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder. It plans to launch the drug in more countries and regions around the world.

Labelling 122

Labelling Drug Development 122

pharmaphorum

SEPTEMBER 23, 2022

The full approval also extends the Retevmo label to include patients with locally advanced as well as metastatic disease. Lilly acquired Retevmo as part of its $8 billion takeover of Loxo Oncology in 2019. The post Lilly bags label extension for RET drug Retevmo in US appeared first on.

Labelling 59

Labelling 59

LifeProNow

DECEMBER 22, 2023

The most recent inspection of the company’s facilities in 2022 found the majority of the inspectional observations repeated those found in past FDA inspections and detailed in a 2019 warning letter. Despite repeated warnings, the company and Badia continued to violate the law.

Labelling 130

Labelling Pharmaceutical Companies Pharmaceutical Companies 130

pharmaphorum

MARCH 1, 2021

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups. GSK’s problems with Trelegy, developed in partnership with Innoviva, stem from the phase 3 CAPTAIN study , which reported findings in May 2019.

Labelling 105

Labelling 105

pharmaphorum

AUGUST 18, 2021

The accelerated approval means GSK’s drug has a broader label in dMMR tumours than both Merck & Co’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab), which so far are approved for dMMR-positive colorectal cancer only. billion takeover of Tesaro in 2019.

Labelling 52

Labelling Drug Development 52

pharmaphorum

JULY 26, 2021

Fresh from its takeover of Alexion, AstraZeneca has picked up a recommendation in the EU for an expansion of the label of Ultomiris, one of the main assets behind the $39 billion merger. The post Boost for AZ as Ultomiris gets CHMP nod for expanded label appeared first on.

Labelling 52

Labelling Biosimilars 52

NY Times

SEPTEMBER 21, 2021

The pandemic has exposed flaws in services for people who can’t easily access a drive-through window for Covid shots or testing or can’t read prescription labels.

Specialty Pharmacies 90

Specialty Pharmacies Labelling Packaging 90

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

Labelling 40

Labelling Vaccines Communication 40

pharmaphorum

AUGUST 4, 2020

The study reviewed all 80 European Medicines Agency (EMA) authorised drugs receiving an orphan designation between 1 January 2013 and 31 December 2019, analysing their HTA outcomes and time to reimbursement across France, Germany, England and Scotland. Rates of approval. A more favourable outcome from the German regulator took on average 1.4

Labelling 112

Labelling 112

LifeProNow

JANUARY 19, 2024

The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization. EtO is the most commonly used sterilization method for medical devices in the U.S.,

Labelling 130

Labelling 130

pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group. .

Labelling 105

Labelling Drug Development 105

ALiEM - Pharm Pearls

FEBRUARY 24, 2023

Methylene blue is FDA approved for the treatment of methemoglobinemia but has increasingly been used off-label in vasoplegic shock as a potent vasoconstrictor. Elsevier; 2019, 247-288. McGraw-Hill Education; 2019 Hajj-Chahine J, Jayle C, Corbi P. How does methylene blue work as a vasopressor? Crit Care Med. EMCrit Project.

Labelling 173

Labelling 173

pharmaphorum

JULY 20, 2021

The US regulator had extended its review of the drug by three months – setting back its action date from April to 29 July – but now says that deficiencies in the marketing application “preclude discussion” of labelling and post-marketing requirements. “Despite….advantageous

Labelling 98

Labelling Communication 98

European Pharmaceutical Review

MARCH 8, 2024

Novo Nordisk stated it expects to file for regulatory approvals of a label expansion for Ozempic ® in the US and EU this year. The study was initiated in 2019 and enrolled 3,533 people with type 2 diabetes and chronic kidney disease, the company noted.

Diabetes 98

Diabetes Labelling 98

LifeProNow

MARCH 30, 2023

In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling.

Grocery Stores 130

Grocery Stores Labelling Dosage 130

Pharmaceutical Technology

AUGUST 8, 2022

The approval was based on findings from the international, randomised, open-label Phase III DESTINY-Breast04 clinical trial. With the approval for this indication, AstraZeneca is entitled to make a milestone payment of $200m to Daiichi Sankyo under a partnership deal signed in 2019.

Chemotherapy 105

Chemotherapy Labelling 105

Pharmaceutical Technology

SEPTEMBER 19, 2022

The latest development is based on findings from the single-arm, open-label Phase II/III ALD-102 (Starbeam) and Phase III ALD-104 clinical trials. In June 2019, the European Commission granted conditional marketing authorisation for bluebird bio’s Zynteglo to treat transfusion-dependent ?-thalassemia. thalassemia.

Adverse Reactions 98

Adverse Reactions Labelling 98

pharmaphorum

JANUARY 29, 2021

JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite.

Labelling 135

Labelling 135

pharmaphorum

MARCH 12, 2021

The label also covers adults with advanced RET fusion-positive thyroid cancer who require systemic therapy after previous treatment with sorafenib/lenvatinib. Retevmo was approved in the US in May last year and is the second approved drug to spring from Lilly’s takeover of Loxo Oncology in 2019.

Chemotherapy 111

Chemotherapy Labelling 111

pharmaphorum

AUGUST 23, 2022

The phase 1/2 trial will be an open-label, dose-escalation study that will test various doses of BV-101 in between 12 and 18 subjects. In 2019, Bayer bought cell therapy company BlueRock Therapeutics, which was created in 2016 via a joint venture between Bayer and Versant Ventures.

Labelling 105

Labelling 105

Pharmaceutical Technology

AUGUST 18, 2022

The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?0/?0 In June 2019, the European Commission (EC) granted conditional marketing authorisation for Zynteglo to treat transfusion-dependent beta-thalassemia. 0 genotypes.

Labelling 98

Labelling 98

Express Pharma

NOVEMBER 26, 2024

Pfizer’s tafamidis capsules, sold as Vyndaqel and Vyndamax, were approved in 2019 and brought in sales of $3.32 It affects more than 120,000 US adults, according to non-profit researcher Institute for Clinical and Economic Review. billion in 2023. “It is better for the patient community to have more options,” Harrison said.

Dosage 105

Dosage Labelling 105

pharmaphorum

JULY 9, 2021

According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis with the shots. . ‘No evidence’ Zynteglo causes blood cancer. .

Vaccines 105

Vaccines Labelling Immunity Immunization 105

pharmaphorum

AUGUST 21, 2022

That status goes to Johnson & Johnson’s Spravato (esketamine), which was approved in March 2019 and is administered as a nasal spray twice a week for four weeks. However, it has a broader label as unlike J&J’s drug it is indicated for use in previously-untreated MDD.

Labelling 97

Labelling 97

Pharma Marketing Network

MARCH 25, 2022

2 In 2019, there were 7 potential family caregivers per older adult. Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. February 2019. Centers for Disease Control and Prevention. Accessed March 12, 2022. National Alliance for Caregiving. Public Health.

Labelling 98

Labelling Drug Development 98

pharmaphorum

NOVEMBER 3, 2021

Around one in five gastric cancers are HER2-positive, opening up a new market for AZ and Daiichi Sankyo, which have been collaborating on Enhertu since signing a multi-billion partnership for the drug in 2019. The post EMA starts review of Enhertu for HER2+ gastric cancer appeared first on.

Chemotherapy 98

Chemotherapy Biosimilars Labelling 98

pharmaphorum

FEBRUARY 8, 2022

Novo Nordisk’s new obesity therapy Wegovy has been recommended for routine NHS use by UK cost-effectiveness watchdog NICE, but in a narrower group of patients than is covered by its MHRA-approved label. The 2019 Health Survey for England estimated 28% of adults in England were obese and a further 36% were overweight, according to NICE.

Labelling 105

Labelling Diabetes 105

pharmaphorum

DECEMBER 23, 2021

billion in 2019, and will be hoping for a swift uptake in the US to get a return on its big investment. Novartis will have to wait for the results of the ORION-4 study – due in 2024 – before it has a chance of matching the labels of Amgen and Sanofi/Regeneron’s drugs. It has a long way to go.

Labelling 104

Labelling 104

pharmaphorum

MAY 27, 2021

It is thought that around five million women in the US have uterine fibroids that cause symptoms, with two-thirds of them inadequately treated with current drugs – generally off-label oral contraceptives or injectable gonadotropin releasing hormone (GnRH) agonists like leuprolide acetate or goserelin acetate.

Labelling 98

Labelling 98

pharmaphorum

AUGUST 4, 2021

The withdrawals – while voluntary – come as the FDA has been taking a closer look at accelerated approvals of cancer drugs, focusing mainly on checkpoint inhibitors that have seen new uses added to their labels at breakneck speed since being launched onto the market.

Chemotherapy 98

Chemotherapy Labelling 98

European Pharmaceutical Review

JULY 5, 2022

Trial data will now be submitted to global regulatory authorities to evaluate a potential label expansion for Takhzyro to include the younger patient population. . Takeda stated that the trial results are consistent with those observed in earlier studies with adult and adolescent patients.

Labelling 98

Labelling 98

ALiEM - Pharm Pearls

MARCH 7, 2024

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. 2019 Oct 28;55(11):717. Identify the medullary pyramids, calyces, renal cortex, and renal pelvis (Figure 4). Transverse view of the right kidney Figure 4. Medicina (Kaunas).

Labelling 177

Labelling Communication 177

pharmaphorum

OCTOBER 25, 2021

The new approval is the first breast cancer indication for Keytruda in Europe, although elsewhere Merck has already started to expand the label for its cancer immunotherapy in TNBC. The US and Japanese regulators approved the Keytruda plus chemo regimen for first-line TNBC treatment earlier this year.

Chemotherapy 87

Chemotherapy Labelling 87

pharmaphorum

SEPTEMBER 20, 2021

The approval comes a few weeks after the biosimilar was cleared for marketing in the EU with a broader label, as it also includes diabetic macular oedema (DMO), another of Lucentis’ approved indications. Sales reached a peak in 2019, when Roche booked $1.8 billion in sales from the drug while Novartis made $2.1 billion and $1.9

Biosimilars 72

Biosimilars Labelling Diabetes 72

pharmaphorum

JUNE 6, 2022

Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021. billion product, mainly from first-line use, if it can claim FDA approval for a broad label covering any ROS1-positive cancer.

Chemotherapy 98

Chemotherapy Labelling 98

pharmaphorum

JULY 4, 2022

There is already a GLP-2 analogue drug on the market for SBS – Takeda’s Gattex (teduglutide) which was approved for SBS in adults in 2012 and children in 2019 – while AstraZeneca’s GLP-1 drug Byetta/Bydureon (exenatide) has also been used off-label to treat the disorder.

Labelling 95

Labelling 95

pharmaphorum

MAY 3, 2022

Both Belsomra and Dayvigo have box warnings on their labels in the US on daytime functioning, including the ability to drive motor vehicles. Belsomra’s first-to-market advantage in the US hasn’t however translated into big annual sales, which have stayed planted just over the $300 million mark since 2019.

Labelling 91

Labelling 91