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.

Labelling 105

Labelling 105

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

European Pharmaceutical Review

APRIL 8, 2024

The expanded label of CARVYKTI has the potential to transform the treatment paradigm for multiple myeloma by providing patients and physicians with a personalised immunotherapy that can be used earlier in the treatment regimen,” commented Ying Huang, PhD, Chief Executive Officer of Legend Biotech.

Labelling 98

Labelling 98

FDA Law Blog: Biosimilars

MAY 23, 2023

We previously noted that “ the skinny label may be dead ” and, while we still can’t be sure if it’s truly gone (but not forgotten), we now know that the Supreme Court won’t hear this case at this time. So, while the skinny label may not actually be dead, there will certainly be a reluctance to use it.

Labelling 40

Labelling 40

Express Pharma

NOVEMBER 8, 2023

Due to their novel mechanisms of action, and positive efficacy and safety profiles, these therapies are expected to improve treatment rates and drive growth within the class II-V MG market*, especially within the treatment refractory segment, in which patients fail to respond to two or more off-label treatments.

Labelling 105

Labelling Compounding 105

European Pharmaceutical Review

JULY 27, 2023

Soliris was first approved the EU in 2017 as a treatment for gMG. Patients who completed the randomised control period were eligible to continue into an open-label extension period evaluating the safety and efficacy of Soliris, which is ongoing.

Labelling 98

Labelling Hospitals 98

pharmaphorum

MARCH 23, 2021

The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis. Dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen while data are carefully analysed to inform next steps on this study.

Labelling 98

Labelling Drug Development 98

pharmaphorum

DECEMBER 18, 2020

The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the drug beyond its earlier label covering the treatment of active systemic lupus erythematosus (SLE) in combination with other medicines.

Labelling 99

Labelling 99

pharmaphorum

NOVEMBER 1, 2021

The full approval for T315I-positive CML came on the back of a non-randomised, open-label phase 1 trial involving 330 patients that is also looking at combinations of Scemblix with other TKIs. The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

Labelling 115

Labelling 115

Express Pharma

AUGUST 4, 2024

The safety of nanoparticles, complexities surrounding medicolegal cases, and long-acting formulations like implants in bioavailability and bioequivalence studies will also be discussed. ” Now in its 11th year, the India Annual Meeting enables attendees to interact, network, and debate the most pressing issues facing the life sciences.

Generic Medicine 105

Generic Medicine Labelling 105

pharmaphorum

SEPTEMBER 11, 2020

Ocrevus (ocrelizumab) was approved in 2017 for relapsing and primary progressive forms of MS and is seen as one of the most successful drug launches in pharma history, generating sales of $3.79 Roche has hit back at Novartis’ newly-approved multiple sclerosis drug Kesimpta, with new data from its already-marketed blockbuster Ocrevus.

Labelling 87

Labelling 87

pharmaphorum

MARCH 8, 2021

The new indication for the Merck & Co/MSD-partnered drug – which is also used to treat ovarian, breast and pancreatic cancer – was approved by the EMA last year with a slightly more restricted label than was previous cleared by the FDA.

Chemotherapy 98

Chemotherapy Labelling 98

pharmaphorum

FEBRUARY 8, 2021

Breyanzi has however been cleared with a similar black box warning on its label for neurotoxicity and cytokine release syndrome (CRS) as Novartis and Gilead/Kite’s therapies. At the moment there are limited fallback options for patients whose lymphoma progresses despite first line chemotherapy and anti-CD20 treatment.

Chemotherapy 111

Chemotherapy Labelling 111

pharmaphorum

JUNE 7, 2021

Kymriah (tisagenlecleucel) was approved for relapsed/refractory ALL in 2017, but its label covers use in children and young adults aged up to 25, who account for the bulk of cases of the blood cancer. The median response duration was 12.8

Labelling 105

Labelling Immunization Immunity 105

Eye on FDA

AUGUST 17, 2022

You can see early in the chart, FDA maintained a very low volume of communications, and at mid-year in 2017 had issued only 52 releases, rising to 166 for the year. Only 20 were about product approvals or label expansions, compared to 46 the year before (the drop in NME approvals was covered here not long ago).

Communication 75

Communication Labelling 75

pharmaphorum

MARCH 9, 2022

The launch of Hemlibra (emicizumab) in 2017, with a label expansion in 2018 to broaden its use – had a speedy impact on Eloctate, which also came from Bioverativ’s stable. Sanofi recorded a $2 billion charge in 2019 that it said was largely down to pressure on its drug.

Labelling 98

Labelling 98

pharmaphorum

DECEMBER 29, 2021

Dupixent (dupilumab) – an IL-4 and IL-13 inhibitor – has dominated the market for biological therapies for atopic dermatitis since it was approved by the FDA in 2017. Dupixent’s label currently calls for dosing every two weeks for all patients. Leo now says it will start rolling the new product out in February.

Labelling 111

Labelling 111

Big Molecule Watch

MAY 20, 2024

CYLTEZO was first approved in the US in 2017 and later approved in the US as an interchangeable biosimilar to Humira in October 2021. The FDA has not yet granted an interchangeability designation for the 100 mg/mL formulation, which was approved with labeling removing all references to interchangeability.

Biosimilars 45

Biosimilars Labelling 45

LifeProNow

MARCH 27, 2023

NEURO-TTRansform NEURO-TTRansform is a global, open-label, randomised trial evaluating the efficacy and safety of eplontersen in patients with ATTRv-PN. The 66-week analysis evaluated percent change from baseline in serum TTR concentration, changes in the mNIS+7 and Norfolk-QOL-DN in the eplontersen group versus an external placebo group.

Labelling 100

Labelling Diabetes 100

pharmaphorum

NOVEMBER 6, 2022

The antibody-based drug has been cleared by the European Commission with a broad label, covering both full-term and pre-term babies and those with a range of health conditions that could make the vulnerable to RSV, said the two pharma groups in a statement. It is the first approval for Beyfortus (nirsevimab) by any regulatory authority.

Vaccines 64

Vaccines Labelling 64

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA).

Documentation 111

Documentation Labelling Hospitals 111

pharmaphorum

APRIL 30, 2021

BMS and bluebird had been hoping for a label allowing third-line use. Janssen entered into a worldwide collaboration and license agreement for cilta-cel with the drug’s originator – China’s Legend Biotech – in December 2017.

Immunization 82

Immunization Immunity Labelling 82

pharmaphorum

SEPTEMBER 25, 2020

The drug is approved both as a monotherapy in first-line NSCLC and also got the green light for use in combination with chemo in 2017. The new data is a boost to Merck’s franchise just as other drugmakers have started to cast jealous eyes at the lucrative market, which accounts for the bulk of Keytruda’s sales.

Chemotherapy 75

Chemotherapy Labelling 75

pharmaphorum

OCTOBER 14, 2021

The findings were based on an ALITHIOS Phase 3b open-label extension study of Kesimpta, a targeted B-cell therapy that Novartis says, “delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment for MS.”. years vs initiation two years later. billion in 2019.

Labelling 59

Labelling Immunization Immunity 59

pharmaphorum

SEPTEMBER 21, 2020

The committee also recommended Lynparza should get its label extended to cover first-line maintenance treatment of ovarian cancer in combination with Roche’s Avastin (bevacizumab), in patients with homologous recombination deficient (HRD)-positive disease.

Labelling 52

Labelling Vaccines 52

pharmaphorum

SEPTEMBER 30, 2022

The approval makes Relyvrio (sodium phenylbutyrate and taurursodiol) the first new therapy option for ALS – also known as motor neuron disease (MND) – since Mitsubishi Tanabe Pharma’s intravenous Radicava (edaravone) was cleared by the FDA in 2017. An oral version of edaravone was cleared this year.

Specialty Pharmacies 98

Specialty Pharmacies Labelling Hospitals Drug Development 98

Pharmaceutical Business Review

OCTOBER 17, 2023

This authorisation was given as per the Resolution RDC 205/2017 to Minjuvi along with lenalidomide followed by Minjuvi monotherapy for treatment of adults who are not eligible for autologous stem cell transplantation, and with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) including DLBCL occurring from low grade lymphoma.

Labelling 52

Labelling 52

Pharmaceutical Business Review

JULY 28, 2023

In 2017, Soliris initially received approval in the EU to treat certain adults with gMG. The 26-week multicentre, open-label trial was designed for evaluating Soliris’s efficacy and safety in 11 patients aged 12 to 17 years.

Labelling 52

Labelling 52

European Pharmaceutical Review

FEBRUARY 23, 2023

11 Future methods are likely to require samples being collected, labelled, filtered and processed to obtain their spectra. 2017; 88, Art. Label-free, rapid and quantitative phenotyping of stress response in E. B, 2017; 372:20160138. This is particularly important for commonly used bacteria such as E. coli via ramanome.

Labelling 121

Labelling Packaging Drug Development 121

Pharma Marketing Network

MARCH 25, 2022

Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Connect at linkedin.com/in/sunnywhite/ . REFERENCES: Gilda’s Club.

Labelling 98

Labelling Drug Development 98

pharmaphorum

MARCH 16, 2022

The Belgian biotech, which was spun out from the Vrije Universiteit Brussel in 2014, is developing a pipeline of radio-labelled, single-chain antibodies led by CAM-H2, currently in a phase 1/2 study in patients with HER2-positive metastatic breast and gastric cancers.

Labelling 59

Labelling 59

pharmaphorum

OCTOBER 7, 2021

In 2017, Teva won approval for Austedo (deutetrabenazine), a tweaked version of tetrabenazine that also claims to offer fewer side effects, but carries a black box warning for depression and suicidality. Sales were $638 million last year and according to Teva will approach the $1 billion mark in 2021, despite the warning label.

Labelling 72

Labelling 72

European Pharmaceutical Review

JULY 5, 2022

In the future, the potential label expansion of Oncoral into other solid cancer indications will be investigated. accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf [Accessed 25.01.22]. 2017; 8(23):38022-38043. For more information about Oncoral, please visit www.ascelia.com/pipeline/oncoral. About the author.

Chemotherapy 104

Chemotherapy Dosage Labelling Compounding 104

pharmaphorum

NOVEMBER 14, 2022

The narrower label for Zejula (niraparib) means it can only be used as second-line maintenance therapy after platinum-based chemotherapy in patients with these cancers whose tumours carry a germline BRCA mutation – around 15% of the population. That was due last Friday, but cancelled when GSK opted to withdraw the approval.

Labelling 52

Labelling Chemotherapy Vaccines 52

pharmaphorum

JULY 8, 2021

If approved, TSLP inhibitor tezepelumab could reach the market with a broader label than currently-used asthma antibodies, which are approved to treat patient with severe asthma characterised by high levels of eosinophils – a type of white blood cell. Results from that programme are due in 2023.

Labelling 52

Labelling 52

pharmaphorum

MARCH 3, 2021

Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009. A further approval in 2017 in childhood asthma has helped the drug to build sales in the US.

Labelling 52

Labelling 52

Pharmaceutical Technology

JANUARY 23, 2023

Therefore, with an inadequate or loss of response to these anti-TNFs, clinicians must prescribe adult therapies off-label to treat younger patients. In addition to Skyrizi’s recent supplementary CD indication, both Tremfya and Skyrizi received US FDA approval in psoriasis in 2017 and in 2019, respectively.

Labelling 59

Labelling Compounding Drug Development 59