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

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

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

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 85

Labelling 85

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 Immunity Immunization 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

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

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

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.

Immunity 79

Immunity Immunization Labelling 79

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

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

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

pharmaphorum

MARCH 11, 2022

Vraylar, sold in some markets as Reagila, was first approved in 2015 for schizophrenia and bipolar disorder, with its label extended in 2017 to include maintenance treatment of schizophrenia and again in 2019 for bipolar depression.

Clinical Pharmacology 52

Clinical Pharmacology Labelling 52

Big Molecule Watch

NOVEMBER 21, 2023

Genentech previously sued Sandoz on December 21, 2017 and Celltrion and Teva on January 12, 2018. They further allege that DRL submitted its aBLA prior to April 21, 2023 seeking approval for a RITUXAN biosimilar labeled with all the various indications for RITUXAN.

Biosimilars 49

Biosimilars Labelling 49

RX Note

JULY 29, 2023

She, on the hand, showed me the Frank Shann Drug Doses 2017 , which writes 0.1 Cephalexin (oral) for UTI prophylaxis Paediatric Protocols for Malaysian Hospitals, 2019: 5 mg/kg ON Frank Shann Drug Doses, 2017 : 12.5 Frank Shann Drug Doses, 2017 : NOT/kg. Frank Shann Drug Doses, 2017 : NOT/kg, 0-10 kg 6.25

Labelling 40

Labelling Hospitals Dosage 40

pharmaphorum

JANUARY 5, 2023

In 2017, reSET became the first FDA-approved DTx with both a safety and efficacy label, after the US regulator licensed it for substance use disorders involving alcohol, cocaine, marijuana, and stimulants. Pear secured approval for reSET-O in the following year.

Labelling 52

Labelling 52

FDA Law Blog: Biosimilars

SEPTEMBER 28, 2023

Richard Marschall, a “naturopathic doctor,” had been convicted in 2017 for a misdemeanor violation of the FDC Act for selling misbranded drugs. While Marschall was convicted of a felony based on one earlier 2017 FDC Act conviction, in a footnote, the 9th Circuit notes that this was actually Marschall’s third FDC Act conviction.

Labelling 52

Labelling 52

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. 2017 saw J&J make its biggest ever acquisition deal after fighting off competition from Sanofi to acquire Swiss biotech Actelion for $30 billion. In 2006, J&J acquired Pfizer Consumer Healthcare for $16.6 billion in cash.

Vaccines 126

Vaccines Biosimilars Labelling Communication 126

Pharmaceutical Technology

APRIL 28, 2023

Originally granted approval in its largest market, the US, in 2017, Ozempic has subsequently obtained approval for three distinct dosages, 0.5mg, 1.0mg, and 2.0mg, for the treatment of type 2 diabetes.

Diabetes 52

Diabetes Dosage Labelling Compounding 52

pharmaphorum

OCTOBER 18, 2022

In January, for example, they started enrolment in the open-label, phase 2 PAVO trial of GSK’s PARP inhibitor Zejula (niraparib) that is investigating the drug’s safety and efficacy in patients with cancers which carry PALB2 mutations. The two companies have been working together for some time.

Labelling 52

Labelling Drug Development 52

pharmaphorum

APRIL 30, 2021

Merck’s drug has been approved for this use since 2017, but failed to show a statistically significant improvement over third-line chemotherapy in either of two confirmatory trials – KEYNOTE-061 and KEYNOTE-062.

Chemotherapy 59

Chemotherapy Labelling 59

RX Note

OCTOBER 5, 2023

Meanwhile, an unnecessary health risk is created in the home whereby the patient or family members may accidentally consume expired medicines or wrong drug (due to unclear or damaged labels). Failure to discard medications properly may also contaminate the environment through poor disposal either via trash or sewer system.

Medication Dispensing 40

Medication Dispensing Community Pharmacies Hospitals Labelling 40

pharmaphorum

AUGUST 24, 2021

Novartis’ CAR-T therapy Kymriah racked up back-to-back approvals in acute lymphoblastic leukaemia and large B-cell lymphoma a few years ago, but hasn’t added to its label since. Now, a bid to move it onto earlier-stage use in lymphoma has ended in failure.

Chemotherapy 52

Chemotherapy Labelling 52