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.

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Labelling 40

FDA Law Blog: Biosimilars

NOVEMBER 6, 2024

The Court looked to the “statute’s words, structure, and historical context” and found that they “establish that, when Congress amended the [Orphan Drug Act] in 2017, it ratified and incorporated the existing regulatory definition of ‘same drug’ into the statute.”

Labelling 109

Labelling 109

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 57

Biosimilars Labelling 57

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.

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Labelling 98

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. .

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Labelling Drug Development 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.

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Labelling Hospitals 98

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.

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Labelling Compounding 100

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.

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Labelling 52

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.

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Generic Medicine Labelling 104

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

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

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

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

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Labelling Hospitals Dosage 40

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

. §374(a)(1)(B)) has required, for years, FDA-regulated industry to allow FDA “officers or employees” to “inspect, at reasonable times and within reasonable limits and in a reasonable manner,” any facility and “all pertinent equipment, finished and unfinished materials, containers, and labeling therein.”

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Documentation Labelling 67

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.

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Labelling Drug Development 98

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.

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Labelling Chemotherapy Vaccines 52

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).

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Communication Labelling 75

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

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 62

Biosimilars Labelling 62

RX Note

MARCH 3, 2024

Aromatase inhibitors, e.g. letrozole, anastrozole - Off-label use Surgical management of endometriosis is indicated for treatment of severe pain or infertility. 114: management of endometriosis, 2010 NICE Endometriosis: diagnosis and management, 2017 It has significant adverse effects (e.g.

Labelling 40

Labelling 40

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.

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Labelling Immunity Immunization 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.

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Labelling Vaccines 52

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.

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Labelling 115

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

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

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.

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Labelling 99

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.

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Labelling 59

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.

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Labelling 52

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).

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Documentation Labelling Hospitals 111

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.

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Compounding Labelling Drug Development 59

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

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.

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Diabetes Dosage Compounding Labelling 52

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.

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Chemotherapy Labelling 98

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

RX Note

FEBRUARY 6, 2024

To navigate this abundance, understanding the key ingredients listed on product label is crucial. Introduction The market overflows with skincare products, making informed choices a daunting task. NOTE: "Aqua" simply translates to water, a common filler ingredient.

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Labelling Community Pharmacies 40

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

epicur

MARCH 12, 2024

For example, Burton (2017) obtained chlorambucil and melphalan from four compounding pharmacies, cyclophosphamide from five pharmacies, and versions of all three drugs from manufacturers following FDA regulations. Review the Basics Several studies have looked at compounded chemotherapy drugs and found wide variances.

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Compounding Chemotherapy Compounding Pharmacies Labelling 52