European Pharmaceutical Review

NOVEMBER 24, 2022

These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. The fourth version was introduced in 2018. An expansive role for holograms… Meditag serialised hologram labels.

Packaging 111

Packaging Labelling Documentation Dosage 111

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. Xeljanz isn’t the only drug in the class to be affected by toxicity concerns of course.

Labelling 135

Labelling 135

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

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

The Guardian - Pharmaceutical Industry

DECEMBER 5, 2023

Then came Orkambi in 2015 and Symkevi in 2018 – both two-drug combinations. Kaftrio is the latest to be labelled unaffordable for a cash-strapped NHS. The drugs that have caused such a stir are made by the US biotech company Vertex. Since 2020, there has been Kaftrio, which is a triple combination. Continue reading.

Labelling 73

Labelling 73

Express Pharma

MAY 22, 2023

The US Food and Drug Administration (FDA) has granted Fast Track designation for the drug in January 2018. This ASP-1929-301 study is currently underway in several countries such as the US and Taiwan, and will enroll 275 patients globally including Indian patients.

Labelling 98

Labelling Drug Development 98

pharmaphorum

AUGUST 4, 2022

Keytruda has struggled to make an impact in prostate cancer, and the disease does not feature on the drug’s very long list of approved indications, despite considerable clinical testing on Merck’s part, or indeed on the label’ of other drugs in the PD-1/PD-L1 inhibitor class like Bristol-Myers Squibb’s Opdivo (nivolumab).

Chemotherapy 105

Chemotherapy Labelling 105

pharmaphorum

JUNE 4, 2021

It has been approved as a second-line treatment for BRCA-mutated, HER2-negative breast cancer after chemotherapy since 2018, and is also used to treat ovarian, pancreatic and prostate cancers, bringing in around $1.8 billion in sales for AZ last year, with Merck booking $725 million in alliance revenues.

Chemotherapy 98

Chemotherapy Labelling 98

pharmaphorum

JUNE 11, 2021

takeover of Bioverativ in 2018, is designed to block the complement pathway of the immune response, which becomes activated in CAD. At the moment CAD is managed using off-label therapies, including rituximab and corticosteroid drugs. Sutimlimab, which Sanofi acquired via its $11.6

Immunity 93

Immunity Immunization Labelling 93

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

Pharmaceutical Technology

JULY 29, 2022

While the prevalence was 1 in 150 children in 2000, it reached the rate of 1 in 44 in 2018, in the US, according to the Centers for Disease Control and Prevention. Off-label medication options. The rate at which children are being identified with autism spectrum disorder (ASD) has tripled in the past two decades.

Communication 105

Communication Labelling Hospitals 105

pharmaphorum

JUNE 23, 2021

Keytruda (pembrolizumab) was given an accelerated approval in 2018 as a second-line therapy for PD-L1-positive cervical cancer, but the new survival data – from the phase 3 KEYNOTE-826 trial – could extend the use of the drug. The company hasn’t disclosed the data yet, but says it will do so at a future medical meeting.

Chemotherapy 82

Chemotherapy Labelling 82

pharmaphorum

NOVEMBER 10, 2022

However, turnover fell back to $148 million in 2021, mainly as a result of strong competition from AstraZeneca and Merck & Co’s class-leading Lynparza (olaparib) – which has a much broader product label – as well as GSK’s Zejula (niraparib). With finances tight, Clovis has deferred a $1.9

Chemotherapy 59

Chemotherapy Labelling 59

pharmaphorum

NOVEMBER 9, 2022

The FDA is due to deliver a decision on the marketing application in the first half of next year, with AZ going after a broad label that would include all patients aged four and over. AZ is developing PT027 with UK partner Avillion under the terms of an agreement first signed in 2018.

Labelling 59

Labelling 59

pharmaphorum

MAY 17, 2021

Apellis Pharma has secured FDA approval for its complement C3 inhibitor Empaveli as a treatment for paroxysmal nocturnal hemoglobinuria (PNH) – with a label that will allow it to challenge Alexion’s established therapies directly. . billion and $1.1 billion respectively last year, although Soliris could lose patent protection next year.

Labelling 52

Labelling Vaccines 52

Big Molecule Watch

NOVEMBER 21, 2023

Genentech previously sued Sandoz on December 21, 2017 and Celltrion and Teva on January 12, 2018. Both cases were dismissed in December 2018, after the parties filed stipulations of dismissal stating that they had entered into settlement agreements.

Biosimilars 49

Biosimilars Labelling 49

Eye on FDA

JULY 19, 2021

Also by mid-year last year, FDA announced 55 approvals, including several Emergency Use Authorization (EUA) announcements for drugs and devices compared to just 44 approvals, EUA’s, or label expansions so far this year ( though the number of new molecular entities is running at a very high pace during the first half of this year).

Labelling 93

Labelling Communication Vaccines 93

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.

Labelling 52

Labelling 52

pharmaphorum

JANUARY 5, 2021

Main rival Keytruda however retains one advantage – a label that include the treatment of patients with low levels of the biomarker – which means that it can be used without chemotherapy in nearly all the first-line NSCLC population.

Chemotherapy 52

Chemotherapy Immunity Immunization Labelling 52

pharmaphorum

OCTOBER 19, 2020

The combination therapies had previously been marketed following accelerated approval in November 2018 on the basis of early stage results. The drug’s US label also covers certain patients with chronic lymphocytic leukaemia, including a chemotherapy-free regimen for previously untreated patients.

Adverse Reactions 59

Adverse Reactions Chemotherapy Labelling 59

European Pharmaceutical Review

OCTOBER 19, 2023

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. Recent advancements for radiopharmaceuticals in oncology include a $1.4

Chemotherapy 105

Chemotherapy Compounding Immunity Immunization 105

pharmaphorum

MAY 25, 2022

Vtama (tapinarof) – originally developed by GlaxoSmithKline – is a first-in-class, once-daily topical therapeutic aryl hydrocarbon receptor modulating agent (TAMA) and has been approved by the US regulator with a broad label spanning mild, moderate, and severe psoriasis and an unlimited duration of use. Otezla – which Amgen acquired for $13.4

Labelling 52

Labelling Biosimilars 52

pharmaphorum

DECEMBER 16, 2020

billion product last year, and that represented a surge from around $1 billion in 2018 revenues. The prospect of adding HFpEF to Entresto’s label looked shaky last year however, when the drug missed its primary objective in the phase 3 PARAGON-HF trial. After a slow start, it has grown to become a $1.7

Labelling 52

Labelling 52

pharmaphorum

MARCH 3, 2021

The court case stems from October 2018, when AstraZeneca began litigation against Mylan and subsequently against 3M Company (3M) asserting infringement of various US patents covering Symbicort. Symbicort was first FDA-approved in 2006 as a treatment for asthma, followed by an extension to its label covering COPD in 2009.

Labelling 52

Labelling 52

pharmaphorum

MARCH 24, 2022

billion takeover of Endocyte in 2018, one of a series of recent deals made by the company in the radiopharma category, and is due to be launched within the next few weeks. After a median follow-up of 20.9 months, patients on Pluvicto had radiographic progression-free survival (PFS) of 8.7 months, compared to 3.4 months, respectively.

Chemotherapy 59

Chemotherapy Labelling 59

pharmaphorum

AUGUST 2, 2021

Tibsovo (ivosidenib) was already on the market when Servier made its play for Agios’ assets, having secured US approvals as a treatment for relapsed or refractory IDH1-mutant AML in 2018 and as a monotherapy for newly diagnosed IDH1-mutant AML in patients aged over 75 or unable to take chemotherapy in 2019.

Chemotherapy 59

Chemotherapy Labelling 59

Pharmaceutical Technology

MARCH 7, 2023

As per one 2018 study , perimenopause is associated with an increased risk of experiencing greater symptoms of depression. However, as per the 2018 guidelines, data on estrogen plus progestin is “sparse and inconclusive”. Zulresso contains brexanolone, which is chemically identical to allopregnanolone, as per the drug’s label.

Labelling 52

Labelling Hospitals 52

RX Note

FEBRUARY 11, 2024

Laboratory analysis of some homeopathic remedies found greater amounts of Atropa belladonna (deadly nightshade, an anticholinergic agent) than claimed on the label. Says, 2016 FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit, 2018

Adverse Reactions 52

Adverse Reactions Labelling Community Pharmacies 52

RX Note

JUNE 9, 2023

FDA Pregnancy and Lactation Labelling Final Rule, 2015 In the past, FDA Pregnancy Categories was used in US. To address this, on 13 December 2014, the FDA published the Pregnancy and Lactation Labelling Rule” (PLLR). Labelling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.

Labelling 52

Labelling Adverse Reactions 52

RX Note

JUNE 8, 2023

This book received highly recommended recognition in Obstetrics and Gynaecology at the British Medical Association (BMA) Medical Book Awards in 2018 and selected as a Doody's Core Title for 2022 and 2023. In the past, package inserts were not always reliable sources of information regarding medication safety during lactation.

Labelling 40

Labelling Packaging 40

pharmaphorum

FEBRUARY 25, 2021

The NHS genomic medicine service, launched in 2018, is leading the drive for more personalised treatment, making genomic sequencing a routine part of diagnosis and treatment, and giving all patients the chance to participate in research. “We now know that 80% of rare diseases have a genetic origin.

Documentation 111

Documentation Labelling 111

pharmaphorum

DECEMBER 8, 2021

Acadia has indicated previously that most patients who completed the LAVENDER trial have entered an open-label extension, which backs up the idea that the side effects are manageable. At 12 weeks, trofinetide-treated patients had a 5.1-point point reduction in the Rett Syndrome Behaviour Questionnaire (RSBQ) scale, compared to a 1.7-point

Labelling 59

Labelling 59

European Pharmaceutical Review

AUGUST 14, 2023

With 51 patients enrolled in open label, single arm trial, Vicore says the trial data “demonstrates that C21 has the potential to transform the treatment of IPF and restore lung function.” The disease is currently considered to be incurable and inevitably progressive.

Labelling 98

Labelling Immunity Immunization Pharmaceutical Companies 98

Big Molecule Watch

JANUARY 25, 2024

FDA Guidances In September 2023, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.”

Biosimilars 45

Biosimilars Labelling Drug Pricing 45

RX Note

JUNE 4, 2023

Cartons or bulk containers of products/cosmetics should be adequately labelled with at least the product name, batch number and where necessary, expiry data or retest date. External Links Guideline on Good Distribution Practice, 2018 Garis Panduan Pengurusan Farmasi Logistik, 2020

Documentation 40

Documentation Labelling 40

pharmaphorum

FEBRUARY 2, 2022

Sales of Ruconest have held up fairly well, despite the FDA rejecting a bid to expand its label to include prevention of HAE attacks in 2018, bringing in $146 million in sales in the first nine months of 2021. For comparison, Takeda reported sales of around $415 million in the first six months of the 2021-22 fiscal year.

Immunity 52

Immunity Immunization Labelling 52