pharmaphorum

DECEMBER 22, 2021

Amgen has won FDA approval for a stronger label for its oral plaque psoriasis therapy Otezla, as it prepares for competition from Bristol-Myers Squibb’s much-touted rival deucravacitinib, which could make its debut next year. The post Amgen builds Otezla’s psoriasis label as rival BMS looms large appeared first on.

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Labelling 59

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.

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Labelling Drug Development 52

pharmaphorum

JANUARY 12, 2021

It was the top-selling drug in the SGLT2 inhibitor class in 2019, with sales of almost $3 billion, helped by side-effect problems that have afflicted first-to-market rival Invokana (canagliflozin) from Johnson & Johnson. The post Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label appeared first on.

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Labelling Diabetes 70

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.

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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.

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Labelling Pharmaceutical Companies Pharmaceutical Companies 130

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.

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Labelling Drug Development 122

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.

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Specialty Pharmacies Labelling Packaging 90

PharmaShots

FEBRUARY 6, 2023

Shots: The company reported the results from the PoC P-II open-label (UNITY) trial evaluating nipocalimab (IV, qw) in 14 patients who are at high risk for sev. HDFN The trial met its 1EPs i.e., the results showed that patients treated with nipocalimab achieved a live birth at or after the gestational age of 32wks.

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Labelling 40

FDA Law Blog: Biosimilars

JUNE 11, 2023

However, over time, data on pediatric labeling changes pursuant to BPCA and/or PREA have been collected. Between 2002 and 2019, there were 768 products with pediatric labeling changes under BPCA and/or PREA. Still, however, it appears FDA has had enough of these 16%.

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Labelling Drug Development 40

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.

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Diabetes Labelling 98

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.

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Labelling 105

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. .

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Labelling Drug Development 105

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.

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Grocery Stores Labelling Dosage 130

GMPSOP

MARCH 3, 2024

Cross contamination in the pharmaceutical industry can be described as an accidental inclusion of product of another batch or unknown foreign material into a finished batch, which was not intended or not mentioned on the label. – In 2019, the FDA publicly reprimanded 21 companies for cross-contamination.

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Health and Personal Care Stores Packaging Labelling Documentation 52

RX Note

JUNE 8, 2023

NOTE: LactMed apps for Android and iOS devices were retired on 16 December 2019. In the past, package inserts were not always reliable sources of information regarding medication safety during lactation. LactMed provides information on substance levels in breast milk and infant blood, as well as possible adverse effects on nursing infants.

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Labelling Packaging 52

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.

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Adverse Reactions Labelling 98

RX Note

JUNE 21, 2023

NOTE: Co-trimoxazole is also used off-label for primary prophylaxis of toxoplasma Gondii encephalitis in patients with HIV. As an alternative to co-trimoxazole preventive therapy, dapsone at dose of 100 mg daily may be used (G6PD test must be normal prior to initiation). mg/day) may be considered during the first trimester only.

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Dosage Labelling 52

pharmaphorum

SEPTEMBER 11, 2022

Bristol-Myers Squibb’s deucravacitinib– one of the main pipeline assets in its $74 billion takeover of Celgene in 2019 – has been approved in its first market as a treatment for moderate-to-severe plaque psoriasis. billion oral psoriasis therapy Otezla (apremilast). Otezla was acquired by Amgen for $13.4

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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.

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Chemotherapy Labelling 105

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

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Labelling Communication 98

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

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

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Labelling 115

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.

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Labelling 98

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.

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Labelling 105

Pharma Packaging Solutions

JUNE 12, 2019

With two busy 2019 quarters booked, Pharma Packaging Solutions knew it needed to expand capacity quickly. Additional labeling equipment was ordered and installed along with a leading-edge environmental control system. More investments are planned to increase efficiency in the second half of 2019.

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Packaging Labelling 40

pharmaphorum

JANUARY 10, 2022

Idorsia reckons Quviviq is a second-generation DORA with a profile that will be able to take on Eisai’s Dayvigo (lemborexant) and Merck & Co’s Belsomra (suvorexant), which were approved by the FDA in 2019 and 2014, respectively. The main side effects listed on its label are headache and – unsurprisingly – sleepiness.

Labelling 52

Labelling 52

pharmaphorum

SEPTEMBER 2, 2021

The regulator is adding new and revised warnings labels to the Pfizer products as well as Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib), which are also approved to treat arthritis and other inflammatory conditions. The result? billion, but fell 15% in the second quarter.

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Labelling 52

pharmaphorum

NOVEMBER 10, 2022

Sales were around $140 million in 2019, and climbed to $165 million the following year, despite the impact of the pandemic. With finances tight, Clovis has deferred a $1.9 million interest payment on debt, and is now in a 30-day grace period that could lead to it being in default.

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Chemotherapy Labelling 59

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.

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Vaccines Labelling 64

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.

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Labelling 173

Pharmaceutical Technology

JANUARY 10, 2023

GlobalData expects that the T2D market will see significant growth from 2019–29, with the 9MM having a total of $45.9 billion in sales in 2019, increasing to $136.2 Specifically, across all the major classes there are significant developments, label updates, and biosimilar launches that are driving their growth.

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Biosimilars Labelling Diabetes Compounding 52

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.

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Labelling Drug Development 98

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. .

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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.

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Chemotherapy Labelling 111

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

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Biosimilars Labelling Diabetes 72

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.

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Labelling Adverse Reactions 52