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.

Labelling 59

Labelling 59

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

pharmaphorum

SEPTEMBER 23, 2022

The full approval also extends the Retevmo label to include patients with locally advanced as well as metastatic disease. Lilly acquired Retevmo as part of its $8 billion takeover of Loxo Oncology in 2019. The post Lilly bags label extension for RET drug Retevmo in US appeared first on.

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Labelling 59

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

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.

Labelling 52

Labelling Drug Development 52

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

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

Labelling 122

Labelling 122

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

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Labelling Vaccines Communication 40

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

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.

Labelling 173

Labelling 173

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

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

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

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

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.

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Labelling 135

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

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

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.

Labelling 105

Labelling 105

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 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.

Labelling 98

Labelling 98

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

SEPTEMBER 11, 2020

billion in 2019 with more growth predicted this year. Results from the open-label phase 3b CASTING study showed 75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to Ocrevus.

Labelling 85

Labelling 85

pharmaphorum

FEBRUARY 8, 2022

Novo Nordisk’s new obesity therapy Wegovy has been recommended for routine NHS use by UK cost-effectiveness watchdog NICE, but in a narrower group of patients than is covered by its MHRA-approved label. The 2019 Health Survey for England estimated 28% of adults in England were obese and a further 36% were overweight, according to NICE.

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Labelling Diabetes 105

pharmaphorum

DECEMBER 23, 2021

billion in 2019, and will be hoping for a swift uptake in the US to get a return on its big investment. Novartis will have to wait for the results of the ORION-4 study – due in 2024 – before it has a chance of matching the labels of Amgen and Sanofi/Regeneron’s drugs. It has a long way to go.

Labelling 105

Labelling 105

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.

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Chemotherapy Labelling 98

pharmaphorum

MAY 27, 2021

It is thought that around five million women in the US have uterine fibroids that cause symptoms, with two-thirds of them inadequately treated with current drugs – generally off-label oral contraceptives or injectable gonadotropin releasing hormone (GnRH) agonists like leuprolide acetate or goserelin acetate.

Labelling 98

Labelling 98

European Pharmaceutical Review

JULY 5, 2022

Trial data will now be submitted to global regulatory authorities to evaluate a potential label expansion for Takhzyro to include the younger patient population. . Takeda stated that the trial results are consistent with those observed in earlier studies with adult and adolescent patients.

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Labelling 98

pharmaphorum

MAY 3, 2022

Both Belsomra and Dayvigo have box warnings on their labels in the US on daytime functioning, including the ability to drive motor vehicles. Belsomra’s first-to-market advantage in the US hasn’t however translated into big annual sales, which have stayed planted just over the $300 million mark since 2019.

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Labelling 97

pharmaphorum

JUNE 6, 2022

Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021. billion product, mainly from first-line use, if it can claim FDA approval for a broad label covering any ROS1-positive cancer.

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Chemotherapy Labelling 98

pharmaphorum

JULY 4, 2022

There is already a GLP-2 analogue drug on the market for SBS – Takeda’s Gattex (teduglutide) which was approved for SBS in adults in 2012 and children in 2019 – while AstraZeneca’s GLP-1 drug Byetta/Bydureon (exenatide) has also been used off-label to treat the disorder.

Labelling 98

Labelling 98

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

ALiEM - Pharm Pearls

MARCH 7, 2024

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. 2019 Oct 28;55(11):717. Identify the medullary pyramids, calyces, renal cortex, and renal pelvis (Figure 4). Transverse view of the right kidney Figure 4. Medicina (Kaunas).

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Labelling Communication 177

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.

Labelling 40

Labelling 40

Pharmaceutical Technology

JULY 29, 2022

Off-label medication options. In a Phase I trial INP-105 demonstrated its ability to reach plasma levels twice as fast as the intramuscular injection of Zyprexa and ten times faster than oral Zyprexa, according to January 2019 press release. The post Can a nasal spray tackle agitation in autism?

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Communication Labelling Hospitals 105

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.

Labelling 52

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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Labelling Immunity Immunization 52

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