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Smart pharmaceutical and healthcare labels: Lets trace medicines from its origin

Roots Analysis

In recent years, the use of smart labels allows the developer to convey a greater amount of information about the product to the consumers, without the need for additional packaging space. Further, smart labels play a critical role in the manufacturing of pharmaceuticals.

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RFID: The future of smart labelling?

Pharmaceutical Technology

What lies ahead for RFID and smart labelling Volpe says “the future is bright” for smart technologies that identify, monitor, and track medications through the supply chain. RFID is an important facet of smart labelling and its evolution, but not the only one.

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Biogen admits slow Aduhelm launch, as scientists question label again

Pharma Phorum

The agency – which originally cleared the drug for all Alzheimer’s patients but narrowed its label to the population studied in clinical trials after an outcry, is currently under investigation by lawmakers in the US.

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Legal challenges put off label use of gender affirming care drugs in jeopardy

Pharmaceutical Technology

Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care. Earlier this week, the Florida Senate advanced a bill to restrict gender-affirming care for transgender minors.

Labelling 135
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Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord

Fierce Pharma

Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord. zbecker. Wed, 01/04/2023 - 11:35

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Novo Nordisk, Eli Lilly replenish Type 2 diabetes stars Ozempic, Mounjaro after off-label weight-loss boom

Fierce Pharma

Novo Nordisk, Eli Lilly replenish Type 2 diabetes stars Ozempic, Mounjaro after off-label weight-loss boom fkansteiner Mon, 03/20/2023 - 10:09

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AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression

Fierce Pharma

AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression. zbecker. Mon, 12/19/2022 - 11:13

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Supply Chain Shortages: Impact on Product Labeling, Artwork, and Packaging

Pharmaceutical Commerce

Supply chain shortages mean short notice changes to products—is your labeling system missing the key ingredients?

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Teva warns 'skinny label' ruling could sow 'competition-killing uncertainty' for generics

Fierce Pharma

Teva warns 'skinny label' ruling could sow 'competition-killing uncertainty' for generics. fkansteiner. Thu, 07/14/2022 - 08:57

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Sanofi, Regeneron's Dupixent delivers another trial win, teeing up likely EoE label expansion in children

Fierce Pharma

Sanofi, Regeneron's Dupixent delivers another trial win, teeing up likely EoE label expansion in children. zbecker. Tue, 10/11/2022 - 10:54

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Inaccurate Labeling, Misleading Claims Found Among CBD Products

Pharmacy Times

A variety of cannabidiol (CBD) products incorrectly listed their CBD and tetrahydrocannabinol content, in addition to making therapeutic and cosmetic claims without FDA approval.

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Experts to come together for compliance event ‘validation ready’ global labeling systems  

Pharma Phorum

exploring ‘validation ready’ global labeling systems . ? . A group of industry experts is set to explore how medical device, clinical trial and pharmaceutical companies can proactively manage labeling risk. Experts to come together for compliance event .

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CVS expands 'talking' prescription labels to all locations to support visually impaired patients

Fierce Healthcare

CVS expands 'talking' prescription labels to all locations to support visually impaired patients. rtorrence. Tue, 11/30/2021 - 10:59

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Pharmaceutical packaging and labeling briefs

Outsourcing Pharma

This capsule of industry news features Amcor, High Purity New England, MG America, and other firms offering packaging and labeling products and services.

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Bullish on growing use of telehealth, Wheel banks $150M to expand white-labeled virtual care services

Fierce Healthcare

Bullish on growing use of telehealth, Wheel banks $150M to expand white-labeled virtual care services. hlandi. Wed, 01/19/2022 - 16:26

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AstraZeneca and Sanofi win big as Europe's human medicines committee endorses approvals, label expansions

Fierce Pharma

AstraZeneca and Sanofi win big as Europe's human medicines committee endorses approvals, label expansions. fkansteiner. Mon, 11/14/2022 - 08:59

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Lilly bags label extension for RET drug Retevmo in US

Pharma Phorum

The full approval also extends the Retevmo label to include patients with locally advanced as well as metastatic disease. The post Lilly bags label extension for RET drug Retevmo in US appeared first on.

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PRISYM ID appoints Software Delivery Manager to oversee clinical labeling team

Pharma Phorum

PRISYM ID appoints Software Delivery Manager to oversee team developing new clinical labeling solutions . . regulated content and label management?solutions, The post PRISYM ID appoints Software Delivery Manager to oversee clinical labeling team appeared first on.

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FDA to Revise Labeling for Prescription Cough Medicine Following Overdose Concerns in Young Children

Pharmacy Times

Benzonatate overdoses were reported in children under 2 years of age after accidentally ingesting as few as 1-2 capsules.

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Schreiner MediPharm, SCHOTT Introduce Prefilled Syringes Powered by RFID Labels

Pharmaceutical Commerce

Can help facilitate digital identification of medications.

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Indegene: e-labeling could make paper inserts obsolete

Outsourcing Pharma

A leader from the life-sciences solutions firm explains how electronic drug labels and inserts offer widespread benefits to various stakeholders. Contract Manufacturing & Logistics

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In 'skinny' label fight between Teva and GSK, Supreme Court asks Biden admin for help

Fierce Pharma

In 'skinny' label fight between Teva and GSK, Supreme Court asks Biden admin for help. fkansteiner. Tue, 10/04/2022 - 09:35

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GSK claps back at Teva in 'skinny' label case, arguing verdict doesn't threaten companies who act 'properly'

Fierce Pharma

GSK claps back at Teva in 'skinny' label case, arguing verdict doesn't threaten companies who act 'properly'. kdunleavy. Tue, 08/23/2022 - 07:22

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Merck's recent Keytruda label expansion in NSCLC is more of a 'long-term' opportunity, CEO says

Fierce Pharma

Merck's recent Keytruda label expansion in NSCLC is more of a 'long-term' opportunity, CEO says kdunleavy Thu, 02/02/2023 - 10:43

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BMS builds case for mavacamten label ahead of FDA decision

Pharma Phorum

The post BMS builds case for mavacamten label ahead of FDA decision appeared first on.

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Johnson & Johnson’s Janssen-Cilag unit gets disappointing ‘restricted’ label for PARP drug in EU

Pharmafile

Johnson & Johnson (J&J)’s Janssen-Cilag unit has announced that its fixed-dose combination drug Akeega has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for patients with metastatic castration-resistant prostate cancer (mCRPC), but that it should be limited to patients with BRCA1/2 mutations. This will put Akeega at a significant disadvantage compared to AstraZeneca and Merck’s rival PARP inhibitor Lynparza (olaparib).

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Cloud Technology Is Favored Method for Tackling Labeling and Supply Chain Challenges, Survey Says

Pharmaceutical Commerce

Conclusion driven by various factors, including product shortages and cost pressures.

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FDA whittles back Aduhelm approval amid concern over broad label

Pharma Phorum

The updated label for Aduhelm (aducanumab) says it should only be used in patients with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia, according to an update from the drug’s developers.

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EU gives narrower label to Apellis, Sobi’s PNH drug

Pharma Phorum

Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The post EU gives narrower label to Apellis, Sobi’s PNH drug appeared first on.

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Harmony’s sleep disorder drug Wakix gets US label extension

Pharma Phorum

The company added another alternative, Xywav (calcium, magnesium, potassium, and sodium oxybates) earlier this year although these drugs lack the cataplexy use on their label. The post Harmony’s sleep disorder drug Wakix gets US label extension appeared first on.

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GSK claims broader ’tissue-agnostic’ label for PD-1 drug Jemperli

Pharma Phorum

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.

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Teva asks SCOTUS to overturn “skinny label” verdict on GSK drug

Pharma Phorum

The case hinges around the concept of “ skinny labelling ” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-called “use” patents.

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Sector specialism is essential for clinical labeling solutions

Pharma Phorum

We have to listen even harder to understand how companies visualize their operating practices going forward but the great news is, I know PRISYM ID is positioned better than anyone to respond and deliver the regulated labeling and content management solutions they need.

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Is Off-Label Marketing by a Pharma Company a Bad Thing?

Pharma Marketing Network

Tune in now to listen to Darshan Talks Podcast, Is Off-Label Marketing by a Pharma Company a Bad Thing? The post Is Off-Label Marketing by a Pharma Company a Bad Thing? appeared first on Pharma Marketing Network. Featured

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ODAC votes to keep bladder cancer labels for Keytruda, Tecentriq

Pharma Phorum

The post ODAC votes to keep bladder cancer labels for Keytruda, Tecentriq appeared first on. Merck & Co’s Keytruda and Roche’s Tecentriq should stay on the market as first-line treatments for bladder cancer, at least until new clinical data becomes available next year. .

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How Label Management Solutions Can Help CDMOS Grow Their In-House Capabilities

Pharma Phorum

BRINGING IT ALL HOME: HOW LABEL MANAGEMENT SOLUTIONS. Growing pains: the perceived barriers to in-sourcing label management. Easing the pain: how can the label management software address these challenges? The benefits of adding labeling as a service are strong.

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Amgen builds Otezla’s psoriasis label as rival BMS looms large

Pharma Phorum

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.

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Supreme Court unlikely to take up Coreg skinny label feud after Teva's $235M loss to GSK, lawyer says

Fierce Pharma

Supreme Court unlikely to take up Coreg skinny label feud after Teva's $235M loss to GSK, lawyer says. fkansteiner. Thu, 11/03/2022 - 12:59

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Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label

Pharma Phorum

The post Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label appeared first on.

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Covectra launches StellaGuard ‘smart’ label anti-counterfeiting

Outsourcing Pharma

The on-pack technology enables consumers, retailers and others to harness mobile devices in order to verify the authenticity of pharmaceutical products. Contract Manufacturing & Logistics

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Synthesis-to-Clinic®: integrating isotopic labeling and human ADME to reduce time to clinic

Pharmaceutical Technology

We asked them to explain how the company has integrated its isotopic labeling and human ADME testing services to help streamline the drug development process and accelerate the time it takes to get drugs to market.

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FDA Approves Updated Label for Bayer’s Finerenone to Include Cardiovascular Study

Pharmacy Times

Modification is based on phase 3 FIGARO-DKD clinical trial investigating CV and kidney outcomes in more than 13,000 patients with CKD associated with type 2 diabetes.

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Alnylam likely to win label expansion for Onpattro in ATTR, but challenging Pfizer won't be easy: analysts

Fierce Pharma

Alnylam likely to win label expansion for Onpattro in ATTR, but challenging Pfizer won't be easy: analysts. kdunleavy. Mon, 09/12/2022 - 16:39