Fierce Pharma

MARCH 22, 2023

AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17

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FDA 331

European Pharmaceutical Review

MARCH 22, 2023

In a recent video , pharmaceutical microbiology expert Tim Sandle highlighted areas of concern and attention relating to mycological contamination control in manufacturing. Pharmaceutical product recalls due to fungal contamination have been increasing. These, together with environmental monitoring trend data, highlight several fungal contamination issues associated with pharmaceutical cleanrooms , cold rooms and other controlled areas.

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Pharmaceutical Pharmaceutical products Distribution Manufacturing 128

Fierce Pharma

MARCH 22, 2023

US again spurns march-in campaign to slash cost of Pfizer, Astellas' Xtandi fkansteiner Wed, 03/22/2023 - 09:50

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MedCity News

MARCH 22, 2023

Research shows that about 73% of benefits leaders believe their companies have increased mental health support, but about 40% of employees either don’t believe or are unsure if their company promotes a healthy workplace. When it comes to if there’s a disconnect between employers and employees in mental health, the issue often lies in communication, said Adam Stavisky, senior vice president of US benefits at Walmart.

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Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

FDA

Fierce Pharma

MARCH 22, 2023

Sanofi and Regeneron's Dupixent scores trial win in tough-to-treat COPD kdunleavy Thu, 03/23/2023 - 01:37

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Fierce Pharma

MARCH 22, 2023

After appeals loss, Johnson & Johnson will take Texas two-step case to the US Supreme Court kdunleavy Wed, 03/22/2023 - 14:39

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MedCity News

MARCH 22, 2023

CMS recently established a unique code for AppliedVR’s flagship product, marking the first time a digital therapeutic or immersive therapeutic has ever been placed in an existing benefit category. The eight-week program is a physician-prescribed solution that allows patients to manage their chronic lower back pain without opioids from the comfort of their own home.

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Physicians Patients Management 110

Fierce Pharma

MARCH 22, 2023

In a surprise approval, FDA green-lights Incyte's PD-1 inhibitor to treat rare cancer type zbecker Wed, 03/22/2023 - 17:30

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Pharmaceutical Technology

MARCH 22, 2023

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. As computing has developed in the past decade, so has the potential to store and use information in the cloud.

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Food and Drug Administration Pharma FDA Pharmaceutical 105

Fierce Pharma

MARCH 22, 2023

Moderna CEO Bancel holds the line on COVID shot pricing at Senate hearing fkansteiner Wed, 03/22/2023 - 15:49

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. It was a money-saving strategy that was paying off until Covid-19 hit. During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages.

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Food and Drug Administration Pharmaceutical Manufacturing Medicine 105

Fierce Pharma

MARCH 22, 2023

FDA expands use of Regeneron's HoFH drug Evkeeza to kids 5 and up kdunleavy Wed, 03/22/2023 - 10:03

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FDA 144

MedCity News

MARCH 22, 2023

Through Maven’s acquisition, Naytal’s over 50 providers will join Maven’s platform, more than doubling the company’s number of providers in the U.K. Maven will also be able to sign on additional U.K.-based clients.

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Fierce Pharma

MARCH 22, 2023

Novartis, after prior deal with NHS England, scraps large-scale Leqvio trial zbecker Wed, 03/22/2023 - 11:10

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MedCity News

MARCH 22, 2023

89bio reported its NASH drug candidate met the main endpoints of a mid-stage clinical trial. In addition to demonstrating efficacy and safety according to measures the FDA says are needed to support a regulatory submission, 89bio says the results also show its drug could offer a dosing edge over potential rivals.

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FDA Safety Biopharma Pharma 103

PharmaVoice

MARCH 22, 2023

As experts wrestle with COVID-19’s lab leak versus animal market debate, here’s what experts say are the suspected origins for some of the worst viral outbreaks in the last century.

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Marketing 98

MedCity News

MARCH 22, 2023

StartUp Health’s presence at ViVE will highlight the launch of its Health Transformer University and the addition of Helmsley Charitable Trust as an investor. Its pavilion will showcase 16 health tech companies and include panel discussions on remote patient monitoring, automation and more.

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Patients 98

European Pharmaceutical Review

MARCH 22, 2023

The 20 th anniversary edition of the CPHI Pharma Awards is open for entries. Three new categories have been created to reflect the surge of innovation sweeping the industry, from new methodologies to sustainability and philanthropic initiatives. The CPHI Pharma Awards 2023 will celebrate global leaders from across 12 categories, including returning categories spanning development and manufacturing of devices and drugs, alongside packaging , supply chain, sustainability, regulatory compliance, an

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MedCity News

MARCH 22, 2023

Regulatory approval of Incyte’s cancer immunotherapy, Zynyz, comes two years after the FDA rejected an application seeking approval in a rare type of anal cancer. The decision makes the new Incyte drug the third approved treatment for metastatic Merkel cell carcinoma.

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Medgadget

MARCH 22, 2023

Cancer therapies have proliferated over the past few decades, improving outcomes for many patients. But this variety requires accurate diagnostics and appropriate decision making to choose the optimal course of therapy. The current gold standard of identifying which cancer mutation is present is new generation sequencing (NGS), which provides a comprehensive genetic report, but can take up to six weeks to complete, requires a significant tumor sample size, and can only be done in an advanced lab

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Patients Biopharma Medical science Medical 86

European Pharmaceutical Review

MARCH 22, 2023

Hovione, a contract development and manufacturing organisation (CDMO) and Laxxon Medical, a pharma-tech company will collaborate to advance 3D screen printing technologies for the pharmaceutical industry. Under the agreement, Hovione will establish Laxxon’s 3D screen printing technology at Hovione’s current good manufacturing practice (cGMP) production sites first in Portugal and later in the US.

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Pharmaceutical Pharma Manufacturing Medical 86

Medgadget

MARCH 22, 2023

Researchers at the Eunice Kennedy Shriver National Institute of Child Health and Human Development have developed a new imaging technique called electromyometrial imaging (EMMI) which clinicians can use to create 3D maps of uterine contraction patterns during labor. The non-invasive imaging method utilizes rapid MRI scanning with an electromyogram obtained through sensors placed on the skin of the belly.

Patients 82

Patients Safety Management 82

MedCity News

MARCH 22, 2023

Recently, scientists shared new findings that may indicate the inner core of the earth has […]

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Medical 102

PharmaTimes

MARCH 22, 2023

Measures include a requirement to publicly register studies and share results among research participants

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Copyright Clearance Center

MARCH 22, 2023

The post Some Additional Wrinkles to US Copyright Terms appeared first on Copyright Clearance Center.

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PharmaTimes

MARCH 22, 2023

Study involves SFX-01 candidate and emerging preliminary pharmacokinetic data from study

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Pharmaceutical Technology

MARCH 22, 2023

A recent study exploring the risk of venous thromboembolism (VTE) in non-hospitalised Covid-19 patients has found that their absolute risk of VTE is low. Fang and colleagues conducted a cohort study of 398,530 adult outpatients with Covid-19, assessing the rates of VTE in the first 30 days of Covid-19 diagnosis and in follow-up. They found that non-hospitalised Covid-19 patients had a low risk of developing VTE, although this risk was slightly higher in the first 30 days after diagnosis.

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Patients Pharmaceutical Medical 59

Pharma Leaders

MARCH 22, 2023

The FDA has accused Procter & Gamble (P&G) of submitting one ingredient list for Nyquil to the agency and using a different one for the over-the-counter product’s physical labeling. In a March 14 warning letter to the company, the agency threatened that a failure to adequately address the matter “may result in legal action,” including the possibility of seizure and injunction.

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FDA Electronics 52

PharmaTech

MARCH 22, 2023

In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.

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Scott Burrows

MARCH 22, 2023

Caring About Safety Has Never Been More Important How safe do you feel on your job? As a workforce safety speaker who once suffered a tragic workplace related accident, I ask you to think carefully before answering. The data for 2022 were not encouraging in terms of improvement. U.S.

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Safety 52

PharmaTech

MARCH 22, 2023

Under a new partnership, Invitae and Deerfield Management will harness genetic and clinical testing data from patients to discover potential novel therapeutics for treating rare diseases.

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Management Patients 52

CLD, Inc.

MARCH 22, 2023

Verbalization activities are a vital part of sales workshops, and for a good reason. Reps communicate with customers daily, whether delivering engaging openers, asking insightful probing questions, sharing marketing resources and approved messaging or compliantly addressing concerns and questions.

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Sales Marketing 52

Pharmaceutical Technology

MARCH 22, 2023

The demand for injectable drugs is rising. According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This was higher than the number of approvals in 2019 and 2020. In addition, in 2022, non-new molecular entity (NME) injectables approvals were the highest they have been for the last decade.

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Pharma Manufacturing Pharmaceutical Medicine 52