Fri.Feb 03, 2023

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FDA Approves Tezepelumab for Self-Administration With New Pre-Filled Pen

Drug Topics

After being FDA approved in 2021, tezepelumab (Tezspire) has been approved again for self-administration.

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J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Fierce Pharma

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

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FDA Approves Sacituzumab Govitecan in Pretreated Metastatic Breast Cancer

Drug Topics

Sacituzumab govitecan significantly improved overall survival over the comparator chemotherapy in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative breast cancer who had received prior treatment.

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections. This marks the second time one of Janssen’s HIV vaccines failed after another showed disappointing results in the Phase IIb Imbokodo trial in August 2021.

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Virtual Care Continues to Evolve into 2023

Drug Topics

The 2022 Virtual Care Survey Report from Summus has determined that many healthcare users have responded positively to virtual care services, as they would like to see more out of such offerings.

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Opinion: Public health layoffs and tech layoffs: a world of difference

STAT

Layoffs in the tech sector — think Google, Amazon, Meta, and the like — from jobs once thought to be secure and prestigious are making headlines. I’ve been seeing an outpouring of media coverage, including support extended toward newly unemployed tech workers, judgements passed on tech leaders, practical suggestions of opportunities , and analyses of underlying causes and next steps.

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More Trending

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The FTC is finally ready take on health data leaks. The problem is bigger than GoodRx

STAT

The Federal Trade Commission took aim at prescription drug coupon site GoodRx this week in an early attempt to crack down on the unfettered sharing of consumers’ health data for advertising. It was the first time the agency had gone after such a health data violation. But with the vast amounts of patient information now being mined and shared online, it’ll be far from the last.

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Merck reports 2% increase in worldwide sales in Q4 2022

Pharmaceutical Technology

Merck (MSD outside North America) has reported a 2% increase in worldwide sales to $13.83bn in the fourth quarter (Q4) of 2022 from $13.52bn in the previous year’s quarter. The company’s pharmaceutical sales recorded a 1% rise to $12.18bn compared to $12.03bn in the prior-year quarter. For the quarter, GAAP earnings per share (EPS) from continuing operations was $1.18, indicating a 22% decline from $1.5 in the same quarter last year.

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Commissioning and Qualification Benchmarking Survey: Help Determine the State of the Industry

ISPE

Commissioning and Qualification Benchmarking Survey: Help Determine the State of the Industry Trudy Patterson Fri, 02/03/2023 - 12:26 iSpeak Blog iSpeak Commissioning and Qualification Benchmarking Survey: Help Determine the State of the Industry 3 February 2023 The ISPE Commissioning and Qualification (C&Q) Community of Practice (CoP) Steering Committee has developed a C&Q benchmarking survey intended to provide a comprehensive view of the current state of the industry, including adoption rate

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STAT+: Leading ALS advocacy group roiled by infighting over money and priorities

STAT

A blistering battle has broken out between the ALS Association and more than a dozen of its state and local chapters, which are resisting a move by the national headquarters to dismantle their offices and run operations around the U.S. Fifteen chapters claim the national office is attempting the takeover in order to grab a larger share of revenue these local offices send to association headquarters, according to a lawsuit filed in a Delaware state court.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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France gets new sterile liquid drug manufacturing facility

European Pharmaceutical Review

Switzerland-based contract development and manufacturing organisation (CDMO) CARBOGEN AMCIS has opened a new facility in France, dedicated to the custom development and production of sterile injectable drug products. The facility forms two new fully-automated production lines for liquid and freeze-dried drugs, including highly potent compounds and advanced therapies such as antibody drug conjugates (ADCs).

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Consumers prioritize shipping in online shopping

Drug Store News

Shipping costs are the top factor when it comes to shopping online, according to a new consumer survey from mobile e-commerce platform Wish.

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Opinion: The FDA is the right agency to regulate CBD products, but it needs help

STAT

The dietary supplement industry has been begging for federal oversight of products containing cannabidiol (CBD), a non-psychoactive compound found in the cannabis plant that is being incorporated into a bewildering range of oils, tinctures, edibles, and other products. Certification by the Food and Drug Administration that these products are safe and useful against many common ailments could unleash a $60 billion annual market by 2030.

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Dove aims to regenerate skin’s moisture with revamped formula

Drug Store News

Dove Body Wash featuring 24-Hour Renewing MicroMoisture contains nanotechnology to regenerate the skin’s moisture level, the company said.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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STAT+: Up and down the ladder: The latest comings and goings

STAT

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others.  That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.

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Alabama hospitals' margin declines 'far more severe' than industrywide losses, prompting calls for more funds

Fierce Healthcare

Alabama hospitals' margin declines 'far more severe' than industrywide losses, prompting calls for more funds dmuoio Fri, 02/03/2023 - 17:05

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STAT+: They were the 10% left out of life-changing treatments. Now these cystic fibrosis patients may finally get help

STAT

Vertex Pharmaceuticals revolutionized the treatment of cystic fibrosis. It also has unfinished business. The Boston drugmaker’s medicines for the genetic disease — which damages the lungs and other organs — have transformed the lives of patients, helping them abandon other time-consuming treatments, shrug off what would have been dangerous respiratory infections, and just live breathing easier.

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Mark Cuban Cost Plus Drug Company partners with OncoPower to provide cost savings to cancer patients

Drug Store News

The collaboration focuses on pricing transparency, affordable access and engaging cancer patients at home to ensure treatment adherence.

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STAT+: Turkish court hands Novartis and Roche a rare win over their efforts to promote an eye treatment

STAT

A Turkish court overturned a decision by the national antitrust regulator that two years ago fined Roche and Novartis more than $30 million for conspiring to spread misinformation about an eye treatment, a rare victory for the companies after legal setbacks elsewhere. In response to appeals filed by both drugmakers, an administrative court in Ankara, Turkey, determined that the Turkish Competition Board failed to demonstrate that Novartis and Roche colluded illegally to promote the eye medicatio

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Drug-resistant bacteria found in eye drops has infected 55 people in 12 states

Pharmafile

A strongly drug-resistant bacteria has been found in multiple brands of artificial tears eyedrops; the most commonly reported was EzriCare Artificial Tears, sold by Walmart, Amazon and other retailers. The bacteria has infected 55 people throughout 12 US states, having killed one patient and leaving others hospitalised or with permanent vision loss.

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American Greetings, ‘Sesame Street’s Cookie Monster deliver personalized greetings

Drug Store News

The company has released a new virtual card featuring the character Cookie Monster from “Sesame Street.

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News Roundup: January 30 to February 3

Drug Topics

Your weekly roundup of the latest news from Drug Topics®.

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DOJ withdraws 'outdated' and 'overly permissive' healthcare antitrust enforcement guidance

Fierce Healthcare

DOJ withdraws 'outdated' and 'overly permissive' healthcare antitrust enforcement guidance dmuoio Fri, 02/03/2023 - 14:37

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DrugBAN AI expected to reduce costs and speed up drug discovery

Pharmafile

In a collaboration between Sheffield University and pharma giant, AstraZeneca, a new AI has been developed which could help deliver new medicines at a faster rate and lower cost. DrugBAN AI has been developed by Professor Haiping Lu and PhD student Peizhen Bai from the University’s Department of Computer Science, alongside AstraZeneca’s Dr Filip Miljković and Dr Bino John.

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With all eyes on new Alzheimer's med, Eisai lays off 91 staffers on its Fycompa team

Fierce Pharma

With all eyes on new Alzheimer's med, Eisai lays off 91 staffers on its Fycompa team fkansteiner Fri, 02/03/2023 - 07:11

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Industry Voices—To pursue health equity, start with your own employees

Fierce Healthcare

Industry Voices—To pursue health equity, start with your own employees pminemyer Fri, 02/03/2023 - 15:40

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GNC, Ghost partner on Ghost Glow V2 launch

Drug Store News

Ghost Glow V2 was reformulated to include the line’s original formula and swap out several other ingredients.

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Clinicians are taking on the onus of bridging the digital divide, survey finds

Fierce Healthcare

Clinicians are taking on the onus of bridging the digital divide, survey finds aburky Fri, 02/03/2023 - 17:01

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STAT+: Pharmalittle: ALS Association and its chapters battle over money and priorities; eye drops recalled over links to drug-resistant infections

STAT

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. We plan to catch up on our reading, stroll about with our official mascot, and, given the frigid weather in our neighborhood, stay indoors to hold another listening party with Mrs.

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Ama???????zon posts strong Q4, full year results

Drug Store News

Amazon’s North American segment reported that its sales increased 13% year-over-year to $93.4 billion.

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VA dodges ivermectin prescriptions that cost payers millions: study

Fierce Healthcare

VA dodges ivermectin prescriptions that cost payers millions: study fdiamond Fri, 02/03/2023 - 13:15

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Pembrolizumab plus chemo improves endometrial cancer survival

European Pharmaceutical Review

A Phase III clinical trial evaluating pembrolizumab with chemotherapy (carboplatin and paclitaxel), improved progression free survival (PFS) for stage III-IV or recurrent endometrial carcinoma. An interim analysis of the results demonstrated that the treatment showed a statistically significant and clinically meaningful improvement in PFS, regardless of mismatch repair status.

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Lilly-backed fund commits $24M to Recurv's push for clinical proof of concept of nano-emulsion taxane

Fierce Pharma

Lilly-backed fund commits $24M to Recurv's push for clinical proof of concept of nano-emulsion taxane ntaylor Fri, 02/03/2023 - 07:16

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Phlo raises £10m to spearhead digital transformation in pharmacy sector

Pharmafile

Published date: 03/02/2023 Summary: Phlo, UK digital pharmacy leaders, have closed a £10m Series A round. This investment will support the scaling of Phlo’s operations and their partnerships with other healthcare providers, ultimately enabling more clinicians and patients to access the benefits of digital pharmacy services. [Glasgow, Scotland] Phlo, UK digital pharmacy leaders, have closed a £10m Series A round led by family office Thairm Bio.

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