STAT

NOVEMBER 30, 2023

ASHEVILLE, N.C. — There was the beeping of monitors, the stiff sheets, the sterile smell of the hospital room. Mostly, there was pain. Sharp, relentless pain. Mike Messino was recovering from a successful surgery, but the nerve blocks had worn off. He spent two full hours waiting for a nurse to inject pain medication. When he’d worked in this hospital, he’d made sure patients didn’t wait longer than 15 minutes for that kind of care.

Hospitals 360

Hospitals 360

PharmaVoice

NOVEMBER 30, 2023

John Mulligan, founder of biotechs like Good Therapeutics and Bonum Therapeutics, discusses how biotechs can thrive when the market is against them.

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STAT

NOVEMBER 30, 2023

The Texas attorney general has filed a lawsuit accusing Pfizer of “unlawfully” and “intentionally” misrepresenting the effectiveness of its Covid-19 vaccine and attempting to censor its critics. The pharmaceutical company violated a state law — the Texas Deceptive Trade Practices Act — by making unsupported claims that its shot was durable and capable of protecting against transmission, according to the 54-page lawsuit filed in a state court by Texas Att

Vaccines 338

Vaccines Pharmaceutical Companies Pharmaceutical Companies 338

Safe Biologics

NOVEMBER 30, 2023

In November, ASBM released two fact sheets on interchangeable biosimilars. Download them here: Physician Perspectives on Interchangeable Biosimilars Interchangeable Biosimilars: Comparing Europe and the U.S.

Biosimilars 130

Biosimilars 130

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.

STAT

NOVEMBER 30, 2023

AbbVie will pay $10 billion for the biotech firm Immunogen, the company said Thursday, acquiring an approved treatment for ovarian cancer and buying into a burgeoning area of oncology. Under the agreement, AbbVie will pay $31.26 per share in cash for Immunogen, a nearly 100% premium to the company’s recent trading price. Central to the deal, expected to close in the middle of next year, is Elahere, an Immunogen product that won Food and Drug Administration approval for advanced ovarian ca

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Chemotherapy 324

pharmaphorum

NOVEMBER 30, 2023

AbbVie has moved to shore up its pipeline following the loss of patent protection for its top-selling drug with a $10.1 billion deal to buy ImmunoGen and its marketed ovarian cancer drug.

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pharmaphorum

NOVEMBER 30, 2023

FDA chief scientist Namandjé Bumpus has been named as principal deputy commissioner, replacing long-serving Janet Woodcock when she steps down early next year. Bumpus is heading for the number two position at the FDA – second only to Commissioner Robert Califf who announced the appointment on X (formerly Twitter) – just over a year after she joined the agency.

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STAT

NOVEMBER 30, 2023

Many commonly suggested ways to addressing climate change present few ethical challenges: Cut fossil fuels. Eat less meat. Don’t buy fast fashion. But what happens when products that contribute to climate change also save lives — millions of them? A new report , published on Nov. 28 by the global health initiative Unitaid, looks into this issue, quantifying the environmental impact of 10 essential public health items.

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Pharma Times

NOVEMBER 30, 2023

The new hub will unite researchers worldwide to exchange ideas and knowledge - News - PharmaTimes

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STAT

NOVEMBER 30, 2023

Worried about your health? You can now avail yourself of noninvasive diagnostics that claim to screen for rare birth defects, cancer-associated mutations, and even Alzheimer’s. Even before the Covid pandemic, a 2018 paper reported that new genetic tests, many of them for increasingly rare conditions, were being released at the rate of 10 a day.

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Labelling 294

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Pharmacy Management

European Pharmaceutical Review

NOVEMBER 30, 2023

Biocon Biologics Ltd has successfully completed integration of Viatris’ biosimilar business in 31 European countries. Following the acquisition of substantially all global biosimilar business of Viatris in November 2022, and the related integration of over 70 emerging market countries in July 2023 and North America in September 2023, now that Viatris’ biosimilars operations have fully transitioned to Biocon Biologics Ltd in Europe, the company declared that this “represents another significant m

Biosimilars 99

Biosimilars 99

STAT

NOVEMBER 30, 2023

Rise and shine, everyone, another busy day is on the way. We can tell because the official mascots are racing madly about the Pharmalot grounds chasing creatures, and the parade of vehicles outside our window is picking up rapidly. As for us, we are dutifully firing up the coffee kettle to brew another cup of needed stimulation. Our choice today is blueberry cobbler.

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Compounding Compounding Pharmacies Chemotherapy 234

Express Pharma

NOVEMBER 30, 2023

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Ivabradine Tablets, 5 mg and 7.5 mg (USRLD: Corlanor Tablets, 5 mg and 7.5 mg). Ivabradine is indicated to reduce the risk of hospitalisation for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction.

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STAT

NOVEMBER 30, 2023

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences.  Sign up to get it delivered in your inbox every Tuesday and Thursday.

Hospitals 231

Hospitals 231

Pharma Times

NOVEMBER 30, 2023

The new method successfully performs sterility assessments within 24 hours - News - PharmaTimes

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STAT

NOVEMBER 30, 2023

Are ADCs having a moment? Is CAR-T safe? And who’s to blame for failed trials? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. We discuss why AbbVie is spending $10 billion on a cancer-focused company that spent four decades on the path to its first FDA approval, a deal with implications for biotech in 2023 and for a burgeoning area in oncology.

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European Pharmaceutical Review

NOVEMBER 30, 2023

In a paper published in Microbiology Spectrum , researchers from Singapore have described a novel microbial contamination-detection method for T-cell cultures that can be achieved within 24 hours, therefore supporting cell therapy manufacturing. This is compared to traditional methods which take between seven to 14 days. Technology such as third-generation nanopore long-read sequencing and DNA extraction, alongside machine learning algorithms, computational analysis and optimisation, were utili

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STAT

NOVEMBER 30, 2023

Radiology has long led the way in the application of artificial intelligence in medicine. More than three-quarters of AI and machine learning devices authorized by the Food and Drug Administration work with medical images — and that dominance was evident at this year’s meeting of the Radiological Society of North America, where AI vendors gathered to tout their latest offerings.

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The Pharmacist

NOVEMBER 30, 2023

Community Pharmacy England has admitted concerns over the minimum number of consultations required for pharmacies to receive full funding for the Pharmacy First scheme. Contractors signing up to provide Pharmacy First – which launches on 31 January 2024 – will receive an initial fixed payment of £2,000, which can be claimed from December 2023. From […] The post CPE admits concern over Pharmacy First minimum consultation number appeared first on The Pharmacist.

Community Pharmacies 91

Community Pharmacies 91

STAT

NOVEMBER 30, 2023

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with a rebound for biotech stocks, the potential of Wegovy, and a major change at the FDA.

Drug Pricing 127

Drug Pricing Drug Development 127

PharmExec

NOVEMBER 30, 2023

Drug reaction with eosinophilia and systemic symptoms (DRESS) is a rare but serious and potentially fatal reaction linked to use of antiseizure medications.

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Express Pharma

NOVEMBER 30, 2023

In the dynamic landscape of pharmaceutical contract manufacturing, the year 2022 witnessed unprecedented growth in revenues, marking the highest surge since 2011. The total commercial dose contract manufacturing organisation (CMO) contract revenue year-on-year (YoY) soared by an impressive 8.4 per cent in 2022. This growth, fueled by persistent high inflation, occurred amid the waning demand for COVID-19 vaccines.

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Vaccines Drug Pricing 90

Pharmaceutical Technology

NOVEMBER 30, 2023

The move is a strategic response amid challenges faced by the non-viral gene therapy sector, with several startups closing this year.

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Express Pharma

NOVEMBER 30, 2023

ACG’s latest capsule filling machine is a customer-centric concept design, developed in ACG’s German R&D facility, that emphasises simplicity, safety, and efficiency ACG has unveiled its next generation capsule filling machine at CPHI and PMEC India 2023. ACG’s latest capsule filling machine is a customer-centric concept design, developed in ACG’s German R&D facility, that emphasises simplicity, safety, and efficiency.

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Packaging 89

Pharmaceutical Technology

NOVEMBER 30, 2023

As more cell and gene therapies get approved to treat common conditions, scaling them up will be a challenge.

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Express Pharma

NOVEMBER 30, 2023

If approved, KarXT would represent the first new pharmacological approach to treating schizophrenia in several decades Karuna Therapeutics has announced that U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for KarXT (xanomeline-trospium) for the treatment of schizophrenia in adults. The application has been granted a Prescription Drug User Fee Act (PDUFA) date of September 26, 2024.

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European Pharmaceutical Review

NOVEMBER 30, 2023

o find out about the current trends in cell and gene therapy manufacturing, EPR spoke to Cell and Gene Therapy Catapult (CGT Catapult)’s Chief Manufacturing Officer, Stephen Ward, and Chief Business Officer, Jeanette Evans. They highlighted key data from the organisations recently published good manufacturing practice (GMP) Manufacturing Survey and Skills Demand reports, which focus particularly on the UK’s landscape.

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Medical Schools 77

Outsourcing Pharma

NOVEMBER 30, 2023

Exonate, an mRNA therapy company focused on treatments for diabetic complications, has announced that its lead ophthalmology asset, EXN407, has achieved its prespecified endpoints in an early study.

Diabetes 98

Diabetes 98

Drug Channels

NOVEMBER 30, 2023

Today’s guest post comes from Josh Bliss, Head of Pharma Solutions at SingleCare. Josh outlines manufacturers’ challenge when educating and informing patients about patient support programs. He then describes the SingleCare prescription discount card and Pharma Solutions , which provides manufacturers with a platform to reach patients. Click here to learn how manufacturers can advertise patient support programs at the point of purchase.

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Outsourcing Pharma

NOVEMBER 30, 2023

A Life Sciences Advisory Board has been launched by Atropos Health, a company that translates data into personalized real-world insights across healthcare.

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World Pharma News

NOVEMBER 30, 2023

University of Virginia School of Medicine researchers have discovered how Lactobacillus, a bacterium found in fermented foods and yogurt, helps the body manage stress and may help prevent depression and anxiety. The findings open the door to new therapies to treat anxiety, depression and other mental-health conditions. The new research from UVA's Alban Gaultier, Ph.D., and collaborators is notable because it pinpoints the role of Lactobacillus, separating it out from all the other microorganisms

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PharmExec

NOVEMBER 30, 2023

The use of real-world evidence can prevent pharma companies from performing studies based on flawed data.

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Express Pharma

NOVEMBER 30, 2023

Making Indian Pharma Inc future-ready Click to download: December 2023 Digital Magazine The post Express Pharma December 2023 appeared first on Express Pharma.

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Pharmaceutical Technology

NOVEMBER 30, 2023

GlobalData tracks 49 drugs in development for Gliosarcoma by 39 companies/universities/institutes. The top development phase for Gliosarcoma is phase i, with 22 drugs in that stage.

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Pharmafile

NOVEMBER 30, 2023

Vivos Therapeutics has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Vivos’ removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances for the treatment of severe obstructive sleep apnea (OSA) in adult patients. Vivos now becomes the first company to have approved and to market a […] The post Vivos Therapeutics gains FDA 510(k) clearance for sleep apnea treatment device appeared first on Pharmafile.

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