STAT

NOVEMBER 14, 2023

A class action lawsuit was filed Tuesday against UnitedHealth Group and a subsidiary alleging that they are illegally using an algorithm to deny rehabilitation care to seriously ill patients, even though the companies know the algorithm has a high error rate. The class action suit, filed on behalf of deceased patients who had a UnitedHealthcare Medicare Advantage plan and their families by the California-based Clarkson Law Firm, follows the publication of a STAT investigation Tuesday.

Nursing Homes 364

Nursing Homes Documentation 364

PharmaVoice

NOVEMBER 14, 2023

Johnson & Johnson Innovative Medicine’s director of diversity, equity and inclusion in clinical trials shares key strategies for making DEI work.

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STAT

NOVEMBER 14, 2023

The nation’s largest health insurance company pressured its medical staff to cut off payments for seriously ill patients in lockstep with a computer algorithm’s calculations, denying rehabilitation care for older and disabled Americans as profits soared, a STAT investigation has found. UnitedHealth Group has repeatedly said its algorithm, which predicts how long patients will need to stay in rehab, is merely a guidepost for their recoveries.

Health Insurance Companies 364

Health Insurance Companies Documentation 364

PharmaVoice

NOVEMBER 14, 2023

For Sarepta — and DMD patients — there’s a lot riding on the treatment’s next steps.

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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 14, 2023

America’s trust in scientists and positive views of science has continued to decline, according to a new report. The Pew Research Center, a nonpartisan think tank, asked a random sample of 8,842 American adults this fall about their views on science and scientists. They found that roughly a quarter of Americans — 27% — said they have not too much or no confidence in scientists to act in the public’s best interests, compared to 12% who said the same in April 2020.

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Big Molecule Watch

NOVEMBER 14, 2023

Regeneron filed a Complaint on November 8 against Celltrion in the U.S. District Court for the Northern District of West Virginia, alleging infringement of thirty-eight patents under the BPCIA based on Celltrion’s submission of an aBLA for CT-P42, a proposed biosimilar of EYLEA (aflibercept), and Celltrion’s provision of Notice of Commercial Marketing with respect to the same.

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Biosimilars 111

Pharma Times

NOVEMBER 14, 2023

The terminal condition currently affects around 5,000 people in the UK - News - PharmaTimes

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STAT

NOVEMBER 14, 2023

In Stockton, California, almost 60% of the city’s 320,000 residents are prediabetic or living with diabetes. Shane Bailey, a 72-year-old longtime resident and U.S. Coast Guard veteran, is one of them. And because she lives in a neighborhood that is considered a food desert because it lacks nearby grocery stores, it can be a huge challenge to access healthy, affordable food.

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Grocery Stores Diabetes 310

Pharma Times

NOVEMBER 14, 2023

The projects will explore early-stage ideas at the frontiers of bioscience - News - PharmaTimes

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STAT

NOVEMBER 14, 2023

I want to bring your attention to a vitally important  investigation  STAT has published today. For more than a year, our reporters have documented how the use of artificial intelligence is driving denial of claims or delaying treatment for seriously ill patients. This latest story goes even deeper, establishing how the denial of claims was by design.

Health Insurance Companies 282

Health Insurance Companies Documentation 282

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PioneerRx

NOVEMBER 14, 2023

The most wonderful time of the year is slowly approaching. Temperatures are falling, days are getting shorter (thanks, daylight savings), and holiday lights are.

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STAT

NOVEMBER 14, 2023

The announcement by the Center for Medicare and Medicaid Services that ten drugs will be subject to price negotiation under the Inflation Adjustment Act has unleashed a storm of debate. Most observers agree that the negotiations will reduce spending for both consumers and taxpayers. The real dispute centers on whether the prospect of price negotiations will reduce future innovation by shrinking the expected future profits for patented drugs.

Vaccines 256

Vaccines 256

PharmExec

NOVEMBER 14, 2023

Novo Nordisk said it will continue providing Levemir vials and the Levemir FlexPen for diabetes control while supplies last, until the full product discontinuation at the end of 2024.

Diabetes 97

Diabetes 97

STAT

NOVEMBER 14, 2023

Top of the morning to you. And a fine one it is. Lots of sunshine and clear blue skies are once again enveloping the Pharmalot campus, where the official mascots are bounding about the grounds in search of creatures to annoy and neighbors sleeping late. As for us, we are as busy as ever hunting and gathering items of interest. We trust you have your own hectic agendas.

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Chemotherapy 252

BioPharma Dive

NOVEMBER 14, 2023

The Series A round for three-year-old startup VectorY is one of the largest private financings in Europe this year, Forbion said.

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STAT

NOVEMBER 14, 2023

PROVIDENCE – In late August, Dr. James E. Fanale was trudging through the Falmouth Road Race — walking up the hills, running down them — for seven miles. Fellow runners encouraged him to “keep trying” whenever he slowed down. But they couldn’t have known — along with most of the people in Fanale’s professional orbit — that he was battling Stage 4 lung cancer.

Hospitals 248

Hospitals 248

European Pharmaceutical Review

NOVEMBER 14, 2023

The Association of the British Pharmaceutical Industry (ABPI) has drawn attention to a new report , which has emphasised the importance of UK advanced manufacturing requiring a long-term strategy to ensure its continued success. This ‘manifesto for growth’, developed by the Manufacturing Five (M5), a coalition of the UK’s leading advanced trade associations, proposed the reforms necessary for the UK to close the gap with global competitors and growth of innovative manufacturing in the country.

Pharmaceutical Manufacturing 94

Pharmaceutical Manufacturing 94

STAT

NOVEMBER 14, 2023

You’re reading the web edition of D.C. Diagnosis, STAT’s twice-weekly newsletter about the politics and policy of health and medicine. Sign up here to receive it in your inbox on Tuesdays and Thursdays. Bon apétit, offsets are served Whenever lawmakers get around to actually making decisions about funding the government, leaders try to balance measures that save the government money with those that cost the government money.

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European Pharmaceutical Review

NOVEMBER 14, 2023

Outsourcing regulatory activities in pharma Here, EPR’s Editor explores some key considerations, approaches and strategies for pharmaceutical companies looking to outsource regulatory activities. Accelerating drug development for simple and complex drug programmes Quotient Sciences leverages more than 30 years of drug development expertise to support small molecule and synthetic peptide drug programmes, in both simple drug programmes as well as complex cases where specialised formulation e

Drug Development 93

Drug Development Pharmaceutical Companies Pharmaceutical Companies 93

STAT

NOVEMBER 14, 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 the latest twist in the Ozempic panic, polarizing data in genome editing, and another biotech in search of “strategic alternatives.

Drug Pricing 176

Drug Pricing Drug Development 176

European Pharmaceutical Review

NOVEMBER 14, 2023

Ajinomoto Co., Inc. is set to acquire Forge Biologics, a viral vector and plasmid contract development and manufacturing organisation (CDMO) and clinical-stage therapeutics company. According to Forge Biologics, the acquisition is an all-cash deal for $620 million, which is Forge’s enterprise value on a cash-free and debt-free basis. The equity value attributable to unitholders of Forge Biologics is approximately $554 million.

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Outsourcing Pharma

NOVEMBER 14, 2023

Owlstone Medical's exegenous volatile organic compound (EVOC) breath test can reveal signs of liver cirrhosis and portal hypertension, a study has found.

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Compounding 105

BioPharma Dive

NOVEMBER 14, 2023

The lobbying group urged broader health insurance coverage for treating obesity, including with GLP-1 agonists like Wegovy.

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Drug Channels

NOVEMBER 14, 2023

It’s time for our most popular event of the year! Dr. Adam J. Fein, CEO of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2024 This event will be broadcast live on Friday, December 15, 2023 12:00 p.m. to 1:30 p.m. ET. This post describes the event, outlines the pricing options, and explains how to purchase a registration.

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Drug Pricing Biosimilars 75

World Pharma News

NOVEMBER 14, 2023

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin) Tecentriq® (atezolizumab). Tecentriq SC can be injected in approximately seven minutes, with most injections taking between four and eight minutes compared with 30-60 minutes for intravenous (IV) infusion, which can free up time for patients, healthcare teams and caregivers.

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pharmaphorum

NOVEMBER 14, 2023

Resilience, empathy, and gratitude. A personal battle with breast cancer. Mike.

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Drug Patent Watch

NOVEMBER 14, 2023

Annual Drug Patent Expirations for POMALYST Pomalyst is a drug marketed by Bristol and is included in one NDA. It is available from one supplier. There are six patents protecting… The post New patent expiration for Bristol drug POMALYST appeared first on DrugPatentWatch - Make Better Decisions.

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pharmaphorum

NOVEMBER 14, 2023

AZ’s oncology hopes dented as Imfinzi flunks NSCLC trial Phil.

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Drug Patent Watch

NOVEMBER 14, 2023

Acetylcysteine is the generic ingredient in seven branded drugs marketed by Cumberland Pharms, Aspen, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Indoco, Rising, Sagent Pharms Inc, Steriscience, Zydus Pharms, Alvogen,… The post New tentative approval for Rising drug acetylcysteine appeared first on DrugPatentWatch - Make Better Decisions.

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pharmaphorum

NOVEMBER 14, 2023

AHA: First data backs AskBio’s heart failure gene therapy Phil.

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Pharmafile

NOVEMBER 14, 2023

NanoSyrinx has announced the appointment of Anthony Johnson MD to its board as non-executive director. This appointment marks part of the company’s plans to expand and strengthen its leadership team as it prepares for further stages of development. Prior to this role, Anthony worked as chief executive officer at Goldfinch Bio and is chair of […] The post Anthony Johnson appointed NanoSyrinx’s non-executive director appeared first on Pharmafile.

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pharmaphorum

NOVEMBER 14, 2023

Autifony swings $770.5m deal with Jazz for CNS drugs Phil.

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Pharmafile

NOVEMBER 14, 2023

Enhanc3D Genomics has announced the appointment of Hazel Jones as chief operating officer. This appointment marks part of the company’s goal to broaden the application of its technology and secure strategic collaboration agreements with pharmaceutical partners. Hazel’s new role will involve leading, scaling and growing the company’s global business operations, playing an instrumental part in […] The post Enhanc3D Genomics appoints Hazel Jones as chief operating officer appeared first on Ph

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Outsourcing Pharma

NOVEMBER 14, 2023

The first-ever national cancer innovation accelerator initiative has been given public support from the White House.

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Pharmafile

NOVEMBER 14, 2023

Autifony Therapeutics has announced that it has entered an exclusive global licensing agreement with Jazz Pharmaceuticals for up to $770.5m, with the intention of discovering and developing drug candidates to target two different ion channel targets associated with neurological disorders. Autifony is expected to lead drug discovery and preclinical development activities on the targets, with […] The post Autifony announces global license and collaboration agreement with Jazz Pharmaceuticals

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