STAT

OCTOBER 11, 2023

BRISTOL, Va. — Stephanie Rosenwinge was excited to work for the queen of abortion. She’d grown up in rural Virginia with an abusive, alcoholic father. Her mother had had an abortion in 1973, and it may have saved her life: As Rosenwinge put it, “My dad was determined to beat the baby out of her.” Rosenwinge herself had been sexually assaulted while serving in the Gulf War, and she was glad she would’ve had a constitutional right to terminate had the attack resu

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PharmaVoice

OCTOBER 11, 2023

Day One Biopharmaceuticals is bucking the cancer drug development trend by working with children and adults simultaneously.

Drug Development 291

Drug Development 291

STAT

OCTOBER 11, 2023

Scientists at a Massachusetts-based biotechnology company and their academic research partners reported Wednesday that an engineered breed of miniature pig containing up to 69 genetic changes produced kidneys that functioned well in monkeys for an average of 176 days and in one animal for more than two years. The results, published in Nature , are an encouraging sign that the long-struggling science of xenotransplantation might one day become a medical reality.

Hospitals 362

Hospitals 362

ALiEM - Pharm Pearls

OCTOBER 11, 2023

What is the most common primary cause of death from ingesting the pictured marine animal? Acute liver failure Acute renal failure Coagulopathy and DIC Respiratory failure Status epilepticus [Image from Canstockphoto] Reveal the Answer 4. Respiratory Failure The pufferfish, considered a delicacy in multiple countries, contains tetrodotoxin which causes sodium channel blockade and can lead to muscle paralysis, respiratory failure, and death.

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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

OCTOBER 11, 2023

LAS VEGAS – Nick Jonas is a global superstar behind electrifying earworms like “Jealous,” “Chains,” and “Sucker,” one-third of the illustrious band The Jonas Brothers — and also a person who lives with type 1 diabetes. He took time out of his world tour to sit down with STAT’s Nicholas St.

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Diabetes 337

PharmaVoice

OCTOBER 11, 2023

The CEO on the secrets of innovative pharma companies, his record collection and what he’d always rather be doing.

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BioPharma Dive

OCTOBER 11, 2023

Once the specialty of a few select drugmakers, CRISPR gene editing is now an essential technology for a growing group of biotechs, many led by former students of the field's pioneering scientists.

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STAT

OCTOBER 11, 2023

It’s no secret that biotech industry funding has fallen from its Covid highs. But with just a few months left in the year, it’s on track to hit lows that predate the pandemic. New data from Pitchbook and the National Venture Capital Association show that both the number of deals and the amount of money that’s being invested in life science companies are down significantly.

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The Pharmacist

OCTOBER 11, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance on full pack dispensing for medicines containing valproate, with regulation changes now in effect. The legislation was amended after a government consultation determined that patients should always receive safety warnings – including a patient card and patient information leaflet contained in full packs […] The post MHRA issues guidance on valproate full pack dispensing appeared first on The Pharmacist.

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STAT

OCTOBER 11, 2023

Chronic kidney disease was the strongest risk factor for sudden cardiac arrest among Hispanic and Latino adults in the first study to evaluate this population in the U.S. for risk factors of this major cause of death. Researchers from Cedars–Sinai Medical Center in Los Angeles identified clinical predictors that influence out-of-hospital sudden cardiac arrest (SCA) — an emergency in which the heart stops beating that affects 350,000 individuals in the United States annually.

Hospitals 277

Hospitals 277

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Pharmacy Management

BioPharma Dive

OCTOBER 11, 2023

The finding from the study of its diabetes drug, which Novo didn’t detail, could help the company in its competition with rival drugmaker Eli Lilly.

Diabetes 120

Diabetes 120

STAT

OCTOBER 11, 2023

Anticipation may be high that Medicare can wring lower prices out of drugmakers, but a handful of states are moving aggressively to slash costs for their residents, a clear sign the battle over affordable medicines in the U.S. is only going to escalate further. These efforts involve Prescription Drug Affordability Boards, which are designed to function like a rate-setting authority.

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Drug Pricing 271

Pharma Times

OCTOBER 11, 2023

The deal gives Kyowa access to a therapy for early-onset metachromatic leukodystrophy - News - PharmaTimes

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STAT

OCTOBER 11, 2023

ANAHEIM, Calif. — Thousands of workers in the medical device industry gathered here this week for the MedTech Conference, creating an eerie dissonance with Disneyland tourists clad in Mickey Mouse ears and fanny packs. Device makers and analysts at the conference, hosted by device lobby AdvaMed, came together to discuss medical technology’s innovation problem, the industry’s deepening relationship with the Food and Drug Administration, and the growing opportunities in digita

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European Pharmaceutical Review

OCTOBER 11, 2023

Late-breaking data from Roche’s Phase III OCARINA II study have revealed that OCREVUS® (ocrelizumab) subcutaneous injection was comparable to IV infusion in providing near-complete suppression of MRI brain lesion activity over 24 weeks, for relapsing or primary progressive multiple sclerosis (RMS or PPMS) patients. OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, which are thought to be a key contributor to myelin and axonal (nerve cell) damage, noted Roche.

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STAT

OCTOBER 11, 2023

A company that Pfizer blamed for problems with a clinical trial testing a Lyme vaccine claims that regulators gave its procedures a clean bill of health during a recent inspection. Care Access served as a contract research organization and had enrolled about 3,000 patients in the late-stage trial. But the patients were dropped last February after Pfizer and its partner, Valneva, claimed that violations of Good Clinical Practice — the international ethical and quality standards used by all

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Vaccines 249

The Pharmacist

OCTOBER 11, 2023

Limiting autumn Covid boosters to the over-80s, and high-risk over-45s, would have been the most cost-effective option, according to a Government impact assessment. But the Joint Committee on Vaccination and Immunisation (JCVI) decided to take a ‘precautionary’ approach in selecting who should be eligible for a booster jab because of uncertainties in the modelling, including […] The post Limiting Covid boosters to the over-80s would be more cost-effective appeared first on The Pharmacist.

Vaccines 104

Vaccines 104

STAT

OCTOBER 11, 2023

Bruce Broussard, CEO of health insurance giant Humana, will step down next year after leading the company for more than a decade. Humana named Jim Rechtin — who is the CEO of Envision Healthcare, the controversial physician staffing firm that is working its way through bankruptcy — as Broussard’s replacement. Rechtin will serve as president and chief operating officer starting Jan. 8 and then take over as CEO in the “latter half of 2024,” the company said in a

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PharmaTech

OCTOBER 11, 2023

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

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STAT

OCTOBER 11, 2023

Hello, everyone, and how are you this fine, sunny morning? The middle of the week has arrived, as you may know, so why not celebrate with a delicious cup of stimulation? After all, you made it this far, which is a likely sign of surviving another few days. And of course, no prescription is required, which is a good thing. Our choice today is hazelnut creme.

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Diabetes 243

Pharma Times

OCTOBER 11, 2023

Eligible patients in Scotland will now have access to Nubeqa and Stivarga - News - PharmaTimes

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STAT

OCTOBER 11, 2023

LONDON — This week, European regulators are considering an appeal from Amylyx Pharmaceuticals after initially recommending against approving the company’s ALS treatment — the latest potential turning point for a drug that has seen its share of ups and downs with regulatory bodies. In June, a European Medicines Agency committee issued a negative review of Amylyx’s drug, called Albrioza, and cast doubt on whether it had demonstrated effectiveness in its pivotal study.

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Drug Development 223

Pharmaceutical Technology

OCTOBER 11, 2023

Biomarin and CSL Behring’s haemophilia gene therapies have boosted innovation in the field, but assessing their cost effectiveness is less than straightforward.

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STAT

OCTOBER 11, 2023

LONDON — The Wellcome Trust — the world’s second largest private funder of biomedical research — announced on Wednesday that Norwegian scientist and public health official John-Arne Røttingen has been appointed its new CEO.   Røttingen, currently the ambassador for global health in Norway, will start in January at the London-based charity.

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PharmaTech

OCTOBER 11, 2023

Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize Ionis’ investigational RNA-based therapeutic candidates for Alzheimer's and Huntington's disease.

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STAT

OCTOBER 11, 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 an update on an erstwhile unicorn, the latest twist in the NASH saga, and the next regulatory debate over ALS.

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Drug Pricing 195

Eye on FDA

OCTOBER 11, 2023

FDA has announced that the Office of Prescription Drug Promotion (OPDP) is planning a study to evaluate the influence that statements made in a promotional communication about patient adherence to a medication may have on the resulting preference for a medicine. OPDP regularly conducts research on a wide-ranging scale to help define the agency’s perspective on how various conditions might impact a target audience of a promotional communication.

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Communication Labelling 98

World Pharma News

OCTOBER 11, 2023

Bayer AG has opened a new cell therapy production plant in Berkeley, California, USA, to bring cell therapies to patients on a global scale. The USD 250 million investment will support the production of material required for clinical trials and potential commercial launch of BlueRock Therapeutics' bemdaneprocel (BRT-DA01), an investigational cell therapy currently in evaluation for treating Parkinson's Disease.

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Outsourcing Pharma

OCTOBER 11, 2023

Technology company, Medable Inc., offering services for modern clincal trials has joined forces with Pluto Health, a smart care coordination services company offering a health coordination platform.

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Express Pharma

OCTOBER 11, 2023

This World Sight Day, Allergan, an AbbVie company, came together with experts in the field of ophthalmology to emphasise eye health and its connection to the workplace. With a focus to create an understanding for eyecare in the workplace, these experts shed light on the prevalence of eye-related issues in today’s digital age and dispelled common myths surrounding eye health.

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Diabetes Hospitals 90

Outsourcing Pharma

OCTOBER 11, 2023

The heavy burden on immediate family members with neurodegenerative diseases and their caregivers, was the initial driving force to study pharmacy for Andrea Pfeifer.

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BioPharma Dive

OCTOBER 11, 2023

The once high-flying biotech is cutting staff for the second time in a year and delaying some research to save cash.

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The Pharmacist

OCTOBER 11, 2023

A Labour government would take ‘tough action’ against the junk food and vaping industries to better protect the health of children, the shadow health secretary has promised. During his keynote address at this year’s Labour Party conference, Wes Streeting said the ‘fundamental problem’ with the NHS was that it ‘gets to people too late’, as […] The post Labour pledges ‘tough action’ against junk food and vaping industries appeared first on The Pharmacist.

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Express Pharma

OCTOBER 11, 2023

Ichnos Sciences, a clinical-stage biotechnology company developing multispecific antibodies for oncology, announced that it has entered into an exclusive worldwide licensing agreement for its OX40 antagonist monoclonal antibody portfolio with Astria Therapeutics, a biopharma company developing therapies for rare allergic and immunological diseases. Within the terms of the agreement, Astria will assume full cost and responsibility for the global development and commercialisation of the licensed t

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Immunity Immunization 82

European Pharmaceutical Review

OCTOBER 11, 2023

As part of newly acquired assets from live biotherapeutics products (LBP) manufacturer Federation Bio, Kanvas Biosciences now has two active microbiome-based clinical programmes. “This acquisition allows us to manufacture and clinically investigate complex microbial consortia much faster than previously envisioned. Rather than devote years to building a manufacturing process from the ground up, we are thrilled to be able to positively impact patients’ lives much faster [by acquiring several key

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Immunity Immunization 79