STAT

JULY 29, 2024

Sarepta Therapeutics demanded a prominent patient advocacy organization censor a video that contained pointed criticism of the company’s recently approved gene therapy for Duchenne muscular dystrophy, STAT has learned. The incident raises questions about the financial ties between Sarepta and the advocacy group, Parent Project Muscular Dystrophy, and whether the drugmaker uses its money to influence, or even muzzle, debate over its Duchenne medicines.

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PharmaVoice

JULY 29, 2024

The mid-stage failure leaves the success of the expensive partnership hanging on a drug that’s already suffered its own setback.

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STAT

JULY 29, 2024

The Food and Drug Administration on Monday approved a blood test intended to detect colon cancer, a product many experts hope will help catch cases of the disease early enough so that they can be more easily treated. The test, called Shield and made by Guardant Health, a Palo Alto, Calif.-based biotech firm, comes with a drawback: It is not as good as a colonoscopy and other tests at detecting precancerous or early stage cancers.

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PharmaVoice

JULY 29, 2024

A brain-on-a-chip developer says better preclinical modeling could help move the needle.

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STAT

JULY 29, 2024

With the number of U.S. dairy herds infected with H5N1 bird flu rising almost daily, fears are growing that the dangerous virus cannot be driven out of this species. That belief is amplifying calls for the development of flu shots for cows. Multiple animal vaccine manufacturers are reportedly at work trying to develop such products. And the U.S. Department of Agriculture is eagerly encouraging the effort, detailing in a notice last week what kinds of evidence would be needed to win licensing app

Vaccines 362

Vaccines 362

Outsourcing Pharma

JULY 29, 2024

The Rainwater Charitable Foundation (RCF), in collaboration with CurePSP and the Aging Mind Foundation (AMF), has announced the allocation of $2 million in grants to support groundbreaking research in primary tauopathies.

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Express Pharma

JULY 29, 2024

Guardant Health, a precision oncology company, announced the U.S. Food and Drug Administration (FDA) has approved the company’s Shield blood test for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease. It is reportedly the first blood test to be approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines.

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Insurance Coverage and Processing 110

STAT

JULY 29, 2024

New blood tests could help doctors diagnose  Alzheimer’s  disease faster and more accurately, researchers reported Sunday – but some appear to work far better than others. It’s tricky to tell if memory problems are caused by Alzheimer’s. That requires confirming one of the  disease’s hallmark signs  — buildup of a sticky protein called beta-amyloid — with a hard-to-get brain scan or uncomfortable spinal tap.

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The Pharmacist

JULY 29, 2024

An MHRA statement of policy intent is designed to recognise approvals from specific foreign territories and to simplify and speed-up the regulatory process for medical devices. Thorrun Govind, solicitor (Brabners LLP), pharmacist and TV health expert, explains what this means. Framework for medical device approvals Under the new MHRA proposed framework for international recognition of […] The post 'MHRA set to streamline UK medical device approvals' appeared first on The Pharmaci

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STAT

JULY 29, 2024

If up to half of Americans no longer qualify for a statin or a blood pressure medication based on a new calculator updated to better predict their risk, that could lead to 107,000 more heart attacks and strokes over 10 years, a new study estimates. The research paper, published Monday in JAMA , is the second in two months drawing attention to widely used medicines designed to prevent the leading cause of death in the United States.

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Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

pharmaphorum

JULY 29, 2024

Otsuka has teamed up with one of the innovation arms of the NHS to explore how a digital therapeutic (DTx) for major depressive disorder (MDD) could be deployed within the health service.The alliance with Health Innovation Oxford & Thames Valley (Oxford HIN) is focusing on Care for MDD, an app-based DTx that has been co-developed by Otsuka and digital health specialist Click Therapeutics.

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STAT

JULY 29, 2024

The human body works hard to prevent outside substances from entering the brain — which makes it a challenge to get drugs into the brain to treat neurological diseases. A study published today in Nature Microbiology opens the door to a potential clever solution, showing how Toxoplasma gondii, a parasite that is able to cross the blood-brain barrier, can be engineered to treat a brain development disorder in mice.

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Communication 329

Express Pharma

JULY 29, 2024

The Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy announced the successful completion of the second session of the PULSE (Pharma Upgradation and Learning Series for Excellence) initiative, held on July 28, 2024. The session focused on the critical topic of Pharmaceutical Quality Systems, lasted over three hours, and included extensive discussions and a Q&A session.

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Pharmaceutical Manufacturing Drug Development 104

STAT

JULY 29, 2024

Americans are facing at least two prescription drug crises simultaneously. One is the outrageously high cost of drugs, which runs to more than $500 billion per year. The other relates to extreme drug shortages requiring rationing of lifesaving medications. Crises can generate opportunities. Mark Cuban, the wildly successful entrepreneur and NBA owner, has committed himself to solving these two problems.

Drug Pricing 322

Drug Pricing 322

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Express Pharma

JULY 29, 2024

Dr Reddy’s Laboratories, has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI) in European markets. According to the statement, Dr Reddy’s had previously received the EU GMP certificate for its Rituximab drug substance and drug product manufacturing facility located in Hyderabad, India.

Biosimilars 104

Biosimilars 104

STAT

JULY 29, 2024

Around November, Kivo Health, a telehealth provider of pulmonary rehabilitation services, will need to start warning older patients that their sessions may not be covered by Medicare in the new year. Kivo was founded in 2022, and it’s covered by Medicare thanks to telehealth flexibilities passed by Congress during the Covid-19 pandemic. Those flexibilities expanded what kinds of care people on Medicare can receive over telehealth — but they are set to expire at the end of 2024.

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Pharma Times

JULY 29, 2024

Coronary heart disease is the most common form of heart and circulatory disease

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STAT

JULY 29, 2024

Want to stay on top of health news? Sign up to get our Morning Rounds newsletter in your inbox. Happy Monday! Are you watching the Olympics this week? As a former distance swimmer, I’m a big fan of watching Katie Ledecky smoke everyone in the mile.

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Vaccines 309

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.

Express Pharma

JULY 29, 2024

Sionna Therapeutics, a US-based clinical-stage life sciences company specialising in cystic fibrosis (CF), has secured exclusive global rights to develop and commercialise multiple advanced compounds through a licence agreement with AbbVie. This strategic acquisition includes Phase 2 compounds ABBV-2222 and ABBV-3067, and Phase 1 compound ABBV-2851, bolstering Sionna’s pipeline and its position in the CF market, says GlobalData.

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Compounding 103

STAT

JULY 29, 2024

You’re reading the web version of Health Care Inc.,  STAT’s weekly newsletter  following the flow of money in medicine.  Sign up  to get it in your inbox every Monday. Inside UnitedHealth’s physician empire UnitedHealth Group is everywhere. Increasingly, it is starting to feel like the Standard Oil of health care.

Hospitals 269

Hospitals Drug Development 269

pharmaphorum

JULY 29, 2024

This comprehensive guide provides pharmaceutical companies with valuable insights into biologics contract manufacturing, including the role of CDMOs and key considerations for successful partnerships.

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Pharmaceutical Companies Pharmaceutical Companies 106

STAT

JULY 29, 2024

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hi there. Today, we learn that Sarepta Therapeutics pressed a patient advocacy group to censor a video containing harsh criticisms of the company — calling into question how the financial ties between biotech companies and advocacy groups impact patients.

Drug Pricing 262

Drug Pricing Drug Development 262

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Pharmacy Management

The Pharmacist

JULY 29, 2024

Pharmacists are dealing with patient need in 'a safe and appropriate way' under Pharmacy First, a leading GP has said. Speaking about Pharmacy First at the NHS England (NHSE) board meeting last week, non-executive director Professor Dame Helen Stokes-Lampard said: 'We have so much unmet need in general practice is that what's happened is that […] The post Leading GP notes 'safe and appropriate' Pharmacy First appeared first on The Pharmacist.

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STAT

JULY 29, 2024

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and refreshing, because that oh-so familiar routine of online meetings, phone calls, and deadlines has returned. But you knew this would happen, yes? After all, the world, such as it is, continues to spin. So time to give it a nudge in a better direction with a cup or three of stimulation.

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Pharmaceutical Companies Pharmaceutical Companies 275

Pharmaceutical Commerce

JULY 29, 2024

A cohort study investigates whether or not the prevalence of these types of illnesses can vary among individuals who are COVID-positive versus negative.

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STAT

JULY 29, 2024

To invest is to embrace an unpredictable future, filled with risks and uncertainties. To navigate this uncertainty, which sits atop a complex and ever-changing market landscape, prudent investors seek ways to make informed decisions that can drive returns and mitigate against potential losses. The principles of excellence in scientific research, it turns out, align remarkably well with best practices for rigorous investment decisions, whether the investment is in a science-based enterprise or so

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pharmaphorum

JULY 29, 2024

Ipsen gets CHMP backing for Alagille syndrome therapy odevixibat, with a new brand name that it hopes will unlock orphan status in the EU

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Pharmaceutical Technology

JULY 29, 2024

Bristol Myers Squibb (BMS) has posted net income attributable to the company of $1.7bn during Q2 2024, a 19% drop versus $2.1bn in Q2 2023.

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pharmaphorum

JULY 29, 2024

Shares in NewAmsterdam Pharma were sliding today after it reported a phase 3 trial of obicetrapib that met its primary objective but didn't meet the expectations of some analysts and investors.The BROOKLYN study compared the oral CETP inhibitor to a placebo given on top of maximum tolerated doses of other lipid-modifying therapies, like statins and ezetimibe, in patients with heterozygous familial hypercholesterolaemia (HeFH), a genetic condition that raises blood cholesterol and the risk of hea

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Pharmaceutical Technology

JULY 29, 2024

Clinical trial trends point to studying combination therapies and lifestyle changes using alternate designs in Alzheimer’s research.

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pharmaphorum

JULY 29, 2024

Flagship Pioneering signs another strategic-level deal with a big pharma group, with GSK agreeing an alliance potentially worth more than $7 billion

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Pharmaceutical Technology

JULY 29, 2024

The US FDA has granted approval for Luye Pharma’s ERZOFRI extended-release injectable suspension for schizophrenia in adults.

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