Sat.Jul 20, 2024 - Fri.Jul 26, 2024

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STAT+: How UnitedHealth harnesses its physician empire to squeeze profits out of patients

STAT

UnitedHealth Group started out as a small, Minnesota health insurance company and has since morphed into a modern-day Standard Oil, exerting unmatched dominance over health care in the United States. It’s no secret that UnitedHealth is a colossus: It’s the country’s largest health insurer and the fourth-largest company of any type by revenue, just behind Apple.

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Citius’ first FDA decision date is approaching — and its CEO has millions on the line

PharmaVoice

Citius Pharmaceuticals CEO Leonard Mazur has personally invested $22.5 million into the company, which is fast approaching a potential turning point.

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Agilent builds its CDMO arm with $925m Biovectra buy

pharmaphorum

Agilent has boosted its contract development and manufacturing organisation (CDMO) capacity with a $925 million deal to buy Biovectra, a Canadian provider of fill-and-finish services and active pharmaceutical ingredients (APIs).It's a statement of intent from Agilent, whose primary business is lab instrumentation and equipment, suggesting that it intends to grow the outsourcing side of its business, which is currently focused on the production of oligonucleotide and peptide medicines.

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Study suggests targeting amyloid beta production could be promising in AD

Pharma Times

The neurodegenerative disease is currently the most common cause of dementia

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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Morning Rounds: Three new bird flu cases in humans brings total to 13 in U.S.

STAT

Want to stay on top of health news? Sign up to get our Morning Rounds newsletter in your inbox. I’m Brittany Trang, STAT health tech reporter and your new Friday morning host.

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NewAmsterdam’s obicetrapib holds potential to become first CETP inhibitor to advance to clinical practice: GlobalData

Express Pharma

NewAmsterdam Pharma has completed the enrollment of 407 patients in the pivotal Phase III TANDEM clinical trial evaluating obicetrapib in combination with ezetimibe in patients with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD). Obicetrapib has demonstrated strong tolerability in more than 800 patients with elevated lipid levels in NewAmsterdam’s clinical trials to date.

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Ionis plots next steps for Angelman drug Biogen passed on

BioPharma Dive

The company plans to start a late-stage study next year, after a smaller trial found its drug offered “robust and consistent” benefits on communication, cognition and motor function.

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Opinion: An aging geriatrician wonders: Who will care for me?

STAT

In 1988, I became one of the first U.S. physicians certified in the new specialty of geriatric medicine, which focuses on the health care of older adults. As an idealistic and optimistic 32-year-old geriatrician, I believed that this branch of medicine would undoubtedly emerge as a vibrant field of medicine, benefiting patients and society. I was also confident that when I reached older adulthood, the health care system would be ready to care for me.

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Budget 2024-25 prioritises R&D, education and business for MSMEs

Express Pharma

Kiran Mazumdar Shaw, Chairperson, Biocon & Biocon Biologics “The Union Budget for FY25 builds further on the government’s pre-election, Interim Budget and has positive indicators on how the government is looking at India’s economic growth and development. The FM’s emphasis on job creation through skilling is a key underlying theme. Internships at large companies with Government and CSR-backed stipends are the right approach to employability and jobs for the future.

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Can Pfizer, Sangamo energise haemophilia A gene therapy?

pharmaphorum

There has been a gene therapy on the market for people with the bleeding disorder haemophilia A since 2022, but take-up has been very slow. Pfizer and Sangamo are hoping for a faster trajectory with their experimental treatment.The partners' one-shot giroctocogene fitelparvovec therapy has cleared a phase 3 trial, showing it was better than regular prophylaxis injections with Factor VIII (FVIII) replacement therapies at reducing bleeding episodes, and could now be heading for regulatory review.

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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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How Cure51’s AI breakthroughs are turning cancer into a manageable disease – an insider’s look

Outsourcing Pharma

Discover the groundbreaking work of Cure51, co-founded by Nicolas Wolikow and Simon Istolainen, revolutionizing cancer treatment through advanced AI and biotechnology.

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STAT+: Jiankui He, creator of CRISPR-edited children, relocates to a Chinese medical tourism hub

STAT

Jiankui He, the Chinese scientist who s parked a global uproar in 2018 when he revealed he had created the first gene-edited children , is again out on his own after being dismissed from an academic post. In January 2019, provincial health authorities found that He’s human CRISPR experiments violated national regulations against gene-editing for reproductive purposes.

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Mankind Pharma to acquire 100 per cent stake in BSV

Express Pharma

Mankind Pharma has entered into a definitive agreement to acquire a 100 per cent stake in Bharat Serums and Vaccines (BSV) from Advent International, for an enterprise value of approximately Rs 13,630 crores, subject to closing-related adjustments. With this acquisition, Mankind Pharma aims to further establish itself in the Indian women’s health and fertility drug market alongside access to other high entry barrier products in critical care with established complex R&D tech platforms.

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PBMs under the cosh at House hearing on drug pricing

pharmaphorum

The top three pharmacy benefit managers in the US felt the heat at a hearing of the House Oversight Committee, as lawmakers grilled executives over their business practices and accused them of monopolising the supply chain.

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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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Pharmacists must be enabled to prioritise SMRs, urges RPS

The Pharmacist

Primary care network (PCN) pharmacists should be enabled to prioritise structured medication reviews (SMRs) in the highest risk patients, the Royal Pharmaceutical Society (RPS) has said in a policy statement today. This follows concerns that PCNs and practices are deprioritising SMRs and directing pharmacists towards other work. RPS England vice-chair Brendon Jiang suggested that the […] The post Pharmacists must be enabled to prioritise SMRs, urges RPS appeared first on The Pharmacist.

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STAT+: Viking accelerates development of obesity drug that could rival Wegovy, Zepbound

STAT

Viking Therapeutics plans to move its injectable obesity treatment into a Phase 3 study faster than expected, bringing the biotech closer to joining the highly competitive GLP-1 drug market.  The San Diego-based biotech previously said it was anticipating to start a Phase 2b trial of the therapy, VK2735, after getting positive results from a Phase 2 study.

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RCC diagnosed incident cases to reach 230,000 in 8MM by 2033: GlobalData

Express Pharma

The burden of diagnosed incident cases of renal cell carcinoma (RCC) is forecast to increase at an annual growth rate (AGR) of 1.40 per cent from around 200,000 cases in 2023 to 230,000 cases in 2033 in the eight major markets (8MM*), according to GlobalData. GlobalData’s latest report, ‘Renal Cell Carcinoma (RCC): Epidemiology Forecast to 2033’, reveals RCC cases are rising because of the longer life expectancy in those with RCC, the increasing prevalence of risk factors, the increasing inciden

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HIV ‘vaccine’ could be made for just $40 a year for every patient

The Guardian - Pharmaceutical Industry

Generic version of a drug already on the market, which can suppress and prevent HIV, would still yield 30% profit if the current price was slashed, researchers say A new drug described as “the closest we have ever been to an HIV vaccine” could cost $40 (£31) a year for every patient, a thousand times less than its current price, new research suggests.

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Welsh rugby great fronts UK atrial fibrillation campaign

pharmaphorum

Former Welsh rugby union captain Alum Wyn Jones is the face of a new awareness campaign launching in the UK today to draw attention to atrial fibrillation (AF), an irregular and potentially life-threatening heart rhythm abnormality.

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STAT+: Jeff Shuren, medical devices head at FDA, to leave the agency

STAT

Jeffrey Shuren, longtime chief regulator of medical devices at the Food and Drug Administration, announced to staff on Tuesday that he is leaving the agency, according to six sources and an email reviewed by STAT. Shuren, who spent 28 years at the agency, started his FDA career in the Commissioner’s Office in 1998. He became director of the Center for Devices and Radiological Health in 2009 and has served in that position ever since.

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MHRA approves new use of semaglutide for cardiovascular prevention

The Pharmacist

The UK’s medicines regulator has approved the use of semaglutide (Wegovy) for cardiovascular prevention in obese and overweight patients with established cardiovascular disease. The Medicines and Healthcare products Regulatory Agency (MHRA) granted the authorisation on Tuesday this week, making it the first weight loss drug to be prescribed as a preventative treatment for cardiovascular events. […] The post MHRA approves new use of semaglutide for cardiovascular prevention appeared first o

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Union Budget 2024-25 reflects a forward-looking and inclusive approach

Express Pharma

“The Union Budget 2024-25, presented by FM Nirmala Sitharaman, marks a significant milestone as the first budget of the re-elected BJP-led NDA government. We at OPPI commend the government’s commitment to improving healthcare access and innovation in India, reflecting a forward-looking approach that aligns with our industry’s aspirations. We deeply appreciate the government’s decision to exempt three critical cancer medicines – Trastuzumab Deruxtecan, Osimertinib, and Durvalumab – fr

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Ask the experts: Should pharmacists take on more responsibility or is it a stretch too far?

Outsourcing Pharma

Back in March this year (2024) under the last UK Conservative government, plans were announced to give greater powers to pharmacy technicians, dental therapists and hygienists after two public consultations.

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STAT+: A pricey Gilead HIV drug could be made for dramatically less than the company claims, researchers say

STAT

Following the release of widely touted study results for a Gilead Sciences HIV treatment, a new analysis finds the medicine — called lenacapavir — could be made for as little as $26 to $40 per person each year, which the researchers argue could alleviate concerns about limited access in many countries. The medicine drew considerable attention last month after a late-stage clinical trial found that twice-a-year injections completely protected cisgender women from contracting HIV.

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Pharmacy bodies join calls for improved contraception access

The Pharmacist

Everyone should have access to a full range of contraceptives in ‘the location of their choosing’, an open letter signed by the National Pharmacy Association (NPA) and the Royal Pharmaceutical Society (RPS) has urged. Dr Janet Barter, secretary of the Faculty of Sexual and Reproductive Health (FSRH), wrote to secretary of state Wes Streeting this […] The post Pharmacy bodies join calls for improved contraception access appeared first on The Pharmacist.

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IPC waves off TABST in Indian Pharmacopoeia

Express Pharma

The Indian Pharmacopoeia Commission (IPC) has made a progressive amendment and waived off the Target Animal Batch Safety Test (TABST) in the Indian Pharmacopoeia, effective July 1, 2024. The TABST, a non-specific safety test for veterinary vaccines, typically involves the administration of vaccine overdose to animals to test that every batch of vaccine produced is safe for a specific species.

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Understanding the Patent Trial and Appeal Board (PTAB) – A Comprehensive Overview

Drug Patent Watch

The Patent Trial and Appeal Board (PTAB) is a crucial component of the United States Patent and Trademark Office (USPTO), established in 2012 by the Leahy-Smith America Invents Act (AIA).

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STAT+: Express Scripts overcharged postal workers by $45 million, audit says

STAT

Express Scripts, one of the largest pharmacy benefit managers in the country, overcharged U.S. Postal Service employees by a whopping $45 million for their prescription drugs during a recent five-year period, according to a federal audit. The findings are likely to intensify scrutiny of the controversial role played by PBMs in the opaque pharmaceutical pricing system.

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NICE says Boehringer stroke drug 'could save millions'

pharmaphorum

NICE clears NHS use of Boehringer's clot-busting drug Metalyse for acute ischaemic stroke, saying it could 'save millions'

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SynaptixBio collaborates with Evotec to boost search for rare disease therapies

Express Pharma

SynaptixBio, a company licensed to commercialise a treatment for a rare, incurable and deadly disease, has announced its collaboration with Evotec, to find further candidate drugs to treat H-ABC, the most severe form of TUBB4A leukodystrophy. Drug research was originally carried out by the Children’s Hospital of Philadelphia (CHOP), the world’s leading centre for leukodystrophy research, under a sponsored research agreement.

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Drafting Detailed Drug Patent Claims: The Art and Science of Pharmaceutical IP Protection

Drug Patent Watch

In the high-stakes world of pharmaceutical innovation, drafting detailed drug patent claims is a critical process that can make or break a company’s future.

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Opinion: To get a fair deal on Wegovy, buying Novo Nordisk might not be Medicare’s worst option

STAT

Medicare and Medicaid are facing a familiar quandary: how to provide coverage for new weight loss drugs with price tags that could effectively bankrupt the federal government’s health care budget while simultaneously ensuring continuous coverage for all other health care services used by millions of Americans. The Centers for Medicare and Medicaid Services announced in March 2024 that it would cover Wegovy (semaglutide), a new and expensive weight loss medication, for beneficiaries with c

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Med List Review – Renal Concerns

Med Ed 101

In this post, I will share some questions that I would investigate from this medication list. I have many questions surrounding renal concerns given the use of sevelamer. Sevelamer is a phosphate binder that is typically used to lower phosphate levels for patients with CKD. If this patient truly has CKD and significant impairment, many […] The post Med List Review – Renal Concerns appeared first on Med Ed 101.

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Gland Pharma receives tentative USFDA approval for Latanoprostene Bunod Ophthalmic Solution

Express Pharma

Gland Pharma a generic injectable-focused pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (USFDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024 per cent. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vyzulta Ophthalmic Solution, 0.024 per cent, registered by Bausch & Lomb.