Tue.Jan 02, 2024

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STAT+: Texas taxpayers wanted to help the poor get health care. Instead, they’re funding a medical school at a wealthy university

STAT

AUSTIN, Texas — Eleven years ago, local officials promised voters in the most liberal county in Texas that if they supported tens of millions of dollars in new taxes, they’d deliver a win-win scenario: Austin would get a new medical school, and poor people navigating the health care system in a state with the country’s worst uninsured rate would get more health care services.

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10 clinical trials to watch in the first half of 2024

BioPharma Dive

A non-addictive pain pill faces its definitive test, while study results in ALS, a rare heart disease and lung cancer could have far-reaching implications.

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Opinion: Today’s at-home microbiome testing industry is fraught with snake oil

STAT

The  blue muffin challenge. Food sensitivity tests. Microbiome test kits. Self-help gastrointestinal health is all the rage. Rightly so: One in four Americans is affected by digestive disorders. And we’re all eating worse, sleeping less, and experiencing more stress , leaving our guts feeling twisted.

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FDA ends busy year with three drug rejections

BioPharma Dive

Amgen had its bid for full approval of the cancer drug Lumakras turned back by the agency, which also issued complete response letters to Zealand Pharma and Merck & Co. in December.

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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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STAT+: Consumer health advocate Sid Wolfe was a thorn in the side. We’re all the better as a result

STAT

The first phone call came some time in late 1996. “Ed, I’d like to introduce myself. My name is Sid Wolfe of Public Citizen,” he said. “And I’ve got something for you.” He started out matter of fact, but spoke very quickly. To be honest, I can’t recall the subject anymore, but I do remember he peppered every sentence with lots of medical terminology.

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Universities join forces to tackle pharmacist shortage in South West England

The Pharmacist

The universities of Bath and Plymouth have teamed up to offer more pharmacist training places at an additional location, to combat workforce shortages that particularly affects the South West of England. From this September, pharmacy students will be able to undertake the University of Bath MPharm course at the University of Plymouth, as well as […] The post Universities join forces to tackle pharmacist shortage in South West England appeared first on The Pharmacist.

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Covid boosters needed as vaccine protection wanes after six months, finds UKHSA

The Pharmacist

There is a continued need for Covid boosters, according to a Government study, which found they provide significant protection against death but this wanes after six months. Researchers from the UK Health Security Agency analysed data on more than 10.6 million cases of Covid-19 in adults that had been recorded by England’s laboratory reporting system […] The post Covid boosters needed as vaccine protection wanes after six months, finds UKHSA appeared first on The Pharmacist.

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An ugly fight over care for the poor in Texas

STAT

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. Power, politics, and care for the poor in Texas Local officials in Austin, Texas promised twelve years ago that if voters approved millions of dollars in new property taxes, it would be a win-win.

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Verona cuts $400m loan deal as it preps COPD drug for market

pharmaphorum

Verona Pharma has agreed a new $400 million debt facility with Oxford Finance and Hercules Capital designed to help the company navigate the possible approval and launch of ensifentrine, its therapy for chronic obstructive pulmonary disease (COPD). The Anglo-US company has already tapped $50 million of the funding and can take another $100 million if an ongoing review of ensifentrine by the US FDA results in regulatory approval.

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STAT+: Pharmacies fear New Year’s financial squeeze from Biden administration rule

STAT

WASHINGTON — The Biden administration seemed to be giving pharmacies a win when they forced pharmacy benefit managers to be more up-front about the behind-the-scenes fees they charge. But now pharmacies are afraid the transition to the new system on Jan. 1 will lead to a cash flow crunch. In the past, PBMs could charge pharmacies performance-based fees long after the fact, and the total amount of the fees has grown in recent years.

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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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'Faster, Please': Key Challenges in Chemicals and Materials R&D

PharmExec

Companies must address myriad challenges to improve upon issues such as data quality and transparency, process efficiency, and artificial intelligence/machine learning preparedness.

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STAT+: Inside Ascension’s legal fight with a Texas agency over caring for the poor

STAT

AUSTIN, Texas — The partnership between one of the nation’s largest Catholic health systems and a local government agency focused on caring for poor patients was supposed to be mutually beneficial for everyone involved. But it didn’t quite turn out that way. The alliance in theory meant that Travis County, home to the growing metro area of Austin, could provide more care to low-income patients cheaper than other big cities in the state.

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AstraZeneca Reaches Agreement to Acquire Cell Therapy Specialist Gracell Biotechnologies

Pharmaceutical Commerce

Agreement includes novel cell therapy for hematology that has the opportunity to bring a potential best-in-class treatment to patients with blood cancers.

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STAT+: It was a turbulent year for the business of health tech. 3 trends to watch in 2024

STAT

Is it too early to say that the health tech boom feels like a million years ago? In 2020 and 2021, the jolt of pandemic and favorable economic conditions created an explosion of adoption and investment for companies that hoped to transform some corner of the stodgy health care system with technology. Those roaring days feel like a distant memory. Many of those would-be disrupters are now struggling through a much different environment.

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Driving QbD as a quality standard in drug development

European Pharmaceutical Review

A paper published in the European Journal of Pharmaceutics and Biopharmaceutics has reviewed the current application status of Quality by Design (QbD) within the framework of the ICH guidelines (ICH Q8(R2) – Q14 and ICH Q2(R2)). Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted.

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STAT+: The biotech scorecard for the first quarter: 17 stock-moving events to watch

STAT

Here is STAT’s biotech scorecard, our regular ledger of stock-moving biotech events, for the first quarter: In December, Vertex Pharmaceuticals announced results from a mid-stage clinical trial showing its experimental, non-opioid drug reduced pain in people with diabetes who have chronic pain. This quarter, the company will read out results from Phase 3 studies of the same pain drug, called VX-548, in people with acute pain following surgery.

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Are You Ready for Inspection?

PharmaTech

Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.

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UnitedHealth’s rehab restrictions, Texas medical school drama, and health care’s biggest profits

STAT

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.  UnitedHealth had rules to deny rehab care for certain MA members Throughout 2023, my colleague Casey Ross and I explored how UnitedHealth Group and its care management subsidiary, NaviHealth, have used an algorithm to cut off rehab care for people enrolled in Medicare Advantage.

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BDR Pharma launches BDENZA oral solution for prostate cancer

Express Pharma

BDR Pharmaceuticals has introduced BDENZA, an oral solution in 32mg/mL for the management of prostate cancer. BDENZA will be available at Rs 27,000 for 150mL. The company informed that the formulation offers lesser side effects in comparison to existing oral dosage forms of Enzalutamide. Dr Aravind Badiger, Director, Technical Formulation, “Changing how we treat prostate cancer, BDENZA ORAL SOLUTION brings a mix of benefits to make things better for patients.

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STAT+: LabCentral, a crucial incubator for local drug discovery, is slated to grow amid industry slowdown

STAT

CAMBRIDGE — Vietnamese-born entrepreneur Jean Pham is “graduating” from LabCentral, a biotech launchpad on the edge of Kendall Square, after enjoying free lab space for the past year. Pham and a pair of employees at her three-year-old company, Cellens, shared high-tech research instruments with scores of other scientists, under a LabCentral program aiding startups owned by women and people of color.

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Glenmark launches biosimilar of anti-diabetic drug, Liraglutide, in India

Express Pharma

Glenmark Pharmaceuticals has launched a biosimilar of anti-diabetic drug, Liraglutide, in India. The drug is being marketed under the brand name Lirafit following the approval from the Drug Controller General of India (DCGI). It is priced at around Rs 100 for a standard dose of 1.2 mg (per day). Liraglutide belongs to the class of glucagon-like peptide 1 receptor agonist (GLP-1 RA) drugs, which increase glucose-dependent insulin secretion and decrease in appropriate glucagon secretion.

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KCLA to host Q&A to dispel ketamine myths following Friends actor Matthew Perry's death

Outsourcing Pharma

A Los Angeles clinic is holding a free webinar covering the facts and myths about ketamine following the death of late actor, Matthew Perry.

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What is LDN good for? And the Power of Compounding

Welltopia Pharmacy

Explore 'What is LDN good for?' Learn how it effectively manages chronic pain, inflammation, and various autoimmune disorders in this comprehensive guide.

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CPhO warns of ‘significant’ and ‘prolonged’ pressures

The Pharmacist

The chief pharmaceutical officer (CPhO) for England has warned that pharmacy teams will experience challenging circumstances over the coming weeks and months, due to high demand, staff shortages, sickness and industrial action. But in a joint letter with the General Pharmaceutical Council (GPhC) published today, CPhO David Webb and GPhC chief executive Duncan Rudkin sought […] The post CPhO warns of ‘significant’ and ‘prolonged’ pressures appeared first on The Pharmacist.

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Novo Nordisk will open AI hub in London

pharmaphorum

Novo Nordisk is planning to open an AI research facility in London, UK, as part of a drive to place the technology at the heart of its drug discovery operations

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Will 2024 be a year of regulatory renaissance?

Express Pharma

On December 6, India’s Central Drugs Standard Control Organisation (CDSCO) issued a letter asking state and union territory regulators to defer the proposed risk based inspections of manufacturing units and private testing labs scheduled between December 11-22, to focus on verifying the supply chain and quality of propylene glycol (PG), a key ingredient in cough syrups.

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Astellas strikes $1.7bn SIRP drug deal with Elpiscience

pharmaphorum

Astellas has licensed up to four macrophage enhancer drugs with potential as cancer immunotherapies from Elpiscience in a $1.

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Digital training programme improves quality of life for dementia patients living in care

Pharma Times

The programme is the only remote, digital delivery nursing home training programme for dementia

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AstraZeneca to advance haematology cell therapy

European Pharmaceutical Review

For an upfront price of $1.0 billion, AstraZeneca has agreed to acquire Gracell Biotechnologies, supporting the development of cell therapies in haematology and autoimmune diseases. Gracell’s FasTCAR-enabled B-cell maturation antigen (BCMA)/CD19 dual-targeting autologous CAR-T cell therapy GC012F, is an asset AstraZeneca will gain access to as part of the new acquisition agreement announced on 26 December 2023.

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Beacon of hope for IgA nephropathy community as full approval granted to Tarpeyo

Outsourcing Pharma

The US Food and Drink Administration (FDA) has approved Calliditas Therapeutics' Tarpeyo (budesonide) delayed-release capsules to reduce the loss of kidney function in adults with IgAN.

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AstraZeneca Bolsters Cellular Therapy Pipeline With Acquisition of Gracell Biotechnologies

PharmExec

Merger agreement includes the Gracell FasTCAR platform, which could significantly improve the efficacy of CAR T-cell therapies.

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Financial factors to support and challenge Pharma in 2024

European Pharmaceutical Review

According to results from a survey by GlobalData, the top challenges for the pharmaceutical industry in 2024 will be inflation, geopolitical conflict and drug pricing pressures. Data outcomes revealed that most respondents from Pharma considered that drug pricing and reimbursement constraints will have a negative impact in 2024. Inflation and geopolitical pressure The second biggest negative impact was thought to be geopolitical conflicts and inflation.

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Bristol Myers Squibb buys Karuna Therapeutics for $14 billion in a deal that includes schizophrenia treatment

Outsourcing Pharma

Bristol Myers Squibb has announced it has acquired Karuna Therapeutics, Inc., for a total equity value of $14 billion or $12.7 billion net of estimated cash acquired.

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Anavex hit as Rett syndrome drug flunks test

pharmaphorum

Shares in US biotech Anavex Life Sciences fell sharply this morning after Rett syndrome candidate Anavex 2-73 failed a phase 2/3 trial

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Nearly three million people received urgent NHS cancer checks in 2023

Pharma Times

The number of people getting tested over the last decade has increased by 133%

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