Thu.May 25, 2023

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STAT+: With Fat Joe concerts and Super Bowl ads, a cadre of billionaires is mounting an unorthodox campaign against hospitals

STAT

WASHINGTON — At a waterfront concert in one of this city’s swankiest neighborhoods, rappers Busta Rhymes and Fat Joe interspersed their hits about love, wealth, and wild parties with mini-lectures about hospitals’ high prices. It was a nostalgia-fueled rager — but it was also a not-so-subtle effort by a billionaire to convince Congress and other policymakers to crack down on the commanding sway of the hospital industry.

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From FTC to SCOTUS, Amgen’s woes are potential ‘game changers’ for the industry

PharmaVoice

The two institutional battles offer a glimpse into the tension between pharma innovation and regulation that could reverberate across the industry.

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Opinion: Adopting the term ‘preaddiction’ would be a serious mistake

STAT

The National Institute on Drug Abuse and National Institute on Alcohol Abuse and Alcoholism recently proposed a new addition to the addiction vernacular: “ preaddiction.” The idea is that the word will help identify and intervene on harmful substance use earlier and more effectively. While it’s an admirable goal, the term fails to align with the evidence.

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J&J antibody drug combination shows promise in multiple myeloma

BioPharma Dive

A pair of dual-acting antibodies displayed early potential to become a new type of drug regimen for the blood cancer, but led to a high rate of side effects as well.

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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+: U.K. unveils $800 million package to bolster life sciences amid concern over biopharma investments

STAT

LONDON — The U.K. government on Thursday unveiled an $800 million package to bolster the life sciences, highlighting officials’ efforts to grow the industry even as biopharma companies have raised alarms about policies they say are deterring them from investing further in the country. The initiative includes a $190 million infusion into the U.K.

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ASCO puts spotlight on advancing antibody-drug conjugate pipeline

BioPharma Dive

Study abstracts released Thursday give investors and analysts a better look at cancer treatments recently licensed by Merck and BioNTech as well as fresh details on other closely watched ADC candidates.

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Bristol Myers data make case for earlier use of bone marrow disease drug

BioPharma Dive

Data released ahead of next month’s ASCO meeting detail how well Bristol Myers’ Reblozyl outperformed the decades-old standard Epogen in treating anemia from myelodysplastic syndromes.

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STAT+: Gilead and Teva defend antitrust claims that prices for HIV medicines were unfairly kept high

STAT

Amid concern that HIV prevention pills are not being widely taken by those at highest risk of infection, AIDS activists hope that a trial getting underway in a federal courtroom this week will help explain why the medicine has struggled to see uptake. The litigation accuses Gilead Sciences of using a range of controversial business tactics that led the U.S. health care system to overspend for HIV medicines.

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Appili Therapeutics receives US patent for ATI-1501

Pharmaceutical Technology

Appili Therapeutics has received a US patent for ATI-1501 , a liquid oral reformulation of metronidazole. The patent claims for ATI-1501 were published by the US patent and trademark office under US application no. 18/072,154, filed on 30 November 2022. It covers the composition and preparation methods for ATI-1501 until 2039. Metronidazole is a widely used frontline oral treatment for parasitic and anaerobic bacterial infections.

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Opinion: Opportunistic CT: There’s gold in them there images

STAT

More than 80 million CT scans are performed each year in the U.S. alone. In fact, most Americans have had a CT scan by the time they reach age 60, and many will have had several scans. While CT scans often provide key information for diagnosing a certain problem, our current approach leaves an immense amount of information unmined. Given the cost and radiation involved in CT scanning, we have an obligation not to leave any useful data on the metaphorical cutting room floor.

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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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Clover collaborates with Kyuan Trade to launch AdimFlu-S (QIS) in China

Pharmaceutical Technology

Clover Biopharmaceuticals has established a commercial collaboration with Keyuan Xinhai (Beijing) Medical Products Trading (Kyuan Trade) for the launch of its quadrivalent seasonal influenza vaccine, AdimFlu-S (QIS), in China. The China National Medical Products Administration approved AdimFlu-S (QIS) in January 2022 for individuals aged three years and above.

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How Medicare’s Aduhelm decision revived old questions about new drugs

STAT

This article is adapted from the latest STAT Report: Decoding Medicare: 10 key coverage decisions and how they’re made. M edicare’s decision to withhold coverage for Biogen’s Aduhelm despite the Food and Drug Administration’s approval of the Alzheimer’s drug has revived longstanding questions about how the federal program determines whether it will pay for new drugs and devices.

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Pfizer's PAXLOVID™ receives FDA approval for adult patients at high risk of progression to severe COVID-19

World Pharma News

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) approved PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID has been available in the U.S. since December 2021 under Emergency Use Authorization (EUA), and the overall benefit/risk profile and indication for use in eligible adults remain consistent

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STAT+: Illumina shareholders elect one Icahn ally to board, as company holds off broader challenge

STAT

Shareholders in the DNA-sequencing firm Illumina on Thursday voted to replace the company’s chairman with a candidate put forward by the activist investor Carl Icahn, even as Illumina held off an effort to oust other directors, including CEO Francis deSouza. Andrew Teno, a portfolio manager at Icahn Capital, will replace John Thompson, the former CEO of software firm Symantec and until now Illumina’s chairman.

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8 Ways to Reduce Medication Errors at Your Pharmacy

Digital Pharmacist

Medication errors have the potential to occur frequently and when we least expect them. Whether it be human error involved in filling the prescription or dispensing it, they can happen at any stage in the process. According to the National Institute of Health. Each year, in the United States alone, 7,000 to 9,000 people die as a result of a medication error By prioritizing patient safety and adopting proactive measures, pharmacies can significantly reduce medication errors – saving lives in the

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Listen: ChatGPT in medicine, a boom in weight loss pills, & Sarepta at the FDA

STAT

Can AI diagnose a disease? Are Wegovy’s days numbered? And what makes AI hallucinate? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. As hospitals and health care companies are racing to implement large language models like ChatGPT into their businesses, STAT reporter Casey Ross joins us to explain what experts want the world to know before embracing generative AI.

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ElevateBio raises funds to advance cell and gene therapies

Pharmaceutical Technology

ElevateBio has raised $401m in a Series D financing round for advancing its technology platforms to expedite the design, production and development of cell and gene therapies. The technology platforms include the Life Edit gene editing platform, an RNA, cell, protein, vector engineering and induced pluripotent stem cells (iPSCs) platform. ElevateBio intends to use the funds to advance its genetic medicine current good manufacturing practice (cGMP) and process development business, BaseCamp.

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Government accused of not taking alcohol harms seriously

The Pharmacist

The government has been accused of not taking alcohol harm seriously enough as a new report shows a sharp rise in alcohol-related deaths. A report published this week by the Public Affairs Committee said it was ‘surprising and disappointing’ that the number of people receiving treatment for alcohol dependency had fallen even as the number of […] The post Government accused of not taking alcohol harms seriously appeared first on The Pharmacist.

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Parkinson’s unmet needs present significant opportunity for new entrants: GlobalData

Express Pharma

Parkinson’s Disease (PD) is a complex, multi-system neurodegenerative disorder that affects movement control. Current treatments focus on the management of dopamine levels in the brain, with levodopa-based therapies remaining the standard of care in the PD market for the past half-century. However, the effectiveness of levodopa declines with time, and both motor and non-motor complications arise.

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New vaccination strategy expected by the end of the year

The Pharmacist

A new strategy that will shape the future of vaccination delivery is expected to be published by the end of the year, a senior NHS England official has said. MPs in the House of Commons Health and Social Care Committee are analysing the role of vaccination in preventative healthcare, as vaccines are one of 10 […] The post New vaccination strategy expected by the end of the year appeared first on The Pharmacist.

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Indegene, ConTIPI Medical partner to launch ProVate, a device to treat pelvic organ prolapse in women

Express Pharma

Indegene announced that it will be expanding its partnership with ConTIPI Medical, a provider of non-surgical and disposable solutions for women with various pelvic floor dysfunctions, to bring a new device to the market. ConTIPI’s ProVate is a ready-to-use device that is inserted vaginally by the user thanks to an easy-to-use applicator, very similar to a menstrual tampon.

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Growth in ‘pharmacy deserts’ as closures increase

The Pharmacist

Pharmacy closures have left increasing numbers of people trying to access a diminishing pool of pharmacies, leading to ‘pharmacy deserts’ in urban areas, new analysis has warned. According to Gophr, the delivery partner for online pharmacies such as Numark, areas of the West Midlands, North West England, South East England and London are at risk […] The post Growth in ‘pharmacy deserts’ as closures increase appeared first on The Pharmacist.

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Illumina chair loses to Icahn pick as proxy battle ends

BioPharma Dive

The decision to replace board Chair John Thompson could change the company’s course as it decides whether to divest liquid biopsy company Grail.

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Centre for Genomic Regulation and Almirall join forces on skin cancer treatments

Pharma Times

The collaboration aims to develop novel preclinical models with a view to identifying new treatments

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Nanoparticle HIV vaccine shows potential in trial

European Pharmaceutical Review

Researchers have characterised robust T-cell responses in volunteers participating in a Phase I trial for a self-assembling nanoparticle HIV vaccine. The results, published in Science Translational Medicine is a major step in the development of a vaccine for overcoming the HIV/AIDS epidemic. “We were quite impressed that this vaccine candidate produced such a vigorous T-cell response in almost all trial participants who received the vaccine,” explained Dr Julie McElrath, PhD, co-senior author

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BioInvent and Transgene and report positive BT-001 data

Pharma Times

Tumour treatment among all phase 1a cohorts in were concluded with no safety concerns

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Meningitis vaccine comes to the forefront with impressive study results

Pharmaceutical Technology

A new vaccine developed by the Serum Institute of India to fight meningococcal disease could help eliminate meningitis across Africa. The results from a trial, published in The New England Journal of Medicine , found the vaccine was associated with a strong immune response and good safety profile. The trial, conducted in 1,800 healthy individuals ranging from ages 2-29 years in Mali and The Gambia in 2021, found NmCV-5 induced a strong immune response across five strains of meningococcal bacteri

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FDA Approves Celltrion’s YUFLYMA (adalimumab-aaty), a Biosimilar to HUMIRA

Big Molecule Watch

Today Celltrion announced that the FDA approved its biosimilar product, YUFLYMA (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of HUMIRA. YUFLYMA is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.

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Pharmapack Awards 2024 entries open

European Pharmaceutical Review

CPHI’s Pharmapack Awards 2024 are open for submissions. Two new categories and eight prizes in total are divided into two separate streams: Exhibitor Innovation Awards and the Health Product Awards. The Pharmapack Awards 2024 (January 24-25 2024) will be held during the event’s opening day. CPHI’s awards provide insight into the industry’s latest developments and innovations that will influence global drug delivery and packaging in the year ahead.

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BenevolentAI CFO resigns as company lays off staff, restructures

BioPharma Dive

The biotech, one of several AI drug discovery specialists to go public in recent years, is cutting up to 180 jobs and reorganizing its pipeline to conserve cash.

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Specifications Grading:  A step towards competency-based education?

Pulses

By: Erika L. Kleppinger, PharmD, BCPS Competency-based education (CBE) is being discussed for health professions education, but transitioning to full CBE may be difficult. A recent AACP Task Force described five essential elements of CBE: 1 Meets health care and societal needs Outcomes based curricular model De-emphasized time Learner-centered culture Authentic teaching and learning strategies aligned to assessments.

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Annexon claims a silver lining in failed eye drug study

BioPharma Dive

The company’s geographic atrophy drug didn’t slow the growth of eye lesions, as similar medicines have in clinical testing. But executives said it may have helped preserve some patients’ vision.

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US banker paid £73m dividend in 2021 after firm won millions in UK Covid contracts

The Guardian - Pharmaceutical Industry

Banks Bourne, sole owner of Tanner Pharma in North Carolina, took sum from Tanner’s UK arm, records show An American banker was paid a £73m dividend in 2021 after his firm won hundreds of millions in Covid contracts, figures show. Banks Bourne, the sole owner of the medical company Tanner Pharma, took the sum from Tanner’s UK division, Companies House records show.

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How Readmission Rates Affect a Hospital's Bottom Line

cureatr

The healthcare industry spends billions of dollars annually due to hospital readmissions. In fact, the Agency for Healthcare Research and Quality (AHRQ) reports that just one readmission costs an average of $15,200 , according to the latest data available. Readmissions will also affect a consumer’s perceptions of the quality of care at hospitals and health systems.

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Amgen Intervenes in Regeneron v. Mylan BPCIA Aflibercept Litigation to Seek Public Access to Sealed Documents

Big Molecule Watch

As we have previously reported , Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial scheduled to begin on June 12, 2023. On May 23, 2023, Amgen filed a motion to intervene in the case “for the limited purpose of invoking the First Amendment and common law rights of public access to judicial records in order to unseal documents that were previously seale