Tue.Jun 13, 2023

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‘The drug bust paradox’: Study shows opioid deaths double after police action

STAT

Police drug busts are strongly associated with a large and sudden spike in overdose deaths, according to a new study. In the week following a major opioid bust, fatal overdoses in the same neighborhood in Indianapolis doubled, the analysis showed. Calls to 911 and the use of naloxone , the overdose-reversal medication, also spiked.

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The ingredients of a successful biopharma collaboration

PharmaVoice

Collaboration is important along the entire spectrum and lifecycle of biopharma, and finding an effective partner is harder than it sounds.

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AMA asks doctors to de-emphasize use of BMI in gauging health and obesity

STAT

CHICAGO — The American Medical Association on Tuesday strongly criticized the body mass index , urging doctors to de-emphasize its use in assessing health and obesity and acknowledging that the measurement has been used for “racist exclusion” and has caused “historical harm.” The AMA, one of the largest medical groups in the U.S., voted to adopt this policy during its annual meeting here.

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Invizius’ ‘angry blood’ research recruits 300th patient

Pharma Times

525-patient trial intends to assess ‘complement activation’ during HD in patients with end stage renal failure - News - PharmaTimes

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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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Teens seeking addiction care unlikely to be offered standard medication

STAT

Adolescents who seek treatment for opioid addiction at an inpatient facility are more likely to be offered horseback riding than given full access to a common, highly effective addiction medication. According to a new research paper, just one out of every eight residential treatment facilities open to patients ages 16 or 17 offers full access to buprenorphine.

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PRIDE: The Uprising for Equitable LGBTQ+ Rights

Putting Patients First Blog

PRIDE: The uprising for equitable LGBTQ+ rights June 13, 2023 By: Omar A. Escontrías, DrPH, MPH, Senior Vice President of Equity, Research and Programs The LGBTQ+ community faces unique health care needs, and access to mental health treatment without stigma is among the most pressing. -Admiral Dr. Rachel L. Levine 17 th Assistant Secretary for Health United States, Department of Health and Human Services As I walk through DuPont and Logan Circles, two Lesbian, Gay, Bisexual, Transgender, Queer/Q

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Beacon Therapeutics enters gene therapy arena with $120m launch

Pharmaceutical Technology

Beacon Therapeutics has kickstarted its entry into the gene therapy field with a $120m Series A financing. The British investment trust Syncona Limited launched the new ophthalmic gene therapy company by combining Applied Genetic Technologies Corporation’s (AGTC’s) late-stage X-linked retinitis pigmentosa (XLRP) programme with two proprietary preclinical programmes.

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STAT+: Biotech executive nominated to Biogen board is mother of director’s child, records show

STAT

Biogen, a biotech giant plagued by years of boardroom strife, said late Monday that the longtime and polarizing director Alex Denner would step down from its board, sending a signal to investors that the company’s fractious recent history might be coming to a close. What Biogen didn’t disclose is that its nominee to replace Denner on the board, Susan Langer, is Denner’s live-in romantic partner and the mother of his child, born in November, according to court records obtaine

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FDA accepts AstraZeneca’s NDA for breast cancer combination therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted AstraZeneca’s new drug application (NDA) for the combination of capivasertib and FASLODEX (fulvestrant), and granted it priority review. The combination therapy is intended to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in adult patients, after recurrence or progression on or after an endocrine-based regimen.

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Opinion: How predominantly white hospital leadership teams hurt care for people of color

STAT

Last year, my father, a Jamaican immigrant with Medicaid insurance, passed away from a heart attack. He was only 63 years old. As he received care, he expressed discomfort with the predominantly white teams handling his case. He believed that both clinicians and non-clinical staff discriminated against him because of his racial and ethnic identity, as well as his public insurance status.

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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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Set out vision for prescribing in community, government urged

The Pharmacist

The government should set out its plans for independent prescribing (IP) in community pharmacy, including by investing in a more ambitious Pharmacy First service, the Company Chemists’ Association (CCA) has urged. The CCA said that the incoming national Pharmacy First service should make use of pharmacist independent prescribers (PIPs) ‘immediately’, and that the government must […] The post Set out vision for prescribing in community, government urged appeared first on The Pharmacist.

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STAT+: Bitter infighting leads 15 chapters to break away from leading ALS advocacy group

STAT

After a bitter dispute, the ALS Association has settled a lawsuit filed by 15 chapters that chafed at managerial moves by the national organization and will now break away to form an alternative organization for patients and their families combating the debilitating disease. The details of the settlement have not yet been disclosed, but in a statement, the ALS Association confirmed that a deal was reached that “allows for separation of the… chapters that desire to operate independe

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World’s largest lutetium-177 production site opens

European Pharmaceutical Review

A new therapeutic radionuclide facility, the world’s largest production site of lutetium-177, has opened in Germany. ITM Isotope Technologies Munich SE ( ITM )’s manufacturing plant in Neufahrn near Munich will produce the innovative medical isotope for targeted cancer therapies. “Radiopharmaceuticals are an essential new class of anti-cancer drugs that have the potential to improve therapy outcomes and quality of life for many patients.

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STAT+: Biogen’s boardroom scandal saddles CEO with first crisis

STAT

This was supposed to be the new Biogen. When Chris Viehbacher, a respected pharmaceutical executive, took over as CEO in November, Wall Street saw him as a steadying force for the wayward company and a strong personality who would stand up to its quarrelsome board. Instead, Biogen’s board has saddled Viehbacher with the first crisis of his tenure at the company.

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Granules India gets USFDA approval for Metoprolol Succinate ER Tablets

Express Pharma

Granules India announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-Release Tablets USP, 25 mg, 50 mg, 100 mg and 200 mg. It is bioequivalent to the reference listed drug product (RLD), Toprol-XL Tablets, 25 mg, 50 mg, 100 mg and 200 mg, of Toprol Acquisition LLC.

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STAT+: Transplant patients say new Medicare guidance puts their donated organs at risk

STAT

Margaret Gamble was supposed to receive a blood test in the mail in May. It’s a regularly scheduled test to check if her kidney — the second she’s received in a transplant — has been damaged in any way. Her kidney needs to be constantly monitored since it’s vulnerable to infections or, critically, rejection by her immune system.

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IPA to host eighth edition of Global Pharmaceutical Quality Summit in Mumbai

Express Pharma

The Indian Pharmaceutical Alliance (IPA) is all set to host the eighth edition of the Global Pharmaceutical Quality Summit (GPQS) from June 22-23, 2023 in Mumbai. The theme for this year’s annual flagship event is ‘Patient Centricity: New Paradigm of Manufacturing and Quality’. The Summit aims to bring diverse stakeholders together, including global regulators, technical experts, and industry stakeholders on a common platform to discuss the key imperatives of operations and build on the Indian p

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Hospitals are testing AI to communicate with patients. They still don’t know how to talk to them about it

STAT

Health systems across the country are exploring blending artificial intelligence into their communication with patients, from billing to after-hours messages about medication or symptoms. But how best to actually talk to patients about the technology and its risks is still an open question. STAT asked six health system leaders how they are disclosing their use of AI to the patients the technology is supposed to benefit.

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Bayer to acquire exclusive license from Cedilla Therapeutics on selective inhibitors in pre-clinical precision oncology

World Pharma News

Bayer and Cedilla Therapeutics, a biotechnology company bringing a new dimension to precision oncology, announced an exclusive license agreement to develop and commercialize Cedilla Therapeutics' CyclinE1/CDK2 complex inhibitors which selectively address oncogenic drivers. Overexpression or genetic activation of Cyclin Dependent Kinase 2 (CDK2) binding partner cyclin E is a key oncogenic process in several cancers.

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STAT+: Pharmalittle: Exec nominated to Biogen board is mother of outgoing director’s child; telehealth company pauses Wegovy ads amid shortages

STAT

Top of the morning to you, and a fine one it is. Sunny skies and cool breezes are enveloping the Pharmalot campus, where the official mascots are snoozing in their respective corners and the short person is sleeping in. As for us, we are going about the usual routine at this time of day — brewing cups of stimulation. Our choice is, once again, roasted coconut.

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Gross-to-Net Bubble Update: 2022 Pricing Realities at 10 Top Drugmakers

Drug Channels

Time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. This year’s review includes the following 10 companies: Eli Lilly and Company, Genentech, GlaxoSmithKline, Janssen, Merck, Novartis, Novo Nordisk, Sanofi, Takeda, and UCB. You can find links to each company’s data below. When rebates and discounts were factored in, brand-name drug prices again declined—or grew slowly—in 2022.

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STAT+: Moving past regulatory obstacles, Protagonist Therapeutics looks to pivotal trial for its rare blood disorder therapy

STAT

FRANKFURT, Germany — Protagonist Therapeutics has run into some speed bumps as it’s developed its medicine for a rare blood cancer characterized by the overproduction of red blood cells. In 2021, the Food and Drug Administration put studies of the drug, rusfertide, on hold after a mouse study raised concerns about skin malignancies (the hold was lifted quickly , after less than a month).

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A cell therapy startup looks to an IPO to avert financial peril

BioPharma Dive

In a sign of the impact the downturn has had on young biotechs, Turnstone Biologics, a former partner of Takeda and AbbVie, is seeking an IPO while acknowledging there is “substantial doubt” it can survive.

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Suicide hotlines shared data with Facebook, providers debate AI disclosure, and Uber Health expands

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Cost of Hospital Readmissions: What the Statistics Tell Us

cureatr

Hospital readmissions are a heavy financial burden for hospitals and health systems, patients, and the U.S. healthcare system at large. Unsurprisingly, minimizing post-discharge adverse events that contribute to readmission s has become a priority for hospital management and administrators.

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‘No nationwide closure’ of LloydsPharmacy after Sainsbury’s branches shut

The Pharmacist

LloydsPharmacy has not announced or considered any other nationwide closures of standalone pharmacies, it confirmed to The Pharmacist today as its Sainsbury’s branches shut. From the end of today, all 237 LloydsPharmacy branches located within Sainsbury’s stores will have ceased operations, following a period of withdrawal since January this year. But the multiple confirmed to […] The post ‘No nationwide closure’ of LloydsPharmacy after Sainsbury’s branches shut appeared first on The Pharm

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Alvotech and Teva reach Ustekinumab (STELARA) Settlement with J&J

Big Molecule Watch

Alvotech and Teva Pharmaceuticals, Inc. announced that they reached a settlement and license agreement with Johnson & Johnson regarding AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab) in the United States. “According to the settlement agreement, AVT04 (ustekinumab) can be marketed in the US, subject to regulatory approval, no later than February 21, 2025.

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Amid Opioid Crisis, Big Pharma Reaches Settlement with Multiple States

PharmExec

Deal will pay $19 billion to states accusing companies of contributing to the issue.

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Biogen’s latest board shake-up includes potentially controversial pick

BioPharma Dive

Three board members — Alex Denner, William Jones and Richard Mulligan — will not stand for re-election. Susan Langer, who was previously the company’s head of corporate strategy, has been nominated to fill one of their seats.

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FDA Panel Unanimously Approves Alzheimer’s Treatment Leqembi

PharmExec

Decision based on data collected from patients in the early stages of the disease.

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US FDA approves Neobiosis’ IND for post-Covid syndrome therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Neobiosis’ investigational new drug (IND) application for ViXome to treat post-Covid-19 syndrome (also known as long Covid). ViXome is an acellular product derived from amniotic fluid. It comprises a heterogeneous population of growth factors, exosomes, cytokines, microRNAs and chemokines. In pre-clinical testing, the therapy showed potent immunomodulatory and pro-reparative effects.

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Ferring, with manufacturing update, takes a step towards first gene therapy sales

BioPharma Dive

The FDA has cleared Ferring’s planned scale-up process for its bladder cancer treatment Adstiladrin, which the company plans to make available in the U.S. later this year.

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Has a biosimilar tipping point been achieved in the US?

pharmaphorum

Has a biosimilar tipping point been achieved in the US? Mike.

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Accelerating Clinical Trials and Reducing Human Error through Innovative Data Solutions (June 2023)

PharmaTech

This is the final segment of this three-part PPD Tech Talk series on Improving Clinical Trials with Innovative Data Solutions featuring experts John Maier and Renay Perry of PPD®, part of Thermo Fisher Scientific.

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Class II approval revs up Huma’s SaMD platform

pharmaphorum

Class II approval revs up Huma’s SaMD platform Phil.

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