Wed.Jun 21, 2023

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Xylazine, or ‘tranq,’ is making opioid overdoses harder to reverse

STAT

For years, public health guidance about opioid overdoses has been relatively simple: Administer naloxone , then call 911. But the days of simply spraying naloxone into an overdose victim’s nose, then watching that person resume breathing and wake up within minutes, are over.

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Duty to serve: an Army officer’s unexpected path to GSK

PharmaVoice

How Court Horncastle, SVP, business unit head of the anti-infective and respiratory team at GSK, applies lessons from combat to his work in antibiotics.

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STAT+: After promising early data, gene therapy trial for Huntington’s takes puzzling turn

STAT

Last year, after a string of high-profile trial failures , the Huntington’s disease community got positive news in the form of very early data from an experimental gene therapy for the rare neurodegenerative condition. On Wednesday, however, the company behind the drug released updated figures that were more mixed — even befuddling. The study from Uniqure, a Dutch biotech, randomized early stage Huntington’s patients to receive low-dose treatment, a high-dose treatment, or a

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Woman of the Week: Stealth BioTherapeutics’ Reenie McCarthy

PharmaVoice

How the CEO navigated a regulatory odyssey to bring the company’s lead program for an ultra-rare disease to a fast track approval.

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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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Scientists successfully unfroze rat organs and transplanted them — a ‘historic’ step that could someday transform transplant medicine

STAT

The rat kidney was peculiarly beautiful — an edgeless viscera about the size of a quarter, gemstone-like and gleaming as if encased in pure glass. It owed its veneer to a frosty, minus 150-degree Celsius plunge into liquid nitrogen, a process known as vitrification, that shocked the kidney into an icy state of suspended animation. Then researchers at the University of Minnesota restarted the kidney’s biological clock, rewarming it before transplanting it back into a live rat ȁ

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First adult anti-inflammatory cardiovascular drug approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved LODOCO ® , the “first drug to target cardiovascular inflammation,” reported Dr Paul Ridker, MPH, Professor of medicine at Harvard Medical School and Director of the Center for Cardiovascular Disease Prevention, Brigham and Women’s Hospital. It is the first anti-inflammatory cardiovascular treatment demonstrated to reduce the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular death in adults with establ

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Avacta announces AVA6000 dose escalation results

Pharma Times

Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes

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Opinion: Pregnancy-related death, like Tori Bowie’s, is a far too common occurrence among Black women

STAT

The horror stories of Black women dying or coming close to death in childbirth never seem to stop coming. The most recent headlines have been about the tragic case of three-time Olympian Tori Bowie , who died in her home from childbirth complications. Her teammate Tianna Madison wrote on Instagram , “THREE (3) of the FOUR (4) of us who ran on the SECOND fastest 4x100m relay of all time, the 2016 Olympic Champions have nearly died or died in childbirth.

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UniQure stock tumbles on ‘confusing’ results for Huntington’s gene therapy

BioPharma Dive

While treated patients appear to be doing better than history suggests they would, mixed findings involving a key surrogate marker perplexed Wall Street analysts and sent shares falling 38%.

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New DNA test aims to make cervical cancer screening more accessible in low-income countries

STAT

A genomic test for the human papillomavirus has shown promise in early-stage trials, raising hopes that it could bolster cervical cancer screening among women living in sub-Saharan Africa, the region with the highest rates of cervical cancer deaths worldwide. The trials were documented in a study , published Wednesday in Science Translational Medicine, led by researchers from Rice University.

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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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Flagship’s latest startup aims to take the guesswork out of small molecule drugs

BioPharma Dive

Empress Therapeutics claims its technology allows it to identify chemical drug candidates faster and more reliably. It has $50 million from Flagship to prove it can.

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CDC advisory panel recommends seniors ‘may’ get RSV vaccine

STAT

A panel of experts  that advises the Centers for Disease Control and Prevention on vaccinations opted Wednesday not to recommend that all seniors get a vaccine to protect against RSV. Instead, the Advisory Committee on Immunization Practices said that anyone 60 and older should be able to get one of the new vaccines — being brought to market by GSK and Pfizer — if they and their physicians think it would be worthwhile.

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Bluebird, playing catch-up, gets decision date for sickle cell gene therapy

BioPharma Dive

The regulator will issue a decision on lovo-cel by Dec. 20, roughly two weeks after a verdict is expected on a rival gene editing treatment from Vertex and CRISPR Therapeutics.

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STAT Virtual Event: The Next Frontier of Drug Pricing Reform

STAT

Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET. Pharmacy benefit managers are intermediaries that are supposed to negotiate lower drug costs. But does the system work for patients? And how can we fix it when it doesn’t?

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AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease. LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease.

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STAT+: Drug middlemen catch flak at another congressional hearing

STAT

Drug middlemen once again were on the hot seat at a congressional hearing on Wednesday. The hearing by the House Education and Workforce health subcommittee was about consolidation in the hospital and health insurance sectors. No hospital or insurance company representatives testified, but JC Scott, president of the pharmacy benefit manager lobbying group Pharmaceutical Care Management Association was tapped as a witness.

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FDA grants priority review to bluebird bio’s BLA for SCD gene therapy

Pharmaceutical Business Review

Bluebird is seeking approval for treating a rare genetic disease, SCD, in patients aged 12 years and above having a history of vaso-occlusive events. A modified form of the β-globin gene added to lovo-cel produces anti-sickling adult hemoglobin thereby treating the underlying cause of SCD. The BLA includes efficacy data from the HGB-206 study’s Group C cohort including 36 patients with median 32 months of follow-up and HGB-210 study including two patients, each followed for 18 months.

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Amid the AI gold rush, a new company forms to vet models and root out weaknesses

STAT

The market for artificial intelligence in health care is about as transparent as a brick wall. New tools achieve impressive results in published studies. But it is often difficult to compare them head to head with similar products, or tell whether they will work on different kinds of patients. A new company is promising to change that — if it can convince AI developers to expose their products to more rigorous testing.

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Lupin gets US FDA approval for Tiotropium dry powder inhaler

Express Pharma

Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule, a generic equivalent of Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder), 18 mcg/capsule of Boehringer Ingelheim Pharmaceuticals. This product will be manufactured at Lupin’s Pithampur facility in India.

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STAT+: European companies outline opposition to proposed overhaul of pharma policy

STAT

BRUSSELS — Leaders of European pharmaceutical companies on Wednesday said that a proposed overhaul of the E.U.’s medicines policies  could render the region’s industry less competitive, the latest step in their opposition to legislation that could shorten the exclusivity period they have to sell their drugs. “A competitive industry will play a key role in a healthier Europe,” Novo Nordisk CEO Lars Fruergaard Jørgensen said at a press briefing held by

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Delix Therapeutics completes dose study for DLX-001

Pharma Times

During research there were not any clinically-relevant adverse events or psychotomimetic effects - News - PharmaTimes

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STAT+: One of biotech’s biggest financiers launches small-molecule startup, in spite of IRA’s looming shadow

STAT

It’s been nearly a year since Congress passed the Inflation Reduction Act, raising a chorus of drug executive and investor complaints that it would decimate the development of small-molecule medicines. After all, it opens the door for Medicare to negotiate the price of small-molecule drugs after nine years on the market (as opposed to 13 years for biologic drugs like vaccines, cell therapies, or gene therapies).

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Romaco India move into new offices in Thane in the Mumbai Metropolitan Region

Express Pharma

Romaco India, Romaco’s Indian branch, has moved into new offices in Thane in the Mumbai Metropolitan Region. 30 employees will be based at Romaco India’s Sales & Service Center in the new premises. A company statement informed, “Romaco India’s workforce has almost tripled since the official opening in 2019. In addition to eight sales staff, 17 service technicians take care of local customers’ needs.

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ASCO 2023 – Jennifer Elliott

pharmaphorum

Pharmaphorum Editor-in-Chief Jonah Comstock spoke with Jennifer Elliott, global solid tumour lead at Takeda, about the company’s Fruquintinib product in late-stage metastatic colorectal cancer, in-licensed from HUTCHMED, and how it could provide new hope for patients with few options.

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England set to move to single-dose HPV vaccination programme

The Pharmacist

From September, teenagers and young adults in England will be offered a single dose of HPV vaccination in England, public health officials have announced. The decision comes after a review of evidence showing that one jab offers comparable protection to the current two-dose schedule. Scotland has already moved to a one-dose schedule after the Joint Committee on Vaccination […] The post England set to move to single-dose HPV vaccination programme appeared first on The Pharmacist.

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Teikoku Pharma bags FDA fast track for post-surgical transdermal analgesic  

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Teikoku Pharma’s dexmedetomidine transdermal system a fast track designation. The delivery candidate, called TPU-006, delivers dexmedetomidine for up to four days. Dexmedetomidine is a common non-opioid analgesic that activates alpha-2 receptors, which inhibits the release of noradrenaline and subsequent propagation of pain signals.

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Data and workforce ‘key’ to pharmacogenomics implementation

The Pharmacist

Health leaders across the UK have highlighted the importance of pharmacogenomics education for the pharmacist workforce, as well as the need to make genomics data easily accessible to clinicians for use in their decision making. At the 10th annual open meeting of the UK Pharmacogenetics and Stratified Medicine Network, Vicky Chaplin, pharmacy genomics lead at […] The post Data and workforce ‘key’ to pharmacogenomics implementation appeared first on The Pharmacist.

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Pfizer's TALZENNA® in combination with XTANDI® receives U.S. FDA approval

World Pharma News

Pfizer (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).

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New RPS England chair announced as Thorrun Govind completes tenure

The Pharmacist

A new chair has been elected to the Royal Pharmaceutical Society's (RPS) English Pharmacy Board (EPB), vowing ‘to ensure elected members are seen and heard’. Erutase Oputu, (left) lead pharmacist at Barts Health NHS Trust, has replaced Thorrun Govind, promising 'the right set of skills and experience to take us through a unique period’ of […] The post New RPS England chair announced as Thorrun Govind completes tenure appeared first on The Pharmacist.

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The first year of the Long COVID project: What has been achieved?

World Pharma News

Since the 1st of June 2022, the Long COVID Consortium, led by HUS Helsinki University Hospital, is working to elucidate the predisposing factors and mechanisms for the development of Long COVID Syndrome (LCS). This is essential to be able to develop and improve the care of patients suffering from the long-term effects of COVID-19 infection.

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FDA Releases Updated COVID-19 Vaccine Guidelines

PharmaTech

The new guidelines contain formulation recommendations for vaccines launching in autumn 2023.

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How are clinical trials becoming more environmentally friendly?

pharmaphorum

How are clinical trials becoming more environmentally friendly? Mike.

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Abu Dhabi Department of Health Forms Strategic Partnership with M42, AbbVie

PharmExec

Collaboration to focus on personalized medicine in the United Arab Emirates capital.

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Patients warned to avoid suddenly stopping antidepressants after BBC programme

The Pharmacist

Patients have been warned not to suddenly stop taking antidepressants after headlines warning that people may be taking them for too long. A BBC Panorama programme reported NHS figures that about two million people have been taking them for five years. The investigation also raised questions about evidence for their long-term use and that this […] The post Patients warned to avoid suddenly stopping antidepressants after BBC programme appeared first on The Pharmacist.

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Veeva Systems, Advanz Pharma Announce Commercial Operations Partnership

PharmExec

Biopharma aims to strengthen field engagement with healthcare professionals.

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