Tue.May 16, 2023

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STAT+: Biden drug czar to summon naloxone makers to White House to discuss pricing

STAT

WASHINGTON — The White House is summoning naloxone manufacturers for a roundtable focused on the medication’s price, the Biden administration’s top drug policy official told STAT. The move would represent the White House’s most concrete action to date to address the price of naloxone , a medication used to reverse opioid overdoses.

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Major regulatory changes are coming to pharma in the EU — and industry’s weighing in

PharmaVoice

The European Union published a long-awaited proposal that could bring sweeping changes to its pharma sector last month, but the legislative fight has only just begun.

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‘We’re failing to make progress’: Studies show ongoing toll of premature Black deaths

STAT

In the last two decades, Black Americans have suffered 1.63 million excess deaths and lost more than 80 million years of life compared to white Americans, according to a new analysis that is the first comprehensive attempt to quantify the impact of health disparities by tallying years of potential life lost. The analysis showed improvement was made in narrowing long-standing health gaps between Black and white Americans between 1999 and 2011, but progress stalled through 2019.

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From farm to pharma: How cows could play a role in the next flu breakthrough

PharmaVoice

SAb Biotherapeutics is working on a novel product that uses cow antibodies genetically engineered into human antibodies to prevent and treat infectious diseases.

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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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Opinion: A breakthrough drug will require big changes for eye care doctors

STAT

Advancement in the science of eye care over the past 10 years has led to dramatically better outcomes for many people with impaired vision. Take anti-VEGF medications for wet age-related macular degeneration (AMD) for example. Anti-VEGFs, which are injected into the eye, slow the growth of blood vessels that often lead to wet AMD, one of the leading causes of blindness in the world.

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Biotech startup Ray raises $100M for vision-restoring gene therapies

BioPharma Dive

Founded in early 2021, the company is using optogenetics to design treatments that could work across disease genotypes and in the later stages of vision loss.

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More Trending

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NPR and DrugPatentWatch – Can drug injector pens be swapped?

Drug Patent Watch

On NPR’s All Things Considered, Sydney Lupkin asked DrugPatentWatch if drug patents could be used to identify injector pens which could then be swapped to fix drug shortages. Referring to… The post NPR and DrugPatentWatch – Can drug injector pens be swapped? appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: Ketamine clinics’ bust serves as warning of business challenge facing psychedelic therapy

STAT

A chain of luxury ketamine clinics called Field Trip started churning through business strategies at an increasingly rapid pace late last year. The money was running out, clinics were half full, and the company’s vice president of clinical services was under intense pressure to launch an at-home ketamine service. It was a challenging assignment, figuring out how to safely provide a sedative to depressed patients away from clinic supervision, but Elizabeth Wolfson said senior leaders gave

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Doctors call for regulation on self-testing kits

The Pharmacist

The Royal College of GPs (RCGP) has called for the Medicines and Healthcare Regulatory Agency (MHRA) to produce regulation on self-testing kits, and for the National Institute for Health and Care Excellence (NICE) to set out guidelines to protect patients. RCGP is calling for a meeting with regulators to discuss concerns around the information patients […] The post Doctors call for regulation on self-testing kits appeared first on The Pharmacist.

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Opinion: The U.S. needs to pressure India to improve drug safety

STAT

On Feb. 2, the Food & Drug Administration issued an alert warning about “Made in India” artificial eye drops that were potentially contaminated with rare drug-resistant bacteria suspected to be the cause of 55 adverse events, including three deaths and several other cases of vision loss from eye infections. These unfortunate events should not come as a surprise.

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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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WHO report highlights progress and gaps in pipeline of antibiotic treatments to combat AMR

Express Pharma

WHO, in partnership with the Global AMR R&D Hub , has released a report for G7 Finance and Health Ministers detailing progress on incentivising the development of new antibacterial treatments. The Global AMR R&D Hub is a partnership of countries, non-governmental donor organisations and intergovernmental organisations to address challenges and improve coordination and collaboration in global AMR R&D using a One Health approach.

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Pfizer RSV vaccine seen as effective against severe disease, FDA documents say

STAT

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine. The agency’s analysis said the vaccine was also shown to be effective at preventing non-severe lower respiratory tract RSV disease that required medical attention at 180 days af

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Robotic platform R-One+ launched by Robocath

Pharma Times

Solution allows a cardiologist to perform coronary angioplasties using an integrated control command unit

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STAT+: Boundless Bio tests a cancer drug targeting once-mysterious DNA loops

STAT

SAN DIEGO — Peering through a microscope more than a half century ago, researchers made a head-scratching finding: they spotted tiny rings of DNA in tumor cells that were largely absent in healthy cells. Now, a San Diego biotech company is targeting these loops of genetic material to try to control the growth and spread of deadly tumors. Boundless Bio is testing a small-molecule drug against what scientists call extrachromosomal DNA, in an initial clinical trial of patients with solid tum

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Research consortium picks eight rare diseases to advance gene therapies

Pharmaceutical Technology

The Foundation for the National Institutes of Health (FNIH) has announced its plans to prioritise eight rare diseases to provide industry standards for manufacturing, preclinical testing and product analytical testing for gene therapy development. This news was announced during the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting in Los Angeles.

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STAT+: General Catalyst, Andreessen Horowitz bet on large language models for health care 

STAT

OAKLAND, Calif. — In a rare partnership, heavyweight tech venture firms General Catalyst and Andreessen Horowitz are co-leading a $50 million seed round aimed at exploring large language models in health care — a high-profile bet that there’s money to be made commercializing the artificial intelligence technology for health systems.

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FPME’s annual event highlights industry growth and innovation opportunities

Express Pharma

The Annual Event of the Federation of Pharmaceutical and Allied Products Merchant Exporters (FPME) was held on May 13, 2023, at the Indian Merchant Chamber in Mumbai. The event was organised to provide a platform for the members of FPME to discuss the latest trends, challenges, and opportunities in the pharma export industry. The event was attended by a diverse group of participants, including pharma exporters, government officials and industry experts.

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STAT+: AI leaders issue a plea to Congress: Regulate us, and quickly

STAT

During an extraordinary hearing Tuesday, members of a Senate subcommittee called for aggressive regulation of generative AI tools — and the makers and users of the technologies themselves urged the senators to quickly follow through. “Regulatory intervention by governments will be critical to mitigate the risks of increasingly powerful models,” said Sam Altman, the CEO of OpenAI, the company behind ChatGPT.

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Flagship’s newest startup is imitating nature to make new drugs

BioPharma Dive

The latest startup from one of biotech’s most prolific company creators has $50 million to explore a new way of designing medicines.

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STAT+: FTC files lawsuit to block Amgen’s purchase of Horizon Therapeutics

STAT

The Federal Trade Commission on Tuesday sued to block Amgen’s $27.8 billion acquisition of Horizon Therapeutics , signaling possible tougher scrutiny of biopharma takeovers even as the pace of deals starts to pick up.   The acquisition, announced in December, was seen as another move by a large pharma company to build out its rare disease pipeline.

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DSIR renews recognition for Venus Remedies’ R&D unit

Express Pharma

Venus Remedies announced the renewal of recognition for its in-house Research and Development (R&D) unit by the Department of Scientific and Industrial Research (DSIR), Ministry of Science & Technology, Government of India. A company statement informed, “With 15 patented products brought to market and several others in the pipeline, VRL’s R&D portfolio demonstrates a progressive approach to drug development.

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Telehealth company Included Health ventures into home care

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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AI-driven biosimilar manufacturing partnership announced

European Pharmaceutical Review

Sandoz and Just – Evotec Biologics have announced a partnership to develop and manufacture multiple biosimilars. Within the agreement, Sandoz will gain access to an artificial intelligence (AI) -driven technology platform that delivers fully integrated drug substance development and continuous manufacturing. This will support the expansion of Sandoz’s pipeline to 24 biosimilar assets.

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STAT+: Pharmalittle: FTC may sue to block Amgen deal for Horizon; Supreme Court declines Teva appeal on skinny labeling

STAT

Oh, what a beautiful morning! Pardon the cliché, but crystal clear blue skies and deliciously cool breezes are encompassing the Pharmalot campus today. So we will celebrate our good fortune with a delightful cup of stimulation. Our choice today is toasted hazelnut. As always, you are invited to join us, or grab a water bottle if you prefer. In any event, the to-do list is growing so we are passing along the latest laundry list of interesting items for you to peruse.

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Eminence Business Media to host third edition of Annual Computer Software Assurance 2023

Express Pharma

Eminence Business Media recently announced the third Annual Computer Software Assurance 2023, Live and In-stereo. The third Annual Computer Software Assurance 2023 aims to strengthen and empower Computer System Validation (CSV) and provide key insights on the CSA approach. The idea is to create a programme that examines various elemental components to strengthen the CSV gameplan, address challenges to boost the existing system and explore various aspects of CSA by analysing the knowledge gaps an

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STAT+: FTC move to block the Amgen-Horizon deal highlights concerns over negotiations with insurers

STAT

In an unexpected move, the Federal Trade Commission on Tuesday filed a lawsuit to block Amgen from acquiring Horizon Therapeutics, claiming the $27.8 billion deal would make it possible for Amgen to develop monopolies through a tactic that manipulates health coverage and drives up consumer costs. At issue is a practice known as bundling. Simply put, a drug company combines two or more medicines in a package deal for health plans and pharmacy benefit managers, which determine lists of medicines t

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Recent developments in stem cell therapies

European Pharmaceutical Review

So far, 2023 has seen several major developments in stem cell-based therapies. Stem cells have the ability to self-renew. Their potential to differentiate into cells of different tissues makes them particularly interesting for applications in regenerative medicine. 1 Since the first therapy using stem cells was developed in 1957, only few stem cell-based therapies have entered the clinic 1 as advanced therapy medicinal products (ATMPs).

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Test – STAT+ Only virtual event

STAT

Opportunities to engage with STAT reporters and leading industry experts Join the conversation! STAT+ subscribers get access to exclusive virtual pop-up conversations with STAT reporters on key stories of the moment, and biotech, pharma and health tech leaders on breakthroughs. Register below for the upcoming conversation. And don’t forget, you can view all past conversations as well.

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Approval provided for Angelini’s cenobamate

Pharma Times

Treatment will now be used across Ireland among adults with focal onset seizures with epilepsy

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GPhC proposes 7.5% increase in fees

The Pharmacist

The General Pharmaceutical Council (GPhC) has proposed raising its fees by 7.5% from April 2024, and has invited feedback via an online consultation survey. The increases would affect fees for the 2024 registration assessment – for which bookings open in February 2024 – as well as registration renewal fees from April 2024. Fees have been […] The post GPhC proposes 7.5% increase in fees appeared first on The Pharmacist.

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P&G launches ‘Ab Feel Karega India’ campaign to raise awareness on nerve health

Express Pharma

P&G Health, the healthcare division of Procter & Gamble and makers of Neurobion, commemorated the Nerve Health Awareness Week 2023 by announcing its ‘Ab Feel Karega India’ campaign. The company informed that the campaign has been launched with to raise awareness and maximise conversations about nerve health in India especially, the rural and semi-urban areas where there is relatively less awareness about this condition.

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Employers Expand Use of Alternative Funding Programs—But Sustainability in Doubt as Loopholes Close

Drug Channels

Last August , I warned you about alternative funding programs (AFPs) –the shady schemes by which commercial plan sponsors drop drug coverage in order to grab charity support intended for uninsured and indigent patients. I’m sad to report that the manipulation of charitable patient assistance programs continues to expand. As you will see below, employers have significantly ramped up their adoption of AFPs, while health plans seem more skeptical.

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Bayer receives U.S. FDA Fast Track Designation for asundexian atrial fibrillation program

World Pharma News

Bayer today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its investigational drug asundexian (BAY2433334) as a potential treatment to prevent stroke and systemic embolism in people with atrial fibrillation (AF). This news follows asundexian's first U.S. FDA Fast Track Designation for the prevention of stroke in patients after a non-cardioembolic ischemic stroke, which was granted in 2022.

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ICYMI: PhRMA CMO Dr. Michael Ybarra speaks with Dr. Fabian Sandoval about clinical trial diversity

PhRMA

Enhancing clinical trial diversity is a challenge, but with a multi-faceted, community-centered approach, we can help underrepresented patients be more involved in the research and development of potential life-saving medical treatments.

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FTC sues to block Amgen’s $27.8B deal for Horizon

BioPharma Dive

The regulator’s challenge will test a more expansive view of how pharmaceutical mergers could harm consumers. Amgen remains confident it can complete the deal, however.

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