Thu.Dec 21, 2023

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Health data breaches hit an all-time high in 2023

STAT

Odds are, you’ve gotten at least one of the unnerving letters in your mailbox this year: “We’re writing to inform you of a cybersecurity incident,” it might start. It’s the standard notice many health care organizations are required to provide when your protected health information gets exposed — and in 2023, data leaks, hacks, and mishandling led more of them to be delivered than ever before.

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Biopharma’s FTC headache deepens with guideline shifts years in the making

PharmaVoice

Closer scrutiny of pharma deals has made the M&A landscape trickier as a new approach seeks to expand the competitive arena.

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STAT’s most memorable photos of 2023

STAT

The past year has brought huge changes in medicine and science — from innovations like the first curative treatment for sickle cell to legislative restrictions on abortion access. But at the center of all these stories are the people they impact: scientists, doctors, patients, and families. As we look back at 2023 in photographs, the faces of so many stand out: investors and researchers moving their industries forward, a man working to escape the cycle of addiction, a physi

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Wearable technology to be offered to thousands with type 1 diabetes in UK

Pharma Times

The condition affects around 270,935 people in England and 16,090 people in Wales - 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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STAT+: Drugs are still mostly tested in white men. Will the FDA change that next year?

STAT

WASHINGTON — Sometime next year drug and medical device companies will have to tell the Food and Drug Administration how they plan to include people of color in clinical trials. But planning isn’t the same as doing, the industry’s track record isn’t great, and it’s not clear whether the FDA will twist arms, experts told STAT.

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Wearable technology to be offered to thousands with type 1 diabetes in UK

Pharma Times

The National Institute for Health and Care Excellence (NICE) has published final guidance announcing a five-year roll-out of a wearable technology for patients living with type 1 diabetes. The new hybrid closed loop systems have proven to be more effective in maintaining healthy blood glucose levels than standard care. The new guidance followed a review of a clinical trial and real-world evidence by the University of Warwick and Warwick Medical School, funded by the National Institute for Health

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NHS expands home-testing kits to detect bowel cancer earlier

Pharma Times

Bowel cancer is currently the third most common type of cancer in England - News - PharmaTimes

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STAT+: Medical marijuana companies are using pharma’s sales tactics with little of the same scrutiny

STAT

WASHINGTON — Medical marijuana companies sell medicine, just like pharmaceutical companies. But they’re not playing by the same rules — and that’s putting patients at risk. Several of the largest medical marijuana companies, like Trulieve, Curaleaf, and Verano, are advertising their products as treatments not just for muscle aches, but for major medical conditions like cancer and depression, without evidence to back up those claims.

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JB Pharma inks Rs 1,089 crore pact with Novartis for select ophthalmology brands

Express Pharma

On the financial details of the agreements, JB Pharma said it will pay USD 116 million (Rs 964 crore), excluding applicable taxes, stamp duty and working capital, for the trade marks licence agreement to Novartis Innovative Therapies AG, Switzerland JB Pharma on Tuesday said it has inked a trade mark licence agreement along with a promotion and distribution pact with Novartis for select ophthalmology brands entailing a total sum of Rs 1,089 crore.

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FDA approves AstraZeneca, Ionis treatment for rare nerve disease

STAT

The Food and Drug Administration approved a novel medicine for a rare and devastating nerve disease Thursday, clearing a treatment that promises to be more convenient than available therapies. The drug, from partners AstraZeneca and Ionis Pharmaceuticals, is a monthly injection for a genetic disorder called ATTR-PN, in which a buildup of toxic bodily proteins progressively damages patients’ peripheral nerves.

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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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Let’s Talk Prostate Cancer calls for action by MEPs

pharmaphorum

An organisation representing the interests of patients with prostate cancer has published a manifesto ahead of the EU elections next year, calling for more screening for the disease in EU member states.

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Obesity drugs’ next tests, and rising threats: 3 chronic disease stories to watch

STAT

Chronic disease is, by its very definition, omnipresent. But changes year to year have the potential to make certain conditions into flaming-red targets for researchers and drugmakers. This year was one for obesity, marked by new — and for the first time, highly effective — weight loss drugs that demonstrated other health benefits.  But whether that wave of interest will persist into the new year, or transfer to some other condition — maybe some liver diseases that are

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NHS expands home-testing kits to detect bowel cancer earlier

Pharma Times

The NHS has announced the expansion of its home-testing kits for bowel cancer in an effort to detect signs of the disease and diagnose it earlier. The expansion of the NHS Bowel Cancer Screening Programme aligns with the health service’s aim of detecting cancers at an earlier stage when they are easier to treat. Currently the third most common type of cancer in England and responsible for almost 43,000 new cases in the UK every year, bowel cancer starts in the large bowel (colon) and the back pa

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Listen: 2023 in review, CEO report cards, and a look at the year ahead

STAT

What does it mean to a bad CEO? Can biotech endure another election year? And can you go to too many J.P. Morgan parties? We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. It’s our last episode of 2023, so we look back on the biggest stories of the year, discuss the best and worst CEOs in the industry, and make some reasonably informed guesses on what 2024 has in store for the drug industry.

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GLP-1R agonist withdrawal effect on weight loss and cardiovascular risks remains unmet need: GlobalData

Express Pharma

Zepbound is Eli Lilly ’s new glucagon-like peptide-1/gastric inhibitory polypeptide (GLP-1/GIP) dual agonist, approved by the FDA in November 2023, showing great promise compared to the other GLP-1R agonists on the market. However, the issue of rebound upon drug withdrawal remains an unmet need in the GLP-1R agonist space Eli Lilly recently published the results of a Phase III trial investigating the maintenance of Zepbound’s weight loss effects in overweight and obesity patients.

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Morning Rounds: Why health care costs are nearly a fifth of the GDP

STAT

Understand how science, health policy, and medicine shape the world everyday. Sign up for our Morning Rounds newsletter  here. Good morning. Don’t miss Nicholas Florko’s jaw-dropping investigation into medical marijuana businesses marketing their products for cancer or depression with no regulatory oversight.

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Sanofi drops lung cancer ADC tusamitamab ravtansine

pharmaphorum

Sanofi ends development of CEACAM5-targeting ADC tusamitamab ravtansine after it fails a phase 3 trial in non-small cell lung cancer (NSCLC)

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STAT+: Pharmalittle: FDA rejects Merck cough medicine; Sanofi abandons an ADC for lung cancer

STAT

Good morning, everyone. Damian Garde here, filling in for Ed Silverman in a week customarily devoted to deciding just which tasks one can get away with putting off until next year. Here’s hoping you’re firmly on the downslope of doing actual work for the remainder of 2023. In the meantime, here are a few tidbits to start your day. And, as always, do let us know if you hear anything interesting out there.

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CDMO expands ADC facility in Scotland

European Pharmaceutical Review

Piramal Pharma Solutions has officially opened new facilities at its antibody-drug conjugate (ADC) manufacturing facility in Grangemouth, Scotland. This expansion enhances the site’s capacity by 70-80 percent and will enable scale-up of commercial ADC manufacturing batches. “The global ADC market is growing strongly and so is the pipeline at Grangemouth, necessitating additional capacity to meet customer demand,” said Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions.

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BioMarin appeases an activist

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with news of an averted activist challenge, biotech on late-night TV, and the latest deal in oncology’s hottest space.

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NICE backs digital technologies for COPD rehab

pharmaphorum

NICE backs NHS use of digital COPD rehab programmes, myCOPD and SPACE for COPD, as an alternative to face-to-face consultations

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NICE recommends combination therapy for prostate cancer

European Pharmaceutical Review

The UK’s National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending Lynparza (olaparib) for use as combination therapy with abiraterone and prednisone or prednisolone, for untreated hormone-relapsed metastatic prostate cancer in adults who cannot have or do not want chemotherapy. This NICE recommendation is based on data from the PROpel Phase III clinical trial, which enrolled 700 patients globally.

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Genevoyager opens CDMO facility for gene therapy development

Pharmaceutical Technology

Genevoyager has announced the opening of contract development and manufacturing organisation facility to manufacture gene therapy products.

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AI specialist Fauna grabs $494m Lilly obesity alliance

pharmaphorum

Lilly partners with Fauna Bio in $494m deal to see if a hibernating squirrel's genomics could unlock new obesity drug targets.

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The key pharmaceutical trends from 2023 according to industry leaders

Outsourcing Pharma

The pharmaceutical industry in 2023 has seen many investments, partnerships, acquisitions and more. As the year ends, industry leaders give the biggest trends to look for in 2024, with artificial intelligence being a hot topic.

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Indivior bags $111m contract from US for overdose therapy

pharmaphorum

Indivior has secured a $111 million BARDA supply contract in the US for its Opvee intranasal therapy for treating opioid overdose

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Pharmacists will be ‘under the microscope’ in delivering Pharmacy First

The Pharmacist

Pharmacy First will put community pharmacy ‘under the microscope’, according to Alastair Buxton, director of NHS Services for Community Pharmacy England (CPE). Mr Buxton was speaking in a recent CPE webinar – called Pharmacy First: Getting to know the service – to help pharmacists prepare ahead of the scheme’s scheduled launch on 31 January 2024. […] The post Pharmacists will be ‘under the microscope’ in delivering Pharmacy First appeared first on The Pharmacist.

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FDA holds back MSD’s chronic cough drug again

pharmaphorum

FDA issues a second complete response letter to MSD's gefapixant for chronic cough, giving GSK a chance to catch up with camlipixant

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Plans being ‘worked up’ in case Pharmacy First launch date is missed

The Pharmacist

The launch date for Pharmacy First of 31 January remains on track although contingency plans are being put in place in case it is pushed back, a Community Pharmacy England (CPE) webinar has revealed. Uncertainty has surrounded the launch date since senior NHS England officials urged caution over the readiness of IT systems. Despite this, […] The post Plans being ‘worked up’ in case Pharmacy First launch date is missed appeared first on The Pharmacist.

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Five decentralized clinical trial organizations raising big VC cash

Outsourcing Pharma

Decentralized clinical trials (DCTs) are gaining increasing interest as they have the potential to make clinical trial operations quicker, more efficient and more accessible to patients. Check out five DCT organizations that have raised big venture capital investments in the last few years.

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Servier facing €431m penalties in new Mediator judgment

pharmaphorum

Servier has been found guilty of fraud and deception over weight loss therapy Mediator by French appeals court, and is fined €431 million

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J&J bets bigger on MeiraGTx’s eye gene therapy

BioPharma Dive

Ahead of a Phase 3 readout that could come next year, the pharma is paying $130 million in upfront and near-term cash for rights to the retinitis pigmentosa treatment that it didn’t already own.

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Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB

Big Molecule Watch

In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents. 1. STELARA® (ustekinumab) Four months after Janssen Biotech, Inc. settled to terminate Samsung Bioepis Co., Ltd.’s inter partes review (IPR) challenge of U.S. Patent No. 10,961,307 (“the ’307 Patent”), directed to methods of treating ulcerative colitis with ustekinumab, Biocon Biologics Inc. has filed its own IPR chall

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Patient-centric advertising: Zero-party data's healing touch

pharmaphorum

Patient-centric advertising using zero-party data can provide effective and personalised healthcare marketing while ensuring compliance with legal regulations and industry standards.

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New patent for Kaleo Inc drug AUVI-Q

Drug Patent Watch

Annual Drug Patent Expirations for AUVI-Q Auvi-q is a drug marketed by Kaleo Inc and is included in one NDA. It is available from three suppliers. There are thirty-one patents… The post New patent for Kaleo Inc drug AUVI-Q appeared first on DrugPatentWatch - Make Better Decisions.

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