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NIH documents show how $1.6 billion long Covid initiative has failed so far to meet its goals

STAT

More than three years ago, the National Institutes of Health launched a $1 billion-plus initiative to find the root causes and potential treatments for long Covid , the chronic disease that has quickly changed the lives of millions of Americans. But a lack of visible progress from the initiative, called RECOVER, has drawn months of criticism from patient advocates, researchers, and lawmakers, including at a Senate hearing last week on the NIH’s budget.

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As Senate’s gaze lands on patents, a former US PTO chief calls the effort a ‘broad misunderstanding’

PharmaVoice

To lower drug prices, lawmakers are turning to the drug patent system to outlaw some common practices — but a former patent agency director says it’s the wrong way to go.

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As weight loss booms, drugmakers look for an edge with oral options

PharmaVoice

Supply of GLP-1 medications falls well short of demand, and oral versions of the drugs loom over Eli Lilly and Novo Nordisk’s dominance.

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Interview: Has Cybin hit the biggest breakthrough in 40 years to treat psychiatric disorders?

Outsourcing Pharma

In an intriguing interview with Cybinâs CEO, Doug Drysdale, OSP senior editor, Liza Laws found out how second-generation psychedelics could be the biggest breakthrough in psychiatry in 40 years.

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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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COVID-19 vaccinations now ‘alarmingly low’ in Europe

pharmaphorum

COVID-19 vaccination rates have fallen precipitously in Europe and should be ramped up this autumn so they are at least in line with influenza vaccine uptake.

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Neurology remains key therapeutic area for Japan pharma majors: GlobalData

Express Pharma

In the dynamic landscape of healthcare, key neurological disorders like Alzheimer’s disease, epilepsy, Parkinson’s disease, and depression pose significant challenges, particularly in the Asia-Pacific (APAC) region, where prevalence is high. The World Health Organization stated in March 2024 that “over 80 per cent of neurological deaths and health losses occur in low- and middle-income countries, and access to treatment varies widely.

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Pharmacy funding falls amid increases for GP practices and hospitals, says think tank

The Pharmacist

NHS spending on community pharmacy and ophthalmic services has been reduced by 19.9% since 2016/17, when real-terms funding is adjusted for need, according to new analysis from the Nuffield Trust. But in the same time period, GP primary care services saw a 10.3% increase in real-terms needs-adjusted NHS funding, while funding for acute care in […] The post Pharmacy funding falls amid increases for GP practices and hospitals, says think tank appeared first on The Pharmacist.

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AZ’s Dato-DXd misses survival endpoint in lung cancer trial

pharmaphorum

The overall survival (OS) data has come in from the TROPION-Lung01 study of AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (Dato-DXd) in lung cancer – and the result likely isn’t what they were hoping for.

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Drug shortage in the US to prove beneficial for Indian pharma companies

Express Pharma

India Ratings and Research (Ind-Ra) expects US-focused pharma companies to sustain their revenue improvement trend in FY25 on account of heightened drug shortages in the US market. This will not only provide potential for volume growth, but also limit price erosion to single digits over the next 12-18 months, leading to improved returns. Also, given the limited original abbreviated new drug application (ANDA) filings and delays in approvals provided by the USFDA, the drug shortage in the US prov

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STAT+: For one rare type of lung cancer, Pfizer pill reduces progression by 81%

STAT

There are a lot of reasons why updated data on Pfizer’s Lorbrena, a treatment for non-small cell lung cancer, might not seem to be a big deal. The results are an update on the clinical trial that resulted in the Food and Drug Administration granting Lorbrena full approval in 2001, so in a sense they are not even that new. For Pfizer investors, Lorbrena isn’t that big a deal, either.

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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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FTC request may signal trouble for Novo/Catalent deal

PharmaVoice

As Novo Nordisk aims to secure its manufacturing foothold for GLP-1s, regulators are digging for clues of anti-competitive behavior.

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New patent for Corcept Therap drug KORLYM

Drug Patent Watch

Annual Drug Patent Expirations for KORLYM Korlym is a drug marketed by Corcept Therap and is included in one NDA. It is available from one supplier.

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Short reads, big impact: How genomics is revolutionising cancer research

pharmaphorum

Discover how genomics is transforming cancer research through the study of DNA, RNA, and ctDNA. Learn about the latest breakthroughs in the field in this insightful short read.

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Alembic announces USFDA approval for Sacubitril and Valsartan tablets

Express Pharma

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Entresto Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, of Novartis Pharmaceuticals.

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The new menstruation: Girls are getting their periods earlier and less regularly

STAT

Menstruation is a critical indicator of health. Whether and when someone with a uterus gets their period — for the first time, and throughout their life — can reflect not only their reproductive health, but their risk of cardiovascular disease, cancer, miscarriage, and premature death. That also makes menstruation a useful measure of population health.

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Deadline looms for Chinese biotech contracts

PharmaVoice

The latest version of The Biosecure Act working its way through Congress could make waves in the U.S. biotech industry.

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Early spike in demand for insect bites advice, suggests NHSE

The Pharmacist

Visits to the NHS England (NHSE) insect bites and stings web page were three times higher in the first three weeks of this month than in the same time period last year, suggesting an early spike in interest, a deputy chief nursing officer (CNO) has said. According to NHSE, the page received a total of […] The post Early spike in demand for insect bites advice, suggests NHSE appeared first on The Pharmacist.

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Digital therapeutics firm Akili agrees $34 million takeover

pharmaphorum

More consolidation in the digital health sector as Akili agrees a $34m takeover by Virtual Therapeutics, returning to private hands.

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Can robots break the cell therapy bottleneck?

BioPharma Dive

A partnership between cell therapy delivery specialist Portal Biotechnologies and precision robotics maker Multiply Labs could address manufacturing hurdles, the CEOs said.

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Opinion: Stigma and the return of syphilis

STAT

Syphilis, one of the oldest infections known to humans, has returned to the U.S. at epidemic rates that have been climbing since 2001. In 2022, the last year with complete data, the highest number of infections were recorded in more than 70 years. It’s not yet clear why syphilis is spreading faster than other sexually transmitted infections. Recent shortages of single injection penicillin needed to treat this infection threatens to make matters worse.

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Tris Pharma receives USFDA approval for ONYDA XR, a liquid non-stimulant ADHD medication

Express Pharma

Tris Pharma, a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, announced the USFDA has approved ONYDA XR (clonidine hydrochloride), a once-a-day extended-release oral suspension with nighttime dosing, for the treatment of ADHD as a monotherapy or as an adjunctive therapy to approved central nervous system (CNS) stimulant medications in paediatric patients six years and older.

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FDA approves Teva Pharmaceuticals’ AUSTEDO XR for TD and HD chorea

Pharmaceutical Technology

The US FDA approved Teva Pharmaceuticals’ AUSTEDO XR as a once-daily treatment option for tardive dyskinesia and Huntington’s disease chorea.

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AstraZeneca throws its hat into the oral PCSK9 ring

pharmaphorum

AstraZeneca has reported the first clinical data with its oral PCSK9 inhibitor AZD0780, which it hopes could offer an alternative to current injectable drugs used to lower cholesterol.

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Researchers identify genetic changes responsible for rare childhood immune disorders

Pharma Times

Affecting the immune system, various forms of SCID are estimated to affect one in 75,000 to 100,000 newborns

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Drug treatment that insists on abstinence? Federal agencies are just saying no

STAT

For as long as the federal government has worked to support substance use treatment, it has operated on a simple premise: Addiction medicine’s objective is to help people using drugs stop — completely and forever. But with over 100,000 Americans dying of drug overdose each year, the Biden administration appears to be changing its tack.

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Merck KGaA announces its largest investment in Asia

Express Pharma

Merck KGaA Darmstadt Germany announced its largest investment in Asia through a ceremony of its € 300 million Bioprocessing Production Center in Daejeon, South Korea. The new facility will accelerate the biotech and pharmaceutical industry’s development by manufacturing vaccines, cell and gene therapies, and protein-based therapies. Once completed, the investment aims to create as many as 300 new jobs and continue to grow and support global demand for critical drugs and therapies.

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FDA grants RMAT status for BlueRock’s Parkinson’s therapy

Pharmaceutical Technology

The US FDA has granted RMAT designation for BlueRock Therapeutics' cell therapy, bemdaneprocel (BRT-DA01), for Parkinson's disease.

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Nippon Shinyaku’s DMD drug fails confirmatory trial

pharmaphorum

The future of Nippon Shinyaku’s Duchenne muscular dystrophy (DMD) therapy Viltepso has been thrown into doubt after it failed a confirmatory clinical trial

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Bicycle Therapeutics secures $555M in private placement equity financing

Outsourcing Pharma

This funding round includes participation from both new and existing accredited investors, reinforcing confidence in Bicycle's innovative approach to precision-guided therapeutics.

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The doctor would treat her sickle cell pain crisis — if she promised not to get an abortion

STAT

Here are some things A. was told when she arrived at the hospital one night in June 2023. That she couldn’t have the pain medicine she usually got for a sickle cell crisis because she was six weeks pregnant, but she could have Tylenol. That if she just took her blood thinner everything would be fine. That she needed to leave, and if she still felt bad by the time she’d wheelchaired out into the parking lot, she could turn around and check herself back into the emergency room.

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AbbVie’s immunology portfolio to offset Humira losses: GlobalData

Express Pharma

For 20 years, AbbVie’s Humira (adalimumab) has been one of the world’s top-selling products. However, the US drug expiry in January 2023 resulted in a 32 per cent decline in sales of Humira in 2023, accompanied by a 7 per cent drop in the company’s total revenue for that year. As further sharp declines are expected for Humira, AbbVie has strategically pivoted to alternative immunology products to bolster its revenue streams.

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OTC medicines should be free for people on low incomes through Pharmacy First, say MPs

The Pharmacist

Over the counter (OTC) medications should be made available for free for people on low incomes as part of the Pharmacy First service in England, an influential group of MPs has suggested. The recommendation came as part of the Health and Social Care (HSCC)’s report, published this week following its pharmacy inquiry. The committee said […] The post OTC medicines should be free for people on low incomes through Pharmacy First, say MPs appeared first on The Pharmacist.

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US Congress passes bill to end Parkinson’s disease

pharmaphorum

The US Congress has passed the first-ever federal bill dedicated to ending Parkinson’s disease, modelled on similar legislation for Alzheimer’s enacted in 2011

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Asahi Kasei's $1.1 billion power move - acquiring Calliditas to dominate global healthcare

Outsourcing Pharma

In a bold move set to reshape the global healthcare landscape, Asahi Kasei Corp. announced its intent to acquire Swedish drug maker Calliditas Therapeutics AB through a voluntary tender offer.

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STAT+: Many docs who tweeted product endorsements also took money from manufacturers, analysis shows

STAT

Most physicians who endorsed a prescription drug or medical device on X — formerly known as Twitter — also received payments from the manufacturers of these products, according to a new analysis that highlights ongoing concerns about financial ties between doctors and industry. The study found 26 of 28 physicians, or 93%, received at least one payment, and the average was more than $27,400 for such things as food and beverages, speaking, consulting, or travel.

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