Sat.Oct 16, 2021 - Fri.Oct 22, 2021

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Pfizer says new data show booster shots of its vaccine are highly protective against Covid.

NY Times

The company said that in a study, boosters cut down the number of breakthrough infections among fully vaccinated people by more than 95 percent.

Vaccines 145
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A test of NICE’s resolve: clinical guidelines for Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

pharmaphorum

The work of the UK’s HTA body, the National Institute for Health and Care Excellence (NICE), is often heatedly debated, and this time it’s for holding back a clinical guideline. Leela Barham looks into the controversy. Updating a previous clinical guideline. NICE began their work to update a 2007 clinical guideline on Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in January 2018.

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Trending Sources

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NICE recommends gene silencing therapy for porphyria patients on NHS

Pharma Times

Givlaari uses ‘gene silencing’ RNA interference technology, to target the production of pathogenic compounds in people AHP

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‘Digital transformation’ requires enterprise-wide change: Rockwell Automation

Outsourcing Pharma

To fully reap the benefits of tech advances, a company leader advises, a life-sciences firm must embrace change and connection throughout the operation.

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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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F.D.A. to Allow ‘Mix and Match’ Approach for Covid Booster Shots

NY Times

The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.

Vaccines 145
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FDA clears AI-powered digital test for early dementia

pharmaphorum

The FDA has approved an artificial intelligence-based test for early detection of dementia that can be carried out on an iPad in five minutes. The CognICA Integrated Cognitive Assessment (ICA) test developed by London, UK-based company Cognetivity Neurosciences has been approved by the FDA as an alternative to traditional pen-and-paper tests with some key advantages, according to its developer.

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More Trending

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New patent for Hq Spclt drug CALCIUM GLUCONATE IN SODIUM CHLORIDE

Drug Patent Watch

Annual Drug Patent Expirations for CALCIUM+GLUCONATE+IN+SODIUM+CHLORIDE Calcium Gluconate In Sodium Chloride is a drug marketed by Fresenius Kabi Usa and Hq Spclt Pharma and is included in two NDAs. It…. The post New patent for Hq Spclt drug CALCIUM GLUCONATE IN SODIUM CHLORIDE appeared first on DrugPatentWatch - Make Better Decisions.

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Federal Court finds Minister of Health’s refusal to grant CSP based on the “Timely Submission Requirement” unreasonable

Pharma in Brief

SUMMARY. The Federal Court has granted Merck Canada Inc.’s ( Merck ) application for judicial review of a decision of the Minister of Health ( Minister ) denying a Certificate of Supplementary Protection ( CSP ) for Canadian Patent No. 2,670,892 ( 892 Patent ) and the drug BELSOMRA (suvorexant). BACKGROUND. A CSP provides patent-like rights and is intended to compensate patentees for a period of patent term lost while innovative pharmaceutical products undergo research and regulatory approval. [

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What HCPs think about medical tweetorials

pharmaphorum

Twitter has been used by health professionals for over a decade to share medical knowledge and education. Until late-2018 they had only 140 characters to do this, increasing to 280 at that time. There have been some collaborative ways to have meaningful interactions on the platform including Twitter journal clubs. Four ways HCPs are using Twitter for medical education.

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NICE approves Ofev for PF-ILD

Pharma Times

Interstitial lung disease (ILD) is a termed used to describe a collection of over 200 lung disorders

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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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Pfizer Says Its Vaccine Is Highly Protective in Children 5 to 11

NY Times

The findings could add momentum for F.D.A. authorization of the pediatric dose, perhaps next week, a long-awaited development that would affect 28 million children.

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COVID-19 lessons can apply to hepatitis treatments: Phesi

Outsourcing Pharma

According to the firm, infectious-disease research advancements could be applied to discovering treatments for millions of hepatitis patients globally.

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Use of digital tools for clinical trials triples during pandemic; survey

pharmaphorum

A new poll of clinical trial sponsors has found that around nine out of 10 of them are running decentralised trials with the help of digital technologies, a big increase on pre-COVID-19 levels. The survey by Veeva Systems found a big increase in the adoption of technologies that enabled remote trials during COVID-19, with increased use of tools such as remote monitoring, electronic data collection and consent forms, and web portals for studies.

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Psychoactive compound to advance research in treatment of depressive disorders

Pharma Times

Lucid-PSYCH is a psychoactive compound potentially viable for the treatment of major depressive disorders

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Here’s Why Developing Countries Can Make the Top Covid Vaccines

NY Times

Pfizer and Moderna are skeptical, but we found 10 companies in Africa, Asia and South America well-positioned to produce the gold-standard mRNA shots.

Vaccines 100
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DrugPatentWatch Ranked Best Biopharmaceuticals Commercial Business Intelligence Platform

Drug Patent Watch

DrugPatentWatch has been ranked the “Best Biopharmaceuticals Commercial Business Intelligence Platform” by Global Health & Pharma News This award is dedicated to honoring the innovation, determination and outstanding levels of…. The post DrugPatentWatch Ranked Best Biopharmaceuticals Commercial Business Intelligence Platform appeared first on DrugPatentWatch - Make Better Decisions.

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Roche scores early adjuvant lung cancer approval for Tecentriq

pharmaphorum

Roche has claimed an earlier-than-expected FDA approval for its checkpoint inhibitor Tecentriq in non-small cell lung cancer (NSCLC), giving the drug a lead in early-stage cases that can be treated with surgery. The US regulator has cleared Tecentriq (atezolizumab) as adjuvant treatment after surgery and platinum-based chemotherapy in patients with tumours in which 1% or more cells express the PD-L1 biomarker, to try to stop the cancer recurring.

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UK doctors: Renewed COVID response is urgent

Pharma Times

The British Medical Association (BMA) has accused the Health Secretary of being “willfully negligent”

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Mix-and-Match Covid Boosters: Why They Just Might Work

NY Times

The F.D.A. may authorize booster shots of vaccines different from the ones that Americans originally received. The science behind the move is promising.

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Fresh Evidence: How Health Systems Steer Prescriptions to Their Own Specialty Pharmacies

Drug Channels

Hospitals and health systems are rapidly expanding their internal specialty pharmacies—and they’re using questionable tactics to boost revenues and profits. A new American Society of Hospital Pharmacists (ASHP) survey of health system pharmacies offers fresh insights into how these systems steer prescriptions to their internal specialty pharmacies: For most health systems' in-house specialty pharmacies, more than 90% of specialty prescriptions are written by system-employed physicians.

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Biogen’s Aduhelm rollout goes from bad to worse

pharmaphorum

Analysts were predicting sales of Biogen’s recently approved Alzheimer’s therapy Aduhelm may start to gather a little momentum in the third quarter, but the drug seems to be going into reverse. As it turned out, Aduhelm (aducanumab) made just $300,000 in the three-month period from July to September, against analysts’ estimates of $12 million, suggesting that few patients are being treated with the $56,000 a year therapy.

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Dupixent hits all endpoints in prurigo nodularis trial

Pharma Times

Dupixent significantly reduced itch and skin lesions compared to placebo in the investigational trial setting

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F.D.A. Authorizes Moderna and Johnson & Johnson Booster Shots

NY Times

The agency will also allow vaccine recipients to pick which vaccine they want as a booster, endorsing a mix-and-match approach.

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Digital revolution transforming drug development: West Pharma

Outsourcing Pharma

A leader from the drug development and manufacturing firm talks about the ways in which advanced digital tools stand to revolutionize the pharma field.

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Dupixent scores a first in rare skin disease prurigo nodularis

pharmaphorum

Sanofi and Regeneron’s Dupixent has become the first biologic drug to show activity in prurigo nodularis (PN), raising the hope of a new treatment option for the rare and highly debilitating skin disease. The two companies are still waiting for the results of a second phase 3 trial, due in the first half of next year, but if that is positive expect to file for approval of Dupixent (dupilumab) in the new indication before the end of 2022.

Immunity 104
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Biotage acquires DNA synthesis and purification company ATDBio

Pharma Times

ATDBio adds important platform solutions to Biotage within DNA and RNA oligonucleotide synthesis and purification

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Will New Covid Treatments Be as Elusive for Poor Countries as Vaccines?

NY Times

Merck has taken a step to make its antiviral pill available in poor nations, but many obstacles remain for broad access to coronavirus drugs.

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Machine Learning, AI, and Platform Technology: Drug Discount Management’s Big Leap Forward

Drug Channels

Today’s guest post comes from Scott Johnsen, VP of Product at Kalderos. Scott discusses the advantages of using artificial intelligence and machine learning to efficiently process reimbursement data and avoid duplicates. Learn more about Kalderos’ solutions to solve drug discount management challenges at scale during a free webinar on November 17: The Power of the Platform: How a Trusted Network Delivers Outcomes That Are a Win for All.

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Health Innovators: Healios’ Richard Andrews

pharmaphorum

In the latest Health Innovators video chat, pharmaphorum’s founder, Dr Paul Tunnah, chats with the founder and CEO of digital mental health pioneer Healios. Rich Andrews explains his background in big pharma and his inspiration for moving into the start-up space with Healios and its focus on mental health and neurodiverse conditions for children and adolescents.

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Antengene to collaborate with LegoChem Biosciences for antibody-drug conjugates

Pharma Times

The two parties will jointly generate and evaluate ADC candidates

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Why Is Good Medical Advice for Pregnant Women So Hard to Find?

NY Times

A recent warning about the pain reliever acetaminophen is a reminder that health risks in pregnancy remain maddeningly, dangerously understudied.

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DrugPatentWatch Custom Market Surveillance

Drug Patent Watch

DrugPatentWatch’s Custom Market Surveillance provides you with a robust platform to monitor your business opportunities from every angle. You’re monitoring your business, but you’re too busy to sift through data.…. The post DrugPatentWatch Custom Market Surveillance appeared first on DrugPatentWatch - Make Better Decisions.

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Alnylam gets NICE backing for porphyria therapy Givlaari

pharmaphorum

UK cost-effectiveness watchdog NICE is set to recommend NHS use of Alnylam’s gene-silencing therapy Givlaari in England and Wales for the rare disease acute hepatic porphyria (AHP), after its advisors issued a positive verdict on the drug. Givlaari (givosiran) has been recommended as a treatment option for people aged 12 and over with AHP, a rare life-threatening genetic condition that causes attacks of severe abdominal pain, vomiting and nervous system disorders, such as seizures, depress

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US approval for J&J and Moderna COVID-19 boosters

Pharma Times

EUA amendments 'based on the available data and information'

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Gates Foundation Pledges $120 Million to Help Get Covid Pills Quickly to Poor Countries

NY Times

Regulatory hurdles and supply chain issues could slow efforts to produce generic versions of Merck’s antiviral molnupiravir for developing nations, despite licensing agreements.

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