Sat.Jun 05, 2021 - Fri.Jun 11, 2021

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Digital fabric could be used to measure health data

pharmaphorum

Researchers in the US have developed a wearable fabric that can sense, store and analyse data that could be used to measure physiological functions or detect illness. The team from Massachusetts Institute of Technology (MIT) claim this is the first example of a fabric which can record data in a digital rather than in an analogue format, allowing it to be programmed like any other digital device.

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Amicus' Pompe disease therapy joins early access scheme

Pharma Times

The MHRA has issued an EAMS scientific opinion opening the door to use of cipaglucosidase alfa with miglustat in eligible patients with Pompe disease

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Phesi COVID-19 study indicates obesity a major complicating factor

Outsourcing Pharma

The virtual clinical development firmâs analysis of patient profiles reflects obesity is the most significant indicator for severity in those under 40.

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New patent for Am Regent drug INJECTAFER

Drug Patent Watch

Annual Drug Patent Expirations for INJECTAFER Injectafer is a drug marketed by Am Regent and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Am Regent drug INJECTAFER appeared first on DrugPatentWatch - Make Better Decisions.

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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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Ensuring accessibility: Crossing the digital divide in healthcare

pharmaphorum

“Rarely does the answer come from the boardroom” – what can user experience teach us about building accessible digital health? No one should be left behind as the world embraces digital healthcare say leading user experience voices. The experts discussed the benefits and merits of co-creation during a session on bridging the digital divide, held during the recent Patient Experience Digital Summit.

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NICE recommends Tecentriq for first-line NSCLC

Pharma Times

Tecentriq is indicated for adults with metastatic NSCLC if their tumours have PD-L1 expression on at least 50% of tumour cells or 10% of tumour-infiltrating immune cells

Immunity 112

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New patent for LUPIN drug SOLOSEC

Drug Patent Watch

Annual Drug Patent Expirations for SOLOSEC Solosec is a drug marketed by Lupin and is included in one NDA. It is available from one supplier. There are four patents protecting…. The post New patent for LUPIN drug SOLOSEC appeared first on DrugPatentWatch - Make Better Decisions.

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Trial finds Orion digital therapeutic helps chronic pain sufferers

pharmaphorum

A digital therapeutic aimed at people with chronic lower back pain based on virtual reality (VR) has shown encouraging results in a clinical trial, helping patients manage the fear of movement that can reduce their activity and impede recovery. The therapy uses a VR headset to guide people with chronic pain through a series of cognitive behavioural therapy (CBT) exercises that are designed to help them overcome the fear of movement – also known as kinesiophobia.

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MHRA approves Venclyxto for newly diagnosed AML

Pharma Times

The approval is based on results from the Phase III VIALE-A study as well as the Phase Ib M14-358 clinical trial

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FDA approves Biogen’s Alzheimer's drug, Aduhelm

Outsourcing Pharma

The US Food and Drug Administration (FDA) has approved Biogenâs Aduhelm (aducanumab) for the treatment of Alzheimerâs: making it the first new treatment approved for the disease since 2003.

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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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New patent for Pfizer drug TOVIAZ

Drug Patent Watch

Annual Drug Patent Expirations for TOVIAZ Toviaz is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are four patents protecting…. The post New patent for Pfizer drug TOVIAZ appeared first on DrugPatentWatch - Make Better Decisions.

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Keeping clinical trial data safe – handling cybersecurity in a risky world

pharmaphorum

The development of vaccines for COVID-19 has been a masterclass in effective collaboration and applied digitisation in healthcare. However the increased complexity and involvement of different parties, exposes manufacturers to heightened threat levels. Abel Archundia discusses how COVID-19 has highlighted the importance of securing clinical trials against cyber threats.

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Cell and Gene Therapy Catapult forms consortium of over 20 organisations

Pharma Times

Consortium will assess multiple process analytical technologies used in the cell and gene therapy industry

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F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

NY Times

Aducanumab is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some prominent experts say there’s not enough evidence it can address cognitive symptoms.

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New patent for Beigene drug BRUKINSA

Drug Patent Watch

Annual Drug Patent Expirations for BRUKINSA Brukinsa is a drug marketed by Beigene and is included in one NDA. There is one patent protecting this drug. This drug has twenty-three…. The post New patent for Beigene drug BRUKINSA appeared first on DrugPatentWatch - Make Better Decisions.

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ASCO21: Gilead sets up first FDA okay for adult ALL with Tecartus data

pharmaphorum

Novartis’ Kymriah has had the CAR-T therapy market for acute lymphoblastic leukaemia (ALL) to itself so far, but Gilead Sciences’ Kite subsidiary is now looming in the rear view mirror – armed with new data for its already-filed rival Tecartus. Results of the phase 1/2 ZUMA-3 trial of Tecartus (brexucabtagene autoleucel) reported at the ongoing ASCO conference revealed a 71% complete response rate with the CAR-T in heavily pre-treated adult patients with B-cell precursor ALL.

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Iksuda Therapeutics raises $47m to progress ADC pipeline

Pharma Times

Iksuda will use the funds to support the progression of IKS03 into first-in-human Phase I clinical trials

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Three F.D.A. Advisers Resign Over Agency’s Approval of Alzheimer’s Drug

NY Times

The drug, Aduhelm, a monthly infusion priced at $56,000 per year, was approved this week despite weak evidence that it helps patients.

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New patent for Veroscience drug CYCLOSET

Drug Patent Watch

Annual Drug Patent Expirations for CYCLOSET Cycloset is a drug marketed by Veroscience and is included in one NDA. It is available from one supplier. There are fifteen patents protecting…. The post New patent for Veroscience drug CYCLOSET appeared first on DrugPatentWatch - Make Better Decisions.

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Country focus: China & APAC’s growing medical needs bring opportunities and challenges

pharmaphorum

Dr Jay Mei from Antengene tells us how the Asia Pacific region is opening up to innovative pharma companies, and gives tips for companies navigating this enormous market. Home to over 60% of the world’s population, Asia Pacific (APAC) is not a region the biopharma industry can afford to ignore. Dr Jay Mei, founder and CEO of Antengene, notes that the region has rich innovation resources but also urgent medical needs, leading to both opportunities and uncertainties for the industry.

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No survival benefit from aspirin in COVID-19 patients

Pharma Times

The NIHR-supported RECOVERY trial found that the anti-inflammatory drug does not improve survival for hospitalised patients with COVID-19

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Novo Nordisk weight-management drug lands FDA approval

Outsourcing Pharma

The pharmacy company's Wegovy (semaglutide) is the first therapy designated for chronic weight management that the agency has granted approval since 2014.

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F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works

NY Times

Aducanumab, or Aduhelm, is the first new Alzheimer’s treatment in 18 years and the first to attack the disease process. But some experts say there’s not enough evidence it can address cognitive symptoms.

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And then there were three: another FDA adcomm member quits over Aduhelm

pharmaphorum

The fallout over the FDA’s decision to approved Biogen’s Alzheimer’s therapy Aduhelm continues to be felt, with a third member of its advisory committee resigning in protest. . The latest to depart the FDA’s Peripheral and Central Nervous System Drugs panel is Aaron Kesselheim of Harvard Medical School, joining fellow committee members Joel Perlmutter and David Knopman who quit earlier this week.

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New hybrid healthcare agency Stirred launches

Pharma Times

Stirred has been launched this week by former senior Pegasus colleagues Jo Spadaccino and Stuart Hehir

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Michael J. Fox Foundation shares Parkinson’s genetic data

Outsourcing Pharma

In partnership with 23andMe, the group has released a wealth of new de-identified data from the largest-ever Parkinsonâs cohort, to aid future research.

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Alzheimer’s Drug Poses a Dilemma for the F.D.A.

NY Times

If the agency approves it, aducanumab would be the first new Alzheimer’s treatment since 2003. Patients are desperate for new options, but some scientists say there isn’t enough evidence it works.

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FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag

pharmaphorum

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. That was the damning conclusion of the influential Institute for Clinical and Economic Review (ICER) in the US to yesterday’s approval of Aduhelm (aducanumab), the first new treatment for Alzheimer’s since 2003, which it says has “no evidentiary basis.” Biogen meanwhile has bee

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SMC backs five new medicines for NHS use

Pharma Times

Servier's Lonsurf and AstraZeneca's Calquence are among the positive decisions

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New patent expiration for Eisai Inc drug FYCOMPA

Drug Patent Watch

Annual Drug Patent Expirations for FYCOMPA Fycompa is a drug marketed by Eisai Inc and is included in two NDAs. It is available from one supplier. There are two patents…. The post New patent expiration for Eisai Inc drug FYCOMPA appeared first on DrugPatentWatch - Make Better Decisions.

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Wisconsin Pharmacist Who Tampered With Vaccine Gets 3-Year Sentence

NY Times

The pharmacist, Steven R. Brandenburg, believed in conspiracy theories and thought vaccines were dangerous, the authorities said.

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NHS patient data upload delayed by two months, says UK

pharmaphorum

The UK’s decision to set back the start date of a new patient data-sharing scheme by two months has been welcomed by privacy campaigners, who have claimed it was being rushed through without sufficient public scrutiny. The centralised database of medical records from 55 million people was due to come online on 1 July, but the start date has now been pushed back to 1 September, according to Minister for Public Health, Primary Care & Prevention Jo Churchill.

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GSK’s PD-1 inhibitor Jemperli approved in the UK

Pharma Times

Conditional marketing authorisation granted for the treatment of recurrent or advanced endometrial cancer

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Drug Patent Expirations for the Week of June 6, 2021

Drug Patent Watch

FYCOMPA (perampanel) Eisai inc Patent: 6,949,571 Expiration: Jun 8, 2021 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or…. The post Drug Patent Expirations for the Week of June 6, 2021 appeared first on DrugPatentWatch - Make Better Decisions.

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Looking to Tackle Prescription Overload

NY Times

Older adults often take more medications than they need, or than is safe. Increasingly, geriatric experts and their patients are exploring the benefits of “deprescribing.”.

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