Sat.Oct 31, 2020 - Fri.Nov 06, 2020

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MHRA looks to AI to hunt for COVID-19 vaccine side effects

pharmaphorum

The UK drugs regulator has awarded a £1.5 million tender to a software company for an artificial intelligence tool that will be used to process “the expected high volume of COVID-19 vaccine adverse drug reactions (ADRs).”. The tender awarded to Maidenhead, Berkshire-based GenPact UK aims to “ensure that no details from the ADRs…are missed” as the UK prepares to start rolling out COVID-19 vaccines – assuming their safety and efficacy is supported in late-stage trials.

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New study assessing antibiotics for COVID-19 sepsis

Pharma Times

It is hoped that findings from the NIHR-funded trial will help better inform treatment decisions

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Trending Sources

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New patent for Aerie Pharms drug RHOPRESSA

Drug Patent Watch

Annual Drug Patent Expirations for RHOPRESSA Rhopressa is a drug marketed by Aerie Pharms Inc and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for Aerie Pharms drug RHOPRESSA appeared first on DrugPatentWatch - Make Better Decisions.

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DFE Pharma: adoption of continuous manufacturing on the rise

Outsourcing Pharma

According to representatives from the pharma solutions provider, incorporation of CM processes, after a slow period, is expanding across the industry.

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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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AI’s infiltration of pharma: How COVID-19 accelerated change

pharmaphorum

The pharmaceutical industry has sometimes been a laggard in terms of digital maturity, but the COVID-19 crisis has provided companies the impetus to rapidly implement the most cutting-edge technologies. At the heart of most of these digital advancements is AI and machine learning. With a collective sense of uncertainty, many are pinning their hopes on a vaccine and treatment, and sophisticated technology could help speed up the process of finding an effective medicine.

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New EU approval for GSK's Zejula

Pharma Times

Zejula is the first PARP inhibitor to be approved as monotherapy in the EU for patients with platinum-responsive advanced ovarian cancer, regardless of biomarker status

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More Trending

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DARPA selects continuous manufacturing partner

Outsourcing Pharma

The agency has chosen Continuity Pharma to aid in development and advancement of continuous manufacturing technology, with the help of a $1.5m grant.

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Ring 20: Could the rare disease get left behind by next-generation gene sequencing?

pharmaphorum

Ring Chromosome 20 Syndrome, or (R)20, is an ultra-rare form of epilepsy with a devastating impact – yet despite huge leaps forward in gene sequencing in recent years, diagnoses are going down instead of up. We spoke to Allison Watson, co-founder of Ring 20 Research and Support, about raising awareness, building the evidence base, and the importance of helping people through a pandemic despite limited funding.

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Novo Nordisk’s Saxenda bags NICE recommendation

Pharma Times

Obesity management treatment recommended following confidential discount

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$26 Billion Settlement Offer in Opioid Lawsuits Gains Wide Support

NY Times

Three distributors and a drug manufacturer have proposed a deal that a majority of states and negotiators for small governments finally seem to like.

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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 Amicus Theraps drug GALAFOLD

Drug Patent Watch

Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Theraps Us and is included in one NDA. There are twelve patents protecting this drug. This drug…. The post New patent for Amicus Theraps drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.

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The ‘failure’ of clinical trials in the search for COVID-19 treatments

pharmaphorum

Professor Jean-Pierre Boissel outlines the urgent need for disruptive R&D approaches that can tackle the search for COVID-19 treatments more effectively. It may not be appropriate to use the word ‘failure’ when summarising the utility of clinical trials in the search for a curative or preventative treatment for disease. For the purposes of this text, let us assume that ‘success’ and ‘failure’ will be used in reference to the objective of clinical trial designers: to obtain sufficient evidenc

Vaccines 104
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Sanofi to buy Kiadis

Pharma Times

The move gives the French drug giant access to Kiadis' natural killer cell technology platform

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Controversial Alzheimer’s Drug Faces Critical Test Before F.D.A. Panel

NY Times

If ultimately approved, the drug, aducanumab, made by Biogen, would be the first new Alzheimer’s treatment in nearly two decades. Some evidence suggests it slows, but does not stop, cognitive decline.

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eClinical analysis offers perspective on leaders of the pack

Outsourcing Pharma

The latest analytical report from Life Science Strategy Group reveals position and perception of the leading players and performers in the eClinical arena.

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Be in the room: Turning patient engagement to patient centricity

pharmaphorum

After three brushes with cancer, Robert Weker understands the patient journey more than many – and he is determined to put that experience to good use. The avid blogger and passionate advocate retired from his R&D role four years ago to focus on his own health, and now works full time on making sure the patient voice is “in the room” when pharma companies make decisions.

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NHS at a 'critical point' as COVID-19 cases climb

Pharma Times

NHS Confederation chief exec calls on public to support non-COVID services

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New patent for Merck Sharp drug JANUVIA

Drug Patent Watch

Annual Drug Patent Expirations for JANUVIA Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from three suppliers. There are three…. The post New patent for Merck Sharp drug JANUVIA appeared first on DrugPatentWatch - Make Better Decisions.

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Stage 4 Breast Cancer Treatment in Germany

Pharma Mirror

To date, breast cancer is one of the most dangerous diseases. Unfortunately, it is not always possible to diagnose it early due to the lack of modern equipment in many countries. Medical tourism is getting popular, and you can easily get stage 4 breast cancer treatment in Germany. Modern hospitals in Germany have the most. The post Stage 4 Breast Cancer Treatment in Germany appeared first on Pharma Mirror Magazine.

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Genprex cancer gene therapy paired with AZ, Merck lung cancer drugs

pharmaphorum

An experimental gene therapy developed by Texas biotech Genprex will be paired with AstraZeneca’s Tagrisso and Merck & Co’s Keytruda – both leading their respective drug classes in the treatment of non-small cell lung cancer (NSCLC). The two phase 1/2 trials are zeroing in on NSCLC patients with specific molecular biomarkers, to see if adding Genprex’ Reqorsa (quaratusugene ozeplasmid) – which delivers a gene that suppresses tumour growth – can enhance the activity of the AZ and Merck

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AZ’s Forxiga wins EU approval for heart failure

Pharma Times

SGLT2 inhibitor approved for heart failure with reduced ejection fraction

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New patent for Merck Sharp drug JANUMET XR

Drug Patent Watch

Annual Drug Patent Expirations for JANUMET+XR Janumet Xr is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There are…. The post New patent for Merck Sharp drug JANUMET XR appeared first on DrugPatentWatch - Make Better Decisions.

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Independent Pharmacies Learn to Live With (and Without) Preferred Networks for 2021

Drug Channels

Last week , I highlighted the largest pharmacy chains that will participate in the 2021 Medicare Part D prescription drug plans (PDP). Today, I examine how independent pharmacies will participate as preferred cost sharing pharmacies via the pharmacy services administrative organizations (PSAOs) that represent these pharmacies in negotiations with plans.

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Using SDTM, ADaM, and SEND for Regulatory Submissions

pharmaphorum

It’s a safe bet that most people’s first introduction to CDISC standards is through the Study Data Tabulation Model (SDTM). This is a content standard that ensures clinical data is submitted in a consistent manner, helping to reduce review time and facilitating cross-study analysis. Another content standard, the Analysis Data Model (ADaM), aims to perform a similar function for analysis datasets.

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MHRA starts rolling review of AZ’s coronavirus vaccine

Pharma Times

British drugmaker confirmed review on Sunday

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New patent for Astellas drug CRESEMBA

Drug Patent Watch

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

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Rare Disease Innovation and Partnering Summit 2020

Drug Channels

Rare Disease Innovation and Partnering Summit 2020. December 1-4, 2020 | Virtual Event www.raredisease-summit.com. This December, tackle challenges faced in ensuring patient access and furthering therapeutic and curative progress at the Rare Disease Innovation & Partnering Summit. Held in a 100% virtual format, this four-day meeting convenes diverse stakeholders to discuss opportunities for continued innovation, advancement of impactful patient advocacy and acceleration of commercial strateg

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Sanofi to acquire Kiadis and NK cell tech for $353 million

pharmaphorum

Sanofi is to acquire Kiadis, a biotech specialising in therapies based around ‘off the shelf’ natural killer (NK) cells, for 308 million euros ($353 million). The French pharma is buying Kiadis for 5.45 euros per share in cash, an offer price representing a premium of 272% over the biotech’s closing price on Friday evening on Amsterdam’s Euronext market.

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EMA begins evaluation of filgotinib for ulcerative colitis

Pharma Times

Gilead and Galapagos’ application for oral JAK1 inhibitor validated by agency

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New patent expiration for Photocure Asa drug CYSVIEW KIT

Drug Patent Watch

Annual Drug Patent Expirations for CYSVIEW+KIT Cysview Kit is a drug marketed by Photocure Asa and is included in one NDA. It is available from one supplier. There are two…. The post New patent expiration for Photocure Asa drug CYSVIEW KIT appeared first on DrugPatentWatch - Make Better Decisions.

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How Hospital Emergency Rooms are Improving Care

Pharma Mirror

Accidents happen, people get sick, unexpected health issues pop up, problems occur when you least expect it – this is why there are emergency rooms and why millions of people go to them every year. Yet, visiting the emergency room can be very stressful and scary. You don’t know what is going to happen to. The post How Hospital Emergency Rooms are Improving Care appeared first on Pharma Mirror Magazine.

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Does my cough sound like COVID? There could be an app for that

pharmaphorum

It could be possible to detect whether someone has COVID-19 or not, just from the sound of their coughing. That’s the conclusion of testing of an artificial intelligence (AI) algorithm developed by the Massachusetts Institute of Technology (MIT), which was able to detect around 98% of cases of COVID-19 from a forced cough delivered down a cell phone – confirmed by coronavirus testing.

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MHRA allows HAE patients early access to berotralstat

Pharma Times

The oral, once-daily therapy is designed to prevent attacks and reduce burden of therapy

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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 two suppliers. There are twenty-seven patents…. The post New patent for Kaleo Inc drug AUVI-Q appeared first on DrugPatentWatch - Make Better Decisions.

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Finality, finally:  Adir and Servier Canada Inc. confirm their perindopril win

Pharma in Brief

The 14 year perindopril litigation in Canada is over, with Adir and Servier Canada Inc. (collectively “ Servier ”) emerging victorious against Apotex Inc. and Apotex Pharmachem Inc. (collectively “ Apotex ”). The end was marked by the Supreme Court of Canada’s dismissal of Apotex’s application for leave to appeal a decision requiring it to disgorge its profits associated with infringement of Servier’s patent.

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