January, 2021

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Pfizer Will Ship Fewer Covid-19 Vaccine Vials to Account for ‘Extra’ Doses

NY Times

After the surprise discovery of an extra dose in every vial, Pfizer executives successfully lobbied the F.D.A. to change the vaccine’s formal authorization language. The company charges by the dose.

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Gene editing: beyond the hype

pharmaphorum

Genome editing is an exciting but still nascent field, and companies in the area face as many obstacles as they do opportunities. Sangamo CEO Sandy Macrae told us how his company is being cautious about the hype and finding ways to be financially viable in an emerging space. ‘Cutting edge’ is, for once, a truly apt description when it comes to gene editing – both because the field is pushing medicine into areas we might never have dreamed possible, and because these technologies involve literall

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PharmaTimes confirms INTCR 2021 virtual finals days

Pharma Times

The 2021 International Clinical Researcher of the Year competition will continue the successes of last year and be conducted virtually.

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eCOA tech helps trials tackle COVID-19 obstacles: IQVIA

Outsourcing Pharma

Two leaders from the clinical technology solutions company discuss how digital tools like eCOAs have been invaluable in facing pandemic-related challenges.

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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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PMN WEBINAR: Video, Voice, and Virtual: Applying New Digital Technology to Enhance Customer Experience

Pharma Marketing Network

2020 was a year defined by unexpected challenges – and related opportunity – for pharmaceutical marketers. Some Key Discussion Topics Include: What have we learned about how to create connection within this new paradigm? Which recent innovations are poised to become the best practices that will create measurable impact in 2021? Tune in to listen to the Pharma Marketing Network and leading experts from GSK, Otsuka & Bayer as we navigate these trends and discuss what you need to know to

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New patent for Veloxis Pharms drug ENVARSUS XR

Drug Patent Watch

Annual Drug Patent Expirations for ENVARSUS+XR Envarsus Xr is a drug marketed by Veloxis Pharms Inc and is included in one NDA. There are seventeen patents protecting this drug. Drug…. The post New patent for Veloxis Pharms drug ENVARSUS XR appeared first on DrugPatentWatch - Make Better Decisions.

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UK left trailing as EU quickly approves Moderna’s COVID-19 vaccine

pharmaphorum

The European Union has approved the coronavirus vaccine from Moderna, leaving the UK trailing because of changes to post-Brexit drug approval rules. With the UK reeling from one of the worst outbreaks of the disease, it’s a worrying situation for one of the countries worst hit by the pandemic that is relying on vaccines to bring the virus under control.

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Researchers identify existing drug’s potential for triple negative breast cancer

Pharma Times

Study suggests that palbociclib could be used to treat around a fifth of people with TNBC

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Neurology’s Growing Need for Disposable Technologies

Pharma Mirror

By Boris Goldstein, Co-Founder & Executive Chairman at Brain Scientific COVID-19 is known for its impacts on a patient’s respiratory system, but it has also been found to affect individuals in unique ways and with varying severity levels depending on their age, risk factors, and comorbidities. Several studies have recently shown that the development of neurological conditions and symptoms are prevalent in COVID patients.

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5 Trends That Will Shape Pharma Marketing in 2021

Pharma Marketing Network

Throughout the year 2020, pharma marketers were forced to explore new strategies in order to keep up with the many evolving trends. Pharma marketers have quickly learned how to adapt to these trends and are prepared to take on new opportunities in 2021. Five trends that will shape the pharma marketing industry in 2021 include media and tech, location independence, relationships despite digital congestion, questioning systems and doubt in institutions, and feelings around trust and wellness.

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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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Decentralized trials, remote monitoring continue surging: KCR

Outsourcing Pharma

A representative from the global CRO outlines how forces like COVID-19, decentralized studies, globalization and others are driving change in the industry.

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Supreme Court Revives Abortion-Pill Restriction

NY Times

In their first abortion case since Justice Amy Coney Barrett joined the court, the justices reinstated a requirement that women seeking medication abortions pick up a pill in person.

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Gilead says Veklury should work against COVID-19 variants

pharmaphorum

Gilead Sciences says its antiviral Veklury should be effective against the new, more contagious COVID-19 variants discovered in the UK and South Africa. According to the US biopharma company, genetic analyses of publicly available sequences for the new variants of SARS-CoV-2 suggest the mutations in the viral spike protein that have made them more transmissible shouldn’t affect the way Veklury (remdesivir) works.

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CRUK scientists develop drug that targets KRAS pathways

Pharma Times

KRAS mutations are found in several hard-to-treat cancers

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New patent for Vertex Pharms drug SYMDEKO (COPACKAGED)

Drug Patent Watch

Annual Drug Patent Expirations for SYMDEKO+%28COPACKAGED%29 Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. There are twenty patents protecting this drug. This…. The post New patent for Vertex Pharms drug SYMDEKO (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.

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PMN WEBINAR: Video, Voice, and Virtual: Applying New Digital Technology to Enhance Customer Experience

Pharma Marketing Network

Pharma-Marketing is owned and operated by eHealthcare Solutions. The post PMN WEBINAR: Video, Voice, and Virtual: Applying New Digital Technology to Enhance Customer Experience appeared first on Pharma Marketing Network.

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COVID-19 a ‘catalyst’ for innovation in 2020: Oracle

Outsourcing Pharma

A leader from Oracle Health Sciences examines the dynamic, challenging year and highlights creativity and ingenuity displayed by research professionals.

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Alzheimer’s Drug Shows Promise in Small Trial

NY Times

Participants with the disease still declined, but much more slowly than those receiving a placebo, investigators say.

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What we’re expecting in 2021, and beyond…

pharmaphorum

From telehealth to digital trials, customer engagement to healthcare data, Healthware Group outlines the key trends that are expected to shake up digital health this year. Well, it goes without saying, COVID-19 has resulted in a rapid adoption of digital technologies across all industries, most notably in healthcare. There are several important aspects to these shifts for pharma, biotech and medical device companies, so what can we expect to see over the next 12 months and beyond?

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Boehringer Ingelheim announces partnership with Google

Pharma Times

Partnership will aim to research and implement quantum computing in pharma R&D

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Approvals in the Crazy Year of 2020

Eye on FDA

Each year in January, it is relevant to look back on the activities of FDA during the course of the previous year and look at how it was the same or different from prior years, and to look at trends in new direction. This past year, needless to say was a doozy on all fronts. Let’s begin by looking at approvals. One might have surmised that the advent of the COVID-era might have thrown off new approvals and that NMEs approved would go diminish.

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New patent for Genus Lifesciences drug GOPRELTO

Drug Patent Watch

Annual Drug Patent Expirations for GOPRELTO Goprelto is a drug marketed by Genus Lifesciences and is included in one NDA. There are six patents protecting this drug. Drug patent litigation…. The post New patent for Genus Lifesciences drug GOPRELTO appeared first on DrugPatentWatch - Make Better Decisions.

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Veeva Systems converts to a public benefit corporation

Outsourcing Pharma

While the change signifies the life-sciences solutions firmâs commitment to help customers and patients, day-to-day functions will remain much the same.

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As Virus Variants Spread, ‘No One Is Safe Until Everyone Is Safe’

NY Times

Rich countries are cornering the market on coronavirus vaccines, leaving poorer regions as potential breeding grounds for variants, like one found in South Africa, that could make vaccines less effective.

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Allergic reactions prompt Moderna COVID vaccine pause in California

pharmaphorum

Public health authorities in California are seeking a halt on dosing of one lot of Moderna’s COVID-19 vaccine after reports of allergic reactions at one immunisation clinic. According to state epidemiologist Dr Erica Pan, there were a higher-than-expected number of suspected allergic reactions at a community clinic being used to administer the shot, with some people needing medical attention in a 24-hour period.

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Xalkori bags FDA green light for rare paediatric non-Hodgkin lymphoma

Pharma Times

Therapy approved for the treatment of paediatric patients with anaplastic large cell lymphoma

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What They Said – Overview of FDA Press Releases for 2020

Eye on FDA

Well. They said a lot. A lot more than ever, as one might expect. This past year, FDA issued a whopping 420 press releases, more so by far than any year previously. COVID certainly made a big impact – a whopping 65 percent of FDA press releases had to do with the subject of the pandemic. In late March FDA began issuing Coronavirus Updates labeled as a “Daily Roundup” except they weren’t actually always a daily release – some days got skipped.

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New patent for Genus Lifesciences drug GOPRELTO

Drug Patent Watch

Annual Drug Patent Expirations for GOPRELTO Goprelto is a drug marketed by Genus Lifesciences and is included in one NDA. There are six patents protecting this drug. Drug patent litigation…. The post New patent for Genus Lifesciences drug GOPRELTO appeared first on DrugPatentWatch - Make Better Decisions.

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Paradigm4, 54gene collaborate on African clinical data

Outsourcing Pharma

With fewer than 3% of analyzed genomes currently coming from Africans, the companies are looking to increase access to and understanding of patient data.

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Which Covid Vaccine Should You Get? Experts Weigh the Effect Against Severe Disease

NY Times

Infectious disease doctors say getting a shot of the J&J vaccine, which has a lower efficacy against the virus than other vaccines, would still be well worthwhile.

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Bad news for Pfizer as blockbuster Xeljanz flunks safety study

pharmaphorum

JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. The post-marketing safety study showed that Xeljanz (tofacitinib) – used to treat rheumatoid arthritis (RA) – was associated with a higher rate of heart attacks and cancer than a TNF inhibitor in patients aged over 50 with underlying cardiovascular risk factors.

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Moderna says its COVID-19 vaccine works effectively against variants

Pharma Times

Lab tests evaluated vaccine's efficacy against UK and South African variants

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Clinical research in 2021: A new era of collaboration and innovation

pharmaphorum

The clinical research community has been disrupted in a number of ways due to COVID-19 and sparked a spirit of collaboration and innovation. Worldwide Clinical Trial’s Aman Khera gives five predictions of how clinical research could change in 2021. The pandemic has propelled the life science industry toward higher expectations for faster, more responsive and more inclusive drug development.

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Pfizer/BioNTech vaccine may work against new virus mutation, scientists say

pharmaphorum

The Pfizer/BioNTech vaccine appears to work against an important mutation in the new coronavirus variants causing havoc in the UK and South Africa, according to research from the drugs giant. Findings of the lab study posted online have not yet been peer reviewed but provide some reassurance for countries like the UK, which are relying on vaccines to bring the pandemic under control.

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RedX Pharma CEO focuses on pipeline that found Lilly’s rising star

pharmaphorum

Back in 2017, the UK biotech RedX Pharma had to sell its prized asset after administrators stepped in to stave off a debt crisis, with Loxo Oncology snapping up the BTK inhibitor for $40 million. That drug, now known as LOXO-305 was one of the stars of the American Society of Haematology (ASH) conference in December, finding its way into Eli Lilly’s pipeline after the big pharma’s $8 billion takeover of Loxo.

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