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

Vaccines 144
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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.

Vaccines 140
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Trending Sources

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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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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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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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Pfizer Will Ship Fewer 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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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.

Vaccines 135

More Trending

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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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Eli Lilly Claims Drug Prevents Coronavirus Infection in Nursing Homes

NY Times

A monoclonal antibody protected residents and staff members in facilities where the virus had appeared.

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Unlocking the potential in rare disease research with decentralised trials

pharmaphorum

A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease. With low and geographically dispersed patient populations in rare disease, deciding where best to place trial sites can be a headache for sponsors.

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ConserV Bioscience to develop ‘broad-spectrum’ coronavirus vaccine

Pharma Times

UK biotech company will collaborate with Lawrence Livermore National Laboratory

Vaccines 122
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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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Boston University taps Shimmer wearables for brain studies

Outsourcing Pharma

The trials, funded by the American Heart Association, will harness the companyâs Verisense wearable sensor platform to examine brain-heart health links.

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Drug Prevents Coronavirus Infection in Nursing Homes, Maker Claims

NY Times

A monoclonal antibody protected residents and staff members in facilities where the virus had appeared.

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First Psychiatry Consortium funded project announced for schizophrenia

pharmaphorum

A partnership between University of Oxford, the Earlham Institute, and the global pharmaceutical companies Biogen Inc and Boehringer Ingelheim is announced today to investigate a new drug target for the treatment of schizophrenia. This is the first project to be funded by the international Psychiatry Consortium, a £4 million collaboration between seven global pharmaceutical companies, and two leading research charities, convened and managed by the Medicines Discovery Catapult, that supports high

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Gilead's Veklury should be effective against COVID-19 variants

Pharma Times

Company has completed genetic analysis for UK and South African variants

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Pfizer pours $25m into Vedanta's Phase II IBD study

Outsourcing Pharma

The pharma giant has invested in the clinical trial exploring the viability of Vedanta Biosciencesâ VE202 inflammatory bowel disease treatment candidate.

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F.D.A. Approves Monthly Shots to Treat H.I.V.

NY Times

A combination of two injectable drugs will provide an alternative to daily pills for people with H.I.V.

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AZ/Daiichi Sankyo’s Enhertu gets second US cancer indication

pharmaphorum

AstraZeneca and Daiichi Sankyo’s Enhertu cancer drug has picked up a second indication, in patients who have stomach cancer and haven’t responded to Roche’s Herceptin (trastuzumab). This latest indication adds to Enhertu first approval at the end of 2019 for advanced HER2-positive breast cancer after two or more HER2-targeted regimens. Around one in five gastric cancers are HER2-positive, opening up a new market niche for AstraZeneca and Daiichi Sankyo, who have been working on Enhertu (trastuzu

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Enhertu bags EU approval for HER2-positive breast cancer

Pharma Times

Approximately one in five breast cancer cases in the EU are HER2-positive

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New patent for Pf Prism drug INLYTA

Drug Patent Watch

Annual Drug Patent Expirations for INLYTA Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are four…. The post New patent for Pf Prism drug INLYTA appeared first on DrugPatentWatch - Make Better Decisions.

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‘It Was a Fraud,’ Cuomo Says of Vaccine Rollout

NY Times

Gov. Andrew M. Cuomo of New York said on Monday that he had asked the pharmaceutical giant Pfizer to directly sell doses to the state, so that it does not have to depend solely on the federal government to distribute doses.

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Pfizer/BioNTech say COVID-19 vaccine works against UK variant

pharmaphorum

Laboratory studies have confirmed that antibodies stimulated by Pfizer and BioNTech’s COVID-19 vaccine can neutralise the new, more transmissible variant of SARS-CoV-2 identified in the UK. The results of the study – published online prior to peer review – are among the first data to indicate that any of the approved coronavirus vaccines can effectively target the mutated spike protein in the UK strain, known as B.1.1.7 lineage or VOC 202012/01.

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NICE no for BMS’ multiple sclerosis drug Zeposia

Pharma Times

Cost-effectiveness estimates 'uncertain', according to NICE

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New patent for Genzyme Corp drug CERDELGA

Drug Patent Watch

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

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Ukraine Ended Secret Government Spending. Vaccine Makers Now Demand It.

NY Times

Seeking to secure vital supplies, the authorities in the country maneuvered around anticorruption rules that require public disclosure of contracts.

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NICE rejects BMS’ Zeposia MS pill in provisional guidance

pharmaphorum

NICE has said that the NHS should not fund Bristol-Myers Squibb’s multiple sclerosis pill Zeposia (ozanimod) for relapsing multiple sclerosis in first draft guidance. The cost-effectiveness body said that trial evidence showed Zeposia cuts the number of relapses and brain lesions compared with Biogen’s Avonex (interferon beta-1a). But in its first draft guidance NICE said that Zeposia’s effect on progression of disability is unclear.

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ViiV Healthcare continues HIV care partnership with Chelsea and Westminster Hospital

Pharma Times

Partnership aims to transform HIV patient care with digital services

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New patent for Evofem Inc drug PHEXXI

Drug Patent Watch

Annual Drug Patent Expirations for PHEXXI Phexxi is a drug marketed by Evofem Inc and is included in one NDA. It is available from one supplier. The generic ingredient in…. The post New patent for Evofem Inc drug PHEXXI appeared first on DrugPatentWatch - Make Better Decisions.

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Enhance Patient Care And Cost Savings By Improving Data Exchange Within The Systems You Already Have

Drug Channels

Today’s guest post comes from Jason Coles, Senior Product Manager for Clinical Effectiveness at Wolters Kluwer, Health. Jason discusses the benefits of accessing patient information across clinical contexts. He introduces us to the Wolters Kluwer drug data solutions. These solutions promote interoperability and help healthcare businesses meet regulations related to health information exchange.

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J&J’s Darzalex Faspro is first US therapy for rare blood disorder

pharmaphorum

Johnson & Johnson’s Darzalex Faspro has become the first product approved by the FDA to treat light chain (AL) amyloidosis, a rare and often fatal blood cell disorder. The new indication is the second for Darzalex Faspro, a subcutaneous version of blockbuster intravenous therapy Darzalex (daratumumab) which is used to treat multiple myeloma on its own and as part of multiple combination therapies.

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SMC kicks of the new year by accepting five new medicines for NHS use

Pharma Times

Darzalex, Rozlytrek and Tavlesse among newly accepted drugs

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New patent for Pf Prism drug INLYTA

Drug Patent Watch

Annual Drug Patent Expirations for INLYTA Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are four…. The post New patent for Pf Prism drug INLYTA appeared first on DrugPatentWatch - Make Better Decisions.

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Federal Court updates guidance on COVID-19

Pharma in Brief

On January 18, 2021, the Federal Court ( FC ) issued its latest COVID-19 Practice Direction , which supersedes all its prior COVID-19 practice directions. The FC’s facilities in Ontario and Quebec have been closed in light of the recent public health measures to combat the pandemic. The FC will continue its operations remotely in these two provinces until further notice.

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Education and empowerment would provide more equal access to care

pharmaphorum

Ella Balasa says she owes her life to the experimental phage therapy she was able access in no small part thanks to her scientific background. Her mission, she told pharmaphorum, is to ensure everyone has the knowledge and power they need to navigate their own healthcare journey, no matter where they are from or what they do. Ella, 28, was diagnosed with cystic fibrosis – a rare genetic disease which causes a build-up of thick, sticky mucus in the lungs, digestive tract, and sinuses – at 18 mont

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NICE publishes final guidance backing Jyseleca for rheumatoid arthritis

Pharma Times

Over 400,000 people in the UK live with RA

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New patent for Genzyme Corp drug CERDELGA

Drug Patent Watch

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

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