Sat.Jun 26, 2021 - Fri.Jul 02, 2021

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BioMarin resubmits haemophilia A gene therapy to the EMA

Pharma Times

Company initially withdrew a marketing authorisation application for the gene therapy last year

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AZ drug for hard-to-treat heart failure has mixed results in trial

pharmaphorum

AstraZeneca has reported the first phase 2 results with a drug for heart failure with preserved ejection fraction (HFpEF), showing it worked as expected but wasn’t able to provide any clinical benefit to patients. . Daily doses of AZD4831 were able to reduce the activity of myeloperoxidase (MPO), an enzyme linked to tissue and blood vessel damage due to inflammation and scar tissues formation (fibrosis) in models of cardiovascular disease, by 69% after 30 days in the phase 2a SATELLITE stu

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The FDA Should Fully Approve Pfizer and Moderna's Vaccines

NY Times

The Pfizer and Moderna vaccines are safe and effective. Full approval from the F.D.A. will help stop the spread of Covid-19.

Vaccines 117
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Signify Health partners on decentralized trials for children’s cancer

Outsourcing Pharma

The trial solutions firm is working with Childrenâs Oncology Group to expand in-home research and care options for investigational immune-oncology therapy.

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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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‘Mix and match’ COVID-19 vaccine study yields promising results

Pharma Times

Mixing different vaccines produces a strong immune response against virus, according to researchers

Vaccines 127
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MHRA grants bluebird ‘innovation passport’ for sickle cell therapy

pharmaphorum

bluebird bio’s sickle cell disease (CD) gene therapy LentiGlobin is the latest recipient of an ‘innovation passport’ introduced in the UK earlier this year to speed up NHS access to promising new medicines. The designation means that LentiGlobin will be reviewed by the Medicines and Healthcare products Regulatory Agency (MHRA) via the new innovative licensing and access pathway (ILAP) introduced last December.

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Formedix launches cloud-based clinical metadata repository

Outsourcing Pharma

The companyâs Ryze technology combines a clinical MDR and study automation platform, designed to accelerate and optimize design and execution of trials.

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bluebird bio’s sickle cell gene therapy granted MHRA ‘innovation passport’

Pharma Times

Innovation passport designation scheme aims to reduce the time to market for promising treatments

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Altimmune ditches nasal COVID vaccine on weak trial data

pharmaphorum

Just a few months after starting clinical trials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immune responses in a phase 1 trial. . It’s a big disappointment for Altimmune, which said back in February that it was hoping to find a more convenient alternative to injected COVID-19 vaccines – and one which would be stable at room temperature, making distribution and delivery easier.

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Training the Next Generation of Indigenous Data Scientists

NY Times

A new workshop explores the right of Indigenous people to govern the collection, ownership and use of their biological and cultural data.

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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 Merck Sharp drug NOXAFIL

Drug Patent Watch

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

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MSD’s Keytruda scores EU approval in certain oesophageal cancer patients

Pharma Times

Checkpoint inhibitor approved in combination with chemotherapy in the first-line setting for these patients

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Merck partners neuroloop on bioelectronic device for inflammation

pharmaphorum

Merck KGaA has joined forces with a unit of medtech firm B Braun – neuroloop – on a way to treat inflammatory diseases using neurostimulator devices. The German drugmaker will work with startup neuroloop on bioelectronics , put simply the harnessing of electrical stimulation to treat human disease, with a focus on chronic conditions like arthritis and inflammatory bowel disease. neuroloop – a spinout of Freiburg University in Germany formed in 2016 – has been working to date on using its device

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An Opioid Case Like No Other: New York vs the Entire Supply Chain

NY Times

New York’s sweeping lawsuit is the first opioid case in which a jury rather than a judge will decide the outcome.

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New patent expiration for Bausch And drug BESIVANCE

Drug Patent Watch

Annual Drug Patent Expirations for BESIVANCE Besivance is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from two suppliers. There are five…. The post New patent expiration for Bausch And drug BESIVANCE appeared first on DrugPatentWatch - Make Better Decisions.

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Sanofi plans €400m investment in mRNA vaccines ‘centre of excellence’

Pharma Times

Sanofi is currently collaborating with Translate Bio on a mRNA-based COVID-19 vaccine candidate

Vaccines 128
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Climate change: The elephant in the waiting room of health

pharmaphorum

Pharma has both an opportunity and a responsibility to do its part in tackling climate change – and the time to act is now, according to speakers at a recent event. Amanda Barrell reports. The pharma industry has clearly stated its commitment to a net zero future, but where are we on that journey, what else can be done, and could organisations achieve more if they worked together?

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Experts to talk rare and orphan diseases, patient experience at webinar

Outsourcing Pharma

On July 7, a group of seasoned industry leaders will offer insights at Rare/orphan diseases, special patient population, a focused, free online event.

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New patent for Neurocrine drug INGREZZA

Drug Patent Watch

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

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Gilead seeks US approval for long-acting HIV drug lenacapavir

Pharma Times

Lenacapavir is designed to inhibit HIV-1 replication by interfering with a number of ‘essential’ steps in the viral lifecycle

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Exelixis’ Cabometyx misses survival target in liver cancer trial

pharmaphorum

Exelixis has suffered a blow to its efforts to expand the use of Cabometyx into additional indications after reporting mixed results in a phase 3 trial in liver cancer. The COSMIC-312 study is comparing Cabometyx (cabozantinib) given alongside Roche’s cancer immunotherapy Tecentriq (atezolizumab) to Bayer’s Nexavar (sorafenib) as a first-line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer.

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Drug Channels News Roundup, June 2021: Amazon's Latest, Patients vs. Accumulators, Generics & Biosimilars, 340B Games, and a Hospital Road trip

Drug Channels

Happy 245th birthday, America! As you declare your vaccinated independence, celebrate with these Drug Channels fireworks: Amazon’s teeny step toward pharmacy disruption How patients view copay accumulators My $0.02 on generic and biosimilar trends Some hospitals seem to be gaming their 340B eligibility Plus, tips on effective hospital marketing. P.S.

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New patent for Indivior Inc drug PERSERIS KIT

Drug Patent Watch

Annual Drug Patent Expirations for PERSERIS+KIT Perseris Kit is a drug marketed by Indivior Inc and is included in one NDA. It is available from one supplier. There are seven…. The post New patent for Indivior Inc drug PERSERIS KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Jazz Pharma’s blood cancer therapy Rylaze wins US approval

Pharma Times

Rylaze has been specifically developed for patients who have developed hypersensitivity to E.

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Zydus Cadila nears world-first human plasmid DNA vaccine approval

pharmaphorum

Zydus Cadila has filed for emergency use approval (EUA) in India of its plasmid DNA-based vaccine for COVID-19, which if given a green light could become the first shot of its type to be cleared for widespread use in humans. . Leaving aside the possible technological milestone, the ZyCOV-D vaccine has a few characteristics that could stand in the way of its rollout, including a need for three doses, whereas all India’s current vaccines only need two.

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Mobile optometry service expands clinical trial support

Outsourcing Pharma

Thanks in part to the recent completion of an $8m investment, 2020 On-site plans to expand its services, including the mobile support of vision research.

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New patent expiration for Parapro Llc drug NATROBA

Drug Patent Watch

Annual Drug Patent Expirations for NATROBA Natroba is a drug marketed by Parapro Llc and is included in one NDA. It is available from two suppliers. There are two patents…. The post New patent expiration for Parapro Llc drug NATROBA appeared first on DrugPatentWatch - Make Better Decisions.

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Highest ever number of HCPs named on Disclosure UK, says ABPI

Pharma Times

Data also shows pharma companies worked with fewer HCPS and HCOs in 2020 compared to 2019

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NIH starts trial of Pear, Chess apps for opioid use disorder

pharmaphorum

Patient recruitment has begun in a National Institutes of Health (NIH) trial of two digital therapeutics (DTx) for people with opioid use disorder (OUD), developed by Pear Therapeutics and Chess Health. . The CTN-0100 study is test strategies to help keep people with OUD on drug treatment, improve the chances that those stabilised with drug treatments for OUD can come off medication without relapsing, as well as to find ways to predict the risk of relapse based on patient characteristics.

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Quest to Help Diabetic Son Endures With a Different Kind of Giving

NY Times

Sean Doherty set up a private equity-like fund with other parents four years ago. Some investments in research have worked. Some haven’t.

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New patent for Pfizer drug LORBRENA

Drug Patent Watch

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

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ABPI launches updated Code of Practice

Pharma Times

The new Code has been updated to reflect changes in the pharma environment

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Manchester joint venture will trial Morningside’s digital health portfolio

pharmaphorum

The University of Manchester has formed a joint venture with Morningside to carry out clinical trials of various digital health technologies developed by the investment group’s portfolio companies. . Health Innovation Manchester and its Academic Health Science Centre are also participating in the JV, which will focus on digital diagnostics and interventions that could play a role in prevention and early detection of disease and helping more patients to receive treatment outside the hospita

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Scleroderma Foundation increases research funding by more than 100%

Outsourcing Pharma

The organization, focused on building awareness and finding therapies for the rare disease, is boosting its annual research funding to more than $2.7m USD.

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New patent for Mayne Pharma drug LEXETTE

Drug Patent Watch

Annual Drug Patent Expirations for LEXETTE Lexette is a drug marketed by Mayne Pharma and is included in one NDA. It is available from one supplier. There is one patent…. The post New patent for Mayne Pharma drug LEXETTE appeared first on DrugPatentWatch - Make Better Decisions.

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