Novo to acquire Dicerna for more than $3B amid RNA drug resurgence
Bio Pharma Dive
NOVEMBER 18, 2021
The acquisition is a rare deal for Novo Nordisk, which has been partnered with Dicerna since 2019.
Sat.Nov 13, 2021 - Fri.Nov 19, 2021
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Omnichannel marketing is the answer but what’s the question?
World of DTC Marketing
NOVEMBER 16, 2021
SUMMARY: Omnichannel marketing employs the simultaneous implementation of channels across personal, non-personal, and media and addresses the integrated needs of multiple stakeholders – consumers/patients, healthcare professionals, and payers. Sounds good but is that the answer? There is no doubt that healthcare is the middle of an evolution not seen in over 30 years.
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In the News: October 2021 Regulatory and Development Updates
Camargo
NOVEMBER 15, 2021
Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. FDA Guidance Addresses Real-World Evidence Data Standards. The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F).
Report: UK disposed of 600,000 AZ vaccine doses after they passed expiry date
Pharma Times
NOVEMBER 16, 2021
The data was obtained by a Freedom of Information request, according to The Independent
Bridging Innovation & Patient Care: The Growing Role of AI
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults
Bio Pharma Dive
NOVEMBER 19, 2021
The decision comes as at least 10 states have already begun opening up booster dose eligibility, with cases remaining at high levels across the country.
It’s getting harder to launch a new drug to physicians
World of DTC Marketing
NOVEMBER 15, 2021
SUMMARY: Physicians are tired and overwhelmed with medical information on new drugs. They don’t have the time to sit in the office and search for more information, and they feel that pharma is giving them “too much” information. An exciting development presented itself. A client launched an Oncology drug based on extensive research with physicians, but the results were not that good during a post-launch evaluation.
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Under-18s with COVID-19 in UK advised to wait 12 weeks for vaccine dose
Pharma Times
NOVEMBER 18, 2021
The UKHSA have said that deferring the vaccine dose could help to reduce even further the small risk of heart inflammation following vaccination
Years later, a first-of-its-kind treatment shows the power, and limits, of gene therapy
Bio Pharma Dive
NOVEMBER 15, 2021
Luxturna, approved four years ago as the first gene therapy for an inherited disease in the U.S., is improving sight and quality of life for several of the patients who received it.
Moderna is corporate greed at its worst
World of DTC Marketing
NOVEMBER 19, 2021
SUMMARY: The U.S. government has provided Moderna with nearly $10 billion in taxpayer money for research and development and the purchase of 500 million doses of this mRNA COVID-19 vaccine. This includes almost the entire cost of clinical development. Additionally, Moderna used patents and non-exclusive rights that the U.S. government made available to them to make this COVID-19 vaccine.
Boost for Amazon’s telehealth business, as Hilton signs up
pharmaphorum
NOVEMBER 16, 2021
Amazon’s push into the provision of remote healthcare services has been rewarded with a top-tier corporate client – the Hilton hotel chain. The deal – first reported by Reuters – involves the Amazon Care platform, which includes remote, online consultations with clinicians, as well as home visits in some areas. It provides primary and preventive care, ongoing support for chronic conditions, and referrals to secondary and tertiary care.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
MHRA authorises Vumerity for multiple sclerosis patients
Pharma Times
NOVEMBER 19, 2021
Vumerity is a next-generation oral fumarate treatment for adults with relapsing-remitting multiple sclerosis
European drugs regulator signals rejection likely for Biogen's Aduhelm
Bio Pharma Dive
NOVEMBER 17, 2021
A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month
AbbVie continues to be what’s wrong with big pharma
World of DTC Marketing
NOVEMBER 18, 2021
SUMMARY: AbbVie continues to profit from Americans by repeatedly raising U.S. prices on its widely-used Humira rheumatoid arthritis drug while cutting the price abroad. AbbVie exploits the U.S. patent system to fend off competitors and increased the price of Humira to $77,000 for a year’s supply, while the price of its cancer drug Imbruvica was raised to $181,529 per year.
AZ, Moderna say mRNA drug is promising in heart failure
pharmaphorum
NOVEMBER 16, 2021
Moderna is already riding high on the strength of its mRNA-based COVID-19 vaccine, but the broader potential of its technology has been shown in a new AstraZeneca-partnered candidate for heart failure. At the American Heart Association (AHA) congress, the two partners presented results from the phase 2a EPICCURE trial that showed that injecting their AZD8601 candidate directly into the heart muscle of patients undergoing coronary artery bypass graft (CABG) surgery seemed to improve heart functio
Vertex receives CHMP positive opinion for Kaftrio in children with cystic fibrosis
Pharma Times
NOVEMBER 15, 2021
Those eligible will have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
A startup emerges with $125M and plans to edit the epigenome
Bio Pharma Dive
NOVEMBER 17, 2021
Chroma Medicine's launch is the latest step in a decadeslong quest by drugmakers to capitalize on research into epigenetics, a way of controlling gene expression without altering DNA.
Global pharma industry gathers at CPhI Worldwide 2021 as surge in partnering expected in 2022
Pharma Mirror
NOVEMBER 19, 2021
Amsterdam, CPhI Worldwide (9-11 November, 2021), which held its first in-person event since 2019, hosted the global pharma community at the Fiera Milano, Milan, welcoming exhibitors and attendees from 146 countries. This year’s smart event was a combination of a three-day live exhibition, and a month-long online event featuring both the latest market insights through live and on demand content sessions and of course networking opportunities.
Pfizer, BioNTech and Zipline deliver COVID-19 vaccines by drone in Ghana
BioPharma Reporter
NOVEMBER 15, 2021
Pfizer and BioNTech have completed long-range drone deliveries of their mRNA COVID-19 vaccine: with partner Zipline claiming to be the first to deliver vaccines in this way at a national scale.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
NICE recommends Inrebic for rare blood cancer
Pharma Times
NOVEMBER 19, 2021
Eligible adult patients with primary or secondary myelofibrosis will now be able to access the treatment on the NHS
Anticipating Aduhelm's costs, Medicare plans big jump in premiums
Bio Pharma Dive
NOVEMBER 15, 2021
While CMS is still weighing whether to authorize wide coverage of Biogen's pricey Alzheimer's drug, administrators are planning to build reserves in case costs skyrocket.
China sees huge bounce in pharma rankings ahead of hybrid CPhI & P-MEC China
Pharma Mirror
NOVEMBER 18, 2021
Shanghai, China’s pharma industry has seen a record improvement in its overall score, growth potential and biologics according to new data. The China specific findings of the CPhI Annual Report rankings[1] are released ahead of CPhI & P-MEC China – which will take place in hybrid form, with Virtual Expo Connect running digitally from November 18th until December 18th, and the in-person event held at the Shanghai New International Expo Center (SNIEC) December 16-18th, 2021.
Respira Labs’ wearable device listens for lung diseases
pharmaphorum
NOVEMBER 19, 2021
US company Respira Labs has developed a device worn on the chest that uses tiny speakers and microphones to project sound into the lungs and listen for signals that could indicate serious lung diseases. The Sylvee wearable uses an artificial intelligence (AI) algorithm to interpret sounds that may indicate trapped air in the lungs, which can be a sign of ill health, using acoustic resonance – similar to the way an ultrasound machine creates visual images.
How Machine Learning Drives Clinical Trial Efficiency
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
EC approves Celltrion’s COVID-19 mAb Regkirona
Pharma Times
NOVEMBER 16, 2021
Treatment authorised for use in adults with COVID-19 who are at high-risk of progressing to severe disease
Pfizer asks FDA to authorize COVID-19 pill
Bio Pharma Dive
NOVEMBER 16, 2021
Study results released earlier this month showed the pill, when given soon after symptoms start, dramatically reduced the risk of COVID-19 hospitalization or death.
Emmes and MedGenome Launch Genomics Strategic Partnership Focused on Advancing Rare Disease Research
Pharma Mirror
NOVEMBER 16, 2021
Rockville, Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced a partnership with MedGenome aimed at accelerating breakthrough treatments, powered by human genomics, for rare disease patients. “This is an exciting opportunity to partner with the leading genetic testing laboratory in India and South Asia to use our collective expertise to help bring faster and more innovative treat
Parliamentary probe finds racism evidence in NHS sickle cell care
pharmaphorum
NOVEMBER 15, 2021
Patients with sickle cell disease are facing racism in the NHS that is putting their lives a risk, claims a new report. . The All-Party Parliamentary Group (APPG) document – entitled No One’s Listening and partnered with the Sickle Cell Society – found “serious care failings” in acute services and evidence of attitudes underpinned by racism in the care of people with SCD, a red blood cell disorder that mainly affects black people.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
JCVI advises extending COVID-19 booster programme
Pharma Times
NOVEMBER 15, 2021
All adults aged 40- to 49-years-old to be offered an mRNA vaccine booster dose
FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer
Bio Pharma Dive
NOVEMBER 18, 2021
Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely.
BioNTech Bags Fast-Track Status for Melanoma Treatment
BioSpace
NOVEMBER 18, 2021
BioNTech is on the Fast Track. This morning, the company announced it received Fast Track Designation from the U.S. Food and Drug Administration for its cancer immunotherapy candidate.
F.D.A. Authorizes Coronavirus Booster Shots for All Adults
NY Times
NOVEMBER 19, 2021
If the C.D.C. agrees, adults who received a second shot of the Pfizer or Moderna vaccine at least six months ago could be eligible by this weekend.
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