Bio Pharma Dive
APRIL 19, 2021
If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies.
World of DTC Marketing
APRIL 11, 2021
QUICK THOUGHT: People believe the COVID-19 vaccine was developed in less than a year but that’s not true. Coronaviruses were first encountered in April 1930, when a strange respiratory disease ravaged poultry farms across North Dakota and Minnesota, killing tens of thousands of baby birds. Further scientific research into the virus and recognition that it was not like influenza A, a flu virus known to cause bronchitis, would transpire over the next 30 years. .
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Camargo
APRIL 14, 2021
In 2020, CDER approved 68 NDAs that used the 505(b)(2) pathway, representing important advances in patient care across a wide range of therapeutic areas. 505(b)(2) Drug Improvement Approvals by Year. In spite of an unusual year due to the COVID-19 pandemic, NDA approvals via the 505(b)(2) pathway increased 6% from 64 in 2019 to 68* in 2020 (Figure 1).
BioPharma Reporter
APRIL 27, 2021
Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily.
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
BioSpace
APRIL 25, 2021
Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China.
pharmaphorum
APRIL 14, 2021
More than 5,000 collaborative studies were thwarted by GDPR rules in 2019 – but is there a way to protect sensitive data while still allowing international health research to thrive? . A coalition of European academy networks has called upon European Union (EU) leaders to rethink how General Data Protection Regulation (GDPR) rules are applied to health data.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
World of DTC Marketing
APRIL 9, 2021
QUICK READ: A two-month analysis of social media and prescription drugs found the number one reason online health seekers use social media is to share and ask questions about medication side effects. I also found an abundance of medication misinformation based on personal experiences and hearsay. In conjunction with leading consumer magazine I worked on a study to determine why people were using social media for information on prescription drugs and to examine and quantify what they were sharing
Camargo
APRIL 7, 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. Rare Disease Clinical Trials Most Often Terminated Due to Regulatory and Recruitment Issues. The difficulty associated with successfully completing rare disease clinical trials is well-known.
BioPharma Reporter
APRIL 15, 2021
Moderna will take mRNA flu and HIV vaccines into Phase 1 trials this year, as well as beginning a pivotal Phase 3 study for its cytomegalovirus (CMV) vaccine candidate.
BioSpace
APRIL 22, 2021
The same group at the University of Oxford and the Jenner Institute that developed the AstraZeneca-Oxford COVID-19 vaccine reported that their investigational malaria vaccine, R21/Matrix-M, demonstrated 77% efficacy in children over 12 months of follow-up.
NY Times
APRIL 25, 2021
Nearly 8 percent of those who got initial Pfizer or Moderna shots missed their second doses. State officials want to prevent the numbers from rising.
Bio Pharma Dive
APRIL 20, 2021
New developments could come soon for two coronavirus vaccines while, a bit further off, the fate of Biogen's Alzheimer's drug hangs in the balance. Important data are expected, too, for Vertex and Sarepta.
World of DTC Marketing
APRIL 13, 2021
QUICK READ: Recent research from Zoom Rx saying that digital interactions with HCPs are myopic and don’t apply to the heavily segmented HCP audience. The future of reaching HCPS is both on and off-line depending on the product, health condition, and specialty. Zoom Rx recently polled HCPs and found 78% of physicians want to maintain some contact with pharma reps.
pharmaphorum
APRIL 19, 2021
The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce. . Last August the UK government finalised a deal with Novavax to purchase 60 million doses of the NVX-CoV2373 vaccine, which will also be manufactured in the country at a plant owned by FUJIFILM Diosynth Biotechnologies in Stockton-on-Tees.
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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
Camargo
APRIL 20, 2021
Cancer is not a single disease, but rather hundreds of different diseases. Thus, there will never be a single cure to cancer. As our knowledge of oncology science advances and expands, a growing number of malignancy types and subtypes are constantly being identified, breaking down target patient populations into ever-smaller fractions. This trend progressively reduces the attractiveness of engaging in the early stages of oncology therapy development in the eyes of Big Pharma and opens the space
BioSpace
APRIL 11, 2021
Researchers are leveraging the messenger RNA (mRNA) technology used to develop the Pfizer-BioNTech and Moderna COVID-19 vaccines for possible treatments for a range of other diseases, including HIV and cancer.
Pharma Times
APRIL 26, 2021
Monoclonal antibody reduced lower respiratory tract infections due to RSV in healthy infants
Bio Pharma Dive
APRIL 14, 2021
Advisers to the agency agreed to wait for more data before recommending new guidance, but aim to reconvene quickly to decide on whether vaccinations with J&J's should be resumed, and for whom.
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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.
World of DTC Marketing
APRIL 21, 2021
QUICK READ: There is so much money in healthcare that every company wants their share even if patients get hurt. The amount of money Pfizer is going to make from their vaccine borders on obscene while PBMs quietly take a cut of every Rx transaction without really adding any value. It’s going to continue until we put politics aside and say “enough.” J&J has had problems in the past, but they’re trying to be an ethical and responsible pharma company.
pharmaphorum
APRIL 12, 2021
A scheduled update to the NHS COVID-19 app has been blocked because it allows location tracking – something prohibited by Apple and Google, which developed some of the code it uses. . The new version of the app used in England and Wales was due to become available today to coincide with the relaxation of lockdown rules, with the public now able to attend venues such as non-essential shops, pub beer garden, gyms and hairdressers.
NY Times
APRIL 15, 2021
Many cannot produce enough infection-fighting cells to fend off the coronavirus. But researchers are testing one therapy that may help: monoclonal antibodies.
BioSpace
APRIL 8, 2021
BioSpace takes a look at the annual compensation for the chief executive officers of vaccine developers.
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.
Camargo
APRIL 28, 2021
Conducting a clinical study in a pediatric patient population requires careful planning, as providing a benefit to a child without causing harm is a weighty responsibility. The first tasks in striking this balance are dose selection and dosing interval determination, and this blog post offers an overview on how PK modeling and simulation can be applied to optimize the safety and efficacy of a product for pediatric populations in clinical trials.
Bio Pharma Dive
APRIL 13, 2021
The FDA and CDC recommended halting vaccinations while they investigate six cases of unusual blood clots in women given the company's shot.
World of DTC Marketing
APRIL 22, 2021
QUICK READ: More TV DTC spots are airing, but DTC marketers are losing the battle between awareness and conversion because of all the noise online. Product websites are stagnant, and online health seekers are going elsewhere to learn about your medication’s side effects and cost. I’ve spent the last six months analyzing clients’ DTC marketing campaigns and they are, for most ineffective.
pharmaphorum
APRIL 6, 2021
From #MeToo to Black Lives Matter, as a society we have been discussing the relationship between representation and equality more than ever over the last few years. . But while progress is being made in so many areas, people with disabilities are still struggling to find a voice above the accepted narrative, says Ross Lannon, the 27-year-old blogger and multi-media content creator behind A Life on Wheels.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Pharma Mirror
APRIL 28, 2021
Ahead of CPhI Discover (17th-28th May, 2021) – global pharma’s largest ever virtual gathering – the CPhI executive post-pandemic pharma survey[i] predicts that pandemic supply chain issues have further cemented a push for repatriated manufacturing globally. The findings suggest that over the next five years, governments and companies will gradually look to reduce complexity and increase regional self-reliance.
BioSpace
APRIL 11, 2021
Six months after a COVID-19 diagnosis, more than 33% of people exhibited some form of brain damage, according to a study appearing in Lancet Psychiatry.
Pharma Times
APRIL 28, 2021
UK government has also offered a first vaccine dose to all individuals in cohorts one to nine
Bio Pharma Dive
APRIL 16, 2021
The request comes less than six months after the FDA authorized Lilly's bamlanivimab, reflecting the spread of virus variants that can elude the drug.
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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