Fri.Jul 30, 2021

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A pharma merger's impact ripples across West Virginia as Viatris plant closes

Bio Pharma Dive

One of the country's oldest and largest drug manufacturing plants will shut down Saturday, a casualty of the 2019 merger between Mylan and Pfizer's Upjohn unit. The impact will be felt by a West Virginia city for years to come.

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How to choose the right digital agency

World of DTC Marketing

INTRODUCTION: One of the most important factors in your digital initiatives’ success, or failure, is the agency you choose. A lot of agencies are competing for our business. Ensuring you have hired the right one is essential to your brand’s success on both the HCP and consumers’ sides. Many CPG brands are bringing their digital marketing and media buying in-house to reduce costs and ensure that the digital strategies are aligned with key brand insights.

Branding 286
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FDA rejects a biotech's kidney drug, but some analysts still see a 'sliver of hope'

Bio Pharma Dive

The agency wants Ardelyx to run another trial to show its drug affects clinical outcomes for patients with chronic kidney disease. Analysts think this could be accomplished, but would take some time.

Drugs 319
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The State of Pediatric Clinical Research: An Interview with Paidion CEO Barry Mangum, PharmD, FCP

Camargo

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? I’ve been in the pediatric arena since 1976, and in those days, I was going to develop my career in pediatric oncology, specifically acute lymphocytic leukemia (ALL).

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Pfizer's fast progress shines spotlight on an emerging vaccine race

Bio Pharma Dive

The big drugmaker surprised analysts and investors this week by projecting Phase 3 results next year, which could put the company on pace with a rival shot from GlaxoSmithKline.

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Annovis Bio’s AD/PD Therapy Reduces Cytotoxic Cascade in Phase IIa Trials

BioSpace

Annovis Bio’s therapy for Alzheimer’s disease is fast-acting and has the potential for Alzheimer’s patients to significantly improve cognition and motor function, according to data presented at the Alzheimer’s Association International Conference® 2021 (AAIC®), held July 26th through 30th.

Trials 104

More Trending

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New Drug Proves to Ease the Itch for Chronic Spontaneous Urticaria

BioSpace

Topline results from a late-stage trial announced Thursday show Regeneron Pharmaceuticals and Sanofi's Dupixent (dupilumab) significantly reduced itch and hives better than antihistamines alone in biologic-naiïve patients with moderate-to-severe chronic spontaneous urticaria.

Drugs 100
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NICE publishes ‘rapid’ guideline on rare blood clots associated with COVID-19 jab

Pharma Times

Although condition is extremely rare, it requires ‘swift diagnosis and urgent treatment’ says NICE

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NotCo Receives $235 Million in Funding to Expand its AI Technology Worldwide

XTalks

NotCo, a Chilean food tech company known to make plant-based milk using its AI technology, called Giuseppe, raised $235 million in its Series D funding round, bringing its total funding to $360 million and a valuation of $1.5 billion. The funding round was led by Tiger Global and participants such as Jack Dorsey, Lewis Hamilton and Roger Federer. Other investors in the company include Bezos Expeditions, EHI, Future Positive and more.

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Beware using telemedicine for voice and speech therapy

Scienmag

As a result of the coronavirus pandemic, people across the world have experienced how teleconferencing platforms like Zoom help folks stay connected—playing games with friends, hosting virtual weddings, and even visiting a doctor. But when it comes to telemedicine, not all medical care is easily translated to a remote format. Credit: Charles Deluvio As a […].

Doctors 98
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Research Shows COVID-19 Victims Suffer Some Degree of Brain Damage

BioSpace

Researches seem to coincide that a person who has recovered from severe COVID-19 symptoms might experience cognitive function and memory loss later on.

Research 106
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Amwell dials in deals worth $320m to buy two digital health players

pharmaphorum

US telehealth group Amwell has agreed to buy two digital health specialists – SilverCloud Health and Conversa Health – as it looks to expand its services amid a boom in virtual healthcare delivery. SilverCloud specialises in digital cognitive behavioural health programmes aimed at people with mental health issues like anxiety and depression, while Conversa offers a telehealth-based patient engagement platform.

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EAPs, Regulatory Flexibility Discussed As House Committee Meets On ALS

BioSpace

The panels discussed key issues such as expanded access programs (EAPs), clinical trial diversity, conditional approval pathways, and patient experience data.

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GPs call for rescue plan to ‘save’ general practice in the UK

Pharma Times

RCGP's chair said that general practice in the UK is currently at a 'breaking point'

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Vertex Hopes to Channel CF Drug Successes into Other Therapies in the Pipeline

BioSpace

The company is eager to diversify, putting Phase II clinical trials in sickle-cell disease, beta-thalassemia, kidney diseases, and pain management.

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GSK’s Nucala approved to treat chronic rhinosinusitis with nasal polyps

Pharma Times

Nucala is the first IL-5 inhibitor to be approved for adult CRSwNP patients in the US

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Biogen adds real-world test for Aduhelm to its confirmatory trial

pharmaphorum

Biogen and partner Eisai have said they will run a large-scale observational study of Alzheimer’s drug Aduhelm in the US to build evidence for the drug’s efficacy following its controversial approval. The ICARE AD-US study will provide information on the long-term effectiveness and safety of Aduhelm (aducanumab) as prescribed in routine clinical practice within the US label, monitoring long-term changes in in cognition, function and neuropsychiatric status in around 6,000 patients ta

Trials 76
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Alnylam's Study on Renal Treatment Shows Promising Results In Phase III Trial

BioSpace

The FDA has already given its go-ahead to use lumasiran to treat PH1 and lower the urinary oxalate levels in pediatric and adult patients under the brand name OXLUMO.

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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U.S. Authorities Seek Documents From Troubled Covid Vaccine Manufacturer

NY Times

Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.

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NIH digital tool aims to boost enrolment into Alzheimer’s studies

pharmaphorum

With a string of new drugs for Alzheimer’s disease making their way through late-stage clinical testing, the demand for suitable subjects to enrol into trials is running at an all-time high – and threatens to outstrip supply. Now, the National Institute on Aging (NIA) – part of the US National Institutes of Health (NIH) – has developed an online recruitment tool to reach out to potential trial candidates through a range of communication channels, including websites, handouts, videos, and

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How To Bring Meaning and Purpose Into Your Clinical Research Job

Clinical Trial Gurus

It is easy to get lost in the minutiae of our daily tasks within clinical research, but what often keeps me going is being aware of my higher purpose, and being aligned with my long term goals.

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Takeda spins norovirus vaccine out into separate company

pharmaphorum

Takeda has decided development of its norovirus vaccine candidate outside Japan will be more efficient if it is spun out into a dedicated company. The Japanese drugmaker has partnered with venture capital company Frazier Healthcare Partners to form HilleVax, which comes into being with full and exclusive ex-Japanese development and commercial rights to TAK-214 (now HIL-214) which has cleared a phase 2b trial.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Expanding Healthcare Technology Across the Care Team to Improve Medication Access

Drug Channels

Today’s guest post comes from David Holladay, President of Access and Adherence at CoverMyMeds. David discusses how common medication access, adherence, and affordability barriers can lead patients to abandon important therapies. He suggests that technology can connect providers with actionable information at the point of care, thereby giving patients access to data that can lead them to make better decisions.

Drugs 52
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Surprise pandemic lessons for pharma

pharmaphorum

Ask people in most western nations to think back to 2019 and consider what they would have said then about the potential impact of a pandemic on their everyday lives and my guess is that the vast majority of us would have had little insight into what would happen. Residents of Southeast Asia who had experienced the SARS outbreak in 2002-04 would likely have had a much better understanding, but even they could not have imagined just how disorganised the response would be in many other parts the w

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#news #biotech Scientists create embyros to save northern white rhino

BioTech 365

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Scientists create embyros to save northern white rhino.

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Can I Get My Second Covid Vaccine Early?

DM Clinical Research

After a year and a half of COVID restrictions, there is finally a light at the end of the tunnel. Once you are fully vaccinated, it is safe to do many of the things you used to enjoy before lockdown. Naturally, you might be wondering: Can I get my second COVID vaccine early? Is there any way to speed up the vaccination process? While this can be tempting, it’s important to get the facts first.

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How Machine Learning Drives Clinical Trial Efficiency

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.

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Small Pharma Reports First Fiscal Quarter 2021 Highlights

BioTech 365

Small Pharma Reports First Fiscal Quarter 2021 Highlights Small Pharma Reports First Fiscal Quarter 2021 Highlights Successful completion of listing on TSX Venture Exchange $58 million financing enables potential rapid advancement of Small Pharma’s patent portfolio LONDON, United Kingdom, July … Continue reading →

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Which pharmaceutical drugs have the most drug patents in Cyprus?

Drug Patent Watch

This chart shows the drugs with the most patents in Cyprus. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Cyprus? appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 98
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ECMOHO Limited Announces Proposed Underwritten Public Offering of American Depositary Shares

BioTech 365

ECMOHO Limited Announces Proposed Underwritten Public Offering of American Depositary Shares ECMOHO Limited Announces Proposed Underwritten Public Offering of American Depositary Shares SHANGHAI, China, July 30, 2021 (GLOBE NEWSWIRE) — ECMOHO Limited (Nasdaq: MOHO) (“ECMOHO” or the “Company”), a leading … Continue reading →

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Novel Therapies form the Nucleus of the Growth in the Crohn’s Disease Therapeutic Market

Delveinsight

Crohn’s disease is one of the most prevalent types of Inflammatory bowel diseases characterized by abdominal pain and diarrhea, with patients often experiencing weight loss and perianal disease. Based on the location of the body, Crohn’s disease affects the disease can be of different types, including ileocolitis, ileitis, gastroduodenal Crohn’s disease, jejunoileitis, and Crohn’s colitis.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.