A biotech wins the first FDA drug approval in a rare type of eye cancer
Bio Pharma Dive
JANUARY 26, 2022
U.K.-based Immunocore's treatment, known as Kimmtrak, is also the first T cell receptor drug to have reached market in the U.S. so far.
Sat.Jan 22, 2022 - Fri.Jan 28, 2022
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The downside of VC funding for biotech
World of DTC Marketing
JANUARY 24, 2022
Venture capitalists have poured $42 billion into drug development over the past three years. Most small biotech companies rely on venture capitalist funding to develop new drugs but is that a good way to go? not necessarily. VCs invest money in biotech because they see a potential windfall via a profitable acquisition or sale, but when the FDA weighs in with delays, VCs can be ruthless.
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Applied Virtual Reality in Healthcare: A comprehensive book on medical XR
pharmaphorum
JANUARY 27, 2022
Walter Greenleaf, PhD, neuroscientist and digital health expert at Stanford University’s Virtual Human Interaction Lab, tells us about the new book Applied Virtual Reality in Healthcare: Case Studies and Perspectives and why he and his co-authors gathered insights from some of the most prominent figures in the field of medical extended reality (XR).
Labnovation’s COVID-19 ART Test Kit Approved by the FDA of the Philippines for Self-Testing
Pharma Mirror
JANUARY 28, 2022
Singapore, Asia’s integrated healthcare company, Clearbridge Health Limite is pleased to announce that Labnovation Technologies, Inc.’s (“Labnovation”) COVID-19 Antigen Rapid (“ART”) Test Kit, which is imported by Clearbridge and registered for use in the Philippines, has been recently approved by the Food and Drug Administration (“FDA”) of the Philippines for self-testing.
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
Atara sells cell therapy plant to Fujifilm for $100M
Bio Pharma Dive
JANUARY 27, 2022
The site, which specializes in manufacturing off-the-shelf immunotherapies, was once a key asset for Atara. New owner Fujifilm will still supply the biotech under a long-term agreement.
The biggest transformation in pharma marketing since DTC
World of DTC Marketing
JANUARY 26, 2022
This is an exciting time to be in healthcare marketing. We’re witnessing the most significant transformation in healthcare marketing since DTC was approved in the ’90s. We’re moving from an era of “promotional marketing” to an age of “data is key” and “helping patients become consumers of healthcare.” HCP’s are moving quickly into digital.
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Checkpoint Therapeutics Announces Positive Topline Results from the Registration-Enabling Trial of Cosibelimab
Pharma Mirror
JANUARY 25, 2022
Waltham, Checkpoint Therapeutics, Inc. (“Checkpoint”) (NASDAQ: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced positive topline results from its registration-enabling clinical trial evaluating the safety and efficacy of its anti-PD-L1 antibody, cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cutaneous squamous cell carcinoma (“cSCC”).
Touting a new way to drug an all-important family of proteins, a startup launches with $100M
Bio Pharma Dive
JANUARY 27, 2022
Backed by some of biotech's most powerful investors, Septerna is looking to usher in the next chapter of medicines that act on G protein-coupled receptors.
Feelings of fatigue predict death in older adults
Scienmag
JANUARY 23, 2022
PITTSBURGH, Jan. 24, 2022 – How fatigued certain activities make an older person feel can predict the likelihood death is less than three years away, according to research published today in the Journal of Gerontology: Medical Sciences by University of Pittsburgh epidemiologists. It is the first study to establish perceived physical fatigability as an indicator […].
Chronic kidney disease: treating a silent killer
pharmaphorum
JANUARY 24, 2022
In November, NICE backed NHS use of AstraZeneca’s diabetes and heart failure drug Forxiga for the treatment of chronic kidney disease. pharmaphorum caught up with AZ’s Joris Silon to discuss unmet needs in the condition. “Many times, I have talked to nephrologists who take care of patients with chronic kidney disease in the later stages, and they have a very simple message – and that is, if we really want to do something for these patients then we need to intervene earlier,” says Joris Silon, se
Indegene expands global operations with new nearshore centers in Americas and Europe
Pharma Mirror
JANUARY 25, 2022
PRINCETON, N.J. and BANGALORE, India, Indegene, a technology-led healthcare solutions provider today announced it established new Global Development Centers in Mexico, Poland and Ukraine to enable life sciences organizations accelerate their digital transformation. The life sciences industry is witnessing tremendous change with a growing focus on personalization, transformation of go-to-market models, and rapid adoption of real-world data and evidence to improve health outcomes.
Moderna follows Pfizer in beginning trial of omicron vaccine
Bio Pharma Dive
JANUARY 26, 2022
The study will test a version of the biotech's COVID-19 shot that's tailored to the infectious variant. New data, meanwhile, help affirm the benefit of a third dose of Moderna's current vaccine.
Innovative phase 2 trial targets advanced liver cancer
Pharma Times
JANUARY 25, 2022
The UCL study will evaluate the safety and effectiveness of MTL-CEBPA in combination with second line standard of care sorafenib versus the use of sorafenib in isolation
Is Vegan Casein the Next Big Plant-Based Innovation?
XTalks
JANUARY 24, 2022
Fooditive Group , a plant-based ingredient manufacturer, recently developed a vegan version of casein, one of the main animal proteins in milk. The Dutch startup used precision fermentation to create vegan casein, making it possible to replace cow’s milk in dairy products without losing flavor, texture or quality. In developing the vegan casein, Fooditive aims to eradicate the downsides of factory farming, antibiotics, hormones and lactose.
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
Fermenta has signed a Definitive Agreement with Aurigene, a stepdown subsidiary of Dr Reddy’s Laboratories Limited
Pharma Mirror
JANUARY 22, 2022
Fermenta Biotech Limited (FBL) today announced that it has signed a Definitive Agreement with Aurigene Pharmaceutical Services Limited (APSL), a stepdown subsidiary of Dr Reddy’s Laboratories Limited (DRL). In this arrangement, FBL will exclusively license its proprietary biocatalytic technology for synthesis of Molnupiravir and supply its enzyme Candida Antarctica B Lipase (CAL B) to APSL, and APSL will exclusively procure the enzyme from FBL.
Merck drug for chronic cough rejected by FDA
Bio Pharma Dive
JANUARY 24, 2022
According to the drugmaker, the FDA asked in a complete response letter for more information related to how the drug's efficacy was measured.
Merck gets EU nod for Keytruda in adjuvant kidney cancer
pharmaphorum
JANUARY 28, 2022
Merck & Co has passed another milestone in its drive to move PD-1 inhibitor Keytruda earlier in the treatment pathway for cancer, with the European Commission approving use of the drug as post-surgery (adjuvant) therapy for renal cell carcinoma (RCC). Adjuvant treatment moves use of the drug into patients with earlier-stage cancer, a key strategy for Merck and other cancer immunotherapy companies as it expands the pool of patients eligible for treatment.
Injection of optimism as HIV vaccine trial begins
Pharma Times
JANUARY 28, 2022
Collaboration of big hitters and introduction of innovation sparks pioneering HIV vaccination trial
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.
OPDP Issues First Regulatory Action Letter of 2022
Eye on FDA
JANUARY 26, 2022
FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent enforcement actions over the past several years is that smaller, less well-known companies have mostly been the recipients of letters from OPDP.
US turns to Gilead's COVID-19 drug to help counter omicron
Bio Pharma Dive
JANUARY 24, 2022
With other COVID treatments ineffective against the variant or in short supply, the FDA is expanding its approval of Veklury to include outpatient use.
Digital therapeutics: a new frontier of medicine
pharmaphorum
JANUARY 25, 2022
The area of digital therapeutics is growing rapidly, and in this piece Ben Hargreaves examines why this is the case, how broadly these therapies can be applied and why investment in the area is mounting. To demonstrate how quickly the digital therapeutics space is developing, it is easiest to state that the first such therapy was approved in 2018 and since that point the annual investment in the space has more than doubled in the intervening years.
FLIP sync: Collaboration for inhibitors and cancer treatments
Pharma Times
JANUARY 26, 2022
Ipsen and Domainex collaboration will provide an exclusive licence to develop innovative inhibitors and pioneering cancer treatments
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.
Time to change thinking around patient recruitment: Elligo
Outsourcing Pharma
JANUARY 26, 2022
A leader from Elligo Health Research (a SCOPE 2022 exhibitor ) discusses flaws in traditional recruitment approaches and offers up some fresh new ideas.
3 ways an IWMS can help streamline your manufacturing operations
Bio Pharma Dive
JANUARY 24, 2022
Manage, maintain and optimize all the tasks, duties and goals that fall under the umbrella of your workplace.
IBM sells off large parts of Watson Health business
pharmaphorum
JANUARY 24, 2022
A private equity group has agreed to take over most of IBM Watson Health, seven years after the business was launched with a pledge to revolutionise healthcare data analysis. Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.
Omicron relief: Pfizer and BioNTech initiate study into targeted vaccine
Pharma Times
JANUARY 26, 2022
COVID-19 vaccine luminaries Pfizer and BioNTech study will examine data from the current booster and consider need for specific Omicron jab
Which drugs have the most supplementary protection certificates?
Drug Patent Watch
JANUARY 27, 2022
This chart shows the drugs with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the long…. The post Which drugs have the most supplementary protection certificates? appeared first on DrugPatentWatch - Make Better Decisions.
Biogen, facing pressure on all sides, sells stake in biosimilars business
Bio Pharma Dive
JANUARY 28, 2022
The biotech will sell the roughly 50% stake it holds in a biosimilars joint venture to Samsung Biologics for as much as $2.3 billion — cash that analysts expect the drugmaker to invest in M&A.
Digital health firms nab record $57.2bn funding in 2021; report
pharmaphorum
JANUARY 26, 2022
The final numbers are in, and now it’s official – digital health companies raked in a massive $57.2 billion in funding last year, beating prior records with a 79% increase over 2020. The data from CB Insights’ annual State of Digital Health report notes that the record investments were apparent across all geographies and were “fuelled by the growing need to provide digital solutions and delivery models to patients during the pandemic.” Highlights of the year included an a
Access to Novartis treatment for Myeloid leukaemia patients
Pharma Times
JANUARY 25, 2022
Novartis UK has announced that the MHRA has given a positive scientific opinion for the investigational treatment, asciminib
The New Age of Decentralized Clinical Trials
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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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