Clinical Trials

BMS reports data that could give its cell therapy an edge over rival J&J product

Abecma, BioPharma, biopharma nl, Bristol-Myers Squibb, cancer, cell therapy, Clinical Trials, Daily, multiple myeloma, Pharma, SYN, Top Story / August 10, 2022

Bristol Myers Squibb has data showing that its multiple myeloma treatment Abecma beat the standard of care, preliminary Phase 3 results that could support moving the FDA-approved CAR T-cell therapy into an earlier line of treatment—ahead of a rival cell therapy. In other BMS cell therapy news, the pharma giant started an R&D alliance focused …

BMS reports data that could give its cell therapy an edge over rival J&J product Read More »

GSK pays $100M to partner on a cancer drug with new twist on immunotherapy

antibody-drug conjugate, BioPharma, biopharma nl, Cambridge, cancer, cancer immunotherapy, Clinical Trials, Daily, deals, GSK, Massachusetts, Mersana Therapeutics, Pharma, SYN, Top Story / August 9, 2022

GSK is partnering with Mersana Therapeutics on the development of an antibody-drug conjugate that is approaching Phase 1 testing. Unlike other ADCs that deliver a toxic drug payload, the Mersana drug is designed to activate the innate immune system to fight tumor cells.

Pfizer to buy sickle cell disease biotech Global Blood Therapeutics in $5.4B deal

BioPharma, Clinical Trials, Daily, deals, Global Blood Therapeutics, New York, Pfizer, Pharma, sickle cell disease, South San Francisco, SYN, Top Story / August 8, 2022

Pfizer’s own R&D efforts in sickle cell disease have fallen short, so the pharmaceutical giant is turning to M&A to gain a presence in the blood disorder. The acquisition of Global Blood therapeutics brings the commercialized drug Oxbryta plus a pipeline of other therapeutic candidates.

ODM standard for CRF design

Clinical Trials, Partner content, Pharma, Press releases, regulation / August 8, 2022

Over the last few years, our industry has become familiar with CDISC standards. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SEND, SDTM, and ADaM. This post shines a spotlight on the lesser-known Operational Data Model (ODM) standard, which is often overlooked as it’s …

ODM standard for CRF design Read More »

FDA turns down Acadia Pharma drug for Alzheimer’s psychosis; new trial needed

ACADIA Pharmaceuticals, alzheimer's disease, anti-psychotic drug, BioPharma, Clinical Trials, FDA, Legal, Nuplazid, Pharma, San Diego, SYN, Top Story / August 7, 2022

Acadia Pharmaceuticals drug Nuplazid failed to win FDA approval for the treatment of psychosis in Alzheimer’s disease patients. The regulator said that the data submitted were not from an adequate and well-controlled study and the company must run another clinical trial.

FDA approval of AstraZeneca drug is first for a new group of breast cancer patients

AstraZeneca, BioPharma, biopharma nl, breast cancer, Clinical Trials, Daiichi Sankyo, Daily, FDA, Legal, Pharma, SYN, Top Story / August 5, 2022

Enhertu, a breast cancer drug from AstraZeneca and Daiichi Sankyo, is now FDA approved for treating patients whose tumors express low levels of the protein HER2. The decision makes the infused therapy the first targeted treatment for this new category of breast cancer patients.

Alnylam drug succeeds in heart study, setting stage for FDA filing and showdown with Pfizer

Alnylam Pharmaceuticals, BioPharma, Cambridge, Clinical Trials, Daily, Massachusetts, Pharma, rare disease, SYN, Top Story, transthyretin amyloidosis, Yvonne Greenstreet / August 3, 2022

Alnylam Pharmaceuticals drug Onpattro, an FDA-approved treatment for nerve pain caused by hereditary transthyretin amyloidosis, now has Phase 3 data showing it can also help the much larger group of patients suffering heart problems from the rare protein disease. An FDA submission is planned, which would pit the Alnylam drug in competition with a blockbuster …

Alnylam drug succeeds in heart study, setting stage for FDA filing and showdown with Pfizer Read More »

H1 & Lokavant Partner to Power Next-Gen Clinical Trials

Clinical Intelligence, Clinical Intelligence Platform, clinical research, Clinical Trial, Clinical Trials, digital health, H1, Health Systems, Life Sciences, Patient Access / August 3, 2022

What You Should Know: – H1and Lokavant today announced an extensive data-and-analytics collaboration to bring enhanced automated intelligence to drug development – As part of the bi-directional partnership, Lokavant will provide performance data on global trial sites and principal investigators from thousands of studies to supplement H1’s existing Trial Landscape clinical trial repository.  Integrating Clinical …

H1 & Lokavant Partner to Power Next-Gen Clinical Trials Read More »

Connecting EHR to clinical trials: How to embrace the promise of real-world data

Cerner, Clinical Trials, Electronic Health Records, Elligo, Kantar Health, Pharma, R&D, Views & Analysis, Views and analysis / August 3, 2022

We all know that real-world data (RWD) from electronic health records (EHR) could boost clinical trial efficiency and improve patient outcomes – so what’s holding us back? It’s been more than two decades since the ground-breaking potential of using electronic health records (EHR) to inform clinical research was first mooted. Since then, progress has been …

Connecting EHR to clinical trials: How to embrace the promise of real-world data Read More »

Aiming to bring drug combos into earlier lines of cancer therapy, IDRx lands $122M

Alexis Borisy, BioPharma, biopharma nl, cancer, Clinical Trials, IDRx, Massachusetts, Pharma, Plymouth, Startups, SYN, Top Story / August 2, 2022

Taking inspiration from the success of drug cocktails that halt viral infections, startup IDRx aims to develop cancer drug combinations that stop tumor escape. The company, founded by serial entrepreneur Alexis Borisy, has set gastrointestinal stromal tumor (GIST) as its first disease target.

Digital transformation: Reimagining clinical trial management [Sponsored]

Astellas Pharma, biopharma nl, Clinical Trials, Daily, dct, decentralized clinical trials, Health Services, Health Tech, Marie Rosenfeld, News, Pharma, sponsored content, Sponsored Post, SYN, Top Story / August 2, 2022

Decentralized clinical trial approaches helped the pharma industry navigate through Covid-19. Now it is becoming increasingly clear that there’s a need for a hybrid approach to decentralized clinical trials that considers the perspectives of patients and the impact to clinical trial sites.

With ‘bold experiment’ in drug pricing, Arcutis aims to stand out in plaque psoriasis

Arcutis Biotherapeutics, BioPharma, California, Clinical Trials, Daily, FDA, Legal, Pharma, Plaque Psoriasis, SYN, Top Story, Westlake Village / August 2, 2022

The FDA approved Arcutis Biotherapeutics drug Zoryve, a topical treatment for plaque psoriasis. With the decision, the company will proceed with a pricing strategy it believes will speed up insurance coverage and patient adoption of the new treatment for the chronic inflammatory skin disorder.

FDA hits pause on Beam Therapeutics’ off-the-shelf cell therapy for blood cancers

Beam Therapeutics, BioPharma, biopharma nl, Cambridge, cancer, cell therapy, Celyad Oncology, Clinical Trials, Daily, FDA, Legal, Massachusetts, Pharma, SYN, Top Story / August 1, 2022

Beam Therapeutics’ application to begin human testing of a cell therapy made with base-editing technology is now under an FDA clinical hold. In other clinical hold news, the FDA lifted a hold on a Celyad Oncology cell therapy clinical trial that was halted in March.

Global comparator data signal “alarm bells” for UK Government, says APBI

ABPI, Clinical Trial Recruitment, Clinical Trials, Life Sciences, Market Access, UK life sciences, UK market access, Views & Analysis, Views and analysis / July 27, 2022

Latest UK Life Sciences Competitive Indicators “ought to ring alarm bells across Government,” says ABPI. Despite the UK’s potential as an international life sciences leader, it lags many competitors in a number of key metrics, including access to new medicines and global share of clinical trial recruitment. Richard Torbett, chief executive at the Association of …

Global comparator data signal “alarm bells” for UK Government, says APBI Read More »

Report finds UK risks falling behind rivals in life sciences

ABPI, BIA, Clinical Trials, competition, Financing, Life Sciences, News, patients, R&D, Sales and Marketing, UK / July 22, 2022

A just-published report on the UK’s life sciences sector “ought to ring alarm bells across government,” according to the Association of the British Pharmaceutical Industry (SBPI). The Life Sciences Competitiveness Indicators report shows that spending on life sciences R&D was £2.7 billion in 2020 – accounting for 0.12% of GDP and ranked third among the …

Report finds UK risks falling behind rivals in life sciences Read More »

Medable Partners with Withings Health Solutions to Integrate Health Devices in Decentralized Clinical Trials

blood pressure, Clinical Trial, Clinical Trials, Connected Health, decentralized clinical trials, digital health, Digital Healthcare, Heart, Medable, Partners, patient experience, Wearables, Withings / July 21, 2022

What You Should Know: – Medable Inc., the leading SaaS platform provider for patient-centered clinical trials, today announced a new partnership with Withings Health Solutions, the business-to-business division of Withings, one of the global leaders in at-home connected health – Withings’ devices will seamlessly connect to Medable’s decentralized clinical trial platform, reducing the burden on sponsors and …

Medable Partners with Withings Health Solutions to Integrate Health Devices in Decentralized Clinical Trials Read More »

ForSight Robotics Raises $55M to Develop Robotic Cataract Surgery Procedure

Clinical Trials, digital health, Eye Care, Machine Learning, public health, Robotic Surgery, Startups / July 18, 2022

What You Should Know: – Israeli-based ForSight Robotics, the pioneer in ophthalmic robotic surgery raises $55M in Series A funding to advance the world’s first surgical platform for fully robotic cataract surgery: ORYOM. The round was led by The Adani Group with existing investors Eclipse Ventures and Mithril Capital. A number of new investors, including …

ForSight Robotics Raises $55M to Develop Robotic Cataract Surgery Procedure Read More »

Practicing for the Next Pandemic with Real-World Data

ALLSCRIPTS, big data, Clinical Trial, Clinical Trials, Health IT, Integrated Delivery Network, Interoperability, Opinion, Predictive Analytics, public health, social determinants of health, Vital / July 18, 2022

Mac Bonafede, Ph.D., MPH, VP of Real World Evidence at Veradigm Data reporting challenges during the current pandemic relate to the lack of connectivity between public health and information technology (IT) reporting systems throughout the country. While access to real-world data (RWD) helps address this situation, the solution goes beyond simple accessibility. Real-world data represents …

Practicing for the Next Pandemic with Real-World Data Read More »

How to accelerate clinical study build

Clinical Trials, digital, Partner content, Pharma, Press releases / July 18, 2022

As you know, clinical trials can be complex. Industry standards are now required for clinical trial submission. This means even more associated costs, resources, time, and effort. The Formedix clinical metadata repository (MDR) can help! So what can it do for you? In a nutshell, it can help you:       How is this possible? Take studies …

How to accelerate clinical study build Read More »

Wysa Secures $20M for AI-Powered Mental Health Chatbot

Accenture, Aetna, AI, Artificial Intelligence, Chatbot in Healthcare, Clinical Trials, depression, digital health, Digital Therapeutics, FDA, google, Health Ventures, mental health, Mental Health Apps, NHS, Startups / July 14, 2022

What You Should Know:  – Wysa, a Boston, MA-based AI digital platform for mental health, today announces it has secured $20M in financing led by HealthQuad, who along with British International Investment (BII), the UK’s development finance institution, joins earlier investors W Health Ventures, Kae Capital, Google Assistant Investments, and pi Ventures amongst others. – …

Wysa Secures $20M for AI-Powered Mental Health Chatbot Read More »

FDA delay means BeiGene, Novartis must wait longer for cancer drug decision

BeiGene, BioPharma, biopharma nl, cancer, China, Clinical Trials, Daily, FDA, Immunotherapy, Novartis, Pharma, SYN, Top Story / July 14, 2022

The FDA has deferred a regulatory decision on an esophageal cancer drug from partners BeiGene and Novartis, citing the need to complete inspections of the China-based facilities where the drug is made. The agency said Covid-19 travel restrictions have prevented it from conducting those inspections.

EMA pilot will see if clinical trial data should be digested ‘raw’

clinical research, Clinical Trials, data, digital, EMA, News, R&D, regulatory / July 14, 2022

A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical trials submitted in support of new marketing application along with the usual structured analyses from sponsors. The pilot will focus on individual patient data from clinical studies in electronic structured …

EMA pilot will see if clinical trial data should be digested ‘raw’ Read More »

Merck strikes a $290M deal for novel prostate cancer drug

BioPharma, Clinical Trials, Daily, deals, Dean Li, Finland, Merck, Orion, Pharma, prostate cancer, SYN, Top Story / July 13, 2022

Merck is partnering with Orion on the clinical development and potential commercialization of a new drug for advanced prostate cancer. Though Merck already has a piece of the prostate cancer drug market, Orion’s drug would offer a new approach for treating cancers that have become resistant to currently available hormone therapies.

Areteia gets $350M to turn failed ALS drug into a therapy for severe asthma

Areteia Therapeutics, Asthma, Bain Capital Life Sciences, BioPharma, biopharma nl, Clinical Trials, Daily, deals, investing, Knopp Biosciences, Pharma, Startups, SYN, Top Story / July 12, 2022

New company Areteia Therapeutics launched with up to $350 million in financing and an asthma drug candidate from Knopp Biosciences. That drug, dexpramipexole, previously failed a pivotal test in amyotrophic lateral sclerosis but more recent clinical testing found that the way the small molecule works has applications in eosinophilic asthma, a severe form of the …

Areteia gets $350M to turn failed ALS drug into a therapy for severe asthma Read More »

Roche pays $55M for late-stage drug for rare kidney disease with no approved treatment

BioPharma, biopharma nl, California, carlsbad, Clinical Trials, Daily, Ionis Pharmaceuticals, kidney disease, Pharma, Roche, SYN, Top Story / July 11, 2022

An Ionis Pharmaceuticals drug has positive Phase 2 results in immunoglobulin A nephropathy, leading Roche to exercise its option to license the rights to the molecule. The pharmaceutical giant gets a contender in the chase to win the first regulatory approval of a therapy for this rare kidney disease.

Vertex builds up pipeline of type 1 diabetes cell therapies with $320M buyout

BioPharma, biopharma nl, Boston, cell therapy, Clinical Trials, Daily, News, Pharma, San Diego, SYN, Top Story, type 1 diabetes, Vertex Pharmaceuticals, ViaCyte / July 11, 2022

Vertex Pharmaceuticals already has a cell therapy candidate for type 1 diabetes but the company says acquiring rival ViaCyte will provide it with complementary assets and technologies. The two companies already share a partner in common: both have therapeutic candidates that use the gene-editing capabilities of CRISPR Therapeutics.

Pfizer, BioNTech Covid-19 vaccine gets full FDA approval for adolescents

BioNTech, BioPharma, biopharma nl, Clinical Trials, Covid vaccines, COVID-19, Daily, FDA, Legal, Pfizer, Pharma, SYN, Top Story / July 10, 2022

The FDA has granted the Pfizer and BioNTech Covid-19 full approval for use in adolescents. In other Covid-19 news, pharmacists were granted additional prescribing powers for an antiviral and Novavax’s European marketing authorization has been expanded to an additional age group.

AbbVie & Alector drop Alzheimer’s med from alliance, shifting focus to a 2nd drug

AbbVie, alector, alzheimer's disease, BioPharma, biopharma nl, Clinical Trials, Daily, neuroscience, Pharma, South San Francisco, SYN, Top Story / July 8, 2022

AbbVie paid Alector $205 million up front five years ago to begin an R&D partnership on two drugs intended to bring an immunotherapy approach to the treatment of Alzheimer’s disease. One of the drugs has reached Phase 2 testing but the pharmaceutical giant has terminated the alliance on a program in Phase 1.

Digital tools driving innovative clinical trials

Clinical Trials, COVID-19, digital, drug development, patients, THREAD, Valencell, Views & Analysis, Views and analysis / July 8, 2022

The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Preliminary research suggests that hybrid DCTs can reduce trial timing and resources, improve patient-centricity and  patient …

Digital tools driving innovative clinical trials Read More »

With new gene therapy data in hand, Sarepta talks with FDA about approval pathways

BioPharma, biopharma nl, Cambridge, Clinical Trials, Daily, Doug Ingram, Duchenne muscular dystrophy, FDA, Massachusetts, Pharma, Sarepta Therapeutics, SYN, Top Story / July 6, 2022

Sarepta Therapeutics has more clinical data showing the safety and efficacy of its experimental gene therapy for Duchenne muscular dystrophy. A pivotal Phase 3 test is already underway and could post data next year but the company is also talking with regulators about the possibility of a submission under the accelerated approval pathway.

CureVac sues BioNTech, claiming Covid-19 vaccine infringes key mRNA patents

BioNTech, BioPharma, biopharma nl, Clinical Trials, COVID-19, CureVac, Daily, Germany, Legal, mRNA vaccines, Pfizer, Pharma, SYN, Top Story, Tübingen / July 5, 2022

Messenger RNA vaccine biotech CureVac is suing BioNTech, alleging that its rival’s Covid-19 vaccine infringes on intellectual property built on more than two decades of research. BioNTech responded that its work is original and the company will defend against the infringement allegations.

AstraZeneca broadens its scope in blood cancers with $100M TeneoTwo buyout

AstraZeneca, BioPharma, California, cancer, Clinical Trials, Daily, lymphoma, Newark, Pharma, SYN, TeneoTwo, Top Story / July 5, 2022

AstraZeneca is acquiring TeneoTwo in a $100 million bet on that biotech’s lymphoma drug candidate, which is designed to go after two targets. It’s the latest deal made by a big pharmaceutical company looking to get its hands on a new type of cancer therapy called a T cell engager.

Ensuring successful digital outreach and retention in atopic dermatitis trials

Atopic Dermatitis, clariness, Clinical Trials, Patient Recruitment, Sales and Marketing, Views & Analysis, Views and analysis, White Papers, Whitepapers / July 5, 2022

Trial organisers face intense competition to find and recruit eligible patients for atopic dermatitis studies. With more than 500 dermatology clinical trials currently underway, it is often heard that there is a ‘’competition for participants’’. Yet evidence from research studies and a survey with 4,000+ atopic dermatitis patients conducted by Clariness shows that this ‘race …

Ensuring successful digital outreach and retention in atopic dermatitis trials Read More »

UK adds £175m funding to clinical research recovery drive

access, clinical research, Clinical Trials, digital, digital health, News, patients, R&D, UK / July 4, 2022

The UK government has made an additional £175 million ($212 million) in funding available for its push to make the country a go-to location for clinical research, adding to £200 million promised in March to strengthen the national data infrastructure. The new money has been announced to coincide with the publication of a new three-year …

UK adds £175m funding to clinical research recovery drive Read More »

Liver injury leads FDA to pause Sanofi’s tests of MS drug acquired in $3.7B deal

BioPharma, biopharma nl, Clinical Trials, Daily, FDA, Legal, multiple sclerosis, Paris, Pharma, Sanofi, SYN, Tolebrutinib, Top Story / June 30, 2022

The FDA placed a partial clinical hold on late-stage tests of Sanofi multiple sclerosis drug tolebrutinib after some patients developed drug-induced liver injury. While U.S. tests are paused, Sanofi said clinical testing in other countries is continuing with additional safety monitoring.

Feds commit $3.2B to lock in Covid-19 vax supply ahead of fall vaccination campaign

BioNTech, BioPharma, biopharma nl, Clinical Trials, COVID-19, Daily, FDA, Moderna, News, Pfizer, Pharma, SYN, Top Story, U.S. Department of Health and Human Services, Vaccines / June 30, 2022

New Covid-19 vaccine booster shots are coming and they’ll likely include protection against the omicron variant. The U.S. government agreed to a purchasing contract covering 105 million doses of the Pfizer/BioNTech vaccine for a planned vaccination campaign in the fall.

From trial design for patients to trial design with patients: a key topic at DIA ’22

Clinical Trials, DIA, drug development, Drug Information Association, Patient Journey, patients, R&D, Views & Analysis, Views and analysis / June 30, 2022

At the 2022 Drug Information Association (DIA) annual meeting last week, it was inspiring to connect with fellow research and development (R&D) stakeholders, regulators, health and digital data partners and more to navigate challenges in drug development that impact patients globally. As an industry, we recognise patients as partners in the development process, but if …

From trial design for patients to trial design with patients: a key topic at DIA ’22 Read More »

Care Access Acquires IBPClin to Expand Decentralized Clinical Trial Capabilities to Latin America

Clinical Trials, decentralized clinical trials, Life Sciences / June 29, 2022

What You Should Know: – Today, Care Access announced the acquisition of IBPClin, a leading clinical trial center in Rio de Janeiro. As a result, Care Access will bring its innovative approach to decentralized clinical research to Latin America. – The acquisition demonstrates progress toward building diverse representation in clinical research and is a strategic first step following Reify Health’s $220 million investment round that was raised to …

Care Access Acquires IBPClin to Expand Decentralized Clinical Trial Capabilities to Latin America Read More »

Reimagining The Future of Pharmacovigilance (PV): Regulations, Tech, Public Perceptions

AI, algorithms, Artificial Intelligence, big data, Clinical Trials, Coronavirus (COVID-19), deep learning, Digital Transformation, GlaxoSmithKline, Heart, Life Sciences, Machine Learning, medication, NLP, Notable, Opinion, public health, risk, Robotic Process Automation, social media, Vital / June 29, 2022

Barry Mulchrone, Senior Director& Head of Pharmacovigilance Oversight and Analytics, IQVIA Annette Williams, VP & Global Head, Lifecycle Safety, IQVIA Monitoring the safe and effective use of medicines has now been an essential part of public health policy for several decades. New advances in technology (e.g., ICH E2B for the electronic exchange of case reports) …

Reimagining The Future of Pharmacovigilance (PV): Regulations, Tech, Public Perceptions Read More »

Two for two: Sanofi snares twin European nods for enzyme replacement therapies

BioPharma, biopharma nl, Clinical Trials, Daily, FDA, lysosomal storage disorder, Paris, Pharma, Pompe disease, Rare diseases, Sanofi, SYN, Top Story / June 28, 2022

Sanofi won European Commission approval for two therapies that treat rare enzyme deficiencies. Xenpoyzme is the first treatment for acid sphingomyelinase deficiency (ASMD) while Nexviadyme is a successor to a blockbuster Sanofi drug for Pompe disease.

BMS cancer drug’s expanded approval gives it an edge over a Gilead cell therapy

BioPharma, Breyanzi, Bristol-Myers Squibb, cancer, CAR-T, cell therapy, Clinical Trials, Daily, FDA, Gilead Sciences, Legal, Pharma, SYN, Top Story, Yescarta / June 28, 2022

The new FDA approval for Breyanzi moves the Bristol Myers Squibb cancer cell therapy into an earlier line of treatment for an aggressive type of blood cancer. The decision also gives the pharmaceutical giant access to an additional pool of patients untapped by a rival cell therapy from Gilead Sciences.

Ipsen’s $247M Epizyme acquisition brings approved cancer drug & more in pipeline

BioPharma, biopharma nl, cancer, Clinical Trials, Daily, deals, Epizyme, Follicular Lymphoma, France, Ipsen, News, Paris, Pharma, SYN, Top Story / June 27, 2022

Ipsen is paying $247 million to acquire Epizyme, a cancer drug developer with one FDA-approved product: follicular lymphoma therapy Tazverik. The drug is a modest seller now, but more cash could be paid out if the small molecule hits sales targets in coming years.

Study exposes lack of diversity in US cancer trials

Clario, Clinical Trials, diversity, News, Phesi, R&D / June 27, 2022

Almost half (48%) of cancer clinical trials in the US have no Hispanic or Latin American subjects, and 42% have no black patients, according to a diversity analysis focusing on thousands of studies conducted in the past 15 years. The analysis – from a dataset that spans more than half a million patients – reveals …

Study exposes lack of diversity in US cancer trials Read More »

As muscular dystrophy drug meets key goal, Italfarmaco plans march forward to regulators

BioPharma, biopharma nl, Clinical Trials, Daily, Duchenne muscular dystrophy, Italfarmaco Group, Italy, Milan, Pharma, SYN, Top Story / June 26, 2022

A Duchenne muscular dystrophy drug candidate from Italfarmaco Group has encouraging preliminary data from a pivotal study. The Milan, Italy-based pharmaceutical company says it now plans to meet with U.S. and European authorities about seeking regulatory approval for the small molecule.

Analysis: Is Oracle Cerner Planning to Build A National EHR?

ACA, ACOs, Affordable Care Act, Cerner, Clinical Trials, Data Integration, digital health, eHealth, EMR/EHR, google, HCM, Health Catalyst, Health IT, healthcare it, HealthShare, HIE, HIEs, IDNs, Innovaccer, integrated care, Interoperability, InterSystems, model, Notable, Oracle, Patient Care, Patient Engagement, Pharma, primary care, rcm, Redox, Signify Research, Telemedicine / June 24, 2022

Earlier this month Oracle closed its $28.3B acquisition of Cerner and shortly after Oracle founder and CTO, Larry Ellison, outlined Oracle’s vision for Healthcare IT post-acquisition. The key elements of this vision included:   – Developing a solution for a national EHR database.  – Leveraging this solution, and similar smaller-scale connected EHR initiatives, to provide life …

Analysis: Is Oracle Cerner Planning to Build A National EHR? Read More »

New data for Intellia’s CRISPR therapy shows potential for one-time treatment of a rare disease

BioPharma, biopharma nl, Cambridge, Clinical Trials, CRISPR/Cas9, Daily, David Lebwohl, gene editing, Intellia Therapeutics, John Leonard, Massachusetts, Pharma, SYN, Top Story / June 24, 2022

An Intellia Therapeutics therapy that uses CRISPR to perform in vivo genomic edits has clinical data showing that the therapeutic effects continue for a year in patients. The biotech now plans to speak with regulators about the design for a pivotal clinical trial testing this therapy, a potential one-time treatment for a rare inherited disease.

Which clinical trial innovation startups will present at INVEST PharmaTech Pitch Perfect?

BeCareLink, BioPharma, Boston Millennia Partners, Climb, Clinical Trials, Daily, dct, decentralized clinical trials, EpHealth, Events, Health Services, Health Tech, HumanFirst, INVEST PharmaTech, mcINVEST, Merck Global Health Innovation Fund, News, Pharma, Sanofi Ventures, Startups, SYN, Top Story, Vistim Labs, Wavemaker Three-Sixty Health / June 23, 2022

The Pitch Perfect contest at MedCity INVEST PharmaTech, the free virtual conference scheduled for July 26, will spotlight five startups seeking to improve clinical trials.

Athira Alzheimer’s drug fails mid-stage, but the biotech still eyes a Phase 3 path

alzheimer's disease, Athira Pharma, BioPharma, Bothell, Clinical Trials, Daily, fosgonimeton, Mark Litton, Pharma, SYN, Top Story, WASHINGTON / June 22, 2022

An Alzheimer’s disease drug from Athira Pharma has failed a Phase 2 clinical trial and the biotech has a surprising theory why. Athira says standard of care drugs Alzheimer’s patients are already taking may diminish the effect of its small molecule and this finding could inform how the company proceeds with an ongoing Phase 3 …

Athira Alzheimer’s drug fails mid-stage, but the biotech still eyes a Phase 3 path Read More »

Moderna facility in UK confirmed, part of 10-year deal with gov’t

Clinical Trials, investment, Manufacturing, Moderna, mRNA, News, NHS, R&D, UK / June 22, 2022

Moderna has said it will open a new R&D and manufacturing facility in the UK which could lead to improved access by NHS patients to mRNA-based vaccines and drug treatments. The facility is the centrepiece of a 10-year agreement-in-principle between the biotech and the UK government – which has been rumoured to be on the …

Moderna facility in UK confirmed, part of 10-year deal with gov’t Read More »

Aiming to catch Alnylam, AstraZeneca & Ionis plan FDA filing for rare disease drug

AstraZeneca, BioPharma, California, Cardiomyopathy, carlsbad, Clinical Trials, Daily, Ionis Pharmaceuticals, Nerves, Pharma, rare disease, SYN, Top Story / June 21, 2022

The planned FDA submission follows the report from AstraZeneca and Ionis Pharmaceuticals that their partnered drug, eplontersen, met the main goals of a pivotal study in treating nerve pain caused by hereditary transthyretin-mediated amyloidosis. The data come one week after rival Alnylam Pharmaceuticals won FDA approval for its second drug for this rare disease.

An introduction to case report forms

case report form, Clinical Trials, CRF, eCRF, Partner content, Pharma, Press releases / June 21, 2022

Different types of CRFs A Case Report Form (CRF) is a printed, optical, or electronic document designed to record all information required to be reported to the sponsor on each trial subject. CRFs play a crucial role in helping to assess the safety and efficacy of clinical products. An electronic CRF (eCRF) is an electronic …

An introduction to case report forms Read More »

Pfizer, Moderna Covid-19 vaccines are now authorized for kids as young as 6 months

BioNTech, BioPharma, biopharma nl, Clinical Trials, Covid vaccines, COVID-19, Daily, FDA, Legal, Moderna, Peter Marks, Pfizer, Pharma, Robert Califf, SYN, Top Story / June 17, 2022

Covid-19 vaccines from Pfizer and Moderna now have FDA emergency use authorization for children as young as 6 months old. If the Centers for Disease Control and Prevention signs off on these shots this weekend, these pediatric vaccines could become available for distribution early next week.

Pharmacy chain Walgreens plans to disrupt clinical trial sector

Clinical Trials, cvs, decentralised clinical trials, diversity, News, patients, R&D, Walgreens / June 17, 2022

Walgreens is the latest US retail pharmacy giant to have a go at disrupting the clinical trials industry, with the launch of a new business unit that will tap into its reserve of patient data, as well as the ability to recruit patients across its retail network. The company says it plans to use a …

Pharmacy chain Walgreens plans to disrupt clinical trial sector Read More »

Walgreens Launches New Clinical Trial Business to Address Access & Diversity

Care Coordination, clinical research, Clinical Trial, Clinical Trials, digital health, Life Sciences, medical records, model, patient experience, Patient Privacy, Pharmacy, social determinants of health, virtual care, Walgreens / June 16, 2022

What You Should Know: – Walgreens today announced the launch of its clinical trial business to redefine the patient experience and increase access and retention in sponsor-led drug development research. – Walgreens flexible clinical trial model combines the company’s vast foundation of patient insights, partner-enabled health and technology capabilities and in-person and virtual care options …

Walgreens Launches New Clinical Trial Business to Address Access & Diversity Read More »

Why diverse clinical trials matter: the pharmaphorum podcast

Abbot, Clinical Trials, Dr. Jennifer Jones-McMeans, podcast, Slider in video, video, Views and analysis / June 16, 2022

In this episode of the pharmaphorum podcast, editor in chief Jonah Comstock welcomes Dr. Jennifer Jones-McMeans, divisional vice president for global affairs for Abbott’s vascular business to discuss diversity and equity in clinical trials. They discuss the nitty-gritty of clinical trial diversity – why it’s been so hard to achieve, why it’s important, and how …

Why diverse clinical trials matter: the pharmaphorum podcast Read More »

BIO panel: How Covid-19 is preparing us to better respond to the next pandemic

BioPharma, biotechnology innovation organization, Clinical Trials, Coalition for Epidemic Preparedness Innovations, COVID-19, Daily, Manufacturing, News, Novavax, Pharma, San Diego, SYN, Top Story, Vaccines / June 15, 2022

Biopharmaceutical companies and public health officials have learned a great deal about pandemic response in the last two years. A panel discussion during the annual meeting of the Biotechnology Innovation Organization explored some of the lessons from Covid-19 and how they can prepare us for the next pandemic.

ImCheck fetches €96M for antibodies that activate immune cells against cancer

Antibody Drug, BioPharma, cancer, cancer immunotherapy, Clinical Trials, France, ImCheck Therapeutics, Marseille, Pharma, Startups / June 14, 2022

ImCheck Therapeutics aims to broaden the reach of cancer immunotherapy with antibody drugs that activate a rare but powerful type of immune cell called gamma delta T cells. The biotech has unveiled €96 million to advance its pipeline, including a lead candidate in development for both liquid and solid tumors.

Tessa Therapeutics takes in $126M for cell therapies, and more biotech financings

BioPharma, biopharma nl, cancer, cell therapy, Clinical Trials, Daily, deals, investing, Pharma, Startups, SYN, Tessa Therapeutics, Top Story / June 12, 2022

Ten biotech companies were able to raise more than $500 million in combined financing in the past week. Here’s a recap of the funding activity, which spanned AI-based drug discovery, cell therapy clinical research, cancer drug development, and more.

4 Steps for Operationalizing the FDA’s Call To Improve Health Outcomes for All Patients

cancer, clinical research, Clinical Trials, COTA, Data Analytics, decision support, digital health, FDA, health equity, hipaa, integrity, Life Sciences, Opinion, Partners, Patient Care, Patient Education, patient safety, point of care, public health / June 10, 2022

C.K. Wang, Chief Medical Officer of COTA, Inc. In April, FDA Commissioner Dr. Robert Califf laid out areas of challenge and opportunity when it comes to improving health outcomes, restoring public trust in science, and making the most of our ongoing investments in data analytics and clinical research. More specifically, Califf made clear that our current healthcare …

4 Steps for Operationalizing the FDA’s Call To Improve Health Outcomes for All Patients Read More »

Owkin bags $180m BMS alliance for cardiovascular clinical trials

Artificial Intelligence, Bristol-Myers Squibb, cardiovascular disease, Clinical Trials, digital, News, Owkin, partnering, R&D / June 9, 2022

Owkin has enticed another big pharma partner with its artificial intelligence-powered clinical development platform, Bristol-Myers Squibb, which is paying $80 million upfront to tap into its expertise. The deal is split between a Series B financing led by BMS and upfront fees, taking the total raised by the Paris, France-based start-up to $300 million, and …

Owkin bags $180m BMS alliance for cardiovascular clinical trials Read More »

ASCO recap: Breast cancer breakthrough, Mirati’s moves, Arcellx ascends & more

American Society of Clinical Oncology, AstraZeneca, BioPharma, biopharma nl, cancer drugs, Chicago, Clinical Trials, Daily, Gilead Sciences, Johnson & Johnson, Mirati Therapeutics, Pharma, SYN, Top Story / June 8, 2022

Breast cancer drugs and cell therapies were prominent in this year’s annual meeting of the American Society of Clinical Oncology. Here’s a recap of some of the news highlights from the biggest cancer conference of the year.

PMV’s ASCO data show signs of drugging ‘undruggable’ p53 protein across tumor types

American Society of Clinical Oncology, BioPharma, cancer, Chicago, Clinical Trials, Cranbury, Daily, New Jersey, p53, Pharma, PMV Pharmaceuticals, SYN, Top Story / June 8, 2022

PMV Pharmaceuticals has its first clinical data showing that its lead therapeutic candidate can hit p53, a tumor-suppressing protein long thought to be undruggable. After reporting the preliminary data during ASCO, PMV said it plans to continue Phase 1 study with the goal of advancing to Phase 2 early next year.

Gilead offers more detail on breast cancer drug’s trial results. Is it enough?

BioPharma, breast cancer, Chicago, Clinical Trials, Daily, Gilead Sciences, Pharma, SYN, Top Story, Trodelvy / June 5, 2022

Gilead Sciences has more detail about breast cancer drug Trodelvy, a blockbuster hopeful it acquired two years ago. Additional data from a pivotal study were presented during the annual meeting of the American Society of Clinical Oncology and they still leave many questions unanswered.

BMS bets $4.1B on lung cancer drug that could best products from Pfizer, Roche

BioPharma, Bristol-Myers Squibb, cancer, cancer drugs, Clinical Trials, Daily, lung cancer, Pharma, San Diego, SYN, Top Story, Turning Point Therapeutics / June 3, 2022

Bristol Myers Squibb is splashing out $4.1 billion to acquire Turning Point Therapeutics, a clinical-stage biotech whose lead drug is currently in pivotal testing as a treatment for certain lung cancers. Recently reported preliminary data suggest the small molecule could have advantages over currently available drugs in the same class from rivals Pfizer and Roche.

Repare relinquishes cancer drug to Roche, gets $125M to finance growing pipeline

BioPharma, biopharma nl, cancer, Clinical Trials, Daily, deals, ovarian cancer, Pharma, Quebec, Repare Therapeutics, Roche, SYN, synthetic lethality, Top Story / June 2, 2022

Roche’s deep oncology pipeline is adding a drug candidate from Repare Therapeutics that works by interfering with a DNA repair mechanism of cancer cells. Repare receives $125 million up front and it retains the right to share in the development and commercialization of the drug, camonsertib.

Akili + Roblox Form First of Its Kind Digital Treatment Partnership

Clinical Trials, digital health, FDA, medication, patient experience, video / May 31, 2022

What You Should Know: – Akili’s EndeavorRx, the first and only FDA-cleared video game ADHD treatment for kids, is uniting with Roblox’s global virtual universes forming a first-of-its-kind partnership.  – Initially, the partnership will establish an exclusive Roblox reward exchange for patients that complete their medically prescribed EndeavorRx treatment. The rewards will enable patients to redeem items via the exchange …

Akili + Roblox Form First of Its Kind Digital Treatment Partnership Read More »

ASCO 2022 ahead: Clinical trial updates and data readouts to watch for

adicet bio, American Society of Clinical Oncology, Amgen, ASCO, BioPharma, cancer, Chicago, Clinical Trials, Daily, Mirati Therapeutics, Pharma, Roche, SYN, Top Story / May 30, 2022

The American Society of Clinical Oncology’s annual meeting begins this week, including the presentation of more than 2,800 abstracts. Amgen, Roche, and Sierra Oncology are among the companies with key presentations at this year’s gathering.

Using technology to reassess the clinical trial landscape

AppliedVR, Clinical Trials, data, digital, Komodo Health, patients, Views & Analysis, Views and analysis, VR / May 30, 2022

Josh Sackman, president and co-founder of AppliedVR, and Web Sun, president and co-founder of Komodo Health, relay how their newly formed collaboration reshapes the clinical trial process by using data, helping to cut costs and allowing for evaluation of broader patient populations.   AppliedVR and Komodo Health are collaborating to perform a clinical trial using the …

Using technology to reassess the clinical trial landscape Read More »

A Balm for Psyches Scarred by War

Clinical Trials, Drugs (Pharmaceuticals), Ecstasy (Drug), Iraq War (2003-11), Johns Hopkins University, Mental Health and Disorders, Mithoefer, Michael, Multidisciplinary Assn for Psychedelic Studies, Post-Traumatic Stress Disorder, Psychiatry and Psychiatrists, Therapy and Rehabilitation, traumatic brain injury, United States Defense and Military Forces, United States Marine Corps, United States Navy, Veterans, Veterans Affairs Department, Vietnam War, your-feed-health, your-feed-science / May 29, 2022

MDMA-assisted treatment for post-traumatic stress disorder “represents real hope for long-term healing,” health experts say.

Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more

BioNTech, BioPharma, biopharma nl, Clinical Trials, Covid-19 Vaccine, Daily, FDA, News, Paxlovid, Pfizer, Pharma, SYN, Top Story, Vaccines / May 27, 2022

Pfizer and BioNTech reported positive clinical data for a Covid-19 booster in children younger than 5, results released ahead of a June FDA advisory committee meeting scheduled to discuss the use of that vaccine and Moderna’s in kids. In other Covid news this week, the CDC issued a health advisory for Pfizer’s antiviral Paxlovid and …

Covid-19 roundup: Boosters for kids, CAR-NK cell therapy, Paxlovid rebound & more Read More »

Can technology help diversify clinical trials?

Clinical Trials, decentralised clinical trials, diversity, Diversity and Inclusion, R&D, Views & Analysis, Views and analysis / May 27, 2022

This is the second in a two-part series examining how pharma can embrace the DEI agenda to create more effective medicines through more representative clinical trials. You can read part one of this article here. As the shift to home working proliferated during the pandemic, work became decentralised – and many businesses were able to …

Can technology help diversify clinical trials? Read More »

Why are clinical trials struggling with diversity?

clinical trial diversity, Clinical Trials, COVID-19, diversity, Diversity and Inclusion, R&D, randomised control trials, Views & Analysis, Views and analysis / May 26, 2022

In the diverse world we live in, the products we produce, the services we create and the places we work should be as equally representative. In recent years this has seen diversity, equity, and inclusion (DEI) become a big focus for industries to get right. Within pharma and healthcare, where greater representation has been proven …

Why are clinical trials struggling with diversity? Read More »

Heart trouble report & clinical hold spell end of Antios, Assembly Bio HBV alliance

Antios Therapetuics, Assembly Biosciences, BioPharma, Clinical Trials, Daily, Doylestown, FDA, hepatitis B, Legal, Pennsylvania, Pharma, SYN, Top Story / May 25, 2022

A clinical hold on an Antios Therapeutics drug has led to the end of a collaboration with Assembly Biosciences less than a year after their alliance began. The partners had hoped pairing their drugs with an approved Gilead Sciences antiviral would produce a combination hepatitis B treatment with the potential for a cure.

Find your inner data and take precision marketing to the next level

Clinical Trials, data, HCP, precision marketing, Sales and Marketing, Thomas Kurian, Treasure Data, Views & Analysis, Views and analysis / May 24, 2022

Data is the powerhouse of the pharmaceutical sector. It powers drug discovery, clinical trials, and operational performance. But sizeable reservoirs of data remain unseen and untapped to commercial operations, allowing insights, opportunities, and efficiencies to leak away. Organisations are missing out on the ability to harness their data to energise precision marketing and transform commercial …

Find your inner data and take precision marketing to the next level Read More »

Biohaven drug fails another clinical test, this time in rare neuromuscular disorder

Biohaven Pharmaceuticals, BioPharma, Clinical Trials, Connecticut, neuroscience, New Haven, Pharma, Rare diseases, SYN, Top Story / May 23, 2022

Biohaven’s migraine drug research led to an FDA-approved product with strong commercial uptake, but its other neuroscience efforts have yet to achieve the same outcomes. Drug candidate troriluzole has failed a Phase 3 test in neuromuscular disorder spinocerebellar ataxia, the molecule’s third failure in a pivotal study in the past two years.

Innoviva’s Entasis acquisition brings a novel antibiotic that’s ready for the FDA

antibiotic, Antibiotic resistance, BioPharma, biopharma nl, Clinical Trials, Daily, Entasis Therapeutics, Innoviva, Massachusetts, Pharma, SYN, Top Story, waltham / May 23, 2022

Entasis Therapeutics is being acquired by Innoviva in a deal that brings an FDA-ready antibiotic developed to address drug-resistant strains of a bacterium that infects critically ill, immunocompromised patients. Innoviva has been steadily building up its stake in Entasis, an AstraZeneca spinout, over the past two years.

ePROs: Better Patient Input for Better Trial Output

Biopharmaceutical, BYOD, clinical research, Clinical Trial, Clinical Trials, data management, decentralized clinical trials, Health IT, Heart, Opinion, patient experience, Patient-centered, Physicians, Telemedicine, Wearables / May 19, 2022

Kris Gustafson, Vice President and Global Head Patient Centered Technologies, IQVIA During the pandemic, electronic clinical outcomes assessments (eCOAs) gained prominence as sponsors looked for more agile tools to help them capture patient data remotely through decentralized clinical trials (DCTs). From the adoption of virtual models like eCOAs and DCTs, a new opportunity emerged to …

ePROs: Better Patient Input for Better Trial Output Read More »

Cerner Collaboration to Increase Access to Cancer Clinical Trials

Biotech, cancer, Cancer Detection, care pathways, Caregivers, Cerner, clinical research, Clinical Trial, Clinical Trials, Health IT, Health Systems, Life Sciences, Machine Learning, Oncology / May 19, 2022

What You Should Know: – Cerner, Elligo Health Research® and Freenome are collaborating to enable a clinical trial through the Learning Health Network to help advance early cancer detection. – Together they will be using the research-activated network of health systems, real-world data (RWD) and multiomics technology, developed by Freenome, with the goal to help accelerate early cancer detection. Importance of Early Cancer Detection …

Cerner Collaboration to Increase Access to Cancer Clinical Trials Read More »

INVEST Pitch Perfect winner: Modality.ai makes Tina the Alexa of clinical trials

Artificial Intelligence, BioPharma, biopharma nl, Clinical Trials, Daily, David Suendermann-Oeft, Devices & Diagnostics, Medical Device, Modality.ai, Pharma, SAN FRANCISCO, Software, Startups, SYN, Top Story / May 18, 2022

Modality.ai has developed a conversational AI system that replaces in-person interviews that are part of neurological assessments for a range of disorders. The startup was judged co-winner in the pharmatech category during the recent MedCity INVEST conference in Chicago.

To focus on cancer, Chimerix sells rights to antiviral drug that defined the biotech

antiviral, BioPharma, biopharma nl, brain cancer, cancer, Chimerix, Clinical Trials, Daily, Durham, Emergent BioSolutions, North Carolina, Pharma, Smallpox, SYN, Tembexa, Top Story / May 16, 2022

Chimerix is selling global rights to smallpox drug Tembexa, the biotech’s only FDA-approved product, as a way to fund clinical development of a therapy in pivotal testing for a rare type of brain cancer. The deal marks Chimerix’s nearly complete departure from the antiviral work that defined the company for most of its history.

UCB’s FDA setback delays competition in U.S. with blockbuster J&J psoriasis drug

Belgium, bimekizumab, BioPharma, Clinical Trials, Daily, FDA, Pharma, psoriasis, SYN, Top Story, UCB / May 13, 2022

The FDA cited manufacturing issues in turning down UCB’s application seeking approval for bimekizumab, an antibody drug developed to treat moderate-to-severe plaque psoriasis. Bimekizumab is already approved and available in other markets around world, but the FDA rejection delays UCB’s antibody drug from competing in the U.S. for now.

BMS builds on BridgeBio alliance, inking deal for rights to KRAS cancer drug

BioPharma, biopharma nl, BridgeBio Pharma, Bristol-Myers Squibb, California, cancer, Clinical Trials, Daily, deals, palo alto, Pharma, SYN, Top Story / May 12, 2022

Bristol Myer Squibb is getting rights to BBP-398, a contender in the chase for drugs that address difficult-to-target KRAS mutations. Meanwhile, BridgeBio Pharma receives some needed cash as it restructures in the wake of the Phase 3 failure of its lead program late last year.

Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11

Children and Childhood, Clinical Trials, Coronavirus (2019-nCoV), Coronavirus Omicron Variant, Disease Rates, Drugs (Pharmaceuticals), Food and Drug Administration, Moderna Inc, New England Journal of Medicine, Teenagers and Adolescence, United States, Vaccination and Immunization, your-feed-science / May 11, 2022

Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.

Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11

Children and Childhood, Clinical Trials, Coronavirus (2019-nCoV), Coronavirus Omicron Variant, Disease Rates, Drugs (Pharmaceuticals), Food and Drug Administration, Moderna Inc, New England Journal of Medicine, Teenagers and Adolescence, United States, Vaccination and Immunization, your-feed-science / May 11, 2022

Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.

Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11

Children and Childhood, Clinical Trials, Coronavirus (2019-nCoV), Coronavirus Omicron Variant, Disease Rates, Drugs (Pharmaceuticals), Food and Drug Administration, Moderna Inc, New England Journal of Medicine, Teenagers and Adolescence, United States, Vaccination and Immunization, your-feed-science / May 11, 2022

Antibody levels rose in the children who received it, suggesting the vaccine protects against infection. But the data were gathered before the arrival of Omicron.

Closely watched Roche drug fails a second pivotal test in lung cancer

BioPharma, cancer immunotherapy, Clinical Trials, lung cancer, Pharma, Roche, Switzerland, tiragolumab / May 11, 2022

Roche reported that its drug tiragolumab failed to achieve one of two main goals of a Phase 3 study in non-small cell lung cancer. The antibody is designed to block TIGIT, a checkpoint protein that has been a hot target for pharmaceutical companies looking for a way to broaden the reach of cancer immunotherapy.

Osmind Secures $40M to Expand Mental Health EHR Platform

behavioral health, Clinical Trials, depression, digital health, Electronic Health Record, mental health, Mental Illness, Partners, Patient Engagement, Precision Medicine, SAN FRANCISCO, Startups / May 10, 2022

What You Should Know: – Osmind, a mental health EHR platform helping clinicians and researchers advance new life-saving mental health treatments, today announced a $40 million Series B investment led by DFJ Growth. The Series B round brings the total amount of funding for Osmind to $57M since the company’s founding in 2020. Justin Kao, …

Osmind Secures $40M to Expand Mental Health EHR Platform Read More »

Pfizer buys its way into migraine with $11.6B Biohaven Pharma acquisition

Biohaven Pharmaceuticals, BioPharma, Clinical Trials, Connecticut, Daily, deals, M&A, Migraine, New Haven, Nurtec, Pfizer, Pharma, SYN, Top Story, Vlad Coric / May 10, 2022

Pfizer is turning to M&A to get its next blockbuster, buying Biohaven six months after the two companies began a commercialization pact centered on the oral migraine drug Nurtec. The acquisition will lead to the spinout of Biohaven’s other assets into a new, publicly traded company capitalized with $275 million.

Digital Documentation: How PDFs Can Help Providers Expedite Care

Care Coordination, clinical research, Clinical Trials, Digital Transformation, FDA, Health IT, HIPPA, InstaMed, Opinion, Partners, Patient Care, Patient Engagement, patient experience, Patient Privacy, Payers, public health, risk, Surescripts, virtual care / May 10, 2022

Deboshree Sarkar, Product Marketing Manager, PDF Editor Product line at Foxit We live in an increasingly digital world. Across industries, companies and consumers have come to rely on the rapid exchange of digital information. Healthcare, however, has been an outlier in this regard. While the healthcare digital transformation has been in play for years, it’s …

Digital Documentation: How PDFs Can Help Providers Expedite Care Read More »

Aiming to treat Parkinson’s by replacing neurons, Aspen Neuroscience nabs $147M

Artificial Intelligence, Aspen Neuroscience, Bayer, BioPharma, cell therapy, Clinical Trials, Daily, deals, investing, Parkinson’s Disease, Pharma, San Diego, Startups, SYN, Top Story / May 9, 2022

Aspen Neurosciences is developing a cell therapy that uses a patient’s own stem cells to develop a personalized treatment for Parkinson’s disease. The approach is slightly different than that of Bayer, whose experimental Parkinson’s cell therapy is made from stem cells sourced from healthy donors.

How cell & gene therapy startups can warm up to investors in this “biotech nuclear winter”

BioPharma, Boston, cell therapy, Clinical Trials, Daily, FDA, gene therapy, Mass General Brigham, Pharma, SYN, Top Story, venture capital / May 9, 2022

Cell and gene therapy research has been hot the past few years but the overall market has cooled down in recent months. During the World Medical Innovation Forum in Boston, a panel of venture capitalists discussed capital formation and what biotech firms need to do to win over investors and advance their research.

Regulatory recap: J&J vaccine limits, full Enhertu approval, a Vertex hold & more

BioPharma, biopharma nl, cancer, Clinical Trials, COVID-19, FDA, Johnson & Johnson, Legal, Pharma / May 8, 2022

The FDA amended emergency authorization of Johnson & Johnson’s Covid-19 vaccine. In other regulatory news this past week, drug approvals include a cancer drug that converted its accelerated regulatory approval to a full regulatory nod, while several companies dealt with rejections or clinical trial setbacks.

PepGen IPO nabs $108M for muscular dystrophy drug with potential edge over Sarepta med

BioPharma, biotech IPO, Cambridge, Clinical Trials, Daily, Duchenne muscular dystrophy, Massachusetts, Oligonucleotide, PepGen, Pharma, Rare diseases, SYN, Top Story / May 6, 2022

PepGen’s technology improves the delivery of a therapy to more tissue types and the clinical-stage biotech plans to use its IPO cash to continue developing its lead program for Duchenne muscular dystrophy. Meanwhile, eye products giant Bausch + Lomb returned to the public markets as a standalone company. Both the PepGen and Bausch + Lomb …

PepGen IPO nabs $108M for muscular dystrophy drug with potential edge over Sarepta med Read More »

Are you a startup seeking to transform clinical trials? Here’s why you should apply to pitch at INVEST PharmaTech.

BioPharma, Clinical Trials, clinical trials recruitment, Daily, Events, Health Services, Health Tech, INVEST PharmaTech, mcINVEST, News, Pitch Perfect, Startups, SYN, Top Story / May 6, 2022

INVEST PharmaTech Pitch Perfect virtual conference July 26 will give startups the opportunity to present their approaches to clinical trial innovation to a team of investor judges. Apply today!

Curebase bags $40m to develop patient-centric trials platform

Clinical Trials, Curebase, decentralised trials, digital, digital health, Financing, News, patients, R&D / May 5, 2022

Curebase has raised $40 million in second-round financing that will help it run more complex interventional trials for its biopharma clients, according to chief executive Tom Lemberg. The Series B takes the total raised by Curebase to $59 million since it was set up five years ago to develop a patient-focused approach to clinical research, …

Curebase bags $40m to develop patient-centric trials platform Read More »

4 Reasons Why You Shouldn’t Ignore CDISC Data Standards

cdisc, CDISC standards, Clinical Trials, formedix, Partner content, Press releases / May 5, 2022

A quick recap: Who are CDISC and what do they do? The Clinical Data Interchange Standards Consortium (CDISC) is a non-profit organization that aims to maximise the impact of clinical research data by establishing and promoting the use of data standards. Basically, these standards make clinical data easier to understand and interpret. “We develop and advance data …

4 Reasons Why You Shouldn’t Ignore CDISC Data Standards Read More »

BMS shows what’s NEX-T for CAR T, plus its strategy for next-gen cancer cell therapy

Abecma, BioPharma, Boston, Breyanzi, Bristol-Myers Squibb, CAR-T, cell therapy, Clinical Trials, Daily, Kristen Hege, Pharma, SYN, Top Story / May 4, 2022

As an oncologist, Kristen Hege first encountered cancer cell therapy research in the mid-1990s. Now as a Bristol Myers Squibb executive, she oversees efforts to improve the pharma giant’s first generation of cell therapies while also building a pipeline of next-generation treatments with better features and properties.

How the Life Sciences Industry Can Boost Diversity and Inclusion Efforts

assistants, Clinical Trial, Clinical Trials, Color, digital health, Diversity and Inclusion, FDA, foundational, global healthcare, H1, Health Disparities, Healthcare Data, Life Sciences, Opinion, patient population, Physicians, Premier / May 3, 2022

Although it is well established that diversity improves outcomes and drives excellence, implementing diversity lags behind in many industries, including life sciences and healthcare.  Diversity is lacking across the entire field, from academic research to clinical work, composition of the workforce, and medical practice. This leads to worse health outcomes and fewer professional opportunities for …

How the Life Sciences Industry Can Boost Diversity and Inclusion Efforts Read More »

HilleVax’s IPO hauls in $200M for clinical test of VLP norovirus vaccine from Takeda

Bausch + Lomb, Belite Bio, BioPharma, biotech IPO, Boston, Clinical Trials, Daily, HilleVax, norovirus, Pharma, SYN, Takeda Pharmaceutical, Top Story, Vaccines / May 1, 2022

Takeda Pharmaceutical spinout HilleVax broke the biotech IPO drought with a $200 million stock market debut for clinical development of a norovirus vaccine. Two eye health companies marked the other IPO activity: Belite Bio went public while Bausch + Lomb set financial terms for what could become one of the biggest IPOs of the year.

Ceryx Medical CEO said its technology could potentially cure heart failure, startup gets funding for first human trials

Clinical Trials, Daily, Devices & Diagnostics, funding, heart failure, medical technology startups, News, pacemaker, SYN, Top Story / April 29, 2022

Ceryx’s device, Cysoni, is designed to pace the heart in rhythm with a person’s respiration, so that the heart rate and breathing are synced. This is typically the case for a healthy person, but for someone with heart failure, that link becomes severed, CEO Stuart Plant said.

Potential blockbuster BMS cardio drug gets FDA nod, first in rare heart disease

BioPharma, Bristol-Myers Squibb, Camzyos, cardiovascular, Clinical Trials, Daily, FDA, Giovanni Caforio, Legal, New York, Pharma, Rare diseases, SYN, Top Story / April 29, 2022

Bristol Myers Squibb drug Camzyos has FDA approval for treating obstructive hypertrophic cardiomyopathy, a rare and potentially fatal heart disorder. The drug is projected to become a blockbuster seller and its approval marks a payoff for BMS’s 2020 acquisition of the medicine’s developer, MyoKardia.

3 Keys to Eliminating Data Breakdowns in Life Sciences

AI, Artificial Intelligence, Biotech, Clinical Diagnostics, Clinical Trials, cloud, Data Analytics, dataset, digital health, Digital Transformation, Life Sciences, Machine Learning, Opinion, Pharma, social media, video / April 28, 2022

Sudish Mogul, Chief Technology Officer of Healthcare Triangle Across life sciences, experts boldly predict that data is the new currency—and that mobilizing data from clinical trials, wearable devices and even social media will ignite innovation in 2022. But leveraging data for innovation depends not just on data analytics, but also access to the right data …

3 Keys to Eliminating Data Breakdowns in Life Sciences Read More »

Biohaven migraine drug partnered with Pfizer lands twin European approvals

Biohaven Pharmaceuticals, BioPharma, biopharma nl, Clinical Trials, Connecticut, Daily, European Commission, Legal, Migraine, New Haven, Nurtec, Pfizer, Pharma, rimegepant, SYN, Top Story / April 27, 2022

The European Commission approved Biohaven Pharmaceuticals migraine drug rimegepant. While the regulatory decision marks another milestone for Biohaven, it’s also a win for Pfizer, which holds rights to commercialize the drug outside of the U.S.

3 Predictions for Post-COVID Clinical Trial Decentralization

API, Cleveland Clinic, Clinical Trial, Clinical Trials, Coronavirus (COVID-19), decentralized clinical trials, digital health, EMR, GE healthcare, global healthcare, Life Sciences, model, Opinion, Partners, primary care, revenue cycle / April 27, 2022

Marc Leighton, VP of Product at Florence Healthcare Prior to COVID, major technological transformation initiatives were already underway at many clinical trial sites, sponsors, and contract research organizations (CROs.) But the move to decentralized trials accelerated dramatically in 2020 and 2021–and it’s not slowing down.  Survey data from WCG Avoca shows that research sites and …

3 Predictions for Post-COVID Clinical Trial Decentralization Read More »

Biofourmis Secures $300M to Expand Virtual Care Offerings

Biofourmis, Clinical Trials, CVS Health, digital health, Digital Medicine, Home Care, in-home care, intel, medical technology, Medtronic, Payers, Startups, virtual care, Virtual Care Platform / April 26, 2022

Kuldeep Singh Rajput, Founder & Chief Executive Officer of Biofourmis What You Should Know: – Biofourmis, a global leader in virtual care and digital medicine raises $300 million in Series D investment led by leading global growth equity firm General Atlantic. CVS Health and existing investors also participated in the round, – Biofourmis also announced that …

Biofourmis Secures $300M to Expand Virtual Care Offerings Read More »

Nkarta’s natural killers flash potential as next-gen cell therapies for cancer

BioPharma, cancer, cell therapy, Clinical Trials, Daily, Nkarta Therapeutics, Paul Hastings, Pharma, South San Francisco, SYN, Top Story / April 25, 2022

Two natural killer (NK)cell therapy candidates from Nkarta now have preliminary Phase 1 clinical data suggesting these therapies are helping patients in two types of blood cancers. Nkarta therapies based on engineered NK cells could offer both efficacy and safety advantages over the first generations of cell therapies, which are made from a patient’s own …

Nkarta’s natural killers flash potential as next-gen cell therapies for cancer Read More »

Roche breast cancer drug fails in Phase 2 following similar stumble by rival Sanofi

BioPharma, breast cancer, cancer, Clinical Trials, Daily, Giredestrant, News, Pharma, Roche, Sanofi, Switzerland, SYN, Top Story / April 25, 2022

Experimental Roche drug giredestrant failed to meet the main goal of a Phase 2 study in advanced breast cancer. The disappointing results allow competitors to gain ground in the field of companies developing oral selective estrogen receptor degraders (SERDs), drugs that block a receptor key to driving breast cancer growth.

Covid-19 vaccines & therapies helped push medicines spending to $407B in 2021

BioPharma, Biosimilar, Clinical Trials, COVID-19, Daily, drug spend, Durham, IQVIA, North Carolina, Pharma, prescriptions, SYN, Top Story, Vaccines / April 24, 2022

While Covid-19 has had a significant impact on drug spending, IQVIA projects that its effect will moderate in coming years. IQVIA’s new report on U.S. medicines spending projects that immunology, oncology, and neurology will continue to drive the growth in drug spending.

Biogen pulls Alzheimer’s drug application in Europe as EMA calls data insufficient

Aduhelm, alzheimer's disease, Biogen, BioPharma, Cambridge, Clinical Trials, European Medicines Agency, Legal, Massachusetts, Pharma / April 22, 2022

Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by a European Medicines Commission committee last December. The company was unable to persuade European regulators to change their minds about the drug.

Financing pushes value of clinical trial tech firm Reify to $4.8bn

Clinical Trials, decentralised clinical trials, digital, digital health, diversity, News, patients, R&D, Recruitment, Reify Health / April 22, 2022

Reify Health has completed fourth-round financing that adds $220 million to its cash reserves and pushes its valuation up to a heady $4.8 billion, with plans to use the new cash to launch a new initiative to make sure clinical trials are inclusive and diverse. The need for diversity in clinical trial populations has been …

Financing pushes value of clinical trial tech firm Reify to $4.8bn Read More »

Reify Health Secures $220M to Support Clinical Trial Diversity at $4.8B Valuation

Biopharmaceutical, clinical research, Clinical Trial, Clinical Trial Monitoring, Clinical Trial Recruitment, Clinical Trials, decentralized clinical trials, digital health, FDA, Life Sciences, Partners, Reify Health, Startups / April 21, 2022

What You Should Know: – Reify Health, a leading provider of solutions that empower the clinical trial ecosystem, announced a $220M Series D funding round dedicated to improving diversity in clinical research. The investment comes less than a year after its Series C and brings the company’s valuation to $4.8B.  – The Series C found was co-led …

Reify Health Secures $220M to Support Clinical Trial Diversity at $4.8B Valuation Read More »

AstraZeneca’s long-acting Covid-19 drug keeps protecting high-risk patients at 6 months

Antibody Drug, AstraZeneca, BioPharma, biopharma nl, Clinical Trials, COVID-19, Daily, Evusheld, Pharma, SYN, Top Story / April 21, 2022

AstraZeneca’s Covid-19 antibody drug Evusheld reduced the risk of infection by 83% after six months. These results published in the New England Journal of Medicine are the latest clinical data supporting the durability of Evusheld, which was designed to offer longer-lasting protection.

AI startup Unlearn adds $50M for better, faster, smaller & cheaper clinical trials

BioPharma, Charles Fisher, Clinical Trials, Pharma, SAN FRANCISCO, Software, Startups, Unlearn.AI / April 19, 2022

Unlearn.AI’s Series B round follows a positive European Medicines Agency draft opinion finding that the company’s artificial intelligence technology can be used in Phase 2 and Phase 3 clinical trials. The startup is now on the hunt for pharmaceutical partners that want to use the technology to speed up their clinical research.

Regeneron captures new piece for cancer with $250M Checkmate Pharma buyout

BioPharma, biopharma nl, cancer, cancer immunotherapy, Checkmate Pharmaceuticals, Clinical Trials, Daily, deals, New York, Pharma, Regeneron Pharmaceuticals, SYN, Tarrytown, Top Story / April 19, 2022

Regeneron Pharmaceuticals is paying $250 million cash to acquire Checkmate Pharmaceuticals, a clinical-stage biotech developing drugs that activate the innate immune system. The biotech’s lead drug candidate is currently in pivotal testing in melanoma.

Why Cheap, Older Drugs That Might Treat Covid Never Get Out of the Lab

Clinical Trials, Cost and Quality, COVID-19, drug costs, FDA, Health Industry, NIH, Pharmaceuticals, Trump Administration / April 19, 2022

In March 2020, Dr. Joseph Vinetz left the contemplative world of his Yale University infectious-disease laboratory and plunged into the covid ward at Yale New Haven Hospital, joining an army of health care workers who struggled to treat the deadly viral disease. There were no drugs against covid-19, and no way to predict which infected …

Why Cheap, Older Drugs That Might Treat Covid Never Get Out of the Lab Read More »

FDA’s tighter scrutiny on drug class leads TG Therapeutics to pull out of cancer

BioPharma, cancer drugs, Clinical Trials, Daily, FDA, Michael Weiss, Pharma, SYN, TG Therapeutics, Top Story, Ukoniq / April 18, 2022

TG Therapeutics is pausing its cancer drug research and withdrawing the approved cancer drug Ukoniq from the market. The move comes as the FDA places greater scrutiny on Ukoniq’s drug class—concerns that will be discussed during an FDA advisory committee meeting scheduled for April 21.

Covid news roundup: Boosters for kids, breath diagnostic, a vax approval & more

BioNTech, BioPharma, biopharma nl, Clinical Trials, Coronavirus (COVID-19), Covid-19 Vaccine, Daily, FDA, Legal, Pfizer, Pharma, SYN, Top Story / April 17, 2022

Pfizer and BioNTech reported preliminary clinical data supporting use of their Covid-19 vaccine as a booster in children ages 5 to 11. In other Covid news, a vaccine developer won marketing authorization in Europe while another one faces a regulatory setback.

BMS and Nektar end cancer drug alliance after two more clinical trial failures

BioPharma, biopharma nl, bladder cancer, Bristol-Myers Squibb, cancer, Clinical Trials, kidney cancer, Nektar Therapeutics, Pharma, SAN FRANCISCO / April 14, 2022

Bristol Myers Squibb and Nektar Therapeutics are ending a cancer drug research alliance after data showed the combination of their respective drugs failed clinical trials in kidney and bladder cancers. The disappointing results come one month after the drug combo failed a pivotal melanoma clinical trial.

Cell therapy biotech Aurion gets $120M to restore vision and revamp organ donor economics

Aurion Biotech, BioPharma, cell therapy, Clinical Trials, Daily, Greg Kunst, Organ Donation, Pharma, Seattle, SYN, Top Story / April 12, 2022

Organ donation has long been a matter of demand outstripping supply, but Aurion Biotech aims to improve the supply part of the equation with a cell therapy. Aurion’s technology turns a single donated cornea into treatments for up to 100 patients and the startup now has $120 million for clinical trials.

FDA gives Gilead reprieve on partial hold for cancer drug studies

BioPharma, biopharma nl, California, cancer immunotherapy, Clinical Trials, Daily, FDA, Foster City, Gilead Sciences, Legal, Pharma, SYN, Top Story / April 12, 2022

An FDA safety review has cleared Gilead Sciences to resume five clinical trials that were placed under a partial hold in January. The experimental Gilead drug, magrolimab, is part of a class of cancer immunotherapies that address a hot target for the field.

Microbiome biotech Kaleido Biosciences shutters amid cash crunch, drug setbacks

BioPharma, Clinical Trials, Daily, Flagship Pioneering, Kaleido Biosciences, layoffs, Lexington, Massachusetts, microbiome, Pharma, SYN, Top Story / April 10, 2022

Kaleido Biosciences, formed by Flagship Pioneering as part of a wave of biotech companies developing microbiome therapies, has laid off its entire workforce and is winding down operations. The shutdown follows a strategic review that failed to turn up any deals to support its clinical-stage pipeline.

PathAI and GlaxoSmithKline Partner to Accelerate Research and Drug Development

AI, Artificial Intelligence, cancer, Clinical Trials, digital health, Drug Research, GlaxoSmithKline, Life Sciences, Oncology, PathAI / April 8, 2022

What You Should Know: – PathAI and GSK announced a multi-year strategic artificial intelligence (AI) partnership today with a focus on accelerating research and- building drug development programs in oncology and non-alcoholic steatohepatitis (NASH). – As part of the partnership, GSK will leverage both PathAI’s expertise and models to advance GSK’s proprietary AI models and focus on designing better …

PathAI and GlaxoSmithKline Partner to Accelerate Research and Drug Development Read More »

Final CMS decision limits coverage of Biogen’s Aduhelm to those in clinical trials

Aduhelm, alzheimer's disease, Biogen, BioPharma, Cambridge, Centers for Medicaid and Medicare Services, Clinical Trials, Daily, FDA, Legal, Massachusetts, Payers, Pharma, SYN, Top Story / April 8, 2022

Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect of limiting use of the drug, but the agency said its decision provides clarity on what drug companies need to show in order to secure Medicare coverage.

Werewolf cancer drug strikes right note with Jazz Pharma, sparking licensing deal

BioPharma, biopharma nl, cancer, cancer immunotherapy, Clinical Trials, cytokines, Daily, Dublin, Ireland, Jazz Pharmaceuticals, Pharma, SYN, Top Story, Werewolf Therapeutics / April 7, 2022

Jazz Pharmaceuticals is licensing rights to a Werewolf Therapeutics cytokine therapy that’s on track to reach clinical testing next year. The deal gives Jazz a drug candidate that expands the company’s scope to immuno-oncology.

Viz.ai Raises $100M for Care Coordination Platform at $1.2B Valuation

AI, Artificial Intelligence, Care Coordination, Clinical Trials, digital health, google, Life Sciences, Medical Device, Partners, SAN FRANCISCO, Startups / April 7, 2022

What You Should Know: – Viz.ai, a San Francisco-based AI-powered disease detection and care coordination platform raises $1000M in Series D funding led by Tiger Global and Insight Partners. The round also included participation from Scale Ventures, Kleiner Perkins, Threshold, GV (formerly Google Ventures), Sozo Ventures, CRV, and Susa.  – The new funds will be used to support Viz.ai’s significant growth trajectory, …

Viz.ai Raises $100M for Care Coordination Platform at $1.2B Valuation Read More »

Pfizer broadens its RSV reach with deal for ReViral and its clinical-stage antivirals

BioPharma, biopharma nl, Clinical Trials, Daily, deals, Durham, North Carolina, Pfizer, Pharma, respiratory syncytial virus, ReViral Therapeutics, SYN, Top Story / April 7, 2022

Pfizer is already in the mix of companies pursuing vaccines for respiratory syncytial virus. The pharma giant is now broadening its scope with a deal to acquire ReViral Therapeutics, a biotech with two clinical-stage antivirals, each taking a different approach to stopping the potentially deadly pathogen.

Novartis cancer drug is now first approved therapy for group of rare, genetic diseases

Basel, BioPharma, cancer, Clinical Trials, Daily, FDA, Legal, Novartis, Pharma, Rare diseases, Switzerland, SYN, Top Story / April 6, 2022

A Novartis drug that stops abnormal cell growth in breast cancer now has an additional FDA approval treating a group of rare disorders characterized by overgrowth in various types of tissue. The regulatory decision makes the drug, Vijoice, the first approved therapy for these disorders termed “PROS.”

Imara’s two trial flops in blood disorders dim drug’s prospects in heart failure

BioPharma, biopharma nl, Boston, Clinical Trials, Daily, heart failure, hemoglobinopathy, Imara, Pharma, sickle cell disease, SYN, Top Story / April 5, 2022

The lead drug candidate of Imara failed two separate mid-stage clinical trials evaluating it in rare, inherited hemoglobin disorders. Imara had been planning to advance the small molecule to yet another Phase 2 study in heart failure, but in light of the twin trial failures, the biotech is now weighing “strategic options.”

Study uncovers new Alzheimer’s genes, links to immune disruption

alzheimer's disease, Clinical Trials, Genetics, immunology, neurology, News, R&D / April 4, 2022

The largest-ever study of genetics in Alzheimer’s disease patients has identified 42 new genes that appear to be linked to the neurodegenerative disorder. The new genes takes the total number associated with Alzheimer’s to 75, opening up new avenues for research of ways to diagnose and treat the conditions, and suggest that immunological dysfunction may …

Study uncovers new Alzheimer’s genes, links to immune disruption Read More »

Labcorp & Medidata to Co-Develop Digital Biomarkers & Expand Decentralized Clinical Trials

Biomarkers, Clinical Trials, cloud, decentralized clinical trials, Digital Biomarkers, digital health, LabCorp, Life Sciences, Medidata / April 1, 2022

What You Should Know: - Medidata, a Dassault Systèmes company, today announced that Labcorp, a leading global life sciences company, has selected Medidata’s technology platform to extend their 14-year partnership, the foundation of their initiative to co-develop digital biomarkers and expand the use and functionality of decentralized clinical trials. Labcorp Drug Development has developed its offerings on Medidata technologies, starting with Rave EDC (electronic data capture), Coder and …

Labcorp & Medidata to Co-Develop Digital Biomarkers & Expand Decentralized Clinical Trials Read More »

Safety concerns sink Akebia drug for anemia from chronic kidney disease

Akebia Therapeutics, Anemia, BioPharma, biopharma nl, Cambridge, chronic kidney disease, Clinical Trials, Daily, FDA, Legal, Massachusetts, News, Pharma, SYN, Top Story, Vadadustat / April 1, 2022

The FDA rejected Akebia Therapeutics drug vadadustat as a treatment for anemia caused by chronic kidney disease. According to the biotech, the agency cited safety concerns and asked for another clinical trial to show that the pill’s benefits outweigh its risks.

Sano raises $11m for patient and trial matchmaking platform

clinical research, Clinical Trials, Financing, Genetics, News, Patient Recruitment, patients, Sano Genetics / March 31, 2022

UK startup Sano Genetics has raised $11 million in first-round financing to develop its go-between service, which aims to overcome one of the big challenges in clinical research by connecting patients with trial sponsors. The Cambridge-based company said the new funding – which adds to around $4 million in seed financing – will be used …

Sano raises $11m for patient and trial matchmaking platform Read More »

VivoSense Raises $25M for Wearable Sensor Biomarkers to Advance Clinical Trials

Biomarkers, Biotech, clinical research, Clinical Trials, Digital Biomarkers, digital health, Life Sciences, Pharma, Precision Medicine, sensors, Startups / March 30, 2022

What You Should Know: – VivoSense, an agile end-to-end scientific solutions company developing novel digital endpoints from wearable sensor data raises $25 Million in Series A funding. – The financing will accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. VivoSense will also use this financing to expand and refine its informatics platform …

VivoSense Raises $25M for Wearable Sensor Biomarkers to Advance Clinical Trials Read More »

Vying to best bigger rivals in Parkinson’s, Neuron23 nabs $100M to reach clinic

BioPharma, Clinical Trials, Daily, investing, Nancy Stagliano, Neuron23, Parkinson’s Disease, Pharma, South San Francisco, Startups, SYN, Top Story, VC / March 30, 2022

Neuron23 is developing drugs that treat neurological conditions by penetrating the blood-brain barrier to reach disease targets in the central nervous system. The biotech’s lead program is a Parkinson’s disease drug candidate with features that could distinguish it from rival compounds that are aiming for the same target.

New blow for ALS pipeline as Biogen and Ionis candidate fails Phase 1 trial

ALS, Biogen, Clinical Trials, Ionis Pharmaceuticals, News, Pharma, R&D / March 29, 2022

Less than six months after the late-stage failure of tofersen, Biogen and Ionis have suffered further disappointment in the amyotrophic lateral sclerosis (ALS) pipeline after BIIB078 (IONIS-C9Rx) failed to demonstrate clinical benefit in a Phase 1 trial. In the randomised, placebo-controlled, dose-escalating trial, researchers evaluated the efficacy of the investigational antisense oligonucleotide BIIB078 as a …

New blow for ALS pipeline as Biogen and Ionis candidate fails Phase 1 trial Read More »

Data and regulatory roundup: Pfizer’s feat, an ADHD miss, Eli Lilly’s CRL & more

BioPharma, biopharma nl, cancer, Clinical Trials, Daily, Eli Lilly, FDA, Legal, Pfizer, Pharma, SYN, Top Story, Ulcerative Colitis / March 27, 2022

A pharmaceutical giant reported a Phase 3 success for a potential blockbuster drug, while four other companies reported disappointing data from their respective clinical trials. Our recap of data readouts and regulatory news also includes one FDA rejection.

AN2 Therapeutics’ IPO raises $69M to take antibiotic from Pfizer into pivotal test

AN2 Therapeutics, antibiotic, BioPharma, biopharma nl, biotech IPO, California, Clinical Trials, Daily, epetraborole, menlo park, Pfizer, Pharma, SYN, Top Story / March 25, 2022

AN2 is developing an antibiotic based on boron chemistry that could offer advantages over carbon-based molecules. The biotech plans to advance its drug candidate, licensed from Pfizer, to a pivotal test in a rare and potentially fatal lung infection caused by mycobacteria.

COTA Promotes Miruna Sasu to President and CEO

cancer, Clinical Trial, Clinical Trials, COTA, digital health, Digital Health Hires, Health IT, Lung, lung cancer, MedStar Health, Oncology / March 24, 2022

Miruna Sasu, Ph.D., MBA, President & CEO at COTA, Inc. What You Should Know: – COTA, Inc., an oncology real-world data and analytics company, announced today that Miruna Sasu, Ph.D., MBA, has been appointed president and chief executive officer.  – Since April 2021 when she was hired as the company’s chief strategy officer, Miruna has …

COTA Promotes Miruna Sasu to President and CEO Read More »

Tempus Launches Pathology-Driven AI Platform

AI, algorithms, Artificial Intelligence, Biomarkers, Biotech, cancer, Clinical Trials, digital health, Digital Pathology, Life Sciences, model, Precision Medicine, Tempus / March 21, 2022

What You Should Know: – Tempus, a provider of artificial intelligence and precision medicine, today announced the launch of Edge, an innovative platform that allows pathologists to access developing AI models intended to identify specimens with potentially actionable biomarkers using a single hematoxylin and eosin stain (H&E) slide. – With access to over 50 petabytes of de-identified …

Tempus Launches Pathology-Driven AI Platform Read More »

Applied XL Raises $3.5M for Real-Time Data Tracking Platform

Clinical Trials, Life Sciences, Startups / March 21, 2022

What You Should Know: – Applied XL, a real-time information company tracking disruptions to the health of people, places, and the planet, today announced it had raised $3.5 million in seed funding led by Hearst Ventures with the participation of the Boston Globe Media Partners and STAT, which are owned by the Henry family. – …

Applied XL Raises $3.5M for Real-Time Data Tracking Platform Read More »

FDA approves Marinus Pharma drug for rare, genetic form of epilepsy

BioPharma, Clinical Trials, Daily, epilepsy, FDA, Legal, Marinus Pharmaceuticals, Neurological Disorder, Pennsylvania, Pharma, Radnor, Rare diseases, SYN, Top Story / March 21, 2022

Marinus Pharmaceuticals drug Ztalmy is now FDA approved for treating the seizures in patients who have CDKL5 deficiency, an inherited form of epilepsy. The drug is the first approved treatment for the rare disorder and it’s also Marinus’s first approved product.

BMS nabs FDA nod for first drug in new class of cancer immunotherapies

BioPharma, Bristol-Myers Squibb, cancer, cancer immunotherapy, Clinical Trials, Daily, FDA, Legal, Melanoma, New York, Pharma, SYN, Top Story / March 21, 2022

Bristol Myers Squibb’s Opdualag has been approved by the FDA, a first for a drug that goes after a new cancer target called LAG-3. The drug is approved for advanced melanoma as part of a combination treatment that includes the already approved BMS cancer immunotherapy Opdivo.

Apellis Pharma eyes a shot at getting first FDA approval in rare vision disorder

apellis pharmaceuticals, BioPharma, Cedric Francois, Clinical Trials, Daily, geographic atrophy, Massachusetts, pegcetacoplan, Pharma, SYN, Top Story, waltham / March 20, 2022

Apellis Pharmaceuticals has additional clinical data that show its drug having an effect on geographic atrophy, a rare vision-loss disorder with no FDA-approved treatment. The biotech plans to include the latest results in a new drug application being readied for submission in coming months.

Day 3 HIMSS Roundup: Glooko Acquires DIABNEXT, GE Healthcare/AliveCor Integration

AI, algorithms, AliveCor, Artificial Intelligence, Atrial Fibrillation, Biotech, breast cancer, cancer, Cancer Detection, care pathways, care teams, Caregivers, Cerner, Clinical Trial, Clinical Trials, cybersecurity, data management, diabetes, diagnostic testing, digital health, Digital Pathology, ecg, GE healthcare, Genomic Testing, Glooko, google, health insurance, Health IT, Health Ventures, healthcare it, Healthy.io, himss, Hypertension, integrated care, IntelyCare, Interoperability, Jvion, kidney disease, Lung, lung cancer, M&A, Medical Device, Medical Device Cybersecurity, Medical Devices, medication, mental health, model, NHS, Oncology, PACS, Partners, Patient Care, Patient Engagement, Patient Monitoring, patient satisfaction, Philips, Physicians, PointClickCare, Precision Oncology, Private Equity, Proscia, remote patient monitoring, risk, Sema4, senior care, Siemens, Siemens Healthineers, Startups, SubjectWell, venture capital, Verily, WASHINGTON / March 16, 2022

Venture Capital, Private Equity, Mergers & Acquisitions (M&A) Activity Glooko Acquires DIABNEXT® to Expand Diabetes Offerings in France Glooko, a leading provider of remote patient monitoring and data management solutions for diabetes and related chronic conditions, today announced the acquisition of DIABNEXT, a Paris-based company whose digital health platform helps people with diabetes better manage …

Day 3 HIMSS Roundup: Glooko Acquires DIABNEXT, GE Healthcare/AliveCor Integration Read More »

Diabetes data put Better Therapeutics’ digital offering on track for FDA filing

Artificial Intelligence, Better Therapeutics, BioPharma, Clinical Trials, Daily, Devices & Diagnostics, diabetes, SAN FRANCISCO, Software, SYN, Top Story / March 15, 2022

Better Therapeutics reported that its digital therapeutic for type 2 diabetes met the main goal of a pivotal study. An FDA submission is expected in the middle of this year, followed by additional clinical trials testing digital therapeutics developed for other cardiometabolic disorders.

Nektar drug key to muti-billion dollar BMS deal fails pivotal test in melanoma

BioPharma, Bristol-Myers Squibb, cancer, cancer immunotherapy, Clinical Trials, Daily, Melanoma, Nektar Therapeutics, News, Opdivo, Pharma, South San Francisco, SYN, Top Story / March 14, 2022

Bristol Myers Squibb bet more than $1.8 billion that Nektar Therapeutics’ drug could be combined with the pharma giant’s Opdivo to expand the reach of that drug to more patients. The drug combination has failed its first Phase 3 in advanced melanoma; separate studies in kidney and bladder cancers are ongoing.

Modest activity, tolerability issues sink lead Harpoon cancer drug prospect

BioPharma, biopharma nl, cancer, Clinical Trials, Daily, Harpoon Therapeutics, Pharma, prostate cancer, South San Francisco, SYN, Top Story / March 11, 2022

Harpoon Therapeutics is discontinuing work on its lead drug in prostate cancer following disappointing data in an early-stage clinical trial. Though Harpoon has other drugs in its pipeline, the decision is a setback to the company’s efforts to develop a new type of cancer immunotherapy.

Alliance aims to drive inclusivity in trials backed by digital devices

Clinical Trials, digital, digital health, Digital Medicine Society (DiMe), News / March 11, 2022

A consortium led by the Digital Medicine Society (DiMe) has been set up to try to end inequities in access to clinical trials, focusing on the increasing number of studies that use digital devices to allow participation. The organisation has teamed up with drugmakers GlaxoSmithKline and Amgen as well as partners in the clinical research, …

Alliance aims to drive inclusivity in trials backed by digital devices Read More »

MorphoSys cuts R&D from Constellation deal to focus on clinical-stage cancer drugs

BioPharma, cancer, Clinical Trials, Constellation Pharmaceuticals, Daily, Germany, Jean-Paul Kress, MorphoSys, Pharma, SYN, Top Story / March 10, 2022

MorphoSys is cutting the drug discovery and R&D work of Constellation Pharmaceuticals, a company it acquired lats year in a $1.7 billion deal. This consolidation of research operations will result in non-cash impairment charge on Constellation’s goodwill.

Scenic Biotech scores $31M to take aim at genetic modifiers for cancer & rare disease

Amsterdam, BioPharma, cancer, Clinical Trials, deals, investing, Netherlands, Pharma, Rare diseases, Scenic Biotech, Startups / March 10, 2022

Targeting mutations isn’t the only way to treat genetically driven diseases. Scenic Biotech is developing molecules to target genes that suppress disease, and it has raised $31 million to advance its pipeline of potential therapies for cancer and rare diseases.

Which Companies Aren’t Exiting Russia? Big Pharma

Clinical Trials, Global Health Watch, Health Industry, Pharmaceuticals / March 10, 2022

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there. Airlines, automakers, banks, and technology giants — at least 320 companies by one count …

Which Companies Aren’t Exiting Russia? Big Pharma Read More »

Sanofi’s hemophilia A data set stage for regulatory filings, matchup with Roche

Biologic Drugs, BioPharma, Clinical Trials, France, hemophilia A, Pharma, Rare diseases, Roche, Sanofi, Sobi / March 9, 2022

An experimental hemophilia A therapy from Sanofi and partner Sobi has met the goals of a pivotal study, and the pharmaceutical giant is now planning global regulatory submissions for later this year. The drug could compete against a blockbuster hemophilia A treatment marketed by Roche.

With lung drug from Pfizer in hand, AN2 tests IPO waters in turbulent market

AN2 Therapeutics, Anacor Pharmaceuticals, BioPharma, biotech IPO, Clinical Trials, Daily, dry-eye disease, Okyo Pharma, Pfizer, Pharma, SYN, Top Story / March 7, 2022

Two biotechs are braving the roiling financial markets to raise money for clinical trials. AN2 Therapeutics is preparing for a pivotal test of its boron-based drug candidate for a rare, chronic lung disease. Okyo Pharma also filed IPO paperwork as it looks to advance to the clinic with its dry eye disease drug.

Alpine Immune Sciences cancer drug trial placed on partial hold after patient death

alpine immune sciences, BioPharma, cancer, cancer immunotherapy, clinical hold, Clinical Trials, Daily, FDA, Legal, Pharma, Seattle, SYN, Top Story / March 7, 2022

The FDA placed a partial clinical hold on a Phase 1 study testing experimental Alpine Immune Sciences cancer drug davoceticept in combination with Merck cancer immunotherapy Keytruda. The partial hold does not affect a separate study testing the Alpine drug as a monotherapy.

Patients Divided Over Alzheimer’s Drug: Is It a ‘Risk I’m Willing to Take’ or Just a ‘Magic Pill’?

aging, Alzheimer's, Clinical Trials, CMS, dementia, Medicare, Navigating Aging, Pharmaceuticals, Prescription Drugs / March 7, 2022

If you listen to the nation’s largest Alzheimer’s disease advocacy organizations, you might think everyone living with Alzheimer’s wants unfettered access to Aduhelm, a controversial new treatment. But you’d be wrong. Opinions about Aduhelm (also known as aducanumab) in the dementia community are diverse, ranging from “we want the government to cover this drug” to …

Patients Divided Over Alzheimer’s Drug: Is It a ‘Risk I’m Willing to Take’ or Just a ‘Magic Pill’? Read More »

Black Female Co-founders CancerIQ Raises $14M to Improve Cancer Early Detection and Prevention

behavior, breast cancer, cancer, Cancer Diagnostics, CancerIQ, care pathways, Clinical Trials, digital health, EMR, Genomics, global health, Health Disparities, health innovation, Healthx, Life Sciences, mckesson, McKesson Ventures, MD, Merck Global Health Innovation Fund, Most Popular, Oncology, Oncology Digital Health Startups, Oncology Platform, OSF Ventures, risk, Startups / March 3, 2022

CancerIQ Co-Founders Feyi Olopade Ayodele & Olufunmilayo (Funmi) Olopade, MD What You Should Know: – CancerIQ, a Chicago-based platform powering early cancer detection and prevention across broad patient populations, announced today it closed a $14M Series B financing round. – The Series B round was co-led by Merck Global Health Innovation Fund (Merck GHI) and Amgen Ventures …

Black Female Co-founders CancerIQ Raises $14M to Improve Cancer Early Detection and Prevention Read More »

How Support Automation Enhances Clinical Trial Management

AI, Artificial Intelligence, clinical research, Clinical Trial, Clinical Trial Recruitment, Clinical Trials, cloud, Interview, Life Sciences, Machine Learning, model, Opinion, patient experience, Private Equity, Vital / March 3, 2022

David Karandish, CEO of Capacity The life of a clinical study relies on data from documentation, meetings, emails and calls; all of which can be overwhelming for patients, clinical trial teams and associates. Although mundane, documenting, executing and collecting data is crucial to move a trial from phase to phase. Clinical trial teams face a …

How Support Automation Enhances Clinical Trial Management Read More »

One year on: How is the UK’s vision of a future-proof research environment shaping up?

ABPI, Clinical Trials, NHS, Patient Centric, patients, R&D, Views & Analysis, Views and analysis / March 3, 2022

One year ago, a UK-wide vision for the country’s future research landscape promised streamlined processes, and a patient-centred, competitive environment. But how far have we come in achieving those aims? And what’s next on the system’s agenda? From Brexit and COVID-19 to the wholescale shift in the way research is designed, conducted, and reported, the …

One year on: How is the UK’s vision of a future-proof research environment shaping up? Read More »

How Support Automation Enhances Clinical Trial Management

AI, Artificial Intelligence, clinical research, Clinical Trial, Clinical Trial Recruitment, Clinical Trials, cloud, digital health, Interview, Life Sciences, Machine Learning, model, Opinion, patient experience, Private Equity, Vital / March 3, 2022

David Karandish, CEO of Capacity The life of a clinical study relies on data from documentation, meetings, emails and calls; all of which can be overwhelming for patients, clinical trial teams and associates. Although mundane, documenting, executing and collecting data is crucial to move a trial from phase to phase. Clinical trial teams face a …

How Support Automation Enhances Clinical Trial Management Read More »

AbbVie makes neuro drug connection with $130M Syndesi Therapeutics acquisition

AbbVie, alzheimer's disease, BioPharma, biopharma nl, Clinical Trials, Daily, deals, life sciences M&A, neuroscience, North Chicago, Pharma, SYN, Top Story, UCB / March 2, 2022

AbbVie has acquired Syndesi Therapeutics, an early clinical neuroscience startup developing drugs that have potential applications in a range of cognitive disorders. Syndesi is based on research from Belgian pharmaceutical company UCB.

FDA rejects Reata Pharma chronic kidney disease drug; new trial needed

Alport syndrome, BioPharma, chronic kidney disease, Clinical Trials, Daily, FDA, Legal, Pharma, Plano, Reata Pharmaceuticals, SYN, Texas, Top Story / February 27, 2022

The FDA told Reata that the clinical data do not show that the drug, bardoxolone, slows the progression of the loss of kidney function in patients who have the rare disease Alport syndrome. The regulatory decision follows an FDA advisory committee vote recommending against approval of the small molecule drug.

Biohaven pays $100M for epilepsy drug prospect; strikes deal for BMS muscle med

Biohaven Pharmaceuticals, BioPharma, Bristol-Myers Squibb, Channel Bioscience, Clinical Trials, Connecticut, Daily, deals, epilepsy, neuroscience, New Haven, Pharma, spinal muscular atrophy, SYN, Top Story / February 25, 2022

Neuroscience drug developer Biohaven Pharmaceuticals is expanding its pipeline to include epilepsy and spinal muscular atrophy. The drug developer is acquiring Channel Bioscience and licensing global rights to a Phase 3-ready drug from Bristol Myers Squibb.

Insilico’s AI-discovered, AI-designed IPF drug enters Phase 1 trials

AI drug discovery, Clinical Trials, Insilico, News / February 25, 2022

Hong Kong-based Insilico Medicine has begun a Phase 1 trial of its AI-discovered and AI-designed anti-fibrotic small molecule inhibitor.  Currently referred to as ISM001-055, the drug is meant to treat ideopathic pulmonary fibrosis using a relatively novel mechanism of action. Insilico announced in February of last year that they had identified and developed the molecule …

Insilico’s AI-discovered, AI-designed IPF drug enters Phase 1 trials Read More »

Kodiak Sciences’ trial failure clouds eye drug’s prospects for challenging Eylea

Age Related Macular Degeneration, BioPharma, biopharma nl, California, Clinical Trials, Daily, eye, Kodiak Sciences, palo alto, Pharma, SYN, Top Story / February 24, 2022

A Kodiak Sciences drug failed to beat a Regeneron Pharmaceuticals product in a key test in the wet form of age-related macular degeneration. The biotech says the failure is due to a subset of undertreated patients, but the results raise the stakes for the drug, its lead product candidate, in other eye diseases.

Sanofi, GSK Covid-19 vax is now ready for regulators; its future may be as a booster

BioPharma, Clinical Trials, COVID-19, Daily, FDA, GlaxoSmithKline, Paris, Pharma, Sanofi, SYN, Top Story, Vaccines / February 23, 2022

Sanofi and GlaxoSmithKline weathered clinical trial delays for their Covid-19 vaccine, but the partners now have data to support filings seeking regulatory authorizations. Key features of the vaccine may be able to persuade the vaccine hesitant; it may also be well-suited for use as a booster.

Helping Clinical Trial Sites Improve Study Recruitment and Retention

AI, big data, cancer, Clinical Trial, Clinical Trials, decentralized clinical trials, HIT, Life Sciences, model, NIH, Opinion, Pharma / February 21, 2022

Tzvia Bader, CEO and co-founder, TrialJectory The clinical trial industry is, once again, at an uncertain crossroads. And while it might be assumed that the outsized impact of the COVID-19 pandemic has resulted in the inability to recruit patients for trials, it is instead, a challenge generated, over time, by the industry itself. Thankfully, there …

Helping Clinical Trial Sites Improve Study Recruitment and Retention Read More »

EarliTec Diagnostics Raises $19.5M to Advance Autism Diagnosis and Treatment in Children

AI, Autism, behavior, Biomarkers, Caregivers, Clinical Trails, Clinical Trials, diabetes, Digital Biomarkers, digital health, FDA, Heart, heart disease, Startups, video / February 18, 2022

What You Should Know: – EarliTec Dx, a digital health company developing novel diagnostic and therapeutic products for children with Autism Spectrum Disorder (ASD) and early childhood vulnerabilities, today announced a $19.5 million financing led by Bernie Marcus, with participation from the Georgia Research Alliance (GRA). – This round of financing will be used to …

EarliTec Diagnostics Raises $19.5M to Advance Autism Diagnosis and Treatment in Children Read More »

Agios strategy shift pays off with FDA approval of first drug for rare anemia

Agios Pharmaceuticals, Anemia, BioPharma, Cambridge, Clinical Trials, Daily, FDA, Legal, Massachusetts, Pharma, Rare diseases, SYN, Top Story / February 18, 2022

Agios Pharmaceuticals has its third FDA-approved product, and the first under its new rare disease strategy. The regulatory decision also marks the first approved treatment for pyruvate kinase deficiency, a rare disease that leads to chronic anemia.

Cash woes at neuro biotech Yumanity lead to 60% staff cut and search for a buyer

BioPharma, biopharma nl, Boston, Clinical Trials, Daily, layoffs, neuroscience, Parkinson’s Disease, Pharma, SYN, Top Story, Yumanity / February 17, 2022

Yumanity’s corporate restructuring means the biotech is now exploring “strategic alternatives” that could include a sale of the company or its assets. The biotech’s lead drug candidate is an experimental Parkinson’s disease drug currently in Phase 1 testing.

H1 Acquires London-Based Faculty Opinions to Broaden Global Doctor Network

clinical research, Clinical Trials, digital health, global healthcare, H1, Health IT, Health Systems, Healthcare Data, Healthcare Mergers & Acquisitions, Life Sciences, Premier / February 16, 2022

What You Should Know: H1, a global healthcare professional data ecosystem to enable life sciences, academic medical institutions, health systems, and payors acquires London-based Faculty Opinions Ltd, formerly known as Faculty of 1000 and F1000 Prime.  Financial details of the acquisition were not disclosed. – A close partner of H1, Faculty Opinions fuses the comments …

H1 Acquires London-Based Faculty Opinions to Broaden Global Doctor Network Read More »

Backed by $100M, Star Therapeutics sets out to find constellations of rare disease

Adam Rosenthal, BioPharma, Clinical Trials, Daily, Drug Discovery, Electra Therapeutics, Pharma, South San Francisco, Star Therapeutics, Startups, SYN, Top Story / February 16, 2022

Star Therapeutics aims to develop drugs for rare diseases, many of which currently have no FDA-approved treatments. The company forms startups focused on particular areas of biology, and its first one, Electra Therapeutics, is going after a rare autoimmune condition that can become fatal in less than four years.

Roivant Sciences launches Hemavant to chase BMS in anemia from blood disease

BioPharma, cancer, Clinical Trials, Daily, Hemavant, London, Matt Gline, myelodysplastic syndrome, Pharma, Roivant Sciences, SYN, Top Story / February 14, 2022

An Eisai drug that produced disappointing data in a myelodysplastic syndrome study is getting another shot under a newly launched Roivant Sciences subsidiary, Hemavant. Roivant executives say the small molecule could be a safer, more effective alternative to MDS therapies marketed by Bristol Myers Squibb.

The Next Vaccine Debate: Immunize Young Children Now, or Wait?

BioNTech SE, Children and Childhood, Clinical Trials, Coronavirus (2019-nCoV), Coronavirus Omicron Variant, Drugs (Pharmaceuticals), Food and Drug Administration, Immune System, Pfizer Inc, United States, Vaccination and Immunization, your-feed-science / February 12, 2022

It’s not clear whether three doses of the Pfizer-BioNTech vaccine will adequately protect young children. But the F.D.A. may authorize the first two doses anyway.

Outlook dims for ProQR’s RNA therapy for vision loss following failure in key test

BioPharma, biopharma nl, Clinical Trials, Daily, Daniel de Boer, LCA10, Leiden, Netherlands, News, Pharma, ProQR Therapeutics, rna therapeutics, SYN, Top Story / February 11, 2022

The lead RNA therapy from ProQR Therapeutics has failed the main and secondary goals of a pivotal study testing it as a treatment for a rare, inherited vision disorder. Despite the disappointing preliminary data, the biotech said it remains confident in the technology that produced the experimental therapy, sepofarsen, and the Phase 2/3 study will …

Outlook dims for ProQR’s RNA therapy for vision loss following failure in key test Read More »

¿Vacunar a los niños pequeños o esperar?

BioNTech SE, Children and Childhood, Clinical Trials, Coronavirus (2019-nCoV), Coronavirus Omicron Variant, Drugs (Pharmaceuticals), Food and Drug Administration, Immune System, Pfizer Inc, United States, Vaccination and Immunization, your-feed-science / February 11, 2022

No está claro si tres dosis de la vacuna Pfizer-BioNTech protegerán adecuadamente a los niños. Pero es posible que la FDA autorice las primeras dos dosis de cualquier manera.

¿Vacunar a los niños pequeños o esperar?

BioNTech SE, Children and Childhood, Clinical Trials, Coronavirus (2019-nCoV), Coronavirus Omicron Variant, Drugs (Pharmaceuticals), Food and Drug Administration, Immune System, Pfizer Inc, United States, Vaccination and Immunization, your-feed-science / February 11, 2022

No está claro si tres dosis de la vacuna Pfizer-BioNTech protegerán adecuadamente a los niños. Pero es posible que la FDA autorice las primeras dos dosis de cualquier manera.

FDA Panel Rejects Lilly’s Cancer Drug Tested Only in China

Clinical Trials, Drugs (Pharmaceuticals), Eli Lilly and Company, Food and Drug Administration, Immunotherapy, lung cancer, New England Journal of Medicine, Pazdur, Richard (1952- ), Prices (Fares, Fees and Rates), your-feed-healthcare / February 10, 2022

The panel debated whether overseas trials could be applied to a more diverse U.S. population. The decision may affect other Chinese drug trials, and spotlights the high cost of immunotherapy.

FDA Panel Rejects Lilly’s Cancer Drug Tested Only in China

Clinical Trials, Drugs (Pharmaceuticals), Eli Lilly and Company, Food and Drug Administration, Immunotherapy, lung cancer, New England Journal of Medicine, Pazdur, Richard (1952- ), Prices (Fares, Fees and Rates), your-feed-healthcare / February 10, 2022

The panel debated whether overseas trials could be applied to a more diverse U.S. population. The decision may affect other Chinese drug trials, and spotlights the high cost of immunotherapy.

The Protein Degradation & Targeting Undruggables Congress

Biotech, Clinical Trials, Events, Infectious Diseases, Oncology, Pharma / February 10, 2022

The 3rd Protein Degradation and Targeting Undruggables Summit is North America’s only in-person, industry-led conference covering clinical progress and commercial scale development of first-in-class degrader technology platforms. Our agenda will cover the key drug development challenges for this therapeutic modality including assessing diverse targets, improving selectivity and delivery to disease-relevant proteins. You will have the …

The Protein Degradation & Targeting Undruggables Congress Read More »

CVS, Medable alliance aims to tackle diversity in clinical trials

Clinical Trials, CVS Health, decentralised trials, digital, digital health, diversity, Medable, News, Patient Recruitment / February 10, 2022

CVS Health has said it will beef up its clinical trials operations, improving its ability to recruit patients from a broad demographic spectrum, via an agreement with digital health company Medable. CVS will harness Medable’s decentralised trials software, deploying it in thousands of CVS  MinuteClinics across the US, to create a network that could unlock …

CVS, Medable alliance aims to tackle diversity in clinical trials Read More »

The Next Vaccine Debate: Immunize Young Children Now, or Wait?

BioNTech SE, Children and Childhood, Clinical Trials, Coronavirus (2019-nCoV), Coronavirus Omicron Variant, Drugs (Pharmaceuticals), Food and Drug Administration, Immune System, Pfizer Inc, United States, Vaccination and Immunization, your-feed-science / February 9, 2022

It’s not clear whether three doses of the Pfizer-BioNTech vaccine will adequately protect young children. But the F.D.A. may authorize the first two doses anyway.

Medable Launches Decentralized Clinical Trials Partner Network

Clinical Trials, decentralized clinical trials, digital health, Life Sciences, Medable / February 8, 2022

What You Should Know: – Medable Inc., a Palo Alto, CA-based provider for patient-centered clinical trials, today launched the Medable Partner Network – uniting a diverse ecosystem of technology, service, data, site, and direct-to-patient partners that work together to accelerate deployment of decentralized clinical trials. – The network includes new partnerships with Advanced Clinical, Cognizant, and CVS, …

Medable Launches Decentralized Clinical Trials Partner Network Read More »

Importance of diversity in pharma and clinical trials

Clinical Trials, decentralised clinical trials, diversity, impetus, Natalie Yeadon, patients, R&D, Views & Analysis, Views and analysis, virtual clinical trials / February 8, 2022

“Diversity.” It’s a word that is very commonly thrown around right now, not just in pharma and healthcare but across all industries. No matter which sector you work in, diversity and inclusion should not be treated as mere buzzwords designed to help improve the perception of a company, but as must-haves. We live in a …

Importance of diversity in pharma and clinical trials Read More »

UBC, Seqster join forces on patient-centric, remote trials

Clinical Trials, decentralised trials, digital, digital health, News, patient centricity, Seqster, United BioSource / February 8, 2022

The rise in the use of decentralised clinical trial (DCTs) designs forced by COVID-19 looks set to outlast the pandemic, and digital health company Seqster has formed another partnership to tap into the shift from traditional site-based studies. The latest agreement is with contract research organisation United BioSource (UBC), which will use Seqster’s expertise in …

UBC, Seqster join forces on patient-centric, remote trials Read More »

Endeavor Bio adds $101M to test ex-Eli Lilly, Roche drug in cancer & lung fibrosis

BioPharma, biopharma nl, cancer, Clinical Trials, Daily, Endeavor BioMedicines, idiopathic pulmonary fibrosis, John Hood, Pharma, San Diego, SYN, Top Story / February 8, 2022

Endeavor BioMedicines aims to kill two birds with one stone—that stone being a small molecule drug. Taladegib targets a cell signaling pathway associated with both cancer and idiopathic pulmonary fibrosis, and the biotech will apply its Series B round toward clinical tests of the molecule on both fronts.

2 collaborations – CVS Health with Medable, and Thermo Fisher Scientific with Medidata Acorn AI – seek to improve clinical trials

Clinical Trials, Consumer / Employer, CVS Health, Medable, Medidata, News, Patient Engagement, Pharmacy, SYN, Thermo Fisher Scientific, Top Story / February 8, 2022

CVS MinuteClinic providers will use Medable’s software platform to improve patient access, engagement and retention during clinical trials. Meanwhile, Thermo Fisher Scientific and Medidata Acorn AI announced a collaboration to develop an application that combines patient recruitment and site performance data for clinical trials.

CVS Health Taps Medable to Bring Decentralized Clinical Trials to Pharmacies Nationwide

Clinical Trials, CVS Health, decentralized clinical trials, digital health, Life Sciences, Medable / February 7, 2022

What You Should Know: – Medable and CVS Health announced a strategic collaboration that will make clinical research more accessible to patients of all demographics. Using Medable’s decentralized trial platform available to CVS Health’s thousands of community MinuteClinics nationwide, most people will be within just five minutes of a decentralized clinical trial research site – …

CVS Health Taps Medable to Bring Decentralized Clinical Trials to Pharmacies Nationwide Read More »

Clarify Health’s new offering shows one way tech can help improve clinical trial diversity

Clarify Health, clinical trial diversity, Clinical Trials, News, R&D / February 7, 2022

The last three years in pharma have seen a growing awareness of and dissatisfaction with a trend that has plagued the industry for its whole life: Nondiverse and unrepresentative clinical trials, which lead to incomplete data and compounded health disparity for minority populations. It’s been more than a year since the US Food and Drug …

Clarify Health’s new offering shows one way tech can help improve clinical trial diversity Read More »

Bridging the pharma-startup gap with PharmStars, a new accelerator programme

AI, Clinical Trials, digital, Digital Therapeutics, Neurological Diseases, PharmStars, Views & Analysis, Views and analysis / February 7, 2022

From remote monitoring tech to enable clinical trials, to AI for drug discovery, to digital therapeutics and drugs with companion apps, digital innovation has the potential to touch every corner of the pharmaceutical sector. The startups know it. Pharma knows it. Yet, somehow, it’s not always easy to make the connection. The world of pharma …

Bridging the pharma-startup gap with PharmStars, a new accelerator programme Read More »

Arcellx’s IPO raises $124M to fuel chase of better CAR T-cell therapy for cancer

Arcellx, BioPharma, biotech IPO, CAR-T, cell therapy, Clinical Trials, Daily, deals, Gaithersburg, investing, Maryland, Pharma, SYN, Top Story / February 6, 2022

Clinical-stage Arcellx raised $123.8 million from its IPO, which the company will use to advance to a pivotal test for its lead program, a CAR T-cell therapy for multiple myeloma. Though Arcellx trails its large pharmaceutical rivals, the biotech contends its technology produces cell therapies with key advantages.

Unity Bio slashes headcount in half to save cash ahead of eye drug readouts

Age Related Macular Degeneration, aging, BioPharma, biopharma nl, Clinical Trials, Daily, Diabetic Macular Edema, Pharma, South San Francisco, SYN, Top Story, Unity Biotechnology / February 4, 2022

Unity Biotechnology’s corporate restructuring is a cash-saving move that allows the company to focus resources on its lead program, a drug in Phase 2 testing for diabetic macular edema and wet age-related macular degeneration. Unity previously restructured in 2020 following the Phase 2 failure of its osteoarthritis drug.

Bayer-led project on AI in trials eyes ‘virtual’ placebo groups

Aalto University, Artificial Intelligence, Bayer, Clinical Trials, digital, Finland, Helsinki University Hospital, Machine Learning, News / February 4, 2022

Last year, Bayer launched a project to explore the use of artificial intelligence in clinical trials, working with Finland’s Aalto University to find ways to use the technology to support decentralised trials and streamline the testing process. Now, an extension of the work is starting that will see if AI can be used to reduce …

Bayer-led project on AI in trials eyes ‘virtual’ placebo groups Read More »

Assumptions to evidence: How NINR project is solidifying UK’s remote trial know how

Clinical Trials, COVID-19, decentralised clinical trials, NIHR, R&D, remote clinical trials, Views & Analysis, Views and analysis, virtual clinical trials / February 2, 2022

Remote, virtual, or decentralised clinical trials are nothing new, but COVID-19 catapulted the model into the mainstream. Now, as the sector settles back into something approaching business as usual, how can we ensure new methodologies are delivering for participants, sites, and the sector alike? As the COVID-19 pandemic ricocheted around the world at the start …

Assumptions to evidence: How NINR project is solidifying UK’s remote trial know how Read More »

MHRA seeks comments on post-Brexit clinical trial legislation

Brexit, Clinical Trials, MHRA, News, patients, regulatory / February 1, 2022

The MHRA has kicked off an eight-week consultation on proposals for changes to laws governing the conduct of clinical trials following the UK’s departure from the EU. The proposals stem from the passage of the Medicines and Medical Devices Act 2021 a year ago, shortly after the post-Brexit transition period ended, which has given the …

MHRA seeks comments on post-Brexit clinical trial legislation Read More »

Philips Launches First At-Home, 12-Lead ECG Integrated Solution for Decentralized Clinical Trials

Clinical Trials, decentralized clinical trials, digital health, ecg, Life Sciences, Philips / January 26, 2022

What You Should Know: – Philips introduced the industry’s first full-service, at-home, 12-lead electrocardiogram (ECG) solution for use in decentralized clinical trials. – The solution is the most advanced patient-centric ECG offering within the company’s cardiac monitoring portfolio, pairing data readings comparable to clinical, site-based ECGs with Philips leading cloud-based data collection and analysis services. …

Philips Launches First At-Home, 12-Lead ECG Integrated Solution for Decentralized Clinical Trials Read More »

Gilead Sciences cancer drug hit with partial hold due to adverse event concern

BioPharma, California, cancer, cancer immunotherapy, Clinical Trials, Daily, FDA, Foster City, Gilead Sciences, Legal, Magrolimab, Pharma, SYN, Top Story / January 26, 2022

Gilead Sciences did not disclose details about the safety concern that led to an FDA partial clinical hold on five studies evaluating its cancer drug, magrolimab. But this experimental cancer immunotherapy introduces a safety risk that’s a known problem for all drugs in this class.

Synthetic Control Arms – ambition to action

Accenture, Acorn AI, Clinical Trials, Debates & Insights, Live webinar, Medidata, R&D, synthetic control arms, synthetic data, Views and analysis, Webinars, Webinars in home page / January 26, 2022

Clinical trials are involved, expensive, and have been done largely the same way for decades but with today’s technology all that can change. With drawn-out timelines and billions in investments, traditional clinical trial methods are increasingly a barrier to cost-efficient and timely drug development. Synthetic data is addressing this head-on by harnessing historical clinical trials …

Synthetic Control Arms – ambition to action Read More »

Sierra succeeds where Gilead missed; FDA filing now planned for blood cancer drug

BioPharma, California, cancer, Clinical Trials, Daily, FDA, Gilead Sciences, Myelofibrosis, Pharma, San Mateo, Sierra Oncology, SYN, Top Story / January 25, 2022

Sierra Oncology myelofibrosis drug momelotinib achieved the main and secondary goals of a pivotal test and the biotech now plans to seek FDA approval. Sierra acquired momelotinib from Gilead Sciences after that company stopped work on the drug due to mixed results in Phase 3 testing.

What is inflation’s impact on clinical trials?

BioPharma, biopharma nl, Clinical Trials, CRO, Daily, hospitals, MedCity Influencers, SYN, Top Story, Virtual Clinical Trial / January 25, 2022

Basic organic chemicals used for the preparation of new medications cost over 54.8% more than they did 12 months ago. Further, with schools and daycare facilities either going fully remote and/or closed, many parents and caregivers had to stay at home, eliminating their availability for study participation.

en English
af Afrikaanssq Shqipam አማርኛar العربيةhy Հայերենaz Azərbaycan dilieu Euskarabe Беларуская моваbn বাংলাbs Bosanskibg Българскиca Catalàceb Cebuanony Chichewazh-CN 简体中文zh-TW 繁體中文co Corsuhr Hrvatskics Čeština‎da Dansknl Nederlandsen Englisheo Esperantoet Eestitl Filipinofi Suomifr Françaisfy Fryskgl Galegoka ქართულიde Deutschel Ελληνικάgu ગુજરાતીht Kreyol ayisyenha Harshen Hausahaw Ōlelo Hawaiʻiiw עִבְרִיתhi हिन्दीhmn Hmonghu Magyaris Íslenskaig Igboid Bahasa Indonesiaga Gaeligeit Italianoja 日本語jw Basa Jawakn ಕನ್ನಡkk Қазақ тіліkm ភាសាខ្មែរko 한국어ku كوردی‎ky Кыргызчаlo ພາສາລາວla Latinlv Latviešu valodalt Lietuvių kalbalb Lëtzebuergeschmk Македонски јазикmg Malagasyms Bahasa Melayuml മലയാളംmt Maltesemi Te Reo Māorimr मराठीmn Монголmy ဗမာစာne नेपालीno Norsk bokmålps پښتوfa فارسیpl Polskipt Portuguêspa ਪੰਜਾਬੀro Românăru Русскийsm Samoangd Gàidhligsr Српски језикst Sesothosn Shonasd سنڌيsi සිංහලsk Slovenčinasl Slovenščinaso Afsoomaalies Españolsu Basa Sundasw Kiswahilisv Svenskatg Тоҷикӣta தமிழ்te తెలుగుth ไทยtr Türkçeuk Українськаur اردوuz O‘zbekchavi Tiếng Việtcy Cymraegxh isiXhosayi יידישyo Yorùbázu Zulu