// Biotech and Pharma Therapeutics
The Heart Failure Market Gets a Little More Crowded, as Eli Lilly and Boehringer Ingelheim Score a Win for Jardiance
Watch out, Farxiga: There’s another SGLT2 inhibitor approved to treat heart failure patients with reduced ejection fraction (HFrEF). On Wednesday, Eli Lilly and Boehringer Ingelheim secured a win for Jardiance in HFrEF, a condition where the muscle of the left ventricle doesn’t pump normally. The in…
endpts.com
Florida, Texas Turn to Antibody Treatments as Covid-19 Surges
The drugs from Regeneron, Eli Lilly and others went largely unused for months, but are embraced now to fight latest coronavirus wave.
www.wsj.com
Aspirin Trialled as Potential Treatment for Aggressive Form of Breast Cancer
Aspirin is being trialled in combination with immunotherapy drugs as part of a potential new treatment for an aggressive form of breast cancer that disproportionately affects younger women and black women. A team at the Christie NHS Foundation Trust in Manchester, funded by the Breast Cancer Now Catalyst Program, will launch a clinical trial to investigate aspirin, hoping it can make tumors more sensitive to immunotherapy in patients with triple negative breast cancer.
www.pharmafile.com
With Alzheimer’s Market Opening Up, Lilly Forms Neuroscience Unit
li Lilly is one of the front runners in the bid to follow Biogen and Eisai onto the market with an anti-amyloid drug for Alzheimer’s disease, and its preparing the ground with a restructuring of its business units. As of 5 September, Lilly’s BioMedicines division will be split in two to form Lilly Neuroscience and Lilly Immunology, which the company said would help prepare for “an exciting period of growth and the potential launch of new breakthrough medicines over the next few years.”
pharmaphorum.com
Two More Cancer Drug Candidates Hit the Fast Track
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications. The first Fast Track designation was awarded to China-based InxMed’s IN10018, which is being developed for the treatment of platinum-resistant ovarian cancer patients. Ireland’s Carrick Therapeutics also snagged the Fast Track designation for its experimental breast cancer drug.
www.biospace.com
// 4th Industrial Revolution
Machine Learning Boosts Spirulina Bioproduction by up to 100 Percent
Collaborating with Google, Lumen Bioscience applied a machine learning approach to increase spirulina biomanufacturing productivity.
www.europeanpharmaceuticalreview.com
Blockchain Use Goes Beyond NFTs and Dogecoin. It’s About You
Blockchain use around the world proves more valuable than the most overpriced NFTs, with a worth that can perhaps be more fairly weighted on the blockchain.
www.pharmaceutical-technology.com
A Unicorn in Women’s Health & Machine Learning Skepticism
The women’s and family health provider Maven Clinic nailed down a $110 million Series D round led by Dragoneer Investment Group and Lux Capital. Normally we wouldn’t spend more than a sentence on such news at a time when nine-figure fundraising rounds are so common. But the deal puts Maven’s valuation over $1 billion in a category of business that until recently has been given short shrift.
www.statnews.com
Rendever Awarded $2M NIH Grant to Research Impact of Virtual Reality on Aging Population
Rendever, a Boston-based virtual reality (VR) platform built to help seniors overcome social isolation through shared experiences, announces that it has been awarded a $2M Phase II Grant from the National Institute on Aging (NIA), a division of the National Institutes of Health (NIH).
hitconsultant.net
Developing Precision Medicine for Chronic Kidney Disease
In a genome-wide association study, Perelman School of Medicine at the University of Pennsylvania researchers identified 182 genes potentially linked to kidney function and 88 genes for hypertension. Researchers can use these genes to target chronic kidney disease and improve precision medicine.
healthitanalytics.com
// Business & Markets
Lilly Bio-Medicines Splitting into Two Business Units
Eli Lilly is undertaking a strategic transformation that will result in the formation of new business units. The Indianapolis company’s Bio-Medicines unit will split into two separate businesses, with one focusing on neuroscience and one aiming at immunology.
www.pharmalive.com
Beckley Psytech Raises $80m for Psychedelic Meds Development
UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinical development of its psilocybin-based therapies.
pharmaphorum.com
AI Firm XtalPi Swells Its Coffers With Another $400m Financing
Artificial intelligence (AI) specialist XtalPi has chalked up a second big financing in the space of a year, raising $400 million and taking its valuation to around $2 billion. Founded several years ago by a team of MIT researchers and previously backed by Google, XtalPi deploys AI to a range of drug discovery and development tasks – such as molecular structure generation and predicting binding affinities and other drug properties – to try to find new drugs therapies.
pharmaphorum.com
The Money Keeps On Flowing In | In the Pipeline
In any market’s upswing, there are always going to be people who make the case that “it’s different this time”, and historically, most of the time that argument doesn’t hold up. But things do change, and right now I also have to add that for several years I’ve also been saying that in my career (post 1989) I have never seen so many interesting and novel therapeutic opportunities as there are right now.
blogs.sciencemag.org
Ultrahuman Secures $17.5M for Fitness Wearable Glucose Tracker
Health tech startup Ultrahuman has raised $17.5 million in Series B funding as it sets out to re-invent fitness-tech via its glucose tracking wearable that helps people improve their diet and exercise. The series B funding came from Alpha Wave Incubation (AWI), which is backed by DisruptAD and managed by Falcon Edge, Steadview Capital, Nexus Venture Partners, Blume Ventures, and Utsav Somani’s iSeed fund.
hitconsultant.net
// Legal & Regulatory
What Antitrust Challenge? Illumina Completes $8B Grail Buyout While FTC, EU Probes Remain Ongoing
In defiance of FTC and EU scrutiny, Illumina said Wednesday it has completed its multibillion dollar acquisition of Grail, setting off what’s likely to be a contentious brawl ahead of the US regulator’s trial expected to begin next week. The finalization of the $8 billion buyout comes as the FTC
endpts.com
FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease
The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested additional clinical study of roxadustat be conducted, prior to resubmission. Roxadustat is approved in China, Japan, Chile, and South Korea for the treatment of anemia of CKD in both non-dialysis-dependent (NDD) and dialysis-dependent (DD) adult patients and has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the European Medicines Agency’s committee responsible for human medicines. The European Commission decision is expected by the end of August.
www.drugs.com
Teva Wins Three, Loses Six in Patent Battle Over Migraine Drug
In a patent infringement lawsuit filed against Eli Lilly, Teva Pharmaceutical won three and lost six patents. The patent lawsuit was over Teva’s Ajovy (fremanezumab-vfrm) to prevent migraines. Eli Lilly has a competitive migraine drug, Emgality (galcanezumab).
www.pharmalive.com
U.S. Court Revives Nearly 6,000 Lawsuits Over 3M Surgical Warming Device
A federal appeals court on Monday revived nearly 6,000 lawsuits alleging that a widely used device produced by 3M Co to keep surgical patients warm caused them to develop infections. The 8th U.S. Circuit Court of Appeals said the Minnesota judge overseeing the litigation over 3M’s Bair Hugger device had wrongly excluded testimony from medical experts supporting the plaintiffs’ claims.
www.pharmalive.com
// Research & Development
Pirfenidone Could Offer ‘Viable’ Heart Failure Treatment
An early phase trial of pirfenidone, which is typically used to treat lung fibrosis, has shown it may also help patients with a common form of heart failure. The trial, funded by the National Institute for Health Research (NIHR), found that pirfenidone could offer a viable treatment for heart failure with preserved ejection fraction.
www.pharmatimes.com
Small Protein Protects Pancreatic Cells in Model of Type 1 Diabetes
A new study has shown that treating type 1 diabetes-prone mice with the small protein MOTS-c prevented the immune system from destroying insulin-producing pancreatic cells, effectively preventing the onset of the autoimmune disease.
medicalxpress.com
Clinical Catch-Up: August 9-13 | BioSpace
AzurRx BioPharma added five new trial sites in Ukraine for its ongoing RESERVOIR Phase II trial of FW-1022 for COVID-19-related gastrointestinal infections. I-Mab announced positive interim data from its U.S. Phase II/III clinical trial of plonmarlimab for treatment of cytokine release syndrome (CRS) in severe COVID-19. Daiichi Sankyo Company and AstraZeneca reported positive topline data from the head-to-head DESTINY-Breast-03 Phase III trial. Impel NeuroPharma published data from its Phase III STOP 301 study of Trudhesa (INP104) for acute migraine.
www.biospace.com
Researchers Discover On/Off Switch for Inflammatory Pain | BioSpace
The Feinstein Institutes for Medical Research, the research unit of New York State health care provider Northwell Health, may have found a way to control neurons that drive inflammation. In a preclinical study published in Proceedings of the National Academy of Sciences (PNAS), scientists presented a new approach to treating diseases that involve inflammation and pain, like arthritis.
www.biospace.com
Researchers Develop New Way to Study Neurodegenerative Diseases: Team Studied Proteins in Cells that Separate Like Oil Droplets in Water
Some proteins in cells can separate into small droplets like oil droplets in water, but faults in this process may underlie neurodegenerative diseases in the brains of older people. Now, researchers have developed a new method to quantify protein droplets involved in these diseases.
www.sciencedaily.com
// Politics
As Biden Signals Interest in Linking Drug Prices with R&D Costs, New Study Finds Costs Per NME are Increasing
Eroom’s law (essentially the opposite of Moore’s law) holds that the development of new drugs has become slower and more expensive over time. And a new analysis, published this month in PharmacoEconomics, confirms not only that costs have gone up over the years but the difficulty in tracking how R&D has shifted.
endpts.com
Global Agencies Seek Clearer Steer On AI In Drug Development & Regulation
Regulators’ experiences and two hypothetical case studies form the basis of a set of recommendations on the use of artificial intelligence in areas such as safety signal detection and improving decision making, which have just been published by the International Coalition of Medicines Regulatory Authorities.
pink.pharmaintelligence.informa.com
Data show voters want bipartisan approach to tackling health care affordability and coverage issues
While the debate to address health care affordability intensifies on Capitol Hill, Americans across political parties agree on a path forward: reduce health care costs broadly and help Americans better access and afford their care through commonsense, bipartisan solutions.
catalyst.phrma.org
