// Biotech and Pharma Therapeutics
Amgen’s Biosimilar Trends Report shows benefit of competition from biosimilars
September 23, 2021 / Amgen / Biologic Drugs
While biosimilars are ‘generic’ copies of biologic drugs, unlike generic copies of small molecule drugs, they involve a complex manufacturing process that monitors variations between batches.
Novartis, determined to dethrone Pfizer, will launch bold Kisqali-Ibrance head-to-head trial in breast cancer
September 19, 2021 / Breast Cancer / CDK 4/6 / Ibrance / Kisqali
Despite two life extension wins, Novartis still finds it tough to convince doctors to use its breast cancer drug Kisqali over Pfizer’s first-to-market Ibrance. Now, with a third survival victory under its belt, the Swiss pharma is determined to overthrow its rival—and it’s launching an ambitious head-to-head trial to make it happen.
Amgen to collab with Verastem on KRAS combination treatment
September 22, 2021 / Amgen / Verastem / KRAS / Oncology
A Phase I/II trial will evaluate the safety, tolerability and efficacy of the combination treatment in patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor, or in patients who have progressed on such a treatment.
Theramex pioneers new treatment for post-menopausal women
September 9, 2021 / Theramex / Women’s Health / Post-menopausal
Throughout the long-term, Phase III clinical trial, the safety of Bijuva/Bijuve was studied over 12 months of treatment, and demonstrated endometrial protection, as well as no significant changes in lipid, coagulation or glucose parameters as compared to placebo.
Novartis expands gene therapy pipeline with Arctos Medical takeover
September 23, 2021 / Novartis / Arctos / Gene Therapy
Novartis has announced its acquisition of Arctos Medical as it looks to expand its gene therapy pipeline further, adding a pre-clinical optogenetics-based AAV gene therapy programme to its portfolio.
// 4th Industrial Revolution
Apple’s Latest iOS Has A New Feature To Help Improve Healthcare Outcomes
September 24, 2021 / Apple / Healthcare / EHR Systems
Multiple large EHR systems are already working to integrate this feature into their platforms.
UnitedHealthcare members to get access to Apple Fitness+
September 24, 2021 / UnitedHealthcare / Apple Fitness+
Starting November 1, fully insured members of UnitedHealthcare who already own an Apple Watch can sign up for a year-long subscription to the tech giant’s fitness platform at no additional cost. UnitedHealthcare estimates that 3 million of its members will be eligible for the program.
Diabetes AI adjustable for surveilling other public health concerns
September 23, 2021 / Diabetes / AI / Public Health
While only modestly accurate, their technique may be generic enough to customize for keeping an eye on other widespread health conditions.
The Irish scientist ‘building’ body parts in Australia
September 24, 2021 / Nanoscience / TCD / Biofabrication
Scientist Cathal O’Connell had aspirations to follow in the footsteps of journeyman apprentices from ancient times who learned their craft travelling from one master to another across cities and towns. But it wasn’t to be, as he happily got stuck in Melbourne along the way.
Welldoc’s Bluestar lands FDA clearance for expanded insulin dosing support
September 22, 2021 / Welldoc / FDA / Insulin / Diabetes / New Tech
The new clearance, which was announced by Welldoc Wednesday, but approved by the FDA earlier this month, expands its earlier approval for insulin dosing support to include bolus and premixed insulin titration for Type 2 diabetes.
// Business & Markets
Digital mental health startup Meru Health bags $38M
September 23, 2021 / Mental Health / Meru Health / Start Up
14 health systems invest in digital health startup Xealth
September 21, 2021 / Xealth / Digital Health
Xealth, a digital health startup spun out of Renton, Wash.-based Providence in 2017, has garnered 14 health system investors to date.
Virpax raises $40M to use delivery systems to improve pain drugs
September 21, 2021 / COVID-19 / Drug Delivery / Nasal Delivery / Pain
Virpax Pharmaceuticals crept onto public markets earlier this year, grossing $18 million to support its work to use delivery systems to improve pain drugs. After seeing its share price soar in response to progress against COVID-19, Virpax filed to raise more money—only for its stock to come crashing back down to Earth.
Thermo Fisher authorizes $3B in share repurchases
September 24, 2021 / Thermo Fisher
Waltham, Massachusetts-based Thermo Fisher’s board of directors approved the repurchase of $3 billion in shares of its common stock in the open market or in negotiated transactions, according to a news release.
// Legal & Regulatory
Insurers sue Merck for ‘monopolistic scheme’ to delay generics of blockbuster cholesterol drug
September 24, 2021 / Insurers / Cholesterol Drug / Merck / Zetia
Insurers Centene and Humana have sued Merck & Co., alleging the drugmaker’s “monopolistic scheme” delayed generic versions of its blockbuster cholesterol drug Zetia from coming to market, causing the insurers to pay higher prices for years.
CDC Breaks with Advisory Panel on Boosters, Recommends Broader Access
September 24, 2021 / CDC / Advisory Panel / Pfizer / BioNTech / Vaccine
The FDA authorized a third shot of the Pfizer-BioNTech vaccine for people over the age of 65, individuals at high risk for severe disease, and front-line healthcare workers. The shot can be given six months after they receive their second shot. Earlier, it was authorized for immuno-compromised individuals.
FDA authorizes software that can help identify prostate cancer
September 21, 2021 / FDA / Prostate Cancer
Cancer that starts in the prostate is called prostate cancer. According to the Centers for Disease Control and Prevention, aside from non-melanoma skin cancer, prostate cancer is the most common cancer among men in the United States. It is also one of the leading causes of cancer death among men.
// Research & Development
U.S. FDA Placed a Clinical Hold on BMN 307 Phearless Phase 1/2 Gene Therapy Study in Adults with PKU Based on Interim Pre-clinical Study Findings
September 13, 2021 / Engineers / Cancer / Pancreatic Cancer / Researchers
Using a specialized gel that mimics the extracellular environment surrounding the pancreas, the researchers were able to grow pancreatic “organoids,” allowing them to study the important interactions between pancreatic tumors and their environment.
Positive results for Lynparza plus abiraterone in metastatic prostate cancer
September 24, 2021 / Lynparza / Prostate Cancer / Abiraterone / AstraZeneca / MSD
AstraZeneca and MSD have announced positive results for their PARP inhibitor Lynparza (olaparib) in combination with abiraterone as a first-line treatment for metastatic castration-resistant prostate cancer (mCRPC) patients, with or without homologous recombination repair (HRR) gene mutations.
Scientific study finds music can ‘tune out pain’
September 23, 2021 / Nurofen / Music / New Study
A study has found that listening to a specially composed music track can achieve “clinically significant” reductions in pain intensity and unpleasantness, according to the researchers behind the work.
Retail pharmacies: The key to making clinical trials accessible for everybody?
September 24, 2021 / Retail Pharmacies / Clinical Trials / Covid-19
Covid-19, if nothing else, has forced the hands of the clinical research community and we have discovered the possibilities for taking giant leaps forward in healthcare by leveraging modern technologies, existing retail infrastructure, and one another.
Repairing heart damage by transiently turning back the clock
September 23, 2021 / Cardiology / Cell Regeneration / Heart Attack / Heart Disease
Unlike many tissues in the human body, the heart lacks the ability to regenerate, rendering it unable to self-replenish heart muscle cells known as cardiomyocytes after injury. Scientists have been exploring various ways to help the heart replace damaged cells and restore its function, but those efforts have yet to yield marketable therapies.
// Politics
Senate proposes expanding pharma penalties for hiking drug prices
September 20, 2021 / Senate / Drug Prices / Drug Makers
A key Senate panel is expanding its plans to punish drug makers that hike prices faster than inflation, according to an internal Senate document described to STAT.
Contributed: A Biden health policy retrospective: Implications for healthcare innovation
September 23, 2021 / Biden / Health Policy / Healthcare
When evaluating new opportunities in any sector it is important to understand non-market influences – the role legislation, regulation, relationships, etc. have on things such as competitive advantage and new entrants – perhaps none more so than in healthcare.
Medicare Takes On Big Pharma in New Biden Plan
September 9, 2021 / Medicare / Big Pharma / Biden
For older Americans, healthcare costs are always a concern. And the costs of prescription medicines can weigh particularly heavy on those who need them to survive. President Joe Biden has called on Congress today to pass legislation that will lower the costs of prescription drug prices.
Elijah E. Cummins Lower Drug Costs Now Act: The Long and Winding Road to Drug Pricing Reform
September 22, 2021 / Drug Prices / Medicare
The Proposal would require that 125 brand-name drugs that cost Medicare the most to be subject to negotiation by Medicare, with a cap on the price for each drug set at 120% of the average price paid in six other countries. The Proposal is part of a $3.5 trillion budget proposal that, as of this writing, faces an uncertain future in Congress.