// Biotech and Pharma Therapeutics
Roche CEO Schwan Puts 3-Time Alzheimer’s Loser Gantenerumab Back In The Spotlight As FDA’s Controversial Aduhelm OK Inspires Blockbuster Forecasts
July 22, 2021 / CEO / Alzheimer’s / FDA
Four years after Roche opted to resurrect its late-stage effort on their Alzheimer’s program for gantenerumab following a clear failure, Roche CEO Severin Schwan is signaling some fresh enthusiasm for its blockbuster prospects in the wake of the controversial Aduhelm OK.
Bayer’s billion-dollar Parkinson’s disease bet snags FDA fast-track tag
July 20, 2021 / Cell & Gene Therapy / Parkinson’s Disease / Regenerative Medicine / Asklepios BioPharmaceutical
The German pharma picked up the treatment, DA01, by buying Versant Ventures out of their regenerative medicine joint venture BlueRock Therapeutics in a deal worth about $1 billion.
Ardelyx latest biotech surprised by unexpected FDA criticism of drug application
July 20, 2021 / Ardelyx / Biotech / FDA / Drug Application
Over the past year, the FDA has alternatively been seen as too lenient or too harsh, depending on the circumstances. The controversial approval of Biogen’s Alzheimer’s drug Aduhelm, for instance, sparked outrage from critics who believe the regulator substantially lowered its standards.
// 4th Industrial Revolution
Introducing The 3d Bioprinted Neural Tissues With The Potential To ‘Cure’ Human Paralysis
July 19, 2021 / 4IR / Neurology / 3D Bioprinting
Researchers at the Chinese Academy of Sciences and University of Science and Technology of China have devised a novel bioprinting-based method of curing previously untreatable spinal cord injuries. Using a custom bio-ink, the Chinese team have managed to 3D bioprint neural stem cell-loaded tissues capable of carrying instructions via impulses from the brain, much like those seen in living organisms.
AI And Big Data Will Continue To Disrupt Pharma Sector, Says Survey
July 19, 2021 / 4IR / Data / Artificial Intelligence – AI
A GlobalData report has revealed the extent to which companies will be using AI and big data in drug discovery and development processes. GlobalData’s latest report has revealed that artificial intelligence (AI) and big data will continue to disrupt the pharmaceutical sector, according to the healthcare industry professionals surveyed.
ACD/Labs, Science Data Experts establish AI partnership
July 14, 2021 / 4IR / Artificial Intelligence / R&D
The two companies will work together to come up with solutions that use machine learning and artificial intelligence to help accelerate innovation in R&D.
Contract Data Analysis Can Help Predict Pharma Demand: Agiloft
July 19, 2021 / 4IR / Machine Learning / Predictive Analytics
The process management solutions firm says drug companies could use contract data to get a better handle on predicting demand and adjusting product output.
AI drug development startups raised $2.1B in 1st half of 2021
July 19, 2021 4IR / Artificial Intelligence / Pharmaceutical Development
The market for artificial intelligence (AI) in drug development and discovery has been red-hot in recent years. The potential impact that AI can offer to human health and pharmaceutical development has grown in concert with the enabling technologies in computer processing and digitization, as well as new breakthroughs in machine-learning research.
// Business & Markets
Managed Marketplaces And Reality TV: How A New Generation Of Gatekeepers Are Opening Biotech Up To Amateur Investors
July 20, 2021 / Private Equity & Venture Capital / Biotech / Healthcare Startups
Amateur investors took center stage in January, when they battled hedge funds betting that the struggling video game retailer GameStop would go bust. But these individual investors were playing with a small piece of the investment pie—they were backing public companies and not private ones, which could be far more lucrative but are hard to access for regular people.
Hong Kong Biotech Start-Up Prenetics Plans $1.3 Billion SPAC Merger
July 15, 2021 SPAC / Mergers & Acquisitions – M&A / Biotech
Hong Kong biotech company Prenetics is set to merge with Artisan Acquisition, a special purpose acquisition company, in a deal that will value the new entity at $1.3 billion or more, according to a source close to the deal. The transaction is expected to close by the end of this year.
Diagnostics Testing Company Joins SPAC Craze with Planned Nasdaq Listing
July 15, 2021 SPAC / Acquisitions / Collaboration Agreements
Months after signing multi-million dollar collaboration agreements with Oxford University and Oxford Suzhou Centre for Advanced Research, Hong Kong-based Prenetics Limited is eyeing a Nasdaq listing following a planned merger with a special purpose acquisition company (SPAC).
The Next SPAC Is Here, Coming From A Pharma E-Commerce CEO, As A Florida Biotech Prices At The Low End
July 20, 2021 SPAC / IPO / Biotech
The newest healthcare blank-check company has arrived, coming from the CEO of a company that is attempting to shake up the digital pharmaceutical space. The SPAC known as Aesther Healthcare Acquisition filed for its initial offering late Monday, putting down $100 million as its raise estimate.
Amgen-Backed Biotech Firm Hummingbird Weighing U.S. IPO
July 21, 2021 / Clinical Stage Biotech / IPO / Oncology & Autoimmune Diseases
Hummingbird Bioscience, a Singaporean clinical-stage biotechnology firm, is considering fundraising options including an initial public offering, according to people familiar with the matter. Hummingbird could seek to raise about $200 million to $300 million in a share sale, which could take place as soon as later this year, the people said.
// Legal & Regulatory
5 FDA Decisions To Watch In The Third Quarter
June 2, 2021 / FDA / Vaccines / Aduhelm
Few forthcoming actions can match that approval’s impact, but the FDA still faces a slate of critical decisions in the months ahead. Looming largest are expected full approvals for Pfizer’s and Moderna’s coronavirus vaccines, which remain only cleared for emergency use more than six months after their initial authorizations.
Happify To Release Prescription App To Treat Depression Under Loosened FDA Rules
July 22, 2021 / FDA / Technology / Depression
Leveraging Food and Drug Administration regulations loosened during the pandemic, Happify Health, which is best known for its consumer wellness app, will launch new prescription-only software to treat depression.
// Research & Development
The First Saliva Test To Measure Glucose Levels In People With Diabetes Will Be Available In 2023
July 19, 2021 / Diabetes / Testing
Currently, people living with diabetes must prick their finger with a lancet once or several times a day to measure blood glucose , but this is about to change.
Rivus Pharmaceuticals Striving for Fundamental Change in Cardio-metabolic Disorders
July 20, 2021 / Cardiology / Metabolic / Clinical
Type 2 diabetes, heart failure, non-alcoholic steatohepatitis (NASH) – all are highly prevalent in America, and this morning, Rivus Pharmaceuticals, Inc. launched with a novel approach to solving them. Rivus is focused on developing an entirely new class of small molecule therapeutics called Controlled Metabolic Accelerators (CMAs).
BioNtech Makes A Splash In Cell Therapy With Purchase Of Factory, R&D Platform From Gilead’s Kite
July 19, 2021 / mRNA / Cell Therapy / Manufacturing
Germany’s BioNTech has already risen to international prominence thanks to its Pfizer-partnered COVID-19 vaccine. Not content to rest on its laurels, the mRNA specialist has lined up a deal for its first U.S. factory as it looks to make a big splash in cell therapy.
// Politics
End of Health Crisis Will Put Heaps of Covid Products in Limbo
July 21, 2021 / FDA / COVID-19
Products Covid-19 vaccines, therapies, and other related products are available in the U.S. thanks to more than 400 emergency use authorizations granted by the FDA during the pandemic.Nearly all of those products are at risk of being taken off the market once the declaration for the public health emergency ends—unless and until they attain full approval.
Why Is It So Hard for Moderate Democrats to ‘Do Popular Things’?
July 14, 2021 / Drug Pricing / Healthcare Costs
Last week, a group of “front line” Democratic House members — lawmakers whose districts are, on average, more red than blue — called for a major change in their party’s impending $3.5 trillion spending bill. Specifically, the moderates argued that, to appeal to the heartland, the legislation must empower the government to dictate prices in the pharmaceutical market, corporate profits be damned.