Pharma Industry News Weekly Recap: July 22, 2021

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// 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 Biotech / Antibody Drug Conjugate Delivery 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. Read Full Article on Endpoints News >>

Industry Taking Notice of Araris Biotech’s Linker Technology for ADC Delivery
July 21, 2021 Biotech / Linker Swiss pharma company Araris Biotech AG is attracting attention based on ongoing research with its linker technology for antibody drug conjugate delivery. The company’s technology is designed to attach any off-the-shelf antibody with any payload without the need for modification. Read Full Article on Biospace >>

Bayer’s Billion-dollar Parkinson’s Disease Bet Snags FDA Fast-track Tag
July 20, 2021 Neurology / Parkinson’s / Gene Therapy 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. DA01 is a pluripotent stem cell-derived dopaminergic neuron therapy. Translation? The company takes donor cells that can develop into any cell type in the body and engineers them to become neurons that produce the neurotransmitter dopamine. Those neurons are then transplanted into a part of the brain called the putamen. Read Full Article on Fierce Biotech >>

Ardelyx Latest Biotech Surprised by Unexpected FDA Criticism of Drug Application
July 20, 2021 Diabetes / Chronic Kidney Disease – CKD Ardelyx developed its drug, called tenapanor, as a way for people with chronic kidney disease to control their phosphorus levels. The biotech reported success in multiple Phase 3 trials, but said the FDA took issue with the “size of the treatment effect” observed in testing and “its clinical relevance,” putting the treatment’s future in doubt for that indication. Ardelyx disclosed late Monday the Food and Drug Administration found “deficiencies” with the company’s application to approve its lead drug for patients with kidney disease, a surprise announcement that sent shares falling more than 70%. Read Full Article on BIOPHARMA DIVE >>

// 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. Once implanted into disabled rats, the scaffolds have shown the ability to restore movement in paralyzed limbs, and the scientists now believe their approach could find human applications in future. Read Full Article on 3D Printing Industry >>

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. The report, ‘Smart Pharma’, showed that 28 percent of companies will be using AI and big data to optimise drug discovery and development processes in the next two years, while 32 percent would be relying on big data to streamline sales and marketing. Read Full Article on European Pharmaceutical Review >>

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. Read Full Article on Outsourcing Pharma >>

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. Read Full Article on Outsourcing Pharma >>

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. A new analysis from Emersion Insights details the progress the industry has made in the first half of 2021. Read Full Article on The Science Advisory Board >>

// 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. These private equity deals fund virtually all biotech startups. Read Full Article on Fierce Biotech >>

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. The SPAC is already traded on the Nasdaq under the ticker ARTAU. Read Full Article on CNBC >>

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). Read Full Article on Biospace >>

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. Led by Suren Ajjarapu, chief executive of online drug marketplace TRxADE Health, the SPAC is targeting pharmaceuticals, medtech and healthcare IT. Read Full Article on Endpoints News >>

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. The company is leaning toward the U.S. as a preferred listing venue, they added. Read Full Article on Yahoo!Finance >>

// Legal & Regulatory

5 FDA Decisions To Watch In The Third Quarter
June 2, 2021 FDA / Vaccines / Aduhelm The Food and Drug Administration made one of the most controversial decisions in its history early last month, when the agency decided to clear Biogen’s Alzheimer’s drug despite contradictory evidence from clinical trials. 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. While the outcome is not in doubt, calls have grown for the FDA to speed its review as news of a standard approval may help convince vaccine hold-outs and skeptics. Read Full Article on BIOPHARMA DIVE >>

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. Read Full Article on STAT >>

Roche in Talks with FDA on Alzheimer’s Candidate, Says CEO
July 22, 2021 FDA / Alzheimer’s / Phase III Swiss drugmaker Roche (ROG.S) is discussing its potential treatment for Alzheimer’s disease with the U.S. Food and Drug Administration (FDA) as clinical trials proceed, Chief Executive Severin Schwan told reporters on Thursday. Roche will complete a Phase-III trial of the medicine in the second half of next year, Schwan said, citing the urgency of finding a way to treat such an unmet medical need and bringing it to patients as soon as possible. Read Full Article on Reuters >>

// 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. Researchers at the University of Newcastle in Australia developed the first saliva test to measure sugar levels in diabetic patients, which could be available to the general public in 2023. Read Full Article on Entreprenuer >>

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). Their intention is to accelerate metabolism to reduce cardiovascular risk and mortality. Read Full Article on Biospace >>

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. BioNTech is laying out a one-time, undisclosed sum to buy a cell therapy R&D platform and clinical manufacturing plant in Gaithersburg, Maryland, from Gilead Sciences’ Kite Pharma. The sale, expected to close by the end of the month, will add another pillar to BioNTech’s cell therapy production network next to its Idar-Oberstein, Germany, plant. Read Full Article on Fierce Pharma >>

// 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. The Food and Drug Administration has been working on guidance for almost a year on how to transition from emergency status, but businesses need to start preparing now, attorneys say. Read Full Bloomberg Law >>

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. Read Full Article on New York Intelligencer >>

Pharma Industry News Weekly Recap: July 22, 2021

// Biotech and Pharma Therapeutics

// 4th Industrial Revolution

// Business & Markets

// Legal & Regulatory

// Research & Development

// Politics

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Pharma Industry News Weekly Recap: July 22, 2021

// Biotech and Pharma Therapeutics

// 4th Industrial Revolution

// Business & Markets

// Legal & Regulatory

// Research & Development

// Politics

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