// Biotech and Pharma Therapeutics
Currax Pharmaceuticals Hosted Ribbon-cutting Ceremony to Mark the Opening of its Nashville Headquarters
October, 2021 / ChemoCentryx / FDA / Autoimmune Disease
Currax Parmaceuticals, LLC (“Currax”). a specialty biopharmaceutical company dedicated to expanding access to clinically differenticated, underappreciated medicines – bot branded and generic – hosted a grand opening celebration of its new headquarters on September 29, 2021.
Takeda to Commercialize Next-Generation Hunter Syndrome Therapy Through Collaboration with JCR Pharmaceuticals
September 30, 2021 / Takeda / JCR
Takeda Pharmaceutical Company Limited and JCR Pharmaceuticals Co., Ltd. announced today a geographically-focused exclusive collaboration and license agreement to commercialize JR-141 (INN: pabinafusp alfa), an investigational, next-generation recombinant fusion protein of an antibody against the human transferrin receptor and iduronate-2-sulfatase (IDS) enzyme for the treatment of Hunter syndrome (also known as Mucopolysaccharidosis type II or MPS II).
U.S. FDA approves AbbVie’s migraine prevention drug
September 28, 2021 / CGRP / Drug Launch / Migraine / Biohaven Pharmaceuticals
AbbVie Inc said on Tuesday the U.S. health regulator approved its once-daily oral medicine for preventive treatment of migraine in adults, adding a third drug to the drugmaker’s arsenal of therapies for severe headaches.
Canadian startup Gini Health launches new product aimed at ‘reversing diabetes’
October 1, 2021 / Canadian / Gini Health / Diabetes
Gini’s diabetes management plan pairs users with a care team that considers their health data and the latest global research to tailor a treatment strategy to their needs. The mobile platform syncs insights from continuous glucose monitoring devices along with data related to weight, activity, sleep, blood pressure and food intake.
Dexcom finds CGM use helps people with Type 2 diabetes stay in range
October 1, 2021 / Dexcom / CGM / Diabets
The company recently published new results on its MOBILE study, which found that CGM use increased time in range for people with Type 2 diabetes. New data shows people who stopped using a CGM saw time in range decrease.
// 4th Industrial Revolution
Japanese pharmaceutical firm taps Israel’s CytoReason for AI drug development
September 30, 2021 / Japanese Pharma / Israel / AI / Drug Development
CytoReason and SPI have been working together for over two years to advance the Israeli startup’s entrance into the Japanese pharmaceutical industry, the third-largest in the world after those of the US and China.
Blockchain and the Pharmaceutical Industry
October 1, 2021 / Blockchain / Pharmaceutical Industry
Leading the pharmaceutical development (CMC – chemistry, manufacturing, and controls) and clinical supply chain function at Avanir Pharmaceuticals, Arul Joseph – alongside his team – manages the development, manufacturing, testing, and packaging of drug substances and drug products, and the distribution of drug products to sites supporting clinical studies.
Study: Wearables could detect flu, cold infection before patient shows symptoms
September 30, 2021 / New Tech / Influenza
The small study zeroed in on two cohorts of participants that volunteered to be infected with the H1N1 virus and the rhinovirus. Researchers developed digital biomarker models that pulled wearable data for early detection of the viruses and severity prediction, which was aimed at the time frame after pathogen exposure and before symptoms developed.
Why Healthcare IT Must Embrace Full-Stack Observability for an Increasingly Digital Future
October 8, 2021 / Healthcare / Digital Future / Covid-19
Applications can assist with scheduling appointments, virtual doctor visits, accessing medical records and conducting tests down to the most complex AI-powered technologies such as medical imaging. As COVID-19 fundamentally transformed the way industries operate, healthcare has been the world’s focus as physicians, nurses, EMTs, and other healthcare practitioners have stepped up to provide routine as well as critical care amid chaos and a period of transformation.
Bioprinted Brain Cells Made Possible with Laser-Based 3D Printing
October 1, 2021 / Bioprinted / Brain Cells / Laser-Based 3D Printing
Scientists from the Université de Montréal have published a study detailing the ability to bioprint adult brain cells. Key to the research was a new laser-assisted technology that made it possible to ensure high levels of cell viability and functionality.
// Business & Markets
FourKites Named a Leader in Pharmaceutical Supply Chain Visibility Report
September 30, 2021 / FourKites / Bayer / Supply Chain
As the pandemic and an unprecedented series of disruptions continue to challenge pharma supply chains worldwide — including shortages of raw materials, changes in demand patterns, global uncertainty and resource shortages — FourKites’ technology is helping industry leaders track critical medical supplies from origin to final destination, thereby reducing costs and ensuring compliance with essential pharma quality standards.
Cedars-Sinai Accelerator selects 8 new health tech startups
September 27, 2021 / Poolbeg Pharma / Eurofins Genomics / AI
The seventh accelerator class includes startups with a range of offerings, from accessible fitness for aging patients to skeletal reconstruction. Each of the eight companies will receive $100,000 and access to clinicians, researchers and administrators to develop their products and grow their businesses.
Digital surgery company Activ Surgery scores $45M, end-of-life platform Empathy bags $30M and other digital health fundings
September 30, 2021 / Digital Surgery / New Tech / Digital Health
The new funds bring Activ Surgical’s total amount raised to $77 million. The company has made a name for itself by creating hardware-agnostic technology that uses computer vision and robotics to drive autonomous and collaborative surgical procedures.
Acceleron provides biggest biopharma deal this year, with $11.5B sale to Merck
September 30, 2021 / Biopharma / Merck / Acceleron / Acquisition
Merck & Co. announced Thursday it has agreed to buy Acceleron Pharma for $11.5 billion. If completed, the deal would be the largest biopharma acquisition this year, and a sign that Merck is willing to spend more than usual to diversify its business beyond the cancer drug Keytruda.
// Legal & Regulatory
Euro Roundup: Commission seeks feedback on pharmaceutical legislation reform
September 30, 2021 / Legislation / Europe
It’s been 20 years since the European Union held its last comprehensive review of general pharmaceutical legislation. The consultation, which grew out of a strategy adopted late last year, is part of a push to reform pharmaceutical legislation in light of changes to society and science and lessons learned since the last major round of revisions.
Another Eisai, Biogen Alzheimer’s drug is filed for speedy FDA review
September 28, 2021 / Alzheimer’s / FDA / Eisai
Eisai is seeking accelerated FDA approval of lecanemab, an Alzheimer’s disease drug that is part of a research alliance with Biogen. The drug is following the same path blazed earlier this year with FDA approval of Biogen Alzheimer’s drug Aduhelm.
5 FDA approval ecisions to watch in the fourth quarter
October, 2021 / FDA / Drug Reviews
The Food and Drug Administration has already made several weighty regulatory decisions this year, butcrucial drug reviews still lie ahead.
// 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 6, 2021 / FDA / Gene Therapy / BioMarin
One mutation eliminated the PAH gene that’s missing in PKU and the second rendered the animals immunodeficient. Of 63 animals treated, six of seven animals administered BMN 307 at the highest dose group (2e14 Vg/kg) had tumors on liver necropsy 52 weeks after dosing with evidence for integration of portions of AAV vector into the genome.
Biohaven’s neurological disorder drug candidate fails study
September 27, 2021 / Biohaven / Neurological Disorder
Biohaven Pharmaceutical Holding Co Ltd said on Monday its drug candidate, verdiperstat, failed to show effectiveness in treating a rare neurological disorder called multiple system atrophy.
Pfizer begins study of oral drug for prevention of COVID-19
September 27, 2021 / Pfizer / Covid-19
Pfizer Inc. said on Monday it hasstarted a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.
GSK, Merck KGaA end cancer drug partnership after study results disappoint
October 1, 2021 / GSK / Merck / Cancer Drug
Bintrafusp alfa was part of a major push by GSK over the past few years to bolster its cancer drug research. As recently as January, the British pharma company was highlighting the treatment as a potential billion-dollar product and a key asset in its late-stage pipeline.
Researchers unravel the genetic cause of a childhood disorder and a potential way to prevent it with drugs
September 30, 2021 / Academic Research / Genetic Diseases / Mouse Models / Rare Diseases
An international research team led by the University of California, San Diego (UCSD) has identified a genetic cause for a syndrome that has stumped clinicians for many years. And the scientists say they might be able to prevent the disease-causing mutation during pregnancy based on promising mouse studies.
// Politics
Defense Department watchdog criticizes oversight of military’s pharmaceutical supply chain
September 23, 2021 / U.S. Military / Supply Chain
Amid mounting concerns over the U.S. pharmaceutical supply chain, a Department of Defense watchdog found an overreliance on foreign suppliers that could harm national security and that the Pentagon failed to assess the risks of shortages or develop strategies to mitigate disruptions.
The U.S. Can Lower Drug Prices Without Sacrificing Innovation
October 1, 2021 / Innovation / Drug Prices / Medicare
Legislation giving Medicare the ability to negotiate drug prices in the United States would make their life-saving potential immediately available to millions of Americans who cannot now afford them, thus extending lives and alleviating suffering. The pharmaceutical industry, however, has done a masterful job of arguing that these Americans must suffer in the short term since lower prices would gut long-term innovation in drug development.
What the Stalemate on Capitol Hill Means for Your Drug Prices
October 1, 2021 / Drug Prices / Capitol Hill / Stalemate
Pressure is building to contain costs that have skyrocketed over the past decade. In a recent Gallup poll, an estimated 18 million Americans said that within the previous three months they had been unable to pay for at least one doctor-prescribed medication.
House committee advances bill to legalize marijuana
September 30, 2021 / Marijuana / U.S. House Judiciary / New Bill
The measure, sponsored by Judiciary Chairman Jerrold Nadler, D-N.Y., passed the chamber last year but stalled in the GOP-controlled Senate. Senate Majority Leader Charles E. Schumer proposed a similar measure in July, sparking hopes among advocates that the legislation would finally make it into law.