// Biotech and Pharma Therapeutics
Roche snags coveted Polivy win in newly diagnosed lymphoma. But is it enough to change 2 decades of established treatment practices?
August 9, 2021 / Antibody Drug Conjugates / Cancer Drugs / Combination Therapy / Lymphoma
After two years of meager sales for Polivy, Roche is trumpeting a much-coveted clinical win that could open up a blockbuster market for the drug. Still, questions remain about the exact size of the opportunity.
Pfizer and BioNTech Covid-19 vaccine to hit 4 billion doses in 2022
August 10, 2021 / Pfizer / BioNTech / Covid-19 / Vaccine
Pfizer and BioNTech are lining up orders of their Covid-19 vaccine for next year and beyond, predicting total capacity in 2022 to rise to 4 billion doses.
August 10, 2021 / Appia / Kite / Cell Therapies / Blood Cancer / Bone Cancer
The deal, which could be worth up to $875 million, will see Appia responsible for preclinical research of two hematopoietic stem cell (HSC) derived chimeric antigen receptor-engineered invariant natural killer T (CAR-iNKT) product candidates manufactured with CARs provided by Kite.
FDA Approves GHB , a ‘Date Rape’ Drug, for Rare Sleeping Disorder
August, 2021 / FDA / GHB / Drug Development / Jazz Pharma / Narcolepsy
Jazz Pharmaceuticals brought in more than $1.7 billion last year selling GHB to narcolepsy patients. With the new approval, sales could soar.
Merck’s Best Seller Racks Up Another Regulatory Win
August 12, 2021 / Merck / Drug Approval / FDA
Merck’s vaunted checkpoint inhibitor Keytruda racked up another regulatory win. On Wednesday, the U.S. Food and Drug Administration greenlit the combination of Keytruda and Eisai’s Lemvima as a first-line treatment for adult patients with advanced renal cell carcinoma (RCC).
// 4th Industrial Revolution
Former ONC head Rucker: APIs will ‘empower totally new business models’
August 12, 2021 / API / ONC
Dr. Don Rucker, former ONC National Coordinator for Health Information Technology, said using APIs for sharing healthcare information will “empower totally new business models” in digital health.
Now Manage Pain With Virtual Reality
August 11, 2021 / Virtual Reality / Pain / XRHealth
XRHealth is a platform that connects patients with virtual reality (VR), digital, and live physical, occupational, and speech therapy. The company has added a virtual reality option for patients with chronic pain. To bring pain management training to its platform, XRHealth partnered with Reducept, a digital pain management method powered by gamified VR and mobile device solutions.
AI finds ‘diamonds in the rough’ among rejected residency applicants
August 10, 2021 / AI / Medical Educators
Medical educators have used machine learning to reconsider—and ultimately select—some 20 qualified residents who had been screened out by human reviewers at their institution.
Consumer acceptance of medical AI coming into focus
August 9, 2021 / AI / Medical AI
Patients are strongly inclined to follow treatment instructions that combine innovative AI recommendations with a physician’s reassuring presence.
Bexson Biomedical aims to extend its wearable drug delivery device to psychoactive drugs
August 11, 2021 / Bexson Biomedical / Drug Delivery Device / New Tech / Psychoactive Drugs
Santa Barbara, Calif.-based Bexson’s effort will apply its existing subcutaneous formulation technology to build several psychoactive drug scaffolds for treating mental health indications, including post-traumatic stress disorder (PTSD) and depression.
// Business & Markets
August 11, 2021 / GentiBio / Cell Therapy / Immunce Diseases / Investors / Diabetes
The size of the Series A is notably large, reflecting the growing interest in using Tregs to treat diseases like Type 1 diabetes.
August 12, 2021 / SPAC Deal / Ginkgo / Antheisa
California synthetic biology firm Antheia has joined forces with Boston-based biotech company Ginkgo Bioworks to strengthen its efforts to develop and produce essential medicines to treat a wide range of diseases.
August 12, 2021 / ATAI / Life Sciences
ATAI Life Sciences, the Peter Thiel-backed umbrella developer of psychedelics and other drugs for mental health conditions, launched a new portfolio company Thursday.
Visus raises $20M ahead of data drop on rival to AbbVie prospect
August 10, 2021 / Venture Capital / Vision Restoration / AbbVie / Eyenovia
Visus Therapeutics has raised a further $20 million as it closes in on the release of midphase data on a potential treatment for age-related long-sightedness. The financing comes on the heels of phase 3 data on rival candidates in development at AbbVie and Eyenovia.
Philip Morris buys developer of inhaled heart attack drug, ramping up push into healthcare
August 10, 2021 / Heart Attack / Cardiovascular / Healthcare / Merger / Acquisitions
Philip Morris is aiming to generate more than 50% of its net revenues from smoke-free products by 2025. Vaping alternatives to cigarettes will account for some smoke-free sales, but Philip Morris wants at least $1 billion of its revenues to come from nicotine-free products. That goal has spurred a flurry of deals in the healthcare sector.
// Legal & Regulatory
August 6, 2021 / FDA / Pompe
Patients with Pompe disease have an enzyme deficiency that leads to the accumulation of a complex sugar, called glycogen, in skeletal and heart muscles, which cause muscle weakness and premature death from respiratory or heart failure. Normally, glycogen – the stored form of glucose – breaks down to release glucose into the bloodstream to be used as fuel for the cells.
FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease
August 11, 2021 / FibroGen / FDA / Kidney Disease / Roxadustat
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.
August 11, 2021 / AbbVie / Soliton / FTC / Merger
August 11, 2021 / False Claims Act / Fraud / Lawsuits / Telehealth
Creaghan Harry of Highland Beach, Florida, allegedly billed $784 million in false and fraudulent Medicare claims, more than $247 million of which was paid out, the DOJ wrote in a Tuesday release detailing the superseding indictment.
August 2, 2021 / Autoimmune Diseases / Drug Approval / Drug Launch / FDA Approvals
The FDA cleared AstraZeneca’s Saphnelo (anifrolumab) to treat moderate to severe systemic lupus erythematosus (SLE), the most common form of lupus, the company said Monday.
// Research & Development
Healthy ‘beige’ fat protects brain from dementia in mouse models
August 11, 2021 / Brown Fat / Dementia / Fat Cells / Obesity
Subcutaneous fat typically contains a mix of unhealthy white fat cells and “beige” adipocytes, which are similar to healthy brown fat in that they’re able to burn energy. Scientists from the Medical College of Georgia at Augusta University believe they’ve found another attribute for beige fat: It may protect against dementia.
Lonza, Sheba Medical Center Leverage Cocoon Platform for Cell Therapy
August 12, 2021 / Lonza / Medical Center / Cell Therapy
Sheba Medical Center, the largest hospital in the Middle East region, and Lonza, a global cell and gene therapy manufacturer, have treated multiple patients with CD19 CAR-T cell immunotherapy targeting B-cell malignancies, with three patients showing complete responses, and another patient is still being evaluated.
‘Forced into a virtual world’: How pharma R&D bounced back from a once-in-a-lifetime pandemic
August 9, 2021 / Clinical Research / Coronavirus / Covid-19 / Drug Development
The usual stream of clinical data simply dried up as people hunkered down into their homes. Patients stopped signing up for trials. Clinic visits were canceled. Clinical researchers—crucial to every clinical trial that’s ever been run—jumped from their studies to help out in COVID clinics.
Pro-Inflammatory Gut Bacterial Molecule Targeted to Fight IBD
August 12, 2021 / OMICs / Microbiome / News
Scientists at Ben-Gurion University of the Negev (BGU) report that they are developing a novel therapeutic strategy for treating Inflammatory Bowel Diseases (IBDs) by sequestering inflammation-inducing molecules secreted by gut bacteria. The method, invented by Ehud Ohana, PhD, the department of clinical biochemistry and pharmacology at BGU, is based on findings from Ohana’s lab showing that gut levels of succinate, a metabolic molecule involved in various biochemical processes in living cells, were markedly increased in IBD, corresponding to changes in succinate-metabolizing gut bacteria.
New Study Shows That Wearable Glucose Monitors Outperform Traditional Measures
August 9, 2021 / New Study / Diabetes /
We have followed the development and maturation of wearable continuous glucose monitors (CGM) solutions since 2014. In 2015, we wrote about the Animas Vibe insulin pump that connected wirelessly to a Dexcom G4 CGM. This past March we covered a new partnership between CGM developer Smart Meter and EHR software provider PointClickCare.
August 12, 2021 / Biden / Medicare / Drug Prices / U.S. Congress
President Joe Biden embraced congressional Democrats’ broad drug pricing agenda, announcing Thursday his support for legislation that would allow Medicare to negotiate directly with pharmaceutical manufacturers and penalizing companies that raise prices faster than inflation.
US Veterans Health Administration rejects Biogen Alzheimer’s drug
August 8, 2021 / US Veterans / Biogen / Alzheimer’s
The US Veterans Health Administration (VHA) has turned down Biogen’s Alzheimer’s drug, Aduhelm (aducanumab), opting not to include the $56,000-a-year drug on its list of approved drugs due to lack of safety and efficacy evidence.
August 9, 2021 / Senate / Legislation
A Senate budget blueprint, which Democrats hope to pass this week, would ease passage of legislation that would mark the biggest expansion of the social safety net in nearly 60 years.