// 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?
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 Capacity to Hit 4 Billion Doses in 2022
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.
Appia and Kite to Develop Cell Therapies for Cancer - BioProcess Insider
Kite will develop CAR-iNKT cells for the treatment of haematological malignancies using Appia Bio’s ACUA technology platform. 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.
Merck’s Best Seller Racks Up Another Regulatory Win | BioSpace
The U.S. FDA greenlit the combination of Keytruda and Eisai’s Lemvima as a first-line treatment for adult patients with advanced renal cell carcinoma.
// 4th Industrial Revolution
No! Not Pharma's Definition of APIs! Former ONC head Rucker: APIs will ‘empower totally new business models’
“I think those APIs for consumers will be as transformative as APIs have been for music, in printing, in travel, in banking and retail,” said Dr. Don Rucker, former ONC National Coordinator for Health IT, at a HIMSS21 lightning session.
Now Manage Pain With Virtual Reality
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
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. The residency program for which the team applied the technique is a large internal-medicine operation that annually deals with massive volumes of residency applications. From 2018 to 2020, for example, the program received more than 8,200 applications. The AI-based decision support tool that kept the 20 outstanding trainees from slipping away can weigh more than 60 qualifications, shortcomings, experiences, skillsets, demographic features and so on.
Consumer Acceptance of Medical AI Coming Into Focus
Patients are strongly inclined to follow treatment instructions that combine innovative AI recommendations with a physician’s reassuring presence. Then again, they’re no less open to such direction when it comes from a physician alone. However, directions from AI alone are far less likely to drive adherence. It follows, then, that individuals will tend to stick with rather than slough off doctors’ orders—thereby improving odds of good outcomes—when “human expertise [is] central to the diagnosis and the treatment recommendation.”
Bexson Biomedical aims to extend its wearable drug delivery device to psychoactive drugs | Drug Delivery Business
Bexson Biomedical announced today that it launched an R&D initiative to develop subcutaneous formulations of psychoactive therapeutics. 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
GentiBio Raises $157M as Cell Therapy for Immune Diseases Draw Investor Interest
The biotech company is working with regulatory T cells, an immune cell type that’s become the focus of several newly launched drugmakers like Abata Therapeutics and Sonoma Biotherapeutics. The size of the Series A is notably large, reflecting the growing interest in using Tregs to treat diseases like Type 1 diabetes.
On Heels of $17 Billion SPAC Deal, Ginkgo Inks Collab with Synthetic Biology Firm | BioSpace
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.
Peter Thiel-backed ATAI Launches New Salvia-focused Biotech & Other News
ATAI Life Sciences, the Peter Thiel-backed umbrella developer of psychedelics and other drugs for mental health conditions, launched a new portfolio company Thursday. The new outfit is called Revixia Life Sciences, and its mission is to bring the main active ingredient in Salvia to the clinic for treatment-resistant depression, substance use disorder and pain, ATAI announced Thursday morning. The ingredient in question is called Salvinorin A, and Revixia says it’s a non-nitrogenous agonist of the kappa-opioid receptor.
Visus Raises $20M Ahead of Data Drop on Rival to AbbVie Prospect
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
News of the takeover comes weeks after the tobacco company bought an oral drug delivery specialist and entered into a bidding war to buy inhaled medicine player Vectura. Health charities have pushed back against Philip Morris’ foray.
// Legal & Regulatory
FDA Approves New Treatment for Pompe Disease
Today, the U.S. Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease. 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
The letter indicates the FDA will not approve the roxadustat NDA in its present form and has requested additional clinical study of roxadustat be conducted, prior to resubmission. 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. The European Commission decision is expected by the end of August.
As AbbVie and Soliton shake hands on a $550M merger, the FTC says ‘not so fast’
Back in May, AbbVie’s Allergan Aesthetics unit signed away $550 million in cash to scoop up drugmaker Soliton and its body sculpting device Resonic. Now, the FTC is requesting a bit more time to review the proposed merger.
More Fraud, Tax Evasion Charges for telemedicine Operator Tied to $784M Scheme
Creaghan Harry was indicted in 2019 for his alleged role in one of the largest Medicare fraud and kickback schemes pursued by the Department of Justice. New superseding charges outline his alleged efforts to conceal the proceeds through shell companies and evade tax payments. Federal prosecutors allege that Harry and two co-conspirators (who were previously charged and pleaded guilty) sought illegal payments from durable medical equipment (DME) companies related to orders for DME braces and medications.
AstraZeneca Nabs FDA Nod to Challenge GSK’s Benlysta with First-in-class Lupus Drug Saphnelo
After a 10-year drought in new treatments for systemic lupus, the FDA has waved through a new drug. AstraZeneca’s Saphnelo, despite mixed phase 3 results, won an approval to challenge GlaxoSmithKline’s aging blockbuster-to-be Benlysta.
// Research & Development
Healthy ‘Beige’ Fat Protects Brain from Dementia in Mouse Models
Beige fat cells play a role in lowering the inflammation associated with white fat and are critical to providing protection from dementia, new research shows. Medical College of Georgia scientists reported that mice without functional beige fat had increased cognitive dysfunction and activated micro…
Lonza, Sheba Medical Center Leverage Cocoon Platform For 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
Clinical trials are the lifeblood of any drug company. Without clinical research, new treatments do not get approved or sold. But what happens when a once-in-a-hundred year pandemic sends the world into lockdown? For pharmaceutical companies, the first sign last year that the pandemic was going to have a major impact on R&D was when nothing started happening.
Pro-Inflammatory Gut Bacterial Molecule Targeted to Fight IBD
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
Dexcom is in the news again this year. The company announced additional clinical studies that support its CGM products’ benefit for people with Type 2 Diabetes (T2D). One of the studies reported that the Dexcom’s G6 mobile CGM can improve overall glycemic control for T2D patients who are treated with basal insulin. The mobile study included 175 adults with T2D who were randomly assigned to continuous glucose monitoring or traditional blood glucose meter monitoring.
Biden Embraces Medicare Drug Price Negotiation as Democrats Seek to Widen Health Coverage
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
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