// Biotech and Pharma Therapeutics

Bayer’s blockbuster hopeful Nubeqa, AstraZeneca’s Forxiga pick up nods from England’s NICE
May 22, 2023 / NICE / Nubeqa / Bayer / Farxiga – Bayer has blockbuster hopes for prostate cancer med Nubeqa, and a new endorsement from the U.K.’s National Institute for Health and Care Excellence (NICE) provides another milestone toward that goal. Read Full Article on Fierce Pharma >>
Novartis buys rare disease gene therapy from Avrobio
May 22, 2023 / Novartis / Avrobio / Disease Gene Therapy – The cash from Novartis will help Avrobio keep the lights on for longer, pushing out its operating runway to the fourth quarter of next year — valuable flexibility in a market that remains challenging for smaller, loss-generating biotechnology companies like Avrobio Read Full Article on Biopharma Dive >>
ReNAgade Launches with $300M to More Easily Deliver RNA Medicines
May 23, 2023 / ReNAgade / RNA Medicines / New Launch – Massachusetts-based start-up ReNAgade Therapeutics launched Tuesday with $300 million in Series A financing and the goal of delivering RNA medicines to previously inaccessible tissues and cells.
Read Full Article on BioSpace >>
PTC pulls back from gene therapy, lays off staff after phase 3 fail but still hopes for rare disease approval
May 24, 2023 / PTC Therapeutics / Friedreich’s Ataxia / Clinical Trial Data / Layoffs – PTC Therapeutics’ phase 3 Friedreich ataxia (FA) clinical trial has missed its primary endpoint. But, while the biotech is cutting other programs and reducing its head count, it thinks the FA data reveal an active drug and justify opening talks with the FDA about a path to approval in the neurodegenerative disease. Read Full Article on Fierce Biotech >>
With Dupixent leading the way, Sanofi’s taking on the ‘big players’ in respiratory diseases: exec
May 22, 2023 / Sanofi / Regeneron Pharmaceuticals / Dupixent / COPD – Sanofi and Regeneron made waves when they presented data from a phase 3 trial that showed that blockbuster Dupixent could become the first biologic to treat chronic obstructive pulmonary disease (COPD) and the first new therapy for the condition in more than a decade. Read Full Article on Fierce Pharma >>

// 4th Industrial Revolution

Why AI-Driven Cancer Screening Will Soon Become Standard of Care
May 23, 2023 / AI / Monash University / Wearables / New Tech – They came up with an ultra-thin wearable patch that is worn on the neck to measure speech, neck movement and touch, as well as breathing and heart rates. It does this using a frequency/amplitude-based neural network called Deep Hybrid-Spectro, which automatically monitors multiple biometrics from a single signal. Read Full Article on Mobi Health News >>
Why AI-Driven Cancer Screening Will Soon Become Standard of Care
May 24, 2023 / AI / Cancer Screening / New Tech / Healthcare – Using AI for advanced cancer patient analysis will hopefully soon become the standard of care, as well as a game changer for the industry. It seems to be cycling between hype and progress now, but over time the use of AI will be an indispensable transformation. Read Full Article on HIT Consultant >>
Does Your Team Have These Modern Skills to Protect Healthcare Data?
May 23, 2023 / Healthcare / Data Protection / News Tech – Healthcare organizations were early adopters for protecting data in the modern environment — from stringent compliance regulations to the need to share health records between offices securely. However, protecting patient data has grown more complex in recent years with the influx of new regulations, cloud computing and myriad other factors. Read Full Article on Healthcare IT Today >>
Data Sharing Transforms the way Physicians Practice; Let’s Make it More Accessible
May 24, 2023 / Data Sharing / Healthcare / Patients – Hill Physicians Medical Group, the largest network of independent physicians in Northern California, considers obtaining discrete, contiguous patient health data one of the most important objectives and biggest challenges. The organization’s 5,000+ physicians, who are treating people across the socioeconomic spectrum, believe that comprehensive health information is crucial to deliver high-quality care for their patients. Read Full Article on Healthcare IT Today >>
RedDress Raises $26M to Use Patients Own Blood to Heal Wounds
May 25, 2023 / RedDress / Blood-based Tech / New Tech – RedDress has pioneered a proprietary blood-based technology to treat chronic wounds that has almost zero risk of rejection and is far more cost-effective. Its ActiGraft product family is an autologous, point-of-care wound management solution that creates – in real-time – an in-vitro blood clot from patients’ own whole blood. Once applied to the wound, the blood clot jump-starts the wound-healing process, serves as a protective covering, and optimizes the body’s own healing potential.
Read Full Article on HIT Consultant >>

// Business & Markets

Novartis to buy Avrobio gene therapy for $88M, leaving rest of the biotech on the shelf
May 22, 2023 / Novartis / AvroBio / Cell & Gene Therapy – Novartis is buying a gene therapy candidate from the cash-constrained Avrobio, striking an unusual deal that will see the Big Pharma pay $87.5 million without committing milestones or royalties to land the clinical-phase asset. The news comes months after Novartis was reported to be lining up a takeover of the biotech. Read Full Article on Fierce Biotech >>
2 small biotechs morph to work on oncology together
May 23, 2023 / Mergers and Acquisitions / Biotech Deals / Immuno-oncology – CohBar and Morphogenesis will morph into TuHURA Biosciences in an all-stock transaction that will see the newly formed, publicly held company work on addressing the major limitations of existing immuno-oncology treatments. Read Full Article on Fierce Biotech >>
Concentra bids on Atea, seeking to acquire another struggling biotech
May 23, 2023 / Atea / Investment Firm / Concentra Biosciences – The investment firm behind privately held Concentra Biosciences is attempting to buy a second struggling biotechnology company in a matter of months, disclosing in a regulatory filing an unsolicited bid for COVID-19 drug developer Atea Pharmaceuticals. Read Full Article on Biopharma Dive >>
Most expensive drugs in the US in 2023
May 22, 2023 / Drug Prices / Drug Costs / Pricing / Gene Therapy – Chalk it up to gene therapies’ potential as one-time, curative treatments—a factor that’s prompted drugmakers to slap hefty price tags on their flagship therapeutics. And while the high cost of gene therapies hasn’t always gone over well in other parts of the world (see bluebird bio), the groundbreaking medicines have found a foothold in the U.S. Read Full Article on Fierce Pharma >>
Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge
May 23, 2023 / Quarterly Sales / Pfizer / Moderna / BioNTech – The effects of the COVID cliff were apparent over the last few weeks as companies reported their first-quarter results. Of 20 leading biopharma companies, just six saw their revenues increase in the first quarter of 2023 compared with the same period last year. Read Full Article on Fierce Pharma >>

// Legal & Regulatory

AbbVie, Genmab Score FDA Nod for DLBCL as Blood Cancer Space Heats Up
May 22, 2023 / AbbVie / Blood Cancer / Genmab / FDA – Friday, AbbVie and Genmab won the FDA’s greenlight for their bi-specific T-cell engager epcoritamab-bysp, now with the brand name Epkinly, for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults. Read Full Article on BioSpace >>
Amgen, J&J Settle Patent Dispute Over Stelara Biosimilar
May 24, 2023 / Amgen / Johnson & Johnson / Patent Dispute / Stelara Biosimilar – Tuesday, Johnson & Johnson and Amgen reached a settlement in their patent dispute over the latter’s biosimilar candidate to J&J’s blockbuster antibody Stelara (ustekinumab), according to a Delaware court filing reported by Reuters. Read Full Article on BioSpace >>
Vital patent for AlzeCure Alzheimer’s drug
May 22, 2023 / AlzeCure / Alzheimer’s / New Drug – AlzeCure – a company that focuses on developing Alzheimer’s disease treatments – has announced that the European Patent Office (EPO) has granted a patent covering the company’s candidate, ACD856. Read on PharmaTimes >>
After years of litigation, Gilead and Teva’s HIV antitrust trial kicks off in California
May 25, 2023 / Gilead Sciences / Teva Pharmaceuticals / Antitrust / Lawsuit – Gilead Sciences and Teva Pharmaceutical Industries have spent years defending against claims they worked together to thwart competition to Gilead’s lucrative portfolio of HIV medicines. Now, the case is finally heading to trial. Read on Fierce Pharma >>
FDA Approves First Nasal Nalmefene Spray for Opioid Overdose
May 23, 2023 / FDA / Drug Approval / Opioid / Nalmefene Spray –The FDA has approved Indivior PLC’s nalmefene nasal spray, now to carry the brand name Opvee, for the emergency treatment of confirmed or suspected opioid overdose, the company announced Monday. Read on BioSpace >>

// Research & Development

Amid high-profile injectable launch, Novo Nordisk scores with its pill version of obesity drug Wegovy
May 23, 2023 / Novo Nordisk / Wegovy / Ozempic / Obesity – Diabetes and weight loss juggernaut Novo Nordisk has presented data from a phase 3 trial that show an oral version of its obesity drug Wegovy performs comparably to its original injected therapy. Read Full Article on Fierce Pharma >>
Palisade Bio’s LB1148 Two Ongoing Clinical Trials Expecting Topline Data Readouts
May 24, 2023 / Palisade Bio / Clinical Trials / San Diego Biotech – Palisade Bio, Inc., a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today provided a clinical program update for its lead product candidate, LB1148, a broad-spectrum serine protease inhibitor which acts to neutralize digestive enzymes, potentially reducing intestinal damage. Read Full Article on BioSpace >>
FDA needs more time for Sarepta’s DMD gene therapy—spurring a deja vu of Exondys 51
May 24, 2023 / Sarepta Therapeutics / FDA / Duchenne Muscular Dystrophy / Accelerated Approval – The FDA needs a wee bit more time to consider the approval of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy (DMD), however, the agency has indicated an accelerated approval is likely in a restricted age group. Read Full Article on Fierce Biotech >>
Lisata Therapeutics Announces Enhancements to Ongoing Phase 2b ASCEND Trial of LSTA1
May 24, 2023 / Lisata Therapeutics / Clinical Trial – Lisata Therapeutics, Inc., a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced protocol changes to the ongoing ASCEND trial, a Phase 2b trial evaluating LSTA1, Lisata’s lead investigational drug, in combination with standard-of-care (“SOC”) gemcitabine/nab-paclitaxel in patients with first-line, metastatic pancreatic ductal adenocarcinoma (“mPDAC”). Read Full Article on BioSpace >>
Phase III Results Prime Dupixent as First Potential Biologic Approval for COPD
May 22, 2023 / Sanofi / Regeneron / Clinical Trials – Sunday, Sanofi and Regeneron released positive Phase III results for their blockbuster drug Dupixent in chronic obstructive pulmonary disease in current and previous smokers. Read Full Article on BioSpace >>

// Politics

California has tried to cut the cost of insulin for years. Why it might finally succeed
May 20, 2023 / California / Insulin / Drug Cost – The high cost of insulin has been a niggling thorn in the side of regulators and patients for decades: Prices for the 100-year-old drug have increased more than 600% in the past 20 years, and stories of patients rationing doses abound. Even the most conservative economists point to it as an example of a market gone sour. Read Full Article on Long Beach Post News >>
House panel advances transparency and PBM bills
May 24, 2023 / House Panel / PBM Bills / Healthcare – The House Energy and Commerce Committee on Wednesday advanced a series of health care measures to promote price transparency and overhaul regulation of pharmacy benefit managers (PBMs) in a mostly bipartisan markup. Read Full Article on AXIOS >>
A more aggressive FTC is starting to target drug mergers and industry middlemen
May 22, 2023 / FTC / Mergers and Acquisitions / Antitrust / Pharmacy Benefit Management – Under the leadership of an aggressive opponent of anticompetitive business practices, the Federal Trade Commission (FTC) is moving against drug companies and industry middlemen as part of the Biden administration’s push for lower drug prices at the pharmacy counter. Read Full Article on Fierce Healthcare >>
Congress highlighted a chemo drug’s price to blast PBMs
May 23, 2023 / Congress / PBM / Drug Price – Congress blasted drug middlemen at a hearing Tuesday, with multiple lawmakers pointing to a huge discrepancy between how much a chemo drug costs at CVS and its price from Mark Cuban’s Cost Plus Drugs. Read Full Article on STAT >>
Small, Rural Communities Have Become Abortion Access Battlegrounds
May 23, 2023 / Abortion Access / Rural Communities / Healthcare – The quest to enact local bans has become particularly acute in small towns, like West Wendover, Nevada, and Hobbs, New Mexico, which are situated by borders between states that have restricted abortion and states where laws preserve access. Read Full Article on MedCity News >>