// Biotech and Pharma Therapeutics
Roche’s Genentech bets on radiopharmaceuticals in partnership with PeptiDream
Interest in radiopharmaceuticals has been taking off ever since Novartis won drug approval of a drug it acquired with the buyout of the biotech Endocyte. Other big drugmakers such as Merck & Co. and Bristol Myers Squibb are acquiring a stake in the new space that, while enticing, still faces several obstacles through development.
Merck KGaA doubles up on AI partners, tapping BenevolentAI and Exscientia for drug discovery push
Merck KGaA is spreading its bets on an artificial-intelligence-enabled future for drug discovery, inking similar three-target deals with BenevolentAI and Exscientia. The deals are collectively worth more than $30 million upfront and $1 billion in potential milestones.
Novo Nordisk parent backs cell therapy manufacturing facility
Cell therapies are viewed as potential one-time treatments able to cure or at least reduce the burden of disease in chronic or fatal conditions. Emily Whitehead, who, in 2012, became the first pediatric leukemia patient given the cancer-fighting CAR-T cell therapy Kymriah, has been in remission since her treatment.
BioNTech secures $90M from CEPI to partner on mpox vaccine as it enters clinic
The German biotech is partnering with the Center for Epidemic Preparedness Innovations (CEPI), accepting up to $90 million from the foundation as part of a broader pandemic preparation initiative. Though the market is already occupied by Bavarian Nordic’s Jynneos, BioNTech and CEPI said in a release Monday that adding to the supply could be useful in future outbreaks and that developing a new shot could help prevent the spread of other orthopoxvirus-based diseases.
Select Health, Mark Cuban team to lower prescription drug costs
Salt Lake City-based Select Health and its pharmacy benefits manager Scripius will be one of the first health plans in the U.S. to provide member access to Mark Cuban Cost Plus Drug Company, meaning members will have direct access to the prescription drug service.
// 4th Industrial Revolution
Telehealth, properly integrated with EHRs, can boost cancer care
That’s sometimes easier said than done, however. Kathy Dalton Ford, chief product and strategy officer at Ronin, which develops clinical oncology software, very much believes virtual care and other technologies can help providers improve their cancer care. But the tools have to be properly calibrated.
Breast Cancer Detection AI Performs On Par with Human Mammogram Readers
The diagnostic performance of a commercially available artificial intelligence (AI) algorithm was comparable with that of human readers of mammograms, according to a study published recently in Radiology.
MIT’s new technique to remotely evaluate cerebral palsy patients
Combining both computer vision and machine-learning techniques, the method analyses videos of patients in real-time and computes a clinical score of motor function based on patterns of poses that it detects in video frames.
FDA advisers discuss future of ‘artificial womb’ for human infants
Independent advisers to the US Food and Drug Administration are meeting this week to discuss the regulations, ethics and possibilities of creating an artificial womb to increase the chances that extremely premature babies would survive — and without long-term health problems.
Merck KGaA Expands in AI-Driven R&D With Two Drug Discovery Deals
Details are scant, but Merck KGaA said the multi-year agreements call for both AI companies to develop small molecule drugs in the areas of oncology, neurology, and immunology. To start, the Darmstadt, Germany-based drugmaker said it has selected three potential first-in-class and best-in-class targets for each alliance, though it is not disclosing those targets.
// Business & Markets
Thyroid Cancer Market is Projected to Grow at a CAGR of 17.18% from 2023-2033
The report offers a comprehensive analysis of the thyroid cancer market in the United States, EU5 (including Germany, Spain, Italy, France, and the United Kingdom), and Japan. It covers aspects such as treatment methods, drugs available in the market, drugs in development, the proportion of various therapies, and the market’s performance in the seven major regions. Additionally, the report evaluates the performance of leading companies and their pharmaceutical products.
Astellas to invest over €330m in a new facility in Ireland
The investment in Ireland will reinforce stable production for global supply and accelerate the development and commercialisation of innovative antibody drugs and other products.
Home care company Inbound Health raises $30M and more digital health fundings
Inbound Health, a value-based care enablement platform for health systems and plans to provide at-home acute and post-acute care, announced the close of a $30 million Series B funding round led by HealthQuest Capital.
Vivante Health Closes $31M to Advance Digital Digestive Health Platform
Vivante’s virtual GI care platform, GIThrive delivers the right care at the right time by pairing data-driven technology with a coordinated team of experienced physicians, registered dietitians and health coaches. Members can access everything they need to manage their digestive health all in one place, 24/7. Whether it’s connecting with the care team, tracking their nutrition and symptoms, or completing self-guided behavioral health modules, members are supported and encouraged every step of the way.
Genentech, PeptiDream Ink Potential $1B Radiopharma Deal
Japanese biopharma PeptiDream on Wednesday announced yet another licensing agreement with Roche’s Genentech, this time worth up to $1 billion. The latest deal builds on previous partnerships between the two companies starting in December 2015 with licensing in 2016 and an expansion deal in 2018.
// Legal & Regulatory
In new lawsuits, Lilly accuses 8 companies of making and selling compounded versions of Mounjaro
Early this summer, Novo Nordisk filed lawsuits accusing several companies of producing and selling compounded versions of Ozempic and Wegovy. Now, Eli Lilly has done the same, taking action against companies that the Indianapolis drug giant claims are marketing unauthorized copycats of its blockbuster Mounjaro.
FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine
San Diego-based ARS Pharma characterized the rejection as a surprise. In addition to the advisory committee support, the company’s discussions with the FDA had gotten as far as physician labeling and post-marketing requirements—steps that are indications a product is on its way to an approval. In its late-Tuesday announcement of the negative regulatory decision, ARS Pharma said the agency is now asking for more data from another study. The company said it will appeal.
FDA greenlights Beacon’s AI-assisted sleep monitoring device
Healthtech company Beacon Biosignals has received FDA 510(k) clearance for the Dreem 3S, a wearable headband designed to capture electroencephalogram (EEG) data from the brain. Equipped with integrated machine learning algorithms, the Dreem 3S facilitates the monitoring of sleep architecture and aids in the diagnosis of disturbed sleep.
Takeda settles antitrust lawsuit over gout drug Colcrys after trial kicked off
The Japanese pharma giant has inked a settlement with drug wholesalers who accused the company of using anti-competitive deals to delay generic entry to its gout drug Colcrys, a court filing shows.
US biotech wins preliminary patent injunction in UPC first
A US biotech company has been granted a preliminary injunction that prevents a competitor from selling products in 17 EU countries in a landmark ruling by the local division of the Unified Patent Court (UPC) in Munich.
// Research & Development
New RSV vaccines can be powerful tools, but rollout poses test
Their arrival in the U.S., alongside a new antibody drug, gives public health officials and physicians powerful new tools to combat respiratory syncytial virus, or RSV, which causes thousands of deaths among young children and older adults each year.
Pfizer’s Vydura recommended by NICE for acute migraines
The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Vydura (rimegepant) as a cost-effective option for the treatment of acute migraines in adults.
Startup AIRNA emerges from stealth to bring RNA editing to a rare disease
Scientists have touted RNA editing as a safer derivation of early gene editing methods. Unlike CRISPR-based therapies, RNA editing can target specific sites in an RNA transcript without permanently changing a patient’s genome.
Broken birth control: Growing calls for research into popular IUD after 6,000+ breakage reports
The initial investigation found that the Paragard IUD had broken thousands of times, sometimes leading to serious health complications for women; both of those concerns continue to persist about the device.
RetinalGeniX Technologies focuses on prevention of blindness, early detection of multiple systemic diseases
RetinalGeniX Technologies Inc. released to the public via OCT Markets a video webinar regarding the retinal screening medical device technology being developed by the company to help prevent blindness and multiple systemic diseases, the company’s business opportunities and the professional background of the company’s management team.
// Politics
PBMs, PhRMA trade blame over drug costs in House hearing
Members of the House Oversight and Accountability Committee skewered the head of the major pharmacy benefit manager lobby in a hearing on Tuesday over PBMs’ role in rising drug costs, including practices like rebates and spread pricing, as Congress inches closer to enacting legislation to reform the industry.
Federal regulation of AI: What the likely framers and innovators are saying now
Last week brought the latest in an occasional series of conversations on AI between governmental leaders and Big Tech honchos. For months, the No. 1 topic on the table has been regulation. Businesses are counterintuitively clamoring for it, and the political parties are—for the moment, anyway—united over it.
Senate HELP on collision course
Chair Bernie Sanders (I-Vt.) and Sen. Roger Marshall (R-Kan.), who are working together on the bill, maintain they have the votes to pass it through the committee. Marshall said he expects some of his Republican colleagues to vote for it as well.
U.S. Sen. Baldwin: Baldwin joins amicus brief against big pharma, in support of medicare negotiating lower prescription drug costs
Today, U.S. Senator Tammy Baldwin (D-WI) joined thirteen of her colleagues in filing an amicus brief in Merck & Co. v. Becerra in the District Court for the District of Columbia urging the federal court to uphold the constitutionality of Congress allowing Medicare to negotiate lower drug prices for consumers.
Revolving door redux: The DEA’s recently departed No. 2 returns to a Big Pharma consulting firm
Washington’s revolving door kept spinning this week as the Drug Enforcement Administration’s recently departed second-in-command returned for a new stint with the high-powered consulting firm where he previously advised Purdue Pharma and a drug distributor fighting sanctions over a deluge of suspicious painkiller shipments.