Latest Headlines from Cafepharma

J&J launches faster Shockwave coronary catheter in the US

Mass Device — Tue, 20 Oct 2026 17:29:24 -0400

Johnson & Johnson (NYSE: JNJ) is launching the latest version of its intravascular lithotripsy catheter for cracking calcium within the coronary arteries, which the company said it designed to cut treatment times in half

Medtronic announces a company president

Mass Device — Tue, 20 Oct 2026 17:27:41 -0400

Medtronic (NYSE: MDT) has promoted a Boston-based veteran of the company to the role of corporate president, reporting to CEO Geoff Martha

Viatris' Ryzumvi wins FDA nod in age-related vision loss

Fierce Pharma — Tue, 20 Oct 2026 17:25:03 -0400

Viatris and Opus Genetics just secured a second FDA approval for their eye drop Ryzumvi. The alpha-adrenergic antagonist snagged the regulator’s okay to treat presbyopia, the gradual and nearly universal loss of near-focus vision that comes with aging. Viatris estimates that the condition affects 128 million Americans.

Novo’s next-generation obesity drug shows 25% weight loss in women in late-stage analysis

CNBC — Tue, 20 Oct 2026 11:45:47 -0400

Novo released new evidence that its experimental CagriSema injection can improve upon the weight loss with its blockbuster GLP-1 obesity injection, Wegovy.
The Danish company said its next-generation obesity drug showed 25% weight loss on average at 68 weeks among adult women in a new analysis conducted after a late-stage trial.

Rapport’s novel oral drug posts Phase II bipolar win

Clinical Trials Arena — Tue, 20 Oct 2026 11:44:25 -0400

Rapport Therapeutics’ Phase II bipolar mania study has met its primary endpoint, as it hopes to compete on the market with the drug’s original owner, Johnson & Johnson (J&J).
In the study (NCT07046494), acute bipolar mania patients treated with RAP-219 achieved a 3.1-point placebo-adjusted improvement in the Young Mania Rating Scale (YMRS) total score after three weeks of treatment. This was based on a mean reduction from baseline of 15.4 points with RAP-219 versus 12.3 points with placebo.

AI Healthcare News Week Ending 10.18.26

CP Wire — Tue, 20 Oct 2026 11:41:59 -0400

AI in healthcare continues the shift from experimentation to evidence-based, accountable implementation. Healthcare organizations are developing governance frameworks for autonomous AI agents, while new applications are targeting cancer biomarker testing and hospital operations.

GSK’s Jemperli scores FDA approval in rectal cancer, backed by high complete response rate

Fierce Pharma — Tue, 20 Oct 2026 11:24:56 -0400

Building on the buzz around a celebrated early trial readout, GSK’s Jemperli has earned a first-in-class FDA approval in a specific type of rectal cancer.

Monday's accelerated approval makes Jemperli the first immunotherapy for patients with stage 2 and 3 locally advanced rectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), a type of genomic abnormality.

Cybersecurity in focus for top medtech lobby

Medtech Dive — Tue, 20 Oct 2026 11:22:30 -0400

Following several high-profile cyberattacks of medical device firms, cybersecurity is top of mind for one of the medtech industry’s prominent lobbying groups.

AdvaMed Chairman Mick Farrell said the lobby is looking to create standards around cybersecurity, privacy, and interoperability at a Monday press event at the MedTech Conference. The CEO compared the effort to coming up with a code of ethics.

Where hospitals’ 340B claims data lawsuits against Lilly stand

Beckers Hospital Review — Tue, 20 Oct 2026 11:20:40 -0400

Two hospitals are challenging Eli Lilly’s 340B claims data policy in federal court, and neither judge has ruled. At the center of both cases is whether hospitals can use state-law claims to challenge drugmakers that condition 340B discounts on claims data. Here’s where things stand.

Epkinly data only one of Genmab’s make-or-break readouts ahead of steep sales erosion

BioSpace — Tue, 20 Oct 2026 11:13:12 -0400

Bracing for patent losses on its cornerstone product Darzalex, Genmab has bet its future on three cancer programs that will deliver pivotal readouts in quick succession.

Pfizer makes ‘business decision’ to end phase 2 trial of autoimmune drug as program’s future uncertain

Fierce Biotech — Tue, 20 Oct 2026 11:08:57 -0400

Pfizer has called time on a phase 2 trial of its CXCR5 antibody in an autoimmune blood disorder, with the company tight-lipped on whether this marks the end of the road for the asset.

The Big Pharma had been evaluating the therapy, dubbed PF-06835375, in a phase 2 study of 61 patients with primary immune thrombocytopenia (ITP) that kicked off in 2022, according to the federal trials register.

Amgen, AZ dive deep into Tezspire's Dupixent-challenging victory in EoE phase 3

Fierce Pharma — Tue, 20 Oct 2026 11:03:44 -0400

With little time elapsed since AstraZeneca and Amgen unveiled a topline win for Tezspire over the summer, the partners are upping the stakes with a detailed look at their inflammation-fighting antibody’s prowess in eosinophilic esophagitis (EoE).

Medtronic wins CE mark for Vitalis portfolio of cardiac pacemakers

Medtech Dive — Tue, 20 Oct 2026 10:59:50 -0400

Medtronic said Monday it has received a CE mark for its Vitalis portfolio of cardiac pacemakers.
The portfolio features five devices, which Medtronic said offer a comprehensive suite of pacing options and include features for conduction system pacing therapy, or CSP.

AZ and Oracle team up on AI platform for clinical trials

Pharmaphorum — Tue, 20 Oct 2026 10:56:26 -0400

AstraZeneca has launched a project with tech giant Oracle that will use AI and real-world data to improve clinical research, for example by identifying suitable patients for clinical trials.

Roche returns to China’s ADC powerhouse Hansoh for $15B biobucks pact

Fierce Biotech — Mon, 19 Oct 2026 11:36:03 -0400

A year after their first antibody-drug conjugate (ADC) team-up, Roche has returned to Hansoh Pharmaceutical for a mammoth $15 billion biobucks pact.

The latest agreement spans a “broad portfolio of ADC programs,” Hansoh explained in an Oct. 19 release. They include two ADCs already in preclinical development at the Chinese biopharma, along with multiple programs focused on targets suggested by Roche but powered by Hansoh’s ADC tech.

Roche to review investment in Germany over health insurance reform

Yahoo Finance — Mon, 19 Oct 2026 11:33:11 -0400

Swiss pharma giant Roche is putting future decisions on investment in Germany on hold, the company said on Monday, amid opposition to new rules requiring pharmaceutical companies to grant higher discounts to health insurance funds.

Eli Lilly's Omvoh takes phase 3 win in pediatric UC, fueling expansion ambitions

Fierce Pharma — Mon, 19 Oct 2026 11:29:54 -0400

Eli Lilly is betting on a pediatric expansion to give it’s IL-23p19 inhibitor Omvoh an edge in the fiercely competitive inflammatory bowel disease (IBD) market.

The Indianapolis-based drugmaker just announced a positive readout for its Shine-2 phase 3 trial of Omvoh in pediatric patients ages six to 17 years with moderately to severely active ulcerative colitis (UC). Half of the children enrolled in the single-arm study achieved clinical remission by one year, achieving the primary endpoint in what Lilly hailed as the longest pediatric IL-23p19 study to date.

Merck KGaA buys Silence in $1.3B deal after siRNA drug's phase 2 blood cancer win

Fierce Biotech — Mon, 19 Oct 2026 11:24:28 -0400

Germany’s Merck KGaA has picked up Silence Therapeutics to the tune of $1.3 billion in the wake of the British biotech’s mid-stage success for its challenger to Takeda’s Mimrylo.

The all-cash deal will see Darmstadt-based Merck pay $20 per share of Silence—an 130% increase on the biotech’s Friday closing price of $8.68.

5 doctors weigh in on the promise, limitations of Grail’s multicancer test

Medtech Dive — Mon, 19 Oct 2026 11:11:33 -0400

As the closely watched screening test moves closer to Food and Drug Administration approval, MedTech Dive asked cancer experts what encourages and concerns them most about Galleri.

FDA clears Sequel’s insulin delivery system in Type 2 diabetes

Medtech Dive — Mon, 19 Oct 2026 11:06:27 -0400

The Food and Drug Administration has cleared the Twiist automated insulin delivery, or AID, system for use in adults with insulin-treated Type 2 diabetes.
Sequel Med Tech, which sells the device, disclosed the 510(k) clearance on Friday. The FDA granted the clearance to Deka Research and Development, Sequel’s partner on Twiist.

As AbbVie’s Crohn’s combo beats Skyrizi in mid-stage test, analysts laud autoimmune vision

BioSpace — Mon, 19 Oct 2026 11:04:32 -0400

AbbVie’s next-gen dual-targeting therapy elicited higher rates of remission than its IL-23 inhibitor Skyrizi in a Phase 2a trial of Crohn’s disease, leading analysts to wonder if the blockbuster can be outdone.

Gilead hits mid-stage trial success for oral bowel disease therapy

Seeking Alpha — Mon, 19 Oct 2026 11:02:25 -0400

Gilead Sciences (GILD) on Monday announced that its oral bowel disease therapy emvistegrast succeeded in a mid-stage trial for patients with ulcerative colitis, an inflammatory disease of the colon.

METiS TechBio Partners with Eli Lilly (LLY) to Advance Lipid Nanoparticle Delivery Systems

Guru Focus — Mon, 19 Oct 2026 10:59:14 -0400

On October 19, 2026, METiS TechBio announced a strategic collaboration with Eli Lilly and Co (NYSE: LLY) to co-develop innovative lipid nanoparticle-based delivery platforms aimed at enhancing tissue-specific targeting of therapeutic agents. This partnership leverages METiS’s AI-driven AiLNP platform to optimize lipid nanoparticle efficiency and biodistribution, combining it with Eli Lilly’s deep expertise in drug discovery and commercialization.

Biotech is booming — and startups are still dying

Pharma Voice — Mon, 19 Oct 2026 10:55:43 -0400

U.S. biotech IPO volume hit a five-year high in the third quarter, with nine offerings raising $2.4 billion, according to an analysis by the global investment bank Locust Walk.

Dealmaking has also been robust, with biopharma M&A reaching $173 billion through the third quarter — already outpacing 2025’s full-year total.

But other indicators paint a different picture.

Global licensing fell to a two-year low in Q3, Locust noted, with deal value down 33% quarter over quarter as average deal size declined and activity shifted “away from biobucks-heavy discovery/preclinical deals.”

Novartis abandons Fabhalta trial in lupus nephritis

Pharmaphorum — Mon, 19 Oct 2026 10:54:02 -0400

A failed phase 2 study has undermined Novartis' hopes of extending the approved indications for its oral complement inhibitor Fabhalta to include lupus nephritis.

Novavax critic Shah Capital ends its activism campaign

Pharmaphorum — Mon, 19 Oct 2026 10:49:08 -0400

Shah Capital has ended its attempts to exert influence over vaccine developer Novavax, bringing more than years of activism and pressure on management to an end.

Eli Lilly's weight-loss pill won backing from a European drug regulator panel

Quartz — Fri, 16 Oct 2026 11:35:31 -0400

Eli Lilly received a recommendation from a European Medicines Agency committee on Friday to approve its weight-loss pill Foundayo for obesity and type 2 diabetes, according to Bloomberg.

Verastem’s KRAS inhibitor posts wins in mPDAC, mCRC and NSCLC

Clinical Trials Arena — Fri, 16 Oct 2026 11:33:28 -0400

Verastem Oncology’s KRAS inhibitor has shown promise in several tumour types, including metastatic pancreatic ductal adenocarcinoma (mPDAC), metastatic colorectal cancer (mCRC), and advanced non-small cell lung cancer (NSCLC).

China looks to ban foreign acquisitions of critical biopharma platforms

Fierce Biotech — Fri, 16 Oct 2026 11:27:43 -0400

As Washington ramps up efforts to tighten cross-border life sciences deals involving Chinese assets, Beijing is moving to tighten its own grip on biomedical innovation, rolling out a draft policy that would ban or restrict the export of key biopharmaceutical technologies.

Estuary sails into kidney disease space with $103M for gene therapies

BioSpace — Fri, 16 Oct 2026 11:25:12 -0400

Estuary Biotherapeutics is seeking to address the root cause of autosomal dominant polycystic kidney disease with two gene therapy programs based on science from Yale.