Latest Headlines from Cafepharma

10 life sciences startups selected for accelerator program

BioSpace — Fri, 04 Sep 2026 12:16:42 -0400

To propel breakthrough science while equipping scientific founders with tools for long-term success, MassBio and SCbio have named 10 startups to the latest cohorts of their Drive accelerator program. Across the five biotechs and five techbios, the companies cover therapeutic modalities including small molecules, antibodies, gene editing, gene therapy, oncolytic viruses and cell therapy.

The Oral GLP-1 Tracker: Novo's Wegovy pill, Lilly's Foundayo grow scripts

Fierce Pharma — Fri, 04 Sep 2026 12:03:06 -0400

Total prescriptions for Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo both grew over the past week, reaching roughly 181K (+3%) and 44K (+8%), IQVIA data showed, as cited by Citi. Both numbers are the two meds' highest so far.

Ionis nets Zanvastro US approval in first for Alexander disease

Pharma Technology — Fri, 04 Sep 2026 11:47:10 -0400

Ionis Pharmaceuticals has secured an approval from the US Food and Drug Administration (FDA) for its therapy, zilganersen, in the rare neurodegenerative disorder Alexander disease – marking the first time a disease-modifying therapy has debuted in this indication.

Daiichi unit American Regent recalls 3 epinephrine batches on particulate, leakage concerns

Fierce Pharma — Fri, 04 Sep 2026 11:44:35 -0400

Daiichi Sankyo subsidiary American Regent is launching a recall of three lots of generic epinephrine as it becomes one of the latest manufacturers to face headaches over particulate contamination in its drug products.

Biotech is back, with H1 progress smoothing glide path through end of year: Truist

BioSpace — Fri, 04 Sep 2026 11:42:02 -0400

With M&A rising, venture capital returning and policy risks easing, biotech is on a positive trajectory following a prolonged post-pandemic slump, Truist Securities declared after a survey of sector leaders.

The biotech sector’s performance over the past 18 months has “more than made up for a challenging 2+ year period,” analysts from Truist Securities said. And with regulatory risks abating, M&A already topping 2025 and more positive trends underway, the firm believes the momentum will continue through the end of the year.

Pfizer punts Seagen ADC, further muddying value of the $43B buyout

BioSpace — Fri, 04 Sep 2026 11:40:39 -0400

The co-development deal comes after Pfizer reported a late-stage failure for a Seagen asset and the discontinuation of another investigational therapy developed by the company as a subsidiary of the pharma.

Gilead’s growing HIV franchise; cell therapy licensing deals plummet

Pharma Voice — Fri, 04 Sep 2026 11:38:36 -0400

Gilead is growing its HIV franchise with a fresh FDA nod.

The agency OK’d a novel medication last week that combines two Gilead HIV treatments into a single pill as an option for patients who want to “simplify their treatment regimen,” the company’s CEO, Daniel O’Day, said in a statement.

Philips has a new single-transducer offering for its women’s health ultrasound

Mass Device — Fri, 04 Sep 2026 11:20:38 -0400

Philips (NYSE: PHG) is expanding its obstetrics and gynecology ultrasound portfolio with the introduction of the eV14-2v transvaginal transducer.
FDA 510(k) cleared and CE-marked, the eV14-2v combines image quality and broad clinical capabilities in a single lightweight transducer, according to Philips.

Novartis and Bristol Myers are halting cell therapy trials for autoimmune diseases after patient deaths

Quartz — Fri, 04 Sep 2026 11:17:20 -0400

Novartis paused eight clinical trials of its experimental cell therapy rap-cel targeting autoimmune and neurological disorders after three patients died from a life-threatening immune reaction, according to Reuters. Bristol Myers has also voluntarily halted enrollment in its own competing CAR-T trials as a precaution.

ADC from AbbVie's ImmunoGen takeout wins FDA approval for rare blood cancer

First Word Pharma — Fri, 04 Sep 2026 11:10:56 -0400

Following a priority review, the FDA on Wednesday approved AbbVie's Decnupaz (pivekimab sunirine-pvzy) to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare form of blood cancer. The drugmaker acquired the CD123-targeting antibody-drug conjugate (ADC) as part of its $10-billion buyout of ImmunoGen in 2023.

GSK inks another Asia alliance, betting up to $1.3B for HUTCHMED’s cancer therapy

BioSpace — Thu, 03 Sep 2026 12:00:41 -0400

For $110 million upfront, GSK will have the exclusive global right to advance HMPL-A830, which combines an EGFR-targeting antibody with a small-molecule KRAS blocker. The asset will be studied for colorectal, pancreatic and lung cancer.

Boston Scientific recalls, discontinues angiographic catheter sales

Mass Device — Thu, 03 Sep 2026 11:57:53 -0400

Boston Scientific recalled and discontinued all Imager II angiographic catheters due to a manufacturing issue, according to an FDA early alert.
Imager II angiographic catheters are diagnostic intravascular catheters used to capture images of the patient’s peripheral vasculature.

Court sides with FDA in tirzepatide shortage fight: 5 notes

Beckers Hospital Review — Thu, 03 Sep 2026 11:55:44 -0400

The 5th U.S. Circuit Court of Appeals affirmed Aug. 27 that the FDA acted lawfully when it declared Eli Lilly’s tirzepatide shortage resolved, according to court documents reviewed by Becker’s The ruling delivers a defeat to compounding pharmacies that had sued to keep making cheaper, unapproved versions of Mounjaro and Zepbound.

Here are five things to know:

Why Roche is 'really excited' about a UCN2 analog for obesity after seeing preclinical data

Fierce Biotech — Thu, 03 Sep 2026 11:53:30 -0400

Roche has decided to pay $190 million upfront for an unusual obesity mechanism after viewing preclinical data that “clearly suggests” the modality can reduce weight while preserving lean muscle, Fierce has learned.

The Swiss pharma’s Genentech unit stumped up the cash last week for rights outside South Korea to HM17321, a corticotropin-releasing factor 2 (CRF2) receptor-selective urocortin-2 (UCN2) analog developed by South Korea’s Hanmi Pharm.

Summit, Akeso’s ivonescimab bests Merck’s Keytruda in China trial—again

BioSpace — Thu, 03 Sep 2026 11:39:45 -0400

New Phase 3 data show that Summit Therapeutics and Akeso’s PD-1/VEGF therapy improved overall survival in patients with a type of lung cancer as compared to Merck’s Keytruda but the results will need to be replicated in non-Chinese patients.

RevMed’s newly approved Rasonque could ‘hold up’ in non-small cell lung cancer

BioSpace — Thu, 03 Sep 2026 11:37:31 -0400

The data, which come from a subgroup in an earlier trial that Truist Securities called “the most relevant” to Revolution Medicines’ ongoing Phase 3 test in RAS mutant NSCLC, showed a 42% overall response rate and overall survival of 16 months.

Novartis may cut around 130 in Switzerland while relocating biologics production

BioSpace — Thu, 03 Sep 2026 11:31:52 -0400

Novartis could let go of about 130 employees in Switzerland due to discontinuing small-volume production of biologics in Kleinbasel by the end of 2027, the company announced in a German-language press release. Fierce Biotech first reported the news.

Haleon secures better shelf space at Walmart, Target in bid to boost market share

AOL/Reuters — Thu, 03 Sep 2026 11:29:47 -0400

Sensodyne toothpaste maker Haleon has quietly negotiated better spots on shelves at U.S. retailers including Walmart and Target, to gain more visibility at a at a time when mounting grocery bills are hitting shopper spending.

AbbVie's Etentamig Improves Responses and Progression-Free Survival in Relapsed Multiple Myeloma

Cure Today — Thu, 03 Sep 2026 11:26:55 -0400

Etentamig achieved co-primary endpoints with ORR 74% versus 45.7% and a 60% relative reduction in progression/death risk versus standard available therapies.
Benefit in progression-free survival was consistent across all prespecified subgroups in this triple-class–exposed relapsed/refractory multiple myeloma population.

Abbott ablation device effective at 1 year in complex cases

Medtech Dive — Thu, 03 Sep 2026 11:24:36 -0400

Abbott said it will use the study results to secure FDA approval for the TactiFlex Duo catheter that offers both PFA and RF energy for tailoring treatment of atrial fibrillation.

China’s clinical trial boom under scrutiny after 3 deaths come to light

Pharma Voice — Thu, 03 Sep 2026 11:23:22 -0400

Chinese clinical trials have become synonymous with speed and savings, but questions have surfaced about the price of those advantages.

Reports surfaced over the summer of three deaths in Chinese trials, including two children — but the deaths were not publicly disclosed when they occurred.

In a letter to FDA Acting Commissioner Kyle Diamantas, Rep. John Moolenaar, chairman of the House Select Committee on China, and Rep. Ben Cline laid out their concerns in stark terms.

Ultragenyx to slash costs after Angelman trial failure

Pharmaphorum — Thu, 03 Sep 2026 11:19:14 -0400

Ultragenyx's therapy for the rare genetic disorder Angelman syndrome, apazunersen, has flunked a late-stage trial, causing the company to start "significant expense reductions."

Alumis’ lupus drug heads to Phase III despite mid-stage miss

Clinical Trials Arena — Wed, 02 Sep 2026 12:12:07 -0400

California-based biopharma company Alumis is taking its immunology candidate, envudeucitinib, to Phase III in a type of lupus, despite the drug missing its goals across the general population in a Phase IIb trial.

Boehringer Ingelheim Licenses Owkin’s K Pro AI Scientist for Accelerated Discovery in Oncology, Immunology

Contract Pharma — Wed, 02 Sep 2026 12:08:32 -0400

Owkin announced a license agreement with Boehringer Ingelheim for K Pro, Owkin’s AI Scientist, along with multimodal patient data. The agreement builds upon a pilot between the companies in 2025 and aims to speed discovery in oncology and immunology.

Stripped of AstraZeneca safety net, BMS could face ‘carnage’ if high-risk clinical trial fails

BioSpace — Wed, 02 Sep 2026 12:02:59 -0400

BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers.

The collapse of AstraZeneca’s reported merger talks with Bristol Myers Squibb extended the long wait for a deal between two major drugmakers and deprived BMS of one possible solution to growth problems that could be compounded soon if a key upcoming readout does not meet expectations.

Biopharma reverse mergers rise 1,600% in Q3 to rival IPOs

BioSpace — Wed, 02 Sep 2026 12:01:25 -0400

Almost as many biotechs have opted for a reverse merger to reach the public markets as those executing more traditional initial public offerings this year.

Trump GLP-1 update teases blockbuster annual sales for Lilly from Medicare program: analyst

Fierce Pharma — Wed, 02 Sep 2026 11:56:20 -0400

As part of the “most favored nation” (MFN) drug pricing deal the Trump administration signed with obesity giants Eli Lilly and Novo Nordisk, Medicare recently launched a “bridge” model, offering weight loss drugs to eligible seniors at $50 per month. Now, we know the initial uptake from the program.

Tavneos no longer available for new patients in UK as Amgen awaits FDA hearing

BioSpace — Wed, 02 Sep 2026 11:49:47 -0400

CSL Vifor holds the marketing authorization for Tavneos in the U.K., where the drug is marketed as Avacopan Vifor. It continues to be sold on the U.S. market by Amgen despite concerns raised by the FDA.

Teva’s immune disorder drug meets main goal in mid-stage trial

Pharma Live — Wed, 02 Sep 2026 10:24:06 -0400

Teva Pharmaceutical Industries (TEVA.TA), said on Wednesday its experimental drug helped prevent gluten-related intestinal damage in adults with celiac disease, meeting the main goal of a ‌mid-stage trial.

uniQure seeks US approval for Huntington's gene therapy after FDA reversal

Yahoo/Reuters — Wed, 02 Sep 2026 10:19:19 -0400

Dutch gene therapy developer uniQure said on Wednesday it had applied for U.S. approval of its experimental treatment for Huntington's disease ‌after the FDA reversed its earlier position on the drug, sending the company's ‌shares up 5% in premarket trading.