Cafepharma Daily New Headlines

Lilly's obesity pill Foundayo gains early blockbuster forecast as analysts float 5M+ prescriptions in 2026

Fierce Pharma — Thu, 02 Apr 2026 12:05:35 -0400

With a second oral GLP-1 for obesity now approved in the U.S., analysts have set to work parsing the blockbuster potential of Eli Lilly’s Foundayo in 2026, as well as the dynamics at play with Novo Nordisk’s equally buzzy Wegovy pill, which launched with a three-month head start on Lilly’s drug in January.

Rare Disease Leaders Call for Regulatory Clarity as FDA Balances Urgency With Rigor

BioSpace — Thu, 02 Apr 2026 12:01:12 -0400

With CBER director Vinay Prasad set to depart the agency at the end of the month, a coalition of patient groups and biotech executives penned a letter imploring the Trump administration to “restore regulatory clarity” for rare disease therapies. Experts on a BioSpace panel last week also acknowledged the challenges faced by a more stringent FDA.

Merit Medical acquires View Point for $140M

Medtech Dive — Thu, 02 Apr 2026 11:58:31 -0400

Merit Medical Systems has acquired View Point Medical in a $140 million deal to expand its oncology portfolio.
View Point sells a system for tumor tissue localization in biopsies and cancer resection surgeries. Merit already has a tissue localization device, but it has a different mechanism.

Approvals in Hand, Lilly and Novo Obesity Pills Will Battle It Out on Hairline Differences

BioSpace — Thu, 02 Apr 2026 11:44:07 -0400

After Eli Lilly achieved the milestone approval of the weight loss pill Foundayo, Novo Nordisk launched a full-court press to defend oral Wegovy, which has been enjoying a record-breaking launch since January.

Immunovant’s FcRn inhibitor flunks phase 3 eye disease trials, validating biotech’s waning interest

Fierce Biotech — Thu, 02 Apr 2026 11:25:53 -0400

Immunovant’s first-generation FcRn inhibitor flunked a pair of phase 3 eye disease trials, appearing to end the last hopes of commercializing the drug.

The company set out plans back in 2022 to assess the therapy, called batoclimab, in two late-stage studies of patients with thyroid eye disease (TED).

Data shows 6.7% of global clinical trials impacted by Middle East disruption

Clinical Trials Arena — Thu, 02 Apr 2026 09:35:25 -0400

An analysis of 65,061 globally recruiting clinical trials across 186 countries finds that 4,361 studies, equivalent to 6.7% of all active trials, are impacted by disruption in the Middle East.

The research, conducted by data analytics firm Phesi, found that across a total of 356,699 recruiting investigator sites, 7,958, or 2.2%, are in the affected region, with Phase III trials accounting for the highest number of impacted sites at 2,732.

J&J’s Impella heart pump shows no patient benefit in 2 trials

Medtech Dive — Thu, 02 Apr 2026 09:33:49 -0400

Study investigators cautioned against routine use of the device in complex percutaneous coronary interventions and to treat heart attack patients who don’t have cardiogenic shock.

Pfizer, BioNTech halt US COVID vaccine study after recruitment struggles

Yahoo/Reuters — Thu, 02 Apr 2026 09:32:20 -0400

Vaccine makers Pfizer and BioNTech halted a large U.S. trial of their updated COVID-19 vaccine in healthy adults aged 50 to 64, saying enrollment in the trials had been too low to generate the needed data.

Merck KGaA acquires JSR chromatography business

Pharmaceutical Technology — Thu, 02 Apr 2026 09:30:29 -0400

Germany-based Merck KGaA (Merck) has completed its previously announced acquisition of the chromatography business of JSR Life Sciences.

This follows the company’s signing of a definitive agreement in October 2025 to acquire the business.

AZ claims another win for Imfinzi in frontline liver cancer

Pharmaphorum — Thu, 02 Apr 2026 09:11:50 -0400

AstraZeneca has built the case for Imfinzi in earlier-stage liver cancer with a second phase 3 trial readout in its EMERALD programme.

The new results come from the EMERALD-3 study, testing a combination of PD-L1 inhibitor Imfinzi (durvalumab) with AZ's CTLA4 inhibitor Imjudo (tremelimumab) – as well as Eisai's multikinase inhibitor Lenvima (lenvatinib) – as a first-line treatment for unresectable hepatocellular carcinoma (HCC) patients who are eligible for a procedure known as transarterial chemoembolisation (TACE).

FDA approves Lilly obesity pill, triggering battle with Novo Nordisk

BioPharma Dive — Wed, 01 Apr 2026 21:12:54 -0400

The Food and Drug Administration on Wednesday approved Eli Lilly’s once-daily obesity pill targeting GLP-1, setting off a commercial fight with Novo Nordisk as the two metabolic drug giants seek to grab an increasing share of a market forecast to reach $100 billion a year by 2030.

AstraZeneca reports positive data from Phase III trial of efzimfotase alfa

Clinical Trials Arena — Wed, 01 Apr 2026 21:11:44 -0400

AstraZeneca has reported positive results from the efzimfotase alfa Phase III clinical trial programme for hypophosphatasia (HPP), a rare metabolic bone disorder.

The global programme included two placebo-controlled, randomised trials and one active-controlled, open-label, randomised paediatric switch trial.

Biogen, on the heels of a $5.6B buyout, turns its sights to early-stage assets

BioPharma Dive — Wed, 01 Apr 2026 21:07:10 -0400

In an interview, Chief Financial Officer Robin Kramer said the combined cash flow from Biogen and Apellis will not only help debt leverage ratios but also free up capacity to do other strategic deals.

Gilead cancels midstage HIV trial as FDA’s clinical hold remains intact

Fierce Biotech — Wed, 01 Apr 2026 20:56:31 -0400

After the FDA placed two of its next-gen HIV drugs on clinical hold last June, Gilead Sciences has now terminated one of the affected trials.

After discussions with the FDA, Gilead has “discontinued safety follow-up” for the phase 2/3 Wonders-2 trial, “effectively terminating the study,” a company spokesperson confirmed to Fierce Biotech.

‘There isn't as much meat left to cut’: Biopharma layoffs maintain slowdown in Q1

Fierce Biotech — Wed, 01 Apr 2026 11:54:45 -0400

Have we passed the peak of biotech layoffs? It’s too early to say for certain—but an intriguing story is playing out in the figures.

According to an analysis of Fierce Biotech’s layoff data, a total of 33 biopharma companies were reported to be either laying off employees or shutting down in the first three months of this year. While still high, this number is indicative of a gradual trend of slowing job cuts that Fierce first identified back in September.

Biotech IPOs Rebound as AI Takes a More Central Role in Drug Development

BioSpace — Wed, 01 Apr 2026 11:53:03 -0400

The recent uptick in IPOs is an encouraging signal after a drought for much of 2025. Experts point to AI as a driving force behind this resurgence.
After hitting a historic low in 2025—only eight biotechs went public, as per a BioSpace tally, the lowest in the post-pandemic era—initial public offerings (IPOs) seem to be on the upswing this year. And while the reasons for this resurgence are many, experts pointed to one largely underappreciated driver of this rebound: the rise of AI.

Regulatory tracker: Vertex secures broader FDA labels for cystic fibrosis meds Alyftrek, Trikafta

Fierce Pharma — Wed, 01 Apr 2026 11:50:14 -0400

Vertex is growing the reach of its cystic fibrosis drugs Alyftrek and Trikafta with FDA label expansions covering patients with any responsive variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Belgian court orders Poland, Romania to accept $2.2B of Pfizer COVID shots

Seeking Alpha — Wed, 01 Apr 2026 11:47:08 -0400

A court in Belgium ordered Poland and Romania to accept the delivery of €1.9B ($2.2B) worth of COVID-19 vaccines developed by Pfizer (PFE) and BioNTech (BNTX) in a dispute over a pandemic-era procurement deal.

Novo's Wegovy nets cardio nod from UK cost gatekeeper, adding 1M+ eligible patients

Fierce Pharma — Wed, 01 Apr 2026 11:33:19 -0400

Novo Nordisk’s GLP-1 heavyweight Wegovy could soon reach many more patients in Britain after the United Kingdom’s cost-effectiveness gatekeeper cleared the drug in a use beyond obesity.

Trump’s MFN pricing expected to delay more European drug launches

BioSpace — Wed, 01 Apr 2026 11:10:40 -0400

Following Insmed’s decision to hold off on launching a newly approved lung disease drug in Europe, experts anticipate more companies will do the same as they seek to avoid price erosion in the U.S. Will Chinese biotechs fill the void?

Bayer’s head of AI on how to keep up with AI’s radical revolution

Medical Marketing and Media — Wed, 01 Apr 2026 11:00:15 -0400

Bayer VP and head of AI Brian Cantwell headlined Transform with a keynote about how to drive AI transformation in pharma marketing in a way that actually provides value.

Telomir seeks FDA approval for Telomir-1 to treat breast cancer

Pharmaceutical Technology — Wed, 01 Apr 2026 10:58:54 -0400

Telomir Pharmaceuticals has submitted an investigational new drug application to the US Food and Drug Administration for Telomir-1 (Telomir-Zn), its lead candidate targeting advanced and metastatic triple-negative breast cancer (TNBC).

FDA flags serious liver injury cases, 8 deaths with ‘reasonable’ link to Amgen's Tavneos

Fierce Pharma — Wed, 01 Apr 2026 10:53:10 -0400

Amgen’s rare disease drug Tavneos is under mounting regulatory scrutiny, with the FDA warning of serious liver injuries, including some fatalities, among patients who received the drug.

Whoop raises $575M, adds Abbott as strategic investor

Medtech Dive — Wed, 01 Apr 2026 10:50:12 -0400

Whoop, the wearable company that sparked a debate on wellness regulations, has raised $575 million.
The series G round values Whoop at $10.1 billion, the company said on Tuesday. Abbott joined as a strategic investor.

Agios mulls early FDA filing for sickle cell therapy

Pharmaphorum — Wed, 01 Apr 2026 10:45:34 -0400

Agios is planning to file its sickle cell disease (SCD) candidate mitapivat with the FDA under the accelerated pathway, based on feedback from the US regulator at a recent meeting.

Will Pfizer’s Lyme disease gamble pay off or set the space back?

Pharma Voice — Wed, 01 Apr 2026 10:43:06 -0400

After GSK’s Lymerix, the only Lyme disease vaccine ever approved, was pulled from the market in 2002 amid a safety controversy, the field went dark and then stalled for more than two decades.

Now, Pfizer and Valneva are advancing a new candidate to prevent the tick-borne illness. But will mixed trial data lead to a win or set the market back once again?

Lilly pays $6.3B upfront for sleep disorder-focused Centessa in latest neuroscience play

Fierce Biotech — Tue, 31 Mar 2026 11:38:55 -0400

Eli Lilly has gone big in the name of neuroscience, paying $6.3 billion in a front-loaded deal for Centessa Pharmaceuticals and its sleep disorder pipeline.

In recent years, U.K.-based Centessa has been focused on a portfolio of orexin receptor 2 (OX2R) agonists, which the biotech has been targeting at conditions related to the sleep-wake cycle. Centessa’s lead program is cleminorexton, formerly known as ORX750, which is undergoing a phase 2 study for two types of narcolepsy as well as idiopathic hypersomnia (IH).

Biogen secures ‘running start’ in kidney disease with $5.6b Apellis buy

BioSpace — Tue, 31 Mar 2026 11:36:25 -0400

In addition to delivering two approved medicines to Biogen’s portfolio, the acquisition of Apellis Pharmaceuticals will support the future launch of the pharma’s own kidney disease asset, currently in multiple Phase 3 trials.

Medtronic to study renal denervation combined with PCI

Medtech Dive — Tue, 31 Mar 2026 11:33:50 -0400

Medtronic detailed plans to further study the blood pressure treatment while releasing additional data from the SPYRAL HTN trials that showed the procedure reduced hypertensive emergencies.

Sanofi eczema drug weighed down by mixed results, safety concerns

BioPharma Dive — Tue, 31 Mar 2026 11:32:27 -0400

Despite hitting key goals across three late-stage studies, the drug, which targets the “OX40” ligand, raises safety and efficacy questions that had at least one analyst lower his sales forecast.