Latest Headlines from Cafepharma

Eli Lilly is pushing its next-generation weight loss drug approval filing to early 2027

Quartz — Thu, 23 Jul 2026 12:24:31 -0400

Eli Lilly said Thursday it plans to file for regulatory approval of its next-generation weight loss drug retatrutide in the first quarter of 2027, pushing back a timeline the company had previously indicated could come before the end of this year.

BeOne jumps aboard onshoring train with $300M to add small molecule production in US

Fierce Pharma — Thu, 23 Jul 2026 12:21:44 -0400

As the recent reshoring zeal rolls on in the United States, BeOne Medicines is beefing up its flagship manufacturing and R&D campus in New Jersey to the tune of $300 million.

The outlay at the site at the Princeton West Innovation Campus in Hopewell helps lift the company’s total U.S. production commitment to more than $1 billion and comes as the persistent threat of import tariffs and drug pricing reform by the Trump administration has sparked a wave of similar pharma investments since 2025.

Time runs out for Vicarious Surgical

Medtech Dive — Thu, 23 Jul 2026 12:03:18 -0400

Shareholders approved a plan to dissolve the robot developer, at one time a well-financed contender to challenge surgical robotics leader Intuitive, and liquidate its assets.

J&J’s bispecific combo slashes myeloma progression risk by 89% in phase 3 trial

Fierce Pharma — Thu, 23 Jul 2026 11:59:26 -0400

Johnson & Johnson has unveiled massive phase 3 survival data for its dual bispecific combination in earlier-line multiple myeloma, delivering another catalyst that could add a new twist in the commercial trajectories of off-the-shelf T-cell engagers versus personalized CAR-T therapies.

Biopharma layoffs must double in H2 for 2026 to match 2025 cuts

BioSpace — Thu, 23 Jul 2026 11:52:57 -0400

With fewer biopharmas making or planning workforce reductions so far year over year, layoff round size and M&A impact on headcounts will likely shape the number of employees who are ultimately on the chopping block.

Takeda gets first OK for orexin narcolepsy drug, in China

Pharmaphorum — Thu, 23 Jul 2026 11:50:54 -0400

China has become the first country to approve Takeda's first-in-class orexin agonist, oveporexton, for the sleep disorder narcolepsy.

Dexcom is first to join FDA/CMS health tech pilot

Pharmaphorum — Thu, 23 Jul 2026 11:48:37 -0400

The FDA has named Dexcom as the first medical device manufacturer that will take part in a pilot programme that could make it easier to bring digital health technologies (DHTs) for chronic diseases to patients more quickly.

Quest Diagnostics (DGX) Surpasses Q2 Earnings and Revenue Estimates

Yahoo/Zacks.com — Thu, 23 Jul 2026 11:33:55 -0400

Quest Diagnostics (DGX) came out with quarterly earnings of $3.12 per share, beating the Zacks Consensus Estimate of $2.81 per share. This compares to earnings of $2.62 per share a year ago. These figures are adjusted for non-recurring items.

Roche confirms outlook despite Vabysmo miss, currency headwinds

Euronext Markets/Reuters — Thu, 23 Jul 2026 11:30:11 -0400

Swiss drugmaker Roche confirmed its 2026 outlook on Thursday after first-half sales fell slightly in Swiss franc terms, dragged down by a stronger domestic currency and weaker-than-expected U.S. sales of its blockbuster eye drug Vabysmo.

What’s in the FDA’s latest batch of rejection letters

Pharma Voice — Thu, 23 Jul 2026 11:22:54 -0400

After a three-month pause, the FDA is once again issuing complete response letters, despite lingering questions about whether the letters are even legal to release.

The FDA’s reasons for rejecting a drug are typically communicated to the public through pharma companies. But the FDA began publishing troves of CRLs last year as part of its push for “radical transparency.”

Pfizer's prostate cancer drug combination gets US FDA priority review

Yahoo/Reuters — Wed, 22 Jul 2026 19:34:02 -0400

Pfizer said on Wednesday the U.S. Food ‌and Drug Administration has ‌granted priority review to its application seeking expanded approval for its prostate cancer treatment combination.

GSK lung cancer drug gets speedy approval following $10.6B deal

BioPharma Dive — Wed, 22 Jul 2026 19:28:31 -0400

GSK could quickly begin making money on a drug it just acquired in one of the year’s biggest biopharmaceutical acquisitions.

The British drugmaker on Wednesday won approval from U.S. regulators to begin selling a therapy known as Jideytro.

Vertex was sole bidder in high-premium Crinetics acquisition

BioPharma Dive — Wed, 22 Jul 2026 19:16:25 -0400

Vertex Pharmaceuticals was the lone bidder in a planned, $10 billion acquisition that has some investors questioning whether the biotechnology giant overpaid on its largest-ever deal.

Financial documents filed Tuesday provide an inside look at the tie-up between Vertex and Crinetics Pharmaceuticals, a California-based company specializing in endocrine drugs.

Trump floats countdown to 200% tariffs on generic drugs imported to US

Fierce Pharma — Wed, 22 Jul 2026 12:03:01 -0400

In an act of policy-by-way-of-social-media-post, President Donald Trump declared on Truth Social last night that, although all generic drugs imported into the U.S. will continue to be tariff-free for the time being, the rate will be raised to 100% for a “one year period of time” starting in August of 2028, after which it will be raised to “200% thereafter.”

Sanofi reprimanded for disparaging Pfizer’s RSV vaccine

Fierce Pharma — Wed, 22 Jul 2026 11:58:30 -0400

A U.K. marketing watchdog has reprimanded Sanofi for using “a highly misleading interpretation of data” to make disparaging claims about Pfizer’s respiratory syncytial virus (RSV) vaccine.

Novartis scraps mid-stage radiopharma asset as Pluvicto soars

BioSpace — Wed, 22 Jul 2026 11:41:51 -0400

The discontinued asset, being trialed for breast cancer and solid tumors, had yielded disappointing data, leading to Novartis’ decision to abandon development, according to a company spokesperson.

US dominates Alzheimer’s disease studies

Clinical Trials Arena — Wed, 22 Jul 2026 11:38:44 -0400

GlobalData’s Clinical Trials Database shows Alzheimer’s disease pipeline activity
concentrated in early-phase trials, with Phase I and II together making up over
three-quarters of studies. The US leads global research at 32.7% of activity,
followed by China, the UK, Japan, and Canada. Late-stage attrition remains the
field’s persistent challenge.

Summit Therapeutics updates ivonescimab survival data ahead of FDA decision date

Fierce Pharma — Wed, 22 Jul 2026 11:30:40 -0400

Aiming to bolster ivonescimab’s case ahead of a key FDA decision, Summit Therapeutics has provided updated overall survival data from the phase 3 HARMONi trial for its PD-1xVEGF bispecific antibody.

Wainua flop narrows AstraZeneca’s path to $80B goal ahead of high-risk readouts

BioSpace — Wed, 22 Jul 2026 11:28:58 -0400

With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.

Arrowhead puts pressure on Ionis with positive data for triglyceride lowering drug

BioSpace — Wed, 22 Jul 2026 11:23:49 -0400

With Phase 3 data showing what analysts called a “potentially best-in-class profile,” Arrowhead Pharmaceuticals plans to submit for FDA approval of plozasiran by the end of the year—hoping to follow to market Ionis Pharmaceuticals’ Tryngolza, which got the regulator’s nod in severe hypertriglyceridemia last month.

Generic drugmaker Sandoz to engage with US after Trump tariff threat

Euronext — Wed, 22 Jul 2026 11:21:11 -0400

Swiss generic drugmaker Sandoz said on Wednesday it would continue discussions with policymakers after U.S. President Donald Trump threatened the industry with steep tariffs unless drugmakers manufacture medicines domestically.

Why the FDA’s top spot could sit empty for months

Pharma Voice — Wed, 22 Jul 2026 11:18:22 -0400

Multiple factors could get in the way of confirming a new commissioner until after the midterm elections, experts said, leaving the agency’s long-term initiatives in limbo.

Johnson & Johnson wins FDA nod for Ottava surgical robot

Mass Device — Wed, 22 Jul 2026 11:12:45 -0400

Johnson & Johnson (NYSE:JNJ) announced today that it received FDA de novo authorization for its Ottava surgical robot system.

Authorization covers multiple procedures across general surgery, including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, gastric sleeve, small bowel resection, appendectomy, lysis of adhesions, fundoplication, and hiatal hernia repair.

CVS is now filling pet prescriptions at its 9,000 pharmacies nationwide

Quartz — Wed, 22 Jul 2026 11:07:52 -0400

Repligen builds in cell therapy with $1.5bn BioLife takeover

Pharmaphorum — Wed, 22 Jul 2026 11:06:14 -0400

Life sciences equipment and consumable manufacturer Repligen has reached a deal to buy cell therapy specialist BioLife Solutions for approximately $1.5 billion.

Sanofi continues tweaks to executive roster as new CEO Garijo settles in

Fierce Pharma — Tue, 21 Jul 2026 23:18:04 -0400

With former Merck KGaA CEO Belén Garijo, M.D., Ph.D., now calling the shots at Sanofi, the French drugmaker continues to refine its executive roster, albeit with fewer high-profile C-suite departures now than earlier in the year.

Trump plans steep tariffs on generic drugs starting in 2028 to spur U.S. production

CNBC — Tue, 21 Jul 2026 23:15:51 -0400

Trump said generic drugs imported into the U.S. will face zero tariffs for two years from August 1, before a 100% levy takes effect in August 2028 and rises to 200% a year later.
The phased schedule is intended to push generic drugmakers to move production onshore, he said.

Novo Nordisk sues Eli Lilly, alleging misleading GLP-1 advertising

CNBC — Tue, 21 Jul 2026 11:58:15 -0400

Novo Nordisk filed a lawsuit against Eli Lilly, alleging that its advertising campaigns for its blockbuster obesity and diabetes drugs are designed to mislead consumers about their superior efficacy relative to the Danish drugmaker’s rival injections.
Novo Nordisk is specifically taking issue with nationwide ads that cite what it called “outdated” clinical trials to compare the highest doses of Lilly’s medicines to lower doses of Novo’s drugs.

Novartis stays ‘geography-agnostic’ in dealmaking amid flurry of China deals

BioSpace — Tue, 21 Jul 2026 11:56:39 -0400

Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma’s second quarter earnings call—though major pickups aren’t completely off the table.

Amgen settles shareholder lawsuit claiming it hid $10.7 billion tax bill

AOL/Reuters — Tue, 21 Jul 2026 11:45:21 -0400

Amgen reached a $74 million settlement of a lawsuit accusing the biotechnology company of waiting too long to disclose that it might owe the Internal Revenue Service $10.7 billion for underreporting six years of taxes.