Fierce Pharma

Lundbeck continues neuroscience evolution as CEO keeps company ‘punching above its weight’

Aug 21, 2026 11:02am

Almost three years into his tenure as Lundbeck’s CEO, Charl van Zyl is confident the company can prove its mettle as a “neuroscience challenger” capable of “punching above its weight.”

The Oral GLP-1 Tracker: Novo's Wegovy pill back on track as Lilly's momentum slows

Apr 21, 2026 10:06am

Fierce Pharma is launching the weekly Oral GLP-1 Tracker, leveraging analysts’ notes and IQVIA data to monitor prescription trends and shifting market shares as Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo vie to become the go-to oral weight-loss solution for millions.

Regulatory tracker: J&J scores EU approval for Tecvayli-Darzalex combo

Jul 1, 2026 1:33pm

In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

 What did we learn from Big Pharma’s Q2 results?

Aug 18, 2026 12:34pm

Fierce editors break down Big Pharma’s second-quarter results, from AI and new leadership to the oral GLP-1 race and potential new blockbusters.

Fierce Pharma Asia—China's IIT scrutiny; Daiichi Sankyo, AZ ph. 3 win; Leo, Tanabe's dermatology deal

Aug 20, 2026 2:11pm

China's investigator-initiated trials, once praised for their speediness, have been drawn into scrutiny for a lack of transparency. AstraZeneca and Daiichi Sankyo's Enhertu earned a win in a phase 3 non-small cell lung cancer trial. Tanabe Pharma secured a $435 million payout for global rights to its dermatology rare disease treatment dersimelagon.

Regeneron podcast turns science learnings into immersive experience

Aug 20, 2026 7:37pm

Regeneron's "Science Illuminated" podcast series transforms scientific topics into a calming, meditative-style video and audio experience.

Roche earmarks $750M to double the size of its Oregon manufacturing facility

Aug 20, 2026 2:31pm

Roche will invest $750 million to double the size of its Genentech unit's manufacturing facility in Hillsboro, Oregon. The new outlay will support the construction of a fill-finish plant that will produce drug-delivery devices, such as prefilled syringes and auto-injectors. The funding will also bring 250 new, high-wage jobs online, Roche said.

Xspray's Dasynoc approval bid foiled again by FDA's manufacturer concerns

Aug 20, 2026 2:27pm

Less than a year after the FDA turned down the resubmitted application for the company’s leukemia prospect Dasynoc, Xspray Pharma has again hit a wall at the U.S. regulator.

Aurinia settles with Teva, helping stave off potential Lupkynis generic until late 2036

Aug 20, 2026 10:53am

Aurinia Pharmaceuticals has struck a patent infringement settlement with Teva Pharmaceuticals, which should help stave off Teva's proposed generic for its lupus drug, Lupkynis (voclosporin), in the United States until December of 2036. With the deal, Aurinia's share price increased by 7%.

B. Braun recalls IV solution from US, Canada hospitals on particle contamination concerns

Aug 20, 2026 10:45am

B. Braun Medical—a maker of IV solutions for hospitals, among other products—has initiated a recall in the United States and Canada spurred by particulate contamination.

Lilly’s long-acting insulin wins NICE blessing ahead of potential UK approval

Aug 19, 2026 3:17pm

Hundreds of thousands of patients with type 2 diabetes could eventually make the switch to a weekly insulin injection and reduce their annual injections by 85% after NICE, the U.K.’s drug cost watchdog, gave Lilly's Onswik its seal of approval for NHS coverage.

Pursuing patient options, Novo kicks off trial testing smaller doses of Wegovy pill

Aug 19, 2026 3:04pm

Just eight months after it introduced its Wegovy pill, Novo Nordisk is testing the GLP-1 in smaller doses in the phase 3 OASIS 5 study.

Lucid Group names leading Publicis Health exec as new CEO

Aug 20, 2026 5:44am

Healthcare comms and commercialization agency Lucid Group has hired Eric Muller as its new chief executive officer.

Boehringer Ingelheim again rises up rare disease reputation rankings

Aug 20, 2026 4:29am

Boehringer Ingelheim has continued its rise up patient groups’ ranking of rare disease companies, adding to last year’s gains to cement its status toward the top of the leaderboards. But the German drugmaker failed to crack the top three of the full table, which the same three companies occupied again.

Ultragenyx, after FDA speed bump, lands 1st gene therapy nod with green light in glycogen storage disease

Aug 19, 2026 10:36pm

If at first you don’t succeed in gene therapy, then try, try again, is the lesson Ultragenyx likely took home this week, pocketing its first FDA nod in the class a little over a year after a separate program stalled on manufacturing grounds.

Regeneron's Pasatru scores FDA approval in ultra-rare bone lesions disorder

Aug 18, 2026 10:14am

Regeneron's Pasatru has crossed the finish line with FDA approval after more than ten years of development. The drug is only the second approved treatment for FOP, an ultra-rare genetic condition that causes patients' soft tissues to turn to bone.

SK strikes settlement with MSN over future Xcopri generic: reports

Aug 19, 2026 11:06am

For the first time, SK Biopharmaceuticals has reached a settlement with a generics manufacturer that has applied for FDA approval of a copycat version of its epilepsy treatment Xcopri, local news outlets report. SK’s deal with India’s MSN Laboratories will allow the Korean company to extend its market exclusivity beyond October 2032, when the protection for its composition-of-matter patent is set to expire.

Contractor SK Pharmteco heralds completion of 2 API plants in Ireland

Aug 19, 2026 10:47am

The summer of the high-potency active pharmaceutical ingredient expansion continues, as yet another manufacturing specialist makes inroads to boost capacity for sensitive, in-demand drug ingredients.

Aurobindo unit, China API maker dinged in latest round of FDA warning letters

Aug 19, 2026 10:03am

After receiving a checkered regulatory scorecard in 2024, Aurobindo’s sterile injectables and oncology unit is back in the FDA’s crosshairs.

Trump taps White House aide Heidi Overton as nominee for next FDA commissioner

Aug 19, 2026 10:21am

After three months without a permanent leader in place, President Donald Trump has named his pick for the new commissioner of the FDA. Heidi Overton, M.D., Ph.D., currently a White House aide, will go before the Senate in an effort to secure the job of the country’s top drug regulator.

Genetix kicks off sickle cell disease awareness campaign with NFL Alumni Association

Aug 19, 2026 3:45am

Genetix Biotherapeutics is teaming up with the NFL Alumni Association for a U.S. awareness and education drive centered on sickle cell disease.

Teva scores rare partial win in CMS price negotiation appeal

Aug 18, 2026 5:09pm

In challenging IRA price negotiations, Teva Pharmaceuticals has gained a partial win as the U.S. Court of Appeals for Washington, D.C., sent a previous ruling back to a lower court for further review. The challenge surrounds the way the CMS determines “bona fide marketing” for a generic or biosimilar drug.

Revance hires Janelle Wichmann as chief marketing officer of skincare unit

Aug 18, 2026 10:48am

Revance has appointed Ulta Beauty and Procter & Gamble alum Janelle Wichmann as its new chief marketing officer for skincare as it looks to boost commercial penetration of its Botox rival, Daxxify.

CSL shares up 17% as immunoglobulin boost points to signs of recovery

Aug 18, 2026 11:00am

After a year of impairments, revenue downgrades and the ousting of its chief executive officer, Australian plasma and vaccine specialist CSL has flashed signs of recovery, projecting mid-single-digit growth in fiscal year 2027 for its largest sector, CSL Behring.

Biokin bispecific ADC iza-bren hits goal in lung cancer trial, boosting case for BMS’ global test

Aug 18, 2026 11:06am

Biokin Pharma’s iza-bren, a first-in-class antibody-drug conjugate partnered with Bristol Myers Squibb, has posted another positive phase 3 readout.