Fierce Pharma

FTC orders Aurobindo to divest 4 drugs to complete $250M Lannett acquisition

Jun 18, 2026 3:11pm

Before Aurobindo can complete its acquisition of Pennsylvania generics specialist Lannet, it will have to divest four drugs from the proposed $250 million buyout to resolve anticompetitive concerns, the Federal Trade Commission said.

Regulatory tracker: FDA accepts Roche's application for Lunsumio-Polivy combo

Jan 2, 2026 8:07am

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.

Pfizer hunts for new CFO as Denton prepares to hang up gloves, wave goodbye to pharma

Jun 18, 2026 10:58am

Pfizer's CFO Dave Denton will officially depart in August, leaving SVP of finance Cecile Guegan to take up his post in the interim.

Novo's success with oral Wegovy has been fueled by 'familiarity': Spherix

Jun 18, 2026 8:47am

Name recognition and "familiarity" with Novo Nordisk's oral Wegovy has contributed to its rapid uptake in its battle with Lilly's oral GLP-1 Foundayo, according to Spherix analyst Jim Hickey, who conducts monthly surveys with doctors who prescribe the treatments.

Eli Lilly cuts 340B discounts for hospitals resisting its claims data submission policy

Jun 2, 2026 11:42am

The drugmaker had issued a June 8 ultimatum to an unspecified number of hospitals that weren't following a data submission policy it implemented in February. Furious hospital industry groups describe the decision as unlawful and urge the administration to intervene.

Amid industry’s cell therapy automation push, Cellares and Ori dominate the field: report

Jun 18, 2026 9:52am

With interest in automated cell therapy production beginning to build from about 2016 onward, some 23 companies working in the field have now raised a collective $1.1 billion across 34 rounds through April 24, data intelligence platform Tracxn said in a new report.

Nortiva purrs into action with long-acting Lynx platform salvaged from Langer startup

Jun 17, 2026 10:04am

Innoviva has revealed the next steps for Langer Lab assets it rescued from Lyndra Therapeutics’ collapse, launching Nortiva Bio to develop long-acting oral medicines and pursue drug development alliances.

4 years after snub, GSK partnership helps Spero get Utebzi across FDA finish line

Jun 17, 2026 2:55pm

Four years after Spero Therapeutics received a complete response letter from the FDA, rejecting its oral treatment for complicated urinary tract infections, the company and its partner GSK have pushed Utebzi across the finish line.

Despite 'decent' data, Verastem rethinks options for approved oncology combo in pancreatic cancer

Jun 17, 2026 2:46pm

With good-but-not-great updated data on its approved oncology combo of avutometinib plus defactinib in first-line metastatic pancreatic cancer, Verastem Oncology will now channel its primary R&D efforts toward other pipeline darlings.

GSK runs first DTC ad for would-be asthma blockbuster Exdensur

Jun 17, 2026 10:56am

GSK has launched the first direct-to-consumer TV spot for Exdensur, stepping up promotion of an asthma drug that the company is tipping to generate blockbuster sales.

Novo security breach claimed by hacking groups seeking multi-million-dollar ransoms: reports

Jun 17, 2026 10:49am

Two different hacking rings acquired sensitive information from Novo and allegedly attempted to extort the company out of millions of dollars.

Novo Nordisk opens Czech plant and unveils $29M upgrade to China facility

Jun 17, 2026 11:08am

Eighteen months after Novo Nordisk purchased a plant in the Czech Republic from Novavax, the Danish drugmaker said it is set to kick off the manufacturing of ingredients for next-generation diabetes and obesity drugs at the facility. The company also announced locally that it will invest $29 million in its plant in China.

After FDA sign-off, Colorado's drug import plan faces tough road ahead

Jun 17, 2026 10:14am

Amid multiple efforts to rein in steep drug costs in the U.S., Colorado has received the all-clear to take matters into its own hands, albeit through a framework that may be difficult to pull off in the real world.

'Biopharma ecosystem is back to full health,' fueled by M&A: PwC

Jun 16, 2026 3:02pm

With pharma and life sciences deal values surpassing $65 billion in the first quarter, marking the strongest quarter in the industry since 2020, analysts from PwC have declared that the “biopharma ecosystem is back to full health.”

FDA, UK drug regulator deepen transatlantic ties with new liaison program

Jun 16, 2026 11:22am

The program looks to support "faster, more coordinated approaches to emerging regulatory challenges and decisions," the United Kingdom's MHRA said.

Moderna hires Novartis vet to lead commercial, upsizes role for Hoge as potential launches loom

Jun 16, 2026 10:02am

As it prepares to launch up to three new products from 2027 through 2028, Moderna is adjusting its way of doing business. The company has hired Ester Banque to become its CCO and has elevated president Stephen Hoge, M.D., to now oversee each of the company’s three divisions: commercial, manufacturing and R&D.

Recipharm channels ‘multi-million-dollar' US manufacturing upgrade, targeting domestic biologics demand

Jun 16, 2026 7:51am

Recipharm has sketched out a “multi-million-dollar” investment in its U.S. manufacturing operations as part of a move to boost its sterile fill-finish capabilities and other production offerings for customers.

Stealth BioTherapeutics removes cloak to become Mighty

Jun 16, 2026 8:19am

Stealth BioTherapeutics is looking to put its tumultuous path behind it with a new name.

PhRMA talks up the power of ‘Medicines First’ in new campaign

Jun 16, 2026 2:42am

U.S. pharmaceutical lobby group PhRMA has launched a new ad offensive that looks to highlight the American life sciences industry’s ability to get new drugs to patients.

DeepIntent gives Helix an AI twist to help marketers query data

Jun 16, 2026 5:28am

DeepIntent has launched an agentic AI tool to help healthcare marketers more efficiently extract insights from databases using natural language.

Germany backs off plan to install variable discount pricing on drugs: report

Jun 15, 2026 3:01pm

Following criticism from drugmakers, Germany has scrapped its plan to install a program that would have reduced the prices of branded pharmaceuticals through a variable structure, according to a report from Reuters.

How lab data powers precision commercialization to drive therapy adoption

Jun 10, 2026 12:29pm

Drug commercialization depends on reaching the right physicians at the right moment.

Merck's Welireg-Keytruda pairing sticks the landing in adjuvant kidney cancer treatment with new FDA nod

Jun 15, 2026 11:03am

The FDA approval clears Welireg's use with Keytruda in earlier-stage kidney cancer, following its 2023 solo nod for advanced disease.

IQVIA taps AI to put overlooked prescribers on marketers’ maps

Jun 15, 2026 11:45am

IQVIA Digital has developed technology to help pharma marketers identify nurse practitioners and physician associates who write prescriptions.

Sanofi, once on FDA course for speedy approval, gains late expansion for Tzield

Jun 15, 2026 10:49am

Sanofi has gained an FDA expansion for its Type 1 diabetes treatment Tzield. The decision came nearly two months after an original target date under former FDA chief Marty Makary’s controversial Commissioner’s National Priority Voucher (CNPV) program.