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Recon: Sino, Boehringer ink cancer drug deal worth $7B; CVS to split pharmacy business from insurance
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
raps · 5d ago↗ source
CVS Health to split into two publicly traded companies amid regulatory scrutiny of its pharmacy‑insurer integration
CVS Health announced it will separate into two independent, publicly traded companies. The move undoes years of acquisitions that combined a pharmacy chain, a pharmacy‑benefit manager and an insura…
STAT · 5d agoNeutral↗ source
Big pharma Q3 earnings roll out as FDA launches rare-disease initiative and uniQure's Huntington's gene therapy enters review

page 5 of 121

111

fda medwatch109

globenewswire health73

1777

Psychiatry & CNS1197

Ophthalmology1035

Endocrinology & Metabolism774

Over the past week, a dozen major pharmaceutical companies reported third‑quarter results, including AstraZeneca, Biogen, GSK, Bristol Myers Squibb, Merck, Sanofi, AbbVie and Regeneron. Pfizer pos…

BioSpace · 5d agoEarningsNeutral↗ source

Bernie Sanders poised to steer FDA user fee renewal, could push for reforms

Democrats' midterm victory may shape the upcoming negotiations on the Prescription Drug User Fee Act, which funds the FDA's review of medicines. Senator Bernie Sanders, a longtime critic of the us…

STAT · 5d agoRegulatoryNeutral↗ source

Democratic doctors and scientists win key Senate and gubernatorial races, boosting health policy influence

Democratic candidates with medical and scientific backgrounds secured several high‑profile victories in the recent midterm elections, contributing to the party’s regain of congressional control. A…

STAT · 5d agoPositive↗ source

Democratic doctors gain ground as MAHA movement falters and Medicare for All resurfaces after midterms

Democrats reclaimed control of both the Senate and the House in Tuesday night’s midterm results, adding four governorships and strengthening their capacity to challenge President Trump’s health‑car…

STAT · 5d agoRegulatoryNeutral↗ source

Ultragenyx to lay off roughly 20% of staff as it halts two rare disease drug programs

Ultragenyx announced it will cut about 20% of its workforce as it ends development of two rare disease drug candidates. The move follows a recent clinical study that failed to meet its primary end…

STAT · 5d agoLayoffsNegative↗ source

CVS Health to split into two separate companies, separating insurance and pharmacy operations

CVS Health announced that it will divide the business into two independent companies. One entity will house its insurance arm Aetna together with pharmacy‑benefit manager Caremark, while the other…

STAT · 5d agoDealNeutral↗ source

Former Madrigal exec sues, alleging retaliation after flagging safety concerns on approved MASH drug

A former senior vice president of clinical development at Madrigal Pharmaceuticals, Michael Charlton, has filed a federal lawsuit claiming he was forced to resign after raising internal safety conc…

STAT · 5d agoNegative↗ source

Novo claims 80% share of oral GLP-1 market as rivalry with Lilly intensifies

Novo's CEO Mike Maziar Doustdar said the company leads the oral GLP-1 market, stating the Wegovy pill holds about 80% of prescriptions since its launch in January. Eli Lilly, however, reported tha…

BioSpace · 5d agoEarningsNeutral↗ source

Democrats win Congress and doctors secure key seats, shifting health policy direction

The recent midterm elections gave Democrats control of both the House and the Senate. Voters also elected a number of doctors and scientists to key congressional positions. These outcomes signal a…

STAT · 5d agoRegulatoryPositive↗ source

Pfizer targets Europe first for upcoming Lyme disease vaccine amid rising US cases

Pfizer is planning to launch its Lyme disease vaccine in Europe first, leveraging its existing tick-borne encephalitis franchise in the region. The vaccine, developed with French partner Valneva,…

BioSpace · 5d agoRegulatoryPositive↗ source

China targets five $1 billion blockbuster drugs by 2030, two already achieved

China's latest five-year plan aims to develop five domestically created drugs that each generate over $1 billion in global sales by 2030. According to industry analysts, two drugs have already sur…

BioSpace · 6d agoPositive↗ source

Democrats Gain Senate Control, Poised to Reverse Trump Health Care Policies

Democrats secured a Senate majority with at least 51 seats after Tuesday's election, ending the Republican trifecta of power. The new majority equips Democrats with oversight tools and the ability…

STAT · 6d agoRegulatoryNeutral↗ source

FDA urges biosimilar sponsors to use alternative efficacy studies while AI reshapes regulatory work

AI is becoming common in regulatory work. Experts say it will not replace regulatory professionals but will help them work more efficiently and free up time for human interaction. They stress that…

raps · 6d agoRegulatoryNeutral↗ source

Boehringer bets big on China, offering $7B biobucks for Sino cancer programs

Boehringer Ingelheim is building up its China strategy, inking a deal to develop new cancer treatments with Sino Biopharmaceutical just weeks after opening an R&D facility in Shanghai.

BioSpace · 5d agoDealNeutral↗ source

Amgen launches autoinjector study for GLP-1 candidate MariTide as Phase 3 readouts loom

Amgen has begun a study of an autoinjector formulation of its GLP-1 drug candidate MariTide, as the company prepares for pivotal Phase 3 data expected next year. The candidate is marketed as havin…

BioSpace · 5d agoNeutral↗ source

Congress faces Dec. 11 deadline to fund government, shaping lame-duck session and health-care agenda

Democrats have taken control of both the House and Senate, but Republicans will remain in power until the new Congress convenes in January. Lawmakers must pass a funding bill by Dec. 11 to avoid a…

STAT · 5d agoRegulatoryNeutral↗ source

Democrats Wyden and Sanders poised to lead Finance and Health committees after Senate flip

The Senate’s recent shift to Democratic control is set to place Sen. Ron Wyden of Oregon at the helm of the Finance Committee and Sen. Bernie Sanders of Vermont as the presumptive chair of the Heal…

STAT · 5d agoRegulatoryNeutral↗ source

Novo and Pfizer say MFN pricing agreements remain unchanged despite Democratic gains in Congress

On their third‑quarter earnings calls, the CEOs of Novo Nordisk and Pfizer said the Most Favored Nation drug‑pricing contracts they signed under the previous administration are still in effect and…

BioSpace · 5d agoRegulatoryNeutral↗ source

FDA urges biosimilar makers to adopt alternatives to clinical efficacy trials

FDA's Office of Therapeutic Biologics and Biosimilars, led by director Sarah Yim, announced that the agency is working to help sponsors rely less on clinical efficacy studies when developing biosim…

raps · 6d agoRegulatoryPositive↗ source

Sanofi drops Nurix STAT6 degrader program amid molecule-specific concerns

Sanofi has halted development of an early‑stage STAT6 degrader program that it licensed from Nurix Therapeutics. The decision was announced after the asset entered Phase 1 trials for type 2 inflamm…

BioSpace · 5d agoNeutral↗ source

BioSpace launches dashboard to track performance of U.S. biotech IPOs in 2026

BioSpace introduced a new IPO dashboard that monitors U.S. biotech companies that went public in 2026. The tool will be refreshed weekly with the latest closing prices and will add any newly liste…

BioSpace · 5d agoNeutral↗ source

Flagship partner Louisa Helms credits high-school librarian for sparking biotech career

Louisa Helms, a BioSpace 40 Under 40 honoree and partner at Flagship Pioneering, reflects on a unique path into biotech. In high school she was mentored by librarian Tammy Carabello, who turned th…

BioSpace · 6d agoPositive↗ source

Biotech startups opt out of AI for drug discovery, say STAT

The latest STAT AI Prognosis newsletter notes that a number of biotech startups are deliberately avoiding artificial intelligence in their drug discovery programs. These companies argue that AI ma…

STAT · 5d agoNeutral↗ source