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Fonte

biopharmadive.com

38articoli totali nell'archivio

biopharmadive.com
healthscience

FDA hold puts Aardvark Prader-Willi drug in limbo

The company plans to unblind the late-stage study that was halted due to safety concerns, which could lead to an overhaul of its…

biopharmadive.com·21 h fa
biopharmadive.com
health

Supreme Court preserves access to abortion pill by mail

The ruling maintains access to the drug while litigation continues. Mifepristone can still be prescribed at pharmacies or by mail…

biopharmadive.com·22 h fa
biopharmadive.com
health

Biotech leaders campaign for Pazdur; Takeda to lay off 4,500 workers

Hundreds of executives and investors are pushing for Rick Pazdur to be the next FDA commissioner. Elsewhere, Takeda detailed its…

biopharmadive.com·22 h fa
biopharmadive.com
Businesspoliticsworld

India’s pharma industry is going global. But can it catch up to China?

A record Sun Pharma acquisition signals global ambitions. But infrastructure, capital and policy gaps could stand in the way of…

biopharmadive.com·1 g fa
biopharmadive.com
health

Create Medicines raises $122M to bolster in vivo CAR-T therapies

The fresh funds will support the biotech's pipeline of RNA-based CAR-T cell therapies for cancer and autoimmune conditions.

biopharmadive.com·1 g fa
biopharmadive.com
healthscience

Biogen pushing tau drug forward despite Alzheimer’s study failure

One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of…

biopharmadive.com·1 g fa
biopharmadive.com
healthscience

With new data, Regenxbio to seek FDA approval of Duchenne gene therapy

Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA…

biopharmadive.com·2 g fa
biopharmadive.com

FDA’s leadership void leaves biotech with renewed ‘uncertainty’

Marty Makary's resignation leaves the agency with temporary directors in three top positions, and a number of newly instituted…

biopharmadive.com·2 g fa
biopharmadive.com
health

Lilly data point to ‘maintenance’ strategies for GLP-1 weight loss

A pair of trial results published in medical journals suggest switching from high-dose injectables to lower doses or pills could…

biopharmadive.com·2 g fa
biopharmadive.com
AIBusiness

Assertio accepts new buyout bid; AI biotech Isomorphic banks $2B

Assertio’s latest offer represents a roughly 31% premium over an initial acquisition proposal. Elsewhere, Kyverna is readying a…

biopharmadive.com·2 g fa
biopharmadive.com

FDA chief Marty Makary resigns from agency, ending tumultuous tenure

Makary’s exit ends a turbulent run marred by leadership upheaval, mass layoffs, political pressure and public spats with…

biopharmadive.com·3 g fa
biopharmadive.com
health

Arvinas, Pfizer find new partner for ‘Protac’ breast cancer drug

A deal with Rigel Pharmaceuticals ends months of uncertainty about the future of Veppanu, a first-of-its-kind, newly approved…

biopharmadive.com·3 g fa
biopharmadive.com

Bristol Myers, Hengrui join forces in drugmaking alliance worth up to $15.2…

The wide-ranging pact involves as many as 13 drugs and marks the latest example of the growing relationship between Chinese…

biopharmadive.com·4 g fa
biopharmadive.com
healthscience

A year after Vertex’s big launch, pain drug research faces a pivotal moment

Journavx revived an area of development long considered a graveyard. Can any other pain drugs keep investor excitement going?

biopharmadive.com·4 g fa
biopharmadive.com
worldhealth

GSK cuts deal with Sino to broaden reach of hepatitis B drug

The marketing deal is the latest in a series of recent pacts between GSK and China-based drug companies, and could speed access…

biopharmadive.com·4 g fa
biopharmadive.com
healthscience

Inhibrx delivers ‘differentiated’ cancer drug data; Fractyl starts diabetes…

Inhibrx, the subject of recent buyout rumors, showed its drug might enhance the effects of Keytruda. Elsewhere, Capricor sued its…

biopharmadive.com·4 g fa
biopharmadive.com

Biotech layoffs are easing, but is the worst over?

BioNTech is one of the most recent companies to announce cuts, but the pace of job losses is slowing.

biopharmadive.com·5 g fa
biopharmadive.com

FDA to reevaluate spurned cell therapy; Under-the-skin Leqembi review extended

Pierre Fabre claims to now be “aligned” with U.S. regulators on the path forward for a twice-rejected treatment. Elsewhere,…

biopharmadive.com·7 g fa
biopharmadive.com
Business

Odyssey, on second try, snags $279M in an IPO

After withdrawing its initial filing last year, the immune drugmaker rebounded and added to a recent run of sizable new biotech…

biopharmadive.com·8 g fa
biopharmadive.com
science

Sarepta tumbles as its gene therapy sales decline further

Even though Elevidys beat Wall Street expectations, analysts expect investor focus to shift toward Sarepta's early-stage RNA…

biopharmadive.com·8 g fa
biopharmadive.com
Businesshealth

Angelini to buy Catalyst in $4B play for rare neuro drugs

The acquisition hands the Italian pharma a group of medicines approved to treat various CNS disorders and gives it wider market…

biopharmadive.com·8 g fa
biopharmadive.com
science

Entrada shares dive as Duchenne results disappoint

While the company claimed a victory, analysts said data from a Phase 1/2 study fell short of expectations. Entrada shares…

biopharmadive.com·8 g fa
biopharmadive.com
health

Roche to acquire digital pathology firm PathAI in deal potentially worth over…

Roche plans to offer PathAI’s tools as part of an effort to improve cancer diagnosis and tailored treatment.

biopharmadive.com·8 g fa
biopharmadive.com
Business

Biotech M&A is accelerating. Track the deals that are happening here.

Catalyst is already the fourth biotech acquisition this month, continuing an acceleration of bigger-ticket deals that’s put 2026…

biopharmadive.com·9 g fa
biopharmadive.com
Businesshealth

Bayer to buy Perfuse for up to $2.45B, bolstering eye drug pipeline

Centered around a glaucoma therapy in mid-stage testing, the deal is Bayer’s first drug company acquisition in several years and…

biopharmadive.com·9 g fa
biopharmadive.com

Novo hikes guidance on Wegovy pill’s fast sales start

In its latest earnings report, the Danish drugmaker said sales and profit should shrink less than the company originally…

biopharmadive.com·9 g fa
biopharmadive.com
healthscience

Avalo shares spike on skin drug data; BioNTech to cut staff

Avalo reported study success in what’s proven to be a tough-to-treat skin disease. Elsewhere, BioNTech announced plans to close…

biopharmadive.com·9 g fa
biopharmadive.com
healthscience

CellCentric raises $220M for a ‘transformative’ multiple myeloma medicine

A Series D round led by Venrock will support an ongoing Phase 2 study, and planned Phase 3 trial, of an oral drug the biotech…

biopharmadive.com·10 g fa
biopharmadive.com
Businesshealth

Cytokinetics heart drug scores in closely watched trial

Myqorzo’s success in “non-obstructive” hypertrophic cardiomyopathy separates it from Bristol Myers Squibb’s rival Camzyos and…

biopharmadive.com·11 g fa
biopharmadive.com
health

Oruka surges as long-acting psoriasis drug shows early promise

A therapy that works similarly to AbbVie’s blockbuster Skyrizi appeared more potent in a mid-stage trial and has the potential to…

biopharmadive.com·18 g fa
biopharmadive.com
health

10 clinical trials to watch in the first half of 2026

After a lengthy downturn, the biotech industry finally gathered momentum in 2025. Key readouts in obesity, infectious disease and…

biopharmadive.com·4 mesi fa
biopharmadive.com
world

Drugs from China are reshaping biotech. Track the licensing deals here.

Bristol Myers’ alliance with Hengrui ranks as the second-largest licensing pact of its kind since the start of 2025, trailing…

biopharmadive.com·8 mesi fa