Clinical biomarkers expected to lift R&D productivity: Iqvia

Pharma's recent slump in R&D productivity — the rate of success in relation to the time and effort invested in drug development — has...

Lilly to withdraw FDA-approved cancer drug after clinical failure

Lartruvo (olaratumab) was the first new drug approved for soft tissue sarcoma in more than four decades, at the time offering patients with the tough-to-treat...

Medicare proposes raising CAR-T pay, but reimbursement solution years away

CAR-T therapies represent a significant clinical advance for patients with certain types of advanced lymphoma. In clinical testing, Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) induced...

FDA’s Woodcock defends accelerated approvals and talks of culture shift in clinical trials

Over more than three decades at the Food and Drug Administration, Janet Woodcock has seen the biotech industry mature from the early days of...
Biopharma companies wanting to treat rare diseases are increasingly pressed to be invested in gene therapy. Novartis and Roche have recognized this with their...
The RDC prosecution could serve as a warning to the drug distribution industry, potentially impacting litigation against the three largest players: McKesson, AmerisourceBergen and...
Biologics have been a business boon to contract manufacturers, Catalent included. Large-molecule drugs are such a focus, in fact, that last year Catalent split its...

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FTC demands could mean months-long delay for Roche-Spark deal

Roche's $4.8 billion takeout of gene therapy specialist Spark Therapeutics looked like a typical biopharma transaction — that is, until the Federal Trade Commission...

Amicus widens UPenn gene therapy collaboration

Biopharma companies wanting to treat rare diseases are increasingly pressed to be invested in gene therapy. Novartis and Roche have recognized this with their...

Celgene wins approval for drug key to Bristol buyout

Approval of Inrebic, which was previously known as fedratinib, is the first domino to fall in Bristol-Myers bet on Celgene's product pipeline. 

Don’t worry about Humira biosimilars, the pipeline will deliver,...

As Humira (adalimiumab) goes, so goes AbbVie. And it may require quite a few new products to replace the rheumatoid arthritis giant, which earned...

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CMS chief declines to provide details on Trump healthcare plan

The administration faces increasing pressure to release a concrete healthcare plan as Democratic presidential candidates are eager to keep the national conversation focused...

Roche cancer drug the 3rd approved for pan-tumor use

Aimed at the molecular catalysts of tumor growth, targeted therapies are treatment mainstays across a wide range of cancer types. 

Novo faces shareholder suit over insulin sales disclosures

Novo is best known for its insulin products like Levemir (insulin detemir) and Tresiba (insulin degludec), as well as other diabetes treatments like...

Celgene wins approval for drug key to Bristol buyout

Approval of Inrebic, which was previously known as fedratinib, is the first domino to fall in Bristol-Myers bet on Celgene's product pipeline. 

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