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...

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...

Hunting productivity, drugmakers pitch new ‘pillars’ of R&D

SAN FRANCISCO — Developing new medicines isn't a resource-efficient endeavor. Estimates vary, but most molecules selected to begin clinical development won't end up on pharmacy shelves...

Bristol-Myers wins shareholder backing for Celgene buyout

While Bristol-Myers executives successfully beat back Starboard and Wellington's efforts to derail the deal, the questions raised by that opposition remain. By buying Celgene, Bristol-Myers...
The cancer field's largest conference has come and gone, and with it a window into the thousands of clinical trials being run in hopes...
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...
MacroGenics stock took a beating Tuesday, dropping far more than any other biotech on the iShares NASDAQ Biotechnology Index as the ASCO conference closed....

Follow RXMonthly

News

Wave delays key data readout for Huntington’s therapy

Investors reacted negatively to the pushed-back readouts, sending shares of the Singapore-based biotech down nearly 20% between Tuesday's market close and Wednesday's. Wall Street analysts,...

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...

Array gets a win in colorectal cancer

Array's combination of Braftovi (encorafenib) and Mektovi (binimetinib) already appears well received in the small clinical setting of advanced melanoma with BRAF V600E or...

Takeda takes another step into cell therapy research

Takeda, on the cusp of closing its deal to acquire Shire, is also working to ramp up its efforts in emerging fields of cancer...

Latest articles

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. 

Subscribe to our newsletter