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...

Sangamo hemophilia A progress boosts shares

While BioMarin and Spark remain out in front, Sangamo's data appear strong enough to warrant consideration of the biotech's therapy in the discussion of potential...

AstraZeneca gets immuno-oncology win in a disease that Merck doesn’t rule

Dive Insight: Anytime a PD-(L)1 inhibitor can beat Keytruda (pembrolizumab) to the market in a specific type of cancer, it should be celebrated as a win. In...

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...
Novo is best known for its insulin products like Levemir (insulin detemir) and Tresiba (insulin degludec), as well as other diabetes treatments...
Wednesday's settlement follows last month's conviction of five former Insys executives, including the company's founder John Kapoor, for their involvement in bribing physicians to...
Known for its work in the field of messenger RNA therapeutics, BioNTech is looking for new ways to grow. Earlier this month, the private...

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Pfizer, Novartis partner in hunt to find drugs for...

Neither Pfizer or Novartis are among the handful of companies at the leading edge of NASH drug development, which has yet to advance a...

J&J invests in integrin therapies via Morphic deal

Four months after Morphic reached an R&D deal with AbbVie, the Waltham, Massachusetts-based biotech has found another drugmaking giant to partner with. Morphic and AbbVie...

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...

No news is bad news for Tocagen

Brain cancers are among the most difficult to treat, as Tocagen's struggles follow late-stage study failures earlier this month from AbbVie and Bristol-Myers Squibb. The...

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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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