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November 08, 2016

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Today's Rundown

  1. The Medicines Company drops MDCO-216 as med comes up short

  2. Bone Therapeutics cans plan to trial cell therapy in U.S.

  3. Mylan seeks FDA approval for biosimilar Herceptin copy

  4. Stanford readies for CRISPR human testing after sickle cell success

  5. BioInvent hit with clinical hold on midstage myeloma test

  6. From FierceBiotechResearch: New antibody cuts mother-to-fetus Zika transmission in mice

  7. From FiercePharma: AbbVie's Humira gets an IP boost as PTO strikes down Coherus challenge

Featured Story

The Medicines Company drops MDCO-216 as med comes up short

The Medicines Company will stop all work on its anticholesterol candidate MDCO-216 several months after posting weak data that did not allow its test of the med to stop early.


Top Stories

Bone Therapeutics cans plan to trial cell therapy in U.S.

Bone Therapeutics has scrapped plans to trial its autologous cell therapy Preob in the U.S. The bone fracture specialist had planned to run a Phase IIb/III trial in the U.S. to complement its activities in Europe, but has pulled back from the proposal to focus on its other pipeline prospect.

Mylan seeks FDA approval for biosimilar Herceptin copy

Mylan has filed for FDA approval of its biosimilar copy of Roche’s Herceptin. The submission tees up Mylan and its partner Biocon to start chipping away at a cornerstone of Roche’s business while advancing their own attempts to establish a portfolio of biosimilars in the U.S.

Stanford readies for CRISPR human testing after sickle cell success

Scientists from Stanford University School of Medicine have used CRISPR in early-stage work to patch up the gene that causes sickle cell disease as they eye human trials in 2018.

BioInvent hit with clinical hold on midstage myeloma test

Swedish biotech BioInvent has been told by the FDA to stop dosing multiple myeloma patients in its Phase II test for BI-505 due to safety concerns.

New antibody cuts mother-to-fetus Zika transmission in mice

An NIAID-funded team has discovered a Zika antibody that reduces mother-to-fetus transmission of the virus in pregnant mice. This research could lead to the development of vaccines or other therapeutics against the virus.

AbbVie's Humira gets an IP boost as PTO strikes down Coherus challenge

With biosimilar challengers champing at the bit to snag a piece of AbbVie’s world-leading Humira sales, much is riding on the company’s IP protection. And Monday, that protection held up, notching a win in the latest battle between AbbVie and Coherus.

News of Note

Asterias Biotherapeutics has given the highest dose of 20 million cells of AST-OPC1 to its first patient with complete cervical spinal cord injury. Statement

Seattle Genetics and med partner Takeda have finished up patient enrollment in their late-stage study of Adcetris as a frontline combo chemotherapy in patients with CD30-positive mature T-cell lymphoma. Release

An artificial intelligence company from the U.K. has penned an exclusive deal with Janssen to use AI tech with its drug development process. Statement

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