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CP Wire Articles

  • Total development agreement could be worth up to $275 million
  • AB928 has the potential to reverse adenosine-induced immune suppression within the tumor microenvironment

... read more

Fri, 07/13/18 - 09:28 am
CP Staff
  • Shares up 38%+ in pre-market trading
  • Clinical Hold was issued on March 9, 2018
  • Axalimogene filolisbac has fast track designation for adjuvant therapy for high-risk locally... read more
Fri, 07/13/18 - 09:05 am
CP Staff

On 7/11/2018 FDA Commissioner, Scott Gottlieb, announced the release of six new draft guidance documents related to gene therapy development. In the announcement, Gottlieb acknowledged the... read more

Thu, 07/12/18 - 09:51 am
CP Staff
  • BT-11 is a first-in-class, oral, locally-acting small molecule
  • BT-11 has demonstrated a 90% reduction of inflammation by acting locally in the gut mucosa in 4 validated mouse models... read more
Thu, 07/12/18 - 09:17 am
CP Staff
  • Trial is Enrolling Patients with Colorectal, Non-Small Cell Lung, Pancreatic or Head and Neck Cancers
  • Earlier study demonstrated an encouraging response rate in patients with... read more
Thu, 07/12/18 - 08:58 am
CP Staff
  • Approved in patients with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a... read more
Wed, 07/11/18 - 10:11 am
CP Staff



  • Ninlaro maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) versus placebo.
  • Ninlaro has orphan drug status in... read more
Wed, 07/11/18 - 09:56 am
CP Staff
  • Tucatinib has been granted orphan drug status for the treatment of breast cancer patients with brain metastases.
  • Overall response rate (ORR) was 61% for Ph Ib triplet study
  • ... read more
Wed, 07/11/18 - 09:37 am
CP Staff

Nextbiotix raises $8 Million in Series A round
Tue, 07/10/18 - 04:53 pm
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Modeled after the Federal False Claims Act, California and Illinois have unique insurance fraud prevention whistleblower programs with two major distinctions: (1) the government does not have to... read more

Tue, 07/10/18 - 11:22 am
JGentile

Takeda Pharmaceutical Company Limited (“Takeda”) announce on 7/10/18 that it has received unconditional clearance from the United States Federal Trade Commission (“FTC”) for the proposed... read more

Tue, 07/10/18 - 09:49 am
CP Staff
  • New site will enable the company to respond to the growing global demand for foot-and-mouth disease and Bluetongue virus control
  • It represents a record investment into the company’s... read more
Tue, 07/10/18 - 09:42 am
CP Staff
  • BPN14770 has received orphan drug designation
  • Also in trials for Alzheimer's and traumatic brain injury
  • Ph I trials showed excellent safety and improved cognitive capability... read more
Tue, 07/10/18 - 09:27 am
CP Staff
  • Eagle believes orphan drug status will also prevent Treanda generics until 2020
  • FDA asked court to clarify that order related to Bendeka and orphan drug status does not affect... read more
Mon, 07/9/18 - 09:32 am
CP Staff
  • Plans to initiate trial in second half of 2018
  • Edasalonexent significantly slowed progression in Ph II trial
  • Edasalonexent is being developed as monotherapy or for use in... read more
Mon, 07/9/18 - 09:04 am
CP Staff

On April 6, 2018, BioGaia became the majority shareholder in MetaboGen with a 62 percent stake. After certain milestones were achieved, BioGaia has extended its ownership to 92 percent of the... read more

Fri, 07/6/18 - 11:49 am
CP Staff
  • There is concern that smallpox could be used as a bioweapon
  • TPOXX was effective in animal models
  • Target PDUFA date is August 8, 2018

SIGA Technologies,... read more

Thu, 07/5/18 - 09:02 am
CP Staff

Walgreens Boots Alliance, Inc. (Nasdaq: WBA) today announced that, following receipt of regulatory approvals, it has completed the previously announced agreement to acquire a 40 percent minority... read more

Thu, 07/5/18 - 08:46 am
CP Staff
  • Bendeka has Orphan Drug Exclusivity until Dec. 2022
  • Company does not expect generic entrants of previous version of Bendeka until Dec. 2022
  • Teva is responsible for all US... read more
Tue, 07/3/18 - 09:54 am
CP Staff

With the recent FDA approval of Epidiolex(marijuana derived cannabidiol (CBD)), a number of questions have been asked about how... read more
Mon, 07/2/18 - 04:40 pm
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