United States

Affinity Bio Partners launches Pennsylvania cannabis biotech company

Tuesday, August 15, 2017

Affinity Bio Partners CEO Christina DiArcangelo Puller announced that she is adding another organization to the Affinity family of organizations by launching Affinity BioCeuticals, a “first of its kind” Cannabis Biotech Pennsylvania corporation. Affinity BioCeuticals is a Neutraceutical company focused on research and development of cannabinoid based therapies. The emergence of more and more indications where cannabinoid based treatment may be impactful to patient’s lives will be the primary focus for Affinity BioCeuticals. 

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Pfizer expands in North Carolina

Tuesday, August 15, 2017

Pfizer, a biopharmaceutical company, has selected Lee County for a new expansion of its manufacturing facilities as the company prepares to produce new gene therapy medicines. Governor Roy Cooper announced the company plans to invest $100 million in its Sanford facilities, creating 40 jobs and building upon a technology first developed at the University of North Carolina at Chapel Hill.

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Executives of Juno Therapeutics under investigation

Monday, August 14, 2017

Shareholder and consumer rights law firm Schubert Jonckheer & Kolbe LLP has launched an investigation into whether certain officers and directors of Juno Therapeutics breached their fiduciary duties to Juno and its shareholders by exposing Juno to civil liability for failing to disclose patient deaths in the phase II/ROCKET trial of its leading product candidate, JCAR015, during the period June 24, 2016, to November 22, 2016. 

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Ocugen receives FDA Orphan designation for ocular graft versus host disease

Thursday, August 10, 2017

Ocugen, a clinical stage biopharmaceutical company developing novel treatments for sight-threatening diseases, announced the FDA has granted orphan drug designation (ODD) for OCU300 (brimonidine tartrate) for the treatment of ocular graft versus host disease (oGVHD). Ocular GVHD is a common complication that occurs in 40-60% of patients who have undergone allergenic hematological stem cell transplantation (allo-SCT) or bone marrow transplants. Driven by autoimmune inflammation, oGVHD induces severe ocular surface disease, which over time significantly diminishes quality of life, and restricts daily activities due to visual impairment.

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First FDA-approved treatment for ALS in 22 years now available in U.S.

Wednesday, August 9, 2017

Mitsubishi Tanabe Pharma America announced RADICAVA (edaravone), an intravenous therapy indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is now available for treatment in the U.S. RADICAVA, the first FDA-approved ALS treatment option in more than 20 years, has been demonstrated to slow the decline in the loss of physical function in ALS patients by 33 percent in its clinical trial.

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FDA approves Idhifa for relapsed or refractory acute myeloid leukemia

Wednesday, August 2, 2017

The FDA approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

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Acalabrutinib granted FDA Breakthrough Designation for MCL

Wednesday, August 2, 2017

AstraZeneca and its hematology research and development center of excellence, Acerta Pharma, announced that the FDA has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor in development for the treatment of multiple B-cell cancers.

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