Industry News

Seattle Genetics, Inc. announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold or partial clinical hold has been placed on several early stage trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML). The clinical holds were initiated to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment. Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events. Overall, more than 300 patients have been treated with SGN-CD33A in clinical trials across multiple treatment settings. Seattle Genetics is working diligently with the FDA to determine whether there is any association between hepatotoxicity and treatment with SGN-CD33A, to promptly identify appropriate protocol amendments for patient safety and to enable continuation of these trials.

Ligand Pharmaceuticals Incorporated, a biopharmaceutical company, has entered into a worldwide license agreement with Ono Pharmaceutical CoL, ltd. Under the license, Ono will be able to use the OmniRat, OmniMouse and OmniFlic platforms to discover fully human mono- and bispecific antibodies.  Ligand is eligible to receive annual platform access payments, development milestone payments and royalties for each product incorporating an OmniAb antibody. Ono will be responsible for all costs related to the programmes.

Pfizer Inc. announced that it has completed the acquisition of the development and commercialization rights to AstraZeneca’s late-stage small molecule anti-infective business, primarily outside the United States. The agreement includes the commercialization and development rights to the newly approved EU drug Zavicefta (ceftazidime-avibactam), the marketed agents Merrem/Meronem (meropenem) and Zinforo (ceftaroline fosamil), and the clinical development assets aztreonam-avibactam (ATM-AVI) and CXL. Zavicefta specifically addresses certain multi-drug resistant Gram-negative infections, including those resistant to carbapenem antibiotics, one of the most significant unmet medical needs in bacterial infections treated with hospital anti-infectives.

Mithra Pharmaceuticals, a company focused on women’s health, announces that it obtained 14 Marketing Authorizations for the commercialization of its product Tibelia in the United Kingdom, Belgium, Holland, Luxembourg, Spain, Portugal, Germany, Hungary, Poland, Norway, Sweden and Finland. Mithra is still waiting for 3 MA in France, Greece and Italy that should be received by the beginning of 2017. The product based on tibolone developed by Mithra will be more competitive due to its extended shelf-life.

Biohaven Pharmaceutical Holding Company Ltd. (Biohaven), a privately-held biopharmaceutical company, has enrolled the first patient in its potentially pivotal phase 2b/3 clinical trial assessing the efficacy and safety of its drug candidate BHV-4157 in patients with hereditary spinocerebellar ataxia (SCA).

BioCardia, Inc, a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, with clinical programs in heart failure and sub-acute infarction, announced the issuance of United States Patent No. 9,517,199 relating to a method of delivering cells to patients who have chronic myocardial infarcts.

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The U.S. Food and Drug Administration (FDA) approved  Biogen’s SPINRAZA™ (nusinersen) under Priority Review for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients. SPINRAZA is the first and only treatment approved in the U.S. for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness.

Cipla Ltd, a global pharmaceutical company, has yielded a final approval for its lead MDI product Fluticasone + Salmeterol (Sereflo) from UK MHRA for its partner in the UK.

Avinger, Inc., a leading developer of innovative treatments for Peripheral Artery Disease (PAD),  announced that the company has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Lightbox L250 imaging console. With this new FDA clearance, the Lightbox L250 now provides detailed measurement of vessels with a few simple taps to a touch screen, helping further improve visualization inside the vessel before, during, and after Pantheris™ Lumivascular atherectomy procedures for the treatment of PAD.

Eisai Co., Ltd. and Keio University  announced they have entered into a new joint research agreement for the discovery and development of new drugs targeting dementia. For this collaborative research, a research lab will be established, and researchers from Eisai and Keio University will work together to identify and validate novel drug targets and biomarkers that could potentially lead to the development of new therapeutics and preventive medicines for dementia.