Neos Resubmits NDA for FDA Review of Orally Disintegrating Tablets; FDA Approves Deltoid Injection Site for Abilify Maintena® Print
By Josh Gee   
Thursday, 30 July 2015 17:48
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 30, 2015. 
Neos Therapeutics, Inc. (NASDAQ: NEOS), a pharmaceutical company with a late‐stage pipeline of innovative extended-release ("XR") product candidates for the treatment of attention deficit hyperactivity disorder ("ADHD"), today announced that it has resubmitted a New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for its amphetamine XR orally disintegrating tablet ("XR-ODT") product candidate, NT‐0202, for the treatment of ADHD.
The NT-0202 NDA resubmission provides information to specifically address the FDA-issued Complete Response Letter received in September 2013. This includes the results from an additional pharmacokinetic study which was conducted with NT-0202 that utilized a commercial-scale manufacturing process, and the requisite stability data. This submission is a Class 2 resubmission, with a target six-month PDUFA review period. If approved, NT-0202 will be the first amphetamine XR-ODT for ADHD. Neos' methylphenidate XR-ODT candidate, Cotempla XR‐ODT™, is currently under review by the FDA and, if approved, will be the first methylphenidate XR‐ODT available for the treatment of ADHD.
"Our product candidates incorporate two of the most commonly prescribed medications for the treatment of ADHD, methylphenidate and amphetamine. Our proprietary modified-release drug delivery technology platform has enabled us to combine two key drug delivery attributes in each of these product candidates: an extended-release profile, which allows for once-daily dosing, and an ODT dosage form, which disintegrates in the mouth, without the need for water," said Vipin K. Garg, Ph.D., President and CEO of Neos.
  
  
  
  
  
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Otsuka America Pharmaceutical, Inc. (OAPI) and Lundbeck today announced that the U.S. Food and Drug Administration (FDA) has expanded the label of Abilify Maintena® (aripiprazole) for extended-release injectable suspension to include a new injection site, the deltoid muscle of the arm. Healthcare providers will now have the option for either a gluteal or deltoid injection site for administering Abilify Maintena to patients with schizophrenia.
   
Abilify Maintena is the first and only once-monthly injection of a dopamine D2 partial agonist (the first injection is accompanied by 14 days of oral antipsychotic therapy) approved for the treatment of adults with schizophrenia. It was originally indicated for only gluteal injection when approved by the FDA in February 2013.1,2 The approval of the deltoid injection site was based on two studies that evaluated the safety and tolerability and pharmacokinetics of Abilify Maintena administered in the deltoid muscle compared to the gluteal muscle in adult patients with schizophrenia.1,3
   
“Having more choices and flexibility in the administration of Abilify Maintena for the treatment of schizophrenia may help strengthen the patient-physician alliance for the long-term management of the disease,” said study investigator David Walling, Ph.D., Chief Executive Officer and Principal Investigator, CNS Network. “It is important to offer an administration option for the deltoid muscle, in addition to the gluteal muscle, because some patients and physicians prefer the deltoid muscle site for injection.”
   
This new deltoid administration offering for Abilify Maintena is scheduled to be commercially available in the fall of 2015.
  
  
  
  
Also Thursday:
  
  
  
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH) today announced that it plans to issue a press release reporting its 2015 second quarter and operational update after the close of the market on Monday, August 10, 2015.
   
Avinger, Inc. (NASDAQ:AVGR) a developer and manufacturer of image-guided, catheter-based systems for the treatment of peripheral arterial disease (PAD) and pioneer of the lumivascular approach to treating vascular disease, today announced that the Company plans to participate in the Canaccord Genuity 35th Annual Growth Conference in Boston.
   
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that it will report financial results for the second quarter ended June 30, 2015, on Thursday, August 6, 2015, before the market opens.
  
Cryo-Cell International, Inc. (OTCQB:CCEL), the world’s first private cord blood bank to separate and store stem cells in 1992, announced today final results of its tender offer to purchase up to 750,000 shares of its common stock at a price of $3.25 per share, which expired at 12:00 midnight, New York City time on Tuesday, July 28, 2015. 
   
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced today the appointment of Tamar Howson to its Board of Directors, effective July 29, 2015.
  
The Female Health Company (NASDAQ:FHCO), which manufactures and markets the FC2 Female Condom® (FC2), today reported its operating results for the quarter and nine months ended June 30, 2015 (third quarter and first nine months of FY2015). 
   
Greatbatch, Inc. (NYSE:GB) today announced it has filed a Form 10 registration statement with the U.S. Securities and Exchange Commission for its proposed tax-free spin-off of its neuromodulation subsidiary, QiG Group LLC, to be known post-spin as Nuvectra Corporation.
   
Greatbatch, Inc. (NYSE:GB), today announced results for its second quarter ended July 3, 2015.
    
HTG Molecular Diagnostics, Inc. (Nasdaq:HTGM), a provider of instruments and reagents for molecular profiling applications, today announced that its management will be presenting at the Canaccord Genuity Growth Conference on Thursday, August 13, 2015 in Boston.
   
Juno Therapeutics, Inc. (Nasdaq:JUNO), a biopharmaceutical company focused on re-engaging the body's immune system to revolutionize the treatment of cancer, today announced the U.S. Food and Drug Administration (FDA) cleared the Company's investigational new drug (IND) application for JCAR015 for treatment of adult patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL).
   
Lombard Medical, Inc. (NASDAQ:EVAR), a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced the acquisition of Silicon Valley-based Altura Medical, a privately-held, venture-backed company that has developed an innovative ultra-low profile endovascular stent graft technology that offers a simple and predictable solution for the treatment of standard AAA anatomies.
   
Lumenis Ltd. (NASDAQ:LMNS), the world's largest energy-based medical device company for aesthetic, surgical and ophthalmology applications, today announced that the LightSheer DESIRE received a Professional Notable honor in the Commerical Equipment category of the 2015 Core77 Design Awards program.
   
MRI Interventions, Inc. (OTCQB:MRIC) today announced financial results for the second quarter ended June 30, 2015.
   
NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that its management is scheduled to present at the Canaccord Genuity Growth Conference in Boston.
   
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced positive top-line data from a Phase 2 clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP). 
    
Nuo Therapeutics, Inc. (OTCQX:NUOT), a pioneer in biodynamic therapies, today announced that its previously reported collaboration with Net Health to add data collection functionality within WoundExpert® for the Aurix™ Coverage with Evidence Development (CED) program (Au Study) will go live in August.
  
Nymox Pharmaceutical Corporation (NASDAQ:NYMX) is pleased to announce that the Company has newly appointed James G. Robinson to the Board of Directors.
   
Perseon Corporation (NASDAQ:PRSN) (NASDAQ:PRSNW), a leading provider of medical systems that utilize energy to treat cancer, today announced the pricing of an underwritten public offering of 5,750,000 shares of common stock, and warrants to purchase 11,500,000 shares of common stock, at an offering price of $0.90 per share and two warrants. 
    
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at the Canaccord Genuity Growth Conference in Boston on Thursday, August 13th at 3:30pm (EDT). 
    
Vital Therapies, Inc. (Nasdaq:VTL), a biotherapeutic company developing ELAD®, a cell-based therapy targeting the treatment of liver failure, today announced results for the second quarter ended June 30, 2015 and provided a corporate update.
   
Vocera Communications, Inc. (NYSE:VCRA), today reported revenue of $25.4 million, a GAAP net loss per share of $(0.20), and adjusted EBITDA of $(1.6) million, for the second quarter of 2015.
   
 vTv Therapeutics Inc. (Nasdaq:VTVT), a clinical-stage biopharmaceutical company, commenced on The Nasdaq Stock Market on July 30, 2015.



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