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First patients enrolled in Phase 3 CAM2038 trial

American Pharmacy News Reports | Oct 10, 2016
The effectiveness of opioids for pain, on one hand, and the potential for their misuse, on the other, has created a dilemma for medical professionals.

Braeburn Pharmaceuticals and Camurus have enrolled the first Phase 3 CAM2038 trial patients to assess the safety and effectiveness of CAM2038 in patients with lower back pain whose present course of treatment involves opioids. Read More »

Regeneron receives positive trial results for CAPELLA

American Pharmacy News Reports | Oct 10, 2016
The Phase 2 CAPELLA trial has turned in positive results.

Regeneron Pharmaceutical's Phase 2 CAPELLA trial has turned in positive results. Read More »

FDA grants AbVie’s G/P regimen Breakthrough Therapy Designation

American Pharmacy News Reports | Oct 10, 2016
The investigational G/P regimen is designed to treat chronic hepatitis C virus.

AbbVie's investigational, pan-genotype regimen of gelcaprevir (ABT-493) and pibrentasvir (ABT-530) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration. Read More »

Teva launches generic version of Epzicom tablets in U.S.

American Pharmacy News Reports | Oct 10, 2016
The new tablets were developed to reduce the amount of HIV-1 and increase CD4+ (T) cells in the blood.

Teva Pharmaceutical Industries has launched Abacavir and Iamivudine tablets, the company’s generic version of Epzicom tablets, in the United States. Read More »

Amgen's ARISE trial produces positive results

American Pharmacy News Reports | Oct 8, 2016
Amgen's ARISE trial turned in positive results.

Amgen's Phase 3 erenumab clinical trial has turned in positive results. Read More »

Bayer and DelSiTech announce Collaboration and Technology License Agreement

American Pharmacy News Reports | Oct 8, 2016
Under the agreement, Bayer will apply DelSiTech's Silica Matrix system to its opthalmology compounds.

Bayer and DelSiTech have issued a joint announcement regarding the signing of a Collaboration and Technology License Agreement. Read More »

Eleventa finalizes Timapiprant trial enrollment

American Pharmacy News Reports | Oct 8, 2016
The Phase 3 trial will assess the ability of Timapiprant to treat adults with atopic eosinophilic asthma.

Eleventa, a portfolio company owned by Maxwell Biotech Venture Fund in association with its development partner Oxagen Ltd., has finalized patient enrollment for its Phase 3 Timapiprant clinical trial. Read More »

FDA gives fast-track approval for Medtronic’s MiniMed 670G

American Pharmacy News Reports | Oct 7, 2016
The FDA has given its approval of the MiniMed 670G hybrid closed looped system.

The U.S. Food and Drug Administration has given its approval of the MiniMed 670G hybrid closed looped system, designed to automatically monitor glucose and give suitable dose to individuals 14 years of age and older. Read More »

FDA approves Athersys' Multistem Phase 3 trial

American Pharmacy News Reports | Oct 7, 2016
Multistem is Athersys' cell therapy product designed to treat of ischemic stroke.

The U.S. Food and Drug Administration, under a Special Protocol Assessment, has agreed to Athersys' design and analysis of a Multistem Phase 3 study. Read More »

AcelRx initiates IAP312 Phase 3 trial for study of Zalviso

American Pharmacy News Reports | Oct 7, 2016
AcelRx Pharmaceuticals has commenced with its IAP312 Phase 3 trial for the study of Zalviso.

AcelRx Pharmaceuticals has commenced with its IAP312 Phase 3 trial for the study of Zalviso, its new investigational product in development to treat moderate-to-severe acute pain in adult hospital patients. Read More »

Corvus releases CPI-444 Pahse 1/1b clinical study data

American Pharmacy News Reports | Oct 7, 2016
The ongoing CPI-444 clinical trial was designed to study the drug as a single agent as well as combined with TECENTRIQ, Genetech’s monoclonal antibody.

Corvus Pharmaceuticals has released the preclinical data and preclinical biomarker data from its Phase 1/1b CPI-444 clinical study. Read More »

FDA approves update to Rexulti label

American Pharmacy News Reports | Oct 7, 2016
The Rexulti label will now show clinical data for the maintenance treatment of schizophrenia.

H. Lundbeck and Otsuka Pharmaceutical Development & Commercialization have reported that the U.S. Food and Drug Administration has approved the update to the Rexulti label. Read More »

Ajanta releases Omeprazole and Sodium Bicarbonate Powder for Oral Suspension in U.S.

American Pharmacy News Reports | Oct 7, 2016

Ajanta Pharma USA has made Omeprazole and Sodium Bicarbonate Powder for Oral Suspension available in the United States. Read More »

Amgen’s AMJEVITA approved to treat inflammatory diseases

American Pharmacy News Reports | Oct 7, 2016

The U.S. Food and Drug Administration has approved Amgen’s AMJEVITA for the treatment of seven different inflammatory diseases. Read More »

Mucodel Pharma concludes successful Exonal clinical trial

American Pharmacy News Reports | Oct 5, 2016
Mucodel is developing Exonal as a possible opioid overdose reversal medication.

Mucodel Pharma, a private company based in Greensboro, North Carolina, that is dedicated to the development of improved rescue therapies to be administered oromucosally, has completed its Exonal (buccal naloxone) clinical study. Read More »

Pacira launches non-opioid EXPAREL for relief from dental pain

American Pharmacy News Reports | Oct 5, 2016
The new product for pain relief following oral surgery offered by Pacira is an alternative to opioid-based medicines.

Pacira Pharmaceuticals has released new data supporting EXPAREL and the benefits it could offer patients who must undergo third molar, or wisdom teeth, removal. Read More »

Epizyme to partner with Foundation Medicine for tazemetostat trial

American Pharmacy News Reports | Oct 5, 2016
The search will be specified to include NHL patients who have EZH2 mutations and constitute specific cohorts.

Epizyme Inc. has agreed to a partnership with Foundation Medicine to identify and enroll support patients for the upcoming Phase 2 trial of tazemetostat on patients who have non-Hodgkin lymphoma. Read More »

Bayer announces FDA approval of Kyleena

American Pharmacy News Reports | Oct 4, 2016
Kyleena will be available this month only with a prescription.

The U.S. Food and Drug Administration has approved Bayer's progestin-containing intrauternine system Kyleena for pregnancy prevention for a span of up to five years. Read More »

Diffusion completes animal toxicology studies

American Pharmacy News Reports | Oct 4, 2016
Diffusion Pharmaceuticals has completed the dosing of two animal toxicology studies.

Diffusion Pharmaceuticals has completed the dosing of two animal toxicology studies that are required by the U.S. Food and Drug Administration for approval of Diffusion’s lead molecule trans sodium crocetinate Phase 3 trial. Read More »

Vical, Astellas announce ASP0113 trial achieves topline results

American Pharmacy News Reports | Oct 4, 2016
The Phase 2 ASP0113 trial has achieved topline results.

Vical Inc. and Astellas Pharma's Phase 2 study of cytomegalovirus vaccine ASP0113 has achieved topline results. Read More »

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