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FDA accepts Eisai's sNDA for perampanel drug for treatment of PGTC seizures

FDA accepts Eisai's sNDA for perampanel drug for treatment of PGTC seizures

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) accepted for review the company's Supplemental New Drug Application (sNDA) for its in-house-discovered AMPA receptor antagonist perampanel for the treatment of primary generalized tonic-clonic (PGTC) seizures. [More]
Janssen announces submission of IMBRUVICA sNDA to FDA for WM treatment

Janssen announces submission of IMBRUVICA sNDA to FDA for WM treatment

Janssen Research & Development, LLC today announced the submission of a supplemental New Drug Application (sNDA) for IMBRUVICA (ibrutinib) to the U.S. Food and Drug Administration by its strategic partner Pharmacyclics, Inc. [More]
Actavis seeks FDA approval to market generic version of Quillivant XR

Actavis seeks FDA approval to market generic version of Quillivant XR

Actavis plc today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Methylphenidate Hydrochloride for Extended-release Oral Suspension, 5 mg/mL. Actavis' ANDA product is a generic version of Pfizer and Tris Pharma's Quillivant XR®, which is a central nervous system stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder. [More]

Highland completes US$25 million offering of Class A Common Shares

Highland Therapeutics Inc., a pharmaceutical company, today announced it has completed a US$25 million offering of Class A Common Shares. The financing was led by a private equity partner that is committed to Highland's long-term success. [More]
Eisai, Helsinn Group announce FDA approval of AKYNZEO for prevention of CINV

Eisai, Helsinn Group announce FDA approval of AKYNZEO for prevention of CINV

Helsinn Group and Eisai Inc. announced today that the Food and Drug Administration (FDA) approved AKYNZEO® for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. [More]
Shire receives FDA guidance on regulatory path for investigational compound SHP 465

Shire receives FDA guidance on regulatory path for investigational compound SHP 465

Shire plc today announced that it has received further guidance from the U.S. Food and Drug Administration on the regulatory path for SHP 465 (triple-bead mixed amphetamine salts MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. [More]
Isavuconazole demonstrates successful outcomes in treatment of mucormycosis

Isavuconazole demonstrates successful outcomes in treatment of mucormycosis

Astellas reported today that isavuconazole demonstrated successful outcomes in the treatment of mucormycosis according to data from the phase 3 isavuconazole VITAL study being presented at IDWeek on October 10, 2014, in Philadelphia, Pa. [More]
Par Pharmaceutical starts shipping generic version of Exforge

Par Pharmaceutical starts shipping generic version of Exforge

Par Pharmaceutical Companies, Inc. today announced that it has begun shipping all four strengths of amlodipine and valsartan tablets, the generic version of Novartis' Exforge. Par received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for amlodipine and valsartan and was granted 180 days of marketing exclusivity. [More]
Bausch + Lomb’s sub-micron loteprednol etabonate ophthalmic gel meets primary endpoint

Bausch + Lomb’s sub-micron loteprednol etabonate ophthalmic gel meets primary endpoint

Bausch + Lomb, a wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX), today announced that its next generation sub-micron gel formulation of loteprednol etabonate was statistically superior to placebo (vehicle gel) in eliminating inflammation and pain following cataract surgery by study day eight, the primary endpoints in the first Phase 3, multi-center, double-masked, vehicle-controlled, parallel-group study. [More]
Guerbet wins Drug Shortage Assistance Award from FDA

Guerbet wins Drug Shortage Assistance Award from FDA

Guerbet, a pioneer in the field of contrast agents for medical imaging, has received a Drug Shortage Assistance Award from the U.S. Food and Drug Administration for its assistance in preventing or alleviating a drug shortage. [More]
AcelRx plans for resubmission of Zalviso NDA

AcelRx plans for resubmission of Zalviso NDA

AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today provided an update on the plans for the resubmission of the Company's New Drug Application (NDA) for Zalviso (sufentanil sublingual tablet system). [More]
CorMedix submits IND application to FDA for Neutrolin

CorMedix submits IND application to FDA for Neutrolin

CorMedix Inc., a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiac, renal and infectious disease, is pleased to announce that an Investigational New Drug application (IND) for Neutrolin was submitted to the United States Food and Drug Administration on Wednesday, September 24, 2014. [More]
MOVANTIK tablets get FDA approval for treatment of OIC in patients with chronic, non-cancer pain

MOVANTIK tablets get FDA approval for treatment of OIC in patients with chronic, non-cancer pain

Nektar Therapeutics reported today that partner AstraZeneca today announced that the US Food and Drug Administration (FDA) approved MOVANTIK (naloxegol) tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of opioid-induced constipation (OIC), in adult patients with chronic, non-cancer pain. [More]
New antifungal drug effective against invasive mold disease in cancer patients with less adverse effects

New antifungal drug effective against invasive mold disease in cancer patients with less adverse effects

A newly developed antifungal, isavuconazole, is as effective as an existing drug, voriconazole, against invasive mold disease in cancer patients with less adverse effects, according to phase 3 clinical data presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, an infectious disease meeting of the American Society for Microbiology. [More]
Soligenix acquires novel orphan drug candidate for treatment of CTCL

Soligenix acquires novel orphan drug candidate for treatment of CTCL

Soligenix, Inc., a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, announced today the acquisition of a novel orphan drug candidate, known as SGX301 (synthetic hypericin). [More]
Mylan releases generic version of Boniva Injection

Mylan releases generic version of Boniva Injection

Mylan Inc. today announced that it has launched Ibandronate Sodium Injection, 1 mg (base)/mL, packaged in 3 mg (base)/3 mL pre-filled glass syringes, which is the generic version of Hoffmann-La Roche's Boniva Injection. [More]
VentiRx's motolimod receives FDA Fast Track designation for ovarian cancer treatment

VentiRx's motolimod receives FDA Fast Track designation for ovarian cancer treatment

VentiRx Pharmaceuticals, Inc., a clinical stage biopharmaceutical company committed to the development and commercialization of novel Toll-like receptor 8 (TLR8) immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the investigation of motolimod (VTX-2337) when administered in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy. [More]
InnoPharma receives FDA approval for generic DACOGEN

InnoPharma receives FDA approval for generic DACOGEN

InnoPharma, Inc. today announced the approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for decitabine for injection, a generic version of Eisai Inc.'s DACOGEN. [More]
FDA accepts Mylan's ANDA filing for generic Copaxone 40 mg/mL

FDA accepts Mylan's ANDA filing for generic Copaxone 40 mg/mL

Mylan Inc. today announced that its abbreviated new drug application (ANDA) for a three times per week Glatiramer Acetate Injection 40 mg/mL has been accepted for filing by the U.S. Food and Drug Administration. [More]
Amgen's ivabradine receives FDA priority review designation for treatment of chronic heart failure

Amgen's ivabradine receives FDA priority review designation for treatment of chronic heart failure

Amgen today announced the U.S. Food and Drug Administration has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). [More]