FDA approved ofatumumab (Arzerra Injection, Novartis Pharmaceuticals Corporation) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Ofatumumab was previously approved for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy was considered inappropriate and also for patients with CLL refractory to fludarabine and alemtuzumab. January 19, 2016. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm482308.htm
Abbott’s Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance
Abbott’s Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California. read more
Immunotherapy Company PDS Biotechnology Strengthens Senior Management Team, Adds Two Drug Development Executives
NORTH BRUNSWICK, N.J., Jan. 20, 2016 /PRNewswire/ — PDS Biotechnology, a clinical-stage biotechnology company developing cancer immunotherapies, is pleased to announce the appointments of Dr. Robert Shepard, M.D., F.A.C.P. as Chief Medical Officer, and Dr. Panna L. Dutta, Ph.D. as Vice President of Drug Development and Manufacturing. read more
Lilly and Incyte Announce Submission of New Drug Application to FDA for Oral Once-Daily Baricitinib for Treatment of Moderate-to-Severe Rheumatoid Arthritis
Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) today announced that Lilly has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of oral once-daily baricitinib for the treatment of moderately-to-severely active rheumatoid arthritis (RA).
As a result, Incyte will receive a milestone payment of $35 million from Lilly related to the NDA submission. If baricitinib is granted U.S. regulatory approval, Incyte will receive a milestone payment of $100 million from Lilly. Incyte could earn additional global regulatory as well as sales-based milestone payments and be eligible for royalties on global net sales of baricitinib.
If approved, Lilly will lead launch and global commercialization efforts for baricitinib in RA. Lilly owns global rights to develop and commercialize baricitinib as an oral treatment for all inflammatory conditions.
This submission milestone will result in a first-quarter charge to Lilly’s GAAP and non-GAAP research and development expense of $35 million (pre-tax). Lilly’s previously-issued 2016 GAAP and non-GAAP EPS guidance of $2.92-$3.02 and $3.45-$3.55, respectively, remain unchanged.
“Lilly’s collaboration with Incyte has produced a rigorous phase 3 program and, if approved, the potential of a promising new treatment option for people with RA,” said David Ricks, president of Lilly Bio-Medicines.
Immunocore Starts Clinical Trial with IMCgp100 in Combination with MedImmune Immunotherapies Durvalumab and Tremelimumab
/PRNewswire/ –Immunocore Limited, a world-leading biotechnology company developing novel T cell receptor (TCR) based biological drugs to treat cancer, viral infections and autoimmune disease, today announced that it has started a Phase Ib/II combination trial for the treatment of metastatic cutaneous melanoma. The trial will evaluate IMCgp100, Immunocore’s lead ImmTAC (Immune Mobilising Monoclonal T-Cell Receptor Against Cancer), in combination with durvalumab and tremelimumab, the investigational immunotherapies of MedImmune, the global biologics research and development arm of AstraZeneca. The open label, four arm, randomized Phase Ib/II trial will explore IMCgp100 paired respectively with durvalumab and tremelimumab as well as investigating all three immunotherapy agents together. The primary goal of the combination trials will be to assess the safety and efficacy of the different combinations. Immunocore is responsible for conducting the trial.
Rapastinel (GLYX-13) Shown to Improve Ketamine or PCP-Induced Cognitive Impairment in Mice
DUBLIN, Jan. 19, 2016 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, announced today that new data on the investigational medication rapastinel (GLYX-13) and its lack of impairment on cognitive function were published in the peer-reviewed journal Behavioural Brain Research. read more
Mylan Launches Generic Felbatol® Tablets
HERTFORDSHIRE, England and PITTSBURGH, Jan. 19, 2016 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) today announced the U.S. launch of Felbamate Tablets USP, 400 mg and 600 mg, which is the generic version of Meda Pharms’ Felbatol® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product. Felbamate Tablets are recommended for monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.(1) read more
Updated Data Shows ONIVYDE® (irinotecan liposome injection) Combination Regimen Increased One Year Survival by 63% in Patients with Metastatic Pancreatic Cancer
CAMBRIDGE, Mass., Jan. 19, 2016 /PRNewswire/ — Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) today announced that an updated overall survival analysis of the Phase 3 NAPOLI-1 study of ONIVYDE® (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin achieved a substantial improvement in 12-month overall survival in patients with post-gemcitabine metastatic pancreatic adenocarcinoma when compared to 5-FU and leucovorin alone. These updated data will be presented at the American Society of Clinical Oncology 2016 Gastrointestinal Cancers Symposium (ASCO GI), January 21-23, 2016, in San Francisco. read more
Stivarga® (regorafenib) tablets will be presented at the 2016 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO GI) in San Francisco, CA, taking place January 21-23. The regorafenib research includes long-term responder data as well as additional analyses across a Phase III clinical trials program that involved more than 3,500 patients with metastatic colorectal cancer (mCRC). Additional data to be presented include the final overall survival analysis of regorafenib from a large Phase III clinical trial in gastrointestinal stromal tumors (GIST). read more
The Medicines Patent Pool Signs First Sub-licences for Hepatitis C Medicine Daclatasvir
GENEVA, January 20, 2016 /PRNewswire/ —
Four companies to help speed access to curative direct-acting antiviral in 112 low- and middle-income countries
The Medicines Patent Pool (MPP) announced its first round of sub-licences for the generic production of Bristol-Myers Squibb’s daclatasvir, a novel direct-acting antiviral that is proven to help cure multiple genotypes of the hepatitis C virus. Generic companies Cipla, Emcure, Hetero and Natco have signed non-exclusive, royalty free agreements with Bristol-Myers Squibb and the MPP to produce and sell daclatasvir in 112 low- and middle-income countries.
ZURICH, Switzerland, January 20, 2016 /PRNewswire/ —
Kuros Biosciences Ltd. (SIX:KURN formerly CYTN) (“Kuros”) today announced the closing of the acquisition of Kuros Biosurgery Holding Ltd. and the change of name of the combined company to Kuros Biosciences Ltd. Starting 20 January 2016 all 508’432’244 Kuros Biosciences Ltd. shares are listed and freely tradable under the ticker symbol KURN on the SIX Swiss Exchange under the International Reporting Standard and include all former 108’015’276 Cytos Biotechnology AG shares, which remain listed and freely tradable under the unchanged ISIN number (CH0011025217).