Dec 6, 2016
Celgene Corporation has announced interim results from the ABOUND clinical trial program evaluating the use of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in patients with advanced non-small cell lung cancer (NSCLC). Interim data presented from the ABOUND trials during the IASLC 17th World Conference on Lung Cancer (WCLC) reinforces the benefit of ABRAXANE/carboplatin doublet therapy in first-line NSCLC.
9 December 2016
AstraZeneca and its global biologics research and development arm, MedImmune, have announced that the US Food and Drug Administration (FDA) has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (mAb). FDA has also granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017.
13 December 2016
The results of Celgene’s randomized phase II tnAcity trial of ABRAXANE® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) were presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) in December 6-10, 2016. The trial found that an investigational weekly combination regimen of ABRAXANE + carboplatin had significantly longer progression-free survival (PFS) (7.4 months) compared to weekly regimens of either ABRAXANE + gemcitabine (5.4 months) or of carboplatin + gemcitabine (6.0 months) as first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC).
Dec 15, 2016
The auction process to acquire Pharmacyclics was too competitive, and Actelion Pharmaceuticals was too expensive for Johnson & Johnson. Is there any deal that will be just right for J&J? Officials from Johnson & Johnson announced that it had ended discussions with Actelion on a potential deal. Analysts say that J&J is flush with cash and needs to do a deal soon. Now, the question is, what is J&J looking for?
Dec 15, 2016
LinkedIn has recently released the list of the 10 top voices 2016 in healthcare. Luca Dezzani, editor of Igeahub.com, has been included in this list. As the Global Medical Director at Novartis Oncology, Dr. Dezanni has been actively writing about clinical research, healthcare, drug and biotechnology industries, diagnostics and medical devices. His contributions also include suggestions regarding the best possible ways to deliver better patient care at the lowest cost. He also emphasized on the possibility of providing personalized treatment to the patients in order to ensure better treatment facilities.
Dec 15, 2016
Lonza has declared that it will buy private-equity backed U.S. capsule maker Capsugel in a $5.5 billion all-cash deal. This will push the Swiss biotech group further into the health care industry.
Dec 16, 2016
The Obama administration has decided to quit on a plan to fight high drug prices that drew strong opposition from both parties and also from apparently all sectors of the healthcare industry. It was confirmed by a spokesperson for the agency regulating Medicare and Medicaid.
Dec. 16, 2016
Eli Lilly and Company and Incyte Corporation have announced that the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency (EMA) has issued a positive opinion recommending the approval of baricitinib – which if approved, would be marketed as Olumiant®. Baricitinib is recommended to be used for treating moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti rheumatic drugs (DMARDs). Baricitinib may be used as monotherapy or in combination with methotrexate. This recommendation from CHMP is expected to be followed by the approval from the European Commission, who will make the decision on marketing authorization.
Dec 19, 2016
Clovis Oncology has got the approval from U.S. FDA for its PARP inhibitor rucaparib for treating women with advanced ovarian cancer, who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA). The brand name of the drug is Rubraca.
Dec 20, 2016
Allergan, a New Jersey based pharmaceutical company, is ending this year on a high note with yet another biotech purchase. It has announced that that it will acquire LifeCell from privately-held Acelity for $2.9 billion in cash. LifeCell focuses on breast reconstruction surgery devices and drugs and is expected to generate $450 million in 2016 revenue.
December 21, 2016
Bristol-Myers Squibb Company and Calithera Biosciences, Inc., a clinical stage biotechnology company focused on discovering and developing new small molecule drugs directed against tumor metabolism and tumor immunology targets for treating cancer, have announced a clinical trial collaboration to evaluate the Opdivo of Bristol-Myers Squibb in combination with CB-839 of Calithera in patients with clear cell renal cell carcinoma (ccRCC). CB-839 is an orally administered glutaminase inhibitor currently in Phase 1/2 clinical studies.
22 December 2016
Roche has announced that the primary endpoint has been met for the phase III HAVEN 1 study assessing emicizumab prophylaxis in people with haemophilia A and inhibitors to factor VIII. The study revealed a statistically significant reduction in the number of bleeds over time in people treated with emicizumab prophylaxis compared to those receiving no prophylactic treatment. All secondary endpoints were also met, including a statistically significant reduction in the number of bleeds over time with emicizumab prophylaxis treatment in an intra-patient comparison in people who had received prior bypassing agent prophylaxis treatment. Injection site reactions were the most common adverse events with emicizumab, as consistent with prior studies.
FDA announced that it had provided an accelerated approval for Spinraza (nusinersen), the new drug from Biogen and Ionis, for treating rare cases of spinal muscular atrophy. It is estimated that the total sales of this drug would reach $3 billion by 2026. On this news, shares of Ionis climbed 10% and Biogen saw its stock shot up 2%. After a year of upheavals, both companies badly needed this win.
Dec. 30, 2016
Abbott Laboratories has announced that it plans to close the acquisition of St. Jude Medical, Inc., on Wednesday, Jan. 4, 2017. The announcement follows receipt of all regulatory clearances required for closing.