March 1, 2017
Bristol-Myers Squibb Company plans for a research collaboration with GRAIL Inc., a life sciences company whose mission is to detect cancer early when it potentially can be cured. GRAIL aims to develop highly sensitive blood tests that detect cancer in its early stages by combining the power of high intensity cancer DNA sequencing, large clinical studies, and leading edge computer science into a diagnostic platform.
March 2, 2017
Roche, Breast European Adjuvant Study Team (BrEAST), the Breast International Group (BIG) and Frontier Science Foundation (FS) have announced positive results from the phase III APHINITY study, which met its primary endpoint and showed that adjuvant (after surgery) treatment with the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta-based regimen) achieved a statistically significant reduction in the risk of recurrence of invasive disease or death (invasive disease-free survival; iDFS) in people with HER2-positive early breast cancer (eBC) compared to Herceptin and chemotherapy alone.
March 3, 2017
Janssen Research & Development, LLC has announced new findings from two pivotal Phase 3 studies reporting the safety and efficacy of guselkumab in the treatment of adults with moderate to severe plaque psoriasis. Data from the VOYAGE 2 study showed that patients treated with guselkumab experienced substantial improvements in skin clearance and other measures of disease activity compared with placebo, and significantly greater improvements compared with the anti-tumor necrosis factor (TNF)-alpha treatment Humira® (adalimumab).
Mar 3, 2017
In an effort to expand the portfolio of central nervous system-based therapies, Otsuka Pharmaceutical will acquire Neurovance Inc. in a transaction that could be worth as much as $250 million.
March 3, 2017
AstraZeneca has decided to partner with Sanofi on an experimental antibody for RSV. The French pharma giant is paying €120 million upfront and up to €495 million more in development and sales milestones to buy into the program. Now, the two Big Pharmas will split R&D costs for MEDI8897, with AstraZeneca in charge of manufacturing and Sanofi Pasteur taking control of the commercialization work.
March 4, 2017
Eli Lilly and Company has announced that patients with moderate-to-severe plaque psoriasis treated with Taltz® (ixekizumab) demonstrated superior efficacy at 24 weeks compared to patients treated with Stelara®* (ustekinumab). Detailed results from the IXORA-S study were presented during the American Academy of Dermatology (AAD) Annual Meeting taking place March 3-7 in Orlando, Fla.
March 6, 2017
Merck and Pfizer Inc. have announced that the U.S. Food and Drug Administration (FDA) has accepted for review three New Drug Applications (NDAs) for medicines containing ertugliflozin, an investigational SGLT2 inhibitor in development for helping to improve glycemic control in adults with type 2 diabetes: one for monotherapy, one for the fixed-dose combination of ertugliflozin and JANUVIA® (sitagliptin), and one for the fixed-dose combination of ertugliflozin and metformin. Furthermore, the European Medicines Agency (EMA) has validated for review three Marketing Authorization Applications (MAAs) for ertugliflozin monotherapy and the two fixed-dose combination products.
March 6, 2017
The FDA has given Seattle Genetics the green light to continue the trials for its armed antibody dubbed SGN-CD33A (vadastuximab talirine) used for the treatment of acute myeloid leukemia. The biotech says it is implementing additional risk mitigation measures in all vadastuximab talirine studies, including “revised eligibility criteria and stopping rules for veno-occlusive disease.” Two months ago, FDA put a clinical hold on the early-stage work of this trial following the deaths of 4 patients.
March 13, 2017
Novartis has gained the FDA approval for LEE011, its CDK 4/6 drug now approved as a frontline therapy for postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with any aromatase inhibitor. Also known as ribociclib, the drug hits the market as Kisqali with peak sales estimates of approximately $2.5 billion a year. This gives the pharma giant a clear shot at a new blockbuster franchise.
March 14, 2017
Merck has received another FDA approval for Keytruda, and this time for classical Hodgkin lymphoma, marking the PD-1 blocker’s first green-light for use in liquid tumors. Regulators handed out the approval for patients who had already failed at least three therapies. The approval was a first for Merck, but it comes 9 months after Opdivo was approved in cHL.
March 14, 2017
Johnson & Johnson announced that final Phase 1 clinical trial data published in JAMA: The Journal of the American Medical Association show that the investigational “prime-boost” Ebola vaccine regimen of Janssen Pharmaceutical Companies induced a durable immune response in 100 percent of healthy volunteers one year following vaccination.
Mar 14, 2017
The PARP inhibitor of AstraZeneca, Lynparza, delay the recurrence of ovarian cancer by more than two years compared to a placebo, according to results from a phase III study presented recently. The strong benefits observed with Lynparza as ovarian cancer maintenance therapy exceeded investor expectations and bolsters AstraZeneca against a competing PARP inhibitor from Tesaro. The new Lynparza study results are also likely to impact the way investors view the market value of Clovis Oncology and its recently approved PARP inhibitor Rubraca.
Mar 20, 2017
Nektar Therapeutics has reported results from the first late-stage clinical trial showing its experimental, addiction-resistant opioid NKTR-181 reduces pain significantly more than a placebo in patients with chronic back problems.
March 23, 2017
The biopharma partners Merck KGaA and Pfizer came away with their first FDA approval of the checkpoint inhibitor avelumab. This made it the fourth drug in this category to make it to the market. The FDA approves this for Merkel cell carcinoma under an accelerated approval process. The drug is currently in 30 clinical programs. The two pharma giants look to wedge their way into a multibillion-dollar market for drugs that are gaining wide use in treating cancer.
March 27, 2017
After seven years of trial and error, the FDA has finally offered a green light for Newron’s Parkinson’s drug safinamide after following two radically different paths to get it on the market in Europe and the US. Previously, FDA refused to even accept their first application in 2014, faulting them for a series of mistakes in the NDA.
March 27, 2017
The FDA has given approval to Tesaro for the use of its PARP drug niraparib, which will now be marketed as Zejula as a maintenance therapy for the treatment of recurrent ovarian cancer. Tesaro had argued that the efficacy data for niraparib qualified for an approval for use in patients who are either HRD positive or HRD negative. This approval also helps position Tesaro against AstraZeneca, which has recently delivered stellar Phase III data on its PARP Lynparza.
28 March 2017
Roche has announced the CE-IVD launch of cobas® HPV for use on the cobas® 6800/8800 Systems for cervical cancer screening. Human Papillomavirus (HPV) is a known cause of cervical cancer and is used to identify women at risk. This HPV DNA assay adds to the growing CE-IVD menu on the cobas 6800/8800 Systems, and gives laboratories the capability to run HPV DNA testing concurrently with other previously released cobas assays including: Chlamydia and Gonorrhea (CT/NG), HBV, HCV, HIV-1, CMV, and three next-generation assays for donor screening: cobas® MPX, cobas® HEV, and cobas® WNV.
You may also be interested in the following articles that were published at IgeaHub in March, 2017:
The ranking model incorporated seven criteria for each organization with focus on revenues generated by pharmaceutical products and growth in pharmaceutical revenues (2015-2016). These additions emphasizes on the company’s pharma product portfolio unlike last year’s ranking which was based on company’s overall growth. The criteria includes pharmaceutical revenues, annual pharmaceutical revenue growth, total R&D expense, total expense, total income, proportion of revenue from top three pharmaceutical products and revenue per employee.
Innovation is the key for the success of the biotech industry. Hence, the innovation strategy of a biotech company must evolve constantly if it wants to remain competitive in the local and international market. Necessity is the mother of innovation, and so the successful biotech companies are always focused on their innovation initiatives in order to bring new products in the market for the benefit of people. For this reason, the scientists and entrepreneurs working in this industry are imaginative, revolutionary, inventive, and ingenious, as well as industrious.
AbbVie, the Illinois-based company develops and markets therapies focused on treating rheumatology, gastroenterology, dermatology, oncology, virology, neurological disorders and metabolic diseases conditions. The company recorded sales of $25.6 billion in 2016 an increase by 12% compared to $22.8 billion in 2015. The earnings per share in 2016 was $3.65.
Bayer operates in three segments: Pharmaceuticals, Consumer Health and Crop Science – and the Animal Health business. The Pharmaceuticals segment focuses on prescription products, especially for cardiology and women’s healthcare, and on specialty therapeutics in the areas of oncology, hematology and ophthalmology.