SYDNEY, April 21, 2015 /PRNewswire/ — US-Australian drug discovery company, Novogen, today announced that its subsidiary joint venture company with Yale University, CanTx, Inc, has today received notification from the U.S. Food and Drug Administration (FDA) that its chemotherapy candidate drug, Cantrixil, has been granted Orphan Drug Designation for ovarian cancer. Orphan Drug Designation is an important […]
Deal activity is rampant as Big Pharma gobbles up next-generation medicines and technologies to help overcome maturing pipelines and biosimilar threats.
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
R&D success and M&A activity loom as large swing factors for the bio sector in 2017 with the regulatory arena potentially at its most amenable for years.
Nearly two decades ago, the promise of precision medicine began making its mark on the pages of medical journals – along with speculation that “therapy with the right drug at the right dose in the right patient” – would define the future of medical treatment.
There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.
(Reuters) – Belgium and the Netherlands will jointly negotiate the purchase of remedies for rare diseases with pharmaceutical groups, the Belgian health ministry said on Tuesday. The joint negotiations will focus on diseases which affect fewer than five in 100,000 people, so-called orphan diseases, for which treatments are often very expensive due to the limited […]
(Reuters) – Israel’s BrainStorm Cell Therapeutics said a mid-stage clinical trial of its adult stem cell treatment showed a “statistically significant” effect in patients with amyotrophic lateral sclerosis (ALS). According to the ALS Association, 5,600 people in the United States are diagnosed each year with the neurodegenerative disease, also known as Lou Gehrig’s Disease, which […]
Pfizer Receives U.S. FDA Breakthrough Therapy Designation For XALKORI (crizotinib) For The Treatment Of Patients With ROS1-Positive Non-Small Cell Lung Cancer
NEW YORK–(BUSINESS WIRE)–Pfizer Inc. announced today that XALKORI® (crizotinib) received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC). Occurring in approximately one percent of NSCLC cases1, ROS1-positive NSCLC represents a particular molecular subgroup of NSCLC.2 XALKORI currently is approved […]
(Reuters) – AstraZeneca’s recently approved ovarian cancer drug Lynparza, or olaparib, can also help men with prostate cancer, according to new clinical trial results on Tuesday. The news is the latest boost to the British company’s cancer drug pipeline, which formed a central plank of its defense against a $118 billion takeover attempt by Pfizer […]
WASHINGTON, April 21, 2015 /PRNewswire-USNewswire/ — Following is the daily “Profile America” feature from the U.S. Census Bureau: LIFESAVING MEDICINE Profile America — Tuesday, April 21st. One of world’s most important medicines — insulin —became available for general use this month in 1923, saving the lives of millions of people suffering from diabetes. Insulin is a hormone […]
INDIANAPOLIS, April 20, 2015 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) announced today that the investigational medicine ixekizumab was statistically superior to placebo in the treatment of patients with active psoriatic arthritis (PsA), as demonstrated by the proportion of patients achieving an ACR 20 response. ACR 20 is a standard assessment that represents a […]
Merz Neurosciences to Present Key Clinical Data at the Annual Meeting of the American Academy of Neurology (AAN)
RALEIGH, N.C.–(BUSINESS WIRE)–Merz Neurosciences, a division of Merz North America (U.S. affiliate of the global Merz Pharma Group), announces that it will present top-line data from its Phase 3 PURE: Post-stroke Spasticity UppeR Limb Study to Investigate Efficacy and Safety of NT 201 clinical trial for incobotulinumtoxinA during the 67th Annual Meeting of the American […]
PHILADELPHIA, April 20, 2015 /PRNewswire-USNewswire/ — Stand Up To Cancer (SU2C) and the American Cancer Society (ACS) announced the formation of a $20 million Dream Team to attack the number one cancer killer in America, lung cancer, here today at the Annual Meeting of the American Association for Cancer Research (AACR), Scientific Partner to SU2C. ACS […]
Swiss drugmaker Roche (RHHBY) is doubling down on its immunotherapy oncology pipeline, on Monday announcing it will pay Indian company Curadev Pharma up to $555 million to develop and market its IDO1 and TDO inhibitors IDO1 (indoleamine-2, 3-dioxygenase-1) and TDO (tryptophan-2, 3-dioxygenase) are enzymes that mediate cancer-induced immune suppression, which tumor cells and a certain […]
Provides clients with broad range of standardized lab testing services and capabilities WILMINGTON, N.C. (April 20, 2015) – Pharmaceutical Product Development LLC (PPD) has opened a central laboratory in Shanghai, China, to deliver global scientific and technical laboratory expertise to meet growing client demand for these services in China. The new facility, which has been […]
-Technology and Industry Leader to Head eClinical Business Unit- NEWTOWN, PENNSYLVANIA, April 20, 2015 – BioClinica®, Inc., a specialty clinical trials services and technology provider, today announced that Mukhtar Ahmed, a recognized business leader within the life sciences, healthcare and technology sectors, will join BioClinica on April 20th as President of its Global eClinical […]
(Reuters) – Eli Lilly and Co said its experimental drug, ixekizumab, reduced the signs and symptoms of active psoriatic arthritis in patients more than a placebo did in a late-stage trial. Up to 30 percent of psoriasis patients develop psoriatic arthritis, an inflammatory form of arthritis that can cause swelling, stiffness and pain in and around […]
(Reuters) – A combination of two Bristol-Myers Squibb drugs that help the immune system fight melanoma led to significantly greater tumor shrinkage than treatment with one of the medicines, according to a midstage study presented on Monday. The combination of Yervoy and the newer Opdivo also reduced the risk of disease progression by 60 percent compared […]
PHILADELPHIA–(BUSINESS WIRE)–Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, today announced the presentation of data on two epigenetic targets in its pioneering therapeutic pipeline. These data were presented this week at the American Association for Cancer Research (AACR) Annual Meeting in Philadelphia, Penn. Epizyme’s AACR 2015 posters […]
(Reuters) – Mindfulness-based cognitive therapy (MBCT) may be just as effective as anti-depressants in helping prevent people with chronic depression from relapsing, scientists said on Tuesday. Depression is one of the most common forms of mental illness, affecting more than 350 million people worldwide. It is ranked by the World Health Organization as the leading […]
The 49-year-old woman had had three melanoma growths removed from her skin, but now the disease was spreading further. A several-centimeter-sized growth under her left breast went deep into her chest wall. Some of the tissue in the tumor was dying because of lack of blood flow. Doctors at Memorial Sloan Kettering Cancer Center offered […]
Tokai Pharmaceuticals Announces Preclinical Results from the University of Maryland Showing Galeterone and Analogs Inhibit Pancreatic Cancer Cell Growth
BOSTON–(BUSINESS WIRE)–Tokai Pharmaceuticals, Inc. (NASDAQ:TKAI), a clinical-stage biopharmaceutical company focused on developing novel therapies for prostate cancer and other hormonally-driven diseases, today announced that scientists in the laboratory of Vincent Njar, PhD, at the University of Maryland School of Medicine presented preclinical data showing that galeterone and novel analogs of galeterone inhibited growth, survival and […]
PORTLAND, Ore., April 20, 2015 /PRNewswire/ — Research published today in the Proceedings of the National Academy of Sciences (PNAS) demonstrates that technology invented by researchers at Oregon Health & Science University’s Casey Eye Institute can improve the clinical management of the leading causes of blindness. Optical coherence tomography (OCT) angiography could largely replace current dye-based […]
(Reuters) – A new type of immuno-oncology treatment from Novartis AG proved safe in a tiny study of three types of solid tumors, but the trial included too few patients and used too small a dose of the experimental product to prove effectiveness, according to data presented at a cancer meeting on Sunday. The so-called […]