Atara Biotherapeutics Inc said it would stop developing its kidney drug after the treatment failed to meet the main goal of a mid-stage study. The drug developer said on Monday that the drug, PINTA 745, did not improve physical function, levels of inflammation and blood sugar in patients in the study. Atara’s shares fell nearly […]
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.
Sangamo BioSciences Inc reported promising preliminary data from two mid-stage studies of its experimental HIV/AIDS therapy. The studies evaluated the drug, codenamed SB-728-T, delivered using a common virus called an adenovirus. Preliminary data suggested that delivering the drug to the target using the virus was better for immune stimulation and control of viral load in […]
AstraZeneca is diving into the world of proteins secreted by cells – collectively known as the secretome – in the hunt for new drugs and better “cell factories” for making biotech medicines. The so-called secretome accounts for around one third of human proteins and the idea of mapping them all follows the decoding of […]
Bayer AG is packing more cancer drugs into its pipeline to gain a bigger share of the almost $100 billion global market for such treatments. Known for Aspirin and the blood thinner Xarelto, Germany’s most valuable company had no cancer treatments on the market a decade ago. By the end of this one, Bayer may […]
Raptor Pharmaceutical Corp said it plans to advance development of its brain disorder drug to a registration study, despite it failing to show statistical significance in a trial. The drug, RP103, is being evaluated in patients with Huntington’s Disease, a type of neurodegenerative genetic disorder that affects muscle coordination and leads to mental decline and […]
More than half of the world’s population will live in countries where medicine use will exceed one dose per person per day by 2020, up from 31 percent in 2005, as the “medicine use gap” between developed and pharmerging markets narrows, according to research by the IMS Institute for Healthcare Informatics.
Danish biotech Genmab, which has seen its shares rocket 163 percent this year, is set for further gains as new research data showed increased potential for its Darzalex blood cancer treatment, analysts said on Wednesday. Patients using the drug had an overall survival rate of 90 percent and a 72 percent progression free survival rate […]
Cara Therapeutics Inc said its arthritis drug met the main goal of reducing pain in patients in the first mid-stage study. The oral drug, CR845, was being evaluated in patients with osteoarthritis in the knee or hip, the company said on Wednesday. Osteoarthritis, also known as degenerative arthritis, is a type of disease that results […]
European and U.S. drug regulators are looking into whether a defective blood clotting test device affected a trial involving Bayer’s top-selling anti-clotting drug Xarelto, hitting the German drugmaker’s shares. The study compared Xarelto, also known as rivaroxaban, with older drug warfarin for preventing strokes in patients with a type of irregular heartbeat common among the […]
China’s food and drug regulator said late on Monday it had rejected applications for 13 new drugs, citing false or incomplete trial data, as the government toughens enforcement of quality standards. The China Food and Drug Administration (CFDA) last month also rejected applications by eight Chinese companies for inadequate trial data related to generic drugs […]
BioAtla Enters Into Strategic License And Option Agreement With Pfizer For A New Class Of Antibody Therapeutics
Agreement combines BioAtla’s Conditionally Active Biologic (CAB) antibodies with Pfizer’s Proprietary ADC Payloads Pfizer gains rights to BioAtla CAB immune checkpoint inhibitors targeting CTLA-4 SAN DIEGO, Dec. 7, 2015 /PRNewswire/ — BioAtla LLC, a biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, today announced that it has entered into a […]
Tonix Pharmaceuticals Holding Corp said it was teaming up with the U.S. Department of Defense to further develop its experimental PTSD drug, which if approved, could be the first treatment for the psychiatric disorder in more than 15 years. The Cooperative Research and Development Agreement with the Department of Defense will allow Tonix to gain […]
Novartis’s copycat version of Amgen’s Neulasta worked just as well as the original drug in preventing a condition that can lead to infections among breast cancer sufferers, the Swiss company said in a statement on Monday. Its pegfilgrastin biosimilar, whose submission for approval was accepted in November by the U.S. Food and Drug Administration, had […]
Company Also Bolsters Board of Directors and Scientific Advisory Board with Outstanding Leaders BOSTON–(BUSINESS WIRE)–SQZ Biotech (SQZ) announced today a partnership with Roche to develop a cell therapy platform that would empower a patient’s own immune cells to fight a broad range of cancers. The deal leverages SQZ’s pioneering technology to engineer B cells as […]
Merck & Co’s immunotherapy Keytruda led to a high response rate for patients with the blood cancer multiple myeloma when added to standard therapy in a small, early stage trial, according to data presented on Monday. The Phase I study tested Keytruda in combination with Celgene’s Revlimid and the corticosteroid dexamethasone in patients whose disease […]
MOUNTAIN VIEW, Calif. – Google Inc. is stepping closer to developing a device to draw blood for medical testing without needles, Wired reported Monday morning. The Internet giant filed a patent application Dec. 3 on a gas-based system designed to draw blood from a fingertip to be used to test blood sugar levels. According to […]
Germany’s Merck KGaA and development partner Threshold Pharmaceuticals said their experimental cancer drug evofosfamide failed to show the desired effects in two late stage studies. Evofosfamide did not meet the main goal of improving overall survival in patients suffering from advanced pancreatic cancer and advanced soft tissue sarcoma, prompting the two companies to give up […]
Johnson & Johnson’s and AbbVie’s cancer drug Imbruvica significantly reduced the risk of death and disease progression compared with chemotherapy in previously untreated patients with a type of leukemia in a late stage study, paving the way for an expanded approval of the medicine. In the trial of 269 patients aged 65 and older with […]
Novartis’ phase III study for its acute myeloid leukemia (AML) drug showed it improved overall survival by 23 percent for patients with FLT3 mutations, the Swiss drugmaker said on Sunday. Basel-based Novartis said the study was the first large controlled trial to show overall survival benefit in FLT3-mutated AML, and that worldwide regulatory submissions […]
Eli Lilly & Co said on Friday it scrapped development of an experimental diabetes treatment that had raised concerns of liver problems. Lilly had delayed applying for marketing the treatment — basal insulin peglispro — earlier in the year, after studies reported an increase in liver fat in patients. A severe buildup of fats in […]