Merck’s vaunted PD-1 inhibitor Keytruda suffered another setback when it failed to meet endpoints in a Phase III head and neck cancer study.
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) – European regulators on Friday recommended approving Pfizer Inc and Merck KGaA’s immuno-oncology drug Bavencio to treat a rare type of skin cancer called Merkel cell carcinoma. In May, Bavencio was approved by the U.S. Food and Drug Administration to treat bladder cancer and in March to treat Merkel cell carcinoma. (bit.ly/2vIbPPG) Bavencio, known […]
ZURICH (Reuters) – A European Medicines Agency (EMA) panel recommended on Friday approval of a new Novartis drug to be used against a tough-to-cure form of blood cancer as the Swiss drugmaker makes headway on refreshing its oncology portfolio. The EMA’s Committee for Medicinal Products for Human Use (CHMP) backed Rydapt against acute myeloid leukemia […]
Vertex Pharmaceuticals announced positive efficacy data from its Phase I and Phase II studies of three different triple combination regimens for cystic fibrosis patients,
NKTR-181 shows significantly less abuse potential compared to oxycodone.
The FDA approved Puma Biotechnology’s breast cancer drug Nerlynx (neratinib).
The FDA is tackling a new way to recruit top talent — talent that will fill a “substantial” number of vacant position.
People hoping to lose a few pounds by substituting artificial sweeteners for regular sugar may end up disappointed, suggests a fresh look at past research.
Fueled by a desire for innovation and new medical breakthroughs, the biotech industry continues to enjoy substantial growth due to increased investment in R&D.
FDA placed a clinical hold on three trials studying Merck’s PD-1 inhibitor Keytruda in combination with products developed by Celgene following Merck’s initial reporting of several patient deaths.
Bristol-Myers Squibb announced promising interim data from its Phase III clinical trial of Opdivo 3 mg/kg compared to 10 mg/kg Yervoy in melanoma.
AstraZeneca and Hutchison China MediTech said they had initiated a global late-stage clinical trial of the experimental drug savolitinib in a relatively rare type of kidney cancer.
Alder BioPharmaceuticals’ late-stage study data on its experimental treatment to prevent episodic migraine fell short of investors’ expectation.
Merck & Co. Inc. said its experimental cholesterol drug met the main goal of reducing coronary heart diseases in a late-stage study, sending the company’s shares up 2.4 percent in premarket trading.
The investigational hemophilia drug emicizumab cut the bleed rate by 87% in patients with resistance to standard therapy versus those receiving another treatment.
Seattle Genetics and Takeda Pharmaceutical Company announced positive results from the Phase III ECHELON-1 clinical trial in previously untreated advanced classical Hodgkin lymphoma.
Shingrix induced a strong immune response in older adults previously been vaccinated against shingles with the currently available live-attenuated zoster vaccine.
Clovis Oncology announced topline results from a confirmatory Phase III ARIEL3 trial of Rubraca (ruparib) in platinum-sensitive ovarian cancer.
Seattle Genetics halted all clinical trials of its vadastuximab talirine due to higher incidents of death associated with the treatment for AML patients.
Physical activity during and after pregnancy improves psychological wellbeing and may protect against postpartum depression, according to a new analysis.