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Pharmafile 12/13/2019 11:10
The Committee for Medicinal Products for Human Use (CHMP), an advisory panel for the European Medicines Agency, has given its recommendation to Genmab’s Darzalex in combination with Bortezomib, Thalidomide and Dexamethasone as a front-line treatment for multiple myeloma (MM) in the European Union. The indication in question relates to newly diagnosed MM patients who are eligible for autologous stem cell transplant (ASCT).
Pharmafile 12/13/2019 08:00
Novartis’ single-chain antibody fragment Beovu has secured recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of wet age-related macular degeneration (AMD), is has emerged. The ruling was reached on the back of Phase 3 data in which Beovu proved itself to be non-inferior compared to Regeneron’s Eylea in terms of average best-corrected visual acuity from baseline throughout one year of treatment.
Pharmafile 12/12/2019 10:27
Novartis Kisqali (ribociclib) plus fulvestrant demonstrated a statistically significant improvement in overall survival rates, with an almost 30% reduction in risk of death compared to fulvestrant on its own in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. This data was published in The New England Journal of Medicine (NEJM).
Pharmafile 12/12/2019 08:05
New Phase 3 data from Roche has shown that its subcutaneously-delivered formulation of Perjeta (pertuzumab) and Herceptin (trastuzumab), in combination with intravenous (IV) chemotherapy, proved non-inferior to its standard IV infusion formulation in the treatment of HER2-positive early breast cancer (eBC). Specifically, the subcutaneous formulation met its primary endpoint, showing non-inferior levels of Perjeta in the blood in addition to comparable efficacy and safety to the standard IV infusion.
Pharmafile 12/12/2019 07:17
Both the regulators governing NHS use of medicines in England, Wales and Scotland – the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC) – have moved to recommend Shionogi’s Mulpleo (lusutrombopag) for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) undergoing planned invasive procedures. The decision was based on evidence indicating that the therapy met all primary endpoints in two trials of 312 CLD patients with severe thrombocytopenia and a platelet count of <50,000/µL.
Pharmafile 12/12/2019 06:01
AstraZeneca’s Imfinzi (durvalumab) is set to be made available in China after the country’s National Medical Products Administration (NMPA) decided to authorise the therapy for the treatment of advanced non-small cell lung cancer (NSCLC). The approval specifically concerns unresectable, Stage 3 forms of the disease in patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (CRT)
Pharmafile 12/11/2019 07:51
NAFTA members have agreed to remove a provision that would have increased protections on biologics drugs. This means Canada, despite agreeing with the previous increase, will instead keep its existing eight years of exclusivity for the drugs before the generic version can enter the market. If the provision was kept in, it would have added significant costs to the healthcare system and to private drug plans.
Pharmafile 12/11/2019 06:15
A chicken farm in Suffolk has been confirmed by the British government to have cases of bird flu. 27,000 birds are set to be culled and a 1km exclusion zone is set up around the farm to stop the disease from spreading. It is the first recorded case in the UK since June 2017. The birds have the H5 strain of avian flu. Officials are reassuring the public that the risk of catching the disease is rare. The Food Standards Agency said that there are no safety risks as long as poultry products were thoroughly cooked.
Pharmafile 12/11/2019 05:46
Bristol-Myers Squibb took the opportunity at the 2019 American Society of Hematology (ASH) Annual Meeting to reveal new efficacy data on its candidate CC-486 in the maintenance treatment of front-line, newly diagnosed acute myeloid leukaemia (AML) in patients who have achieved remission with intensive induction chemotherapy. The drug was tested in 472 patients at least 55 years old with de novo or secondary AML with intermediate or poor-risk cytogenetics who had achieved their first complete remission (CR) or complete remission with incomplete count recovery (CRi) after receiving i.
Pharmafile 12/10/2019 07:54
Takeda Pharmaceutical Company Limited presented at the 61st American Society of Hematology (ASH) Annual Meeting, 29 company-sponsored abstracts to highlight its commitment to advancing treatments for rare bleeding disorders. These scientific updates from the company showed off investigational and early-stage therapies as well as data from Phase 3 trials in disease states like leukemia and lymphoma.
Pharmafile 12/10/2019 06:28
Three executives of Samsung Electronics have been sentenced to jail for their role in committing fraud at its biotech affiliate Samsung Biologics. Prosecutors accused the executives of ordering their employees to destroy internal documents, including hiding nearly two dozen computers, computers servers, and notebooks under the floors of Samsung Biologics factories near Seoul.
Pharmafile 12/10/2019 06:05
Janssen has unveiled new Phase 3 data on the efficacy of Darzalex (daratumumab) when combined with bortezomib, melphalan and prednisone (D-VMP) in the treatment of newly diagnosed, transplant-ineligible multiple myeloma at the 2019 American Society of Hematology (ASH) Annual Meeting in Orlando. In a pre-specified interim analysis conducted after a median follow-up of over three years, the Darzalex combo registered an estimated overall survival rate of 75% compared to 62% for bortezomib, melphalan and prednisone (VMP) alone.
Pharmafile 12/09/2019 07:00
AbbVie used the platform of the American Society of Hematology (ASH) conference to present four-year follow-up analysis data on venetoclax in combination with rituximab (VenR) in the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL). The data, harvested following the completion of the MURANO trial, examined participants who had been off venetoclax for a median of 22 months.

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