With more than half of the U.S. population fully vaccinated and mask mandates being lifted throughout the country, America looks to resume “normal life” before the pandemic took over.
Top 10 Pipelines To Watch
Acquisitions, Analysts, Annual Reports, Blockbuster Deals, Blockbusters, Business, Clinical Trials, Deals, Dengue, Department of Health and Human Services (HHS), Dermatology, Diffuse Large B-Cell Lymphoma (DLBCL), EMA, European Commission, European Medicines Agency (EMA), FDA, FDA/Regulatory, February 2020, Future Blockbusters, Hemophilia A, Hospital-Acquired Bacterial Pneumonia, Issue Archives, Licensing, Natural Killer Cells (NK Cells), New Drug Applications, New Molecular Entities, NMEs, Oncology, Potential Blockbusters, Priority Review, Priority Review Status, Product Pipelines, R&D, Rare Diseases, Senate Panel, Special Reports, Top 10 Pipelines, Top 10 Pipelines To Watch, VaccinesAs pharma companies bolster their pipelines via multibillion-dollar acquisitions, drug manufacturers continue to heavily invest in the oncology space.
A recent report written by SVB Leerink analysts that looked at eight companies and their research-and-development portfolios found that in the past five years, they progressed only 24 percent of their new molecular entities to approval.
FDA Approves Record-Breaking 59 Novel Drugs in 2018
Approvals, Calcitonin Gene-Related Peptide (CGRP), Cancer, Dravet syndrome, Epilepsy, Fabry Disease, FDA, FDA/Regulatory, First-In-Class, Hereditary Transthyretin Amyloidosis (hATTR), Migraine, New Molecular Entities, Polyneuropathy, RNA Interference (RNAi), SeizuresOver the course of 2018, the FDA approved 59 different novel drugs that range for the treatment of various cancers, chronic obstructive pulmonary disease (COPD), traveler’s diarrhea, migraine headaches and more.
Among the industry group PhRMA’s findings was that overall R&D spending was at an all-time high in 2017, hitting $71.4 billion, up from $65.5 billion in 2016 and from $29.8 billion in 2001.
Nektar Therapeutics announced the submission of a New Drug Application to the U.S. Food and Drug Administration for the new molecular entity NKTR-181, a mu-opioid agonist for pain relief. The company also inked a non-exclusive clinical collaboration deal with Syndax Pharmaceuticals to develop Nektar’s NKTR-214, a CD122-biased agonist in combination with entinostat, Syndax’s HDAC inhibitor in metastatic melanoma.
Eight PDUFA Dates to Watch in August 2017
Acute Lymphoblastic Leukemia (ALL), Acute Myeloid Leukemia (AML), Biotech, Blood Cancers, Cardiovascular Deaths, Glaucoma, Head & Neck Cancer, Hepatitis C, Kidney Cancer, Melanoma, Nasdaq Biotech Index, New Molecular Entities, New York Stock Exchange, Parkinson's Disease, Prescription Drug User Fee Act (PDUFA), Rabies, StocksThe biotech industry did OK in July 2017. The NYSE ARCA Biotech Index and the iShares NASDAQ Biotechnology Index (ETF) grew about 1.9 percent and 2.9 percent, respectively last month. There have been 26 new molecular entity approvals so far this year. With that figure in mind, here are eight companies looking at PDUFA dates in August 2017.
Special Feature – First Year After Launch: The specialties win again
Ankylosing Spondylitits, Antipsychotics, August 2017, Autoimmune Diseases, Biotech, Blockbusters, Breast Cancer, CDK 4/6 Inhibitors, First Year After Launch special feature, First-In-Class, Hepatitis C, Luteinizing Hormone-Releasing Hormone (LHRH) Agonists, New Drug Applicationa, New Molecular Entities, Plaque Psoriasis, Potential Blockbusters, Product Launches, Psoriatic Arthritis, Specialty Medicines, TherapeuticsJust like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.
A listing of the the new molecular entities launched in the United States during 2015 that generated 2016 sales of at least $200 million
2017 Annual Report: State Of The Bio Industry
ACA, Approvals, Biologics, Biosimilars, Biotech/Biopharma, Blockbusters, Business, Clinical Trials, Deals, FDA/Regulatory, June 2017, M&A, New Molecular Entities, Potential Blockbusters, Product Pipelines, R&D, Special Reports, State of the Bio Industry, Tufts Center for the Study of Drug DevelopmentR&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.