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Home » Topics » Drugs

Drugs
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EMA Highlights Trial Innovation, Real-World Data Advances

March 30, 2023
The EMA said it expects the progress to continue in the next two years. Read More

Bicycle and Novartis Team Up to Develop Novel Molecules

March 30, 2023
Bicycle will receive an upfront payment of $50 million and is eligible to receive up to $1.7 billion in milestone payments. Read More

EU Approves Amicus Therapeutics Pombiliti for Late-Onset Pompe Disease

March 30, 2023
Pombiliti must be administered along with an enzyme inhibitor. Read More

Approved Alzheimer’s Treatments Ramp Up Research Enthusiasm, Experts Say

March 30, 2023
GOTHENBURG, SWEDEN — The approval of two Alzheimer’s disease-modifying therapies is giving the field a much-needed shot in the arm, experts said during a panel discussion at the Alzheimer’s and Parkinson’s Disease 2023 meeting. Read More

Califf Defends Against Proposed Cuts to FDA’s Budget for Fiscal 2024

March 30, 2023
If the FDA is forced to go back to fiscal 2022 levels — as House Republicans are proposing — there will be fewer inspections, new drug products won’t get approved and drug companies will flock to other countries, said FDA Commissioner Robert Califf during a fiscal 2024 budget hearing on Wednesday. Read More

Esperion Sues Daiichi Sankyo Over $300M Milestone Payment

March 30, 2023
Esperion is suing Daiichi Sankyo over a failure to pay a $300 million milestone payment for the cardiovascular drug Nexletol (bempedoic acid), a treatment for heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease. Read More

FDA Approves Over-the-Counter Naloxone Nasal Spray

March 30, 2023
The FDA has approved the first over-the-counter (OTC) naloxone nasal spray — Emergent BioSolutions’ opioid overdose therapy Narcan, 4 mg — and is encouraging other producers to apply for OTC status. Read More

FDA Generics Program Resumes In-Person Meetings

March 29, 2023
The plan is to include “only core participants with a primary speaking role in-person while others will join virtually.” Read More

Glenmark Pharmaceuticals’ Generic of Leo Pharma’s Enstilar Approved

March 29, 2023
Glenmark’s product is eligible for 180 days of generic drug exclusivity. Read More

Cyclerion’s Mitochondrial Diseases Candidate Gets Orphan Drug Nod

March 29, 2023
A 29-day study showed the drug candidate was associated with improvements in several disease-relevant biomarkers. Read More

White House Outlines New Drug Manufacturing Goals to Improve Supply Chain

March 29, 2023
The White House has laid out “bold goals” to use biomanufacturing breakthroughs to produce at least 25 percent of all active pharmaceutical ingredients (API) for small-molecule drugs in the U.S. within five years. Read More

Bipartisan PBM Transparency Act Advances Out of Committee

March 29, 2023
The Senate Commerce, Science and Transportation Committee has passed a bill that would force pharmacy benefit managers (PBM) to be upfront about their often murky pricing practices and compel them to stop what legislators are calling unfair and deceptive conduct that drives up costs for consumers. Read More
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