U.K. Health Authority Investigates Epilepsy Drug’s Link to Autism
U.K. Health Authority Investigates Epilepsy Drug’s Link to Autism
The Medicines and Healthcare products Regulatory Agency’s investigation comes after a study showed prenatal exposure to topiramate roughly triples a child’s likelihood of having autism or intellectual disability.
The Medicines and Healthcare products Regulatory Agency’s investigation comes after a study showed prenatal exposure to topiramate roughly triples a child’s likelihood of having autism or intellectual disability.
drug safety
Two Children Die After Receiving Novartis Gene Therapy
Andy Carstens | Aug 12, 2022 | 1 min read
No deaths had previously been associated with the muscle-wasting treatment Zolgensma.
Experimental Pill to Treat Parkinson’s Is Safe, Trial Finds
Andy Carstens | Jun 10, 2022 | 2 min read
Testing in animals and lab-grown cells suggests the experimental drug could enhance the function of lysosomes within cells.
Participant’s Diagnosis Halts Gene Therapy Clinical Trial
Amanda Heidt | Aug 12, 2021 | 3 min read
The FDA pauses the research program on a lentivirus-based treatment for a rare neurological condition after a patient developed a bone marrow disorder that could presage leukemia.
Infographic: The Value of Scaling: PSC Suspension Cultures
Thermo Fisher Scientific | Mar 17, 2021 | 1 min read
As research and therapeutic applications for pluripotent stem cells (PSCs) grow, so does the need to reliably and cost-effectively generate large numbers of high-quality cells.
Activities Discovered for Some Inactive Drug Ingredients
Ruth Williams | Jul 23, 2020 | 4 min read
Screens of hundreds of drug excipients reveal that some can interact with biological targets, contradicting their FDA categorization as inert.
Doctor Who Blocked Thalidomide Dies
Kerry Grens | Aug 11, 2015 | 1 min read
Frances Oldham Kelsey, a physician who halted use of a drug that caused birth defects in babies, has passed away at age 101.
Chronic Weed Use Shrinks Brain Region
Bob Grant | Nov 12, 2014 | 2 min read
Long-term marijuana smokers have less gray matter in their orbitofrontal cortex than nonsmokers, but other brain circuits may compensate by increasing connectivity.
Epigenetic Cancer Therapy Clears Phase I
Tracy Vence | Apr 7, 2014 | 2 min read
Investigational drug that inhibits proteins involved with epigenetic regulation shows activity against certain blood cancers in an early-stage clinical trial.
Opinion: Translational Biotechnology
John D. Loike and Jennifer E. Miller | Feb 17, 2014 | 4 min read
Regulators must consider both the promise and potential pitfalls of new technologies when determining whether to move them into clinical trials.
FDA Considers Easing Controls on Diabetes Drug
Dan Cossins | Jun 11, 2013 | 2 min read
A panel of advisors says that the agency should loosen restrictions on the sale of a diabetes drug with a spotty clinical safety record.
How Safe Is Your Medicine Cabinet?
Megan Scudellari | May 1, 2013 | 7 min read
After numerous high-profile safety scares, clinicians and regulators push to fix critical weaknesses in the FDA’s monitoring system for approved drugs.
Opinion: Regenerating Safely
Dan Orlando | Jan 21, 2013 | 3 min read
Patient safety is paramount in regulating new stem cell treatments.
Fears over Fast-Tracking Drugs
Edyta Zielinska | Sep 10, 2012 | 1 min read
Doctors question whether a government initiative to speed approval for promising new drugs is ensuring safety.
Call for Diabetes Drug Ban
Sabrina Richards | Apr 30, 2012 | 2 min read
A consumer advocacy group calls for a ban of a diabetes drug after evidence surfaces that it may increase the risk of cancer.
FDA Ups Recent Recalls
Bob Grant | Nov 9, 2011 | 1 min read
The US regulatory agency recalled 54 percent more drugs from the second to third quarters of 2011.
Opinion: Sustainable Drug Monitoring
Jur Strobos and Andy Stergachis | Aug 31, 2011 | 3 min read
Pharmacovigilance must keep pace with global distribution of drugs in resource-limited settings.
European Drug Agency Faces Scrutiny
Tia Ghose | Aug 4, 2011 | 1 min read
Europe’s anti-fraud office has launched an investigation into potential conflicts of interest at the EU’s drug approval agency.