FDA: Page 76
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FDA
FDA renews ban on Indian drugmaker after fresh violations
Pan Drugs failed to maintain basic sanitary standards at its Vandodara facility, and FDA inspectors uncovered evidence of falsified documents.
By Ned Pagliarulo • Sept. 8, 2016 -
BioMarin hits snag with latest rare disease drug
The biotech has once again been thwarted in moving its pipeline forward due to regulatory actions.
By Suzanne Elvidge • Sept. 7, 2016 -
Karyopharm tees up filing for multiple myeloma drug
Results from a Phase 2b trial showed roughly 20% of heavily pretreated patients responded to treatment. But more data is needed to support an NDA.
By Ned Pagliarulo • Sept. 7, 2016 -
FDA
Jazz subsidiary warned over misbranding of cancer drug
A promotional poster at the ASCO meeting in June landed Celator in hot water with the FDA's Office of Prescription Drug Promotion.
By Ned Pagliarulo • Sept. 6, 2016 -
Dynavax shares fall as FDA cancels vax adcomm
While a regulatory decision is still expected by December for Dynavax's hepatitis B vaccine, the FDA said it would not review additional data related to several patient sub-populations.
By Suzanne Elvidge • Sept. 6, 2016 -
Novo Nordisk faces delay for insulin combo
The setback could give rival Sanofi a crucial one-month edge over Novo in the race to bring an insulin combo product to market.
By Lisa LaMotta • Sept. 6, 2016 -
FDA
FDA strengthens warnings on opioids, benzodiazepines
The new actions taken this week are part of the agency's widening efforts to combat the opioid abuse epidemic.
By Suzanne Elvidge • Sept. 2, 2016 -
Tonix preps to enter PTSD market
The biotech cleared Phase 2 and is readying its lead compound for late-stage trials.
By Lisa LaMotta • Aug. 31, 2016 -
Novartis wins US approval for biosimilar Enbrel
Erelzi is only the third biosimilar drug approved in the U.S., following copies of Amgen's Neupogen and Johnson & Johnson's Remicade.
By Ned Pagliarulo • Aug. 30, 2016 -
Biosim threat stiffens for Roche's Herceptin
A number of Roche's top-selling cancer drugs face looming competition from biosimilars in both the U.S. and Europe.
By Ned Pagliarulo • Aug. 28, 2016 -
Theranos planning appeal of federal penalties
Health regulators last month handed down sweeping sanctions to the blood-testing company, banning founder Elizabeth Holmes from the business for two years.
By Ned Pagliarulo • Aug. 26, 2016 -
Sagent recalls injectable antibiotic
One lot of Oxacillin is being pulled from the market after metal particulate was found in a vial of the drug.
By Ned Pagliarulo • Aug. 25, 2016 -
FDA
FDA unexpectedly snubs Amgen drug
Approval had been expected for the drug, a treatment for a type of hormone imbalance in patients with chronic kidney disease.
By Ned Pagliarulo • Aug. 25, 2016 -
With PDUFA date for rucaparib set, Clovis eyes rebound
A high-profile failure of Clovis' lung cancer drug earlier this year had led the company to cut a third of its staff and pin its hopes on rucaparib.
By Ned Pagliarulo • Aug. 24, 2016 -
Puma's neratinib closing in on EU market
European regulators accepted a filing for the biotech's breast cancer drug, despite known gastrointestinal issues caused by the drug.
By Suzanne Elvidge • Aug. 23, 2016 -
Amgen refutes 'flawed' cholesterol study
The big biotech pushes back against a recent medical journal article that criticized its cholesterol drug pricing.
By Suzanne Elvidge • Aug. 22, 2016 -
Courtesy of Sanofi
FDA delays Sanofi's diabetes combo
The three-month delay occurred because Sanofi submitted new information about the drug’s pen-delivery device at the FDA’s request, which resulted in a “major amendment” to the original NDA.
By Kirell Lakhman • Aug. 22, 2016 -
FDA
Chinese/Indian manufacturing facilities facing repercussions
All products coming from the Indian company, Laxachem Organics, are banned from importation into the U.S.
By Nicole Gray • Aug. 18, 2016 -
Another Indian API facility added to EU's 'do not import' list
German inspectors found close to 35 issues at the Artemis Biotech facility.
By Nicole Gray • Aug. 18, 2016 -
Avalere: FDA fees are outpacing drug approvals
Manufacturer's user fees have been increasing, but so has the number of drugs approved. One report says that more can be done to increase efficiency at the FDA.
By Lisa LaMotta • Aug. 17, 2016 -
Ipsen hopes to be David to Allergan's Goliath
The French biotech is hoping a new indication for its boulinum toxin Dysport will allow it to compete more effectively with Allergan's market-leading Botox.
By Nicole Gray • Aug. 17, 2016 -
Boehringer seeks real-world data to support reversal agent
The pharmaceutical company is hoping to bolster sales of Pradaxa with real-wrold data supporting the use of its anti-coagulant reversal agent Praxabind.
By Nicole Gray • Aug. 16, 2016 -
Chinese regulators advance overhaul of drug manufacturing
Draft guidelines released last week are a continuation of CFDA's efforts to raise quality standards for domestically produced drugs.
By Ned Pagliarulo • Aug. 15, 2016 -
Endo ditches pursuit of abuse-deterrence for Opana
The specialty pharmaceutical company has withdrawn its sNDA after discouraging discussions with regulators.
By Lisa LaMotta • Aug. 15, 2016 -
Shire launches new treatment for hereditary bleeding disorder
Vonvendi is the first recombinant replacement treatment for von Willebrand disease, a condition with very few treatment options currently on the market.
By Nicole Gray • Aug. 10, 2016
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