Drugs
An analysis of pharmacy benefit manager (PBM) drug formulary exclusions by the Tufts Center for the Study of Drug Development says that no comparative clinical and cost-effectiveness studies were conducted for 10 of 16 drugs excluded by both CVS Caremark and Express Scripts. “Lack of evidence of comparative clinical
Drugs
A 6/29-7/8/15 FDA Los Angeles District Office inspection at Hartley Medical Center Pharmacy, Long Beach, CA, found that the pharmacy was not receiving valid prescriptions for individually-identified patients for a portion of the drugs it produced. Investigators also observed serious deficiencies in the pharmacy’s
Drugs
Former FDA commissioner David Kessler told the CBS Evening News 5/9 that FDA shares responsibility for the nation’s opioid epidemic, along with drug companies and doctors. “We didn’t see these drugs for what they truly are,” Kessler said in discussing what he terms “one of the great
Drugs
FDA is warning that the antipsychotic medicine olanzapine (Eli Lilly’s Zyprexa, Symbyax, and generic equivalents) can cause a rare and serious skin reaction that can progress to affect other parts of the body. The agency has ordered a new warning to the drug labels for all olanzapine-containing products
Drugs
FDA has given positive feedback to Paratek Pharmaceuticals on the design of a proposed oral-only Phase 3 study of omadacycline for treating acute bacterial skin and skin structure infections (ABSSSI). In its feedback, the agency confirmed that a proposed comparator is acceptable and that the proposed study design would
Drugs
University of Pittsburgh researcher Kenneth Walker has entered into a voluntary settlement agreement with HHS’ Office of Research Integrity (ORI) due to “research misconduct” associated with work supported by the National Institute of Diabetes and Digestive and Kidney Diseases. ORI found that Walker engaged in research misconduct by falsifying and
Drugs
FDA has approved an expanded label for Janssen’s Imbruvica (ibrutinib) based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The approved label now includes overall survival data from the Phase 3 RESONATE-2 (PCYC-1115) trial in treatment-naïve CLL/SLL
Drugs
PharMEDium Services has recalled sterile preparations compounded with a single recalled lot of Fresenius’ Kabi Sensorcaine-MPF (bupivacaine HCl). Fresenius Kabi recalled its product due to the presence of particulate matter (glass) that was identified during a reserve sample inspection. The list of affected codes/lots can be found on
Drugs
FDA has approved a Theravance Biopharma supplemental NDA for Vibativ (telavancin) to expand the antibiotic’s label to include data describing the treatment of patients with concurrent Staphylococcus aureus bacteremia in both currently approved indications. Vibativ is approved in the U.S. for treating adult patients with hospital-acquired and
Drugs
Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee voted 16-4 to recommend the safety and efficacy of KemPharm’s Apadaz (benzhydrocodone/acetaminophen oral tablets) for an indication of short-term (up to 14 days) management of acute pain. During the committee meeting, FDA asked the advisors
Drugs
Researchers from many countries say that responding to President Barack Obama’s call to modernize the current regulatory landscape for precision medicine will be no easy task. The worldwide regulatory challenges that arise in response to calls for precision medicine were explored in a 2014 workshop in Hobart, Australia. Information
Drugs
FDA or Congress should develop a true conditional approval system similar to the one operating since 2006 in the European Union, according to Fairleigh Dickinson University executive director of the Rothman Institute of Innovation and Entrepreneurship Joseph Gulfo. Writing in an online Forbes commentary, Gulfo uses a recent advisory committee
Drugs
FDA has approved a Tolmar Pharmaceuticals NDA supplement to update the label for Eligard (leuprolide acetate for injectable suspension), indicated for the palliative treatment of advanced prostate cancer. The update covers drug stability data that show, prior to mixing, Eligard may be stored at room temperature (59 – 86° F) for
Drugs
CDER researchers writing in the journal Clinical Cancer Research say that a 9/29/10 agency final rule revising IND safety reporting regulations and guidance did not have the intended effect on the safety reporting practices of commercial sponsors of oncology drug products. More than five years since the final
Drugs
All 30 members of the combined FDA Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted during a 5/3-4 joint meeting to recommend that FDA modify the Risk Evaluation and Mitigation Strategies (REMS) for extended-release and long-acting (ER/LA)
Drugs
FDA has granted an orphan drug designation for Allena Pharmaceuticals’ ALLN-177, oxalate decarboxylase, for treating pediatric hyperoxaluria. The company says that the compound is being developed to treat patients with disorders of oxalate metabolism. There currently are no effective treatments for hyperoxaluria in children, it says, and the orphan
Drugs
To further the possibility of FDA guidance to encourage product sponsors to engage patients throughout the drug research and development lifecycle, the National Health Council and the Genetic Alliance convened a 12/9/15 meeting with 36 stakeholders to inform the scope and content of a proposed FDA guidance document.
Drugs
Professors Amy Kapcynzki (Yale Law School) and Aaron Kesselheim (Harvard Medical School) propose that the federal government make some drugs more affordable by invoking the existing “government patent use” law. Writing in Health Affairs, the two say that the high cost of patent-protected prescription drugs can strain budgets and
Drugs
FDA has ordered drug compounder Medaus (Birmingham, AL) to conduct an immediate recall of all sterile drug products based on GMP deficiencies documented during a recent inspection. The just-posted agency recall letter says the March inspection observed “insanitary conditions including poor aseptic production practices” that resulted in a lack
Drugs
Wave Life Sciences has entered into a research, license and option agreement with Pfizer to investigate developing nucleic acid therapies aimed at silencing the underlying causes of debilitating metabolic diseases. “The collaboration will focus on genetically defined targets and bring together Wave’s proprietary stereopure drug development platform, across antisense
Drugs
Brothers Malvinder Mohan Singh and Shivinder Mohan Singh, the former majority owners of Ranbaxy Laboratories, say they will fight a three-person Singapore arbitration panel’s 2-1 ruling that they must pay about $386 million in damages to Daiichi Sankyo in response to a Daiichi complaint that the two
Drugs
Harvard Medical School professor Eric Campbell says that the “financial rewards companies reap” from engaging in behaviors that result in payments to settle civil and criminal cases “far outstrip any penalties they pay.” Campbell is quoted in a Fair Warning online story on a Public Citizen report detailing major drug