Drugs
Merck says it would be helpful if FDA would include in a draft guidance on bioavailability studies submitted in NDAs or INDs the reason or trigger for revising the 3/2014 draft guidance and a summary of key changes from the 2014 document. Pharmaceutical Research and Manufacturers of America (PhRMA)
Drugs
FDA has opened a public docket to receive comments on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that certain solid, oral dosage forms of immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging for outpatient dispensing. A
Drugs
Heritage Pharmaceuticals has recalled one lot of amikacin sulfate injection, USP, 1g/4 mL (250mg/mL) and one lot of prochlorperazine edisylate injection, USP, 10mg/2mL (5mg/mL) due to microbial growth having been detected in each lot. The drug products are manufactured by Emcure Pharmaceuticals and distributed by Heritage.
Drugs
An FDA 5/13 public meeting on the future of insulin biosimilars heard from stakeholders representing many different perspectives. Mylan head of global clinical research Abhijit Barve said any “additional requirements not based on risk or clinical relevance will only be a barrier to development” of biosimilar insulins. “In fact,
Drugs
A recent updated Justice Department guidance intended to help department prosecutors evaluate corporate compliance programs in the context of investigations of business entities confirms that three fundamental issues are relevant to any such evaluation. Attorneys Gregory Brower and Stanley Garnett (Brownstein Hyatt Farber Schreck) write in a Washington Legal Foundation
Drugs
FDA has released two documents relating to its work on regenerative medicine therapies. The first, Standards Development for Regenerative Medicine Therapies, says the agency is working with the National Institute of Standards and Technology and stakeholders to facilitate efforts to coordinate development of standards for regenerative medicine therapies as required
Drugs
A 5/20 Supreme Court decision in a Merck Fosamax case involving the company’s alleged failure to warn about atypical femur fractures “will change the dynamics of litigation involving the impossibility defense, and will introduce new litigation uncertainty due to a shift in the decision maker for impossibility preemption.
Drugs
FDA has accepted for priority review an Amarin supplemental NDA for Vascepa (icosapent ethyl) capsules, indicated to reduce residual cardiovascular risk in patients with statin-managed LDL-C cholesterol, but persistent elevated triglycerides, an important indicator of cardiovascular disease. Vascepa is currently indicated as an adjunct to diet to reduce
Drugs
The Supreme Court has rejected a request that it reconsider a 7th Circuit Court of Appeals ruling throwing out a $3 million jury verdict in the death of an Illinois attorney who committed suicide in 2010, six days after starting to take GlaxoSmithKline’s Paxil (paroxetine) for depression. An Illinois
Drugs
FDA has granted Bayer a Breakthrough Therapy Designation for Aliqopa (copanlisib) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies. MZL is an indolent form of non-Hodgkin’s lymphoma (iNHL)and accounts for about 10% of all non-
Drugs
FDA has approved a Celgene supplemental NDA for Revlimid (lenalidomide) in combination with rituximab for treating adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma. The company says that this is the first FDA-approved combination treatment regimen for patients with these indolent forms of non-Hodgkin’
Drugs
Researchers say that confirmatory trials for only 20% of cancer drug indications approved under the FDA accelerated approval pathway demonstrated improvements in overall patient survival. Writing in JAMA Internal Medicine the researchers say that reassessment of the requirements for confirmatory trials may be necessary to obtain more clinically meaningful information.
Drugs
Two FDAers involved in the agency’s development and implementation of a benefit-risk framework throughout a drug’s lifecycle told a 5/16 public meeting held in conjunction with the Duke-Margolis Center for Health Policy that stakeholders should be thinking about benefit-risk at each stage of drug
Drugs
Four senators — Ted Cruz (R-TX), Mike Braun (R-IN), Rand Paul (R-KY), and Mike Lee (R-UT) — are asking FDA to expand the agency’s Parallel Track provision from HIV/AIDS to other critical diseases as a way to bring life-saving drugs to patients faster. In a
Drugs
The Biotechnology Innovation Organization (BIO) says FDA should highlight and recognize that its draft guidance on natural history studies for rare disease drug development can apply to a wider range of stakeholders, such as advocacy and patient organizations. It says the guidance should encourage patient organizations to consider the guidance
Drugs
A 9/10-9/14/18 FDA inspection at AMMD Labs, Pompano Beach, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. A 5/2 Warning Letter says the violations were: * failing to perform, for each batch of drug product, appropriate laboratory
Drugs
Pharm D Solutions has recalled all sterile compounded drug products due to FDA inspection concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. “Administration of a non-sterile product that is intended to be sterile by
Drugs
FDA has placed a clinical hold on Newron Pharmaceuticals’ proposed Phase 2-3 pivotal studies with evenamide for treating schizophrenia due to agency concerns about central nervous system events found during a recently completed study in rats as well as another at high doses in dogs, and the potential implication
Drugs
DEVICES FDA has cleared a Cynosure 510(k) for the SculpSure, a hyperthermic laser treatment for lipolysis of the flanks. The device works by disrupting subcutaneous fat cells. The hands-free device features a flexible applicator system to treat multiple anatomical areas of the body, according to the company. SculpSure,
Drugs
Allergan has submitted a citizen petition asking FDA to refuse to receive and approve any ANDA that references the company’s NDA for Viberzi (eluxadoline) tablets, indicated for treating adults with irritable bowel syndrome with diarrhea, if the ANDA does not include comparative clinical endpoint data to demonstrate it is
Drugs
New FDA “regulatory tools” were used to approve a Novartis NDA for Piqray (alpelisib) tablets, indicated for treating postmenopausal women and men with a certain type of breast cancer. These tools helped streamline the review without compromising the quality of our assessment, the agency said in a release. “This drug
Drugs
Three researchers say that despite increasing interest in use of real-world evidence (RWE), there is no standard definition of the term that has been uniformly embraced. Writing online in JAMA Oncology, the researchers say FDA defines RWE as “data regarding the usage, or the potential benefits or risks of