Drugs
Former FDA attorney William McConagha has moved from Sidley Austin to Skadden, Arps, Slate, Meagher & Flom as health care litigation and enforcement practice partner in Washington, DC. After spending 17 years at FDA, McConagha joined Sidley in 2012 as a partner. At FDA, McConagha served in various positions, including
Drugs
FDA has denied a 2/2/19 petition submitted by a Philadelphia law firm asking that the agency ensure that all manufacturers of methscopolamine bromide tablets adhere to the agency’s 2016 Botanical Drug Development guidance and take enforcement action against non-compliant manufacturers. The agency response says that FDA
Drugs
FDA has issued Merck a complete response letter on a supplemental BLA seeking to update the dosing frequency for Keytruda (pembrolizumab) to include a 400 mg dose infused over 30 minutes every six weeks for multiple indications. The submission is based on pharmacokinetic modeling and simulation data, Merck says, adding
Drugs
FDA has sent Aurobindo Pharma an Establishment Inspection Report (EIR) for Unit 4 of the company’s general injectable formulation manufacturing facility on Pashamylaram, Hyderabad, India. A report on the Indian Web site Livemint says the company did not disclose details of the EIR in its regulatory filing. FDA inspected
Drugs
CDER Office of Generic Drugs (OGD) director Sally Choe says the organization gave final or tentative approval to more than 1,000 ANDAs in calendar year 2019. Writing in the OGD annual report, Choe says that while the numbers “indicate another accomplished year for the program, we know what truly
Drugs
Rep. Kevin McCarthy (R-CA) and David Schweikert (R-AZ) are asking FDA to hold public workshops on the development of Valley Fever diagnostics, drugs, and biologics to inform the development of a guidance to help with approval of these and related products. In their letter, the two write that
Drugs
FDA has extended its review of Heron Therapeutics’ NDA for its HTX-011 for up to three months, resulting in a new PDUFA goal date of 6/26. The agency sent the company a 4/30/19 complete response letter relating to chemistry, manufacturing, and controls and to non-clinical
Drugs
The First Circuit Court of Appeals has sent back to a Massachusetts federal court a case in which purchasers of direct insulin glargine alleged that Sanofi artificially restricted competition in the market for insulin glargine by impermissibly extending its monopoly over such products. The appeals court reported that the purchasers
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: R-Garden, Redmond, WA (2/5): FDA inspected the company 8/2019 and cited serious GMP violations for its dietary supplements. For
Drugs
FDA has approved the switch of three prescription drugs to over-the-counter status for GlaxoSmithKline’s Voltaren (diclofenac sodium topical gel, 1%), Alcon’s Pataday (olopatadine HCl ophthalmic solution/drops, 0.1%) twice daily and Pataday (olopatadine HCl ophthalmic solution/drops, 0.2%) once daily. Voltaren is indicated for
Drugs
The Justice Department says Hector Kellum, a former senior executive at an unidentified New Jersey generic drug company, pleaded guilty 2/14 to his role in a conspiracy to fix prices, rig bids, and allocate customers for generic drugs. The New York Times identified Kellum’s former employer as Novartis’
Drugs
FDA says that a January enforcement operation conducted with the government of India stopped some 500 shipments of illicit and potentially dangerous unapproved prescription drugs and combination medical devices from reaching American consumers. An FDA statement says Operation Broadsword, the first bilateral enforcement operation conducted with India, targeted packages entering
Drugs
CDER has published the FY 2019 GDUFA Science and Research Report detailing “significant accomplishments in developing the scientific basis supporting new and revised guidances for industry and in refining methods for the scientific evaluation of equivalence for generic drug products.” In FY 2019, the report says, FDA awarded 14 new
Drugs
Boehringer Ingelheim says the three case study examples in an FDA draft guidance on bridging for drug-device and biologic-device combination products are helpful in illustrating the stepwise approach described in the guidance. However, the company comment says that with the understanding that the three cases describe different scenarios,
Drugs
Manatt Health senior advisor Ian Spatz says the FDA proposal to create a process for agency approval of state-sponsored drug importation plans is not likely to generate significant savings for states or even enough to justify the cost of establishing such a program. Writing online in Stat, Spatz says
Drugs
After recently meeting with FDA in a Type C meeting, Sellas Life Sciences Group says it has finalized the design and plan for a Phase 3 study of nelipepimut-S (NPS) vaccine in combination with trastuzumab (Genentech’s Herceptin) for treating patients with triple negative breast cancer in the adjuvant
Drugs
FDA has accepted for review an Epizyme supplemental NDA seeking accelerated approval for Tazverik (tazemetostat), a methyltransferase inhibitor, for patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior lines of systemic therapy. Tazverik gained its first accelerated approval last month for adults and pediatric
Drugs
FDA has accepted for review a FibroGen NDA for roxadustat for treating anemia associated with chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients. The agency has set a user fee review action target date of 12/20. The NDA filing triggers a $50 million milestone
Drugs
FDA says it is keeping a close eye on the medical product supply chain during the current coronavirus outbreak. “We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.,"
Drugs
The White House Council of Economic Advisers (CEA) says that foreign “free-riding” on U.S. investments and innovations in drug development has increased over the last 15 years. In a report, “Funding the Benefits to Biopharmaceutical Innovation,” CEA argues that if developed countries did not pay below the value
Drugs
Researchers from FDA and two universities say that pharmacogenomic information included on drug labels can facilitate a better understanding of pharmacogenomics among researchers, healthcare professionals, and the public, to advance the science of precision medicine. Writing in Drug Discovery Today, the researchers provide an overview of pharmacogenomic information in 362
Drugs
FDA has accepted for priority review a Seattle Genetics NDA for tucatinib for use in combination with trastuzumab and capecitabine for treating patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or