Drugs
FDA has granted Octapharma USA an orphan drug designation for Octagam [immune globulin intravenous (human) 10% liquid] for treating dermatomyositis, a rare acquired disorder characterized by chronic inflammatory and degenerative changes of the muscles and skin. Octagam is currently approved for treating chronic immune thrombocytopenic purpura (ITP) in adults. It
Drugs
FDA has approved two new indications for Merck’s Keytruda (pembrolizumab) for treating certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. One indication is for first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.
Drugs
Attorney Stephen Wood (Chuhak & Tecson) says a stay of discovery should be mandatory to weed out frivolous False Claims Act cases before defendants have to bear the cost of discovery. Writing in a Washington Legal Foundation Legal Backgrounder, Wood says that the small percentage of whistleblower cases that succeed
Drugs
The Supreme Court has refused to hear the appeal of a Philadelphia law firm that wanted FDA to either withdraw its approval for use of Janssen’s Risperdal (risperidone) in children or require a Boxed Warning about the potential for side effects including gynecomastia. FDA rejected the petition from Sheller
Drugs
Seeking to reduce federal government expenditures on the National Institutes of Health (NIH), President Donald Trump reportedly is considering imposing a 10% cap on the NIH’s indirect costs, money it gives grantees to support administration, equipment, IT, lighting, heating, electricity, and other overhead. An NIH source who was briefed
Drugs
Pharmaceutical Manufacturing Research Services (PMRS) is asking FDA to stay its approval of an Inspirion Delivery Sciences NDA for Roxybond (oxycodone HCl) tablets. The PMRS petition asks the agency stay the effective date of approval of the NDA with labeling claims pertaining to chronic use and abuse deterrence until FDA
Drugs
A New York federal court has dismissed for a second time a case against Bristol-Myers Squibb over its blood thinner Eliquis. The first time the case was heard, the court rejected as preempted the plaintiff’s design defect claims and said the case could be amended on non-design
Drugs
FDA Oncology Center of Excellence (OCE) director Richard Pazdur says the Center has begun coordinating clinical review of oncology products. Writing in an online American Journal of Managed Care post, Pazdur says that applications are submitted to CDER, CBER, or CDRH and, if appropriate, OCE forms a clinical review team
Drugs
CDER’s Professional Affairs and Stakeholder Engagement staff is hosting a 6/15 public meeting called “Safe Use Symposium: A Focus on Reducing Preventable Harm from Drugs in the Outpatient Setting.” CDER director of professional affairs and stakeholder engagement John Whyte says in an FDA Voice blog post that those
Drugs
In a 5/15 letter to Sen. Patty Murray (D-WA), ranking Democrat on the Senate HELP Committee, HHS secretary Tom Price says the administration’s budget blueprint calls for increasing and restructuring the medical product user fee programs at FDA to be 100% user fee supported programs, with no
Drugs
AstraZeneca says that FDA should not approve a Teva 505(b)(2) application referencing Faslodex (fulvestrant) intramuscular injection as the listed drug and that proposes a drug product asserted to have a different formulation unless certain conditions are met. The AstraZeneca petition says FDA should require that: * the application contain
Drugs
Former FDA deputy commissioner for policy William Schultz says that newly confirmed agency commissioner Scott Gottlieb will need to make an early decision on whether to accept industry proposals to reduce the standards under which drugs can be advertised, standards that Schultz says have “protected patients for more than 50
Drugs
FDA has approved the expanded use of Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for treating cystic fibrosis. This more than triples the number of rare gene mutations that the drug can treat, from 10 mutations to 33. The agency based its decision, in part, on laboratory testing, which it used in conjunction
Drugs
Former FDA commissioner Robert Califf has accepted the position of vice chancellor for health data science for Duke Health. In this capacity, Califf also becomes the director of a new cross-campus center at Duke University for integrated health data science. “This center, which has not yet been formally named,
Drugs
FDA has placed a Concert Pharmaceuticals study of its hair loss therapy, CTP-543, on clinical hold to allow the agency to review requested data. FDA told the company that the Phase 2a clinical trial for alopecia areata can proceed after it reviews recently completed non-clinical toxicology studies if
Drugs
FDA has granted Bayer a priority review on its NDA for copanlisib for treating relapsed or refractory follicular lymphoma (FL) patients who have received at least two prior therapies. Copanlisib is an intravenous pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor that the company says has “predominant inhibitory activity against
Drugs
FDA has approved an Abon Pharmaceuticals ANDA for clofarabine injection, 20 mg/20 mL, single-use vial, a generic copy of Genzyme’s Clolar injection, indicated for treating pediatric patients one year of age and older with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens. According
Drugs
A 10/24-11/1/16 FDA inspection at Vertical Pharmaceuticals, Bridgewater, NJ, found “serious violations” of Postmarketing Adverse Drug Experience reporting requirements, according to a 5/10 Warning Letter from the agency’s New Jersey District Office. Specific violations listed on an FDA-483 included: * failing to develop written
Drugs
FDA has approved a Pharmadax ANDA for a generic copy of Seroquel XR (quetiapine fumarate) extended release tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg. Pharmadax has launched the product with their marketing partner TruPharma LLC. Seroquel XR is a once-daily tablet indicated for treating
Drugs
Enforcement officials are closely scrutinizing drug and medical company speaker programs for False Claims Act violations. Attorney Matthew Curley (Bass, Berry & Sims) writes in an online blog post that drug and device manufacturers accounted for nearly half of the enforcement recoveries from the healthcare industry last year. Curley says
Drugs
Eleven Democratic senators have written to President Donald Trump expressing concern about the impact of his proposed budget cuts and workforce reductions for the Department of Health and Human Services on implementation of the bipartisan 21st Century Cures Act. The 5/16 letter says that in the bill “Republicans and
Drugs
The CDER Office of Generic Drugs says that 21 product-specific guidances for generic drug development were added since 5/1. Products covered by the guidances are acetcylsteine; amphetamine; aprepitant; azelastine HCl; biscodyl, polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride; carbidopa, levodopa; chlordiazepoxide HCl, clidinium bromide; clonazepam; edoxaban