Drugs
The Consumer Healthcare Products Association (CHPA) says FDA should deny a citizen petition filed by a Sajoy Varghese of the Jesse Brown VA Medical Center, Chicago, seeking an amendment of the marketing status of Imodium (loperamide) from nonprescription (over-the-counter) to prescription. “Based on the available evidence demonstrating a
Drugs
Allergan says its transfer of Restasis patents to the St. Regis Mohawk Tribe will shield the patents in administrative proceedings involving the U.S. Patent Trial and Appeal Board. The tribe will exclusively license the patents back to Allergan in exchange for ongoing payments. A Reuters report says the deal
Drugs
The relative share of new cardiovascular drugs receiving FDA marketing approval dropped by 52% from the 1980s through 2016, according to a Tufts Center for the Study of Drug Development analysis in its September/October Impact Report. The report (purchase or subscription required) says that although clinical development time for
Drugs
A 1/4-1/11 FDA inspection at HomeoCare Laboratories, Yonkers, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 9/7 Warning Letter. The letter says the inspection also determined that the firm’s products HBP Relief, Cholestop, and IBS Relief
Drugs
FDA has published a draft guidance, Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations, to assist sponsors of microdose radiopharmaceutical drugs on the nonclinical studies recommended to support human clinical trials and marketing applications. The guidance discusses how to refine nonclinical study recommendations for this class of drug given its unique
Drugs
FDA has accepted for review two Array BioPharma NDAs to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for treating patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The company says that FDA told it that based on a
Drugs
CDER director Janet Woodcock is scheduled to testify before a 9/13 House Energy and Commerce Subcommittee on Health about “Modernizing FDA’s Regulation of Over-the-Counter Drugs.” The hearing is intended to provide members an opportunity to better understand the current framework in place at the agency for
Drugs
FDA commissioner Scott Gottlieb says reviews of all orphan drug designation requests older than 120 days were completed 8/28, well ahead of the 9/21 deadline the agency had set for itself. The reviews were part of a comprehensive orphan drug modernization plan Gottlieb announced 6/29. Writing in
Drugs
Gilead is asking the 9th Circuit Court of Appeals to rehear or rehear en banc a whistleblower case involving three of the company’s HIV drugs that was initially thrown out by a California federal court. In its petition for a rehearing, Gilead says the whistleblowers’ complaint alleges that the
Drugs
Researchers at the Oregon Health & Sciences University say that a majority of doctors on Twitter with significant financial conflict (at least $1,000 in general payments in 2014) and frequent tweets (at least 100 total tweets) mention specific drugs for which they have a conflict, and almost none disclose
Drugs
FDA continues to urge the adoption of continuous manufacturing (CM) by drug manufacturers. The agency is seeking comments until 9/21 on about the science, technology, and best practices concerning CM, says CDER Office of Pharmaceutical Quality director Michael Kopcha in an FDA Voice blog post. He notes that despite
Drugs
Galena Biopharma has agreed to pay the federal government more than $7.55 million to resolve allegations under the civil False Claims Act that it paid kickbacks to doctors to induce them to prescribe its fentanyl-based drug Abstral. The government contends that the company provided 85 free meals to
Drugs
Janssen Sciences has decided to discontinue development of its investigational hepatitis C treatment regimen JNJ-4178, a combination of three direct-acting antivirals — AL-335, odalasvir and simeprevir. While ongoing Phase 2 studies with JNJ-4178 will be completed as planned, the decision to abandon the program is based on
Drugs
A top priority for FDA commissioner Scott Gottlieb is to modernize how clinical information is collected. “FDA continues to advance the use of new tools and clinical trial designs,” he said in an online post of a speech to stakeholders. “For example, we’re seeing wider use of adaptive approaches,
Drugs
FDA has issued Novartis a priority review voucher after approving qualifying rare disease product Kymriah (tisagenlecleucel), indicated for treating certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (see earlier story). As amended by the FDA Safety and Innovation Act, the agency awards priority review vouchers
Drugs
A new study in The BMJ found an association between expedited drug development and review pathways and the likelihood of subsequent safety-related labeling changes. “Further research is required to understand the underlying process factors contributing to the differential rates in safety changes that were observed in this analysis,” the
Drugs
Daiichi Sankyo says that FDA should deny without delay a Pharmaceutical Manufacturing Research Services (PMRS) petition calling for the agency to stay the effective date for the 4/20 approval of Daiichi’s RoxyBond (oxycodone hydrochloride) immediate-release tablets submitted by Inspirion Delivery Sciences. The Daiichi response says the PMRS
Drugs
Verastem is reporting positive top-line results from its Phase 3 DUO study evaluating the efficacy and safety of duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase-delta and P13K-gamma in patients with relapsed or refractory chronic lymphatic leukemia/small lymphocytic lymphoma (CLL/SLL). A
Drugs
United Therapeutics has submitted its fourth petition to FDA since 1/14/16 “to ensure that proposed generic treprostinil inhalation solution products meet the same high standards of quality as United Therapeutics’ brand-name product Tyvaso (treprostinil) inhalation solution.” FDA denied the previous three petitions without comment on whether it
Drugs
FDA says that Genentech is recalling to the hospital level three lots of Activase (alteplase) 100 mg vials that were co-packaged with sterile water for injection. An agency statement says that the vials of sterile water for injection manufactured by Pfizer’s Hospira unit and packaged with Activase 100
Drugs
FDA concerns about PD-1/PD-L1 inhibitors have spread to clinical trials conducted by AstraZeneca and Celgene, with clinical holds ordered on their new development program. Last week, CDER director Janet Woodcock said the agency was stepping up its safety surveillance on PD-1/PD-L1 inhibitors after an
Drugs
Researchers in CDER’s Office of Biotechnology Products (OBP) are studying chemical reactions that occur in therapeutic protein products and can have a significant impact on protein function. CDER laboratory of biochemistry chief V. Ashutosh Rao writes in a Spotlight on CDER Science post that the chemical reactions are of