Drugs
Attorneys Josephine Torrente and Gugan Kaur (Hyman, Phelps & McNamara) say that FDA statistics on the approval and denial rates of Formal Dispute Resolution Requests (FDRR) can be deceiving because a formal denial often can be coupled with agency guidance on a way forward that leads to the product being
Drugs
Members of the FDA Oncologic Drugs Advisory Committee voted unanimously to recommend approval of Celltrion’s CT-P10, a proposed monoclonal antibody biosimilar to Biogen’s Rituxan (rituximab) for treating adult patients in three proposed indications. The company’s BLA seeks approval for these indications: (1) relapsed or refractory, low-
Drugs
Biotechnology Innovation Organization (BIO) has submitted comments to FDA on its draft guidance Opioid Use Disorder (OUD): Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment. The group commended the agency for “recognizing the need and interest in expanding primary and secondary endpoints used in clinical trials for medications
Drugs
The federal government has filed an amicus brief supporting Merck’s position before the Supreme Court that a state failure-to-warn suit is preempted if it involves labeling changes that were rejected by FDA. The government filing notes that a federal district court had ruled that the state suits
Drugs
FDA has issued guidances to advance development of transdermal and topical delivery systems (TDS) as part of a broader effort to bring generic competition to the drug marketplace. FDA commissioner Scott Gottlieb says the “increased transparency and predictability provided by these and other product-specific recommendations gives applicants seeking to
Drugs
FDA medical reviewers are raising safety concerns about Trevena’s next generation opioid oliceridine injection, for which the company is seeking an indication for managing moderate-to-severe pain in adult patients for whom an intravenous opioid is warranted. The Trevena NDA will be considered by the agency’s Anesthetic
Drugs
FDA has denied a 5/1/17 petition submitted on behalf of Esophageal Cancer Action Network and asking that the agency require a new warning concerning the risk of esophageal cancer for all over-the-counter (OTC) drug products labeled to relieve or prevent heartburn associated with reflux disease, acid
Drugs
Although it denied an Agile Therapeutics formal dispute resolution request involving a decision by the CDER Division of Bone, Reproductive, and Urological Products (DBRUP) that Agile’s Twirla could not be approved due to concerns about its in vivo adhesion properties, the CDER Office of New Drugs (OND) proposed a
Drugs
FDA has accepted for review a Novartis NDA for once-daily siponimod (BAF312) for treating secondary progressive multiple sclerosis (SPMS) in adults. If approved, siponimod would be the first oral treatment approved for SPMS that significantly delays disability progression, Novartis says. The submission was filed with a priority review voucher
Drugs
FDA has approved an Akcea Therapeutics and Ionis Pharmaceuticals NDA for Tegsedi (inotersen) for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Tegsedi is described as a RNA-targeting therapeutic that reduces the production of TTR protein through a once-weekly subcutaneous injection. Approval was based on data from
Drugs
FDA has accepted for priority review a Karyopharm Therapeutics NDA that is seeking accelerated approval for selinexor, an oral SINE compound indicated for treating patients with penta-refractory multiple myeloma. The agency has set a user fee review action target date of 4/6/2019. Karyopharm says Selinexor functions by
Drugs
FDA has tentatively approved an Ortho Dermatologics NDA for Bryhali (halobetasol propionate) lotion for the topical treatment of plaque psoriasis in adult patients. In clinical trials, the lotion demonstrated significant treatment success over a vehicle as early as week two, according to the company. “Its safety has been established in
Drugs
FDA has granted MediciNova an orphan-drug designation for MN-166 (ibudilast) as adjunctive therapy to chemotherapy drug temozolomide for treating glioblastoma. Ibudilast has been marketed in Japan and Korea since 1989 to treat post-stroke complications and bronchial asthma. MediciNova is developing MN-166 for progressive multiple sclerosis (MS)
Drugs
A June FDA inspection of drug supplier McKesson has resulted in a three-item Form 483 citing deficiencies with product tracing requirements. The inspection took issue with the firm’s “deficient” systems to identify all illegitimate product subject to a notification from a trading partner, and to quarantine suspect or
Drugs
Silver Star Brands has recalled six products for humans (including four Native Remedies and two Healthful Naturals and two PetAlive products after testing found microbial contamination. “Administration or use of drug products with microbial contamination could potentially result in increased infections that may require medical intervention and could result in
Drugs
The New Jersey Supreme Court says 532 product liability claims against Roche alleging that the company inadequately warned of inflammatory bowel disease caused by Accutane should be dismissed. Of the 532 plaintiffs, 18 were New Jersey residents and 514 were residents of 44 other jurisdictions. The claims were designated as
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA complex innovative trial design (CID) pilot meeting program “should help to promote the regulatory acceptance of and agreement on CIDs that support regulatory decision-making across review divisions.” In a comment letter, the association recommends that the agency establish a
Drugs
FDA has cleared an Allergan 510(k) for its CoolSculpting nonsurgical fat reduction device to treat the submandibular (below the jawline) area. In addition, FDA clearance was expanded to include patients with a BMI of up to 46.2 when treating the submental and submandibular areas. Clearance was based on
Drugs
FDA has approved Genetech’s Hemlibra (emicizumab-kxwh) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A without factor VIII inhibitors. The company says Hemlibra is the only prophylactic treatment for people with hemophilia A and without factor VIII inhibitors
Drugs
Retired Canadian health researcher Saeed Qureshi is asking FDA to withdraw guidances and related recommendations about assessments of drug dissolution characteristics of drug products such as tablets and capsules. In a 10/1 petition, Qureshi asks for removal of three specific guidances from 1997, 2017 and 2018, and the dissolution
Drugs
GlaxoSmithKline says it is revising its policy on working with healthcare professionals to allow payments to some doctors who promote company products. “This policy update is being made to ensure we continue to operate responsibly and improve how we help prescribers to understand new data and clinical experience with our
Drugs
FDA has cleared a CarboFix in Orthopedics 510(k) for the CarboClear Carbon Fiber Transverse Connectors to be used in conjunction with its Carbon Fiber Pedicle Screw System, a device used to surgically treat oncological patients. The device, according to the company, offers enhanced radiation therapy planning abilities, allowing radiation