Drugs
FDA has announced a 3/29-30 public workshop on “Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation.” The agency says the workshop will include presentations on nitrosamines chemistry and toxicology, and on the findings of nitrosamines as impurities in drugs. It will also include an open discussion
Drugs
FDA has approved safety-related labeling changes for Adamas Pharmaceuticals Parkinson’s drug Gocovri (amantadine HCl). The changes involve adding a postmarketing experience subsection to the Adverse Reactions section of the label and revising the Patient Counseling Information/Patient Information/Medication Guide.
Drugs
FDA has approved a BioCryst Pharmaceuticals supplemental NDA for Rapivab (peramivir injection) expanding the patient population for treating acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, Rapivab was indicated for patients two years and
Drugs
FDA has released an FDA-483 with two observations issued following an 8/25-11/2/20 inspection at Hopkinton Drug, a Hopkinton, MA, producer of non-sterile drug products. The two observations were: * non-microbial contamination observed in the production area; and * failing to provide adequate segregation, cleaning of
Drugs
FDA has approved a BioCryst Pharmaceuticals supplemental NDA for Rapivab (peramivir injection) expanding the patient population for treating acute uncomplicated influenza to include patients six months and older who have been symptomatic for no more than two days. Prior to this approval, Rapivab was indicated for patients two years and
Drugs
FDA has released notes from three workgroup and subgroup meetings as part of PDUFA 7 reauthorization discussions between the agency and industry representatives: * Manufacturing and Inspections Workgroup, 11/18/20. The meeting focused on finalizing discussions at the subgroup level for industry proposals relating to pre-approval/pre-licensure inspections
Drugs
FDA says its review of the Web site and Facebook page maintained by American Global Health Products, Bellevue, WA, indicated the company takes order for several AloeCure brand products. A 1/22 Warning Letter says the company makes claims for the products that establish that they are intended for use
Drugs
FDA has given the green light to NeurMedix to begin a pivotal Phase 3 clinical trial to evaluate its lead drug candidate, NE3107 in Alzheimer’s disease patients. The planned 316-patient placebo-controlled trial (NCT04669028) of the small molecule, orally administered, anti-inflammatory, insulin-sensitizing agent with a novel
Drugs
FDA has issued a complete response letter to Eagle Pharmaceuticals for its ANDA for vasopressin. The company says it has had two conversations with the agency about the letter and will have an additional meeting with FDA within 30 days. Eagle says it believes it can respond to questions FDA
Drugs
FDA has lifted a clinical hold on Mustang Bio’s lentiviral gene therapy MB-107 and a pivotal Phase 2 clinical trial after reviewing a “comprehensive” CMC package that the company says was submitted in late December. Mustang says it will proceed with its plans to initiate the pivotal Phase
Drugs
Attorney Scott Lassman has petitioned FDA to refuse to approve proposed dosing modifications sought by Par Sterile Products for its Vasostrict (vasopressin injection) based on patient genotype. The 1/29 petition says the Par request should be denied “in the absence of rigorous and convincing clinical evidence, including evidence from
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. American Global Health Products, Bellevue, WA (1/22) FDA says its review of the firm’s Web site and Facebook page indicated the company takes order for several AloeCure
Drugs
FDA has set up an interim process to communicate issues identified following a review of records or other information requested prior to or in lieu of a drug/biologic pre-approval/pre-license inspection. During the Covid-19 emergency, manufacturing records are being requested under 704(a)(4) of the
Drugs
A recent FDA pilot program has removed almost 30 illegal Web sites that were offering opioids for sale. “The pilot program has proven to be an effective tool in maximizing the impact of FDA's efforts to limit the illegal sale of unapproved opioids online and we are pleased
Drugs
Merck says Phase 3 data from the KEYNOTE-598 study evaluating its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with Bristol-Myers Squibb’s Yervoy (ipilimumab) compared with Keytruda monotherapy did not show improved overall survival (OS) or progression-free survival in patients with metastatic non-small cell lung
Drugs
Concert Pharmaceuticals is discontinuing development of schizophrenia drug CTP-692 after reporting disappointing data from a Phase 2 clinical trial evaluating it as an adjunctive treatment. According to the company, the study failed to meet the primary endpoint or other secondary endpoints. CTP-692 is described as a deuterated form
Drugs
Fresenius Kabi was issued a six-item FDA Form-483 after an inspection in May 2020 documented GMP deficiencies at its Melrose Park, IL manufacturing facility. For example, Fresenius’ responsibilities and procedures applicable to the quality control unit were not in writing and fully followed, the inspection form said. The
Drugs
FDA has cleared a Vertex Pharmaceuticals IND to proceed with a clinical trial for VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell therapy to treat Type 1 diabetes. VX-880 has the potential to restore the body’s ability to regulate glucose levels by restoring pancreatic
Drugs
FDA has granted Ascentage Pharma an orphan drug designation for its novel Bcl-2 inhibitor, APG-2575, for treating patients with follicular lymphoma (FL). The company says FL is a heterogeneous disease and the second most common subtype of non-Hodgkin lymphoma (NHL) among adult patients in the U.S.
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) has released charts showing program metrics for the first quarter of the 2021 Fiscal Year. The post shows statistics on the number and percentage of core initial promotional material reviews completed in 45 days in each of the three months, percentage of
Drugs
FDA has cleared a Passage Bio IND application for PBFT02, an adeno-associated virus (AAV)-delivery gene therapy that is being studied for treating patients with frontotemporal dementia (FTD) with granulin (GRN) mutations. FTD is a debilitating form of early onset dementia that currently has no approved disease-modifying therapies,
FDA Policy/General
Some 29 advocacy groups, led by Public Citizen and Physicians for Responsible Opioid Prescribing, are urging the Biden administration not to appoint acting commissioner Janet Woodcock as commissioner of FDA. In a 1/27 letter to incoming HHS officials, the groups say that in her role as CDER director for