Drugs
FDA has released a draft guidance entitled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” which is intended to assist sponsors in identifying optimal dosage during clinical development and prior to submitting a marketing application. The guidance appears to aim at shaking
Drugs
FDA has approved a Novo Nordisk label update for Rybelsus (semaglutide) tablets 7 mg or 14 mg for a first-line treatment option for adults with Type 2 diabetes who have not previously started any treatment. “This update removes a previous limitation of use that stated the medication should not
Drugs
AstraZeneca says it will permanently discontinue marketing and distributing Lumoxiti (moxetumomab pasudotox-tdfk) for injection 8/31. It is indicated for treating adults with relapsed or refractory hairy cell leukemia. In a company letter to healthcare professionals, it notes the discontinuation decision was not related to any safety or effectiveness
Drugs
An FDA inspection at the Alembic Pharmaceuticals solid oral drug formulation manufacturing facility in Jarod, Gujarat, India, resulted in an FDA-483 with five observations. The Indian financial news platform BQ Prime reports the company disclosed the 12/8-12/16/22 inspection in a financial exchange filing. BQ Prime
Drugs
FDA has published a guidance, Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format, to help ensure that applicants include in the Dosage and Administration section of proposed labeling all the information needed for safe and effective dosing and administration of a drug
Drugs
FDA has granted Qualigen Therapeutics an orphan drug designation for QN-302 and its use in treating pancreatic cancer. QN-302 is described as a small molecule selective transcription inhibitor with strong binding affinity to G4s prevalent in cancer cells. “Pre-clinical in-vitro and in-vivo studies of QN-
Drugs
Oramed Pharmaceuticals says it is discontinuing clinical development of its Type 2 diabetes drug ORMD-0801 after a Phase 3 clinical trial (ORA-D-013-1) missed its primary and secondary endpoints. The trial enrolled 710 Type 2 patients who experienced inadequate glycemic control on two or three oral glucose-
Drugs
FDA has signed an Agreement on Mutual Recognition between the Swiss Confederation and the U.S. relating to pharmaceutical good manufacturing practice. A 1/12 notice to international colleagues says FDA and the Swiss Agency for Therapeutic Products will be able to use each other’s good manufacturing practice inspections
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it has some concerns about the practical implementation of the International Council for Harmonization Q12 guidance on implementation considerations for FDA-regulated products. It also says it has concerns about the implications for industry’s ability to maintain global submission. In a
Drugs
FDA has approved an AstraZeneca NDA for Airsupra (albuterol/budesonide) for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. The pressurized metered-dose inhaler contains a short-acting beta2-agonist (albuterol) and an anti-
Drugs
A SheppardMullin report on “2023 Top-of-Mind Issues for Life Sciences Companies” looks at several FDA issues as well as other federal agencies. In 2022, the report says, the CDER Office of Prescription Drug Promotion (OPDP) continued its downward trend in enforcement, issuing just one Warning Letter and three
Drugs
A 4/26-5/9/22 FDA inspection at the Sun Pharmaceutical Industries drug manufacturing facility in Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 12/15/22 Warning Letter says specific violations were: * failing to establish and follow appropriate
Drugs
CDER Office of Medication Error Prevention and Risk Management director Claudia Manzo says stakeholders have observed that the older REMS (risk evaluation and mitigation strategy) document format was not standardized or structured and generally could not be easily searched, queried, or managed. They suggested using structured product label (SPL) as
Drugs
FDA has released a six-item Form FDA-483 that cites analytical laboratory Valisure over deficient laboratory practices after a 5/26-7/6/22 agency inspection. The inspection led to a 12/5 untitled letter involving testing issues associated with the lab, which was behind the identification of several
Drugs
Spectrum Laboratory Products has recalled three lots of epinephrine (L-adrenaline) USP, a bulk active pharmaceutical ingredient used to manufacture or compound prescription products. The recall is based on customer complaints about product discoloration. “The use of a finished dose product manufactured or compounded with this recalled product could result
Drugs
The Association for Accessible Medicines (AAM) says it appreciates FDA issuing a draft guidance with recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference-listed drug. “The draft guidance effectively consolidates various policies we’ve seen in other documents or heard from
Drugs
While drug and biologic approval totals were precipitously lower last year (see CDER Dismisses 26% Drop in 2022 Drug Approvals), the Center’s “first cycle approval” rate for NDAs/BLAs approved in 2022 also fell from 86% in 2021 to 76% (28 of the 37 novel approvals) in 2022, according
Drugs
FDA has accepted for priority review an Otsuka Pharmaceutical and H. Lundbeck supplemental NDA for brexpiprazole for use in treating agitation associated with Alzheimer’s dementia. Brexpiprazole was previously approved in 2015 for use as an adjunctive therapy to antidepressants in adults with major depressive disorder and as a treatment
Drugs
While CDER novel drug approvals fell 26% last year to 37 NDAs/BLAs getting the green light, the Center is not worried that this may signal any slowing workload trend at the agency. The 37 approvals are the lowest since 2016 when 22 approval were tallied (see Nature article on
Drugs
FDA has accepted a Roche BLA for priority review for glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody for treating adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. FDA has set a user fee review action target date of
Drugs
Hospira has recalled one lot of injectable vancomycin HCl single-dose fliptop 1.5 g vials due to two visible glass particulates observed in a single vial. “If administered intravenously, patients may experience adverse events such as local irritation or swelling, vasculitis/ phlebitis, antigenic or allergic reactions, and microvascular obstruction,
Drugs
FDA has issued Ipsen Biopharmaceuticals a complete response letter on its NDA for palovarotene, an investigational treatment for reducing new abnormal bone formation (heterotopic ossification) in people living with fibrodysplasia ossificans progressiva (FOP). The ultra-rare disease causes permanent and continuous bone formation in soft and connective tissues like muscles,