Drugs
TG Therapeutics has withdrawn its accelerated approval of Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for treating adults with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen, and with relapsed or refractory follicular lymphoma who
Drugs
FDA has issued Hiers Enterprises (dba Northwest Compounding Pharmacy) a Form FDA-483 after inspecting the firm in 11/2021. The inspection cited the firm for producing hazardous drugs without providing adequate containment and cleaning of utensils to prevent cross-contamination. FDA also said the firm compounded drug products containing
Drugs
FDA has granted aTyr Pharma an orphan drug designation for efzofitimod and its use in treating systemic sclerosis (SSc, also known as scleroderma). The company describes efzofitimod as a potential first-in-class immunomodulator that downregulates innate and adaptive immune responses in uncontrolled inflammatory disease states via selective modulation of
Drugs
FDA and HHS have issued a statement that the shelf-life of Eli Lilly’s bamlanivimab and etesevimab, for treating Covid-19, are being evaluated, and an update regarding a shelf-life extension is planned for early next month. In the interim, all bamlanivimab and etesevimab vials may be retained
Drugs
Adagio Therapeutics says its adintrevimab for the prevention and treatment of Covid-19 has markedly reduced neutralizing activity in vitro against the omicron BA.2 variant. “Based on feedback from FDA regarding adintrevimab’s lack of neutralizing activity against the BA.2 variant,” the company says, “Adagio is pausing the
Drugs
FDA has published a guidance, Bioavailability Studies Submitted in NDAs or INDs — General Considerations, with recommendations on how sponsors can meet bioavailability requirements as they apply to dosage forms intended for oral administration. The document also applies to non-orally administered drug products when it is appropriate to rely on
Drugs
FDA has told Protagonist Therapeutics that it intends to rescind the company’s breakthrough therapy designation for rusfertide and its use in treating polycythemia vera. In an updated company slide presentation, the agency attributed its rescission decision to “observed malignancies, in follow-up to the FDA clinical hold imposed on
Drugs
AbbVie and Genmab say they plan to engage global regulatory authorities based on topline results from the EPCORE Phase 1/2 trial of epcoritamab in patients with relapsed/refractory large B-cell lymphoma. An AbbVie statement says the topline results demonstrated a confirmed overall response rate of 63.1% with
Drugs
FDA has published a new draft guidance, Diversity Plans to Improve Enrollment of Participants from Under-represented Racial and Ethnic Populations in Clinical Trials, that expands on an earlier guidance intended to help the industry improve clinical trial diversity. The document says individuals from several named populations are frequently under-
Drugs
The House Committee on Oversight and Reform has released an interim staff report, “The Firm and the FDA: McKinsey & Company’s Conflicts of Interest at the Heart of the Opioid Epidemic.” A committee statement says the report “presents preliminary findings from the committee’s investigation into McKinsey’s consulting
Drugs
FDA has issued a draft guidance, Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use, describing how the agency intends to evaluate such waiver requests. The document also makes recommendations on the timing and process for requesting the waiver. “This guidance
Drugs
The International Council for Harmonization says three of its guidelines have reached Step 2 in the development process and are now in the public consultation period. The guidelines are: * E11A on pediatric extrapolation; * revision of Q2(R2) on validation of analytical procedures; and * Q14 on analytical procedure development.
Drugs
Some 30 members of the House and Senate have written to the CEOs of seven manufacturers of naloxone, asking them to apply for over-the-counter (OTC) status for the drug. In a statement, the lawmakers say that despite naloxone’s effectiveness in reversing opioid overdoses and FDA’s public
Drugs
A 7/6-7/28/21 FDA inspection at Generitech Corp., Fresno, CA, found significant violations of current good manufacturing practice (CGMP) regulations and unapproved new drug and misbranding violations. A just-released 3/1 Warning Letter lists specific CGMP violations as: * failing to thoroughly investigate any unexplained discrepancy or
Drugs
FDA says 2021 inspections at three Ultra Seal facilities in Highland and New Paltz, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/14 Warning Letter lists the violations for each facility as: * ULTRAtab Toc Drive o failing to establish and
Drugs
A 9/20-9/24/21 FDA inspection at Yusef Manufacturing Laboratories, Clearfield, UT, found significant repeated violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 2/8 Warning Letter lists specific violations as: * failing to conduct at least one test to verify the identity
Drugs
Veru Inc. has announced positive efficacy and safety results from an interim analysis of a double-blind, randomized, placebo-controlled Phase 3 Covid-19 clinical trial evaluating oral sabizabulin 9 mg versus placebo in 150 hospitalized patients at high risk for Acute Respiratory Distress Syndrome. The company says the primary
Drugs
Just-released FDA Bioresearch Monitoring (BIMO) Program metrics report for fiscal year (FY) 2021 shows substantially fewer clinical investigator (CI) inspections conducted due to Covid-19 travel restrictions. In FY 2019 and before Covid had been detected, CDER conducted 574 CI inspections, but in FY 2021 that number fell to
Drugs
The Biotechnology Innovation Organization says there are several ways FDA could improve its draft guidance on developing non-opioid analgesics for acute pain. Its recommendations cover considerations for a general acute pain indication, novel mechanism of action, use of FDA expedited programs, FDA-sponsor engagement, chronic pain guidance development, and
Drugs
Myovant Sciences and Pfizer say they have received notice from FDA that it found deficiencies in a supplemental NDA on Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing moderate to severe pain associated with endometriosis. The notice said the deficiencies preclude discussion of
Drugs
Eli Lilly says new data on its investigational monoclonal antibody lebrikizumab show the therapy in combination with standard-of-care topical corticosteroids (TCS) achieved at least 75% improvement in overall disease severity compared to a placebo plus TCS. The company says that the data from its Adhere trial also showed
Drugs
FDA has placed a partial clinical hold on Curis’ TakeAim Lymphoma study, a Phase 1/2 open-label dose escalating clinical trial investigating emavusertib in patients with B-cell malignancies. The company says CDER’s Division of Hematologic Malignancies 2 followed suit by extending a partial hold originally placed by