Drugs
Nektar Therapeutics and Bristol Myers Squibb have decided to end the clinical development program for bempegaldesleukin in combination with Opdivo (nivolumab) for treating renal cell carcinoma (RCC) and bladder cancer based on results from pre-planned analyses of two late-stage clinical studies of the combination therapy. In the Phase
FDA Policy/General
BioDelivery Sciences International has entered into an agreement with Endo Pharmaceuticals to terminate Endo’s licensing rights for pain drug Belbuca (buprenorphine) buccal film. As a result of the agreement, the world-wide rights to Belbuca will be transferred back to BioDelivery Sciences on undisclosed terms. Annual sales for the
FDA Policy/General
DEVICES FDA has approved a Roche PMA for the cobas MPX test for use on the cobas 6800 and 8800 Systems. The test enables donor screening laboratories to “apply the most advanced PCR-based diagnostic technology to the surveillance of donated blood and plasma in the United States, preventing the
Devices
FDA has cleared a SonoScape 510(k) for its flagship video endoscopy system HD-550 for gastrointestinal diagnosis. The device uses a 4-LED light source for 1080P high definition in multi-spectrum and multi-mode applications. It also features chromoendoscopy Spectral Focused Imaging and versatile Intelligent Staining Technology light
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Generic Clearance for Quick Turnaround Testing of Communication Effectiveness” (OMB Control Number 0910-0876). The agency says that occasionally it will need to communicate with consumers and other stakeholders about immediate health issues which could affect public
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled Bioavailability Studies Submitted in NDAs or INDs — General Considerations. The document provides recommendations to sponsors planning to include bioavailability information in INDs, NDAs and supplemental NDAs. To view the notice, click here.
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TG Therapeutics has withdrawn its accelerated approval of Ukoniq (umbralisib), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for treating adults with relapsed or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
Biologics
FDA has approved an Amneal Pharmaceuticals BLA for bevacizumab-maly, a biosimilar referencing Genentech’s Avastin. The product will be marketed under the proprietary name Alymsys. The therapy was developed by mAbxience, a global biotech company claiming over 10 years of experience in developing and manufacturing biopharmaceuticals. The biosimilar is
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
Biologics
FDA has extended by three months its review of a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and imdevimab) for treating Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals. “The extension is due to ongoing discussions with the FDA on pre-exposure prophylactic use, for which
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet. The document addresses agency recommendations regarding clinical trials for such drugs. To view the notice, click here.
Devices
FDA has granted InspectIR an emergency use authorization for the first Covid-19 diagnostic test that detects Covid-19 chemical compounds in breath samples. “The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites,
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use. The document is intended to assist ANDA applicants seeking approval of a drug that is qualitatively different or quantitatively different from
FDA Policy/General
Federal Register notice: FDA is making available a final guidance on Compounding Animal Drugs from Bulk Drug Substances. The document describes FDA’s current thinking about such compounding, identifies the agency’s enforcement priorities, and describes circumstances under which FDA generally does not intend to take action against veterinarians or
Biologics
Pfizer and BioNTech say they will seek FDA approval for a booster shot of their Covid vaccine for children ages 5-11. The companies say trial data demonstrate a high immune response following a booster dose in the age group. A Pfizer statement says there was a 36-fold increase
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
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials. The document offers recommendations to sponsors developing medical products on the approach for developing a Race and Ethnicity Diversity Plan to enroll adequate
FDA Policy/General
A California state appeals court has upheld almost all of a massive $344 million civil penalty judgment against Johnson & Johnson’s Ethicon unit awarded in a bench trial for circulating misleading instructions about its transvaginal pelvic mesh products. Legal Newsline reports the appeals court only struck $42 million in
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