FDA Policy/General

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Unilife Corp. and Amgen have entered into a strategic collaboration for injectable drug delivery systems. According to the companies, Unilife has granted Amgen exclusive rights to Unilife’s wearable injectors within select drug classes for use with certain Amgen assets, while preserving rights previously granted to other Unilife customers. Also, Unilife has granted Amgen non-exclusive rights to all proprietary Unilife delivery systems within the oncology, inflammation, bone health, nephrology, cardiovascular and neuroscience therapeutic areas, the companies add.

Chugai Pharmaceutical Co. has decided to stop early a Phase 3 study involving Alecensa in ALK fusion gene positive non-small cell lung cancer (NSCLC) patients after positive results were reviewed by an independent data monitoring committee. The committee recommended that the J-ALEX Study be stopped early after data showed that patients lived significantly longer without disease worsening when treated with Alecensa compared to crizotinib, according to the company. It enrolled 207 patients with ALK fusion gene positive advanced or recurrent NSCLC who either had not undergone chemotherapy or had undergone one chemotherapy regimen. The subjects were allocated to the Alecensa group or the crizotinib group in a one to one ratio. Data will be presented at a future medical meeting, Chugai says.

GlaxoSmithKline says that ViiV Healthcare, the global specialist HIV company majority owned by Glaxo, with Pfizer and Shionogi as shareholders, has completed two transactions with Bristol-Myers Squibb to acquire its late-stage HIV research and development assets and its portfolio of pre-clinical and discovery stage HIV research assets. According to Glaxo, the transaction includes the acquisition of fostemsavir, an attachment inhibitor currently in Phase 3 development for heavily treatment experienced patients. It has received FDA breakthrough therapy designation.

Mast Therapeutics has delayed patient enrollment in its Phase 3 EPIC study of vepoloxamer for treating patients with sickle cell disease experiencing vaso-occlusive crisis. The company says it expects to report top-line results in the second quarter of 2021.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome