The nationwide cheese recall due to listeria risk stemming from cheese manufactured by Deutsch Kase Haus has affected 130 additional cheeses and products, and the FDA, along with officials from several states, is investigating. Included in the recall are more than 100 products from MDS Foods, 22 items from Dutch Valley Food Distributors, three cheese brands from Biery Cheese and roast beef sandwiches from Albertsons and Randalls stores.
Gilead Sciences has agreed to pay $125 million upfront to acquire Sarepta Therapeutics' priority review voucher, which Sarepta received when the FDA approved its Duchenne muscular dystrophy drug Exondys 51, or eteplirsen, in September. Sarepta plans to use the voucher funds as capital to support development of its next-generation RNA-targeted antisense platform and exon-skipping candidates.
The FDA has accepted The Medicines Co.'s new-drug application for IV Carbavance, or meropenem-vaborbactam, for priority review as a treatment for complicated urinary tract infection. Data from an ongoing late-stage trial is expected to be released in the third quarter of the year.
A public-private collaboration in sub-Saharan Africa has developed biotech cowpeas that are resistant to the pod borer Maruca vitrata to help farmers prevent yield losses and reduce the need for insecticides. The project is being applied in Nigeria, Ghana, Malawi and Burkina Faso.
In comments submitted to the Environmental Protection Agency, BIO said it supports the EPA's proposed renewables enhancement and growth support rule, and its efforts to enhance the effectiveness and efficiency of the Renewable Fuel Standard. "This change in REGS will help toward the timely approval of pathways and expand advanced biofuel volumes and cellulosic volumes," and changes in regulations for ethanol flex fuels "would benefit consumers while also helping to achieve the statutory goals of the RFS," said Brent Erickson, executive vice president of BIO's Industrial & Environmental Section.
Pfizer's biologics license application for inotuzumab ozogamicin has been accepted for priority review by the FDA as a treatment for relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The agency's action date is in August.
The FDA has sent a complete response letter to Amphastar Pharmaceuticals regarding its marketing application for an intranasal formulation of naloxone, an emergency treatment for opioid overdose. The agency cited issues with the user human factors study, among others.
Vericel's ixmyelocel-T has been granted a fast-track designation by the FDA as a treatment for advanced heart failure due to ischemic dilated cardiomyopathy. The drug candidate met its primary target in a Phase IIb study, inducing a 37% reduction in the composite endpoint in patients with the condition.
The European Commission granted conditional approval to Roche Holding and Chugai's Alecensa, or alectinib, as a monotherapy for ALK-positive advanced non-small-cell lung cancer in adult patients who previously received crizotinib. Roche is still required to submit additional data from a late stage-study, which it plans to do during the first half of the year.
The National Institute for Health and Care Excellence has recommended against National Health Service use of Ipsen's Cabometyx, or cabozantinib, as a treatment for patients with pretreated advanced renal cell carcinoma. The regulator did not consider the drug cost-effective and was uncertain about any additional benefits of the drug because it said the meta-analysis evidence presented by Ipsen was "unreliable."
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