AbbVie's breakthrough therapy Mavyret, or glecaprevir and pibrentasvir, has been approved by the FDA as an eight-week regimen treatment for previously untreated patients with hepatitis C virus. The drug is indicated for adult patients with HCV genotypes 1 through 6 without cirrhosis or with mild cirrhosis, including those with moderate to severe renal disease and patients being treated with dialysis.
The Senate unanimously approved legislation that would permit patients diagnosed with life-threatening illnesses who have exhausted other treatment options and cannot take part in clinical trials to use experimental treatments in the FDA approval pipeline as long as the drugs have undergone at least an early-stage clinical study. The right-to-try bill, sponsored by Sen. Ron Johnson, R-Wis., now moves to the House, where similar legislation is under consideration.
Portola Pharmaceuticals has refiled its biologics license application for AndexXa, or andexanet alfa, with inclusion of additional manufacturing information per the FDA's request in a complete response letter issued a year ago. The drug is being developed for reversal of direct or indirect factor Xa inhibitors to address uncontrolled or life-threatening bleeding.
The FDA has granted tentative approval to Perrigo's generic version of Galderma Laboratories' Mirvaso, or brimonidine topical gel, 0.33%. The drug is intended to treat adult patients with persistent erythema of rosacea.
The Senate has approved a bill that seeks to boost the pharmaceutical industry's spending on childhood cancer drug research and development, which is included in larger legislation that would reauthorize FDA user fees. The measure goes to President Donald Trump for his signature.
Bristol-Myers Squibb said it will acquire IFM Therapeutics in an effort to strengthen its cancer portfolio. BMS will make a $300 million upfront payment, while IFM investors will also benefit from additional contingent payments that could reach $1.01 billion based on the achievement of specific milestones.
Celyad revised its agreement with Celdara Medical to increase the share on future revenues from chimeric antigen receptor T NKR-2, being developed as treatment for refractory solid and hematological tumors, which showed "increased confidence in the clinical opportunity" during a Phase I study. Under the new terms of the deal, Celdara will receive an additional $12.5 million in cash and another $12.5 million in stock.
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Kenya's National Biosafety Authority approved biotech corn and cotton field trials, which are scheduled to start in October. The assessment of the trials is "a step towards final application for release of the biotech maize into the market for either consumption or cultivation," Health Secretary Cleopa Mailu said.
Aemetis signed an agreement with InEnTec to produce high-value, low-carbon cellulosic ethanol using InEnTec's advanced gasification technology until 2024. Aemetis will incorporate InEnTec's technology with LanzaTech's patented microbial fermentation technology.
Learn more about key policy issues affecting biotechnology in Washington, D.C., and state capitals around the country. With the unpredictability of the federal level coupled with the increasingly hostile state legislatures, it is vital that the biotechnology industry amplify its voice on the federal, state and local levels. Become an advocate for biotechnology by joining BIO Action today. Now, more than ever, we need your voice! Text BIO to 52886 or visit BIO's website.
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