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BioWorld - Saturday, May 9, 2026
Home » Topics » North America » U.S.

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Gala Therapeutics gets breakthrough device designation for Rheox system

Sep. 17, 2019
By Liz Hollis
Chronic bronchitis affects more than 9 million people in the U.S., but current treatments fail to address the overproduction of mucus. Gala Therapeutics Inc., of Menlo Park, Calif., is looking to change that.
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Some state AGs balking at Purdue settlement attempt in massive opioid suit

Sep. 13, 2019
By Mari Serebrov
With little more than a month to go before a trial begins in a multidistrict litigation (MDL) against several opioid manufacturers, privately owned Purdue Pharma LP is continuing its efforts to settle with all the plaintiffs involved.
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Health of U.S. patent system in the eye of the beholder

Sep. 13, 2019
By Mari Serebrov
Depending on who's talking, the U.S. patent system may, or may not, be in dire need of reform. In a Senate Judiciary subcommittee hearing Wednesday on the bipartisan STRONGER Patents Act, Sen. Chris Coons (D-Del.) stressed the need to undo the precedent set by the Supreme Court's 13-year-old eBay decision that weakened injunctive relief in infringement cases and to resolve some of the unintended consequences of the 2011 America Invents Act (AIA).
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Draft proposal shows how HHS price negotiations could take shape

Sep. 11, 2019
By Mari Serebrov
Whether it's mere political posturing or a genuine prescription to control U.S. drug prices, a Democratic plan taking shape in the House provides an idea of what direct government negotiation might look like.
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As U.S.-China tensions curb biopharma investment, both sides could be victims

Sep. 11, 2019
By Elise Mak
BEIJING – The ongoing trade war between the U.S. and China has helped put the biotechnology field on the U.S. foreign investment restriction list, causing a chilling effect on the market.
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Global drug supply chain jeopardized by unpredictable trade talks

Sep. 11, 2019
By Elise Mak
BEIJING – China's position as a global power in active pharmaceutical ingredients (API) could be jeopardized by the ongoing and worsening trade war with the U.S. Perhaps more worrisome for the pharma industry, any disruption to Chinese supply chains could have a serious impact on drug manufacturing and accessibility globally.
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Led by U.S. scientists, funded by Chinese, cross-border firm Oncologie eyes both markets

Sep. 11, 2019
By Elise Mak
BEIJING – Despite tensions between the U.S. and China, especially in the tech sector, Oncologie Inc. maintains its plans to pursue drug development in both markets. The clinical-stage startup, led by U.S. scientists and funded with Chinese capital, has stationed itself in both Boston and Shanghai to focus on developing innovative cancer therapies simultaneously in China and the U.S.
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Sumitomo Dainippon strikes rich tie-up with Roivant; shells out $3B for ownership in five 'Vants'

Sep. 11, 2019
By Michael Fitzhugh
Japan's Sumitomo Dainippon Pharma Co. Ltd. plans to pay $3 billion to acquire Roivant Sciences Ltd.'s ownership interests in five biopharma companies, plus options to acquire up to six more from the prolific company-builder. The deal, slated to close in October, would give Sumitomo Dainippon controlling interests in Myovant Sciences Inc., Urovant Sciences Inc., Enzyvant Therapeutics Inc. and Altavant Sciences Inc., as well as an equity stake of more than 10% in Roivant itself.
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Axonics looks to take on Medtronic after getting FDA nod for r-SNM system

Sep. 10, 2019
By Liz Hollis
Irvine, Calif.-based Axonics Modulation Technologies Inc., which has developed an implantable rechargeable sacral neuromodulation (r-SNM) device for the treatment of urinary and bowel dysfunction, has won the FDA's nod for its system to help patients with fecal incontinence.
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Shockwave nabs FDA breakthrough designation to fracture coronary calcium via lithotripsy

Sep. 9, 2019
By Stacy Lawrence
Santa Clara, Calif.-based Shockwave Medical Inc. is working to build its business around the use of intravascular lithotripsy (IVL) in multiple arterial indications. Lithotripsy has been used to destroy kidney stones for decades, but now Shockwave's system is applying that technology to indications including coronary artery disease (CAD), above-the-knee peripheral artery disease (PAD) and below-the-knee PAD that each require a specific catheter.
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