Baxter International Inc.’s fourth quarter earnings per share came in well below consensus and the company lowered expectations for 2023’s first quarter and full-year performance citing “ongoing macroeconomic challenges and supply chain headwinds.” Topline results that beat expectations provided cold comfort to investors who saw the stock price drop 12% following the release of the quarterly report. Baxter also provided additional details on the restructuring including limited layoffs along with the quarterly update.
Feeling “ashamed” of having to use metal flesh-piercing forceps to stabilize the cervix during the insertion of intrauterine contraceptive devices, David Finci a gynecologist and co-founder of Aspivix SA, turned to his brother Julien, a medical device engineer, for his thoughts on how to design a more suitable instrument.
U.S. drug prices continue to be in the crosshairs of Congress, with the Senate Judiciary Committee once again sending five bipartisan bills targeting anticompetitive pricing tactics to the full Senate Feb. 9 with do-pass recommendations.
With China taking steps to enact or propose amendments to more than 60 intellectual property (IP)-related laws and regulations over the past few years, drug and device companies doing business in the country need to keep abreast of the changes. Despite China’s efforts, most of the participants in the Feb. 9 U.S. Patent and Trademark Office’s quarterly China IP webinar indicated in a pre-webinar survey that they have yet to see much of an improvement in China’s enforcement and regulation of IP rights.
Woebot Labs Inc. posted uplifting news for women who have suffered from baby blues and their big brother, post-partum depression. The company recently enrolled the first patient in its pivotal trial of WB001, a digital therapeutic for post-partum depression (PPD). WB001 received U.S. FDA breakthrough device designation in 2021, indicating the acute need for accessible treatment for the common condition.
Complete Genomics Inc. launched a new line of genetic sequencers designed to decode DNA in greater quantities – and at a lower price point – than existing sequencing tools. The new products could signal a new era of more affordable testing, leading to wider availability and the potential to fulfill the long-desired promise of precision medicine.
The U.S. International Trade Commission (USITC) is launching an investigation into the importation from China of certain thyroid hormone receptor-beta agonists, products containing them and the manufacturing processes being used.
A federal court cut off efforts Feb. 6 to halt a U.S. program allowing prescription drug imports from Canada before the program gets off the ground. The U.S. District Court for the District of Columbia dismissed a suit by the Pharmaceutical Research and Manufacturers of America (PhRMA) and other organizations, saying that they lacked standing because neither they nor their members face “a concrete risk of harm from the inchoate importation program.”
While the new inflation-based rebate on certain Part B drugs may generate billions of dollars in savings for Medicare, implementing the rebate could be more challenging than the U.S. Congress and the Biden administration expected when the Inflation Reduction Act was enacted last August.
The U.S. FDA and makers of medical devices have several collaborative programs, but the two sides have joined forces yet again in a new collaboration, this time to address both product quality issues and supply chain resiliency.
RSS
