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Talks continue on ACA overhaul; GSK recalls inhalers in US


Essential IR Insights Newsletter Fall - 2023

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Talks continue on ACA overhaul; GSK recalls inhalers in US

* A group of House Republicans met Vice President Mike Pence on Tuesday night but did not emerge with an agreement on how to repeal and replace the Affordable Care Act, The Wall Street Journal reported. Lawmakers and congressional staffers said they are considering a provision that would allow states to opt out of certain requirements of the ACA, the Journal added.

Reuters said it is now less likely that Republicans would have a deal before Friday, when Congress goes on a two-week recess.

The Washington Post also reported on the news.

* Lawmakers on Capitol Hill are trying to complete a bill to renew the FDA's four drug and device user fee programs by Sept. 30 or the agency will lose more than half of its funding, resulting in substantial layoffs of scientists and other staff. But Sen. Lamar Alexander, R-Tenn., chairman of the Senate Health, Education, Labor and Pensions Committee, said he was not going to let that happen and pledged during an April 4 hearing to work across the aisle to get the job done.

M&A and capital markets

* The bidding war for German drugmaker Stada-Arzneimittel AG is drawing to a close as final offers are reportedly expected on Friday, Reuters reported, citing three people close to the matter. The company declined to comment on the reports of the timing of the deal.

* Blueprint Medicines Corp. raised about $215.6 million in net proceeds via an underwritten public offering of 5,750,000 shares.

* Integra LifeSciences Holdings Corp. increased its credit facility by $700 million to $2.2 billion to finance the acquisition of Johnson & Johnson's Codman Neurosurgery business.

Drug and product pipeline

* GlaxoSmithKline PLC is recalling 593,088 Ventolin asthma inhalers in the U.S. and Puerto Rico due to a defective delivery system, as an elevated number of units were out of specification results for leak rate. The three affected lots originated from GlaxoSmithKline's Zebulon, N.C., plant, which will continue to make the inhalers.

* Roche Holding Ltd.'s Herceptin and Novartis AG's Tykerb demonstrated clinical benefit as a combination treatment for certain metastatic colorectal cancer patients in a phase 2 trial.

* The U.S. FDA granted priority review status to Bristol-Myers Squibb Co.'s supplemental biologics license application that seeks to extend the use of Opdivo to treat patients with certain types of colorectal cancer.

* Kite Pharma Inc.'s findings of its investigational CAR-T treatment showed an 82% objective response rate among patients with severe and aggressive non-Hodgkin lymphoma, a blood cancer. CAR-T is a form of therapy in which a patient's own blood is modified and then reintroduced into the body.

* The addition of NewLink Genetics Corp.'s indoximod to therapy with Merck & Co. Inc.'s Keytruda improved the response rate of advanced melanoma patients, according to phase 2 clinical trial results presented April 4 at the American Association of Cancer Research conference in Washington, D.C.

Operational activity

* Eisai Co. Ltd. secured marketing rights in Japan and Asia to Meiji Seika Pharma Co. Ltd.'s safinamide, an experimental Parkinson's disease drug, according a press release. Under the licensing deal, Meiji Seika will receive an unidentified upfront payment, and development milestone and sales royalty payments.

* The U.S. FDA highlighted concerns regarding Dr. Reddy's Laboratories Ltd.'s drug manufacturing plant in Srikakulam, India, Reuters reported.

The day ahead

Early morning futures indicators pointed to a mixed opening for the U.S. market.

In Asia, the Hang Seng was up 0.57% to 24,400.80, and the Nikkei 225 was up 0.27% to 18,861.27.

In Europe, around midday, the FTSE 100 climbed 0.09% to 7,328.53, and the Euronext 100 was up 0.15% to 984.38.

Now featured on S&P Global Market Intelligence:

* Roche bulks up drug pipeline amid fierce oncology competition: Roche is investing heavily in R&D and its non-oncology franchise to offset growing oncology competition.

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