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US FDA panel backs Amgen's bone drug; Lilly's breast cancer drug gets UK nod


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US FDA panel backs Amgen's bone drug; Lilly's breast cancer drug gets UK nod

Top news

* Scientists from the U.S. Food and Drug Administration's advisory committee voted overwhelmingly to recommend approving Amgen Inc.'s osteoporosis drug Evenity despite concerns regarding cardiovascular risks found in an earlier clinical trial.

* The U.K. National Institute for Health and Care Excellence recommended Eli Lilly and Co.'s Verzenio for treating certain breast cancer patients. In a draft guidance, the drug price watchdog gave the nod to Verzenio, combined with an aromatase inhibitor, for treating locally advanced or metastatic — which means the cancer has spread across the body — HR+/HER2-, breast cancer as first endocrine-based therapy.

* JPMorgan Chase & Co. Chairman and CEO Jamie Dimon said rising healthcare costs are a serious economic issue facing the U.S., and he believes universal healthcare coverage can help lower some spending.

On the policy front

* Another 1,000 people lost Medicaid eligibility in Arkansas in December 2018 due to the state's work requirements policy, bringing the total number of people removed from the health insurance program for low-income Americans in 2018 to over 18,000, according to data from the state's Department of Human Services.

* Meanwhile, opponents to a similar work requirements program in Kentucky filed an amended complaint Jan. 14 aiming to block the requirements from going into effect.

M&A and capital markets

* North Carolina's attorney general does not object to HCA Healthcare Inc.'s $1.5 billion purchase of Mission Health System Inc., a North Carolina-based hospital system. Attorney General Josh Stein signed off on the merger, allowing hospital giant HCA to move forward with its acquisition.

* S&P Global Ratings downgraded Akorn Inc.'s rating to B- from B due to continued uncertainty regarding several business challenges. The outlook on the rating is stable, reflecting Akorn's sizable cash balance, which gives company management time to address the issues, S&P said.

Drug and product pipeline

* The U.S. FDA approved a generic version of H. Lundbeck A/S's Sabril — the first copy of the epilepsy drug to ever be approved in the U.S.

Israel's Teva Pharmaceutical Industries Ltd. will market the medicine, which is also known as vigabatrin, to treat complex partial seizures, or focal seizures, in epilepsy patients 10 years and older who have had inadequate responses to several alternative treatments.

* The U.S. Food and Drug Administration rejected Actelion Pharmaceuticals Ltd.'s application to seek an expanded use for its blood pressure drug Opsumit. The Johnson & Johnson unit sought an expansion in the usage of Opsumit to treat adults with inoperable chronic thromboembolic pulmonary hypertension — high pressure in the blood vessels of the lungs caused by the formation of blood clots and related scarring — to improve blood flow to the lungs and exercise capacity.

* Aradigm Corp. has completed an independent third-party evaluation of two phase 3 studies for its respiratory disease drug Apulmiq as requested by the U.S. FDA. Hayward, Calif.-based Aradigm is seeking approval for Apulmiq, known in the EU as Linhaliq, for treating non-cystic fibrosis bronchiectasis, patients with chronic lung pseudomonas aeruginosa infections.

Operational activity

* Dublin-based Allergan PLC has filed a petition in the U.S. Supreme Court to challenge the invalidation of its patents related to dry-eye treatment Restasis despite the company signing a licensing deal with the St. Regis Mohawk Tribe to shield the drug from generic competition.

Our features

Drug companies chase deals for cell and gene therapies, biotech's 'next wave': As the market for cell and gene therapies becomes more established and research activity builds, both big pharmaceutical companies and smaller biotechs are seeking to gain ground in what could become a medical arms race.

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The day ahead

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

In Asia, the Hang Seng fell 0.54% to 26,755.63, while the Nikkei 225 was down 0.20% to 20,402.27.

In Europe, around midday, the FTSE 100 was down 0.52% to 6,827.00 and the Euronext 100 was up 0.28% to 934.38.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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