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ACA mandate struck down; Roche's Kadcyla OK in EU; Novartis' Zolgensma giveaway

Top news

* The U.S. Court of Appeals for the 5th Circuit in New Orleans declared the Affordable Care Act's individual mandate unconstitutional but did not invalidate the law in its entirety. The appeals court returned the case to the lower district court in Texas to decide if other provisions in the 2010 healthcare law could survive without the individual mandate.

The 5th Circuit heard oral arguments in the case in July after a federal judge in Texas ruled in December 2018 that the ACA was unconstitutional. President Donald Trump has not provided a replacement for the Obama healthcare law.

* The European Commission approved Roche Holding AG's Kadcyla as a postsurgery therapy for adults with HER2-positive early breast cancer. These patients also have residual invasive disease in the breast and/or lymph nodes, having received taxane-based and HER2-targeted therapy prior to surgery. Postsurgery treatment aims to get rid of any remaining cancer cells in the body, cutting down the risk of the disease coming back.

* Novartis AG is planning to give away doses of Zolgensma, its gene therapy for spinal muscular atrophy that costs $2.1 million, through a free-drug program in 2020, Reuters reported, citing a company spokesman.

Under the initiative, the Swiss company's AveXis unit will allocate 50 doses of Zolgensma, the world's most expensive drug, beginning Jan. 2 until June for infants under two years of age. Up to 100 doses of the medicine will be given away through 2020, Reuters said.

* Illumina Inc.'s proposed $1.2 billion acquisition of fellow gene sequencer Pacific Biosciences of California Inc. is the latest to fall prey to antitrust authorities' increased scrutiny of large-scale deals in the healthcare industry and is one of the few set to actually face the U.S. Federal Trade Commission in court over the deal.

The FTC joined its U.K. counterpart, the Competition and Markets Authority, on Dec. 17 in unanimously filing to block a deal that could create a monopoly in the sequencing industry, according to the regulators. Leerink analyst Puneet Souda said the deal is unlikely to be approved, considering two major markets are now against the transaction.

* The World Health Organization has prequalified a biosimilar of Roche's breast cancer treatment Herceptin, or trastuzumab, to be supplied by Samsung Bioepis NL BV, in an effort to make the treatment with a global average cost of $20,000 more affordable and available to women globally. The United Nations specialized agency for international public health prequalifies medicines to facilitate access with the goal of addressing widespread diseases in places with limited access to quality medicine.

* In a recurring column dubbed First in Human, S&P Global Market Intelligence talks about a phase 1 study from King's College London and Compass Pathways that showed that patients experienced no adverse effects from taking psychedelic substance psilocybin, and how Tonix Pharmaceuticals Holding Corp. could be one step closer to developing a new once-daily drug for depression.

On the policy front

* The Trump administration unveiled a proposed rule and draft guidelines under a two-pronged approach to import drugs from Canada and other foreign nations into the U.S., without specifying a timeline for executing on the plans. Health and Human Services Secretary Alex Azar said the administration also does not have a projection on any cost savings from importing drugs into the U.S.

The proposed rule, if finalized, would authorize U.S. states, potentially working with wholesalers or pharmacies, to develop programs that would allow importation of certain prescription medicines from Canada. The U.S. drug industry and Canadian officials have opposed the Trump administration's import plans.

* Meanwhile, the Trump administration's two-pronged strategy to import prescription drugs into the U.S. is unlikely to clear the key statutory hurdles of ensuring no additional safety risks to Americans and providing a significant reduction in consumers' costs, health policy experts said.

Both strategies involve complicated processes outlined in a proposed rule and a set of industry guidelines that may take years to implement. Economic analysts from the U.S. Food and Drug Administration, which is tasked with carrying out the importation plans, said they were unable to estimate the cost savings from the proposed rule.

M&A and capital markets

* Getinge AB agreed to acquire privately held Dutch company Applikon Biotechnology B.V. for 840 million Swedish kronor. Getinge could pay up to 630 million kronor in additional earnout fees in 2021-2022 upon the achievement of certain earnings performance in 2020-2021.

* Zafgen Inc. is merging with privately held biotech Chondrial Therapeutics Inc., with the combined company to be renamed Larimar Therapeutics Inc. Chondrial will become a wholly owned subsidiary of Zafgen while holding about 60% of the combined company's shares.

Drug and product pipeline

* The Oncologic Drugs Advisory Committee, a panel of outside advisers to the FDA voted unanimously to approve Epizyme Inc.'s experimental therapy tazemetostat for patients whose epithelioid sarcoma has spread to other parts of the body or to nearby tissue or lymph nodes and are not eligible for curative surgery. Epithelioid sarcoma is a rare, slow-growing type of soft tissue cancer. Tazemetostat is slated for a Jan. 23, 2020, FDA decision date.

Additionally, the Cambridge, Mass.-based company is seeking the FDA's accelerated approval for tazemetostat to treat relapsed or refractory follicular lymphoma — a cancer that affects white blood cells — among patients who have received at least two prior lines of systemic therapy.

* The U.S. FDA approved the new drug application for Bausch Health Cos. Inc.'s Arazlo topical lotion for treating acne vulgaris in patients at least nine years old. Arazlo is the first tazarotene acne treatment available in a lotion form.

* GlaxoSmithKline PLC's investigational drug Benlysta helped patients with active lupus nephritis — inflammation of the kidneys due to systematic lupus erythematosus — in a late-stage study dubbed Bliss-LN. Results showed that patients saw an improvement in their disease over two years when treated with the combination of Benlysta and standard therapy.

* The FDA granted accelerated approval to Seattle Genetics Inc. and Tokyo-based Astellas Pharma Inc.'s Padcev to treat adult patients with locally advanced or spreading urothelial cancer who have not responded to a PD-1/L1 inhibitor — a cancer therapy that targets the immune system — and platinum-containing chemotherapy.

* AbbVie Inc. said the European Commission approved Rinvoq for treating adult patients with moderate to severe active rheumatoid arthritis who cannot take or have responded inadequately to one or more disease-modifying anti-rheumatic drugs.

* Minerva Neurosciences Inc. has no plans to further develop MIN-117 as a potential treatment of major depressive disorder after the therapy failed to significantly reduce symptoms of depression compared to placebo in a mid-stage study.

* Glenmark Pharmaceuticals Inc. initiated a voluntary recall of all unexpired lots of its stomach medicine ranitidine in 150-milligram and 300-milligram dosages in the U.S. due to the potential presence of higher than approved levels of a potentially cancer-causing substance called N-nitrosodimethylamine.

Operational activity

* Akcea Therapeutics Inc. retained the rights to develop and commercialize heart drug Akcea-APOCIII-LRx after Novartis declined to exercise its option to do so. Boston-based Akcea is developing the therapy for multiple diseases including familial chylomicronemia syndrome — a disease that prevents the body from breaking down fats — and cardiovascular disease.

* Ultragenyx Pharmaceutical Inc. sold royalty rights for the net sales of its genetic disorder treatment Crysvita in the EU, U.K. and Switzerland to Royalty Pharma Ltd in a $320 million deal. Crysvita, or burosumab, is approved by the U.S. FDA to treat X-linked hypophosphatemia in patients aged six months and older.

* Ian Read, former president and CEO of Pfizer Inc., and James Kilts will be appointed board members of Viatris, a business combination of generic-drug maker Mylan NV with Pfizer's off-patent drugs unit Upjohn. Read, Pfizer's executive chairman, will retire from the company effective Dec. 31.

The day ahead

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

In Asia, the Hang Seng decreased by 0.30% to 27,800.49, while the Nikkei 225 was down 0.29% to 23,864.85.

In Europe, around midday, the FTSE 100 increased by 0.21% to 7,558.69, and the Euronext 100 increased by 0.01% to 1,140.42.

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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