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Republicans unveil drug bill; J&J CEO refuses to appear in talc powder hearing

Top news

* U.S. House Republicans offered an alternative drug pricing package pumped full of provisions already adopted on a bipartisan basis by various Capitol Hill committees. The House Republican legislation is intended to rival Speaker Nancy Pelosi's drug pricing package, H.R. 3. House Republican leaders said they have White House support on their package, known as the Lower Costs, More Cures Act, or H.R. 19.

Republicans have rejected the idea of giving the federal government the power to negotiate the prices of the most expensive prescription drugs on behalf of the Medicare program and the commercial insurance market — the central provision in Pelosi's bill.

* Johnson & Johnson CEO Alex Gorsky will not testify before the U.S. House of Representatives on the health risks from asbestos found in the healthcare giant's talcum powder, but the Dec. 10 hearing will proceed anyway.

The U.S. House Subcommittee on Economic and Consumer Policy said Dec. 9 that Gorsky was given nearly a month's notice of the hearing and offered multiple scheduling accommodations, but the company declined to participate. The hearing, led by Subcommittee Chairman Raja Krishnamoorthi, will assess detection methods and public health implications of asbestos in talc powders.

* Sanofi's CEO, Paul Hudson, announced plans to exit diabetes and cardiovascular research and save €2 billion by reallocating resources in the next two years. In his first strategy update since joining Paris-based Sanofi from Swiss pharma group Novartis AG in September, Hudson said the focus will turn to hematology, rare disease, neurology and cancer. Diabetes and cardiovascular research have historically been two of the French pharma group's most important therapeutic areas.

Hudson also announced a simplified, corporate structure, with the company split into three business units: a stand-alone consumer business; a specialty care unit; and a general medicines unit, comprising established medicines and diabetes and cardiovascular products.

* The European Commission granted extended approval for the use of Vertex Pharmaceuticals Inc.'s Kalydeco in treating infants with cystic fibrosis from ages 6 months to less than 12 months, weighing 5 kilograms and more. The label extension covers patients who have at least one of the specified nine mutations in their cystic fibrosis transmembrane conductance regulator gene.

Cystic fibrosis is a life-threatening and rare inherited disease that causes the buildup of sticky mucus in the lungs and digestive system, potentially leading to severe damage of the affected organs.

* Christopher Collins, the former New York Republican congressman who pleaded guilty in October to insider trading involving a small Australian biotech company, agreed under a settlement with the U.S. Securities and Exchange Commission to never again serve on the board of any public company.

* The healthcare sector added 45,200 jobs in November, bouncing back from the industry's 2019 low in October, according to data from the U.S. Bureau of Labor Statistics. November's numbers, the industry's second-highest mark of 2019, come after the industry reported 11,900 jobs added in October, the lowest figure of the year.

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On the policy front

* Three Capitol Hill health committee leaders revealed more details about their compromise legislation to end surprise medical bills and reduce the prices of prescription medicines a day after declaring a deal had been reached on the package. But the heads of the House and Senate — Speaker Nancy Pelosi, D-Calif., and Senate Majority Leader Mitch McConnell, R-Ky., respectively — have yet to commit to letting the bill come up for a vote.

Additionally, it is unclear if the sponsors of the legislation, known as the Lower Health Care Costs Act of 2019, have garnered enough votes to get it through their respective chambers.

M&A and capital markets

* Roche Holding AG again extended its $4.3 billion takeover offer for Spark Therapeutics Inc. to give U.S. and U.K. regulators more time to examine the deal. The offer will now expire at 5 p.m. ET on Dec. 16, unless further extended.

* HVIVO PLC is merging with Open Orphan PLC, a rare disease and orphan drug-focused pharmaceutical services company. Under the reverse takeover transaction, hVIVO shareholders will receive 2.47 Open Orphan shares for each hVIVO share they own.

* UnitedHealth Group Inc.'s OptumRx Inc. unit will acquire Michigan-based specialty pharmacy Diplomat Pharmacy Inc.'s outstanding common shares for $4 each, or an implied stock valuation of $303.1 million.

Drug and product pipeline

* Bristol-Myers Squibb Co. said multiple studies demonstrated that its chimeric antigen receptor T cell therapy, dubbed liso-cel, showed benefits for patients with relapsed or refractory chronic lymphocytic leukemia, or CLL; small lymphocytic lymphoma; and relapsed or refractory large B cell non-Hodgkin lymphoma. These cancers affect the white blood cells in the blood.

* Eli Lilly and Co.'s investigational Bruton's tyrosine kinase, or BTK, inhibitor Loxo-305 helped reduce the tumor size of patients with CLL in a phase 1/2 trial called Bruin. Interim results also showed responses in patients that had either established a resistance to prior BTK therapy, were intolerant to BTK therapy or had a resistance to prior B cell lymphoma 2 therapy.

* Brussels-based UCB SA said its experimental drug rozanolixizumab helped patients with primary immune thrombocytopeni, or ITP, achieve clinically relevant improvements in platelet count and reduced immunoglobin G levels in a mid-stage trial called TP0001. Primary ITP is an autoimmune bleeding disorder in which the blood does not clot due to a low number of platelets.

* KalVista Pharmaceuticals Inc.'s medicine KVD001 failed to correct the vision of patients with diabetic macular edema who had previously not responded to other therapies in a mid-stage clinical trial. Diabetic macular edema is a common problem in patients with diabetes, and is the leading cause of blindness in the U.S.

Operational activity

* Solasia Pharma K.K. signed an exclusive licensing deal with Maruho Co.Ltd. for the commercialization of SP-04, Solasia's investigational therapy for chemotherapy-induced nerve damage. Under the deal, Maruho will pay Solasia ¥1 billion up front, with up to ¥18 billion in milestone payments.

The day ahead

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

In Asia, the Hang Seng was down 0.22% to 26,436.62, and the Nikkei 225 decreased 0.09% to 23,410.19.

In Europe, around midday, the FTSE 100 decreased 0.93% to 7,166.27, and the Euronext 100 decreased 1.04% to 1,111.47.

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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