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House adopts Pelosi drug bill; Hahn confirmed; EMA backs Pfizer's Humira copycat

Top news

SNL Image
House Speaker Nancy Pelosi
Source: AP Photo

* After a fierce debate between Democrats and Republicans, the U.S. House adopted Speaker Nancy Pelosi's legislation that would permit the federal government to negotiate the prices of the most expensive prescription drugs on behalf of the Medicare program and the commercial insurance market. The vote was 230 to 192.

However, Senate Majority Leader Mitch McConnell, R-Ky., has already said he has no plans to ever bring up the bill for a vote in his chamber. President Donald Trump also has indicated he would veto the Elijah E. Cummings Lower Drug Costs Now Act, or H.R. 3, if it ever made it to his desk.

* The U.S. Senate has confirmed cancer doctor Stephen Hahn to be the 24th commissioner of the U.S. Food and Drug Administration, an agency that oversees products that account for about one-fifth of the nation's economy. The Senate cleared Hahn's nomination Dec. 12 in a 72 to 18 vote.

The new FDA leader is under pressure from Republicans and Democrats to take action to curb the youth vaping epidemic — a concern that dominated his Nov. 20 confirmation hearing. Trump had vowed in September to clear the U.S. market of non-tobacco-flavored e-cigarettes that have not undergone FDA review, but later backed away from that pledge.

* Pfizer Inc. Amsparity, a biosimilar to AbbVie Inc.'s top-selling arthritis drug Humira, was among the five therapies recommended by the European Medicine Agency's Committee for Medicinal Products for Human Use in December. The committee also recommended granting a marketing authorization to Novartis AG Beovu for treating an eye disease called neovascular age-related macular degeneration.

* The U.S. FDA granted accelerated approval to Sarepta Therapeutics Inc.'s Vyondys 53 injection to treat Duchenne muscular dystrophy after previously rejecting the drug. Vyondys 53 is the first treatment for DMD patients with confirmed mutation of the dystrophin gene amenable to exon 53 skipping.

In August, the FDA flagged the risk of infections related to intravenous infusion ports and kidney-related toxicity seen in preclinical models of the injection.

* Meanwhile, PerkinElmer Inc.'s kit to screen for a rare genetic disorder has been approved by the U.S. Food and Drug Administration, the first of its kind to test for Duchenne muscular dystrophy in newborns.

On the policy front

* Health insurers that offer Medicare Advantage plans received an estimated $6.7 billion in 2017 for presenting chart reviews — without supporting medical records from patients — to inappropriately hike risk-adjusted payments, according to a report published by the U.S. Department of Health and Human Services' Office of Inspector General. These insurers added diagnoses of serious illnesses such as cancer, diabetes and heart disease in 99.3% of these chart reviews without documented service records, raising potential concerns about the completeness and validity of data submitted to the Centers for Medicare and Medicaid Services, the study noted.

* A Medicaid adviser for Congress supports delaying a proposed federal rule that would increase the government's oversight of additional Medicaid payments to providers.

Members of the Medicaid and CHIP Payment and Access Commission said during a Dec. 12 meeting that the changes outlined in the proposed rule could harm access to care and limit needed federal funding for certain providers. The commission agreed to submit a public comment on the proposed rule outlining the concerns and asking the CMS to delay implementation.

* As the future of Medicaid work requirements is being considered by a federal appeals court, South Carolina became the first non-Medicaid expansion state to have the controversial waiver policy approved by the federal government. About 83,461 people will be required to provide evidence to be exempt from the policy or meet the work requirements, according to the state's Department of Health and Human Services.

M&A and capital markets

* Evercel Inc. said NewLink Genetics Corp. rejected its two offers to acquire the Ames, Iowa-based biopharmaceutical company. On Nov. 25, Evercel disclosed it made alternative offers to buy Newlink — one of which entailed acquiring the latter for $1.75 in cash per share — but NewLink's board rejected the offers without conducting discussions.

* Genor BioPharma Co. Ltd. is planning to raise about $200 million from a Hong Kong IPO, Bloomberg News reported, citing people familiar with the matter. Shanghai-based Genor BioPharma, which develops treatments for cancer, autoimmune and metabolic diseases, got in touch with potential advisers for the share sale, according to the insiders.

Drug and product pipeline

* Roche Holding AG said adding Tecentriq, or atezolizumab, to its existing medicines Zelboraf and Cotellic helped reduce the risk of disease worsening or death in certain patients with skin cancer.

* Transgene SA stopped developing an investigational lung cancer drug after patients did not respond to the treatment, missing the main goal of a mid-stage study. The French biotechnology company evaluated TG4010 in combination with chemotherapy and Bristol-Myers Squibb Co.'s Opdivo as an initial treatment for certain patients with advanced nonsquamous non-small cell lung cancer.

Operational activity

* Assertio Therapeutics Inc. is selling all rights related to its pain drug Gralise to Pine Brook, N.J.-based privately held company Alvogen Inc. for a transaction value of about $127.5 million. Assertio's President and CEO, Arthur Higgins, said the sale will allow the company to focus on anti-inflammatory drug Cambia and another pain drug, Zipsor.

* Zoetis Inc.'s board increased the company's quarterly dividend by 22% to 20 cents per share.

* Bristol-Myers Squibb Co. said its head of strategy and business development, Paul Biondi, departed to pursue an external opportunity, Reuters reported. Biondi, who has been with the company since 2002, left as the company was concluding its $74 billion takeover of Celgene Corp.

The day ahead

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

In Asia, the Hang Seng inched up 2.57% to 27,687.76, and the Nikkei 225 rose 2.55% to 24,023.10.

In Europe, around midday, the FTSE 100 was up 1.84% to 7,406.99, and the Euronext 100 increased 1.11% to 1,138.63.

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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