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Friday, June 28, 2019

Senate Committees Advance Prescription Price Lowering Bills

Four bills aimed at lowering prescription drug prices were advanced out of the U.S. Senate Judiciary Committee this week and will head to a vote on the Senate floor.
The bipartisan bills, RAPS reported, are part of a package of bills the Senate aims to vote on before the end of July. Another bill that is currently in the Senate Finance Committee could join the four that were approved by the Judiciary Committee for a full Senate vote, RAPS said. The future of the bills is uncertain due to partisan conflicts, the president’s mercurial whims and whether or not the legislation has any real teeth that will do anything about pricing concerns that have become a political mainstay in the most recent national elections.
According to the New York Times, the bills have a wide range of price-lowering possibilities, “from ending surprise medical bills to curbing prescription drug price surges.” Among the provisions of the bills is a plan that will limit the maneuverability companies have had in regards to building up a thicket of patents to protect a drug’s exclusivity, much like AbbVie has done with Humira.

Connecticut Sen. Richard Blumenthal told RAPS that he hopes the legislation regarding patents will be approved in order to create greater competition and lower prices. Humira, which earned AbbVie about $20 billion last year, has patent protection in the U.S. until 2023. It is the most widely-prescribed drug in the world. Bernstein Research analyst Ronny Gal also told RAPS that those patent-protecting rules that currently exist are one of the reasons that drug prices are so much higher in the United States than elsewhere. Despite calls to lower drug prices, Gal speculated that the bill targeting patent protection will either be watered down or could fail. He told RAPs that “Republicans in the Senate are unlikely to back a plan from House Democrats that would hurt pharmaceutical companies and allow for direct negotiation of the top 250 drugs for all payers, not just the government.”
Plans also include support for Trump’s recent executive order regarding the requirements of hospitals, insurers and doctors to disclose how much care will cost prior to receiving it. Another bill will deter the filing of “sham citizen petitions” that are attempts to block the approval of generics or biosimilar competition to branded drugs.
These bills in the Senate will likely come to the floor about the same time the Trump administration and 18 Republican-led states will seek to have the entire Affordable Care Act thrown out following a legal decision that rendered the mandate moot.

Health insurers in red after Dem debate

Health insurers and managed care providers are under modest pressure following the conclusion of the two-day debate between Democratic candidates for President.
Of the 20 candidates, four support a government-run single payer system but there was disagreement on scrapping private health insurance coverage offered under the Affordable Care Act.
Selected tickers: UnitedHealth Group (UNH -2.4%), Anthem (ANTM -1.4%), Centene (CNC -1.4%), Humana (HUM -1.3%), WellCare Health Plans (WCG-0.7%), Molina Healthcare (MOH -0.8%), Cigna (CI -0.6%), eHealth (EHTH-0.2%), Health Insurance Innovations (HIIQ +1.1%)

Game-changer of a call on Heron Therapeutics?

Heron (NASDAQ:HRTX) had a rough early May after receipt of a CRL for its HTX-011.
Cowen, however, has a possibly game-changing call this morning, says Notable Calls. The team there filed a FOIA request with the FDA to get more detail on HTX-011 rejection.
Bottom line, according to Cowen: The issues are largely procedural and resolvable with proper protocols, training, and employee oversight. Cowen expects resubmission in H2, allowing for a new PDUFA target date in early 2020.
Both the Sell-Side and SA authors remain bullish on Heron, with the SA Quant Rating is Very Bearish.

European advisory group rejects expanded label for Novartis’ Revolade

The European Medicines Agency’s advisory group CHMP has adopted a negative opinion against approval for Novartis’ (NYSE:NVS) Revolade (eltrombopag) for treatment-naive patients at least two years old with severe aplastic anemia.
Revolade is currently approved in the EU for adults with severe aplastic anemia, HCV-positive adults with thrombocytopenia (low blood platelets) and patients at least one year old with immune thrombocytopenia.

Walgreens to trim store base in U.K.

Walgreens Boots Alliance (NASDAQ:WBA) confirms plans to close 200 Boots stores in the U.K.
The closures are expected to take place over the next 18 months.
“WBA has now approved an outline plan to consolidate around 200, principally local pharmacy, stores where we have a large number within close proximity. We believe this is the right thing to do as it means that we can invest more in staffing those stores while not reducing our 90% coverage within a 10-minute drive of a Boots,” says Boots U.K. Managing Director Sebastian James.

Amgen withdraws European application for Remicade biosimilar

The European Medicines Agency’s advisory group CHMP reports that Amgen (NASDAQ:AMGNwithdrew its marketing application on May 27 for ABP 710, its biosimilar to Johnson & Johnson’s (NYSE:JNJ) Remicade (infliximab).
The agency says that the company informed it that the withdrawal was related to a change in strategy for the product.

FDA OKs Pfizer’s Avastin biosimilar

The FDA approves Pfizer’s (NYSE:PFE) Zirabev (bevacizumab-bvzr), its biosimilar to Roche’s (OTCQX:RHHBY) cancer med Avastin.
Shares are up 1% premarket on light volume.