- BMS to acquire heart drug group Cardioxyl in $2bn deal (pharmatimes.com)
Bristol-Myers Squibb is acquiring private US biotech Cardioxyl in a deal that could be worth more than $2 billion…it is paying $300 million upfront and potentially a further $1.775 billion on the attainment of certain development, regulatory and sales-based milestones for the group…The move strengthens BMS’ heart-failure offering with access to Cardioxyl’s lead candidate CXL-1427, a novel nitroxyl donor in Phase II clinical development as an intravenous treatment for acute decompensated heart failure…
- Congress Looks to Halt Rise of Generic Drug Prices with New Rebates (raps.org)
As drug price increases continue to make waves on the national level, Congress is taking the matter into its own hands by requiring generic drugmakers under the Medicaid Drug Rebate Program to pay higher rebates if generic prices rise too quickly…The new penalty for such price increases on generics, which is included in the recently passed budget deal, basically amounts to additional rebates that generic drug manufacturers would have to pay if the price of a generic for a given quarter outpaces the inflation-adjusted baseline Average Manufacturer Price…Under the Bipartisan Budget Act of 2015, the additional rebate...would now be applied to generics, too, beginning in Q1 of 2017...the change could create issues for generic manufacturers around updating their Medicaid price reporting systems, figuring out the potential financial impact of the change, and posing new strategic pricing questions for generic drug launches and market withdrawals.
- Many ‘me-too’ drugs didn’t start off that way: report (pharmalot.com)Nearly All Later Entrants to Drug Classes Were in Clinical Testing or Regulatory Review Before First-in-Class Approval (csdd.tufts.edu)
For many years, drug makers were criticized for racing to market with so-called me-too medicines. These are drugs that arrive in the marketplace after the first in a particular class of medicines is approved for treating a certain malady…Instead of developing something that offers little, if any, improvement over a first-in-class drug…critics have contended that drug makers should use precious R&D resources to focus on developing therapies for ailments that are lacking treatments…Now...a new analysis suggests the me-too phenomenon often occurred because companies were simply engaging in concurrent drug development, rather than opportunistic efforts to ride on the coattails of a successful medicine.
- Pfizer partners with South Africa to produce pneumococcal vaccine (reuters.com)
Pfizer has partnered with South Africa's Biovac Institute to produce a potentially life-saving pneumonia vaccine for infants…The five-year partnership…will see technology transfer and skills upgraded for the production of 'Prevenar 13' vaccine on a sustainable basis…There is more that we can do to cut the costs of the vaccine, and that is to manufacture the vaccine here in Cape Town…vaccine prices have sky-rocketed over the last decade...
- Mylan gets FTC’s OK for Perrigo deal (drugstorenews.com)Mylan not relying on acquisitions if Perrigo bid fails: chairman (reuters.com)
Mylan has cleared another hurdle in its ongoing attempt to acquire Perrigo, announcing Tuesday that the Federal Trade Commission had given the deal its OK, as long as Mylan divests itself of some products following the acquisition’s completion. With the completion of this step — and the recent U.S. court decision not to issue an injunction on behalf of Perrigo against Mylan — all Mylan needs is word from Perrigo’s shareholders on whether or not they will accept the company’s $27 billion acquisition offer…
- Record $254 billion in health savings attributed to use of generics in 2014 (drugstorenews.com)Generic Drug Saving in the U.S. Seventh Annual Edition: 2015 (gphaonline.org)
Few factors have played as significant a role in helping curb health care costs over the past decade as generic drugs…since 2005, generics have saved patients $1.68 trillion. In 2014 alone, the report notes, generic drugs trimmed more than $254 billion from health care spending. Slightly more than a third of those savings were from generics taken by people over 65…“This new report reinforces that generic drugs are a critical part of any solution to rising costs for patients, payers and for the entire health care system,”
- Blog: Texas docs plead for relief from ‘meaningless abuse’ (modernhealthcare.com)EHR State of Mind - ZDoggMD (letdoctorsbedoctors.com)
Texas Medical Association wants Congress to intervene and make changes to the federal electronic health-record incentive payment program it's calling "meaningless abuse."…The group says Stage 3 of the program meant to get physicians using EHRs could jeopardize Medicare doc payment rules… wants Congress to lift what it's describing as the $31.6 billion program's “convoluted and tedious” meaningful-use requirements…TMA President Dr. Tom Garcia asked legislators to co-sponsor two bills to alter the meaningful-use landscape…One is the Flex-IT 2 Act...which would delay Stage 3 meaningful-use rules until at least Jan. 1, 2017. The other is the Transparent Ratings on Usability and Security to Transform Information Technology, or TRUST IT Act which is aimed at ensuring health IT systems perform better in the field.
- United States Lags Behind Other Nations in Rx-to-OTC Switch Approvals (klinegroup.com)
In contrast to the U.S. FDA, regulatory agencies outside the United States have been much more aggressive in approving switches for conditions outside the typical OTC paradigm…increasing patient choice by making more medicines available without a prescription is a priority for the British government…The United Kingdom leads the world in the range of products available without a prescription…Industry research conducted by Kline for its…suggests that switch receptivity in the United States may be changing. There are a wide variety of categories with switch candidates that may have significant impact on many companies across the OTC and Rx markets.
- Four Fun Facts About the Walgreens-Rite Aid Merger Agreement (drugchannels.net)Sec. and Exch. Com. Form 8-K AGREEMENT AND PLAN OF MERGER Among WALGREENS BOOTS ALLIANCE, INC., RITE AID CORPORATION (files.shareholder.com)
Late last week, Walgreens Boots Alliance filed an 8-K with the full text of its merger agreement with Rite Aid….The document containing the Agreement and Plan of Merger weighs in at a hefty 137 pages. Below, I highlight four fun facts about the deal’s timing, its termination fees, and what the companies will do to achieve antitrust approval.
- The deal must be completed before Halloween 2016.
- If Rite Aid backs out of the deal, then it owes as much as $370 million to Walgreens Boots Alliance.
- WBA could owe Rite Aid a termination fee as large as $650 million.
- To get the deal approved, WBA is willing to dump as many as 1,000 stores.
- HCA Acquires 14 Urgent Care Centers in Las Vegas (investor.hcahealthcare.com)
HCA (Hospital Corporation of America) today announced the acquisition of Urgent Care Extra’s Nevada operations, which include 14 urgent care centers in Las Vegas…The...centers join HCA’s Sunrise Health System...which includes four hospitals and four surgery centers. The purchase also includes six additional urgent care centers that are under development in the market…This acquisition adds a strong network of leading urgent care centers to our Las Vegas network and complements our presence in the market…









