- Testosterone Suits Soar Past 2,500 As Legal Milestone Looms For AbbVie (forbes.com)
…lawyers for AndroGel maker AbbVie will present their selection of 16 plaintiffs they’d like to represent the growing class of men who are suing the company over allegations that its product, a topical form of testosterone, caused blood clots, heart attacks and other adverse events. Lawyers representing the men will do the same in a process that will culminate in the selection of 12 “bellwether” cases to be tried starting late next year…men suing over testosterone has soared…to 2,744…Claims have been filed against seven makers of testosterone products…The court chose AbbVie as the subject of the first trials, with the first six bellwethers to involve men alleging “thromboembolic” injuries…and the second six alleging heart attacks or strokes...
- OPA announces opposition to marijuana oligopoly ballot initiative (ohiopharmacists.org)Ohio voters weigh legalizing recreational marijuana use (reuters.com)
Ohio Pharmacists Association, the state organization representing Ohio’s pharmacist practitioners, announced their opposition to the Ohio Marijuana Legalization Initiative, Issue 3, which if passed which would place legalized marijuana and a protected oligopoly of select commercial marijuana growers into the Ohio Constitution…OPA is unconvinced that marijuana is appropriate or beneficial as a form of treatment for illness or disease. Further, OPA rejects any medical marijuana proposal that removes the function, counsel, and expertise of the prescriber and pharmacist from the prescription process, as Issue 3 does…“If there is going to be a legitimate discussion about marijuana policy or the possible effectiveness of marijuana for medical purposes, then let’s have it. But ‘Responsible Ohio’ bypasses the discussion altogether in an effort to benefit to a few wealthy investors. Issue 3 is a slap in the face to Ohioans who genuinely care about sensible marijuana policy.”
- WBA to divest as many as 1,000 stores to secure Rite Aid deal approval (drugstorenews.com)
The merger agreement between Walgreens Boots Alliance and Rite Aid must be consummated by Oct. 27, 2016, or the deal is off, according to documents filed to the Securities and Exchange Commission on Thursday…If Rite Aid walks away from the deal at any time, Rite Aid will forfeit a $325 million termination fee to Walgreens. Rite Aid may also be required to pay up to an additional $45 million to cover expenses incurred by Walgreens…Conversely, Walgreens will forfeit $325 million to Rite Aid if it's not able to secure regulatory approval of the deal, a figure that could double to $650 million if Walgreens "enters into, consummates or announces certain acquisitions within eight to 12 months of the date of the merger agreement…Walgreens is willing to divest as many as 1,000 locations, or other holdings not to exceed an aggregate value of $100 million, in an effort to secure approval of the acquisition..
- Walgreens Store Sales Seen as Hurdle for Rite Aid Approval (bloomberg.com)
Walgreens Boots Alliance Inc.’s deal to acquire Rite Aid Corp. is expected to draw antitrust scrutiny not only because the company would grow to 12,700 locations, but because of what goes on behind the scenes with drug payments…Federal Trade Commission…will look closely at whether the merging of the No. 1 and No. 3 pharmacy chains in the U.S. will lead to higher prices for prescription drugs...the FTC will probably review the approximately $9.4 billion deal market-by-market instead of on a national basis, since CVS, Walgreens, Wal-Mart and Rite Aid together control only about half of the U.S. retail pharmacy market...The rest is held by independent stores, smaller chains and mail-order companies. Walgreens is likely to sell or shutter some stores...
- FTC raises anticompetitive concerns about FDA naming proposal for biosimilars (pharmalot.com)Nonproprietary Naming of Biological Products Guidance for Industry DRAFT GUIDANCE (fda.gov)In Response to a Request for Comments on Its Guidance for Industry on the “Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability” (ftc.gov)
What’s in a name?..A contentious debate over identifying biosimilars is sparking concern from antitrust regulators. These drugs are designed to emulate expensive biologics and are forecast to save billions of dollars in US health care costs. But finding the best approach for naming biosimilars has confounded regulators and divided the pharmaceutical industry amid clashes over patient safety and the potential for big profits…At issue is whether biosimilars should be given the same name as biologics. Two months ago, the Food and Drug Administration issued draft guidelines that suggested both biologics and biosimilars can use the same name. But the agency also proposed that biosimilar names add a four-letter suffix that differs from the four-letter suffix that should follow a biologic brand name medicine…
- McKesson significantly exceeds Wall Street expectations with Q2 results (drugstorenews.com)
McKesson…exceeded Wall Street analyst expectations by 32 cents, reporting adjusted earnings of $3.31, up 19% as compared to year ago figures. Revenues for the second quarter ended Sept. 30 were $48.8 billion, up 10%. On a constant currency basis, revenues increased 14% over the prior year…McKesson…repurchased approximately 2.5 million shares totaling nearly $500 million, announced the acquisition of the U.K. pharmacy operations of Sainsbury’s and the acquisition of the pharmaceutical distribution business of United Drug Group in Ireland…
- Philidor Said to Modify Prescriptions to Boost Valeant Sales (bloomberg.com)
..specialty pharmacy that fills prescriptions for Valeant Pharmaceuticals International Inc. has altered doctors’ orders to wring more reimbursements out of insurers, according to former employees and an internal document…Workers at the mail-order pharmacy, Philidor RX Services LLC, were given written instructions to change codes on prescriptions in some cases so it would appear that physicians required or patients desired Valeant’s brand-name drugs -- not less expensive generic versions -- be dispensed, the former employees said. Typically, pharmacists will sell a generic version if not precisely told to do otherwise by a “dispense as written” indication on a script. The more "dispense as written" orders, the more sales for the brand-name drugmaker.
- Warner Chilcott Agrees to Plead Guilty to Felony Health Care Fraud Scheme and Pay $125 Million to Resolve Criminal Liability and False Claims Act Allegations (justice.gov)
Warner Chilcott U.S. Sales LLC, a subsidiary of pharmaceutical manufacturer Warner Chilcott PLC, has agreed to plead guilty to a felony charge of health care fraud, the Justice Department announced...The plea agreement is part of a global settlement with the United States in which Warner Chilcott has agreed to pay $125 million to resolve its criminal and civil liability arising from the company’s illegal marketing of the drugs Actonel, Asacol, Atelvia, Doryx, Enablex, Estrace and Loestrin…company committed a felony violation by paying kickbacks to physicians throughout the United States to induce them to prescribe its drugs, manipulating prior authorizations to induce insurance companies to pay for prescriptions of Atelvia that the insurers may not have otherwise paid for and making unsubstantiated marketing claims for the drug Actonel…As part of today’s resolution, the whistleblowers will receive approximately $22.9 million from the federal share of the civil recovery.
- AmerisourceBergen posts 13.7% revenue increase for fiscal 2015 (drugstorenews.com)
AmerisourceBergen…reported $136 billion in revenue for its fiscal year 2015 ended Sept. 30, representing an increase of 13.7%. Adjusted diluted earnings per share from continuing operations were $4.96, an increase of 24.9% over the prior fiscal year…we made a strategic acquisition of MWI Veterinary Supply and earlier this month announced a definitive agreement to acquire PharMEDium Healthcare Holdings…these acquisitions strengthen our position in the pharmaceutical supply channel, and enhance our ability to grow in the future..
- Valeant says Philidor pharmacy shutting down as it cuts ties (reuters.com)Valeant ditches Philidor (reuters.com)Kevin O'Leary on the Valeant controversy (reuters.com)
Valeant Pharmaceuticals International Inc, seeking to allay investor concerns about its business practices, said Friday it is cutting ties with a specialty pharmacy called Philidor Rx Services accused of helping it inflate revenue…The news failed to stem Valeant's sliding share price, which lost another 12 percent on Friday even after Bill Ackman…told investors the shares were "tremendously undervalued."…three top U.S. drug benefit managers...said they would no longer work with the pharmacy (Philidor). Express Scripts, CVS Health and OptumRx…said they made the decision after conducting audits of the pharmacy…Valeant shares have lost more than half their value since September as the company has come under attack on several fronts. U.S. prosecutors are also investigating the company over drug pricing…










