- Arizona accuses drugmaker Insys of fraudulent opioid marketing (reuters.com)
Arizona sued Insys Therapeutics Inc...accusing the drugmaker of engaging in a fraudulent marketing scheme aimed at increasing sales of a fentanyl-based cancer pain medicine called Subsys...The lawsuit by Arizona Attorney General Mark Brnovich in Maricopa County Superior Court in Phoenix comes during a series of federal and state investigations centered on Insys’ drug Subsys amid a national opioid addiction epidemic...The lawsuit accused Arizona-based Insys of paying doctors sham speaker fees in exchange for writing prescriptions of Subsys and of misleading insurers into believing patients who were prescribed the opioid had cancer when they actually did not...The lawsuit seeks an injunction, restitution for customers and the disgorgement of any illegally earned profits…
- FDA steps up oversight of cell therapies (biopharmadive.com)
The Food and Drug Administration is stepping up its enforcement of the existing rules covering stem cell therapies in order to protect patients from unproven or potentially dangerous treatments...Under "a comprehensive policy framework" that will be put into place next quarter, individual providers and companies will be able to gain approval for products and procedures through a lower-cost and more streamlined process...A new working group will pursue unscrupulous clinics through legally enforceable means in order to protect public health...Patients desperately seeking solutions for potentially fatal diseases can get to a point that they will clutch at any solution offered...FDA Commissioner Scott Gottlieb's statement shows an awareness of the potential for "unscrupulous actors" in the field, and their impact both on vulnerable people and on the reputation of sound researchers and companies..."These dishonest actors exploit the sincere reports of the significant clinical potential of properly developed products as a way of deceiving patients and preying on the optimism of patients facing bad illnesses. This puts the entire field at risk. Products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science. To make sure the agency is separating the promise from the unscrupulous hype, we are stepping up our enforcement activity in this area," said Gottlieb...
- Top 5 Highest Grossing Specialty Drugs of the Year (specialtypharmacytimes.com)
Prescription drug spending has skyrocketed over the past few years, with many Americans struggling to access proper treatment. Lawmakers have attempted to address this issue, but it is likely that the trend of escalating drug spending will continue as costly specialty drugs dominate the market...All of the drugs that had the highest sales in 2016 are for specialty conditions, including autoimmune disorders and hepatitis C virus; however, the emergence of biosimilars may threaten their revenue into the future...
- 5. Infliximab (Remicade) - Johnson & Johnson and Merck report a 10.6% decrease in revenue from 2015, with infliximab generating nearly $7.83 billion in 2016...
- 4. Rituximab (Rituxan) - Partners Roche and Biogen reported total revenue of $8.58 billion for rituximab in 2016, which is a 2.7% increase from 2015. The drug is approved to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and granulomatosis with polyangiitis...
- 3. Etanercept (Enbrel) - This autoimmune disease drug treats rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. Amgen and Pfizer reported $8.87 billion in total sales for etanercept in 2016.
- 2. Ledipasvir/sofosbuvir (Harvoni) - When this drug hit the shelves, many patients with HCV and healthcare providers experienced sticker shock. The high cost of the curative drug and the prevalence of HCV have driven the $9.08 billion sales for the drug, according to the article.
- 1. Adalimumab (Humira) - In 2016, adalimumab grossed $16.08 billion in sales, which is a 14.7% increase in revenue for AbbVie, according to the article. The drug is approved to treat several autoimmune conditions, including rheumatoid arthritis, ulcerative colitis, and psoriasis.
- Could indication-based pricing really work? (biopharmadive.com)
Why should it cost more than 30 times as much for essentially the same drug just because it’s being used to treat an eye condition rather than cancer?...So-called indication-specific pricing may seem absurd to some observers but makes perfect sense to industry insiders. Drugs are often approved to treat several different diseases, often with varying patient population sizes. For example, Allergan plc's Botox (onabotulinumtoxin A) is approved to treat more than eight indications, including wrinkle reducing and migraines. While insurers may choose to cover these indications differently, indication-based could mean these two indications are priced at opposite ends of the pricing spectrum, for example, and could better align reimbursement with value...There are plenty of examples of drugs approved for wildly different patient populations. Yet, so far, indication-based pricing is not a reality in the U.S.
- Herpes vaccine company backed by Peter Thiel vows future testing will follow FDA guidelines after offshore trial sparks ethics furor (cnbc.com)
The CEO of a herpes vaccine company at the center of a controversy over an offshore clinical trial,,,said that future testing of the drug will follow U.S. Food and Drug Administration oversight rules, as demanded by a new group of financial backers that includes venture capitalist Peter Thiel...In an impassioned interview, Rational Vaccines Chief Agustin Fernandez said he feared the great promise of the vaccine developed by the late university professor William Halford was being overshadowed by criticism over Halford's decision to test the drug using American patients on the West Indian nation of St. Kitts and Nevis without monitoring by the FDA or an institutional review board, as is traditional...Fernandez...said that he now understands it is necessary from now on to conduct further trials following FDA oversight standards if Rational Vaccines hopes to market the vaccine in the United States...
- Big-name tech investors pour millions into marijuana — both medicinal and not (statnews.com)
The storied Silicon Valley venture firm Benchmark Capital has launched a slew of tech companies: Twitter, Uber, Snapchat, Instagram. Now its search for the next big thing has led it to…pot...Benchmark recently invested $8 million in Hound Labs, a startup here in Oakland that’s developing a device for drivers — and law enforcement — to test whether they’re too buzzed to take the wheel...Wealthy investors are pouring tens of millions into the cannabis industry in a bid to capitalize on the gold rush that’s expected when California legalizes recreational marijuana on Jan. 1. They’re backing development of new medicinal products, such as cannabis-infused skin patches; new methods for vaporizing and inhaling; and “budtender” apps like PotBot, which promises to scour 750 strains of cannabis and use lab research, including DNA analysis of each strain, to help customers find the perfect match...Among the noted investors: tech and biotech mogul Peter Thiel, who co-founded PayPal and made a fortune with the cancer drug startup Stemcentrx. Thiel contributed $300,000 to the California ballot campaign that paved the way for legalization. And in the first public endorsement of the industry from a major biotech investor, Thiel’s Founders Fund has sent millions to Privateer Holdings, a Seattle private equity firm that backs research into medical marijuana products, among other cannabis-related ventures...
- FDA Details Plans for More Efficient Inspections, Facility Evaluations
The US Food and Drug Administration's Center for Drug Evaluation and Research and Office of Regulatory Affairs will soon launch an effort to streamline the two offices' inspection and facility evaluation efforts...CDER Director Janet Woodcock and Associate Commissioner for Regulatory Affairs Melinda Plaisier said it is vital that the two offices quickly implement the plan in order to meet commitments under the recently reauthorized user fee agreements, specifically citing the agency's promise to communicate final inspection classifications to generic drugmakers within 90 days of an inspection beginning in October 2018...We plan to operationalize the plan in the fall of 2017 for nearly all human drugs...FDA details the plan—which includes specific operating models for pre- and post-approval inspections, surveillance inspections and for-cause inspections—in a 20-page white paper obtained by Focus entitled Integration of FDA Facility Evaluation and Inspection Program for Human Drugs: A Concept of Operations...
- First Gene-Transfer Therapy Approved for U.S. Market (ashp.org)Pioneering cancer drug, just approved, to cost $475,000 — and analysts say it’s a bargain (statnews.com)
FDA...announced the approval of tisagenlecleucel, a first-in-class chimeric antigen receptor (CAR) T-cell immunotherapy consisting of genetically modified autologous T cells, for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in children and young adults...After modification in the laboratory and infusion back into the patient, the CAR T cells target and eliminate both normal and malignant CD19-expressing B cells. The genetic modification enhances the initiation of T-cell activation and the persistence of the transformed T cells...Novartis will market tisagenlecleucel as Kymriah. Labeling for the product states that it is indicated in patients up to age 25 years with ALL that is refractory or in second or later relapse...Tisagenlecleucel has an FDA-required risk evaluation and mitigation strategy (REMS) program that includes elements to assure safe use. The labeling states that the immunotherapy is available "only through a restricted program."...
- J&J ordered to pay $417 million in trial over talc cancer risks (reuters.com)
A California jury...ordered Johnson & Johnson to pay $417 million to a woman who claimed she developed ovarian cancer after using the company's talc-based products like Johnson's Baby Powder for feminine hygiene...The Los Angeles Superior Court jury's verdict in favor of California resident Eva Echeverria was the largest yet in lawsuits alleging J&J failed to adequately warn consumers about the cancer risks of its talc-based products...The verdict included $70 million in compensatory damages and $347 million in punitive damages. It was a major setback for J&J, which faces 4,800 similar claims nationally and has been hit with over $300 million in verdicts by juries in Missouri...The 63-year-old claimed she developed terminal ovarian cancer after decades of using J&J's products. Her lawyers argued J&J encouraged women to use its products despite knowing of studies linking ovarian cancer to genital talc use...
- Bill to allow imported drugs from Canada aims to create competition (mmm-online.com)
As lawmakers grapple with addressing sky-high drug prices, the debate around allowing importation of lower-priced versions of the same branded medications from Canada has again cropped up in policy circles…Sen. Bernie Sanders has been a major advocate...introducing the Affordable and Safe Prescription Drug Importation Act...bill would create a legal pathway for U.S. pharmacies to import lower-priced versions of branded medications from Canada and possibly other countries...The Congressional Budget Office has estimated that Sanders' bill would save the U.S. federal government nearly $7 billion over the next decade. But a number of influential stakeholders, including drugmakers and former FDA commissioners, have expressed concern about whether the legislation would increase safety risks...Sanders' bill...would require HHS to allow wholesalers, pharmacies, and individuals to import prescription drugs manufactured at FDA-inspected facilities that are operated by licensed companies in Canada. In the policy statement, the senator said that Canadian pharmaceutical manufacturing standards are comparable to U.S. regulations…