- Judge invalidates Allergan patents on dry-eye medicine Restasis (cnbc.com)
A Texas judge invalidated Allergan patents on its dry eye medicine Restasis on the grounds that the patents cover obvious ideas...Judge William Bryson issued the ruling in federal court in Marshall, Texas, in a longstanding dispute between Allergan and generic drugmakers led by Mylan NV and Teva Pharmaceutical Industries Ltd...The ruling could enable the generic drug companies to sell their own versions of Restasis, which generated around $1.5 billion in sales for Allergan last year and accounted for more than 10 percent of the company's revenue...Allergan's stock price dropped about 5 percent on the news...The patents at issue were the same ones Allergan transferred to a Native American tribe in an effort to protect them from administrative review...
- Shortages of drugs and saline reported as Puerto Rico hurricane damage lingers (fiercepharma.com)
Shortages of drugs and saline produced in Puerto Rico are beginning to materialize after Hurricanes Irma and Maria wreaked havoc on production on the island, which produces about 10% of the U.S. drug supply including products like Lipitor and blood thinner Xarelto...Saline solution was already suffering supply restraints before the storms knocked out power to plants across island, affecting saline production at a facility operated by Baxter International...The company, which has said it lost days of production as a result of the storms, has put customers on allocation of sodium chloride and will try to make up for some of that supply by importing saline and glucose from plants in Australia and Ireland...The FDA has said that there are about 40 drugs manufactured in Puerto Rico, 13 of them exclusively, and that shortages of some of those will be materializing within days. The storms knocked out power, and while manufacturers have backup generators, they could be without commercial power for months. Most of the facilities that have resumed production, maintain only partial operations…
- California deals pharma a double whammy with signing of copay coupon bill (fiercepharma.com)California Takes On Drug Pricing: Real Progress Or Illusion? (healthaffairs.org)
Gov. Jerry Brown signed California's AB-265, which will limit the use of copay coupons and other discounting strategies for branded prescription drugs when a cheaper generic is available. Brown authorized that bill on the same day he signed SB-17, a separate piece of legislation which will force drugmakers to give warning of and explain price hikes...Exceptions to the copay coupon law include cases in which patients complete step therapy or receive prior authorization for the branded drug...the bills represent two significant regulatory steps on drug pricing...they are a setback for the drug industry in California. But other states could follow the model as many around the country look to take pharmaceutical prices into their own hands...PhRMA,...opposed both proposals...concerned with AB-265 because it doesn't ensure that patients who need a branded med over a generic will be able to get that drug...When patients receive short-term co-pay assistance for expensive drugs, they may be insulated from price hikes, but insurance companies, the government and employers still bear the burden of these excessive prices...these costs are eventually passed on to consumers in the form of higher premiums...
- The Other Side of Opioid Limits (drugtopics.modernmedicine.com)
Proponents argue that limits reduce the risk of addiction, but are they keeping pharmacists from caring for their patients?... As the opioid crisis worsens, pharmacies, pharmaceutical manufacturers, and legislators are scrambling to help solve the problem. Recently, those efforts have focused on limiting opioid supplies. But in the effort to prevent unnecessary medications, are pain patients getting left behind?...Express Scripts and CVS Caremark recently announced a seven-day supply limit, and PhRMA...supported a seven-day limit...one-size fits all approach and will supplant providers’ clinical decision-making and the needs of patients who have legitimate need for these medications...payer limits restrict patients with legitimate pain management needs from accessing opioids. Those limitations...will force patients not at risk of abuse or misuse to work with their prescriber and pharmacist—which will cost the health-care system and “significantly” impact patients with limited resources, physical restrictions, or transportation issues...
- Missouri appeals court overturns $72 million verdict against Johnson & Johnson over talc cancer risks (cnbc.com)
J&J won the reversal of a verdict in favor of the family of a woman whose death...stemmed from her use of the company's talc-based products...J&J, which won one Missouri trial, says it faces lawsuits by 4,800 plaintiffs nationally asserting similar claims over its talc-based products...It also faces cases in California, where in August a jury awarded a woman $417 million...Johnson & Johnson...won the reversal of a $72 million verdict in favor of the family of a woman whose death from ovarian cancer they claimed stemmed from her use of the company's talc-based products like Johnson's Baby Powder...The Missouri Court of Appeals for the Eastern District said that given a recent U.S. Supreme Court decision that limited where injury lawsuits could be filed, the case over Alabama resident Jacqueline Fox's death should not have been tried in St. Louis.
- The little red pill being pushed on the elderly (cnn.com)
CNN investigation exposes inappropriate use of drug in nursing homes...The maker of a little red pill intended to treat a rare condition is raking in hundreds of millions of dollars a year as it aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe...Nuedexta (dextromethorphan/quinidine), is approved to treat a disorder marked by sudden and uncontrollable laughing or crying -- known as pseudobulbar affect...This condition afflicts less than 1% of all Americans, based on a calculation using the drugmaker's own figures, and it is most commonly associated with people who have multiple sclerosis or ALS (amyotrophic lateral sclerosis)...The number of pills (from 2012) rose to roughly 14 million in 2016, a jump of nearly 400% in just four years...Nuedexta's financial success...is being propelled by a sales force focused on expanding the drug's use among elderly patients suffering from dementia and Alzheimer's disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company...
- China may relax trial requirements for new drugs, allowing foreign data (fiercebiotech.com)
China has said it will accept data from clinical trials run overseas in a bid to shorten the time it takes to approve new drugs and medical devices...It’s the latest in a string of regulatory initiatives implemented by Chinese authorities that could be a boost for international biopharma companies as well as Chinese patients, who sometimes have to wait six or seven years after launch in Western markets for drugs to be launched in China...The country’s huge and increasingly affluent population is facing an ever-growing burden of chronic diseases like cancer and diabetes, and the government has been under pressure to improve access to healthcare and new medicines...The latest wide-ranging set of proposals...recognizes that China is lagging behind other countries when it comes to approving new drugs. It’s approved 100 innovative new drugs in the last five years, around a third the number in developed markets...
- Cancer drug study data was falsified, says AstraZeneca (telegraph.co.uk)
An early lab study supporting a cancer drug bought by British drugmaker AstraZeneca was falsified, the company has admitted...AstraZeneca bought a majority stake in US rival Acerta Pharma at the end of 2015 for $4bn on the strength of its novel drug acalabrutinib under development for treating blood cancers and solid tumours. More than 2,000 patients are taking part in more than 25 acalabrutinib clinical trials...Last month Acerta retracted an abstract, published in medical journal Cancer Research in August 2015 – four months before the AstraZeneca investment – purportedly showing the drug was effective in treating solid tumours in mice...AstraZeneca admitted this evidence had been fabricated. It blamed a “former Acerta employee who acted alone to falsify a pre-clinical data set provided through external collaborations”. It confirmed the incident pre-dated its investment and US medicines regulator the Food and Drug Administration had been notified...AstraZeneca added: “It’s important to note that this isolated issue had no impact on the integrity of acalabrutinib data in any clinical trials, and there was no risk to patient health.”...
- What’s new on pharma’s worry list? Cybersecurity, natural disasters, and much more (fiercepharma.com)
Anyone who’s read a Securities and Exchange Commission filing in the U.S. recognizes the risk disclosure section, where biotech and pharma companies list the pitfalls of investing in their shares. Like an investor-oriented version of the risk disclosures in drug ads, they run the gamut from garden-variety competition to political unrest in farflung markets...The accounting and advisory firm BDO sifted through those statements to discover just what the top 100 life sciences companies are most worried about these days.
- Natural disasters, war, conflicts and terrorist attacks...
- The ability to maintain company infrastructure, including IT security and privacy...
- Labor concerns—including pension costs, rising healthcare costs, immigration and outsourcing...
- Litigation. Every company examined listed legal proceedings and lawsuits as risks to their operations...
- Competition and marketing challenges figured in at the top...filings, along with intellectual property protections (or loss thereof) and the success (or not) of current and future drug launches all tied for first place...
- regulation, by FDA and other authorities at the state and federal levels...
- Shire, Pfizer antitrust lawsuits could rewrite the rules for formulary contracts: report (fiercepharma.com)
Shire filed a lawsuit in a federal court against Allergan, claiming anticompetitive practices in its reimbursement contracts with payers on the eye drug Restasis. It's the latest in a series of similar cases, and the verdicts could well upturn all pharma-payer negotiations...Shire makes a rival product, Xiidra, and its fight against Allergan challenges longstanding negotiation practices that many makers of follow-on products argue are stifling competition...The verdicts in these cases could well rewrite the rules that govern how drugmakers form contracts with payers...Any verdicts in favor of the antitrust arguments could make it easier for manufacturers of biosimilars and other products entering well-established markets to steal share from the incumbents...In Shire's case, it’s arguing that Allergan improperly entered into exclusive contracts for Restasis with Medicare Part D providers. Those exclusive deals prevent makers of rival dry-eye remedies from competing for patients, the suit said...