- Drug pricing will continue to loom large for pharma in 2016 (statnews.com)
As the year winds down, STAT reporters are taking a look at the stories they’re most eager to track in 2016...Of all the health care issues that loomed large this past year, none was more controversial — and compelling — than pharmaceutical pricing...Wall Street may have cheered the added revenue, but pricing strategies were increasingly under attack. Poll after poll found most Americans believe prices are too high. And more lawmakers — and presidential candidates — are listening...At the center of it all was Martin Shkreli, the 32-year-old “pharma bro” who single-handedly created a furor by jacking up the cost of an old, life-saving drug and repeatedly taunting his critics. Shkreli was arrested this month for securities fraud and ousted from the two drug companies that he ran. But while he may be out of the picture, pricing will remain a flashpoint in the year ahead...Here’s a look at what to expect on pricing — and on other key issues that are likely to engulf drug makers, regulators, and patients in 2016.
- Count the cost
- New commish
- Read the label
- Big deals
- Figure of speech
- Drug Approvals and Priority Reviews Highlight Cancer Treatment News (specialtypharmacytimes.com)
- Atezolizumab/Nab-Paclitaxel Highly Effective in Breast Cancer
- Pembrolizumab Effective in ER-Positive Breast Cancer
- Neratinib 3-Year ExteNET Data Similar to Primary Analysis
- Buparlisib Modestly Effective in Breast Cancer
- Avelumab Effective in PD-L1-Positive Breast Cancer
- Adding Denosumab Improves DFS in Breast Cancer
- FDA Approves Alectinib for ALK-Positive NSCLC
- FDA Approves Cooling Cap to Prevent Hair Loss
- Priority Review Granted to Palbociclib Plus Fulvestrant
- FDA Approves Bendamustine Hydrochloride for CLL, NHL
- Priority Review to Crizotinib for ROS1 NSCLC
- FDA Approves Uridine Triacetate for Chemo Overdose
- Nonprofit vows to lower generic drug costs (bostonglobe.com)
...in this Central Massachusetts town (Blackstone Valley), a small team of drug industry veterans has launched a startup (Drew Quality Group) to counter...price gougers by making affordable generic medicines to treat critical diseases. And they’re doing it as a nonprofit...We want to create a competitor to stabilize the prices...When you end up with a single-source manufacturer, they can charge any price they want...typically have only a single producer, are in short supply either because their manufacturer is grappling with safety problems or there is no domestic supplier and an overseas producer no longer finds it profitable to make drugs to treat small numbers of patients...By operating as a nonprofit, Drew Quality won’t have to pay the same taxes a drug company does. Nor will it have to focus on cost-cutting by sending work overseas...The group wants to employ people close to home and make sure patients get access to therapies they need without being squeezed financially...And while it plans to underprice companies that have boosted prices substantially, Drew Quality will still charge enough to pay its employees and plow some money back into the business...the cost of its generic drugs will be closer to the discounted prices that were charged before companies pushed them higher.
- CEO Behind ‘Female Viagra’ Leaves Company After Valeant Purchase (fortune.com)
Cindy Whitehead, CEO of Sprout Pharmaceuticals, the maker of the recently approved “female Viagra” drug Addyi (flibanserin), is leaving her post only months after Valeant bought the company…Whitehead was instrumental in bringing Addyi to market. She fought through two Food and Drug Administration rejections of the drug in 2010 and 2013, pushing forward until it was finally approved in August. That effort included purchasing the drug rights herself and forming Sprout after Boehringer Ingelheim dropped it following the first rejection by the FDA…Valeant quickly bought the privately-held company for $1 billion in August after Addyi’s final FDA approval. Though, blockbuster sales have so far eluded the drug. From its launch on Oct. 17 until Nov. 6, only 227 prescriptions were written for the drug…For comparison, Viagra notched more than half a million prescriptions in its first month…Now, Valeant…is opting to switch up Sprout’s leadership…“Having built a team to take Addyi to market, we mutually agreed that it was the right time to transition to new leadership for the next phase of global commercialization.”
- FDA still seems reluctant to regulate mobile health apps (medcitynews.com)
Remember when the Food and Drug Administration was going to regulate mobile health apps? The year was 2013...There was even a bill from the congressman representing Silicon Valley that aimed to tame the “Wild West” of mobile and wireless health. The House Energy and Commerce Committee even held three...days of hearings...Rep. Mike Burgess asking then-national health IT coordinator Dr. Farzad Mostashari to magically create interoperability...Now, it sounds like the FDA might almost be ready to throw its hands up and walk away...the agency circulated a draft guidance that really didn’t say much...The 2013 final version clarified policy a bit, stating that the FDA generally would focus only on mobile apps that serve as medical devices, and mostly stay away from regulating consumer technology...Earlier this year, an FDA specialist in digital health told Bloomberg that the agency would be “almost hands-off” when it comes to consumer wellness and fitness gadgets...
- Drugmaker Settles Free Speech Dispute as FDA Agrees on Label (bloomberg.com)
U.S. regulators have backed off an attempt to limit Pacira Pharmaceuticals Inc.’s promotion of its pain drug, striking an agreement that’s likely to fan the flames of debate over free speech and drug marketing...After the drugmaker filed suit citing its constitutional rights to free speech, the Food and Drug Administration agreed to let Pacira broadly promote the medication Exparel (bupivacaine), rather than limiting its sales team to talking only about its use after bunion and hemorrhoid surgeries...The painkiller, a non-narcotic shot, hadn’t been studied for use with other surgeries, such as dental or orthopedic procedures. While its FDA-approved label notes that fact, it doesn’t explicitly say the medication can only be used for surgeries that have been studied. Pacira argued that meant it could market the treatment for broader use...FDA has faced difficulty in its efforts to police drug marketing. In August, a court ruled the agency couldn’t bar Amarin Corp. from talking to doctors about unapproved uses of its fish-oil pill. While doctors are already allowed to prescribe drugs off-label, drugmakers have been restricted on promoting such uses...Drugmakers are able to give doctors information about unapproved uses if doctors specifically request it. The Amarin ruling allows pharmaceutical companies to hand out the information more widely without a request…
- It’s official: FDA shoots past 2014’s new drugs record with Roche lung cancer med nod (biopharmadive.com)
FDA last Friday approved Alecensa (alectinib) for the treatment of ALK-positive non-small cell lung cancer for patients with the disease refractory to therapy with Xalkori (crizotinib). The approval comes well before the drug's March 2016 PDUFA date...This marks the agency's 42nd newly approved medication this year, topping a banner 2014 that saw 41 new drug approvals...there will be a continuing flurry of drug approvals over the next four years (225, to be exact, and most of them in cancer-related therapeutic spaces).
- DEA eases requirements for natural cannabis-derived drug research (reuters.com)
Drug Enforcement Administration...relaxed some restrictions on research evaluating cannabidiol, an extract of the marijuana plant, for medicinal use...The modifications will ease some requirements imposed by the Controlled Substances Act on possession of cannabidiol (CBD) for a specific Food and Drug Administration approved research protocol...researchers who expanded the scope of their studies and required more CBD than initially approved had to request, in writing... the changes...a previously registered CBD clinical researcher who is granted a waiver can readily modify the protocol and continue research seamlessly. (waiver effectively removes a step from the approval process)...A handful of companies are developing cannabis-derived drugs. Pioneering the effort is Britain's GW Pharmaceuticals, which is slated next year to deliver the results of four late-stage U.S. studies of its botanical pot-based epilepsy treatment...INSYS Therapeutics Inc and Zynerba Pharmaceuticals Inc are working on much earlier stages of development with synthetic cannabis for a number of disorders.
- FDA launches Web-based precision medicine platform for next-generation sequencing (healthcareitnews.com)FDA Launches precisionFDA to Harness the Power of Scientific Collaboration (blogs.fda.gov)
Food and Drug Administration...launched the beta version of precisionFDA, its new collaborative platform for the exploration of next-generation gene sequencing...First announced in August, the platform features more than 20 public and private sector participants…Next-generation sequencing enables researchers to compile a vast amount of data on a person's exact order or sequence of DNA...scientists can look for meaningful differences in DNA that can be used to suggest a person's risk of disease, possible response to treatment and assess their current state of health. Ultimately, what we learn about these differences could be used to design a treatment tailored to a specific individual...The hope is to grow this community and improve the usability of precisionFDA in the coming months and years...One way we'll achieve that is by placing the code for the precisionFDA portal on the world's largest open source software repository, GitHub, so the community can further enhance precisionFDA's features...
- FDA MedWatch warns of bad lots of baclofen from Taizhou Xinyou Pharma API plant (fiercepharmamanufacturing.com)
The FDA is warning compounders to be on the alert for batches of baclofen APIs manufactured at the Taizhou Xinyou Pharmaceutical and Chemical plant in China because of the risk of contamination with particulates...The FDA MedWatch alert said the products shouldn't be used to compound sterile injectable drugs and asks that health professionals in the fields of anesthesiology, pain management, neurology and pharmacy to be on the alert for any such batches made at the plant based in Taishou City, Zhejiang Province...last month, it was reported the FDA cited a Pfizer plant in China while U.K. regulators recently found shortcomings at a GlaxoSmithKline plant there. About 40 facilities in China are currently on the regulatory agency's import ban list.