- What will 2019 bring for science and medicine? We asked the experts (statnews.com)
It has been a tumultuous year for science and medicine...We asked a whole host of experts — scientists, CEOs, policymakers, and professors — to weigh in on what themes they expect to see emerge in the next 12 months.
- We’re getting closer to a universal flu vaccine
- The CRISPR story is just getting started …
- And so is the focus on China.
- The opioid crisis isn’t slowing down, either.
- Speaking of cannabis (and psychedelics) … it’s only heating up.
- Cancer research will increasingly focus on organoids.
- You’ll get more control of your health data.
- Broadly, though, expect a reckoning in the AI space.
- None of this will keep prices down.
- We’ll get a clearer picture on antibiotic resistance threats.
- Pharmacies may have to change to stay relevant. - FDA weighs legalizing interstate sales of cannabis-based CBD in food and drinks (cnbc.com)2018 Farm Bill Legalizes Industrial Hemp (natlawreview.com)
The Food and Drug Administration is looking for "pathways" to legalize the sale of CBD oil and other cannabis-based compounds in food and beverages in a move that could remove one of the last remaining legal hurdles for companies hoping to sell such products across state lines...FDA Commissioner Scott Gottlieb outlined steps the agency is considering in regulating cannabis products after President Donald Trump signed the farm bill into law on Thursday. The legislation — an $867 billion, five-year spending bill that funds agricultural, nutrition and other federal programs — also loosened some federal restrictions on cannabis. It legalized hemp by removing it from the Controlled Substances Act while preserving the FDA's authority to regulate the products...
- Walgreens Boots Alliance’s plans $1 billion in cuts, stock drops (cnbc.com)
Walgreens Boots Alliance announced plans...to its cut annual costs by $1 billion within three years and reported first-quarter results that beat Wall Street’s estimates...The results also showed sales are struggling in Britain, one of its largest markets...Walgreens shares are down more than 2 percent this year bringing its market value to $69.3 billion. The stock has been under pressure as investors worry about the impact Amazon will have as it expands into the pharmacy business. To prepare for increased competition, Walgreens has announced partnerships with Kroger, Alphabet’s Verily and others...
- This Week in Managed Care: December 21, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Crash and burn: Why three biotechs failed in 2018 (statnews.com)
There is an appointed time for everything — including in biotech. There is a time to start a company, a time to wind it down, a time to go public, and a time to delist the stock...For every hopeful biotech toiling for decades before finally realizing a profit, there are countless others that run out of money or bet on a product that never delivers...STAT took a look at some of the biopharma and biotech companies that wound down their operations over the course of 2018 and what those companies’ executives are doing now.
Orexigen Therapeutics
Argos Therapeutics
Sancilio Pharmaceuticals - This Year in Managed Care: 2018 Recap (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Trusts and CCGs to pick Brexit leads as NHS steps up ‘no deal’ prep (hsj.co.uk)
- Providers and commissioners must nominate a board member responsible for Brexit preparation
- Anxiety about staff or members of the public stockpiling
- National operational response centre being established as staff assigned to Brexit readiness
In terms of medicines supply, the guidance said the government has agreed it will be prioritised, and stockpiling organised centrally will be supplemented by “additional national actions”...Today’s guidance reiterates previous instructions from the health secretary that medicines should not be stockpiled locally...HSJ understands national NHS leaders are seriously concerned some staff or parts of the UK may begin stockpiling particular medicines – or letting patients stockpile them – which could lead to shortages elsewhere. Local NHS chief executives said senior national figures had this week shown “anxiety” and “serious worry” about the potential consequences of Brexit.
- The 20 most expensive pharmacy drugs in 2018, featuring names big and small (fiercepharma.com)
More and more, specialty drugs carrying eye-popping price tags are winning FDA approvals. While more are certainly on the way—look at Novartis' recent presentation that a gene therapy could be worth millions per patient—analysts at drug pricing website GoodRx have tallied up the most expensive pharmacy-dispensed drugs in the U.S. per month as of November...Some are marketed by small pharma companies such as Vyera Pharmaceuticals, while top biotechs and pharmaceutical companies market others. Some have seen controversy, while others are lesser known. Rare disease meds make up much of the list, while some treatments such as those for hepatitis C treat diseases that affect millions of people...
- The valsartan carcinogen mess taught pharma a surprise manufacturing lesson. Will 2019 bring more? (fiercepharma.com)
Industry wisdom is that there is nothing new to learn about tablet making. Drugmakers have been doing it essentially the same way for more than 100 years. But that idiom was turned on its head this year when the FDA learned suspected carcinogens could be formed in “sartan” drugs from a specific sequence of manufacturing steps and chemical reactions—and that the U.S. drug supply had been riddled with them for years...The initial discovery of one of the impurities, N-nitrosodimethylamine, came this summer at a U.S. drug manufacturer that had used valsartan API from China’s Zhejiang Huahai Pharmaceutical...the FDA has since learned that the impurities were found in the APIs of other drugmakers, including Aurobindo and Mylan, and in finished products from Sandoz, Teva and others...
- New Organization Says It Is Improving Presentation of Clinical Guidelines (ajmc.com)Free Access to Guideline Summaries in the New AiCPG Guideline Repository (aicpg.org)
A new nonprofit announced it will help fill the gap that was left earlier this year when federal budget cutbacks shut down a website that housed clinical guidelines for healthcare professionals...A new nonprofit announced it will help fill the gap that was left earlier this year when federal budget cutbacks shut down a website that housed clinical guidelines for healthcare professionals...The shutdown included AHRQ’s National Quality Measures Clearinghouse...The new nonprofit, The Alliance for the Implementation of Clinical Practice Guidelines, said recently it was launching Guideline Clearinghouse 2.0. AiCPG said it was created for the “charitable, educational and scientific purposes of freely disseminating evidence-based clinical practice guidelines information to the healthcare community in order to educate clinicians to improve patient care...A new nonprofit announced it will help fill the gap that was left earlier this year when federal budget cutbacks shut down a website that housed clinical guidelines for healthcare professionals.