Author: Peter

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.

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...

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

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...

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

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...

Pharmacists rank third in Gallup’s 2018 survey of honesty and ethical standards, maintaining their consistently strong showing in the annual measure of diverse professions. Health-related professions swept the top three, with nurses ranking first and medical doctors ranking second – just one percentage point ahead of pharmacists...“We want to thank pharmacists for their trusted work as the face of neighborhood healthcare, which is reflected consistently in Gallup’s survey,” NACDS president and CEO Steve Anderson said...“Just as Americans walk into their pharmacies for access to quality care, policymakers turn to these professionals for advice on pressing issues. These issues include addressing the opioid abuse epidemic, reducing patients’ out-of-pocket costs for prescription drugs, and improving access to care through newer pharmacist-provided services.”

A federal judge has blocked a Trump administration policy that reduces payments to hospitals under a drug discount program, ruling...that the government overstepped its authority in an attempt to address the high cost of prescription medications...The decision is a win for the 2,000-plus hospitals participating in the program, known as 340B, most of which serve large numbers of low-income patients...In 2017, the Department of Health and Human Services reduced its reimbursements for some drugs by about 28 percentage points...

Walgreens has undertaken a partnership to bring Aspen Dental-branded dental offices to two of its locations in Florida. The companies said the collaboration is aimed at helping transform Walgreens’ stores into health destinations that improve healthcare access in convenient settings...The companies held a “floss-cutting” ceremony at a location in Palatka, Fla. On Dec. 13, with the second Aspen Dental at Walgreens location set to open in the second quarter of 2019. The Aspen Dental office will offer free new patient exams and X-rays for patients without insurance and will feature an onsite denture lab to quickly turnaround custom dentures, repairs, relines or adjustments...

Barbara McAneny, president of the American Medical Association, recently described a patient with metastatic prostate cancer who tried to kill himself after he could not get the medication he was prescribed for bone pain because...his insurer...denied coverage...my patient nearly died of an underdose...McAneny was talking about the suffering caused by government pressure to reduce opioid prescriptions, which has led to denials of treatment and arbitrary dose reductions...A Medicare rule that take effect on January 1 will compound that problem...