Blog
RSS FeedPosted by Michael Wonder on 20 Nov 2017
2018 Medicare Parts A & B premiums and deductibles announced
17 November 2017 - Today, the Centers for Medicare & Medicaid Services announced the 2018 premiums, deductibles, and coinsurance amounts for ...
Posted by Michael Wonder on 20 Nov 2017
Use of health care databases to support supplemental indications of approved medications
20 November 2017 - Can health care databases be used to confirm a supplemental indication that has been demonstrated in a ...
Posted by Michael Wonder on 19 Nov 2017
What if you knew Alzheimer’s was coming for you?
17 November 2017 - Simple blood tests may soon be able to deliver alarming news about your cognitive health. ...
Posted by Michael Wonder on 19 Nov 2017
FDA begins adding suffixes to newly approved biologics' names
17 November 2017 - The US FDA this week began adding four-letter meaningless suffixes at the end of newly approved ...
Posted by Michael Wonder on 18 Nov 2017
Drug companies are warming up to the idea of an Amazon pharmacy
17 November 2017 - Takeda CEO ‘in favour of a more effective distribution system’. ...
Posted by Michael Wonder on 18 Nov 2017
U.S. FDA extends review for Tlando; Advisory Committee meeting date of 10 January 2018 remains unchanged
17 November 2017 - Lipocine today announced the U.S. FDA has extended the review period for the new drug application ...
Posted by Michael Wonder on 17 Nov 2017
How to avoid a disastrous gene therapy price battle
18 November 2017 - Single-use drugs that could cure diseases are valuable -- but wildly expensive. ...
Posted by Michael Wonder on 17 Nov 2017
Towards a single development programme for new antibiotics in EU, Japan and US
17 November 2017 - EMA, PMDA and FDA to further align data requirements and explore options to streamline paediatric development. ...
Posted by Michael Wonder on 17 Nov 2017
Celgene and bluebird bio announce bb2121 anti-BCMA CAR-T cell therapy has been granted breakthrough therapy designation from FDA and PRIME eligibility from EMA for relapsed and refractory multiple myeloma
16 November 2017 - Designations based on preliminary clinical data from ongoing phase I study of bb2121 in heavily pre-treated multiple ...
Posted by Michael Wonder on 17 Nov 2017
Alnylam initiates rolling submission of new drug application to U.S. FDA for patisiran for the treatment of hereditary ATTR amyloidosis
16 November 2017 - Company plans to complete submission by year end. ...
Posted by Michael Wonder on 16 Nov 2017
CMS proposes policies to lower the cost of prescription drugs and combat the opioid crisis
16 November 2017 - The proposed rule eliminates administrative hurdles to providing more affordable prescription drugs and will allow Medicare ...
Posted by Michael Wonder on 16 Nov 2017
FDA expands approval of Sutent to reduce the risk of kidney cancer returning
16 November 2017 - FDA approves adjuvant treatment for adult patients at a high risk of kidney cancer returning after nephrectomy. ...
Posted by Michael Wonder on 16 Nov 2017
FDA approves Genentech’s Gazyva for previously untreated advanced follicular lymphoma
16 November 2017 - The first treatment option to demonstrate superior progression-free survival over standard-of-care Rituxan-based therapy. ...
Posted by Michael Wonder on 16 Nov 2017
Uwe Reinhardt, 80, dies; a listened-to voice on health care policy
16 November 2017 - Uwe Reinhardt, an economist whose keen, caustic and unconventional insights cast him as what colleagues called ...
Posted by Michael Wonder on 16 Nov 2017
FDA approves new treatment to prevent bleeding in certain patients with haemophilia A
16 November 2017 - The U.S. FDA today approved Hemlibra (emicizumab-kxwh) to prevent or reduce the frequency of bleeding episodes in ...