17
Apr
2018
Tag: commercialization
11
Apr
2018
Bionest
Apps and Drugs/ Apps as Drugs
In our January post on what we planned to watch for in 2018, we predicted that digital health would come to the foreground of activity this year. And indeed, we are starting to see a lot of buzz around digital health. In March, Novartis and Pear Therapeutics announced the first development deal between a major...
6
Mar
2018
Bionest
Setting (Financial) Records in I/O
On February 14, Bristol-Myers Squibb (BMS) and Nektar announced the largest-ever deal in history involving a single development-stage drug in a partnership that greatly expands combination testing of BMS’s checkpoint inhibitor Opdivo (nivolumab) and Nektar’s T-cell stimulating molecule NKTR-214. Many recent immuno-oncology collaborations have involved cost sharing but no other financial transactions, and the...
20
Sep
2017
Bionest
Advances and Set Backs for CAR-T Therapy
Late August and early September was a period of big news — both positive and negative — on the CAR-T front. On the positive side, Novartis’ received the first FDA approval of a CAR-T therapy for Kymriah (tisagenlecleucel), for the treatment of children and young adults with B-cell precursor acute lymphoblastic leukemia that is refractory...
5
Jul
2017
Bionest
FDA: Thinking “Outside the Box”
On May 17, the U.S. Food and Drug Administration granted an expanded approval to Vertex’s Kalydeco (ivacaflor), tripling the number of mutations in the cystic fibrosis (CF)-associated gene CFTR that the drug can treat, from 10 to 33. The agency’s action was unusual in that, for the first time ever, they based their decision on...
20
Jun
2017
Bionest
ASCO 2017 — Some Take-Aways
Several members of the Bionest team attended ASCO this year — the biggest cancer conference in the world, attracting over 30,000 oncology researchers, biopharmaceutical executives, public health experts, investors and journalists. As we predicted in our pre-ASCO post, one of the biggest take-aways from the conference was the continued and ever-growing emphasis on combination...
6
Jun
2017
Bionest
Roche Gains Important MS Approval — and Takes Unprecedented Pricing Steps
On March 29, the US Food and Drug Administration approved Roche’s Ocrevus (ocrelizumab) for the treatment of either relapsing multiple sclerosis (MS), or primary progressive MS (PPMS). The approval was particularly noteworthy as Ocrevus is the first therapeutic approved for the treatment of PPMS, a form of the disease that accounts for 10-15% of MS...
31
May
2017
Bionest
FDA Changes the Game: First Cancer Drug Approval Based on Biomarker
The U.S. Food and Drug Administration has issued its first drug approval to a treatment for patients with a specific genetic biomarker, rather than based on an initial tumor location, such as breast cancer. On May 23, the agency granted an accelerated approval to Merck’s Keytruda (pembrolizumab) for the treatment of adult and pediatric patients...
23
May
2017
Bionest
And They’re Off….. Watching the CAR-T Race
On March 29, Novartis announced that the US Food and Drug Administration had accepted the company’s BLA filings for CTL019 (tisagenlecleucel-T) for the treatment of pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Two days later, Kite Pharma announced that they had completed the rolling submission for their own...
16
May
2017