Farmas USA

Confío en que hoy subamos por la designación del jefe de la FDA

FDA Nominee Scott Gottlieb Commits to ‘Gold Standard’

https://www.wsj.com/articles/fda-nominee-scott-gottlieb-commits-to-gold-standard-1491415312

http://blogs.sciencemag.org/pipeline/archives/2017/04/05/gottlieb-at-the-fda

Los comentarios del segundo artículo valen la pena

Otro artículo interesante de hoy sobre la separación de Mallinckrodt del lobby farmacéutico por su falta de dinero destinado a investigación.

Mallinckrodt Leaves Pharmaceutical Trade Group Ahead of Potential Changes to Bylaws

https://www.wsj.com/articles/mallinckrodt-leaves-pharmaceutical-trade-group-ahead-of-potential-changes-to-bylaws-1491406538

Sera un 1.06 por accion

Mack

TIG

Key 2016 and post year-end highlights:

• Cx601 reached significant value inflection points in Europe and the U.S.
  • Day 120 List of Questions responses submitted to the European Medicines Agency (EMA) to support the Marketing Authorization Approval (MAA) for Cx601 following submission of the application in March 2016
  • Day 180 List of Outstanding Issues (LoOI) received from the Committee for Medicinal Products for Human Use (CHMP) of the EMA
  • European Commission decision anticipated in 2017, triggering a payment of EUR 15.0 million from Takeda Pharmaceuticals upon approval of the market authorization
  • The global pivotal Phase III trial for the U.S. registration of Cx601 is expected to begin in the first half of 2017. TiGenix is also exploring further expedited pathways to accelerate the submission and review process for its future Biologics License Application (BLA)
  • Cx601 delivered positive follow-up results at 52 and 104 weeks, confirming the long-term safety and efficacy profile
• Strong relationship with Takeda Pharmaceuticals
  • Licensing agreement for the ex-U.S. rights of Cx601 signed in July 2016 for up to EUR 355.0 million in regulatory and sales milestones and EUR 25.0 million on signing
  • EUR 10.0 million in equity investment realized in December 2016
  • Exercised option to develop and commercialize Cx601 in both Japan and Canada
• Continued progress with pipeline
  • First patient enrolled in Phase I/II clinical trial of Cx611 for the treatment of severe sepsis
  • Promising Phase I/II trial results of AlloCSC-01 in Acute Myocardial Infarction (AMI)
• Strong cash position at December 31, 2016 of EUR 78.0 million, due to:
  • Equity raise of EUR 23.8 million in March 2016 with marquee investors
  • Upfront cash payment of EUR 25.0 million from Takeda deal in July 2016 and EUR 10.0 million of equity investment in December
  • EUR 34.1 million (USD 35.7 million) raised with Nasdaq IPO

Tigenix se targue d'une situation financière solide

http://www.lecho.be/entreprises/pharma-biotechnologie/Tigenix-se-targue-d-une-situation-financiere-solide/9880463?ckc=1&ts=1491478770

BCLI

Esta está para corto absoluto con un bonito gap a más de la mitad del precio actual. Yo voy a intentar buscarle punto de entrada.

BrainStorm Cell Therapeutics ALS Data Not As Promising As Press Releases Indicate

https://seekingalpha.com/article/4060673-brainstorm-cell-therapeutics-als-data-promising-press-releases-indicate

Que solo hablo yo... ¿Alguien tiene intención de cazar el dividendo de MACK?

REGN

Regeneron's evinacumab a Breakthrough Therapy for inherited cholesterol disorder

https://seekingalpha.com/news/3255889-regenerons-evinacumab-breakthrough-therapy-inherited-cholesterol-disorder

Y hablando de colesterol, tenemos AMRN muy olvidada...

es que un poco aburrida ya es ...

AMRN

No sabía que existiera la categoria de breakthrough therapy, pero le encuentro mucho sentido... si crees que tienes algo que puede salvar vidas ya, para qué demorarlo 8 años.

Breakthrough Therapy designation was created to expedite the development and review of drugs that target serious or life-threatening conditions. It provides for more frequent interactions with the FDA review team, the involvement of more senior agency personnel and a rolling review of the New Drug Application (NDA).

REGN

SGYP

Su campaña contra el estreñimiento. Aunque no la sigáis os reiréis. Y parece trending topic con la tontería.

http://www.businesswire.com/news/home/20170406005330/en/