Top Pharma News - May 2016

Taltz? (ixekizumab) Now Available in the U.S. for Treating Plaque Psoriasis

May 2, 2016

Eli Lilly and Company has announced that Taltz? (ixekizumab) injection 80 mg/mL for the treatment of moderate-to-severe plaque psoriasis is now available in the United States by prescription order through a contracted network of specialty pharmacies. Patient support programs are also offered by Lilly for ensuring that eligible patients have access to Taltz and available resources. U.S. FDA approved Taltz in March 2016 for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for phototherapy or systematic therapy.

AstraZeneca Acquires Takeda’s respiratory business

03 May 2016

AstraZeneca is an innovation-driven, global biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. The company has recently announced that it has completed the acquisition of Takeda Pharmaceutical Company Limited’s core respiratory business.

FDA Grants Priority Review for Supplemental Biologics License Application of Amgen for BLINCYTO? (Blinatumomab)

May 3, 2016

Amgen has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for BLINCYTO? (blinatumomab) for including new data supporting the treatment of adolescent and pediatric patients with Philadelphia chromosome?negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

Bristol-Myers Squibb and AbbVie Announce the Approval of Empliciti? (elotuzumab)by European Commission for the Treatment of Multiple Myeloma

May 11, 2016

Bristol-Myers Squibb Company and AbbVie has announced that the European Commission has approved Empliciti? (elotuzumab) for treating multiple myeloma as combination therapy with dexamethasone and Revlimid? (lenalidomide) in patients who have received at least one prior therapy. Now, Empliciti is the first and only immunostimulatory antibody approved for multiple myeloma in the European Union (EU).

European Commission Approves the Immuno-Oncology Combination, Opdivo? (nivolumab) + Yervoy? (ipilimumab) Regimen of Bristol-Myers Squibb, for Treatment of Advanced Melanoma

May 11, 2016

Bristol-Myers Squibb Company has announced that the European Commission (EC) has approved Opdivo in combination with Yervoy for treating advanced (unresectable or metastatic) melanoma in adults. This combination represents the first and only approved combination of two Immuno-Oncology agents in the European Union (EU). Due to this approval, it has become legitimate to market Opdivo + Yervoy Regimen in all 28 Member States of the EU.

Novartis Separates its Pharmaceuticals Division into two business units: Novartis Pharmaceuticals and Novartis Oncology

May 17, 2016

Novartis has announced that it has created two business units reporting to the CEO: Novartis Oncology and Novartis Pharmaceuticals. The Innovative Medicines Division at Novartis will be formed by these business units. The Executive Committee of Novartis (ECN) will be effective from July 1, 2016, and the leader of each business will join this committee. Bruno Strigini will become CEO of Novartis Oncology and Paul Hudson will be appointed as CEO of Novartis Pharmaceuticals. Both will report directly to CEO of Novartis, Joseph Jimenez. In the meantime, David Epstein, currently Division Head and CEO, Novartis Pharmaceuticals, has decided to leave Novartis.

Entresto? of Novartis given strong Class I recommendation for the Treatment of Heart Failure in both US and EU

May 21, 2016

Novartis’ Entresto? (sacubitril/valsartan) has been given a Class I recommendation, the strongest endorsement, in updated clinical practice guidelines simultaneously released by the American Heart Association (AHA), the American College of Cardiology (ACC), and the Heart Failure Society of America (HFSA) in the US, and the European Society of Cardiology in the EU.

Merck Receives Positive CHMP Opinion in the European Union for ZEPATIER? (elbasvir and grazoprevir)

May 27, 2016

Merck has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of ZEPATIER? (elbasvir and grazoprevir). This is an investigational, once-daily, fixed-dose combination tablet that is used for the treatment of adult patients suffering from chronic hepatitis C virus (HCV).

StrimvelisTM receives European marketing authorisation to treat ADA-SCID

27 May 2016

GlaxoSmithKline (GSK), Ospedale San Raffaele (OSR), and Fondazione Telethon (Telethon) have announced that the European Commission has approved Strimvelis, the first ex-vivo stem cell gene therapy for the treatment of patients with a very rare disease called ADA-SCID (Severe Combined Immunodeficiency due to Adenosine Deaminase deficiency). A child born with ADA-SCID does not have an immune system that is healthy and fully-functioning. Consequently, this system is not able to fight off everyday infections. It has been estimated that approximately 15 children per year are affected by ADA-SCID in Europe.

FDA Approves Once-Monthly ZINBRYTA? (daclizumab) of Biogen and AbbVie for Multiple Sclerosis

May 27, 2016

Biogen and AbbVie have announced that The U.S. Food and Drug Administration (FDA) approved ZINBRYTA? (daclizumab), a new once-monthly, subcutaneous, self-administered treatment for relapsing forms of multiple sclerosis (RMS).  The companies also added that because of its safety profile, ZINBRYTA should generally be used for patients who have had an inadequate response to two or more therapies indicated for treating multiple sclerosis (MS).