August 1, 2016
Pfizer Inc. has announced that it has acquired Bamboo Therapeutics, Inc., a privately held biotechnology company based in Chapel Hill, N.C. Bamboo Therapeutics focused on developing gene therapies for treating patients with certain rare diseases related to neuromuscular conditions and the central nervous system. This acquisition will provide Pfizer with a clinical and several pre-clinical assets that complement the rare disease portfolio of the company, including an advanced recombinant Adeno-Associated Virus (rAAV) vector design and production technology, and a fully functional Phase I/II gene therapy manufacturing facility that Bamboo acquired from the University of North Carolina earlier this year. In this way, this acquisition will significantly expand Pfizer’s expertise in gene therapy.
GSK and Verily Agree to establish Galvani Bioelectronics – a new company dedicated to the development of bioelectronic medicines
01 August 2016
GSK has announced an agreement with Verily Life Sciences LLC (formerly Google Life Sciences) to form Galvani Bioelectronics in order to enable the research, development and commercialisation of bioelectronic medicines. In the new jointly owned company, GSK will hold a 55% equity interest and Verily will hold 45%. Galvani Bioelectronics will be headquartered in the UK, and the parent companies will contribute existing intellectual property rights and an investment of up to £540 million over seven years, subject to fruitful completion of various development and discovery milestones.
Takeda and Seattle Genetics Announce Positive Data from Phase 3 ALCANZA Clinical Trial of ADCETRIS® (Brentuximab Vedotin) for CD30-Expressing Cutaneous T-Cell Lymphoma
August 1, 2016
Takeda Pharmaceutical Company Limited and Seattle Genetics, Inc. have announced that the Phase 3 ALCANZA clinical trial assessing ADCETRIS (brentuximab vedotin) in patients with cutaneous T-cell lymphoma (CTCL) met its primary endpoint. It showed a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4).
Aug. 2, 2016
Amgen and Advaxis, Inc. have announced a global agreement for the development and commercialization of Advaxis’ ADXS-NEO. It is a novel, preclinical investigational cancer immunotherapy treatment that is designed to activate the immune system of a patient to respond against the unique mutations, or neoepitopes, contained in and identified from the tumor of each individual patient. This collaboration brings together the development expertise of Amgen in immuno-oncology with the MINE™ (My Immunotherapy Neo-Epitopes) program of Advaxis, which is uniquely positioned for developing a customized approach to treat cancer.
Takeda Gets Marketing Authorization for NINLARO™ (ixazomib) in Relapsed/Refractory Multiple Myeloma in Canada
August 8, 2016
Takeda Pharmaceutical Company Limited has announced Takeda Canada has received approval from Health Canada for NINLARO™ (ixazomib) capsules in combination with lenalidomide and dexamethasone for treating adult patients with multiple myeloma who have received at least one prior therapy. It is estimated that approximately 7,500 people live with multiple myeloma in Canada. The approval was mainly based on the results of the final analysis of the pivotal Phase 3 trial, TOURMALINE-MM1. It demonstrated that NINLARO in combination with lenalidomide and dexamethasone extended progression-free survival significantly, with a manageable safety profile in patients with relapsed/refractory multiple myeloma.
Merck’s Phase 3 Study Results Evaluating ZEPATIER™ (elbasvir and grazoprevir) in Patients with Chronic Hepatitis C Receiving Treatment for Opioid Dependence Published
August 8, 2016
Merck has announced the publication of results from C-EDGE CO-STAR, which is a Phase 3 trial evaluating the use of ZEPATIER™ (elbasvir and grazoprevir) 50mg/100mg tablets in patients with chronic hepatitis C (HCV) genotype (GT) 1, GT4 and GT6 infection who receive opioid agonist therapy (OAT) (methadone and buprenorphine) that is normally used for the treatment of opioid addiction. The results were recently published online in the Annals of Internal Medicine, which indicated that treatment with 12 weeks of ZEPATIER resulted in high rates of sustained virologic response 12 weeks after the completion of therapy (SVR12, considered virologic cure based on undetectable HCV RNA levels).
FDA Approves KEYTRUDA® (pembrolizumab) of Merck for Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
August 8, 2016
Merck has announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA®(pembrolizumab). It is the company’s anti-PD-1 (programmed death receptor-1) therapy, at a fixed dose of 200 mg every three weeks, for treating patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. This indication for KEYTRUDA is approved under the FDA’s accelerated approval regulations, based on tumor response rate and durability of response.
Pfizer Announces Publication of New Analysis Showing the Effectiveness of Long-Term Therapy with VYNDAQEL (tafamidis) for the Treatment of Rare Neurodegenerative Disease
August 8, 2016
Pfizer Inc. has announced the publication of a new post-hoc analysis of data from three studies of VYNDAQEL in patients with mild transthyretin familial amyloid polyneuropathy (TTR-FAP). The analysis, which included patients with the Val30Met mutation treated over varying periods of up to 5.5 years, presented that treatment with VYNDAQEL started during the early stage of the disease resulted in minimal neurological disease progression. It also resulted in preservation of body weight, which frequently declines as the disease progresses. VYNDAQEL was well tolerated with no new safety signals observed. The new findings were published online in ‘Amyloid: The Journal of Protein Folding Disorders’.
August 19, 2016
Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved TROXYCA® ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules. These are intended for oral use, CII for the management of pain severe enough to require daily, around-the-clock, and for which alternative treatment options are insufficient. TROXYCA ER has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes. Yet, abuse of TROXYCA ER by these routes is still possible.
Lilly and AstraZeneca Receive FDA Fast Track Designation for AZD3293 for Treating Early Alzheimer’s Disease
Aug 22, 2016
Eli Lilly and Company and AstraZeneca have announced that they have received Fast Track designation from U.S. Food and Drug Administration (FDA) for the development program in Alzheimer’s disease for AZD3293. It is an oral beta secretase cleaving enzyme (BACE) inhibitor currently in phase 3 clinical trials. The Fast Track program of FDA is designed to expedite the development and review of new therapies for treating serious conditions and tackle key unmet medical needs.
Novartis announces positive phase III results showing effectiveness of BAF312 in patients with secondary progressive multiple sclerosis
August 25, 2016
Novartis has announced the results of the Phase III EXPAND study that evaluates the safety and efficacy of oral, once-daily, BAF312 (siponimod) in secondary progressive multiple sclerosis (SPMS). The study confirmed that BAF312 met its primary endpoint of a reduction in the risk of disability progression, compared with placebo. This EXPAND study represents the largest randomized, controlled study in SPMS to date.