Weekend News: Business, Finance and Innovations in Biotech and Pharma Industries (GSK, Acorda, Celator, CRISPR )


These are the top stories of the weekend;

GSK and Innoviva’s Lung Disease Treatment Showed Positive Results

GlaxosmithKline’s and Innoviva’s Anoro Ellipta (umeclidinium/vilanterol, UMEC/VI) developed for the treatment of moderate chronic obstructive pulmonary disease (COPD) showed positive results in the study carried out to investigate the safety and efficacy of Anoro Ellipta in patients whose symptoms continued even when they were on tiotropium monotherapy.

A 12-week study was carried out on 494 patients, they were switched from 18 mcg of tiotropium to 62.5/25 mcg of UMEC/VI. The drug was administered once-daily via the Ellipta inhaler for 12 weeks. Statistically significant improvement in the primary and secondary efficacy endpoints were noticed in the patients who were switched to UMEC/VI than those who continued with tiotropium.

COPD is a lung disease which includes chronic bronchitis, emphysema or both. The disease is characterized by the obstruction to airflow which interferes with the normal breathing.

Anoro Ellipta is a combination long-acting muscarinic antagonist (LAMA). The combination works by relaxing the muscles in the airways to improve breathing.


Acorda’s Epilepsy Treatment Compound Discontinued

New York based Acorda Therapeutics will discontinue the development of the epilepsy seizure clusters’ treatment, Plumiaz (diazepam) nasal spray. The results of the ongoing clinical trials do not indicate it to be bioequivalent to Valeant’s Diastat rectal gel.

The results showed unexpectedly lower nasal mucosa absoption of diazepam in epilepsy patients compared to the healthy volunteers. The compound received orphan drug status in 2012. Under the section 505(b)(2), re-filing of New Drug Application (NDA) is required.


Celator’s Blood Cancer Drug Receives Breakthrough Therapy Status

U.S. FDA given Breakthrough Therapy designation to the Celator Pharmaceuticals’ investigational blood cancer drug, Vyxeos (CPX-351).

In a Phase III trial in older patients with high risk acute myeloid leukemia (AML) it showed positive results. The detailed results of the trial will be presented at American Society of Clinical Oncology (ASCO) conference next month.

We are very happy the FDA granted Breakthrough Therapy designation for Vyxeos,” said Scott Jackson, CEO of the small NJ-based biotech, in a release. “The breadth of the designation, which includes all adults with t-AML and AML-MRC, is encouraging as AML patients are in need of advancements in treatment. We look forward to working with the FDA to bring Vyxeos to patients as quickly as possible”.


Caribou’s CRISPR/Cas9 Deal with Genus for Livestock Species Welfare

California based leader of CRISPR/Cas9 gene editing technologyCaribou Biosciences and UK based Genus, global leader of animal genetics collaborated for a four year research program which is subjected to extension for another three years, funded by Genus. Genus receives worldwide, exclusive licence to Caribou’s leading CRISPR/Cas9 gene editing technology platform for the development of new traits in pigs, cattles and potentially other livestock species and to explore profound benefits for the livestock species.

Other than the upfront payment, Caribou is eligible to receive regulatory and commercial milestone payments as well as royalties on the sales of licensed product from Genus. Additional details about the agreement were not disclosed.

One of the prime objectives of the programme will be the further development and optimization of Genus’ Porcine Reproductive and Respiratory Syndrome Virus (PRRSv) resistant pig.

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