Dec. 18, 2014, 11:41 AM
- Thinly-traded nano cap Agenus (AGEN +11.3%) jumps on triple normal volume in response to the successful outcome of the Phase 3 clinical trial of GlaxoSmithKline's (GSK +2.4%) shingles vaccine candidate, HZ/su. One of the key components of the vaccine's adjuvant system, AS01B, is Agenus' QS-21 Stimulon adjuvant.
- Previously: Glaxo shingles vaccine candidate successful in Phase 3 study (Dec. 18, 2014)
Dec. 18, 2014, 8:31 AM
- Chinese authorities approve the start of clinical trials for an experimental Ebola vaccine developed by the Academy of Military Medical Sciences and Chinese biotech outfit Tianjin CanSino Biotechnology. The trials are supposedly going to commence this month. No other details are available.
- Glaxo (NYSE:GSK) and Merck (NYSE:MRK) remain the front runners.
Dec. 18, 2014, 7:40 AM
- A Phase 3 clinical trial assessing the safety and efficacy of GlaxoSmithKline's (NYSE:GSK) HZ/su investigational vaccine for the prevention of shingles met its primary endpoint of overall vaccine efficacy across all age cohorts compared to placebo. In patients aged 50 years and older, HZ/su reduced the risk of shingles by 97.2% compared to control. The trial, started in August 2010, in ongoing in 18 countries and involves more than 16,000 patients.
- Shingles is a painful itchy rash that develops on one side of the body that is caused by a reactivation of latent chicken pox virus (varicella zoster virus, VZV). Age and an altered immune system are the main risk factors. More than 90% of adults are at risk for shingles.
- HZ/su combines gE, a protein found on VZV, with an adjuvant, ASO1B, that is designed to enhance the immunological response.
- The company plans to present the data at a future scientific conference.
Dec. 11, 2014, 11:58 AM
- The Global Alliance for Vaccines and Immunisation, Gavi, plans to spend as much as $300M for up to 12 million doses of an Ebola vaccine as soon as the World Health Organization (WHO) recommends one for use. An additional $90M could be used to support countries that introduce the vaccine and to rebuild devastated health systems and restore immunisation services in Ebola-stricken countries.
- Gavi is funded by governments and the Bill & Melinda Gates Foundation.
- Two vaccine candidates are currently being tested in humans in Phase 1 trials. The first trial, assessing Merck (MRK +0.8%) and NewLink Genetics' (NLNK -0.8%) candidate, experienced a hiccup recently when four volunteers complained of joint pain in their hands and feet. The trial is on hold as a precaution, but will restart on January 15 contingent on no further adverse events. The second trial, assessing the combination of GlaxoSmithKline's (GSK +0.4%) monovalent cAd3-EBO Z Ebola vaccine candidate with Bavarian Nordic's MVA-BN Filo booster vaccine, has experienced no adverse events to date.
- Johnson & Johnson (JNJ +0.8%) will begin testing its Ebola vaccine candidate in January and says it will have 250K doses for clinical study by May.
- Previously: Merck-NewLink Ebola vaccine trial interrupted (Dec. 11, 2014)
- Previously: Phase 1 underway for Ebola booster vaccine regimen (Dec. 4, 2014)
- Previously: J&J to begin testing Ebola vaccine in January; expects 250K doses ready by May (Oct. 22, 2014)
Dec. 5, 2014, 1:57 PM
- As expected, the Biotechnology Industry Organization (BIO) gives a resounding thumbs up in support of adding Ebola to the FDA Priority Review Voucher Program Act. Under the act, developers of a vaccine or treatment for a qualified tropical disease receive a voucher for FDA priority review for another product of its choice.
- Late Wednesday, the U.S. House of Representatives voted unanimously to add Ebola to the Act. Additional refinements to the legislation include making it easier for the Secretary of Health and Human Services to add to the list of qualified diseases, allowing the vouchers to be sold and transferred multiple times and shortening the timeline for notifying the FDA of the intention to use a priority review voucher.
- The changes bring the tropical diseases priority review voucher program more in line with the rare pediatric disease priority review voucher program.
- Ebola-related tickers: (GSK +0.2%)(JNJ +0.5%)(MRK +1%)(NLNK +2.2%)(TKMR -1.4%)(HEB +0.6%)(SRPT -0.8%)(BCRX +0.8%)(CMRX +3.2%)
Dec. 5, 2014, 7:19 AM
- Doctors say that simple intravenous fluid drips could save the lives of many Ebola patients, but they are not being deployed due to a perception that no treatment will work. Many patients are succumbing to extreme dehydration and electrolyte depletion caused by vomiting and diarrhea, according to Ian Roberts of the London School of Hygiene and Tropical Medicine and Anders Perner of Copenhagen University. "Ebola treatment must be more that just a setting for quarantine. Patients will be reluctant to attend treatment centers unless the care they receive...is superior to the care provided by family members."
- The epidemic in West Africa has claimed more than 6,000 lives out of ~17,000 that have been infected. All but 15 of the deaths have occurred in Sierra Leone, Guinea and Liberia.
- ETFs: IRY, IXJ
- Ebola-related tickers: (NYSE:GSK) (NYSE:JNJ) (NYSE:MRK) (NASDAQ:NLNK) (OTCQB:AEMD) (NASDAQ:TKMR) (NYSEMKT:HEB) (NASDAQ:SRPT) (NASDAQ:BCRX)
Dec. 4, 2014, 1:38 PM| Comment!
Dec. 4, 2014, 8:23 AM
- In a Phase 1 trial sponsored by the University of Oxford, 30 healthy volunteers will receive Bavarian Nordic's MVA-BN Filo booster vaccine in combination with the monovalent cAd3-EBO Z Ebola vaccine co-developed by GlaxoSmithKline (NYSE:GSK) and the U.S. National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). Recent preclinical research suggests that employing an MVA-based booster dose may deliver a more robust and durable immune response to the primary vaccine.
- The study involves 60 healthy adults divided into three cohorts each receiving different doses of the cAd3-EBO Z vaccine. Half of each cohort will also receive the booster dose of MVA-BN Filo.
- The primary endpoint is safety and tolerability. The secondary endpoint is the cellular and humoral immune response. Preliminary results should be available in 1H 2015.
- Both cAd3-EBO Z and MVA-BN Filo have been developed in collaboration with NIAID, which also investigated the prime boost regimen of MVA-BN Filo and Crucell Holland B.V.'s AdVac technology. Crucell is part of J & J (NYSE:JNJ) unit Janssen Pharmaceuticals. Bavarian Nordic and Janssen are collaborating on the development and manufacture of large quantities of their vaccine regimen and intend to start clinical trials shortly.
- Related tickers: (NYSE:MRK) (NASDAQ:NLNK)
Dec. 4, 2014, 7:07 AM
- GlaxoSmithKline (NYSE:GSK) will eliminate 900 jobs from its operations in Research Triangle Park, North Carolina as part of its previously announced plan to reduce costs by ₤1B ($1.6B). The company has 99,000 employees worldwide with 17,000 in NC.
- Glaxo is under pressure to cut costs due to soft revenue growth. For example, sales of Advair, its asthma drug, are expected to decline ~30% in 2015 due to increased competition.
- Previously: Report: Glaxo planning reorganization (Nov. 30, 2014)
Dec. 3, 2014, 6:33 PM
- Array BioPharma (NASDAQ:ARRY) +24% AH says it reached a deal with Novartis (NYSE:NVS) to regain global rights to its binimetinib cancer treatment as well as an upfront payment of $85M.
- The agreement is subject to NVS and GlaxoSmithKline (NYSE:GSK) completing a series of transactions which were unveiled in April and remain subject to regulatory approval.
- ARRY says binimetinib is advancing in three phase 3 clinical trials and that it plans to file for its first regulatory approval in H1 2016.
Dec. 3, 2014, 3:36 PM
- Actelion Ltd (OTCPK:ALIOF) (OTC:ALIOY) submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Uptravi (selexipag) for the treatment of patients with pulmonary arterial hypertension (PAH).
- Selexipag is selective IP prostacyclin receptor agonist. Prostacyclin activates the IP receptor inducing vasodilation and inhibiting proliferation of vascular smooth muscle cells. If approved, it will be the first such drug cleared for use in PAH.
- In April 2008, the company signed a license agreement with Nippon Shinyaku under which Actelion has global development and commercialization rights to selexipag outside of Japan. The firms will be partners in Japan.
- Actelion plans to submit an NDA to the FDA shortly.
- PAH-related tickers: (GSK -0.8%)(GILD -1.9%)(MSTX -1.5%)(ARNA +1.7%)(OTCPK:BAYRY -1.8%)(UTHR -1.2%)
Dec. 1, 2014, 9:05 AM
- The Australian Pharmaceutical Benefits Scheme (PBS) approves the reimbursement of GlaxoSmithKline (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta (umeclidinium/vilantrol) for the maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Reimbursement will begin December 1, 2014.
- COPD afflicts ~530K Australians.
- Previously: Anoro Ellipta cleared in Australia
Nov. 30, 2014, 5:24 AM
- GlaxoSmithKline (NYSE:GSK) is poised to announce a workforce restructuring as soon as this week that will include hundreds of job cuts in the U.S., Bloomberg reports.
- U.S. sales are flagging due to increased respiratory drug competition, including the company’s best-selling Advair asthma medication.
- Glaxo pledged in October to cut costs by £1B ($1.56B) over three years, with half the savings coming in 2016.
Nov. 28, 2014, 9:49 AM
- Lyon, France-based Flamel Technologies (FLML +0.6%) sells its Pessac, France-located manufacturing and development facility to Swedish CDMO (contract development and manufacturing organization) Recipharm for €10.6M as part of a five-year service agreement. Flamel retains access to the capabilities of Pessac as well as other Recipharm facilities for its production and development activities. The sale includes the royalty contract for Coreg CR with GlaxoSmithKline (GSK +0.3%).
- Flamel and Recipharm agree to negotiate an agreement with the objective of incorporating the former's drug delivery technology into the latter's contract development business.
- In a separate transaction, Recipharm will make a €10.5M investment in Flamel's common stock.
Nov. 28, 2014, 9:23 AM
- The European Commission approves Boehringer Ingelheim's Vargatef (nintedanib), in combination with docetaxel, for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumor histology, after first-line chemotherapy. Adenocarcinoma is the most common form of lung cancer.
- Nintedanib is an oral angiokinase inhibitor which simultaneously inhibits endothelial growth factor receptors (VEGFR), platelet-derived growth factor receptors (PDGFR) and fibroblast growth factor receptors (FGFR) signalling pathways. It is currently being investigated in various other cancers.
- Earlier this month, Europe's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion supporting approval of nintedanib, branded as Ofev, for the treatment of ideopathic pulmonary fibrosis (IPF). The FDA approved it for IPF in October.
- Previously: Europe Ad Comm supports approval for BI pulmonary fibrosis drug
- Previously: BI begins enrollment in Phase 3 CRC trial
- ETFs: IBB, BIB, IRY, BIS, IXJ, DRGS
- Lung cancer-related tickers: (NYSE:BMY) (NYSE:MRK) (NASDAQ:CLVS) (NASDAQ:FPRX) (NASDAQ:BIND) (NYSE:GSK) (NASDAQ:ARIA) (NASDAQ:ECYT) (NYSE:AZN) (OTC:MKGAF) (OTCPK:MKGAY) (NASDAQ:ONTY) (NYSE:PFE) (NASDAQ:HTBX) (OTCQX:RHHBY) (NASDAQ:INCY)
Nov. 28, 2014, 7:41 AM
- GlaxoSmithKline (NYSE:GSK) declines to exercise its option to license Dynavax's (NASDAQ:DVAX) DV1179, an investigational bifunctional inhibitor of toll-like receptors (TLR) 7 and 9, after it failed to meet its pharmacodynamic endpoints related to the reduction in interferon alpha-regulated genes in a Phase 1b/2a study in patients with active systemic lupus erythematosus.
- Dynavax will now have full global rights to develop DV1179 and other TLR 7/9 inhibitors for all indications.
GSK vs. ETF Alternatives
GlaxoSmithKline PLC incorporated in United Kingdom. The Company creates, discoveres, develops, manufactures and markets pharmaceutical products including vaccines, over-the-counter (OTC) medicines and health-related consumer products.
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