Fri, Apr. 24, 9:34 AM
- In results published in The Lancet, GlaxoSmithKline's (GSK -0.2%) investigational malaria vaccine, RTS,S, demonstrated a statistically significant reduction in malaria in children who received RTS,S followed by a booster shot of the vaccine at 18 months.
- RTS,S reduced the number of clinical malaria cases in young children (aged 5 - 17 months at first vaccination) by 36% and in infants (aged 6 - 12 weeks) by 26%, over an average follow-up period of 48 months.
- The vaccine incorporates Agenus' adjuvant, QS-21 Stimulon, which boosts the immune system's response to antigens in the vaccine.
- Trial data were submitted to the European Medicines Agency in June 2014 for review by its Committee for Medicinal Products for Human Use (CHMP). A positive opinion together with a recommendation from the World Health Organization (WHO) would support licensure applications to regulatory authorities in sub-Saharan African countries.
Thu, Apr. 16, 11:40 AM
- In an ex-U.S. study sponsored by Adamis Pharmaceuticals (ADMP +5%), its albuterol HFA product candidate, APC-2000, demonstrated equivalence to GlaxoSmithKline's (GSK -0.2%) Ventolin Evohaler HFA (salbutamol sulfate) in patients with mild-to-moderate asthma. Equivalence was measured as the change from baseline in Forced Expiratory Volume (FEV1) at two doses (100 mcg and 200 mcg).
- The company plans to advance APC-2000 to Phase 3 development with the objective of demonstrating non-inferiority (no worse than) to Ventolin.
Mon, Apr. 13, 12:03 PM
- GlaxoSmithKline's (GSK -0.6%) new U.S. pharmaceutical operations chief Jack Bailey aims to tweak the company's sales compensation scheme that was implemented in 2011 in response to the hot water it was in with the U.S. government over its marketing practices, charges that it settled in 2012 by paying a $3B fine and signing a corporate integrity agreement.
- The program, implemented by now-retired Deidre Connelly, pays sales bonuses based on product knowledge, business acumen and understanding the needs of patients and doctors rather than on the volume of prescriptions written, which is the traditional way to incentivize sales reps.
- The U.S. sales team lacks enthusiasm for the new approach because the data are generated by written tests and simulations conducted by third parties. The group believes that this is contributing to sales declines due to misplaced incentives in light of the continued emphasis (at least periodically) by sales management on prescription volume.
- Mr. Bailey maintains the organization's commitment to not link bonuses to prescription volume, especially since the program has been rolled out in 150 countries. He is just looking to simplify it.
- Previously: GlaxoSmithKline's (NYSE:GSK) $3B hit from the DoJ earlier this week is being billed as the... (July 5, 2012)
Thu, Apr. 2, 9:32 AM
- Heron Therapeutics (NASDAQ:HRTX) reaches its enrollment objective of ~900 patients in its Phase 3 study, MAGIC, evaluating its lead product candidate, Sustol (granisetron injection, extended release), for the prevention of delayed-onset chemotherapy-induced nausea and vomiting (CINV) following administration of highly emetogenic (vomit inducing) chemotherapy (HEC) agents.
- The trial is comparing Sustol plus fosaprepitant and dexamethasone to the current standard-of-care treatment for CINV, ondansetron plus fosaprepitant and dexamethasone. The primary efficacy endpoint is the proportion of patients who achieved a complete response in the 24 - 120 hours following chemotherapy. A complete response is defined as no emesis (vomiting) and no rescue medications.
- CINV affects as many as 80% of patients undergoing chemotherapy. No products are currently approved by the FDA for the treatment of delayed-onset CINV following administration of HEC agents.
- Sustol is a 5-HT3 receptor antagonist, which has the preferred treatment for CINV following the administration of moderately emetogenic chemotherapy (MEC). The FDA has only approved one 5-HT3 receptor antagonist to date, GlaxoSmithKline's (NYSE:GSK) Zofran (ondansetron hydrochloride), clearing it in 1991.
Fri, Mar. 27, 9:19 AM
- The experimental Ebola vaccines from GlaxoSmithKline (NYSE:GSK) and NewLink Genetics (NASDAQ:NLNK) (NYSE:MRK) appear to be safe, based on interim results in a mid-stage trial in Liberia. The vaccines, administered as a single injection, are being evaluated for safety and efficacy on more than 600 people there. Based on the positive results, the study will now progress to the next phase of efficacy testing where additional volunteers will be injected with one of the vaccines or placebo to see if their immune systems produce anti-Ebola antibodies.
- The Ebola epidemic, its course winding down, has claimed more than 10,000 lives.
Mon, Mar. 23, 4:26 PM
- According to Thomson Reuters' 2015 Drugs to Watch report, as many as 11 blockbuster drugs (peak sales of at least $1B within five years) are expected to clear the regulatory process this year. This is a significant jump from 2014's tally of three (Gilead's (NASDAQ:GILD) Sovaldi and Zydelig; Glaxo (NYSE:GSK) and Theravance's (NASDAQ:THRX) Anoro Ellipta). In reverse order (forecasted 2019 consensus sales in parentheses):
- 11. Novartis' (NYSE:NVS) Cosentyx (secukinumab) for psoriasis and psoriatic arthritis ($1.08B); 10. Sanofi's (NYSE:SNY) Toujeo (insulin glargine) for diabetes ($1.26B); 9. Otsuka Pharmaceutical (OTCPK:OTSKY) and Lundbeck's (OTCPK:HLUYY) Brexpiprazole for schizophrenia and depression ($1.35B); 8. Merck's (NYSE:MRK) Gardisil 9 HPV vaccine ($1.64B); 7. Amgen's (NASDAQ:AMGN) evolocumab for hypercholesterolemia/hyperlipidemia ($1.86B); 6. AbbVie's (NYSE:ABBV) Veikira Pak for hepatitis C (cleared 12/19/14) ($2.5B); 5. Vertex Pharmaceuticals' (NASDAQ:VRTX) lumacaftor plus ivacaftor for cystic fibrosis ($2.74B); 4. Pfizer's (NYSE:PFE) Ibrance (palbociclib) for breast cancer ($2.76B); 3. Novartis' LCZ696 for chronic heart failure ($3.73B); 2. Regeneron Pharmaceuticals' (NASDAQ:REGN) Praluent (alirocumab) for hypercholesterolemia ($4.41B) and 1. Bristol-Myers Squibb's (NYSE:BMY) Opdivo (nivolumab) for melanoma ($5.68B).
Thu, Mar. 19, 4:05 PM
- The FDA joint advisory committee reviewing Glaxo's (NYSE:GSK) sNDA for the use of Breo Ellipta to treat asthma voted 17 - 3 in favor that the safety data was adequately demonstrated in adults with asthma.
- It voted 18 - 2 in favor of its efficacy in adults at least 18 years old, but 16 - 4 against the data showing a benefit in adolescents ages 12 - 17 years.
- Related ticker: (NASDAQ:THRX)
- Previously: Ad Comm meeting approaches for expanded indication for Glaxo's COPD med (March 17)
Wed, Mar. 18, 7:45 AM
- Two 24-week Phase 3 trials (PINNACLE 1 & 2) evaluating AstraZeneca's (NYSE:AZN) PT003 in patients with chronic obstructive pulmonary disease (COPD) achieved their primary efficacy endpoints of statistically significant improvement in lung function compared to placebo.
- PT003 is a twice-daily fixed-dose combination of glycopyrronium, a long-acting muscarinic antagonist (LAMA) and formoterol fumarate, a long-acting beta-2 agonist (LABA). It is the first LAMA/LABA combination to be delivered in a pressurized metered dose inhaler using the porous particle co-suspension technology developed by Pearl Therapeutics, which AZN acquired in 2013. The successful outcomes of the PINNACLE studies are the first from a series of pipeline candidates using Pearl's technology.
- PT003 was assessed in over 3,700 patients in over 275 study sites. The primary efficacy endpoint was trough forced expiratory volume in one second (FEV1). PT003 demonstrated statistically significant improvements in FEV1 versus placebo and the individual components glycopyrronium (PT001) and formoterol fumarate (PT005). PT001 and PT005 also showed statistically significant improvements in FEV1 compared to placebo.
- The company plans to file regulatory applications beginning this year. It will present the study results at a scientific meeting later this year.
- Related tickers: (NYSE:GSK) (NASDAQ:THRX) (NYSE:NVS) (NASDAQ:REGN) (NYSE:SNY) (NYSE:TEVA) (OTCQX:RHHBY)
Tue, Mar. 17, 1:11 PM
- In an interview in London, Novo Nordisk (NVO -1.4%) deputy CEO Kaare Schultz, the heir apparent to current chief Lars Sorensen, said the company's focus on diabetes will likely grow from today's 79% to 80 - 90% in 10 years. "This is the key focus for the company and we see strength in staying focused."
- In addition to a new ultra-long-acting insulin, Novo has two GLP-1 offerings in the pipeline, a once-weekly injection and a first-ever GLP-1 pill. It is also experimenting with an oral insulin. GLP-1 (glucagon-like peptide-1) receptor agonists have a three-pronged mechanism of action to reduce blood sugar: they slow down the process of food leaving the stomach, hinder the liver from producing too much sugar and help the pancreas produce more insulin.
- Another bright spot is the strong growth of its daily GLP-1 Victoza (liraglutide) despite the presence of once-weekly offerings GlaxoSmithKline's (GSK +0.3%) Tanzeum (albiglutide) and Eli Lilly's (LLY -0.4%) Trulicity (dulaglutide).
- The company has exposure in hemophilia and some rare diseases but decided to exit the inflammatory diseases space last year.
- It plans to launch its obesity drug Saxenda (liraglutide [rDNA origin] injection) in the U.S. as early as next month using 500 of its 3,000-strong sales force. Peak sales could reach $1B+.
Tue, Mar. 17, 9:57 AM
- A joint meeting of the FDA's Pulmonary-Allergy Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee is scheduled for Thursday, March 19, to review GlaxoSmithKline's (GSK -0.2%) supplemental New Drug Application (sNDA) seeking approval for the use of Breo Ellipta (fluticasone furoate 100 mcg and vilanterol 25 mcg inhalation powder) as once-daily maintenance treatment of asthma in patients at least 12 years old. The committee will discuss efficacy, but the primary focus is safety and whether a large safety trial to evaluate serious asthma outcomes is necessary.
- Breo Ellipta is currently cleared for the treatment of chronic obstructive pulmonary disease (COPD).
- Glaxo's respiratory franchise is its largest segment, representing 27% of its $23B business the past four quarters.
- Draft Agenda; Draft Questions; Briefing Doc
Mon, Mar. 16, 8:58 AM
- Under agreements with the University of Oxford, GlaxoSmithKline (NYSE:GSK) and the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID), Emergent BioSolutions (NYSE:EBS) has manufactured a modified vaccinia Ankara (MVA) Ebola Zaire vaccine candidate (MVA EBOZ) that will be use in a Phase 1 trial to be conducted in the U.K. to assess the safety of MVA EBOZ as a heterologous boost to Glaxo's Chimp Adenovirus type 3 (ChAd3) Ebola vaccine candidate.
- Emergent performed proof-of-concept work and manufactured the MVA EBOZ vaccine candidate at a 200L scale in an avian cell line, which eliminates the requirement of eggs in the manufacturing process. The scalable process has the potential to meet the demand for multi-million doses in a few months.
Fri, Mar. 13, 4:09 AM
- Following long investment in the firm, GlaxoSmithKline (NYSE:GSK) has taken profits in Aspen Pharmacare (OTCPK:APNHY) by selling half of its 12.4% stake in the South African drugmaker for $853M.
- Glaxo CFO Simon Dingemans said the disposal will help give the company flexibility to invest in new opportunities in the wake of its $20B+ asset swap with Novartis and will also help protect its sizeable dividend payments to shareholders.
- GSK +1.4% premarket
Fri, Mar. 6, 4:27 PM
- Reuters reports GlaxoSmithKline (NYSE:GSK) is firing 110 Chinese employees following a probe launched in response to its local bribery scandal. GSK was fined RMB3B ($479M) by a Chinese court last year for bribing doctors to use its drugs, and five execs were given suspended prison sentences.
- The drug giant insists all of the misconduct uncovered by its probe happened before mid-2013 - the point where Chinese authorities first levied bribery accusations against GSK. The company adds it has "increased our monitoring of expense claims and increased our compliance efforts" in response to the events.
Thu, Mar. 5, 10:47 AM
- Phase 3 trials to assess the safety and efficacy of the experimental Ebola vaccine co-developed by Merck (MRK +0.2%) and NewLink Genetics (NLNK +0.8%) will commence in two days in Guinea according to a statement by the World Health Organization (WHO). The trials will be conducted in the Basse Guinee region which dealt with the most Ebola cases.
- A "ring vaccination" strategy will be employed whereby everyone who has been in contact with a newly diagnosed Ebola patient will be vaccinated, an approach used to eradicate smallpox in the 1970s.
- Trials of two vaccine candidates, Merck/NewLink and GlaxoSmithKline (GSK +0.1%), in Liberia appear to be working. No new cases have been reported for 13 days.
- Trials for Glaxo's offering will begin in Guinea when supplies are available.
Mon, Mar. 2, 2:58 AM
- GlaxoSmithKline (NYSE:GSK) and Novartis (NYSE:NVS) have completed a series of asset swaps worth more than $20B that will reshape both drugmakers.
- Glaxo is forming a consumer health joint venture with Novartis, while at the same time buying the Swiss company's vaccines business and divesting its cancer drugs portfolio to Novartis.
- Following completion of the transactions, Glaxo plans to return £4B ($6.16B) to shareholders.
- Previously: Novartis announces billions of dollars in deals with GSK, Eli Lilly (Apr. 22 2014)
Fri, Feb. 27, 12:20 PM
- According the the World Health Organization (WHO), a recommendation from the Strategy Advisory Group of Experts (SAGE), an independent advisory body, to commence the widespread introduction of an Ebola vaccine won't happen until at least August due to the timing of results from clinical trials.
- Liberia is currently testing vaccine candidates from GlaxoSmithKline and Merck-NewLink. Sierra Leone and Guinea will announce their plans soon.
- The steep decline in Ebola cases will make it more difficult to prove the efficacy of the experimental vaccines so some of the testing may have to be moved to Sierra Leone, according to the U.S. National Institutes of Health.
- More than 23,500 cases of Ebola have been reported in the three African countries, with more than 9,500 fatalities. Only 99 new confirmed cases were reported for last week.
- (GSK -0.6%)(MRK -0.5%)(NLNK +1.2%)(GILD -0.8%)
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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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