Fri, Dec. 2, 9:27 AM
- GlaxoSmithKline (NYSE:GSK) submits a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of a once-daily, closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for the treatment of patients with chronic obstructive pulmonary disease (COPD). The product will be administered via the company's Ellipta dry powder inhaler.
- The company submitted its marketing application in the U.S. several weeks ago. Additional applications in other markets will be be made in 2017.
Fri, Dec. 2, 7:46 AM
- The Japanese Ministry of Health, Labour and Welfare approves the use to GlaxoSmithKline's (NYSE:GSK) Relvar Ellipta (fluticasone furoate/vilanterol 100/25 mcg) for the treatment of symptoms associated with chronic obstructive pulmonary disease (COPD).
- Relvar is a combination of an inhaled corticosteroid (fluticasone furoate) and a long-acting beta2 agonist (vilanterol). It is administered once daily using the Ellipta dry powder inhaler. It has been commercially available in-country since 2013 for the treatment of asthma.
Thu, Nov. 24, 1:35 PM
- A Phase 3 clinical trial assessing GlaxoSmithKline's (NYSE:GSK) asthma med Nucala (mepolizumab) for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA) met both co-primary endpoints and all secondary endpoints.
- The proportion of patients achieving a duration of remission of at least 24 weeks significantly favored the mepolizumab cohort compared to placebo [n=16/68 (28%); n=2/68 (3%); p<0.001].
- The proportion of patients achieving remission at weeks 36 and 48 also significantly favored mepolizumab [n=22/68 (32%); n=2/68 (3%); p<0.001].
- The most common serious adverse event in the mepolizumab group was asthma (4%). The most common serious adverse events for placebo were asthma (4%), influenza (3%) and pneumonia (3%).
- Complete results will be presented at an upcoming medical conference. Global regulatory applications are on tap for 2017.
- Mepolizumab is a humanized IgG monoclonal antibody that binds to interleukin 5 (IL-5), a cytokine that plays a key role in regulating the function of eosinophils, white blood cells that cause airway inflammation.
- EGPA, also known as Churg-Strauss syndrome, is a rare systemic vasculitic (inflammation of the blood vessel walls) disorder. It affects as many as four million people worldwide. Symptoms vary but almost all sufferers have asthma and/or nasal sinus polyps and elevated blood eosinophils.
Mon, Nov. 21, 10:43 AM| Mon, Nov. 21, 10:43 AM | 1 Comment
Mon, Nov. 21, 7:20 AM
- GlaxoSmithKline (NYSE:GSK) files a New Drug Application (NDA) with the FDA seeking approval of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Earlier this year, the company announced its plans to accelerate the timing of the submission, originally projected to happen in H1 2018.
- It plans to file its marketing application in Europe in the coming weeks followed by submission in other countries in 2017.
Fri, Nov. 18, 12:54 PM
- ViiV Healthcare, the HIV-focused company majority owned by GlaxoSmithKline (GSK -0.7%) and Pfizer (PFE -0.4%), initiates two Phase 3 studies assessing an injectable regimen of cabotegravir and rilpivirine for the treatment of HIV-1 infection. The studies, FLAIR and ATLAS, will evaluate the safety and efficacy of the two-drug combo, administered once per month, in both treatment-naive and treatment-experienced patients.
- According to ClinicalTrials.gov, the estimated final data collection date for the primary endpoint is July/August 2018 for both studies. The estimated completion date for both is April/May 2022.
- Cabotegravir, developed by ViiV, in an integrase strand transfer inhibitor. It is also being evaluated in a tablet formulation.
- Rilpivirine [marketed as EDURANT by Janssen (JNJ -1.2%)] is a non-nucleoside reverse transcriptase inhibitor.
Wed, Nov. 16, 12:16 PM
- Results from a seven-year continuation study assessing GlaxoSmithKline's (GSK -1%) Benlysta (belimumab) for the long-term treatment of patients with active autoantibody-positive systemic lupus erythematosus (SLE) showed treatment with belimumab plus standard-of-care (SOC) therapy delivered meaningful improvements in patients' daily lives, including quality-of-life and fatigue. The data were presented at the American College of Rheumatology and Association of Rheumatology Health Professionals Annual Meeting in Washington, D.C.
- The open-label extension study enrolled patients who completed the Phase 3 BLISS-76 trial which randomized 819 patients across 136 sites in 19 countries. The primary endpoint was the patient response rate at week 52 as measured by a composite measure of disease activity called the SLE Responder Index.
- The continuation phase enrolled 268 patients, comprising the modified intent-to-treat population. 140 (~48%) completed the study and 128 withdrew. There were no clinically significant trends associated with the withdrawals.
- Participants received the same dose of belimumab (1 or 10 mg/kg every 28 days) as BLISS-76 plus SOC. Following the regulatory approval of belimumab, the patients receiving the lower dose were increased to the higher dose.
- By year 7, 76.5% of patients showed a response to treatment as measured by a newer scale called SRI4 (Systemic Lupus Responder Index). In additional, quality of life measures of physical and mental health improved as well.
- The FDA approved Benlysta in March 2011 followed by approval in Europe in July 2011. It is the only drug approved in the last 50 years to treat SLE.
Wed, Nov. 9, 8:08 AM
- Biotechs and Big Pharma look like they will jump out of the blocks this morning. Most leading names are up premarket.
- Sampling: (NASDAQ:AMGN) +4%; (NASDAQ:GILD) +2%; (NASDAQ:REGN) +3%; (NASDAQ:BIIB) +4%; (NASDAQ:VRTX) +2%; (NASDAQ:CELG) +3%; (NYSE:BMY) +2%; (NYSE:PFE) +5%; (NYSE:MRK) +2%; (NYSE:AZN) +1%; (NYSE:GSK) +1%; (NYSE:JNJ) +2%; (NYSE:ABBV) +4%; (NYSE:LLY) +3%; (NYSE:NVS) +3%; (NYSE:AGN) +4%; (NASDAQ:TEVA): +6%
Wed, Nov. 9, 3:03 AM
- Healthcare stocks, the weakest sector this year, may become winners, as Obamacare reforms are set to be "repealed and replaced" and major legislation Clinton proposed is unlikely to be imposed on drugmakers.
- While Trump hasn't set out a comprehensive alternative to the Affordable Care Act (which may see 22M Americans lose current coverage), he said he'll encourage competition between markets in different states.
- Insurance stocks: UNH, AET, ANTM, CI, HUM, WCG, CNC, MOH, GTS, HQY
- Drugmakers premarket: MYL +5.8%, NVS +3.4%, SNY +2.9%, AZN +2.4%, GSK +1.9%, PFE +1.8%, CELG +1%, ABBV, MRK, BMY, LLY, JNJ, ABT, ACET, ZTS, BIIB, REGN
Wed, Oct. 26, 9:29 AM
Wed, Oct. 26, 7:18 AM
Mon, Oct. 24, 7:01 AM
- GlaxoSmithKline (NYSE:GSK) files a Biologics License Application (BLA) with the FDA seeking approval of its shingles vaccine, branded as Shingrix, for the prevention of herpes zoster in people aged 50 years and older.
- In clinical studies, a two-dose regimen of Shingrix showed 90% efficacy in participants at least 70 years old and was maintained in those aged 80 and above, significantly better than Merck's (NYSE:MRK) ZOSTAVAX which is only 18% effective in people aged 80+.
- Shingles is characterized by a painful, itchy rash caused by the reactivation of latent chicken pox virus, varicella zoster. The risk of developing shingles increases with age and altered immune system status.
- Shingrix is a non-live, adjuvanted subunit (HZ/su) vaccine that combines gE, a protein found on the herpes zoster virus, with the adjuvant ASO1B which boosts the immune response to gE.
- Regulatory submissions in Europe and Canada will be made this year followed by Japan in 2017.
Wed, Sep. 28, 9:46 AM
- Teva Pharmaceutical Industries (TEVA +0.5%) announces its U.S. commercial launch of a generic equivalent to ViiV Healthcare's Epzicom (abacavir and lamivudine) tablets, 600 mg/300 mg. It is indicated, in combination with other antiretroviral agents, for the treatment of HIV-1 infection.
- According to IMS, the U.S. market for the branded product is ~$450M.
- ViiV Healthcare is the HIV-focused company formed by GlaxoSmithKline (GSK +0.9%) and Pfizer (PFE +0.1%).
Fri, Sep. 23, 9:03 AM
- Janssen Biotech (NYSE:JNJ) submits its Biologics License Application (BLA) to the FDA seeking approval of sirukumab for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), a chronic systemic inflammatory condition affecting ~1.5M Americans.
- The data supporting the filing was generated in five late-stage studies in its SIRROUND program.
- Sirukumab is being co-developed by GlaxoSmithKline (NYSE:GSK) and Janssen Biologics in a partnership that began in late 2011. It is a human monoclonal IgG kappa antibody that binds to interleukin-6 (IL-6), a cytokine that plays a key role in autoimmune conditions. The companies expect it to be a blockbuster generating peak sales of $1B+. It is also being investigated for the treatment of major depressive disorder, lupus nephritis, systemic lupus erythematosus, asthma and polymyalgia rheumatica.
Tue, Sep. 20, 2:55 AM
- GlaxoSmithKline (NYSE:GSK) has promoted Emma Walmsley, head of consumer healthcare, to be its new chief executive, after considering internal and external candidates.
- Walmsley, who joined Britain's biggest drugmaker in 2010 from L'Oreal, will replace Andrew Witty, who previously announced his decision to retire on March 31, 2017.
Fri, Sep. 16, 12:07 PM
- C.R. Bard (NYSE:BCR) upgraded to Outperform from Market Perform by Wells Fargo.
- DexCom (NASDAQ:DXCM) upgraded to Buy from Hold by Desjardins. Downgraded to Neutral from Buy with a $92 (1% downside risk) price target by BTIG Research.
- Alimera Sciences (NASDAQ:ALIM) upgraded to Outperform from Market Perform by Cowen & Company.
- Seattle Genetics (NASDAQ:SGEN) upgraded to Neutral from Sell by Goldman Sachs. Price target raised to $47 (13% downside risk) from $30.
- Akorn (NASDAQ:AKRX) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $34 (19% upside) from $33.
- Community Health Systems (NYSE:CYH) upgraded to Positive from Neutral by Susquehanna. Price target raised to $18 (66% upside).
- AstraZeneca (NYSE:AZN) upgraded to Buy from Hold by Jefferies. Price target raised to GBX 5,800 (14% upside) from GBX 5,400. Downgraded to Neutral from Outperform with a GBX 5,200 (2% upside) price target by BNP Paribas.
- McKesson (NYSE:MCK) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $189 (15% upside) from $210.
- Cardinal Health (NYSE:CAH) downgraded to Neutral from Buy by Goldman Sachs. Price target lowered to $83 (8% upside) from $90.
- Novavax (NASDAQ:NVAX) downgraded to Neutral from Outperform by Wedbush. Price target lowered to $2 (44% upside) from $14. Downgraded to Neutral from Buy by Citigroup. Price target lowered to $1.50 (8% upside) from $12. Downgraded to Neutral from Overweight by JPMorgan and Piper Jaffray.
- Raptor Pharmaceutical (NASDAQ:RPTP) downgraded to Market Perform from Outperform by Cowen & Company.
- Vitae Pharmaceuticals (NASDAQ:VTAE) downgraded to Market Perform from Outperform by BMO Capital.
- Atara Biotherapeutics (NASDAQ:ATRA) downgraded to Sell from Neutral by Goldman Sachs. Price target lowered to $16 (18% downside risk) from $23.
- GlaxoSmithKline (NYSE:GSK) downgraded to Underperform from Neutral with a GBX 1,520 (6% downside risk) price target by BNP Paribas.
- Applied Genetic Technologies (NASDAQ:AGTC) downgraded to Neutral from Buy by Roth Capital. Price target lowered to $12 (34% upside) from $34. Downgraded to Hold from Buy by Cantor Fitzgerald. Price target lowered to $15 (68% upside) from $32.
- Cepheid (NASDAQ:CPHD) downgraded to Neutral from Outperform by Baird.