Jul. 28, 2014, 10:58 AM
- Contrary to a Financial Times report, GlaxoSmithKline (GSK -0.8%) says that it has no plans to spin off its consumer healthcare division according to Bloomberg.
- It is proceeding with a JV with Novartis (NVS -0.8%) to create a consumer health company with ~6.5B pounds ($11B) in annual revenue. The transaction won't close until next year, though.
Jul. 28, 2014, 2:13 AM
- GlaxoSmithKline’s (NYSE:GSK) chief exec has announced the possibility of spinning off the group's consumer healthcare business in the future, should it offer more value as a standalone company.
- Sir Andrew Witty outlined that there were no such plans in the near term but is open to the idea of further restructuring.
- Glaxo has faced many challenges this year, including global bribery scandals and last week's guidance cut due to slipping sales and profit.
Jul. 27, 2014, 6:58 AM
- The FBI has been interviewing current and former GlaxoSmithKline (NYSE:GSK) employees in connection with bribery allegations made against the drug maker in China, the WSJ reports.
- Additional reports continue to surface on corrupt Glaxo practices in many other countries, with Syria being the most recent case - reported last week.
- The SEC and the U.K.'s Serious Fraud Office are also conducting investigations into possible criminal violations of the company's commercial practices.
Jul. 25, 2014, 2:57 AM
- GlaxoSmithKline (NYSE:GSK) is now facing corruption claims in Syria, where it's has been accused of bribery to secure business.
- The drugmaker is investigating the claims which date back to 2010 after a whistleblower's email was sent to the company.
- Syria is now the sixth country to be investigated by Glaxo for smaller-scale bribery claims compared to the $480M Chinese allegations which have plagued the company since last July.
- GSK -0.2% AH
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Jul. 24, 2014, 9:32 AM
- The European Medicines Agency (EMA) accepts GlaxoSmithKline's (GSK -0.1%) regulatory application for its malaria vaccine candidate RTS,S. If approved, it will be the first vaccine to earn marketing authorization anywhere in the world.
- RTS,S contains Agenus' (AGEN) QS-21 Simulon adjuvant which enhances the immune response when used in combination with antigens in vaccines.
Jul. 23, 2014, 9:11 AM
Jul. 23, 2014, 8:12 AM
- GlaxoSmithKline (NYSE:GSK) Q2 results (€): Total Revenues: 5,561M (-16.0%), Pharmaceuticals: 3,773M (-16.6%), Vaccines: 766M (-2.5%), Consumer Healthcare: 1,022M (-21.9%), Seretide/Advair: 1,095M (-19.4%); COGS: 1,722M (-12.7%); R&D Expense: 809M (-22.9%); SG&A Expense: 2,055M (-7.3%); Royalty Income: 72M (-12.2%); Net Income: 654M (-37.4%); EPS: 0.134 (-37.7%); Quick Assets: 4,165M (+15.1%); Gross Profit: 3,839M (-17.4%); COGS: 31.0% (+3.9%); Gross Margin: 69.0% (-1.7%); Operating Profit: 1,137M (-20.9%); Operating Earnings Yield: 20.4% (-5.9%); Net Earnings Yield: 11.8% (-25.5%).
- 2014 Guidance: Core EPS Growth: flat versus 4 - 8% growth.
Jul. 23, 2014, 7:53 AM
Jul. 22, 2014, 1:40 PM
- In a Phase 3 trial comparing a once-daily dose of Solzentry (maraviroc) (PFE +0.7%) with Prezista (darunavir) (JNJ +1.1%) and Norvir (ritonavir) (ABBV +0.2%) to emtricitabine/tenofir with darunavir plus ritonavir (DRV/r) in antiretroviral-naive patients, the maraviroc combination failed to achieve its primary endpoint of -10% non-inferiority (no worse than) at Week 48.
- The proportion of study subjects who were virologically suppressed (HIV-1 RNA < 50 copies/ml) was 77.3% for the maraviroc cohort and 86.8% for the DRV/r group.
- The study results were presented by ViiV Healthcare at the 20th International AIDS Congress in Melbourne, Australia earlier today. ViiV is a specialist company focused on HIV that was established in late 2009 by Glaxo (GSK -0.1%) and Pfizer.
- ViiV Healthcare CSO and CMO Dr. John Pottage says, "Athough this investigational two-drug regimen was inferior to the three-drug regimen in this study, maraviroc remains a valuable antiretroviral therapy when used in combination with other antiretrovirals and dosed twice daily in adults with confirmed CCR5-tropic HIV."
Jul. 17, 2014, 11:51 AM
- On the basis of its interim analysis of the data from the Phase 3 clinical trial evaluating Glaxo's (GSK) combination therapy of Mekinist (trametinib) and Tafinlar (dabrafenib) compared to vemurafenib in patients with BRAF V600E or V600K mutation-positive unresectable or metastatic cutaneous melanoma, the Independent Data Monitoring Committee recommends stopping the trial early. The combination therapy demonstrated efficacy in terms of Overall Survival (OS) (primary endpoint) that surpassed the pre-determined boundary.
- The IDMC recommendation is based on headline data. A more extensive analysis will be completed the next several months.
Jul. 17, 2014, 8:28 AM
- The U.S. District for the District of New Jersey grants Mylan's (NASDAQ:MYL) motion for a permanent injunction against GlaxoSmithKline (NYSE:GSK) from supplying Paroxetine CR, the generic form of Glaxo's Paxil CR, to Apotex, which marketed the product. The Court also awards Mylan prejudgment interest and permits it to take an accounting so that it can determine the amount of additional damages it has suffered since September 30, 2013 as a result of Glaxo's ongoing breach. The Court denied all of GSK's post-trial motions.
- The Court awarded Mylan $106.7M in damages after a favorable jury verdict in March 2014. Mylan is the only firm with an FDA-approved generic version of Paxil.
Jul. 17, 2014, 2:44 AM
- GlaxoSmithKline (NYSE:GSK) has confessed to a more than decade-old scandal in which staff were caught bribing Chinese officials.
- The admission does not fare well for the company which is also involved in a similar current lawsuit - accused of bribing doctors and officials to boost drug sales in China.
- The DOJ is presently investigating the recent allegations. If a pattern is found, the Justice Department will likely take a tough stance towards the company.
Jul. 16, 2014, 7:22 AM
- Glaxo (NYSE:GSK) and Theravance (NASDAQ:THRX) start a Phase 3 clinical trial evaluating the safety and efficacy of the "closed" triple combination of FF/UMEC/VI in patients with chronic obstructive pulmonary disease (COPD). The once-daily treatment consists of an inhaled corticosteroid (fluticasone furoate - FF), a long-acting muscarinic antagonist (umeclidinium - UMEC) and a long-acting beta2-adrenergic agonist (vilanterol - VI) delivered via Glaxo's Ellipta inhaler.
- The Phase 3 trial will enroll ~10K patients and will compare the triple combo therapy to two other approved once-daily treatments in terms of the reducing the annual rate of moderate-to-severe exacerbations.
Jul. 14, 2014, 6:19 PM
- Codexis (NASDAQ:CDXS) +84.4% AH on news it granted a license to GlaxoSmithKline (NYSE:GSK) to use its CodeEvolver platform technology to develop enzymes for use in pharmaceutical and health care products.
- CDXS says it is eligible to receive up to $25M over a period of about two years, and could receive additional milestone payments of up to $38.5M per project, depending on successful application of the technology.
Jul. 14, 2014, 12:44 PM
- The husband-and-wife team whose company was retained by Glaxo (GSK -0.4%) to investigate an anonymous whistle-blower will be tried on charges of illegally acquiring private personal information reports the NY Times. The company hired ChinaWhys to look into the person who informed Chinese authorities of bribery by company representatives as a means to close business with local doctors. Glaxo also hired the firm to clarify the circumstances that enabled a camera to be placed in the Shanghai bedroom of Glaxo China Chief Mark Reilly. A subsequent video of Mr. Reilly and his Chinese girlfriend was mailed to CEO Andrew Witty.
- The couple, Brit Peter Humphrey and American Yu Yingzeng, are being held at the Pudong Detention Center in Shanghai. Their trial is slated to begin on August 7. They have been indicted on charges of gathering personal household registrations (hukou), entry and exit records, phone records and business registrations. The maximum penalty for the charges is three years incarceration.
- Glaxo's business practices are currently under investigation in Britain and Europe.
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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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