- Fourth Scientist Pleads Guilty to Stealing GSK Information for China (biospace.com)
Ex-GlaxoSmithKline researcher Lucy Xi has pled guilty to conspiracy to steal trade secrets from her former company to help a rival firm launch a business in China. She is the fourth person to plead guilty to the offense...Xi and co-defendants Yan Mei, Yu Xue, Yan Mei, and Tao Li created Renopharma in the guise of conducting research and development of anti-cancer therapies. However, it was found that Renopharma had been operating as a repository of stolen GSK information and was receiving compensation and subsidies from the People's Republic of China to do so...READ MORE
- U.S. appeals court says GSK cannot be sued over generic drug suicide (reuters.com)
U.S. appeals court...tossed a $3 million verdict against GlaxoSmithKline over the suicide of an attorney who took a generic version of the company’s antidepressant Paxil, finding the company could not be held liable for injuries allegedly caused by a generic copy...The case weighing whether brand-name manufacturers can be sued for injuries blamed on generic drug versions was closely watched within the pharmaceutical and legal industries...Under a 2011 ruling by the U.S. Supreme Court, generic drug companies cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the brand-name versions’ labels...decision follows a series of state court rulings in similar cases. The top courts of Massachusetts and California ruled brand-name manufacturers could be sued by generic drug users...West Virginia’s Supreme Court...rejected liability claims against brand-name manufacturers for alleged failures to warn over a generic company’s drug.
- CVS Health removes 17 drugs from formulary, adds outcomes-based program (biopharmadive.com)
CVS Health...put out its standard control formulary for 2018, days after competitor Express Scripts announced its own drug coverage list for next year...Last year, CVS made biosimilars preferable over their reference product on its formulary, while this year the PBM expects to expand value-based deals to add further benefit for its customers...last year...it opted to include the highly touted, but still very new class of biosimilar products over longer-used reference products...This year, CVS Health looks set to change the game once again with an outcomes-based management program that will specifically target drugs for breast cancer, non-small cell lung cancer, obesity and chronic obstructive pulmonary disease...In each of these cases, manufacturers will have to cover costs over a pre-specified threshold if patients don't reach certain outcomes...Outcomes-based strategies have long been talked about as a means to control drug pricing. But there have only been a handful of such agreements put into practice and usually with specific drugmakers for specific products...CVS Health will remove 17 drugs from the 2018 formulary list across 10 drug classes...
- How a Major Drugmaker Plans to Cure Disease… Without Drugs (fool.com)
Hacking into the body's nervous system may allow GlaxoSmithKline to commercialize an entirely new field of medicine...GlaxoSmithKline plc has the resources to pursue long-term bets in medicine that could eventually change the course of disease treatment and yield large payoffs...to literally eavesdrop on the body's electrical system and enter into the body's own internal conversations in order to heal disease...every organ has a nerve connection that regulates its function. Organs are controlled by patterns of electrical impulses transmitted through nerve fibers, but when organs dysfunction in chronic disease, the electrical patterns are different. That fact opens up the possibility that inserting patterns in nerves to certain organs can correct conditions that lead to disease...scientists are just beginning to realize the possibilities of using nerve signals to restore organs to normal function and actually treat disease...Bioelectronic medicines have the potential of doing to the pharmaceutical industry what biopharmaceuticals did to small molecules back in the 1980s…
- GSK pledges renewed environmental commitment with aggressive climate change and nature targets (fiercepharma.com)
GlaxoSmithKline is committing to a new environmental plan with two ambitions: eliminate its impact on climate change and neutralize its impact on nature by 2030...In environmental parlance, the goal is a net zero impact on climate change and a net positive impact on nature by the end of the decade...The twofold approach means GSK will reduce its environmental footprint as much as possible—and where it can’t reduce, implement restoration programs—while also contributing more to nature than it takes out...READ MORE
- Cashing in on DNA: race on to unlock value in genetic data (reuters.com)
How much is your DNA worth? As millions of people pay for home tests to check on ancestry or health risks, genetic data is becoming an increasingly valuable resource for drugmakers, triggering a race to create a DNA marketplace...GlaxoSmithKline’s decision to invest $300 million in 23andMe and forge an exclusive drug development deal...crystallizes the value locked up in genetic code...Firms like EncrypGen, Nebula Genomics, LunaDNA and Zenome are using blockchain...to secure sensitive DNA records and create a transaction ledger. The new players all have slightly different models, with most simply provide data platforms, where people are rewarded for providing data...For drugmakers...access to this data offers a way to accelerate drug development, since finding a drug target linked to a human genetic variant doubles the chance of producing a new medicine.
- Big Pharma faces $26.5B in losses this year as next big patent cliff looms, analyst says (fiercepharma.com)
With 18 branded drugs on the line, patent losses this year could jeopardize $26.5 billion in annual sales from Big Pharma, projected to be the biggest fall-off until at least 2025…Which companies are at risk? Roche, GlaxoSmithKline, Eli Lilly, Pfizer and AstraZeneca to name a few...This year's potential patent expiry damage is much more daunting than 2015 and 2016, when only four and nine meds from companies...lost exclusivity, respectively...Anticipated expirations for 2017 include Roche’s Rituxan, GSK’s Advair, Eli Lilly’s Humalog and Cialis, AstraZeneca’s Byetta, Pfizer’s Viagra and Merck’s Vytorin...the 2017 patent losses and associated sales declines will "continue to pressure growth" in the industry...about 45% of the sales at risk looking forward are for biologics, which will face biosimilar competition rather than generics..."erosion rates will be slower," but still "unpredictable.
- GSK resumes some doctor payments, backtracking on blanket ban
GlaxoSmithKline, which five years ago stopped paying doctors for promoting its drugs, said...it would allow such payments once again in limited circumstances...The British group’s 2013 no-payment pledge marked a first for an industry battling past scandals over sales practices. But other drugmakers failed to follow suit, leaving it at a competitive disadvantage...Drugmakers have long used so-called key opinion leaders to promote the benefits of their products to other prescribing physicians and the decision to abandon this strategy was questioned by a number of analysts...GSK’s new updated policy...will now permit payments to global experts who speak about the science behind novel new medicines...“These changes are being made for a select number of innovative products in a limited number of countries and apply to restricted time periods in a product’s lifecycle,” the drugmaker said.
- EU drug regulators step up work to prepare for ‘no deal’ Brexit (reuters.com)
Drug regulators across Europe are hiring extra staff and increasing their workload as the role of British experts in the EU-wide system of medicines supervision winds down ahead of Brexit...Britain has already stopped taking on new projects that will extend beyond March 29, 2019 and is preparing to hand over existing drug review work to other countries...Despite a vote by UK members of parliament this week calling for Britain’s continued participation in the Europe regulatory network for medicines, there is no certainty that any such deal will be reached...That reflects the wider lack of clarity over Britain’s future relationship with the world’s biggest trading bloc after it leaves the EU next March...The Brexit-induced disruption also comes at a time when regulators are having to grapple with oversight of a range of new health technologies, such as gene therapy, and a slew of big data on health outcomes...Global drug companies, including UK-based GlaxoSmithKline and AstraZeneca, have been vocal in calling for continued close EU-UK ties after Brexit. The issue is also important to many Japanese drugmakers that have made Britain their European base.
- GSK must pay $3 million in generic Paxil suicide lawsuit: U.S. jury (finance.yahoo.com)
GlaxoSmithKline must pay $3 million to a woman who sued the drug company over the death of her husband, a lawyer who committed suicide after taking a generic version of the antidepressant Paxil…The jury's award followed a trial in federal court...over the death of Stewart Dolin...who jumped in front of an oncoming commuter train in 2010 after taking a generic equivalent of GSK's Paxil...GSK maintains that because it did not manufacture or market the medicine ingested by Mr. Dolin, it should not be liable," GSK said. "Additionally, the Paxil label provided complete and adequate warnings during the time period relevant to this lawsuit...Dolin's lawyers had requested $39 million. They alleged GSK had evidence paroxetine increases the risk of suicide by older users by as much as 670 percent, yet failed to include that on the warning label...