AZ News From The Street 2016

Discussion in 'AstraZeneca' started by anonymous, Jan 4, 2016 at 10:06 AM.

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  1. anonymous

    anonymous Guest

    Well that's a relief for Medi I'm sure!! But what about the other sites?
     

  2. anonymous

    anonymous Guest

    For sale:


    AstraZeneca looks at selling U.S. campus to raise cash
    by Eric Palmer |
    Aug 26, 2016 11:03am

    AstraZeneca ($AZN) has raised billions of dollars in short-term cash by pawning off the rights to a growing list of its drugs that it says are not important for its long-term future. Pfizer ($PFE) just this week agreed to pay $1.5 billion for AstraZeneca’s antibiotics portfolio. But the U.K. drugmaker is trying a new twist on its asset sales practice, putting its U.S. headquarters in Delaware up for sale with plans to lease it back to pick up some money.

    The campus in Fairfax, DE, went on the market this week, Delawareonline reported. An AstraZeneca spokesperson told the news service that the drugmaker is looking at a number of options, including redeveloping the site.

    In an emailed statement today, AstraZeneca spokeswoman Abigail Bozarth said: "In May, we said we would be evaluating whether it made most sense to keep our North America Commercial Headquarters at the current location in Wilmington, or to move to a new location nearby."

    "This is a continuation of the evaluations currently underway and we remain committed to keeping our North America commercial headquarters in Delaware. While no decisions have been made at this point, we continue to assess all options, one of which is the redevelopment of our current site. In order to fully explore this possibility, AstraZeneca will be soliciting bids from real estate developers in the coming months, and that requires us putting the site on the market for sale," Bozarth said.

    The move comes as AstraZeneca is in the midst of a variety of cost-cutting moves and as CEO Pascal Soriot works feverishly to build up the drugmaker’s top and bottom lines. The company in April announced it intended to make $1.1 billion in cost cuts and followed that up in May by whacking the jobs of about 1,600 U.S. contract sales reps.

    While it is unclear how much the real estate deal might bring, property experts told the publication that a sale for redeveloping the campus might actually yield a substantial return, given its location and how much underutilized space there is. AstraZeneca has actually taken several buildings down on the site, following an earlier round of cost-cutting and layoffs.
     
  3. anonymous

    anonymous Guest

    last one out turn off the lights
     
  4. #164 anonymous, Aug 31, 2016 at 11:56 AM
    Last edited by a moderator: Aug 31, 2016 at 12:02 PM
    anonymous

    anonymous Guest

    AstraZeneca to pay $5.5M to settle bribery allegations
    Aug 31, 2016, 10:18am EDT
    //bizjournals.com&l=http%3A//www.bizjournals.com/philadelphia/bio/6321/John+George']John George [/URL] Senior Reporter Philadelphia Business Journal

    //bizjournals.com&l=http%3A//www.bizjournals.com/company/astrazeneca-plc/21347']AstraZeneca[/URL] has agreed to pay $5.52 million to resolve allegations the pharmaceutical company’s sales and marketing made improper payments to staff to state-employed health care officials in China and Russia.

    Under the terms of settlement, which resolves a U.S. Justice Department investigation into the matter, AstraZeneca did not admit or deny any wrongdoing.

    When asked about the settlement, AstraZeneca issued the following statement:

    "We are pleased to have a resolution of these matters. The SEC has acknowledged our cooperation during the entire course of the inquiry, and the DOJ has closed its investigation. The described conduct occurred between 2005 and 2010, and as noted in the [Security and Exchange Commission]'s order, we began enhancing our compliance program prior to the start of the investigation. Strong ethics and acting with integrity are central to AstraZeneca’s code of conduct, which is reinforced through ongoing training and monitoring."

    The company said the decision to pay $5.52 million to settle the issue was consistent with its longstanding disclosure that “resolution of these matters could involve the payment of fines and/or other remedies.”

    The settlement was disclosed in a public filing by the SEC, which charged the drug company with violating the books and records and internal controls provisions of the Foreign Corrupt Practices Act.

    The filing noted an SEC investigation found that employees of AstraZeneca’s subsidiary in China allegedly made improper payments in the form of cash, gifts and other items to foreign official health care providers as incentives to purchase or prescribe AstraZeneca pharmaceuticals, and also made payments in cash to the local officials to get reductions or dismissals of proposed financial sanctions against the subsidiary. The investigation also found that employees of AstraZeneca’s subsidiary in Russia also allegedly made improper payments in connection with pharmaceutical sales.
     
  5. anonymous

    anonymous Guest

    Y'all are fucking crooks
     
  6. anonymous

    anonymous Guest

    Did DF happen to work there?
     
  7. anonymous

    anonymous Guest

    Scum
     
  8. anonymous

    anonymous Guest

    Asthma, COPD etc. approach

    AstraZeneca, Glaxo Explore Prevention Potential of Asthma Shots
    Ketaki Gokhale KetakiGokhale
    September 2, 2016 — 2:45 AM EDT

    If AstraZeneca Plc and GlaxoSmithKline Plc have their way, doctors and patients may someday talk about eosinophils the way they talk about cholesterol.

    Eosinophils, a type of white blood cell, are often found in higher-than-normal numbers in asthma patients’ blood and lungs. In healthy people, they release toxins intended to kill invading germs -- but in some, they also cause the inflammation associated with asthma.

    AstraZeneca and Glaxo are studying therapies that reduce eosinophil levels to see whether they can change the trajectory of respiratory disease, similar to cholesterol-cutting statins prescribed to prevent heart attacks. The potential market is huge: While severe asthma affects about 35 million people globally, about 600 million people suffer from asthma and the lung conditions known collectively as chronic obstructive pulmonary disease, or COPD, according to AstraZeneca.

    “The dream for the long-term is that you intervene in asthma earlier with a medicine that could fundamentally change the disease course, or even prevent someone at risk from developing disease at all,” said Tom Keith-Roach, global vice president of respiratory at AstraZeneca.

    Stalling Sales
    Widening use of their existing medicines and developing new ones for severe asthma is key for the British drugmakers amid patent expirations on their blockbuster inhalers. Glaxo’s Advair has generic competitors in Europe, with a possible copycat version in the U.S. next year. At 3.68 billion pounds ($4.83 billion), it was the company’s top seller last year.

    Revenue from AstraZeneca’s Symbicort lung treatment has been under pressure since 2014, when its patent was revoked in the U.K. and a copy of the inhaler from Teva Pharmaceutical Industries Ltd. won backing from European regulators. Symbicort brought in $3.4 billion last year, making it the company’s best-selling medicine after cholesterol-lowering pill Crestor.

    AstraZeneca will present data from two late-stage tests of its injectable drug benralizumab at the European Respiratory Society meeting starting Saturday. The drug curbs severe asthma by depleting eosinophils. AstraZeneca aims to file for regulatory approval for benralizumab for severe asthma patients in the U.S. and Europe this year, and present data that looks at the medicine as a treatment for COPD in 2018.

    Benralizumab would compete with Glaxo’s Nucala, which also reduces eosinophils and is approved in the U.S., Europe and Japan. Glaxo is studying whether eosinophils can be used as a trait to identify people who would benefit from earlier treatment, much like high cholesterol is used to identify candidates for statin therapy to avert heart disease, said Neil Barnes, medical head at the global respiratory franchise.
    “At the moment the evidence about the beneficial effects of lowering cholesterol is really strong,’’ Barnes said. In patients with COPD, which includes emphysema and chronic bronchitis, evidence is growing that if people with high eosinophil counts are given inhaled steroids, they have fewer attacks, he said.

    Glaxo-funded research has also identified a potential pitfall of lowering eosinophil levels too much: a slightly higher risk of pneumonia. Further studies are needed, the researchers wrote in the Lancet Respiratory Medicine journal in July.

    Smoker’s Cough
    Glaxo is conducting a three-year study of how well three of its inhalers reduce lung exacerbations in 10,000 people with COPD, also known as smoker’s cough. That study, which will conclude next year, is also looking at whether treating patients with high eosinophil counts also reduces the number of annual lung exacerbations.

    Most people who have COPD are at least 40 when symptoms begin and have had long-term exposure to cigarette smoke or other lung irritants like air pollution. Unlike asthma patients, people with COPD get progressively worse and account for more hospital admissions, according to Glaxo’s Barnes.

    COPD flare-ups and asthma attacks are expensive for health-care systems. In the European Union, the annual costs from treatment, hospitalizations and lost productivity due to lung diseases are around 82 billion euros ($92 billion), according to the European Respiratory Society.

    Taming Costs
    New treatments that curb flare-ups in severe, uncontrolled asthma and COPD patients may be key to taming the costs of emergency hospitalization. The prices of such drugs, however, restrict their use for the time being. The cost of Glaxo’s Nucala is $2,575 per monthly injection, according to data compiled by Bloomberg.

    AstraZeneca is studying benralizumab dosing once every four weeks and also once every eight weeks. The Cambridge, England-based drugmaker is studying two more injectable respiratory medicines in humans, targeting different biomarkers, including the proteins periostin and DPP4, both linked to asthma.

    “The more we understand what’s driving the inflammation of an individual patient, the better we can then engineer specific medicines to suppress that disease activity," said AstraZeneca’s Keith-Roach. “It’s a completely different philosophy from saying everyone with asthma should get an inhaled steroid.”
     
  9. anonymous

    anonymous Guest

    douche bag - you forgot that diagnosing neutrophil infiltration of the lung has NO ESTABLISHED STANDARD... oops you mean "doc I can't breathe... where's my inhaler" will be replaced with...

    hold on there.. let me take a lung biopsy... hmmm I can see on the slide your neutrophil infiltration ratio is larger... let's inject a super expensive antibody that has a super slow onset of action.. can you hold your breath for a few weeks while this puppy kicks into action...

    gee you are turning blue ? that's strange...

    when you drink the coolaide compare the sales of Crestor to the sales of Repatha... oh yeah those bullshit overpriced antibodies do not sell...

    sad to say but these are products that if they do experience success... sales top out at $1B globally... hugely smaller than the small molecules they replace...

    oops better shrink the company size....
     
  10. anonymous

    anonymous Guest

    Astrazeneca (AZN) Presents Benralizumab Phase III Data
    Zacks Equity Research
    September 6, 2016

    AstraZeneca plc AZN recently announced further results from two pivotal phase III trials on its respiratory disease candidate, benralizumab, for the treatment of severe asthma.

    The positive results from the SIROCCO and CALIMA trials were presented at the European Respiratory Society (ERS) International Congress. Top-line results from the trial were reported earlier in May.

    The SIROCCO and CALIMA trials are randomized, double-blind, parallel-group, placebo-controlled studies, evaluating the safety and efficacy of benralizumab as an add-on therapy in the treatment of severe uncontrolled asthma with eosinophilic inflammation in patients aged 12 years and older. The study met its primary endpoint. Data demonstrated that adding benralizumab to standard-of-care medicine led to significant reduction in the annual asthma exacerbation rate compared to placebo.

    The trials also demonstrated that treatment with benralizumab can lead to improved lung function and asthma symptoms such as wheeze, cough, chest tightness and shortness of breath.

    The studies evaluated the effect of two dosing regimens of benralizumab 30mg administered in 4-week and 8-week regimens. All these benefits were observed in the 8-week dosing regimen while no additional benefits were seen in the 4-week regimen, suggesting that fewer doses of the drug can be effective.

    AstraZeneca expects to file for regulatory approval in both the U.S. and the EU this year. Benralizumab is also being evaluated in the phase III VOYAGER program for the treatment of patients with severe COPD (both data and regulatory filings in the U.S. and the EU are expected in 2018).

    AstraZeneca expects the candidate to generate peak sales of $2 billion. We remind investors that AstraZeneca has in-licensed the drug from Kyowa Hakko Kirin in all countries except Japan and some other Asian countries.

    In Jul 2015, AstraZeneca inked an agreement with Kyowa Hakko Kirin for an exclusive option to commercialize the candidate in Japan, in both asthma and COPD indications.

    As per the company’s press release, about 315 million individuals in the world suffer from asthma, which will likely increase to 400 million by 2020.
     
  11. anonymous

    anonymous Guest

    PARPi competition:

    Tesaro may have the Right PARP. On June 29, 2016, Tesaro announced positive Phase III data for niraparib, its PARPi to treat ovarian cancer. We believe niraparib has a better efficacy profile than AstraZeneca’s Lynparza and Clovis’ rucaparib, as it demostrated high progression-free survival (PFS) of 22 months in BRCAmut and thirteen months in non-BRCAmut pateints, compared to PFS of eight or nine months in BRCAmut pateints from Lynparza and rucaparib’s Phase III.
     
  12. anonymous

    anonymous Guest

    Can easier dosing propel AstraZeneca's severe asthma med past Glaxo's Nucala?
    by Carly Helfand |
    Sep 14, 2016 12:09am

    AstraZeneca may not be first with its severe asthma med. But it’s hoping it can still be best, and new study data have some analysts believing that’s possible.

    In results unveiled last week at the European Respiratory Society International Congress, AZ’s candidate, benralizumab--when added to the standard of care--cut down on disease exacerbations by up to 51% and improved lung function and asthma symptoms in severe eosinophilic asthma patients.

    What’s more, a four-week dosing regimen showed no additional benefit over an 8-week dosing regimen--a factor that “may support less-frequent dosing,” the British drugmaker said in a statement.

    If that’s the case, the data could set benralizumab apart from its on-market rivals, GlaxoSmithKline’s Nucala and Teva’s Cinqair, both of which are dosed every four weeks. AZ’s prospect is “late to the game, but potentially best in class in class in terms of dose,” Shore Capital analyst Tara Raveendran said, as quoted by Français Express.

    Bernstein’s Ronny Gal, though--who called the results “decent”--noted to clients this week that the exacerbations data is “similar” to what benralizumab’s rivals have already posted. That echoes his assessment in late 2014 that “the efficacy and safety differences between the various drugs are rather small, and thus we expect the primary adoption factors would be order of market entry and formulation.”

    When it comes to order of market entry, the point goes to Glaxo, which won FDA approval for Nucala late last year. On the company’s Q2 conference call, CEO Andrew Witty told investors that GSK was “ahead of our expectations in the U.S. and Europe” with the drug, with 3,100 patients already taking it.

    And Gal has predicted GSK has the edge in the formulation department, too: Nucala is administered subcutaneously, compared with Cinqair, which is an intravenous formulation. And while AZ’s contender will also be a subcutaneous med, the company's development “program was rushed forward and is thus a bit riskier,” Gal wrote in 2014.

    Of course, by the time benralizumab hits the scene, AZ won’t have to go through the same market-building exercise that’s currently occupying Glaxo’s time. It’s “very complex to get patients on these kinds of drugs,” Witty said on the call, noting that “it takes a few months to set up a process, and on average it takes us about 6 weeks to get the patient from a point where a physician says ‘I want to prescribe’ to actually being able to administer the drug."

    The reason? “It takes so long to go through all the various reimbursement insurance triggers,” he said.

    Glaxo, though, believes all the hard work will pay off--and it isn’t scared of AZ jeopardizing Nucala’s future, either.

    As Witty explained, the potential for triple combinations that include Nucala reminds him of the scenario 20 years ago, when Glaxo launched the components that later made up blockbuster Advair. “It was only when we brought Advair out that it really drove the dominance of GSK in that space.” It would take nemesis AZ “another 5 or 6 years to try and catch up," and they have never really been able to in terms of share.

    “I think this may be somewhat similar,” he noted, suggesting that there’s potential for the triple combo “to be the absolute clincher of the whole respiratory strategy for GSK.”
     
  13. anonymous

    anonymous Guest

    and one to rule them all?

    Roche to beat Novartis, Pfizer to pharma throne by 2022 as industry passes $1T mark
    by Eric Sagonowsky |
    Sep 15, 2016 8:51am

    Roche, headquartered in Basel, Switzerland, is expected to surge to the No. 1 spot in total prescription drug sales by 2022, according to a new report.

    Crosstown rivals Novartis ($NVS) and Roche ($RHHBY) will be neck and neck for the No. 1 spot in pharma sales till 2022, with Roche ahead by a nose at the finish line, according to a new market analysis. Along the way, a 6.3% annual growth rate industrywide will take global prescription drug sales past the $1 trillion mark.

    Roche is forecast to tally $52.6 billion in 2022 prescription drug sales, representing a 4% annual expansion over 2015’s total of $38.7 billion, according to EvaluatePharma’s new World Preview report. Novartis, with 2015 prescription sales of $42.5 billion, will end up with $52.5 billion at the end of the period, missing Roche’s tally by about $100 million. Pfizer ($PFE), Sanofi ($SNY), Johnson & Johnson ($JNJ), Merck ($MRK) and GlaxoSmithKline ($GSK) each follow in order, with other big-name players behind them.

    But as with all forecasts, this one isn't written in stone. Facing a more serious biosimilar threat than Novartis, Roche could find itself knocked out of the pole position, EP said. Many of the bestselling drugs in the industry, including Roche’s Rituxan and Avastin, are forecast to suffer from biosim competition by 2020.

    Overall, the world’s prescription drug industry is expected to ride 6.3% growth through 2022 to $1.12 trillion, up from $741 billion in 2015. That’s as new launches “hopefully take the torch from industry’s superstars, like Harvoni, whose light is now fading,” the report said.

    Roche's immuno-oncology therapy Tecentriq is expected to be one of those, by 2022 becoming one of the world's best-selling drugs, EP said. Gilead ($GILD), Biogen ($BIIB) and GlaxoSmithKline are the companies that have performed best on recent launches, the analysts said.

    Notably, Celgene ($CELG) and Shire ($SHPG) are expected to post double-digit growth over the period, according to the analysts, expanding sales by an annual clip of 16% and 19%, respectively.

    Pfizer led 2015 pharma sales at $43.1 billion, a tally that's now expected to grow to $49.1 billion by 2022, according to EP. Novartis was expected to be the top player by 2020, as of last year's report.

    EvaluatePharma sees Roche’s pipeline as the most valuable in the industry, although the Basel-based pharma’s strategy comes with risk. The company’s candidates in multiple sclerosis, Alzheimer’s, haemophilia and macular degeneration help its overall pipeline reach a value of $43.2 billion, far eclipsing Novartis’ pipeline value of $24.1 billion and AstraZeneca’s at $23.2 billion.

    Companies behind those in pipeline value are Eli Lilly ($LLY), AbbVie ($ABBV), Pfizer, Sanofi, Celgene, Biogen and J&J, respectively.

    In the big picture, following a “spectacular four-year bull run,” the industry’s outlooks are more mixed moving forward, EP said, as pricing pressures take a toll in the U.S. and other “brakes” to growth loom. Among those are biosimilar threats and clinical setbacks. Spending pressures could also hamper sales growth, as healthcare systems struggle with their growing drug bills.
     
  14. anonymous

    anonymous Guest

    AstraZeneca Diabetes Drug Combination Shows Promise in Study
    Ketaki Gokhale KetakiGokhale
    September 16, 2016 — 5:48 AM EDT Updated on September 16, 2016 — 10:14 AM EDT

    • Bydureon and Forxiga reduced weight, blood pressure in trial
    • Combination may be additional option before insulin treatment
    AstraZeneca Plc said a combination of two diabetes medications significantly lowered blood sugar, weight and blood pressure in a study that will support its use to delay insulin treatment.

    The approved drugs Bydureon and Forxiga together reduced a measure of blood sugar more than either drug alone, the main goal of the trial of almost 700 patients. The U.K.’s second-biggest drugmaker presented the data Friday at the European Association for the Study of Diabetes meeting in Munich.

    Doctors often prescribe insulin for patients whose blood sugar remains high after taking metformin, the generic medicine that’s the first line of treatment. Drugmakers are exploring whether insulin injections can be delayed by therapies such as Bydureon and Forxiga, as well as competing products from Novo Nordisk A/S, Eli Lilly & Co. and Sanofi. Injected insulin can cause low blood-sugar levels and weight gain, which are especially dangerous in people with diabetes.

    “Insulin has a cost which comes attached to it,” Fouzia Laghrissi-Thode, vice president of cardiovascular and metabolic diseases at Cambridge, England-based Astra, said in an interview. Delaying its use “may be a big advantage.”

    Cheap Insulin
    Lower-cost copies of injectable insulin are becoming available, after the U.S. Food and Drug Administration approved Eli Lilly’s biosimilar version of Sanofi’s Lantus. Copies will be available at a 30 percent discount to branded insulin, said Laghrissi-Thode. As a result, the cost of the treatments from Astra and others will have to be considered in the context of how much they benefit patients, she said.

    Astra’s clinical trial found that Bydureon and Forxiga met secondary goals of reducing body weight and blood pressure more than either medicine alone. The combination had similar rates of adverse events to the medicines administered individually, and the most common ones were diarrhea, injection-site nodules, nausea and urinary tract infections.

    Flushing Sugar
    Bydureon belongs to a class of medicines known as GLP-1s, which stimulate insulin production in the body, while Forxiga is a pill that helps flush out excess sugar through the urine. Astra’s clinical trial was the first to combine the two types of anti-diabetes medicines. Its competitors Sanofi, Novo and Eli Lilly are betting on their own different combinations of anti-diabetes medications and insulin.

    Combination treatment is the likely future of type 2 diabetes therapy, said Serge Jabbour, director of the Diabetes Center at the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia. Some physicians were already prescribing Bydureon with Forxiga before the release of Astra’s data, because the medications address different types of malfunctions in the bodies of patients with Type 2 diabetes, he said.
    “Now we know that when people have type 2 diabetes they have at least eight defects, not just two -- what we thought initially,” said Jabbour, who was paid by AstraZeneca to lead the study. “We believe that there are probably more defects that we have not discovered yet. That’s why one drug will not really do it.”
     
  15. anonymous

    anonymous Guest

    AstraZeneca Diabetes Drug Combination Shows Promise in Study
    Ketaki Gokhale KetakiGokhale
    September 16, 2016 — 5:48 AM EDT Updated on September 16, 2016 — 10:14 AM EDT

    • Bydureon and Forxiga reduced weight, blood pressure in trial
    • Combination may be additional option before insulin treatment
    AstraZeneca Plc said a combination of two diabetes medications significantly lowered blood sugar, weight and blood pressure in a study that will support its use to delay insulin treatment.

    The approved drugs Bydureon and Forxiga together reduced a measure of blood sugar more than either drug alone, the main goal of the trial of almost 700 patients. The U.K.’s second-biggest drugmaker presented the data Friday at the European Association for the Study of Diabetes meeting in Munich.

    Doctors often prescribe insulin for patients whose blood sugar remains high after taking metformin, the generic medicine that’s the first line of treatment. Drugmakers are exploring whether insulin injections can be delayed by therapies such as Bydureon and Forxiga, as well as competing products from Novo Nordisk A/S, Eli Lilly & Co. and Sanofi. Injected insulin can cause low blood-sugar levels and weight gain, which are especially dangerous in people with diabetes.

    “Insulin has a cost which comes attached to it,” Fouzia Laghrissi-Thode, vice president of cardiovascular and metabolic diseases at Cambridge, England-based Astra, said in an interview. Delaying its use “may be a big advantage.”

    Cheap Insulin
    Lower-cost copies of injectable insulin are becoming available, after the U.S. Food and Drug Administration approved Eli Lilly’s biosimilar version of Sanofi’s Lantus. Copies will be available at a 30 percent discount to branded insulin, said Laghrissi-Thode. As a result, the cost of the treatments from Astra and others will have to be considered in the context of how much they benefit patients, she said.

    Astra’s clinical trial found that Bydureon and Forxiga met secondary goals of reducing body weight and blood pressure more than either medicine alone. The combination had similar rates of adverse events to the medicines administered individually, and the most common ones were diarrhea, injection-site nodules, nausea and urinary tract infections.

    Flushing Sugar
    Bydureon belongs to a class of medicines known as GLP-1s, which stimulate insulin production in the body, while Forxiga is a pill that helps flush out excess sugar through the urine. Astra’s clinical trial was the first to combine the two types of anti-diabetes medicines. Its competitors Sanofi, Novo and Eli Lilly are betting on their own different combinations of anti-diabetes medications and insulin.

    Combination treatment is the likely future of type 2 diabetes therapy, said Serge Jabbour, director of the Diabetes Center at the Sidney Kimmel Medical College at Thomas Jefferson University in Philadelphia. Some physicians were already prescribing Bydureon with Forxiga before the release of Astra’s data, because the medications address different types of malfunctions in the bodies of patients with Type 2 diabetes, he said.
    “Now we know that when people have type 2 diabetes they have at least eight defects, not just two -- what we thought initially,” said Jabbour, who was paid by AstraZeneca to lead the study. “We believe that there are probably more defects that we have not discovered yet. That’s why one drug will not really do it.”
     
  16. anonymous

    anonymous Guest



    Even if we are first to market, Trulicity Jardiance combo will still kick our ass.
     
  17. anonymous

    anonymous Guest

    AstraZeneca Withdraws EU Application for Ovarian-Cancer Therapy
    Kristen Hallam
    September 21, 2016 — 6:36 AM EDT

    AstraZeneca Plc said it is withdrawing an application for European approval for an ovarian-cancer medicine following disagreement with regulatory authorities.

    The decision won’t affect the ongoing development of the treatment, called cediranib, the Cambridge, England-based company said today in an e-mailed statement. The drugmaker had sought approval from the European Medicines Agency in June 2015 to sell the drug for use with platinum-based chemotherapy in adults with a type of ovarian cancer that’s relapsed.

    “Following lengthy engagement with the EMA, it was clear that there would remain a difference of opinion on the overall benefit-risk of cediranib and on some of the study methods,” a company spokeswoman said. “So, on balance, we decided to withdraw the application for combination with chemotherapy to focus our attention on combination studies of cediranib with other medicines.”

    Cediranib is being tested in late-stage trials in combination with AstraZeneca’s approved ovarian-cancer treatment Lynparza and the experimental durvalumab cancer therapy, she said.

    AstraZeneca hasn’t submitted cediranib for approval for use with chemotherapy in any other markets, and the drug was only expected to bring in about $145 million in sales by 2022, according to data compiled by Bloomberg.
     
  18. anonymous

    anonymous Guest

    Money well spent???

    Big Pharma takes big lease in South S.F. to consolidate California operations

    Sep 27, 2016, 12:25pm PDT Updated Sep 27, 2016, 12:53pm PDT

    Drug developer AstraZeneca PLC will bring more than 350 California employees together in the massive Cove at Oyster Point development in South San Francisco, the company said Tuesday.

    The move to 163,000 square feet currently under construction could go a long way toward relieving a biotech space logjam. It comes as Big Pharma players, including Merck & Co. Inc., scout local sites in an effort to cozy up to hot, young Bay Area drug developers.

    [​IMG]


    The Cove, now in the second phase of construction by HCP Inc. at Highway 101 and Oyster Point Boulevard, already has landed high-profile biotech startups, such as neurodegenerative drug developer Denali Therapeutics Inc. and cancer drug maker CytomX Therapeutics Inc. But AstraZeneca (NYSE: AZN) could dwarf those companies with its expected fourth-quarter 2017 move-in.

    The move represents a homecoming of sorts, since AstraZeneca CEO Pascal Soriot led Genentech Inc. for about a year after the South San Francisco-based biotech powerhouse's 2009 acquisition by Roche.

    The practical part of the move is in bringing together AstraZeneca's homegrown and acquired operations in the Bay Area. It has sites in Mountain View and its MedImmune vaccines unit currently works out of space in Hayward. Meanwhile, Acerta Pharma, a cancer drug developer in which AstraZeneca took a majority stake in December 2015, is based in Redwood City, and its Pearl Therapeutics concentrates on respiratory diseases, such as chronic obstructive pulmonary disease and asthma, in Redwood City.

    ZS Pharma of San Mateo, which AstraZeneca bought last December, is not part of the consolidation, but AstraZeneca said it will "revisit the decision" next year.

    What's more, the move puts AstraZeneca, based in Cambridge in the United Kingdom, in the heart of the Bay Area's biotech industry. The location is just west along Oyster Point Boulevard from partner NGM Biopharmaceuticals' new site, for example, and would give the Big Pharma developer of drugs such as FluMist and acid reflux treatment Nexium access to more up-and-coming companies that could expand AstraZeneca's portfolio.

    Combining all those employees at one site — AstraZeneca did not say whether it would lay off in the process — would put the existing space on the market at a time when early-stage companies, Merck (NYSE: MRK) and others are competing with the tech industry to lock up real estate along the Peninsula.

    "Our new South San Francisco location — where biotech and Silicon Valley intersect — brings all of our California employees to one site and provides opportunities to access exciting science both inside and outside our walls," Sean Bohen, executive vice president of global medicines development and chief medical officer at AstraZeneca, said in a prepared statement.
     
  19. anonymous

    anonymous Guest

    better prospects?

    Zuckerberg initiative poaches AstraZeneca board member
    [Reuters]
    September 28, 2016

    LONDON (Reuters) - The $3 billion health initiative set up by Facebook co-founder Mark Zuckerberg and his wife Priscilla Chan has hired one of AstraZeneca's non-executive directors to head up its science drive.

    The British drugmaker said on Wednesday that Cornelia Bargmann would step down from its board next month to take up a new role as president of Chan Zuckerberg Science, part of the Chan Zuckerberg Initiative.

    Leif Johansson, AstraZeneca's chairman, said the board was sorry to see her leave but understood Bargmann's decision to focus on the new assignment.

    Zuckerberg and Chan unveiled their new initiative last week, with a goal to "cure, prevent or manage all disease within our children's lifetime".

    Their plan echoes the big global health ambitions of the Bill & Melinda Gates Foundation, another philanthropic endeavor funded by tech industry money that has similarly tapped the pharmaceuticals sector in the past for key staff.

    On the plus side, AstraZeneca also said it had hired Columbia University genetics expert David Goldstein to the consultative role chief adviser for genomics. Goldstein, who will continue his academic jobs, had previously served as chair of AstraZeneca's genomics advisory panel.

    The company unveiled a 10-year plan in April for a massive gene hunt in the biggest bet yet by a drugmaker on the potential of genetic variations to unlock routes to new medicines.
     
  20. anonymous

    anonymous Guest

    Some diabetes market news from a competitor:

    Question, how do you focus on new, truly innovative products by cutting your R&D?
    Will they just buy other companies that actually have, or had, innovative R&D to get their new "truly innovative" products like AZ tries to do now? Seems that way!

    U.S. payer pressures force Novo Nordisk to cut loose 1,000 staffers
    by Tracy Staton |
    Sep 29, 2016 7:39am

    Novo Nordisk, pressured by U.S. payers and stepped-up competition in its signature diabetes market, will lay off 1,000 people worldwide to cut costs and sharpen its focus on “truly innovative” new products.

    The cuts will come in R&D, as the Danish drugmaker steers away from the “me-too” products payers are increasingly reluctant to cover. They’ll hit the headquarters in Bagsvaerd, near Copenhagen. And they’ll affect the company’s commercial operations worldwide.

    It’s a major retrenchment for Novo, which has generally been free of mass job cuts other global drugmakers have made over the past decade, but it comes at a time of unprecedented pricing pressure in the U.S., its largest market. Payers have been playing hardball in diabetes, demanding hefty discounts in exchange for exclusive formulary spots, and Novo has lost some of those fights. Express Scripts, for instance, has excluded several of its drugs for the past two years, and this year barred Tresiba, a new basal insulin Novo had pegged as a key growth driver.

    The formulary exclusions and mandatory discounts have pulled in the reins on Novo’s industry-beating growth, and last quarter, the company surprised analysts by cutting its sales and earnings guidance for the year to the lower end of its range. The layoffs, which amount to about 2% of its worldwide workforce of about 42,000, won’t affect that guidance, the company said in a statement.

    Payer pressure is having more far-reaching effects than simple cost-cutting, too. Recognizing that slight improvements--such as dosing convenience--aren’t enough to win coverage for new products, Novo will be scrapping pipeline drugs accordingly.

    “The next line of products have to have an even greater height of innovation, which means those that do not have that height of innovation will have to be culled,’’ CEO Lars Rebien Sørensen told Bloomberg TV Thursday. “Otherwise, it’s going to be difficult for us to get reimbursement for our drugs. Me-too or me-better drugs will not be good enough in the future and hence we need to prioritize.”

    In another sign of changing times at Novo, Sørensen, the company's longtime CEO, said earlier this month that he would step down before his contract ends, ceding his place to incoming chief Lars Fruergaard Jorgensen, who's currently the company's EVP and head of corporate development.