国际动态存档 （2015年7月2期）

 Pfizer announced Tuesday that sales in the second quarter fell 7 percent versus the year-ago period to $11.9 billion, hit by the strong US currency, although the figure topped analyst estimates of $11.4 billion. The drugmaker noted that excluding currency effects, revenue rose by 1 percent in the quarter. Net income in the quarter slipped 10 percent to $2.6 billion. ...read more...

July 27 (Reuters) - Eli Lilly and Co on Monday said it would continue a large study of its high-profile experimental drug to raise "good" HDL cholesterol and lower "bad" LDL cholesterol, acting on the recommendation of a data monitoring committee. The independent panel of scientific advisors made its recommendation after taking an interim look at data from the Phase III study of the medicine, called evacetrapib, and assessing whether the trial had potential of attaining its primary goals, Lilly said. Such reviews are called futility analyses....read more...

The newly approved cholesterol-lowering drug, Praluent, is powerful almost beyond belief. It can drive levels of LDL cholesterol, the dangerous kind, into the 20s or even the teens, numbers almost never before seen in adults. In general, it lowers cholesterol by 50 percent to 70 percent, compared with 25 percent to 55 percent with statins. The $14,600 yearly price of the drug, which is injected under the skin once every two weeks, is a stunner. Yet for some patients, that might actually be a bargain....read more...

 LONDON (Reuters) - Two of the most anticipated new heart drugs to be launched in recent years have been priced well above analyst expectations, fuelling the debate about whether modern medicines cost too much. Praluent, made by Sanofi and Regeneron Pharmaceuticals, and Entresto from Novartis are both treatments that represent significant advances for millions of patients at risk of serious heart problems....read more...

 "It was the most startling side effect I've ever come across." That's how Elizabeth Miller, head of the immunization department at Public Health England, described some recent vaccine research you've probably never heard about: Pandemrix, a shot designed to stave off swine flu, also appears to be causing narcolepsy in some children....read more...

European Union nations have until August 20 to suspend the sale of some 700 generic drugs made in India, the EU's executive confirmed on Monday. The European Commission took the action after an Indian firm contracted by drug companies to test the medications was found to have manipulated data. On-site verifications last year at GVK Biosciences showed irregularities "in each and every one of the nine trials inspected," the European Medicines Agency said in a May report recommending the suspension....read more...

At age 45, Allergan Chief Executive Brent Saunders already pulled off something like $150 billion worth of deals. Now he’s going to get ready to do it again. Last year alone Saunders was credited with an amazing $97 billion worth of mergers and acquisitions – sometimes as buyer, sometimes as seller. With today’s $40 billion sale of Allergan’s generics business to Teva Pharmaceuticals, he caps off one of the most amazing acts of using deals to redefine a company in the drug industry’s history....read more...

 U.K. doctors and public health officials may be required to report any financial ties to drug makers under plans that are being considered by U.K. government officials, The Telegraph reports. The move comes after the paper ran an undercover investigation showing how National Health Service staffers were allegedly paid by drug makers that lobby health care providers to use specific medicines....read more...

 PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) today announced the European Medicines Agency (EMA) validated for review the Marketing Authorization Application (MAA) for Empliciti, an investigational Signaling Lymphocyte Activation Molecule (SLAMF7)-directed immunostimulatory antibody, for the treatment of multiple myeloma as combination therapy in adult patients who have received one or more prior therapies. The application was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP). ...read more...

Amgen Inc. said the U.S. Food and Drug Administration granted approval for its Kyprolis combination therapy as a second-line treatment for patients with relapsed cases of multiple myeloma. The approval allows earlier use of Kyprolis for multiple myeloma--an incurable blood cancer that often becomes resistant to treatment....read more...

 Pathogenic bacteria develop killer machines that work very specifically and highly efficiently. Scientists from the University of Freiburg have solved the molecular mechanism of a fish toxin that could be used in the future as a medication to treat cancer. The scientists have now published their research in the journal Nature Communications....read more...

 Antitumor activity of pembrolizumab (Keytruda) was confirmed in patients with advanced squamous cell carcinoma of the head and neck (SCCHN) in a recently reported expansion cohort of KEYNOTE-012.Of the 99 patients available for preliminary efficacy analysis, overall response rate (ORR) was 18.2% (95% CI, 11.1-27.2) with 18 partial responses and 31.3% with stable disease. Each patient received a fixed dose of 200 mg of IV pembrolizumab every 3 weeks. ...read more...

 Sanofi and Regeneron Pharmaceuticals announced that the FDA approved Praluent (alirocumab) for certain patients with high cholesterol, making it the first PCSK9 inhibitor cleared in the US. Specifically, the drug is indicated as an adjunct to maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolaemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL cholesterol. Last month, an FDA advisory panel backed approval of the cholesterol therapy, although some committee members suggested that the drug should be limited to certain patients such as those with familial hypercholesterolaemia. ...read more...

 PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza^™ (daclatasvir), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA). This approval marks the first time patients with chronic hepatitis C virus (HCV) genotype 3 have a 12-week, once-daily, all-oral treatment option. Daklinza is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. Sustained virologic response (SVR) rates are reduced in HCV genotype 3-infected patients with cirrhosis receiving this regimen. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir for 12 weeks. ...read more...

Hospitals can improve patient outcomes, teamwork and surgeons' compliance with care quality standards using a performance assessment common among Fortune 500 companies, according to a study published in the Journal of the American College of Surgeons. Researchers, led by Alex B. Haynes, M.D., of Boston's Ariadne Labs, used the "360-degree" multisource feedback method for 385 surgeons across eight Harvard Medical School hospital surgical programs. They also collected feedback from nearly 3,000 nursing and surgical colleagues, employees and supervisors to help surgeons identify areas where the surgeons fell short of company goals for both technical and interpersonal and communication skills....read more...

 Huge sales leaps for AbbVie's ($ABBV) Humira have been powering revenue forecast beats for the company in recent quarters. But this time, international sales of the drug took a hit, leading the Illinois pharma to fall short of analysts' top-line expectations. AbbVie's total revenue checked in at $5.5 billion, falling about 3% below consensus estimates of $5.6 billion, Evercore ISI analyst Mark Schoenebaum wrote in a Friday note to investors. While U.S. Humira sales of $2.1 billion topped Wall Street's $1.97 billion prediction, its ex-U.S. haul of $1.396 billion fell short by more than $200 million--a performance that overshadowed the company's EPS beat and full-year guidance confirmation....read more...

 The long-awaited US Food and Drug Administration decision on at least one cholesterol-lowering PCSK9 inhibitor is due to be announced. The FDA is scheduled to say whether it agrees with its own advisory committees that it should approve alirocumab (Praluent/Sanofi-Regeneron). The agency could also reveal its decision on a competitor drug called evolocumab (Repatha/Amgen), though that announcement is officially scheduled for Aug. 27. The Amgen product was approved July 21 in Europe....read more...

Bristol-Myers Squibb said revenue increased by 7% to $4.2 billion in the second quarter of 2014 even as US sales fell by 3% during the quarter. Still, the company's immunology drug, Opdivo, is off to a strong start with its new lung-cancer indication, with executives telling investors during the earnings call that the drug is performing well in both academic and community settings. Opdivo was granted an indication in lung cancer in March—three business days after it was granted Priority Review....read more...

Sunesis Pharmaceuticals Inc said the U.S. Food and Drug Administration called for more clinical evidence before considering approval for its cancer drug, sending the company's shares down 60 percent in after-market trading. The drug, vosaroxin, failed a late-stage trial in October as it did not significantly improve the overall survival of patients compared with a placebo...read more...

The language of clinical trials is indeed very clinical – data, protocols, endpoints, p-values, etc. – reflecting the scientific rigor of these tests. But it’s important to remember that they involve real people – and often patients with serious medical needs for whom the potential medicine being tested is their best hope. Before any potential new medicine can be given to humans in clinical trials, it must go through rigorous preclinical testing for safety....read more...

Newswise — UCLA scientists have discovered a groundbreaking experimental therapy that has the ability to suppress the development of ulcerative colitis (UC), a disease which causes inflammation in the digestive tract and colon cancer. The treatment utilizes a chemical inhibitor able to block an RNA molecule (microRNA-214) involved in the transmission of genetic information. High levels of microRNA-214 are typically seen in UC patients, who have an increased risk of developing colon cancer. It is still unclear why colitis patients also develop colon cancer....read more...

There's new evidence that two inexpensive generic drugs can improve survival rates for women who develop breast cancer after menopause. In two large studies published Friday in The Lancet, a class of hormone-therapy drugs called aromatase inhibitors and bone-preserving drugs called bisphosphonates improved survival and recurrence rates in postmenopausal women with early breast cancer....read more...

 The FDA has granted a breakthrough therapy designation to the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) as a potential treatment for patients with BRAFV600E-mutant non-small cell lung cancer (NSCLC), according to a second quarter financial statement released by Novartis.The FDA designation was supported by evidence from a single-arm phase II clinical trial that was presented at the 2015 ASCO Annual Meeting by Bruce E. Johnson, MD....read more...

July 23 (Reuters) - Switzerland's Roche is lining up more new drugs to drive sales in a two-year window before cheap copycats of its biotech medicines hit the market, including a promising cancer immunotherapy it hopes to launch by late 2016. The strategy is working so far, with group sales in the first half increasing by a slightly better-than-expected 3 percent as demand for recently introduced products helped offset the strength of the Swiss franc. ...read more...

THOUSAND OAKS, Calif., July 23, 2015 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Kyprolis^® (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy. The sNDA is based on data from the global Phase 3 ENDEAVOR trial. The ENDEAVOR study is the first of two head-to-head Phase 3 trials of Kyprolis versus Velcade^® (bortezomib)....read more...

Roche isn't in denial about oncoming biosimilar competition for its top-selling cancer drugs. But CEO Severin Schwan says its new meds are on track to fill in the gap--and sales growth in the first half of the year go some way toward proving that case. The Swiss drugmaker's first-half sales grew by 3%, a touch better than analysts had expected. Demand for new products--and increased sales for older heavyweights such as Herceptin--overcame the strong Swiss franc to deliver that growth....read more...

The FDA later this week is expected to announce whether it has approved Sanofi's and Regeneron's Praluent (alirocumab)—one of two highly anticipated drugs that dramatically reduce cholesterol levels. PCSK9 inhibitors are antibodies that deactivate a specific protein in the liver, which subsequently reduces levels of cholesterol in the bloodstream. Amgen, too, has a PCSK9 inhibitor in development, called Repatha (evolocumab). An FDA advisory panel ruled 13-3 in June in favor of recommending Praluent for approval and 11-4 in favor of Amgen's Repatha....read more...

Biosimilar competition may take a bigger bite out of branded sales than we think. The top 10 biologics facing biosimilar competition will see sales fall to $49 billion by 2020, consensus estimates say. That's down from $62 billion last year. But according to Morningstar analysts, that 2020 sales number is too high. In their view, biosimilars will strike sales of that group all the way down to $35 billion, Morningstar said in its latest Healthcare Observer report...read more...

 New data being presented this morning on experimental Alzheimer’s drugs from Biogen and Eli Lilly are likely to leave researchers and investors slightly disappointed, while not changing anyone’s mind about whether or not the medicines can eventually slow the progression of the disease, as many hope....read more...

 Biosimilars, biologic agents developed to be "highly similar" to approved drugs with expired patent protection, appeared to be on the verge of becoming available in the United States with the US Food and Drug Administration (FDA) approval of Zarxio® (filgrastim-sndz, Sandoz) in March 2015.^[1,2] Although, at the time of writing, the launch of Zarxio has been delayed by legal action taken by the manufacturer of the original (reference) biologic Neupogen® (Amgen), the arrival of biosimilars is still keenly anticipated by clinicians in rheumatology, gastroenterology, and oncology in particular, where biologics are most frequently used, and by pharmacists, who are closely monitoring the implications of biosimilars for formulary management...read more...

The U.S. Food and Drug Administration today announced the winners of the 2014 FDA Food Safety Challenge, a prize competition to advance breakthrough ideas on how to find disease-causing organisms in food – especially Salmonella in fresh produce. The grand prize winner and runner-up winner will receive $300,000 and $100,000 in prize money, respectively. The winners are: ...read more...

 Shares in XOMA dropped as much as 81 percent Wednesday after the company reported that gevokizumab did not meet the primary endpoint of time to first acute ocular exacerbation in the Phase III EYEGUARD-B trial of patients with Behçet's disease uveitis. "Although the study did not achieve its main objective, we did see signals of drug activity such as preserved visual acuity, less severe ocular exacerbations and a reduced incidence of reported macular oedema in patients treated with gevokizumab," remarked the company's chief medical officer Paul Rubin. ...read more...

WASHINGTON (AP) -- Amgen on Tuesday received European approval for its first-of-a-kind cholesterol drug that lowers levels of the artery-clogging substance more than older drugs that have been prescribed for decades. The highly-anticipated decision introduces a new option for patients at risk for heart disease. But questions remain about the drug's price — estimated by one analyst at about $3,750 per year outside the U.S. — and its ability to reduce heart attack and death in the long term....read more...

 Novartis AG must wait until Sept. 2 to sell the first biosimilar drug to be approved in the United States, a copycat version of Amgen Inc's $1.2 billion-a-year Neupogen, a U.S. appeals court said on Tuesday. The ruling stemmed from a lawsuit Amgen filed last October in federal court in San Francisco in which it accused Novartis' generic drugs unit Sandoz of infringing on a patent for Neupogen, which boosts white blood cell counts to fight infections in cancer patients...read more...

Worried that health insurers' urge to merge will put even more pressure on your prices? You're in good company. Novartis ($NVS) CEO Joe Jimenez agrees. For years, pricing freedom in the U.S. has allowed drugmakers to set prices higher than in other countries and raise them along the way. The tactics help offset budget pressures overseas and can drive sales growth for meds on the decline...read more...

 Bristol-Myers Squibb announced Tuesday that the FDA designated its experimental drug BMS-663068 a breakthrough therapy when used in combination with other antiretroviral agents to treat HIV-1 infection in heavily treatment-experienced adults. According to the company, BMS-663068, an oral prodrug of BMS-626529 and first-in-class HIV-1 attachment inhibitor, "is thought to work at an earlier point in the replication process to prevent the virus' initial interaction with immune cells entirely." ...read more...

The European Commission cleared the PD-1 inhibitor for locally advanced or metastatic squamous (SQ) NSCLC after prior chemotherapy, consolidating BMS' lead over arch-rival Merck & Co - whose Keytruda (pembrolizumab) is not yet approved in the EU or indeed for lung cancer in any market. BMS said the approval of Opdivo (nivolumab) "marks the first major treatment advance in SQ NSCLC in more than a decade in the EU" and looks likely to replace the current standard of care. The drug was approved for melanoma in the EU last month...read more...

PHILADELPHIA and OXFORD, England, July 20, 2015 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc (Nasdaq:ADAP), a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced that data from its Phase I/II study of its affinity enhanced T-cell receptor (TCR) therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published in Nature Medicine. The paper entitled NY-ESO-1 Specific TCR Engineered T-cells Mediate Sustained Antigen-specific Antitumor Effects in Myeloma by Drs. Aaron P. Rapoport, Edward Stadtmauer and Gwendolyn Binder-Scholl et al. describes the persistence and tumor trafficking, antitumor effect and safety profile of Adaptimmune's NY-ESO TCR therapeutic (ADAP NY-ESO TCR) in 20 patients with advanced multiple myeloma. ...read more...

A clinical trial has shown that patients with a specific molecular subtype of diffuse large B-cell lymphoma (DLBCL) are more likely to respond to the drug ibrutinib (Imbruvica) than patients with another molecular subtype of the disease. The study appeared online July 20, 2015, in Nature Medicine. ...read more...