Senseonics has received a PMA for the sensor out to 90 days, but plans call for a 180-day version of the device and eventually a version that lasts for a year.

Senseonics’ newly approved Eversense implantable continuous glucose monitoring (CGM) system could be in patient’s hands as early as next month. Tim Goodnow, the Germantown, MD-based company’s president and CEO spoke with MD+DI just a few hours removed from the start of the American Diabetes Association’s 78th Scientific Sessions in Orlando, FL. about the approval and upcoming plans for the device.

Read more: https://www.mddionline.com/eversense-latest-game-changer-diabetes-market

For the first time in the world, researchers at the University of Gothenburg, Sweden, have demonstrated that probiotics, dietary supplements with health-promoting bacteria, can be used to affect the human skeleton. Among older women who received probiotics, bone loss was halved compared to women who received only a placebo. The research opens the door to a new way to prevent fractures among the elderly.

Read more: http://www.worldpharmanews.com/research/4454-probiotics-can-protect-the-skeletons-of-older-women

Alzheimer's disease could be better treated, thanks to a breakthrough discovery of the properties of the metals in the brain involved in the progression of the neurodegenerative condition, by an international research collaboration including the University of Warwick. Dr Joanna Collingwood, from Warwick's School of Engineering, was part of a research team which characterised iron species associated with the formation of amyloid protein plaques in the human brain - abnormal clusters of proteins in the brain. The formation of these plaques is associated with toxicity which causes cell and tissue death, leading to mental deterioration in Alzheimer's patients.
They found that in brains affected by Alzheimer's, several chemically-reduced iron species including a proliferation of a magnetic iron oxide called magnetite - which is not commonly found in the human brain - occur in the amyloid protein plaques. The team had previously shown that these minerals can form when iron and the amyloid protein interact with each other. Thanks to advanced measurement capabilities at synchrotron X-ray facilities in the UK and USA, including the Diamond Light Source I08 beamline in Oxfordshire, the team has now shown detailed evidence that these processes took place in the brains of individuals who had Alzheimer's disease. They also made unique observations about the forms of calcium minerals present in the amyloid plaques.

Understanding the significance of these metals to the progression of Alzheimer's could lead to more effective future therapies which combat the disease at its root.

Read more: http://www.worldpharmanews.com/research/4456-alzheimer-s-breakthrough-brain-metals-that-may-drive-disease-progression-revealed

Regenerative medical devices group Tissue Regenix has been granted a Human Tissue Authority (HTA) licence to import and distribute its portfolio of human tissue derived products from the US for use in the UK market.

The HTA license will initially be used to import the CellRight ‘BioRinse’ portfolio of osteoinductive bone products from a manufacturing facility in San Antonio, Texas into the UK.

The group acquired CellRight in August last year, securing access to the US biotech’s osteoinductive and wound care scaffolds “that enhance healing opportunities of defects created by trauma and disease”.

Read more: http://www.pharmatimes.com/news/tissue_regenix_secures_hta_license_to_import_cellright_products_1241791

Among women in China, rates of breast cancer rose around 3.5% each year between 2000 and 2013. In comparison, breast cancer among American women decreased by about 0.4% a year over the same timeframe. China's rapid urbanisation and development of multiple 'megacities' - a city with 10 million or more inhabitants - reveals higher rates of breast cancer in urban areas, and in more densely-populated areas. In Chinese cities where the population is 1 million or more, the incidence of breast cancer is 60 per 100,000 women.
Dr. Lee Schwartzberg, Executive Director of the West Cancer Center, a leading oncology research and treatment practice, and oncology scientific lead at George Clinical says the increase in breast cancer among women in China is likely due to many factors.

"There are various risk factors associated with breast cancer. These include being less physically active, consuming alcohol or having an unhealthy diet. For women, reproductive factors, like having fewer children, might increase risk."

China's notorious one-child policy was in place from the late 1970s until 2015 (when it was replaced with a two-child policy) and reduced the country's birth rate. The average age of women at the birth of their first child has also risen, as has contraceptive use, and rates of breastfeeding - which has been linked to a reduced risk of breast cancer - have declined.

Read more: http://www.worldpharmanews.com/business-and-industry/4452-breast-cancer-is-one-of-the-most-common-cancers-in-china-and-it-is-on-the-rise

UK-based drug discovery AdoRx Therapeutics has raised $10 million to fund its work on identifying new cancer therapeutics, in an investment round financed by Epidarex Capital and CRT Pioneer Fund.

AdoRx was founded in 2017 by healthcare investor Epidarex Capital, and has since assembled a group of pharma industry veterans led by Pete Finan, former head of the Novartis Institutes of BioMedical Research UK site.

The company is focusing its efforts on the discovery of new modulators of the adenosine pathway for the treatment of cancer.

Read more: http://www.pharmatimes.com/news/adorx_raises_$10m_for_new_cancer_therapeutics_1241146

US regulators have approved a label expansion for Shire’s Cinryze, allowing its use in children aged six and above with hereditary angioedema.

HEA is a rare, debilitating and potentially life-threatening rare genetic disease that causes swelling in the face, extremities and GI tract, thought to affect around

Cinryze (C1 inhibitor [human]), acquired by Shire through its purchase of ViroPharma in 2014, works by raising plasma levels of C1-INH in patients with the condition, who are prone to swelling due to an underlying deficiency of this protein.

Read more: http://www.pharmatimes.com/news/shire_bags_paediatric_label_expansion_for_cinryze_in_the_us_1241152

Sarepta’s gene therapy for Duchenne muscular dystrophy has produced stellar results in the first three patients treated in a clinical trial, raising hopes that it could halt or even reverse the muscle wasting disease.
The data were reported during Sarepta’s R&D update yesterday and – by the end of the day – shares in the US biotech had risen by a third, having been up almost 60% at one point. Analysts at Leerink said the results were a ‘home run’ and way ahead of expectations, and positions Sarepta as a “leader in this field.”
DMD – a rare muscle-wasting disease that mostly affects boys and typically is fatal by age 30 – is caused by a defect in the gene coding for dystrophin, a protein found in muscles that is critical for movement.
The data from the three boys – who appeared at the R&D event to rousing applause – showed that Sarepta’s AAVrh74.MHCK7 gene therapy led to the production of a truncated form of dystrophin at a level 38% of normal – which may not seem that impressive at first glance but according to clinicians could have a dramatic impact on the disease.

Read more: http://www.pmlive.com/pharma_news/sarepta_soars_on_positive_duchenne_data_1240923

For at least 20 years, research has shown that for many people, moderate consumption of alcohol can protect the heart, but the reason for this is poorly understood. A study conducted at the University of São Paulo's Biomedical Science Institute (ICB-USP) in Brazil suggests that this cardioprotective mechanism may be associated with activation of ALDH2 (aldehyde dehydrogenase-2), a mitochondrial enzyme that helps rid the organism of both the toxic byproducts of alcohol digestion and a type of reactive molecule produced in heart cells when they suffer major damage, such as that caused by a heart attack.
"Our data suggest moderate exposure to ethanol causes minor stress in heart cells but not enough to kill them. Intracellular signaling is reorganized as a result, and heart cells eventually create a biochemical memory to protect against stress, also known as preconditioning. When the cells are submitted to a higher level of stress, they know how to deal with it," said Julio Cesar Batista Ferreira, a professor in ICB-USP's Anatomy Department and principal investigator for the research project, which was supported by the São Paulo Research Foundation - FAPESP.

The Brazilian researchers are working in partnership with scientists at Stanford University in the United States. Recent results obtained during Cintia Bagne Ueta's postdoctoral research have been published in Cardiovascular Research.

To study the cardioprotective effects of alcohol at the cellular level, the researchers simulated a condition similar to myocardial infarction in mouse hearts kept alive in an artificial system. In this ex vivo model, the heart continues to beat outside the body for several hours while being perfused with an oxygenated and nutrient-enriched solution.

The scientists then simulated a clinical condition known as ischemia-reperfusion injury by interrupting the flow of oxygen and nutrients to the heart for 30 minutes. When the flow was restarted, the heart began beating again slowly, and after an hour, the researchers assessed the damage. In this model, approximately 50% of cardiac cells die on average unless there is some type of intervention.

"Lack of oxygen used to be considered the main cause of damage, but research has shown that during ischemia, the cells change their metabolism and enter a sort of dormant state. When the artery is unblocked [reperfusion], the tissue is flooded with nutrients and oxygen, and cell metabolism collapses," Ferreira explains.

In response to stress, cardiac cells produce large amounts of 4-HNE (4-hydroxy-2-nonenal), a reactive aldehyde that is toxic in excess and destroys essential cellular structures.

The mitochondrial enzyme ALDH2 normally rids the organism of accumulated aldehydes - both 4-HNE in stressed cardiac cells and the acetaldehyde resulting from ethanol breakdown in the liver after a bout of drinking.

In previous research, however, Ferreira's group in partnership with colleagues at Stanford led by Daria Mochly-Rosen showed that ALDH2 activity during the process of ischemia and reperfusion was significantly reduced. These findings were published in Science Translational Medicine and Circulation Journal.

"The amount of 4-HNE becomes so large inside the cardiac cells that it ends up attacking the enzyme ALDH2, which should be metabolizing it," Ferreira said.

"In our new study, we observed that ALDH2 activity in the heart exposed to ethanol before ischemia-reperfusion injury remained equal to that seen in a healthy heart. We believe the stress caused by a moderate dose of ethanol leaves a memory and that the cell learns to keep ALDH2 more active," added the coordinator of the FAPESP-funded research.

Five groups

Mice were divided into five groups to explore the mechanisms underlying the observed cardioprotective effect. The hearts in the control group suffered no damage and received no treatment or intervention. The hearts in the second group were submitted to ischemia and reperfusion, losing approximately 50% of their cells as a result.
In the third group, before inducing the ischemic injury, the researchers exposed the hearts extracted from male mice to ethanol for ten minutes, at a dose equivalent to two cans of beer or two glasses of wine for an average man. The dose was adjusted according to each animal's mass.

"We endeavored to follow the recommendation of the World Health Organization (WHO), which is up to one dose per day [18 grams of alcohol] for women and up to two doses per day for men. In the case of mice, it was around 50 millimolar," Ferreira explained.

The hearts were washed for ten minutes to remove surplus alcohol, and the flow of oxygen and nutrients was then interrupted, as for group two. An analysis performed approximately one hour after reperfusion showed that only 30% of the cells had died. In other words, the damage was reduced by almost 60% in comparison with group two. Also, the FAPESP-supported study found that ALDH2 activity was twice as high as in the untreated group and equivalent to the level measured in the control group, which was not submitted to the insult.

In the fourth group, the hearts were treated with ethanol and exposed to a drug that inhibits ALDH2 activity. In this case, the rate of cell death rose from 50% to 80%, confirming that the protection provided by ethanol does indeed depend on the action of this enzyme.

The fifth and last group consisted of hearts from mice with a mutation in the gene encoding ALDH2 that reduced the enzyme's activity by almost 80%. As Ferreira explained, the mice were genetically modified to simulate this mutation, which is very common among humans of East Asian descent and affects over 500 million people worldwide.

"In this group, when we exposed the hearts to ethanol, the damage caused by ischemia and reperfusion was greater," he said. "The rate of cell death rose from 50% to 70%. However, when we treated this group's hearts with Alda-1, an experimental drug that activates ALDH2, it fell to 35%."

Treatment with Alda-1 was not found to benefit the hearts of mice without the ALDH2 gene mutation when exposed to ethanol. "This suggests that both the experimental drug and alcohol act on the same molecular mechanism to activate ALDH2," he added.

Alda-1 has completed Phase I clinical trials in the US and is classified as safe for use in healthy humans. In a new phase of trials due to begin soon, it will be administered to patients with heart disease.

Read more: http://www.worldpharmanews.com/research/4449-research-shows-how-a-moderate-dose-of-alcohol-protects-the-heart

Pancreatic Cancer UK is calling for greater investment in research funding for pancreatic cancer as new data reveals that just three percent of patients with the most common form will survive beyond five years.

Ninety-five percent of people with pancreatic cancer are diagnosed with pancreatic ductal adenocarcinoma (PDAC), but because of the way that data is published true survival rates for this type of the disease were previously not known.

This is because information about PDAC was previously published together with that for another type called pancreatic neuroendocrine tumours (PNET), which has a far higher survival. Therefore the true survival for PDAC appeared better than it really is; the most recent statistics for England having shown a five-year survival rate of less than seven percent of patients.

Read more: http://www.pharmatimes.com/news/pancreatic_cancer_survival_much_lower_than_thought,_research_finds_1240926

Roche is buying the shares it does not already own in US molecular information company Foundation Medicine (FMI), in a deal valued at $2.4 billion.

The Swiss drugs giant said it is paying 137.00 per outstanding share in cash, equating to a total company value of $5.3 billion on a fully diluted basis.

The price represents a premium of 29 percent to FMI’s closing price on 18 June and a premium of 47 percent and 68 percent to its 30-day and 90-day volume weighted average share price on that date, respectively.

Read more: http://www.pharmatimes.com/news/roche_snaps_up_rest_of_foundation_medicine_for_$2.4bn_1240733

Janssen has presented data from pivotal Phase III clinical studies backing use of esketamine spray in treatment-resistant depression.

The nasally-administered drug is a non-competitive and subtype non-selective activity-dependent N-methyl-D-aspartate (NMDA) receptor antagonist, offering a new mechanism of action from currently available therapies for depression.

Maintenance data show that continuing treatment with esketamine nasal spray plus an oral antidepressant in patients beyond 16 weeks “showed clinically meaningful and statistically significant superiority” to treatment with an oral antidepressant plus placebo nasal spray in delaying time to relapse of symptoms of depression.

Also, patients in stable remission treated with esketamine nasal spray plus an oral antidepressant reduced the risk of relapse by 51 percent compared to patients receiving an oral antidepressant plus placebo nasal spray, the firm noted.

Read more: http://www.pharmatimes.com/news/phase_iii_success_for_janssens_esketamine_in_treatment-resistant_depression_1240737

Britain’s Dementia Discovery Fund has formed a research collaboration with US group Immuneering Corporation that aims to identify novel drug targets and candidates for Alzheimer's disease.

Under the deal, the DDF will invest $1.3 million for the use of Immuneering's proprietary computational drug discovery platform to analyse publicly available data sets from Alzheimer’s disease patients.

The aim is to identify clinically identifiable, mechanistically linked subpopulations within Alzheimer’s disease and generate new molecular entities that will lead to new medicines to treat the condition.

“The successful discovery of new treatments for dementia will require new approaches that are both systematic and different to what has been attempted to date,” said Tetsu Maruyama, chief scientific officer of DDF.

Read more: http://www.pharmatimes.com/news/ddf,_immuneering_form_$1.3m_alzheimers_research_collaboration_1240367

It’s taken more than three months to work through the detail, but Sanofi has now signed a deal to transfer its anti-infectives unit to Evotec.
The main elements of the agreement remain unchanged form when it was announced in March. Around 100 Sanofi employees will go onto Evotec’s payroll but will stay at the its site in Lyons, and more than 10 infectious disease R&D programmes will be transferred to the German biotech. Sanofi is also stumping up €60m in initial funding and says it will provide “significant” ongoing support without specifying numbers.
The deal comes after extensive negotiations with France’s powerful unions and government officials over the job security of the French employees under their new management, and the deal includes “specific long-term commitments of employment,” according to Evotec. It’s been reported that that includes five-year employment contracts.

Read more: http://www.pmlive.com/pharma_news/evotec_says_sanofi_deal_makes_it_anti-infectives_powerhouse_1240361

A team of researchers says it has linked sensitivity to an allergen in red meat to the buildup of plaque in the arteries of the heart. While high saturated fat levels in red meat have long been known to contribute to heart disease for people in general, the new finding suggests that a subgroup of the population may be at heightened risk for a different reason - a food allergen. The study, which is supported by the National Heart, Lung, and Blood Institute, part of the National Institutes of Health, appears in Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB), a peer-reviewed journal of the American Heart Association.
"This novel finding from a small group of subjects from Virginia raises the intriguing possibility that allergy to red meat may be an underrecognized factor in heart disease," said study leader Coleen McNamara, M.D., a professor of medicine in the Cardiovascular Research Center of the University of Virginia Health System, Charlottesville. "These preliminary findings underscore the need for further clinical studies in larger populations from diverse geographic regions and additional laboratory work."

The number of people with red meat allergies in the United States is unclear, but researchers estimate that it may be 1 percent of the population in some areas. The number of people who develop blood antibodies to the red meat allergen without having full-blown symptoms is much higher--as much as 20 percent of the population in some areas, the researchers say.

Only in recent years did scientists identify the main allergen in red meat, called galactose-α-1,3-galactose, or alpha-Gal, a type of complex sugar. They also found that a tick--the Lone Star tick--sensitizes people to this allergen when it bites them. That is why red meat allergies tend to be more common where these ticks are more prevalent, such as the Southeastern United States, but also extending to other areas, including Long Island, New York.

Researchers have suspected for some time that allergens can trigger certain immunological changes that might be associated with plaque buildup and artery blockages, but no one had identified a specific substance that is responsible for this effect. In the current study, researchers showed for the first time that a specific blood marker for red meat allergy was associated with higher levels of arterial plaque, or fatty deposits on the inner lining of the arteries. The blood marker they identified is a type of antibody (immunoglobulin or IgE) that is specific to the alpha-Gal allergen.

Read more: http://www.worldpharmanews.com/research/4445-researchers-find-link-between-allergen-in-red-meat-and-heart-disease

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced data from the final analysis of the CLL11 study evaluating Gazyva®/Gazyvaro® (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL) which will be presented during the Presidential Symposium at the 23rd European Hematology Association (EHA) Annual Congress, 14 - 17 June, in Stockholm. After a follow-up of nearly five years, final results showed clinically meaningful improvements with Gazyva/Gazyvaro plus chlorambucil across multiple endpoints, including progression-free survival (PFS) and overall survival (OS), when compared head-to-head with MabThera®/Rituxan® (rituximab) plus chlorambucil. Gazyva/Gazyvaro-based treatment reduced the risk of death by 24% compared to MabThera/Rituxan-based treatment (median OS not reached vs. 73.1 months, HR= 0.76; 95% CI 0.60-0.97; p<0.0245). These new data add to the growing body of evidence for the OS benefit with Gazyva/Gazyvaro in first-line CLL after the previously reported OS benefit with Gazyva/Gazyvaro combined with chlorambucil versus chlorambucil alone.
"We are very pleased that the majority of patients treated with Gazyva/Gazyvaro are still alive after nearly five years of follow-up in the CLL11 study," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "This meaningful survival benefit compared to MabThera/Rituxan-based therapy reinforces that Gazyva/Gazyvaro-based therapy is an important option for people with previously untreated CLL."

Read more: http://www.worldpharmanews.com/roche/4446-new-long-term-data-confirm-roche-s-gazyva-gazyvaro-extends-the-lives-of-people-with-chronic-lymphocytic-leukaemia-compared-to-mabthera-rituxan

AbbVie has unveiled new data showing high and durable undetectable minimal residual disease rates in patients with chronic lymphocytic leukaemia treated with venetoclax in combination with rituximab.

According to a new subgroup analysis from the pivotal Phase III MURANO trial, 83 percent of patients given the combination maintained undetectable minimal residual disease (uMRD) and were progression-free at 13.8 months of follow-up.

Also of note, patient best uMRD response rates were consistent independent of risk factors, including 17p deletion, IGVH mutation and TP53 mutation, the firm noted.

“In this analysis of MRD data in patients with chronic lymphocytic leukaemia given venetoclax in combination with rituximab, high and durable undetectable MRD rates were achieved in peripheral blood at the end of combination treatment assessment regardless of the risk features,” said Peter Hillmen, Professor of Experimental Haematology, Leeds Teaching Hospital in the UK, and lead investigator of the MURANO study.

Read more: http://www.pharmatimes.com/news/abbvie_unveils_high_undetectable_disease_rates_for_venetoclaxrituximab_combo_1240372

The University of Tokyo's Research Center for Advanced Science and Technology (RCAST), Fujitsu Limited, and Kowa Company Ltd. today announced that using IT-based drug discovery technologies, which entails computer-based virtual design and evaluation, they have successfully created new small molecule compounds that can inhibit cancer-causing "target proteins," and that demonstrate promise against cancers that have shown resistance to existing drugs. In order to link the results of this research to the creation of new drugs, Kowa intends to improve upon the small molecule compounds discovered through this research

Read more: http://www.worldpharmanews.com/development/4442-university-of-tokyo-s-rcast-fujitsu-and-kowa-successfully-create-promising-new-compounds-to-fight-drug-resistant-cancer

Pfizer Inc. will extend its donation of the antibiotic Zithromax® (azithromycin) to the International Trachoma Initiative through 2025, building on the company's 20-years of work to help eliminate the world's leading infectious cause of blindness. Approximately 163 million people are at risk of developing the disease and this recommitment ensures that Pfizer, through the International Trachoma Initiative (ITI), will continue to provide trachoma endemic countries with donated antibiotics that are a critical component of the global strategy to eliminate this neglected tropical disease (NTD).
Pfizer's continued donation program will help accelerate significant progress made in the last decade to reduce trachoma through increased donations, resulting in a roughly 50 percent decrease in the number of people at risk of trachoma worldwide today compared to 2011.

Read more: http://www.worldpharmanews.com/pfizer/4444-pfizer-announces-extension-of-zithromax-antibiotic-donation-program-through-2025-to-help-eliminate-world-s-leading-infectious-cause-of-blindness

A gene therapy for an inherited eye disease developed by Nightstar Therapeutics has picked up a coveted designation from the FDA that could accelerate its development.
The RMAT (regenerative medicine advanced therapy) status has been given to NSR-REP1, the London-based biotech’s therapeutic for choroideremia, a rare, degenerative retinal disorder that mainly affects males and causes blindness.
RMAT status is analogous to breakthrough status for drugs but applies to cell therapies and - since November 2017 - has been open to gene therapies. It combines the benefits of the breakthrough and fast-track programmes, which include early interaction with the regulator to help therapies that could make a big difference to patients move swiftly through development and review. There is currently no treatment for choroideremia, which typically leads to vision loss in early adulthood.

Read more: http://www.pmlive.com/pharma_news/uk_firm_nightstar_bags_fda_fast-track_status_for_gene_therapy_1240048

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved Avastin® (bevacizumab) in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for the treatment of women with advanced (stage III or IV) ovarian cancer following initial surgical resection.


“Today’s approval is an important advance for women newly diagnosed with this type of ovarian cancer,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We’re committed to advancing medicines in areas of unmet need and this FDA approval of Avastin plus chemotherapy gives women with advanced ovarian cancer a new treatment option that has been shown to significantly delay disease progression or death.”

“This approval represents an important milestone as the first medicine, other than chemotherapy, for women with advanced ovarian cancer after their initial surgery,” said Melissa Aucoin, chief executive officer, National Ovarian Cancer Coalition (NOCC). “Ovarian cancer is the fifth leading cause of cancer-related deaths among women in the United States, and this approval underscores Genentech’s dedication to bringing new treatment options to women with gynecological cancers.”

The approval for Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for the treatment of women with stage III or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection, is based on data from the pivotal Phase III GOG-0218 trial. Women who received Avastin in combination with chemotherapy, and continued use of Avastin alone, had a median progression-free survival (PFS) of 18.2 months compared to 12.0 months in women who received chemotherapy alone (HR=0.62; 95% CI 0.52 - 0.75, p<0.0001). This PFS benefit was achieved with a fixed-duration treatment (up to 22 cycles of Avastin total). Avastin has boxed warnings for GI perforation, surgery and wound healing complications and hemorrhage.

Avastin is now approved for ten distinct uses across six different types of cancer in the United States. This indication represents Avastin’s fourth gynecologic oncology indication in four years, including advanced cervical cancer and two different forms of ovarian cancer that recurred after platinum-based chemotherapy.

Read more: https://www.drugs.com/newdrugs/fda-approves-genentech-s-avastin-bevacizumab-plus-chemotherapy-women-advanced-ovarian-cancer-4765.html

US regulators have again expanded the list of approved uses of MSD’s immunotherapy Keytruda, issuing a green light for the treatment of primary mediastinal large B-cell lymphoma (PMBCL).

Marking the drug’s second approval for a haematologic malignancy, Keytruda (pembrolizumab) can now be prescribed for patients with refractory primary forms of PMBCL, a type of non-Hodgkin lymphoma, or those who have relapsed after two or more prior lines of therapy.

The decision gives PMBCL patients access to the first anti-PD-1 therapy for their condition.

Keytruda was cleared via the US Food and Drug Administration’s accelerated pathyway on the back of data from the KEYNOTE-170 trial involving 53 patients with relapsed or refractory PMBCL.

The data showed an objective response rate (ORR) of 45 percent, with a complete response rate (CRR) of 11 percent and a partial response rate of 34 percent.

Read more: http://www.pharmatimes.com/news/keytruda_approved_for_second_blood_cancer_1240033

Cancer Research UK has begun testing a novel immunotherapy vaccine for lung cancer in Phase I trials, under a collaboration agreement with Asterias Biotherapeutics.

AST-VAC2, which came to the charity via its Clinical Development Partnerships (CDP) scheme, is derived from a standardised human embryonic stem cell line as opposed to from a patient’s own cells, a process which is “costly, slow and inefficient”.

Its dendritic cells are engineered to express a modified form of telomerase, a protein almost always present at high levels in various types of cancer cells but rarely in healthy cells.

This modified form of telomerase, called hTERT, can stimulate a natural immune response targeted at cancer cells.

Researchers hope that the vaccine will prove to be effective in preventing recurrence of the lung cancer, or in combination with other therapies treat patients with advanced disease.

Read more:
http://www.pharmatimes.com/news/cr_uk_tests_asterias_novel_lung_cancer_immunotherapy_jab_1239301

Long-term antiviral treatment cuts the risk of cancer in HIV patients as they age, a new study says.


People with HIV are at increased risk for both AIDS-related cancers (Kaposi sarcoma, non-Hodgkin lymphoma or invasive cervical cancer) and non-AIDS-related cancers (lung and larynx cancer, melanoma and leukemia).

Antiretroviral therapy (ART) is a major part of HIV treatment, and previous research has shown a link between long-term viral suppression and reduced risk for certain types of cancer. However, no studies have specifically examined the effect of long-term viral suppression on overall cancer risk.

In this study, Stanford University researchers compared cancer rates between 1999 and 2015 among more than 42,000 HIV-positive veterans and more than 104,000 uninfected veterans.

Read more: https://www.drugs.com/news/antiviral-treatments-reduce-cancer-risk-hiv-patients-74917.html

After months of threats and promises, President Donald Trump finally unveiled his strategy for realizing more affordable prescription medicines in the US. Trump pledged to take on the “tangled web of special interests” that drive up drug prices and chided supply chain middlemen for getting “very rich” under the current system.

The lack of specifics, though, produced a general shrug from industry and the investment community and
Jill Wechsler
visible disappointment from public health activists. The administration’s “American Patients First” blueprint, unveiled at a May 11 Rose Garden speech, blasts “global freeloading” by industrial nations and proposes major changes in Medicare and Medicaid drug coverage policies, but stops short of authorizing the federal government to directly negotiate Medicare drug prices and or to permit “safe” importation of prescription drugs from other countries, as sought by Democrats and consumer advocates.


Read more: http://www.pharmexec.com/us-maps-strategy-reform-drug-pricing