FDA Approves New Drug to Treat Skin Cancer

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The U.S. Food and Drug Administration has approved a new therapy treatment for skin cancer, specifically metastatic melanoma.

The drug combination, which was partly developed at UCLA, has shown promise in treating this kind of skin cancer or melanoma without causing a secondary skin cancer.

This combination of drugs has a very high success rate particularly for patients with a BRAF mutated melanoma with lower risk of adverse side effects. The drugs have been tested at UCLA and in 135 other sites around the US, Europe, Australia and Russia.

Skin Cancer Treatments Are Scarce

The drug vemurafenib, also known as Zelboraf, was combined with cobimetinib, or Cotellic, and given to 495 patients with BRAF V600, a mutation-positive advanced skin cancer or melanoma. Patients saw such a tremendous improvement that the study was continued, and the FDA granted it Priority Review status, which led to the drug being approved.

These New Treatment Prevents Secondary Skin Cancer From Forming

Currently, 70,000 Americans are diagnosed with skin cancer or melanoma per year, and 8,000 of these people die from the disease. Half of the Americans diagnosed have a mutated proten called a BRAF mutation, which is treated with vemurafenib. By combining it with cobimentinib, not only does the drug therapy block the signal for the melanoma to grow as a cancer, but it can also prevent any other skin cancers from forming.

By Pich

Source: Clapway.com

Major pharmaceutical company to move into AstraZeneca site

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A MAJOR pharmaceutical company is set to move into the former AstraZeneca site in Loughborough – creating around 180 jobs over the next five years.

Almac Group, which has its headquarters in Craigavon, Ireland, has confirmed a £16m investment to expand its services to meet ongoing client demand in Loughborough.

The Almac Group provides all of the services required to take a new drug or compound from concept right though to final patient delivery.

This includes discovery, research, development and manufacturing.

In Loughborough, the company will be involved in the development and manufacture of drug products to be used during clinical trials.

These drug products are usually developed into tablets and capsules which are both stable and acceptable for human consumption during these trials.

The company has successfully completed negotiations to operate “a significant proportion” of the 69-acre site, which was formally occupied by AstraZeneca – Loughborough’s biggest employer.

This will be Almac’s first facility in England.

Specifically, Almac will occupy the formulation development and analytical testing facilities at the site.

Recycling company Jayplas acquired the 69-acre site in 2012 with a plan to develop the facility into a leading UK science park known as The Charnwood Campus.

Almac has now commenced recommissioning of the facilities with operations focusing initially on expanding both “non-potent and potent solid oral dose processing”.

It is anticipated that approximately 180 new jobs will be created over the next five years adding to Almac’s global workforce which currently stands at more than 4,000 people.

They are set to move into the site by early 2017.

Graeme McBurney, managing director at Almac Pharma Services said: “As we experience increased client demand for our pharmaceutical development and niche commercial manufacturing services, this latest expansion will significantly enhance Almac’s offering, increasing capacity and capability and further demonstrating our continued commitment to support our global clients in the development and manufacturing of their drug products.”

By Matt Jarram


AstraZeneca diabetes drug combination faces delay after FDA rebuff

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U.S. health regulators declined to approve a fixed-dose diabetes drug combination from AstraZeneca (AZN.L), delaying its launch and dealing a blow to an important plank of the drugmaker’s business.

AstraZeneca said on Friday it had received a so-called complete response letter from the Food and Drug Administration (FDA) stating that more clinical data were required before it could approve the combination of saxagliptin and dapagliflozin.

Such letters typically outline concerns and conditions that must be addressed to gain U.S. approval and the move means AstraZeneca faces an unspecified wait in getting its potential blockbuster drug cocktail to market.

Deutsche Bank analyst Richard Parkes said the FDA move probably reflected lack of data on the new formulation rather than safety or efficacy concerns and it seemed likely a launch would simply be delayed by between 12 and 24 months.

Morgan Stanley analysts said a best-case scenario was an 8-10 months’ delay but this could extend to a few years if new clinical trials were needed.

Last year, during its defence against a $118 billion takeover attempt by Pfizer (PFE.N), AstraZeneca predicted the saxagliptin and dapagliflozin fixed-dose combination could generate peak annual sales of $3 billion, out of total diabetes revenue of $8 billion expected by 2023.

Shares in the company were flat by late morning, underperforming a 1.5 percent rise in the European drugs sector .SXDP.

AstraZeneca said the FDA wanted to see more clinical trial data from ongoing or completed studies and it might also require information from new studies.

The individual component drugs in the new mix are already approved and marketed for the treatment of type 2 diabetes, under the brand names Onglyza and Farxiga, and the FDA move is not expected to affect their status, the company added.

Sales of Onglyza reached $391 million in the first half of 2015, with recently launched Farxiga selling $205 million.

Onglyza is a type of diabetes medicine known as a DPP-IV inhibitor, similar to Merck’s (MRK.N) highly successful Januvia.

Farxiga belongs to a newer drug class called SGLT2 inhibitors, which have created great excitement since a clinical trial last month showed that Eli Lilly’s (LLY.N) Jardiance slashed deaths in patients at risk of heart attack and stroke.

 Source: Reuters

(Editing by William Hardy, Jane Merriman, Adrian Croft)

CU Cancer Center study reports ‘robust antitumor activity’ of TAK-733 drug in mouse models of colorectal cancer

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A University of Colorado Cancer Center study recently published online ahead of print in the journal Oncotarget reports “robust antitumor activity” of the drug TAK-733 in cells and mouse models of colorectal cancer. In all, 42 of 54 tested cell lines were sensitive to the drug, as were 15 of 20 tumors grown on mice from patient samples. Nine of these patient-derived tumors showed regression, meaning that tumor tumors shrank in response to the drug.

“This was a large preclinical study that showed good activity for the drug and gave preliminary evidence for a potential biomarker that could predict which tumors would respond best to the drug,” says Christopher Lieu, MD, investigator at the CU Cancer Center and assistant professor of medical oncology at the University of Colorado School of Medicine.

Specifically, the drug intercedes in the MAPK signaling pathway, a cascade of cellular communication that controls cell growth and survival and is frequently altered in many cancers (especially including melanoma, non-small cell lung cancer, and colorectal cancer). The drug does this by silencing an essential link in this signaling chain, namely the molecule MEK. Without activity of the MEK kinase, MAPK signaling cannot occur and instead of surviving and proliferating, cancer cells dependent on this pathway die.

A handful of successful MEK kinase inhibitors exist, including trametinib and selumetinib.

“The preclinical results for TAK-733 were fairly impressive. We had high hopes that TAK-733 could be a next-generation MEK inhibitor that might support or replace the use of current drugs,” Lieu says.

The study seemed a perfect precursor to a human clinical trial of TAK-733 in colorectal cancer.

“However, as dramatic as some of the responses were, the drug has had some challenges in development when used in the context of a real, human body,” says Lieu.

Some promising cancer drugs are derailed by the existence of harmful side-effects. This is not necessarily the case for TAK-733. Instead, another necessary step for drugs seeking human clinical trials that could lead to approval is the consistency of the drug’s “pharmacokinetics”.

“When you give a patient ‘x’ amount of a drug, we need to know that ‘y’ amount of it will become bioavailable to cells,” Lieu says.

In this study, it seemed as if the drug’s path through the body was uneven. To Lieu’s point, “x” amount of the drug did not always lead to “y” amount of absorption or bioavailability, nor to a specific process the body used to metabolize and excrete the drug.

In Lieu’s opinion, targeting the MAPK signaling pathway in colorectal cancer remains extremely promising and doing so by silencing the MEK kinase remains an attractive target. In fact, Lieu hopes to push forward with research into possible uses of MEK inhibitors in combination with other targeted therapies for the treatment of colorectal cancer. However, as is so frequently the case in cancer science, the road from this drug’s preclinical promise to its possible clinical success appears as if it will be longer and more winding than researchers hoped.

“It’s not just the activity of a drug that matters, it’s the safety and tolerability and bioavailability,” Lieu says.


University of Colorado Anschutz Medical Campus / news-medical.net


YK-4-279 compound works against some forms of leukemia: Study

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A compound discovered and developed by a team of Georgetown Lombardi Comprehensive Cancer Center researchers that halts cancer in animals with Ewing sarcoma and prostate cancer appears to work against some forms of leukemia, too. That finding and the team’s latest work was published online Oct. 8 in Oncotarget.

The compound is YK-4-279, the first drug targeted at similar chromosomal translocations found in Ewing sarcoma, prostate cancer and in some forms of leukemia. Translocations occur when two normal genes break off from a chromosome and fuse together in a new location. This fusion produces new genes that manufacture proteins, which then push cancer cells to become more aggressive and spread. One of those proteins is EWS-FLI1. YK-4-279 appears effective in controlling the cancer promoting functions of EWS-FLI1.

“EWS-FLI1 is already known to drive a rare but deadly bone cancer called Ewing sarcoma, which occurs predominantly in children, teens and young adults,” says Aykut Üren, MD, professor of molecular oncology at Georgetown Lombardi. “It also appears to drive cancer cell growth in some prostate cancers.”

In this new study led by Üren, mice with EWS-FLI1-driven leukemia were given injections of YK-4-279 five days per week for two weeks and compared with untreated mice. By the end of the first week the mice receiving YK-4-279 had much lower numbers of leukemia cells. At the end of two weeks the treated mice were nearly normal by many measures, while the untreated mice had overwhelming numbers of cancer cells and died on average after three weeks, the researchers say. By contrast, mice receiving only two weeks of YK-4-279 lived nearly three times as long.

“The fact that treated mice did not get sick from the YK-4-279 gives us an early indication that it might be safe to use in humans, but that is a question that can’t be answered until we conduct clinical trials,” Üren explains. “We are looking for ways that would allow us to administer more of it, or even to formulate a pill.”

Üren says much more work remains for the team in order to translate this drug from a laboratory application into clinical trials.

Support for this work came from the Children’s Cancer Foundation, St. Baldrick’s Foundation, Go4theGoal, the Burroughs Wellcome Fund Clinical Scientist Award in Translational Research, the Austrian Science Fund (FWF), the Children´s Cancer Research Institute and from grants from the National Institutes of Health (RC4CA156509, R01CA133662, R01CA138212).

YK-4-279 was designed in the Georgetown University Medical Center Drug Discovery Program. Georgetown University is owner of patented intellectual property described in the paper. Üren and co-author Jeffrey Toretsky, PhD, are named as co-inventors on the patent. Georgetown University has licensed the technology for commercialization. Toretsky has a minority ownership interest in the company that has licensed the technology and occasionally serves as a consultant.


Georgetown University Medical Center

NHS drug shortages: why are we running out of some treatments in the UK?

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The NHS is facing shortages of some important drugs used to relieve pain and treat cancer

The NHS is running low on some key drugs used to treat cancer and other diseases. The alternatives can cost more money and provide less effective treatment. Last year nine out of 10 GPs said they had been forced to write prescriptions for “second choice” medicines because their preferred drug was out of stock.

Writing in the British Medical Journal, Margaret McCartney, a GP in Glasgow said shortages “harm patients directly” and put pressure on primary care.

Dr McCartney said: “Instability of basic drug supplies is an avoidable pressure, one being absorbed (as usual) by general practice.

“A combined total of 5% of my latest day on call was spent trying to fix prescription supply problems, one by tedious one.”

Bladder cancer

One drug that is in short supply is the BCG vaccine, used to treat bladder cancer. It can prevent cancer from returning and reduce the risk of it becoming invasive.

Since a Canadian factory stopped production in 2012, more patients have been forced to undergo a removal of the bladder because they cannot be treated with the drug.

Some such patients will go on to wear a urostomy bag, or plastic bladder, outside their bodies for the rest of their lives. Faced with the shortage, doctors are having to give patients just one third of the dose normally recommended. Bladder cancer is the seventh most common cancer in the UK, with 10,000 pepole diagnosed with the disease every year.

 Controlling pain

Another drug in short supply is clonazepam, which is used for both epilepsy treatment and to relieve pain in palliative care. The cost has risen since since manufacturer Roche discontinued supplies to the UK because of profitability and low demand. The drug now has to be imported from abroad at a higher cost.

Ashgate Hospice in Chesterfield told the BBC they have had to cut back on the use of the injectable drug by 80 per cent because the price has risen from 67p a vial to £33. The shortage is likely to mean more pain for patients struggling with terminal illnesses at the end of their life.

 What more could the Government do?

Some argue that the Department of Health’s emphasis on pushing down costs puts more pressure on drug availability. According to the British Generic Manufacturers Association, the Department of Health drives a hard bargain, meaning fewer companies choose to tender for contracts. As a result, supplies can run short if a problem occurs.

In some instances, the NHS could look to alternative treatments which could be licensed in the UK to fill the gap from an unavailable drug. The Department of Health said: “We work closely with the Medicines and Healthcare products Regulatory Agency, NHS England, the pharmaceutical industry and others in the supply chain to help prevent medicine shortages and to minimise the risk to patients on the rare occasions that issues do arise.”

By: Sophie Jamieson

Source: The Telegraph

Roche drug succeeds in hard-to-treat form of multiple sclerosis

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Switzerland’s Roche said on Monday its experimental drug ocrelizumab had proved effective against hard-to-treat primary progressive multiple sclerosis in a keenly awaited final-stage clinical trial.

The injectable antibody medicine is the first product to show positive study results in both the progressive form of the disease and more common relapsing forms, underscoring its multibillion-dollar sales potential.

Chief Executive Severin Schwan had told Reuters in an interview earlier this month that the drug’s success in relapsing MS already made it a “huge opportunity” and a positive result in primary progressive multiple sclerosis (PPMS) would be “pure upside”.

The drugmaker now plans to submit data to global regulatory authorities for approval of ocrelizumab in treating both forms of multiple sclerosis in early 2016, implying it could reach the market around a year later.

Results from a pivotal Phase III study of the drug in PPMS showed that treatment with ocrelizumab significantly reduced the progression of clinical disability and the effect was sustained for at least 12 weeks.

The incidence of serious adverse events associated with ocrelizumab, including serious infections, was also similar to placebo.

Safety is crucial to success. Because MS is caused by abnormal immune system attacks on the protective sheath surrounding nerve cells, treatments need to adjust the body’s immune response, which can lead to dangerous side effects.

Preliminary data from the clinical trial will be presented at the annual congress of the European Committee for Treatment and Research in Multiple Sclerosis on Oct. 10.

Shares in Roche gained 2.5 percent by 0715 GMT, also buoyed by encouraging results reported at the weekend for its new immune-system boosting drug atezolizumab in lung and bladder cancer, that the company hopes will help it win quick regulatory approval.

By Ben Hirschler

Source: Reuters

(Editing by Louise Heavens and David Holmes)

Researchers find key cellular enzyme that could be effective drug target for urologic cancer cells

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Researchers at the SUNY Upstate Medical University have found that a key cellular enzyme, c-Abl, could be an effective drug target in cancer cells for urologic cancers, such as prostate and kidney.

Ongoing research into treatments for kidney cancer is especially important since kidney cancer is known to be resistant to current chemotherapy and radiation.

In this study, researchers uncovered a mechanism whereby the Heat Shock Protein 90, or Hsp90, could be disrupted or disengaged from its role as chaperone of cancer cells. By acting as a guardian of cancer cells, Hsp90′s role is to help cancer cells grow and thrive. This disruption is essential to halt the growth and kill the cancer cells.

Previous research showed that the disruption of Hsp90 from its activator, Aha1, sensitizes cancer cells to Hsp90 drugs. The Upstate researchers used specific compounds aimed at the regulator of Aha1, known as c-Abl1, to successfully disconnect Aha1 from Hsp90. With the regulator Aha1 disrupted, researchers were able to show that Hsp90 drugs can be used more effectively in inhibiting kidney cancer cells growth. Hsp90 drugs have been tested successfully in clinical trials for breast cancer, lung cancer, leukemia (multiple myeloma) and gastric cancer.

Upstate’s research was led by Mehdi Mollapour, Ph.D., an assistant professor of urology and biochemistry and molecular biology; Diana Dunn, a graduate student in the laboratory; and Mark Woodford, a research assistant; and was completed in collaboration with Dimitra Bourboulia, Ph.D., an assistant professor; and Gennady Bratslavsky, M.D., professor and chair of urology, all at Upstate Medical University.

According to Mollapour, the findings of this study will not only “help enhance the efficacy of Hsp90 drugs in the clinic, but also lay a foundation for future studies aiming to understand combination therapy with Hsp90 drugs.”

The scientific community is working with measured enthusiasm studying and testing ways to disrupt Hsp90′s role as a guardian of cancer cells, thereby enabling cancer survival. The research was conducted at Upstate and used kidney tumors from patients that were treated by urologic surgeons at Upstate Urology.

About 61,000 new cases of kidney cancer are diagnosed each year, with about 14,000 people dying from the disease.

The most common form of kidney care is renal cell carcinoma, which is resistant to chemotherapy. Mollapour says, “this type of study brings Hsp90 drugs closer to a clinical trial testing in kidney cancer patients.”

Source: SUNY Upstate Medical University / news-medical.net

Doctors ‘face jail over pharma payments’

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Jeremy Hunt says pharma sales reps have been ‘ripping the NHS off’

Healthcare professionals who have inappropriate financial links with pharma companies will face prosecution and up to 10 years in jail, under Government plans for a major crackdown on industry transparency.

From next year Health Secretary Jeremy Hunt plans to bring in new rules to force all NHS hospitals and GP clinical commissioning groups to keep a registers of all payments accepted from pharma companies – to weed out corruption in the NHS.

Mr Hunt is acting in the wake of allegations made in the national press. Prescribing staff were recorded discussing payments with a fictitious pharma company, who offered to pay to arrange meetings about NHS formularies, switching drugs and influencing doctors’ prescribing decisions.

Under the new transparency rules, any member of staff who fails to declare full details of payments they receive will face disciplinary action. If they are found guilty of wrongdoing they could be prosecuted under the Bribery Act, which can result in unlimited fines and up to 10 years in jail. It is not clear if there will be any sanctions for pharma companies above investigated by the Prescriptions Medicines Code of Practice Authority.

Writing in The Daily Telegraph, Mr Hunt says the plans for a UK ‘Sunshine Act’ – similar legislation to that in place in the US which requires mandatory disclosure of all payments made by pharma companies to doctors – will promote greater transparency in the industry.

Mr Hunt said the revelations made in the investigation were “disturbing evidence of NHS staff and professionals, alleged to have received payment or hospitality from pharmaceutical firms and medical device manufacturers to influence NHS purchasing decisions.”

“Even worse, the investigation suggested that some NHS staff and professionals making these decisions may have been influenced by extravagant hospitality,” Mr Hunt says. “It’s hard not to conclude that some sales reps have been ripping the NHS off, and diverting taxpayers’ money away from patient care.”

Hunt says he does not want to stop ‘sensible collaboration between private firms and the health service “but we must not tolerate abuse,” he adds.

The ABPI says it welcomes the move, as “a positive addition to the existing industry-led drive for disclosure and transparency around industry relationships with healthcare professionals.” The trade body has its own plans for a publicly accessible database to record payments made by companies to named doctors, although this will not be mandatory.

In response to the article, Dr Virginia Acha, the ABPI’s executive director of research, medical and innovation, says: “We would welcome the opportunity to work with the Department of Health and NHS England as plans for the ‘Sunshine Rule’ develop, to ensure that we maximise our combined efforts on disclosure for the benefit of patients and the public.

“It appears that whilst declarations of gifts and hospitality made under the proposed Sunshine Rule signal a common ambition for greater transparency in our relationships, it will cover just a small proportion of the important interaction between industry and HCPs in comparison to our own disclosure requirements.

“For that common ambition for greater transparency to really improve relationships between healthcare professionals and industry, we also need to align on the great value of those relationships to deliver advances in science and treatment for patients, including research.  We have always maintained these interactions are a critical part of advancing improved healthcare outcomes for patients within appropriate and transparent governance frameworks.”

Source: Pharmafile online - By Lilian Anekwe

Female Viagra approved by health regulators

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The first prescription drug designed to boost sexual desire in women has been approved by regulators in the US. The move by the Food and Drug Administration (FDA) was a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.

But stringent safety measures on the daily pill called Addyi mean it will probably never achieve the sales of Viagra, which has generated billions of dollars since the 1990s.

The drug’s label will bear a boxed warning – the most serious type – alerting doctors and patients to the risks of dangerously low blood pressure and fainting, especially when the pill is combined with alcohol.

The same problems can occur when taking the drug with other commonly prescribed medications, including antifungals used to treat yeast infections.

“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” said Dr Janet Woodcock, director of the FDA’s drug centre.

Under an FDA-imposed safety plan, doctors will only be able to prescribe Addyi after completing an online certification process that requires counselling patients about Addyi’s risks.

Pharmacists will also need certification and will be required to remind patients not to drink alcohol while taking the drug.

Opponents of the drug say it is not worth the side effects, which also include nausea, drowsiness and dizziness. They point out that the FDA rejected the drug twice, in 2010 and 2013, due to these risks.

“This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all,” said Leonore Tiefer, a psychologist and sex therapist who organised a petition last month calling on the FDA to reject the drug.

Patients should stop taking the drug after eight weeks if they do not see any improvement, notes the FDA release.

Sprout Pharmaceutical’s drug is intended to treat women who report emotional stress due to a lack of libido. Its approval marks a U-turn by the FDA, which previously rejected the drug twice due to lacklustre effectiveness and side effects.

The decision represents a compromise of sorts between two camps that have publicly feuded over the drug for years.

On one side, Sprout and its supporters have argued that women need FDA-approved medicines to treat sexual problems. But safety advocates and pharmaceutical critics warn Addyi is a problem-prone drug for a questionable medical condition.

Beginning with the drug’s launch in October, doctors who see patients complaining about a loss of sexual appetite will have a new option.

 “Women are grasping, and I feel like we need to offer them something that acknowledges that, and that we can feel safe and comfortable with,” said Dr Cheryl Iglesia, a surgeon and official with the American Congress of Obstetricians and Gynecologists.

 The search for a pill to treat women’s sexual difficulties has been something of a holy grail for the pharmaceutical industry. It was pursued and later abandoned by Pfizer, Bayer and Procter & Gamble, among others. But drugs that act on blood flow, hormones and other biological functions all proved ineffective.

 Addyi, known generically as flibanserin, is the first drug that acts on brain chemicals that affect mood and appetite. Women and their doctors will have to decide whether the drug’s modest benefits warrant taking a psychiatric pill on a daily basis.

 Company trials showed women taking the drug generally reported one extra “sexually satisfying event” per month, and scored higher on questionnaires measuring desire.

 Ms Tiefer and other critics said the FDA was pressured into approving the drug by a feminist-themed lobbying campaign funded by Sprout and other drugmakers. For now, executives at Sprout, based in Raleigh, North Carolina, are setting modest expectations for Addyi, their first and only product. The company will focus its 200 sales representatives on promoting the drug to medical specialists.

Women with insurance can expect to pay between 30 dollars (£19) and 75 dollars (£47.86) per month for Addyi.

 The FDA specifically approved the drug for premenopausal women with hypoactive sexual desire disorder, a lack of sexual appetite that causes distress. Surveys estimate that 8 to 14% of women ages 20 to 49 have the condition, or about 5.5 to 8.6 million US women.

 Because so many factors affect sexual appetite, there are a number of alternate causes doctors must rule out before diagnosing the condition, including relationship issues, medical problems, depression and mood disorders. The diagnosis is not universally accepted, and some psychologists argue that low sex drive should not be considered a medical problem.


Source: Western Morning News

Authour: WMNA Greenwood