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Wednesday, September 5, 2018

Evotec, Celgene Partner In The Field Of Targeted Protein Degradation


  • THE COLLABORATION WILL FOCUS ON TARGETED PROTEIN DEGRADATION
  • EVOTEC’S PANOMICS AND DATA ANALYTICS PLATFORMS WILL BE LEVERAGED
  • FINANCIALS INCLUDE UPFRONT PAYMENT AS WELL AS SIGNIFICANT POTENTIAL MILESTONE-BASED PAYMENTS AND ROYALTIES
Evotec AG (FSE: EVT) (XETRA: EVT) (OTC PINK: EVTCY), (TecDAX, ISIN: DE0005664809) announced today that Evotec and Celgene Corporation (“Celgene”) have entered into a third long-term strategic drug discovery and development partnership in the field of targeted protein degradation.
In this collaboration, Evotec and Celgene will leverage Evotec’s Panomics platform in order to identify drug targets which are traditionally difficult to track. Evotec’s Panomics platform applies in particular high-end proteomics and transcriptomics at industrial scale to profile and select promising drug candidates on the basis of comprehensive cell biological profiles. Evotec’s Panomics platform also includes an integrated data analytics platform, “PanHunter”, which facilitates the analysis and interpretation of large ‘omics’ data sets.
The collaboration will leverage the state-of-the-art proteomics expertise of Evotec scientists at the sites in Munich, Germany, and Toulouse, France. Under the terms of the agreement, Evotec will receive an undisclosed upfront payment as well as significant milestone-based payments and tiered potentially double-digit royalties on each licensed programme. Celgene holds exclusive rights for all programmes arising from this collaboration.
Dr Cord Dohrmann, Chief Scientific Officer of Evotec, commented: “We are very excited to enter into this third partnership with Celgene, opening opportunities to expand beyond neurodegeneration and oncology. Addressing traditionally undrugable targets via targeted protein degradation is a highly attractive and promising approach which has not been explored systematically.”
ABOUT PANOMICS/PANHUNTER
Panomics involves the innovative use of genomics, transcriptomics and proteomics data in an integrated fashion. Evotec has established high-throughput transcriptomics and proteomics technologies, which can be used as unbiased read-outs in drug discovery and development. This includes “PanHunter”, a proprietary, integrated, user-centred bioinformatics platform for panomics data analysis.
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Novartis sells parts of Sandoz U.S. to India’s Aurobindo for $900 m


 Novartis said on Thursday it would sell the dermatology and generic U.S. oral solids portfolios of Sandoz U.S. to India’s Aurobindo Pharma Ltd for $900 million (696 million pounds), as the Swiss drugmaker looks to focus on higher growth areas.

The deal also includes about 300 products and additional development projects of Sandoz and an additional $100 million in performance-based payments, Novartis said.
The 131-year-old Sandoz unit was hurt by price pressure in the United States, prompting Novartis Chief Executive Officer Vas Narasimhan to sell the Sandoz unit.
He has so far said Sandoz businesses elsewhere remain core parts of Novartis. Narasimhan is also keeping Sandoz biosimilars business – less-expensive near copies of complex biological medicines whose patents have expired – on hopes that rising demand from cash-strapped governments and insurers seeking to contain costs will help Sandoz boost its margins.
Novartis had earlier this year expressed its intention to sell the Sandoz unit after reporting disappointing sales form the unit.
“Through this transaction, we are refocusing our business but also striving to ensure continuity of supply of important long-used generic medicines for patients and customers in the US,” said Richard Francis, Sandoz chief executive.
Following the transaction, the Sandoz U.S. portfolio will continue to be substantial, and will include biosimilars, value-added medicines and complex generics such as injectables, respiratory and ophthalmics, the company said.
“Overall the transaction will position Aurobindo as the 2nd largest dermatology player and the 2nd largest generics company in the U.S. by prescriptions,” said N. Govindarajan, Managing Director of Aurobindo Pharma. http://bit.ly/2MRmXqA
As part of the transaction, Aurobindo Pharma USA Inc, a unit of the Hyderabad, India-based company, will acquire the plants in Wilson, North Carolina, as well as Hicksville and Melville, New York, Novartis said.
About 750 employees as well as the field representatives for the PharmaDerm branded dermatology business are expected to transfer to Aurobindo upon closing, Novartis said.
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New CDC Guidelines Detail Treatment of Pediatric Mild Traumatic Brain Injury


New evidence-based guidelines, developed by the Centers for Disease Control and Prevention (CDC) with input from the American College of Emergency Physicians (ACEP) and others put forward recommendations for a broad range of health care providers responsible for detection and management of pediatric mild traumatic brain injury, most of which are concussions.
The CDC recommendations are outlined in an Annals of Emergency Medicine editorial and span diagnosis, prognosis, management and treatment in a variety of clinical settings. From 2005-2009, there were almost 3 million emergency visits for pediatric mild traumatic brain injury, according to the CDC.
“The experts in emergency departments are often the first care providers to evaluate a child’s head injury,” said Angela Lumba-Brown, MD, pediatric emergency physician, lead author and Clinical Assistant Professor of Emergency Medicine at Stanford University. “These guidelines standardize a framework for recognizing, treating and managing a child’s recovery from mild traumatic brain injury – encouraging appropriate use of diagnostic imaging, safe prescribing, and making sure each child, family or caretaker is equipped with the information they need for a quick and safe recovery.”
Key recommendations include that mild traumatic brain injury does not require imaging in an acute care setting. Computed tomography (CT) imaging should be considered when there is suspicion of more severe forms of injury, the authors wrote. The CDC suggests that clinicians screen for risk factors because recovery will vary by individual characteristics. Non-opioid analgesics should be prescribed by the emergency department along with counseling about risks of overuse. The child and family should be educated before discharge about the warning signs for more serious injury and the expected course of recovery. And, the new recommendations call for providers to describe healthy sleep habits and other strategies to help facilitate recovery.
The CDC is offering new tools that can help health care providers with implementation of the guidelines, including a checklist for diagnosis and management; patient discharge instructions; recovery tips for parents to support their child; and a letter to schools to be filled in by healthcare providers.
More information about the guidelines is available at http://www.cdc.gov/HEADSUP.
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Morgan Stanley Upgrades Anthem, Sees Opportunity In PBM Shakeup


Mergers and regulated pricing reform have shaken the pharmacy benefits management space — and the chaos may play out in Anthem Inc ANTM 1.56%’s favor.

The Analyst

Morgan Stanley analyst Zack Sopcak upgraded Anthem from Equal-weight to Overweight and increased the price target from $273 to $368.

The Thesis

By Sopcak’s estimates, Anthem should seize underappreciated market share and post accelerated profit growth in a post-rebate environment that champions transparency. (See the analyst’s track record here.)
“Rapid evolution of the PBM market and model greatly advantages an integrated managed care (MCO)/PBM solution, in our view, just as Anthem is bringing its PBM in-house,” Sopcak said. Anthem’s withdrawal from the Express Scripts Holding Co ESRX 3.31% service is seen to set the stage for incremental scale.
Considering UnitedHealth Group Inc UNH 0.32%’s precedent in integrating its PBM, as well as Anthem leadership’s involvement in UnitedHealth’s execution, Sopcak expects Anthem to record $1.1 billion in PBM-driven pretax profit in 2021. With relatively low risk, the transition is seen to yield a fresh and profitable opportunity.
“Tighter integration of pharmacy with medical benefits should both enhance Anthem’s margins and opportunities to compete for new business in Medicare and Medicaid,” the analyst said. “In addition, we model heightened capital deployment, which could consist of tuck-in M&A akin to recent deals or share repurchases,as the PBM accelerates free cash generated and access to unregulated capital starting in 2020.”
Morgan Stanley raised its price target to account for Anthem’s PBM in-sourcing, underappreciated PBM growth and accelerated core growth.
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A Vaccine to Prevent Acne? It May Be Possible One Day


Acne and adolescence go hand in hand. But researchers say the skin lesions might become a torment of the past if preliminary tests of an experimental vaccine pan out.
So far, the vaccine has only been tried on animals and human skin samples. It uses antibodies to target a toxin secreted by the bacteria responsible for acne, explained study author Chun-Ming Huang. He’s a professor of dermatology at the University of California, San Diego.
Potentially, such a vaccine could help the 85 percent of U.S. teens and more than 40 million American adults suffering with the lesions, scars and emotional stigma of acne, he added.
Huang said his team is “actively seeking a company to work with us to conduct a clinical trial.”
According to Huang, “The efficacy of this vaccine has been validated in human acne biopsies. It works to reduce inflammation in acne lesions.”
If the results of clinical trials are positive, it’s possible the vaccine could be available “within three to five years,” he said.
Acne “afflicts 650 million people — almost one in 10 — and is the eighth most common disease worldwide,” Huang noted.
Current treatments — such as skin creams, antibiotics or systemic retinoids — often provoke unpleasant side effects, such as extreme skin dryness and irritation, according to background notes with the study.
For many skin-pocked teenagers and adults, the frustration and shame of uncontrolled acne has been linked to a higher risk for clinical depression and suicide or suicidal thoughts.
The proposed acne vaccine focuses on acne-causing bacteria that is common on human skin, the study authors explained. This bacteria — known as P. acnes — releases a toxin known as CAMP. In theory, the vaccine works by generating antibodies that eliminate this toxin.
“Once the toxin is neutralized, inflammation in the acne lesion will be suppressed,” Huang said.
Testing with mice and human skin samples showed that the vaccine “significantly diminishes” both P. acnes “colonization” and inflammation. Whether such success can be replicated by direct administration to people remains to be seen, however.
Nevertheless, Huang suggested that acne vaccines that are “bacteria-specific” should mean side effects would be minimal.
Emmanuel Contassot is a dermatology faculty member at the University of Zurich, in Switzerland, and author of an editorial accompanying the study.
“Vaccination is a very promising approach” to acne intervention, he said.
“Current treatments consist of antibiotics or retinoids, both being not specific and associated with side effects,” Contassot said. “Targeting P. acnes with a vaccine would be more specific and less toxic than chemical therapies.”
Still, Contassot pointed out that it’s important to understand that P. acnes comes in various strains, some good, some bad.
“The good ones participate actively in skin barrier integrity, notably by preventing [harmful] bacteria to proliferate. The bad ones are involved in acne,” he explained.
Any effective and safe vaccine must target the bad bacteria while preserving the good ones, he stressed. In fact, “targeting the wrong antigen might worsen patients’ condition by disturbing skin integrity,” Contassot added.
On that front, Contassot said Huang and his colleagues appear to be on the right track. But he thinks further research is needed prior to clinical studies.
The new findings were published online Aug. 29 in the Journal of Investigative Dermatology.
More information
SOURCES: Chun-Ming (Eric) Huang, Ph.D., professor, department of dermatology, University of California, San Diego; Emmanuel Contassot, Ph.D., faculty of medicine, dermatology department, University Hospital and University of Zurich, Switzerland; Aug. 29, 2018, Journal of Investigative Dermatology, online
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130 Now Sickened by Salmonella-Tainted Honey Smacks Cereal


One hundred thirty people across 36 states have now fallen ill with salmonella after eating Kellogg’s Honey Smacks cereal, the U.S. Centers for Disease Control and Prevention said Tuesday.
For the time being, the “CDC advises consumers and retailers not to eat, serve or sell any Kellogg’s Honey Smacks cereal,” the agency said in a statement.
Many of the illnesses linked to the Salmonella Mbandaka strain have been severe — so far, 34 people have been hospitalized, although no deaths have been reported.
“Laboratory testing identified the outbreak strain of salmonella in unopened and opened boxes of Honey Smacks cereal collected from retail locations and from ill people’s homes,” the CDC said.
The illnesses first surfaced in early March and have continued, with the last illnesses reported on Aug. 7. On June 14, Kellogg Co. announced it was recalling certain boxes of Honey Smacks cereal due to the possibility of contamination with salmonella.
But the CDC said Tuesday that the cereal is still being sold in some locations, despite the recall this summer.
The cereal under recall includes Honey Smacks 15.3 oz. size with the UPC code of 3800039103 (on the bottom of the package) and a “Best If Used Before” date of JUN 14, 2018, through JUN 14, 2019 (at the top of the package).
Also included are Honey Smacks in the 23 oz. size with the same “Best Before” date and the UPC code of 3800014810.
No other Kellogg products are affected by the recall, and people who find they have purchased one of the recalled products should “discard it and contact the company for a full refund,” the company said. The cereal has a shelf life of about a year if left unopened.
More details can be found at Kellogg’s website. People can also reach out to their state’s health department.
Salmonella can trigger serious illness, and can even be fatal for children, frail or elderly people, and people with weakened immune systems. Illnesses typically last four to seven days, with symptoms including fever, diarrhea, nausea, vomiting and abdominal pain.
More information
Find out more about the salmonella outbreak at the U.S. Centers for Disease Control and Prevention.
SOURCES: U.S. Centers for Disease Control and Prevention, news release, Sept. 4, 2018; U.S. Centers for Disease Control and Prevention, news release, July 13, 2018; Kelloggs Co., news release, June 14, 2018
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Kavanaugh sidesteps abortion, ObamaCare in 2nd day of confirmation


Supreme Court nominee Brett Kavanaugh avoided drawing a line in the sand on landmark healthcare issues—such as the legality of the ACA—in the same way his predecessors also declined to comment during the confirmation process on cases that they could end up litigating.
Kavanaugh was questioned on several healthcare-related issues on his second day before the Senate Judiciary Committee; notably the Affordable Care Act and abortion rights. Critics of Kavanaugh have expressed concern that his confirmation—which would notably skew the court to the right—could lead the court to overturn precedent on those matters.
Wednesday’s hearing was no less contentious than its opening day, with many of the senators questioning Kavanaugh dealing with interruptions from protesters, the majority of which spoke on healthcare issues.
Sen. Sheldon Whitehouse, D-R.I., asked if Kavanaugh would uphold consumer protections in the ACA, and Kavanaugh demurred.
“I can’t give assurances on a specific hypothetical,” Kavanaugh said.
Alliance for Justice
✔@AFJustice
.@SenWhitehouse: “In my office, you told me you could provide no assurance to me that you would uphold a statute requiring insurance companies to provide coverage for pre-existing medical conditions. Is that still true, in public?”
Kavanaugh wouldn’t answer. 
2:28 PM – Sep 5, 2018
By declining to take an official stance on certain issues, Kavanaugh said he was following the “Ginsburg standard”—named after current Justice Ruth Bader Ginsburg—as have many of his predecessors. In her 1993 confirmation hearings, Ginsburg declined to offer “previews” of how she might rule on certain cases, as it would undermine the judicial process.
Kavanaugh has weighed in on the ACA before, however. In 2011, as a D.C. federal court judge, he dissented on a ruling that upheld the law, dodging the legality of the ACA itself but instead arguing that the Republican-led lawsuit should have been dismissed as the court did not have jurisdiction on the matter.
Though Kavanaugh said he was sticking to her “standard,” Ginsburg did affirm her personal support for abortion rights in her confirmation hearings, while later appointees Samuel Alito, John Roberts, Sonia Sotomayor, Elena Kegan and Neil Gorsuch did not elaborate on their own abortion views, ABC News reported.
Ranking member Dianne Feinstein, D-Ca., asked Kavanaugh directly where he stands on Roe v. Wade—the 1973 landmark decision that established the constitutional right to privacy extended to abortion—and he said the ruling is an “important precedent of the Supreme Court” that has been reaffirmed in a number of cases since, notably Planned Parenthood v. Casey in 1992.
“I understand the importance of the issue. I understand the importance that people attached to the Roe v. Wade decision, to the Planned Parenthood v. Casey decision,” Kavanaugh said. “I don’t live in a bubble—I live in the real world, and I understand the importance of the issue.”
PBS NewsHour
✔@NewsHour
Roe v. Wade is “settled as a precedent of the Supreme Court entitled the respect under principles of ‘stare decisis,'” Brett Kavanaugh tells @SenFeinstein, referring to the doctrine of following judicial precedent. “It has been reaffirmed many times over the past 45 years.”
10:48 AM – Sep 5, 2018
Groups in opposition to Kavanaugh’s confirmation, such as Planned Parenthood, warned that merely noting the Roe decision’s long history as precedent doesn’t necessarily mean it could not, or would not, be overturned on his watch.
Abortion rights activists have been among Kavanaugh’s loudest opponents. Planned Parenthood’s advocacy arm launched a $6 million ad campaign in tandem with the start of Kavanaugh’s hearings, with television spots to air in Washington, D.C., and Alaska, which is home to Sen. Lisa Murkowski, a crucial Republican swing vote.
Kavanaugh was also questioned on his dissent in a case where an immigrant teen was granted an abortion after the Department of Health and Human Services sought to block her access. It’s the only abortion case he’s ruled on to date.
Kavanaugh argued that the government’s request—that the young woman, referred to as Jane Doe, be transferred to an immigration sponsor to discuss her options before undergoing the procedure—did not constitute an undue burden on access. His ruling was overturned by the full D.C. Circuit Court, and in his dissent to that decision, Kavanaugh argued that he had originally ruled in line with Supreme Court precedent.
“I did my level best in an emergency … to follow precedent,” he told senators on Wednesday. “I always try to do be as careful as I can in following precedent of Supreme Court.”
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