Most Physicians Disenchanted With Their Profession

Seven out of 10 physicians would not recommend their profession to their children or other family members, and more than half are thinking about retiring within the next 5 years, including one-third of those under the age of 50, according to a new national survey by The Doctors Company, a physician-owned medical malpractice insurer.

The survey of more than 3400 US physicians uncovered a “complex picture” of the attitudes of physicians nationwide toward the important issues facing the industry, with physicians reporting feeling disenchanted with the practice of medicine, the authors note in their report.

While the rate of change within practice models may have slowed in recent years, many physicians view the adoption of electronic health records (EHRs) and new reimbursement models as compromising the traditional doctor-patient relationship and the ability to provide quality patient care, the authors say.

Yet the survey also shows that physicians have not wavered in their advocacy for preserving the doctor-patient relationship and providing high-quality care.

Among the key findings from the Future of Healthcare survey:

* More than half of physicians (54%) plan to retire within the next 5 years because of pressure from declining reimbursement, increased administrative burden, and industry consolidation. The average age of men who took the survey was 62; for women, it was 55. Male physicians are more likely to retire than female physicians. Women are more likely to report that they are primary care physicians (PCPs) and men are much more likely to report being surgical specialists, so the burdens leading doctors to retire may be felt less on the PCP level, the authors say.

* More than half of physicians (54%) believe EHRs have had a negative impact on physician-patient relationships. “Doctors are concerned that EHRs are burdensome and distracting during patient interaction. One doctor suggested that the software causes major frustration to patients and physicians alike,” the authors report.

* Nearly two-thirds (61%) of physicians believe EHRs are having a negative impact on efficiency and productivity. “Many comments suggest that doctors are frustrated with the functionality, reliability, and lack of interoperability within their EHRs,” the authors note.

* More than 40% of doctors think value-based care will have a negative impact on the physician-patient relationship. “Many doctors worry that pay-for-performance reimbursement doesn’t take into account the nuances of the doctor-patient relationship and puts a focus on population-level data instead of individual outcomes,” the authors say. Along this same line, 63% of the physicians surveyed said they believe value-based care and reimbursement will have a negative impact on their earnings.

* Almost two-thirds (62%) of doctors say they don’t plan to change practice models, perhaps indicating that the pace of practice change seen in recent years may have run its course, the authors say.

* Three quarters (75%) of solo practitioners plan to stay independent. “Private practices are increasingly being acquired by health systems that want to better control the continuum of care, and some medical groups are merging to create larger practices to drive efficiency, cost savings, and better technology,” the authors note. “Nonetheless, three quarters of the solo practitioners who took this survey told us they don’t expect to be a part of that industry shift, but rather expect to remain independent. While many are staying put in their current practice model, physicians expressed concern about how industry changes will impact the future of individual and small group practices.”

* Physicians have mixed views on accountable care organizations, with 43% saying they do not plan to participate and 57% saying they plan to participate, are undecided, or need more information.

* Physicians also have mixed feelings about clinically integrated networks (CINs): 38% do not plan to participate in a CIN and 37% are either undecided or need more information about participating in a CIN.

* Physicians are also split on independent physician associations: 30% plan to participate, 36% do not plan to participate, and 34% are either undecided or need more information.

* More than half (56%) of physicians don’t plan to participate in patient-centered medical homes, 15% plan to participate, and 29% are undecided or need more information.

The survey included physicians in a range of medical specialties from 49 states and the District of Columbia who are insured by The Doctors Company.

The report was created in partnership with Modern Healthcare Custom Media and is available online.

https://www.medscape.com/viewarticle/903051

Cadila Healthcare gets final approval from USFDA for Exemestane tablets

Zydus Cadila has received an approval from the USFDA to market Exemestane tablets (US RLD, AROMASW tablets), 25 mg, the company said in a statement to the exchanges on Friday.

The company will produce these tablets in its formulations manufacturing facility at SEZ, Ahmedabad. “The estimated sales of Exemestane tablets are $68.6mn,” said Cadila in a press note.

“These tablets are belongs to the group of medicines called aromatase inhibitor used in women after menopause for the treatment of early breast cancer (cancer that has not spread outside the breast) in women who have cancer that needs the female hormone estrogen to grow have had other treatments for breast cancer for 2-3 years and are switching to Exemestane to complete five years in a row of hormonal therapy,” the company said. These tablets are also used in the treatment of advanced breast cancer after treatment with other therapies.

The group now has 220 approvals and has so far filed over 330 ANDAs, since the commencement of the filing process in FY04, the company added.

https://www.marketscreener.com/CADILA-HEALTHCARE-LTD-34067618/news/Cadila-Healthcare-receives-final-approval-from-USFDA-for-Exemestane-tablets-27381631/

VALNEVA: FDA Approval of Accelerated IXIARO Vaccination Schedule

Valneva SE (“Valneva” or “the Company”), a commercial stage biotech company focused on developing innovative lifesaving vaccines, announced today that the U.S. Food and Drug Administration (FDA) has approved an alternate IXIARO immunization schedule of two doses administered seven days apart for adult travelers aged 18-65 years old. This accelerated schedule comes in addition to the previously approved schedule.

IXIARO is the only Japanese encephalitis (JE) vaccine licensed and available in the United States (U.S.). The vaccine was approved with a two-dose primary immunization with the two vaccinations administered 28 days apart. The newly-approved accelerated vaccination schedule allows rapid immunization in adults with the two doses given seven days apart. This rapid schedule has already been approved and is used in Europe and Canada.

Franck Grimaud, Valneva`s Chief Business Officer, commented, “Many people make their travel plans at the last minute, so being able to receive IXIARO`s two shots within seven days makes it easier for travelers, ultimately enhancing the value proposition of our product. The U.S. is IXIARO`s largest market and we expect that this new schedule will encourage more U.S. travelers to seek prevention against this devastating disease.”

The FDA`s revised schedule follows previous approvals by Health Canada and the European Medicines Agency, who authorized accelerated IXIARO vaccination schedules for adult travelers in March 2018 and April 2015, respectively.

https://www.marketscreener.com/VALNEVA-54466/news/VALNEVA-Announces-FDA-Approval-of-Accelerated-IXIARO-Vaccination-Schedule-27381634/

Pfizer: NICE approval of MYLOTARG for acute myeloid leukaemia

Pfizer comment on the NICE approval of MYLOTARG (gemtuzumab ozogamicin) for treatment of previously untreated, de novo, CD33-positive acute myeloid leukaemia (AML) in combination with chemotherapy.

MYLOTARG will now be available through the National Health Service (NHS) for eligible patients in England and Wales.

AML is a rare and aggressive blood cancer that affects approximately 2,600 people in the UK each year. If left untreated, the average life expectancy is less than 10 months. The goal of AML treatment is to help patients achieve a prolonged complete remission, however, few new treatment options have become available for AML patients in the last few decades, with chemotherapy remaining the standard-of-care since the 1970s.

The Final Appraisal Determination (FAD), NICE approval of MYLOTARG, recommends use in combination with daunorubicin and cytarabine as an option for untreated CD33-positive acute myeloid leukaemia (AML), except acute promyelocytic leukaemia, in people 15 years and over, only if they start induction therapy when either the cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics or when their cytogenetic test results are not yet available, and they start consolidation therapy when their cytogenetic test confirms that the disease has favourable, intermediate or unknown cytogenetics (because the test was unsuccessful).

Craig Eagle, Head of Oncology, Pfizer UK said: We welcome the NICE approval of MYLOTARG for eligible patients living with AML. Pfizer has worked tirelessly with the AML community to ensure patients in the UK have access to appropriate treatment options and this important, potentially life-changing medicine offers renewed hope for some people living with AML in England and Wales.

Haematologist Professor Nigel Russell from the Centre for Clinical Haematology, Nottingham University Hospital Trust said Over the past few decades, there has been little innovation in how we treat AML. Despite slow improvements in outcomes, the prognosis for patients with this type of blood cancer remains poor. Gemtuzumab ozogamicin is a targeted therapy that is given with standard chemotherapy and prolongs the time spent in remission compared to standard treatments. It provides a welcome addition to the treatment options for eligible patients with AML and is an important step towards ensuring that some very sick blood cancer patients can access appropriate treatments to achieve a prolonged, complete remission.

Novartis Kymriah was approved for acute lymphoblastic leukaemia earlier this year while NICE rejected Janssens Imbruvica and NICE have reconsidered their view on Pfizers BESPONSA.

https://www.marketscreener.com/PFIZER-23365019/news/Pfizer-NICE-approval-of-MYLOTARG-for-acute-myeloid-leukaemia-27381632/

Carl Zeiss Meditec: FDA Approval for SMILE Astigmatism

ZEISS, a technology enterprise operating in the fields of optics and optoelectronics, issued the following news release:

Today, the ZEISS Medical Technology Segment announced the FDA Premarket Approval (PMA) for ReLEx(R) SMILE(R) PMA expanding myopia treatment to patients with astigmatism. The PMA also provides for a small entry incision to be made, allowing the SMILE(R) procedure to be potentially less disruptive to the corneal surface tissue.

“The expansion of Myopia treatment to patients with Astigmatism will enable current and future SMILE(R) surgeons to expand their patient base, paving the way for a new generation of refractive surgery patients,” said Jim Mazzo, Global President Ophthalmic Devices at Carl Zeiss Meditec.

ZEISS ReLEx SMILE utilizes the high-precision femtosecond laser VisuMax(R) to create a lenticule inside the cornea and access incision in a single treatment step. Its outstanding cutting precision, exceptional speed and gentle treatment make it an ideal platform for advanced corneal surgery such as SMILE(R). Incisions are made through microscopic-photodisruptions of tissue, created by ultrashort pulses.

Many patients are patiently awaiting this approval, reported John F. Doane, M.D., F.A.C.S. of Discover Vision Centers. “We and our patients are excited to say the least. Refractive surgery just keeps getting better with Carl Zeiss Meditec’s FDA approval of SMILE(R) for compound myopic astigmatism,” Doane added.

VisuMax laser is the first femtosecond laser to receive FDA PMA approval for the treatment of a refractive indication in addition to 510k clearances for LASIK flap, keratoplasty, and ICR. With the approval of ReLEx(R) SMILE(R), patients can now benefit from a minimally invasive surgery, performed on one laser versus two.

Refractive surgeons benefit from SMILE(R)’s versatility, offering patients a more comfortable treatment option. With the approved new indication range the surgeon has also the option to benefit from extended technical parameters.

“Thanks to our continued collaboration with partner surgeons worldwide, we are able to pave the way for new developments and technologies in the refractive space,” said Dr. Ludwin Monz, President, and CEO of Carl Zeiss Meditec. “Now with the FDA approval for US SMILE(R) Astigmatism, we can now extend this great treatment option to US Astigmatism patients as well.”

ReLEx(R) SMILE(R) from ZEISS made its U.S. debut in 2016. In the last 10 years, over 1.5 million SMILE(R) treatments have been performed worldwide constituting over 10% of global laser vision correction procedures. To date, there are over 1700 surgeons using SMILE(R) in over 70 countries. The technology behind SMILE was recently featured in the Scientific Background on the Nobel Prize in Physics 2018. Dr. Gerard Mourou and Dr. Donna Strickland were awarded the Nobel Prize for his method to generate high-intensity ultrashort optical pulses. Their invention of so-called chirped pulse amplification is essential to generate the ultrashort laser pulses of the ZEISS VisuMax femtosecond laser system. ReLEx(R) SMILE(R) is a registered trademark of Carl Zeiss Meditec. For more information about ReLEx(R) SMILE(R), visit http://www.zeiss.com.

VisuMax(R) and ReLEx(R) SMILE(R) are registered trademarks of Carl Zeiss Meditec. Not all products, services or offers are approved or offered in every market and approved labeling and instructions may vary from one country to another. For country specific product information, see the appropriate country website. Product specifications are subject to change in design and scope of delivery as a result of ongoing technical development.

https://www.marketscreener.com/CARL-ZEISS-MEDITEC-AG-435842/news/Carl-Zeiss-Meditec-FDA-Approval-for-SMILE-Astigmatism-27381679/

Biogen New SPINRAZA Data Presented at World Muscle Society

• NURTURE study participants were alive and did not require permanent ventilation, in contrast to natural history of spinal muscular atrophy (SMA)
• Study participants achieved motor milestones with 100 percent sitting independently and 88 percent able to walk
• Additional data feature biomarkers as an indicator for clinical development work in SMA

Biogen Inc. (Nasdaq: BIIB) today announced new interim results from NURTURE, an ongoing open-label, single-arm efficacy and safety study of SPINRAZA^® (nusinersen) in 25 presymptomatic infants with SMA. The data are being presented today in a late-breaking session at the 23^rd Annual Congress of the World Muscle Society (WMS) held in Mendoza, Argentina.

“The NURTURE study results demonstrate that early diagnosis and treatment with SPINRAZA has the potential to dramatically change the course of SMA,” said Wildon Farwell, M.D., senior medical director, clinical development at Biogen. “This is the longest available span of data on infants with SMA who began treatment in a presymptomatic period and indicates that children treated early with SPINRAZA can achieve motor milestones they would likely not attain without treatment.”

The interim analysis evaluated survival and respiratory intervention rates in infants (n=25) who were genetically diagnosed with SMA and began treatment in the presymptomatic stage of the disease. As of May 2018 all patients in the study were alive and none required tracheostomy or permanent ventilation. Additionally, 22 of the 25 participants were able to walk either with assistance or independently according to the motor milestone standard of the World Health Organization and all 25 were able to sit without support.

The motor skills of study participants were also evaluated using the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND), an assessment which considers 16 different types of movement to create an overall score between zero and 64. The mean CHOP INTEND scores were 62.6 for study participants with three copies of the SMN2 gene and 61.0 for those with two copies of the gene.

All NURTURE study participants were 14 months or older at the time of the analysis. Participants included infants with two copies of the SMN2 gene (n=15) who are likely to develop a fatal, early-onset form of SMA known as Type 1, and infants with three copies of the SMN2 gene (n=10) who typically develop SMA Type 2 or 3. People living with SMA Types 2 and 3 may never be able to walk or will lose that ability over time. No new safety concerns were identified.

Additional research presented at WMS compared levels of phosphorylated neurofilament heavy chain (pNF-H) in plasma in more than 300 patients from SPINRAZA clinical trials, including those in the NURTURE study, and a control group of people without SMA. The data demonstrated that treatment with SPINRAZA is associated with a rapid decline followed by stabilization of pNF-H in plasma at levels close to those of healthy controls. The results are part of Biogen’s ongoing work to identify and validate biomarkers that could provide insight on the disease progression of SMA.

https://www.marketscreener.com/BIOGEN-4853/news/Biogen-New-SPINRAZA-nusinersen-Data-Presented-at-Annual-Congress-of-the-World-Muscle-Society-De-27381772/

Cell therapy, now artisanal and costly, heads for mass production

-Not so long ago, manipulating living cells to serve as therapies was a difficult and mysterious art. Only a few biomedical companies and academic labs could claim proficiency.

But in recent years, there’s been an explosion of knowledge about how cells work, how they can become diseased and how they can be cured. Three groundbreaking cell and gene therapy products have been approved since 2017; two for relapsing blood cancers, and one for a genetic disease that leads to blindness.

This transformation attracted nearly 70 presenting companies to La Jolla for this year’s Cell & Gene Meeting on the Mesa, an annual conference in the field.

These treatments are now costly and performed for a small number of patients. But scaling up this artisanal industry through mass production is expected to reduce costs and bring the benefits to many more people.

To prepare for this wave of cell therapies, the U.S. Food and Drug Administration has been updating its standards for assessing therapies, standards developed for pills and injections of drugs, not of living cells.

“It’s the nature of this whole meeting that the process of characterizing something as squishy and variable as human biology, packaging it and heading toward the clinic, is cutting-edge for the FDA,” said Taylor Crouch, CEO of San Diego’sOrganovo.

Organovo made a name for itself by selling “bioprinted” human liver cells for toxicology screening of potential drugs. The San Diego company is preparing to take its technology to patients with end-stage liver disease, Crouch said.

The company collects cells from donor livers, and prints them with a device that arrays the cells into a three-dimensional form, with various cells that support each other, Crouch said.

Transplanted liver cells could supplement function of a diseased liver until a donor liver can be found or perhaps even help the patient’s own liver recover, Crouch said.

The company plans to file in 2020 to begin clinical testing, Crouch said.

Another presenting company, Athersys, is in late-stage or Phase 3 clinical testing of its cell therapy for strokes caused by blood clots. The product, called MultiStem, consists of cells taken from a donor’s bone marrow, grown in the lab and frozen. When needed, they are thawed and then infused into a patient, said Gil Van Bokkelen, president and CEO of the Cleveland-based company.

MultiStem consists of a class of cells that reproduce prolifically in the lab, so the cells from one donor can yield “millions of clinical doses,” he said. These cells reduce inflammation, promote regeneration, and are tolerated by the patient’s immune system, Van Bokkelen said.

“We can administer them just like Type O blood,” he said.

San Diego’sViaCyte is clinically testing a cell therapy for type 1 diabetes. The San Diegocompany’s product replaces insulin-producing pancreatic “beta” cells, which are destroyed in the disease.

ViaCyte turns embryonic stem cells into precursors of these beta cells. These cells are then encapsulated in a device that is implanted into patients. The company is testing two variants of this approach.

Early human testing of one approach, using cells shielded by a semi-permeable membrane, hit a roadblock when the devices caused growth of fibrous tissue. This blocked diffusion of insulin into the patient. Testing has been suspended while ViaCytereworks the encapsulating material, with help from W.L. Gore & Associates, the makers of Gore-Tex.

That trial is expected to be restarted next year once approval is granted, said Paul Laikind, ViaCyte’s CEO.

Meanwhile, ViaCyte has advanced development of a somewhat different device, which allows direct contact between the cells and patient tissue. This risks an immune reaction, so patients receiving the devices must take immune-suppressing drugs.

So far, side effects have been like those expected from taking immune-suppressing drugs, and appear controllable, Laikind said. But it’s too early to know if the cells can produce therapeutic quantities of insulin.

Patients and others looking for more information on clinical trials from these companies can search for the name of the company on http://www.clinicaltrials.gov.

https://www.marketscreener.com/ORGANOVO-HOLDINGS-INC-30479665/news/Organovo-Cell-therapy-now-artisanal-and-costly-heads-for-mass-production-27378810/