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Friday, August 31, 2018

Zydus Cadila gets US FDA nod to market 2 products


Drug firm Zydus Cadila today said it has received final approval from the US health regulator to market Gemfibrozil tablets and Aripiprazole orally disintegrating tablets in the US.
The company has received the US FDAs final clearance to market Gemfibrozil tablets in strengths of 600 mg and the other product in strengths of 10 mg, 15 mg, 20 mg, and 30 mg, Zydus Cadila said in a statement. Both the drugs will be manufactured at the groups formulations manufacturing facility at Moraiya, Ahmedabad, it added.
Gemfibrozil tablets are used together with the diet to treat high cholesterol and triglyceride levels in people with pancreatitis, Zydus Cadila said. The drug is also used to lower the risk of stroke, heart attack or other heart complications in people with high cholesterol and triglycerides, who have not benefited from other treatments, it added.
Aripiprazole is an atypical anti-psychotic. The drug is used to treat certain mental/ mood disorders, such as bipolar disorder, schizophrenia, Tourettes disorder, and irritability associated with autistic disorder, Zydus Cadila said.
It may also be used in combination with other medication to treat depression, it added. The group now has 215 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs), Zydus Cadila said.

Abbott Laboratories 401(k) program to help employees who have student debt


A new perk at Abbott Laboratories that helps employees save for retirement even as they pay down student debt has caught the attention of a national employer group that is asking the government to clear the way for more companies to offer a similar benefit.
Abbott had sought and received the blessing of the Internal Revenue Service for a program that would allow workers who direct a certain amount of their paycheck toward student loan repayments to still get an employer contribution in their 401(k) retirement accounts, even if the workers don’t contribute themselves.
On Wednesday, the ERISA Industry Committee, which advocates on behalf of large employers regarding benefit plans governed by the Employee Retirement Income Security Act, sent a letter to the IRS commending the agency for its ruling. The IRS did not name the company when it publicly released its ruling in August, but Abbott confirmed it was the employer that had requested and received the ruling.
Because the IRS ruling applied only to Abbott, the ERISA group wants the agency to issue a broader ruling that would make the guidance generally applicable, a move that could encourage more employers to implement similar programs.
“Many employers recognize the burden that student loan debt can have on their workers’ ability to save for retirement and would like to help these workers,” Will Hansen, senior vice president of retirement policy for the group, wrote in the letter. “However, while we believe that current law allows employers to make contributions to their retirement plans on behalf of workers who repay student loan debt, the IRS has yet to clearly articulate that such contributions will not affect the tax-qualified status of an employer’s retirement plan.”
The IRS declined to comment on whether it was considering issuing broader guidance.
Student loan help has become a hot issue in employee benefits, but many employers who wish to offer it don’t know the best way to go about it, said Jeffrey Holdvogt, a partner in the employee benefits practice at McDermott Will and Emery. Most employers with a student loan perk make monthly cash payments against an employee’s debt to the loan holder, typically about $100 per month, but those payments are taxed.
Abbott’s program is unique because the employer makes a tax-free contribution to an employee’s 401(k) on the condition that the employee make student loan payments. Holdvogt said it was the first time he has heard of the IRS approving of contributions being conditioned on an employee doing something independent of the retirement plan.
The benefit doesn’t generally cost the employer any more, because the company would expect to match an employee’s 401(k) contributions anyway, he said.
The thumbs-up the IRS gave the program “is quite likely to kick-start a lot of interest from other employers and potentially be something that really causes a change in the way employers provide these types of benefits,” Holdvogt said.
The rising cost of college, as well as rising admissions, has caused student debt to triple nationally since 2005. In Illinois, more than 60 percent of students who graduate college have student debt, with an average bill of nearly $30,000, and those struggling to pay it off forgo critical years of saving. College graduates with student loans have retirement assets that are 50 percent lower than their peers without debt by age 30, and it can be difficult to catch up, according to a June report from the Center for Retirement Researchat Boston College.
At Abbott, which started enrolling employees in the voluntary program this month, any U.S. employee who devotes at least 2 percent of his or her paycheck to paying off student loans can get a 5 percent 401(k) contribution from Abbott. That’s the same percentage match given to employees who contribute 2 percent to their 401(k)s. The program will allow people to accumulate savings in their retirement accounts without committing any of their own money.
The medical device manufacturer, which is based in the north suburbs, said a couple of hundred people have signed up for the program so far and it anticipates several thousand will eventually take advantage of it.
“Student loan debt is one of the biggest financial concerns in the U.S. today and we’re thrilled we’ve been able to address this issue for our employees in an innovative, meaningful way,” Steve Fussell, executive vice president of human resources, said in an emailed statement. “We’re proud to be pioneers in this space and hopeful we may have paved a pathway for more companies to help employees with this crushing problem.”
While other companies wishing to offer the same benefit could also request an individual ruling from the IRS to protect them from questions down the road, having broader guidance affirming the legality of the practice would open the door wider, said Holdvogt. The letter from the ERISA industry group is a first step toward pushing the agency in that direction.
“The more interest there is, the more groups submit requests, the more likely it is the IRS will issue guidance,” Holdvogt said. “They want to be helpful.”

Glaxo researcher admits plot to steal secrets to sell in China


A cancer researcher has pleaded guilty to conspiring to steal biopharmaceutical trade secrets from GlaxoSmithKline in what prosecutors said was a scheme to set up companies in China to market them.
Yu Xue entered a guilty plea in federal court Friday to a single conspiracy count.
Prosecutors have described the 48-year-old U.S. citizen as one of the top protein biochemists in the world. She had worked at GlaxoSmithKline’s research facility in suburban Philadelphia for about a decade until charges were brought against her in early 2016.
Prosecutors had accused her of downloading and emailing confidential information and working with four others, including two people in China, charged in connection with the scheme.
During the hearing, Xue said she thought she held a patent for the information and did not understand it was a trade secret.

FDA Warns of Dangers of Liquid Nitrogen in Food, Drinks


You risk serious injury if you consume or handle food and drink products where liquid nitrogen is added just before consumption, the U.S. Food and Drug Administration warned Friday.
These products — which have names such as “Dragon’s Breath,” “Heaven’s Breath” and “nitro puff” — are available in food courts, kiosks, state or local fairs, and other places where food and drinks are sold.
Examples of such products include liquid nitrogen-infused colorful cereal or cheese puffs that emit a misty or smoke-like vapor, and alcoholic and nonalcoholic drinks prepared with liquid nitrogen that emit a fog.
Liquid nitrogen isn’t toxic, but its extremely low temperature can cause severe damage to skin and internal organs if mishandled or consumed, the FDA said in a news release. Inhaling the vapor released by liquid nitrogen in food or drinks can also cause breathing problems, especially among people with asthma, according to the agency.
“The main issue is that liquid nitrogen must be fully evaporated from food or beverage before it is served,” explained Dr. Robert Glatter, an emergency room physician at Lenox Hill Hospital in New York City.
“In liquid form, it can cause burns to the mouth, esophagus and upper airway, leading to perforation or rupture of the organs — which could be deadly,” Glatter said. “It may also cause burns of the fingers or hands when it is handled in the liquid state.”
And people with asthma or lung disease who inhale the vapors might experience constriction of their airways, triggering an asthma attack or worsening of their lung disease, he added.
“Beyond this, it may also lead to inflammation in the lungs and aspiration, which can reduce the ability to breathe, as well as trigger infections such as pneumonia,” Glatter said.
In fact, the FDA said it has received reports of severe and life-threatening injuries caused by liquid nitrogen in food and drinks, and also reports of breathing problems.
“With state fairs upon us, parents and teens need to understand the potential risks of foods such as nitro popcorn and nitrogen-infused cereals, which promise excitement and thrill but may end with a trip to the emergency department,” Glatter noted.
People who’ve suffered an injury after handling or consuming food or drinks prepared with liquid nitrogen should consult a health care provider, and also consider reporting their injury to MedWatch, the FDA’s safety reporting program, the agency said.
More information
The U.S. Food and Drug Administration has more on food safety.
SOURCES: Robert Glatter, M.D., emergency room physician, Lenox Hill Hospital, New York City; U.S. Food and Drug Administration, news release, Aug. 30, 2018

Attention Biotech Investors: September FDA Dates


August was a pretty steady month for biotechs. In terms of new molecular entity or NME approvals, the month was productive, with the FDA giving the go-ahead for seven of these products containing active moieties that haven’t been previously approved by the agency.
Several drug approvals came through this month and the second-quarter reporting season panned out to be a better one for biotechs, with large-caps reporting both earnings and revenue beats.
Now, here are the PDUFA catalysts that could trigger moves in the biotech space in September.
PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

Roche Seeks Expanded Use For its Lung Cancer Drug

  • Company: Roche Holdings AG Basel ADR RHHBY 0.55%
  • Type of Application: sBLA
  • Candidate: Tecentriq in combination with Avastin, paclitaxel and carboplatin, or chemotherapy
  • Indication: first-line treatment of non-squamous non-small cell lung cancer, or NSCLC
  • Date: Sept. 5
The application was submitted based on the Phase 3 IMpower150 study, which met the its co-primary endpoints of overall survival and progression-free survival. Tecentriq is currently approved to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has ALK and EGFR mutations.

Will FDA Go Against Panel Verdict And Back GlaxoSmithKline’s COPD Drug?

  • Company: GlaxoSmithKline plc (ADR) GSK 1.78%
  • Type of Application: sBLA
  • Candidate: Mepolizumab
  • Indication: Chronic obstructive pulmonary disease, or COPD, with an eosinophilic phenotype
  • Date: Sept. 7
Mepolizumab is GlaxoSmithKline’s add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with COPD, guided by blood eosinophil counts.
FDA’s Pulmonary Allergy Drugs Advisory Committee, which met in late July to discuss the sBLA for the drug, voted against its approval by a 16-3 margin.
Mepolizumab has already been approved by the FDA for treating patients with severe eosinophilic asthma.

No Headaches For Teva’s Migraine Drug?

  • Company: Teva Pharmaceutical Industries Ltd (ADR) TEVA 0.91%
  • Type of Application: BLA
  • Candidate: Fremanezumab
  • Indication: Migraine
  • Date: Sept. 16
The original PDUFA date for Fremanezumab was extended in May by three months. At that time, the company said there was no additional data request from the FDA.
Fremanezumab is a quarterly or monthly injection for the preventive treatment of migraine in adults.

Adamis Seeks Approval For Expanded Use Of Allergy Drug

  • Company: Adamis Pharmaceuticals Corp ADMP 1.79%
  • Type of Application: sNDA
  • Candidate: Low dose Symjepi (epinephrine) injection
  • Indication: Anaphylaxis
  • Date: Sept. 27
Adamis communicated FDA acceptance of its application Feb. 12, 2018.
Symjepi 0.3 mg dosage is already approved for treating Type 1 allergic reactions, including anaphylaxis, in patients weighing 66 pounds or greater. The low dose version, the review of which is pending before the FDA, is of 0.15 mg in strength and is intended to potentially treat patients weighing 33-65 pounds.
Anaphylaxis is a serious life-threatening allergic reaction.

Insmed Awaits Word On Lung Disease Drug After Mixed Panel Vote

  • Company: Insmed Incorporated INSM 8.62%
  • Type of Application: NDA
  • Candidate: Amikacin Liposome Inhalation Suspension, or ALIS
  • Indication: Nontuberculous mycobacterial, or NTM, lung disease caused by Mycobacterium avium complex, or MAC
  • Date: Sept. 28
NTM lung disease is a rare, progressive and potentially fatal disease. FDA’s Antimicrobial Drugs Advisory Committee, which met on Aug. 7 to discuss the safety and efficacy of ALIS, voted 12 to 2 in favor of the therapy.
The committee also voted in favor of the surrogate endpoint of sputum culture conversion used in the Phase 3 COVERT study reasonably predicting clinical benefit.
However, the committee voted against the safety and effectiveness of ALIS in the broadest population of adult patients with NTM lung disease caused by MAC.

Can Second Time Be Charm For Antares?

  • Company: Antares Pharma Inc ATRS
  • Type of Application: NDA
  • Candidate: XYOSTED (testosterone enanthate)
  • Indication: Testosterone deficiency
  • Date: Sept. 29
Following the issue of a complete response letter in October 2017, Antares made a resubmission, which was deemed by the FDA as a complete, class 2 response on March 29, 2018.

Eli Lily Seeks Approval For Migraine Drug

  • Company: Eli Lilly And Co LLY 0.11%
  • Type of Application: BLA
  • Candidate: Galcanezumab
  • Indication: Migraine in adults
  • Date: September (no date provided)
Galcanezumab is a monoclonal antibody that binds to calcitonin gene-related peptide, CGRP, produced in the neurons that plays a key role in the transmission of pain. The candidate is being evaluated as a once-monthly, self-administered injection via auto-injector pen or prefilled syringe.
The BLA submission was based on three studies, namely EVOLVE-1, EVOLVE-2 and REGAIN.

Pfizer’s Lung Cancer Drug Awaits FDA Nod

  • Company: Pfizer Inc. PFE
  • Type of Application: NDA
  • Candidate: Dacomitinib
  • Indication: Non-small cell lung cancer, or NSCLC
  • Date: Sep. (no date provided)
The FDA accepted the NDA for Dacomitinib in April, with the candidate, a pan-human epidermal growth factor receptor tyrosine kinase inhibitor, being evaluated as a first-line treatment for patients with locally advanced o metastatic NSCLC.
Pfizer also said the European Medicines Agency has also accepted the Marketing Authorization Application for dacomitinib for the same indication.

California set to serve healthy, ‘ethical’ food in institutions


California lawmakers on Thursday passed a bill requiring hospitals, healthcare facilities and prisons to offer plant-based meals, saying that even inmates deserve to have healthy and “ethical” meal choices.
The legislation, SB 1138, which passed overwhelmingly, allows patients and prisoners to choose a non-meat option at every meal, regardless of whether they are doing so for health, environmental or personal reasons.

The measure, sponsored by state Senator Nancy Skinner, a Democrat from Berkeley, still requires approval from Governor Jerry Brown to become law. Brown has not said whether he will sign the bill.
The bill would result in “minor costs to California Department of Corrections and Rehabilitation to prepare a plan to implement the provision of plant-base meals on an overall cost-neutral basis,” according to the Assembly Appropriations Committee.
“By guaranteeing access to plant-based food, SB 1138 respects the health, ethical and diet choices of those in hospitals or other institutions who don’t have the option to prepare their own meals,” Skinner said in a written statement.
The lawmaker said serving plant-based meals was also good for the environment, citing a 2014 study in the journal Climatic Change that vegetarian diets were associated with a reduction in food-related greenhouse gas emissions.

Curae, 3 affiliate hospitals in Miss. file for bankruptcy


Curae vows to keep hospitals open while new owner is found.
The health system has accumulated $96 million in liabilities.
Unanticipated EHR costs cited as a one of ‘several factors.’

Curae Health and three affiliated hospitals in Mississippi have filed for bankruptcy protection after claiming more than $96 million in liabilities, the Clinton, Tennessee-based hospital chain announced this week.
The affiliated Mississippi hospitals are: Gilmore Memorial Hospital, in Amory; Panola Medical Center, in Batesville; and Northwest Mississippi Medical Center in Clarksdale, which Curae leases.
Four Mississippi hospitals filed for Chapter 11 in the past week, including unaffiliated Magee General Hospital, which filed last Friday.
Curae said in a media release that the goal of the bankruptcy filing was “to ensure that the communities where these hospitals are located will continue to have access to local healthcare services.”
The not-for-profit health system blamed insolvency on “several factors.”
“Many rural hospitals across the country have faced year-over-year financial challenges due to government funding cuts, unfunded care mandates and other pressures,” Curae said.
“Our hospitals were not immune to these issues and after exhausting other possibilities, the decision was clear that the hospitals could not continue to operate under mounting debt and tightening financial resources,” the statement read.
Those pressures included unexpected expenses related to electronic medical records and a cash crunch that came as vendors demanded payment for outstanding debts.
Curae said the bankruptcy became the only viable course because cost-savings measures were outstripped by “a dramatic decline” in net revenues that came immediately after the hospitals were acquired from Community Health Systems in 2016.
Local media reported that bankruptcy filings made in Nashville showed that Curae Health and the three hospitals have $3.4 million in cash and cash equivalents and $96 million in liabilities. It owes lender ServisFirst $18.8 million. It owes Community Health Systems, which previously owned the three hospitals, $28.6 million.
“The conversion to a not-for-profit system combined with a lower cost structure was unable to keep pace with the dramatic decline in revenue,” Curae said.
Ownership of Curae’s Lakeland Community Hospital in Haleyville, Alabama, was transferred to a local authority this spring and it’s now managed by Java Medical Group. Curae’s fourth hospital, Russellville Hospital in northwest Alabama, has not filed for bankruptcy.

GOING FORWARD

Curae says its 1,245 employees will be paid through the bankruptcy proceedings.
The health system’s Mississippi hospitals “will be sold as going concerns to arms-length third parties who are able to keep them in operation so that they can continue to serve the community.”
“All potential acquirers of the hospitals will have the opportunity to express their interest in acquiring one or all of the hospitals and to bid for them in a fair and open process,” Curae said.
“We have been working with various interested parties to assist them in their review of the hospital(s) and anticipate filing a motion with the bankruptcy court to authorize the sale of the hospitals in the near term. Once the legal process is completed we hope the hospitals will emerge in a stronger financial and market position,” Curae said.
The North Carolina Rural Health Research Program says 87 rural hospitals have closed nationwide since 2010, including five rural Mississippi hospitals since 2013.