Prescription and over-the-counter eye ointment recalled

Possible sterility issues caused a massive recall of eye ointments, including 91 lots of over-the-counter ointments sold at Walmart, Walgreens and elsewhere.

Another 59 lots of prescription eye ointments made by Altaire Pharmaceuticals for Perrigo Company were included in Wednesday’s announcements. In the company-written, FDA-posted notice of the Perrigo recalls, Altaire said the recalls were, “due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility.”

While the notice said none of the products have tested outside the sterility guidelines, the risk is “administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.”

Of the over-the-counter eye ointments in this recall, 74 lots were sold as Walmart’s store brand, Equate:

Restore Tears Lubricant Eye Drops, Twin Pack; Eye Allergy Relief Drops; Sterile Lubricant Stye Ointment; Comfort Gel Lubricant Eye Gel, Twin Pack; Restore PM Nighttime Lubricant Eye Ointment; Night & Day Restore Tears Lubricant Eye Pack; Equate Support Advanced, Twin Pack; Supprot advanced Lubricating Eye Drops Dose Preservative Free; Support Advanced Lubricant Gel Drops Multi-Dose Preservactive Free; Support Moisture Lubricant Eye Drops; and Support Harmony Lubricant Eye Drops.

If you use any of the above Equate products, click here to see if your ointment was in a recalled lot.

Another six lots of eye ointments were sold as Walgreens store brand:

Lubricant Eye Drops Moisturizing, lot No. 19095; Lubricant Eye Drops Moisturizing Twin Pack, lot No. 19095; Sodium Chloride Ophthalmic Ointment, 5% Hypertonicity Eye Ointment, lot No. TCI; Sodium Chloride Ophthalmic Solution, 5% Hypertonicity Eye Drops, lot Nos. 19105 and 19050; and Lubricant Eye Ointment PF Soothing, lot No. TDB.

And 11 over-the-counter ointments made for Perrigo were sold as Puralube Ophthalmic Ointment. The lot Nos. for those were RJH, SCC, SGA, SGH, SHH, SLL and TAC in the 3.5gm tubes; and RKM, SGA, SIF and SKE in the 1gm tubes.

The 59 lots of prescription ointments are Neomycin and Polymixin B and Bacitracin Zinc Ophthalmic Ointment; NEO-POLY DEX (Neomycin and Polymixin B and Dexamethasone) Ophthalmic Ointment; NEO-POLYCIN HC (Neomycin and Polymixin B and Bacitracin Zinc and Hydrocortisone Acetate) Ophthalmic Ointment; POLYCIN (Polymixin B and Bacitracin Zinc) Ophthalmic Ointment; Bacitracin Ophthalmic Ointment; and Sulfacetamide Sodium Ophthalmic Ointment.

The recalled prescription drug lot list can be found here.

https://www.marketscreener.com/PERRIGO-COMPANY-PLC-15809538/news/Perrigo-Massive-prescription-and-over-the-counter-eye-ointment-recall-over-sterility-concerns-28855299/

Celyad provides update on CAR-T therapies in solid tumors

Celyad (NASDAQ:CYAD) announces that preliminary interim data from the ongoing SHRINK and alloSHRINK Phase 1 trials assessing safety and clinical activity of the NKG2D-based CAR-T therapies CYAD-01 (autologous) and CYAD-101 (allogeneic) for the treatment of metastatic colorectal cancer (mCRC) was presented at the European Society for Medical Oncology (ESMO) 21^st World Congress on Gastrointestinal Cancer (WCGIC).

SHRINK Phase 1 Trial Update: Treatment with CYAD-01 with standard FOLFOX chemotherapy was generally well-tolerated, with no reports of cytokine release syndrome (CRS) grade 2 or higher, related serious adverse events (SAEs) were observed.

A dose–dependent effect on the kinetics of cells with higher levels of cell engraftment was observed.

AlloSHRINK Phase 1 Trial Update: No clinical evidence of Graft-versus-Host Disease (GvHD) have been observed.

Host-versus-Graft (HvG) response against the allogeneic CYAD-101 cells appears to be controlled following the second and third infusions of the allogeneic cell therapy.

Initial observations of disease control, including partial response and stable disease, were observed with CYAD-01 and CYAD-101, in patients who have received prior FOLFOX chemotherapy.

CYAD-101 appears to provide better relative cell engraftment as compared to CYAD-01, at the same dose levels.

Recruitment in alloSHRINK trial is ongoing and preliminary results from the cohort are expected by year-end 2019.

https://seekingalpha.com/news/3475865-celyad-provides-update-car-t-therapies-solid-tumors

Cytori Restructures In Bid To Focus Resources On Lung Cancer Drug

Thinly traded nano-cap biotech Cytori Therapeutics Inc CYTX 0.99%, which has been trading in penny stock territory for about a year now, could see some activity in the wake of a company announcement Friday.

What Happened

Cytori said in an filing with the SEC that CFO Gary Titus notified the company of his intention to resign from his position effective immediately; Cytori said he will continue with the company as an adviser.

The company said its board has approved the appointment of Alan Lins as Titus’ successor as vice president of finance and controller.

The company also said in a filing it has commenced restructuring activities that include a reduction in combined staffing in its California facilities by 46% overall, a reduction in its office space in San Diego; and the streamlining and outsourcing of operations.

Why It’s Important

These actions will extend Cytori’s cash resources, allowing it to focus on its drug pipeline and ATI-1123 in particular, according to the company.

Cytori issued an update Monday on the development of ATI-1123 in the wake of feedback from the FDA that suggested the company could use the 505(b)(2) pathway for regulatory submission.

The regulatory body also said completed non-clinical studies are sufficient to support the initiation of the clinical trial of ATI-1123 in patients with platinum-sensitive small cell lung cancer who have progressed at least 60 days after the initiation of the first-line therapy.

ATI-1123, a substantially redesigned and reformulated new drug based in part on the active pharmaceutical ingredient docetaxel, is in a Phase 1 trial.

Cytori intends to proceed with a follow-on Phase 2 trial.

Cytori said it expects to incur a restructuring charge of about $71,000 primarily in the third quarter of 2019.

https://www.benzinga.com/general/biotech/19/07/14033987/cytori-cfo-resigns-biotech-restructures-in-bid-to-focus-resources-on-lung-cancer-drug

Zai Lab started at Outperform by Macquarie

https://www.benzinga.com/stock/ZLAB/ratings

A look at Cigna’s international NGO health plans

Cigna has more than 15 million members in the U.S. But plenty of people might not realize an additional 1.5 million of the insurance giant’s members live abroad—some of whom are in some of the most dangerous regions of the world.

This growing market is where Angela Rooney, who is Cigna’s nongovernmental organizations (NGOs) director, specializes.

Cigna has been in the business of insurance for NGOs doing humanitarian work worldwide for 60 years, Rooney said in an interview with FierceHealthcare in June during an NGO workshop hosted by the insurer in Washington, D.C. That includes being available to meet the needs of NGO workers around the clock.

Cigna’s NGO team could be assisting a member with a snakebite one day and helping with another group in a war zone the next, Rooney said.

“Their missions are very important to us,” Rooney said.

Because the circumstances NGOs are operating in can be so varied, Rooney said that Cigna builds benefits packages for each that are tailored to the region they’re working in. For example, a group in a remote location with limited or no internet access may not be able to fully take advantage of telehealth.

The healthcare infrastructure in these regions can also be quite different, she said. Cigna builds a coverage network around where NGOs are located when they contract for benefits.

“It’s duty of care at its extreme,” Rooney said. “Everyone who works at Cigna for our NGOs thinks it’s so fulfilling because you’re helping people in desperate need and doing some good for the world.”

The insurer operates such plans in more than 100 countries and provides local case managers to NGOs in Kenya, South Africa, Chile, Belgium, Spain and Malaysia. Stateside case managers are also based in Miami, Florida.

Cigna also operates an international medical board in several countries and is directly contracted with more than 1,550 providers in Africa alone. The continent is a key growth target for the insurer, Rooney said; Cigna has offered insurance products in Africa since 2008 but significantly expanded its scope with the launch of Hollard Cigna Health in 2016, which is a partnership with Hollard Insurance Group, another payer active in Africa.

Cigna’s membership on the continent has grown to more than 200,000 people.

A crucial focus for Cigna’s NGO team is the mental health of workers in the field, Rooney said. Burnout is a risk, she said, and many of these workers are in dangerous situations. A key solution is including video counseling visits in benefits packages, which can be easier for workers to keep up with than in-person therapy.

Mental health checks are also built into the onboarding and offboarding processes, both for Cigna’s plan specifically and within most NGOs, Rooney said.

“They’re so committed that they don’t really want to break assignment to leave,” Rooney said. “So, the more we can offer support and tech processes, they can remain in that location.”

Pre- and post-international work also includes routine physicals and health checks. Cigna deploys physicians who specialize in tropical diseases where needed and works with local specialty doctors as well when possible.

Rooney said she and her team never know when they’ll get that call about an emergency situation—but they’re always ready.

“This is when NGOs need you and you’ve got to be there,” she said.

https://www.fiercehealthcare.com/payer/a-look-at-cigna-s-international-ngo-health-plans

Post-Shire buy, Takeda investors want execs to return pay if performance lags

Takeda wrapped up its $60 billion Shire takeover early this year with massive support from shareholders, despite previous resistance. But the weight on the deal’s mastermind, Takeda CEO Christophe Weber, is far from over.

At the company’s general meeting last week, the majority of Takeda investors backed a proposal that would allow Takeda to claw back executive pay should the Shire deal not live up to expectations.

Though 52.2% of attending shareholders voted in favor of the new clause, it fell short of the two-thirds majority needed to move through, according to a securities filing posted on Tuesday. Still, it’s a clear sign that investors intend to keep members of management responsible for their major decisions.

The proposal didn’t specifically name Shire, but it referred to “excessive investment in the past” in general. If an impairment loss arises later that renders the compensation amount under the long-term incentive plan incorrect, or if the indicators for performance-based pay are erroneous, the pay package should be recalculated and the difference be returned, it says.

In the previous fiscal year that ended in March, Weber racked up 1.76 billion yen ($16.3 million) in total pay, with about half from long-term incentives, according to Takeda’s just-filed annual report. Those figures are on par with Celgene CEO Mark Alles’ $16.2 million for the 2018 calendar year.

Unlike its Western peers, Takeda doesn’t lay out the details of how it calculates compensation for executives. A separate proposal that asks Takeda to disclose the logic and math behind each individual executive’s pay was also defeated, even though it racked up almost half of all votes in favor.

Influential proxy advisers Institutional Shareholder Services (ISS) and Glass Lewis previously backed both proposals and likely influenced foreign investors, who own 50.7% of the Japanese pharma, Nikkei Asian Review reported. The financial newspaper also said that Takeda will consider increasing transparency behind executive pay and adding a clawback provision in its internal rules rather than making them formal revisions to the articles of incorporation.

Weber’s efforts to take in Shire ended with his victory in January after 88% of votes supported the deal a month before. But the French-born CEO had to fight hard. Descendants of the Takeda founding family, including former Takeda chairman Kunio Takeda, openly objected to the buyout, citing high risks as the company took on a $31 billion loan to fund the deal. Concerns also pointed to competition to Shire’s hemophilia franchise, which made up about 20% of the Irish company’s revenue.

ISS and Glass Lewis previously both recommended that investors vote to approve the gigantic deal. “The deal diversifies the company in terms of products and geographies, and provides strong cash flow generation that, combined with divestments, allows for relatively rapid deleveraging, despite maintaining top of the range leverage in the mid-term,” ISS said in a report to clients, as quoted by Reuters in November.

To help pay down debt, the company recently sold Shire’s eye drug Xiidra to Novartis for $3.4 billion upfront and up to $1.9 billion in potential milestone payments. As of March, Takeda’s net debt was 4.7 times its adjusted earnings. The plan is to sell some noncore assets worth $10 billion and bring down the ratio to 2x within three to five years.

https://www.fiercepharma.com/pharma/shire-deal-haunts-takeda-ceo-as-investors-want-execs-to-return-pay-if-performance-lags

Grifols Gets FDA OK for Xembify® for Primary Immunodeficiencies

– Xembify® is Grifols’ first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies

– Grifols is a frontrunner in disease treatment with immunoglobulins, and this approval will enable the company to further expand its portfolio of plasma-derived medicines to benefit of patients and healthcare professionals

– Xembify® represents a significant R+D+i milestone for Grifols and an important step forward in its long-term sustainable growth strategy

– The company plans to launch Xembify® in the United States in the last quarter of the year and is working to obtain additional approvals in Canada, Europe and other global markets

https://www.prnewswire.com/news-releases/grifols-announces-fda-approval-of-xembify-20-subcutaneous-immunoglobulin-for-primary-immunodeficiencies-300880234.html