Lannett to cut 50 jobs at Wyoming plant

Lannett Co. is eliminating about 50 positions at its Cody Laboratories subsidiary as part of a restructuring and cost reduction plan expected to generate $10 million in annual savings for the Northeast Philadelphia generic drug.

Cody Laboratories, based in Wyoming, develops and manufactures active pharmaceutical ingredients [APIs] of pain management medicines. Lannett bought the company in 2007 to diversify its product offerings and it had about 130 employees at the start of the year. Lannett said in 2017 it was investing $50 million to expand the plant.

“In recent years the regulatory and competitive landscape for pain management APIs has changed, extending Cody’s timeline to profitability and causing us to revise our plan for this business,” said Tim Crew, Lannett’s CEO. “We determined the substantial continuing investment to attain the size and scale necessary to become a broad competitive force in that space was inconsistent with our renewed focus on our core business, where we see a great deal more near-term opportunities to grow high value assets.

“Nevertheless,” Crew continued, “Cody continues to offer intriguing vertical integration opportunities. We remain committed to investing in Cody’s operations, albeit in a more targeted and selective manner.”

As part of the Cody site’s restructuring, the company intends to transfer production of finished dosage liquid pharmaceutical products to its Carmel, N.Y., facility, and discontinue the manufacture of the less profitable products the plant makes.

Lannett said it expects the restructuring to be substantially completed by this December. The company estimates that it will incur about $5 million of total costs to implement the plan, comprised primarily of severance and employee related costs.

https://www.bizjournals.com/philadelphia/news/2018/06/29/lannett-layoffs-50-jobs-wyoming-cody-labs.html

Allscripts acquires specialty medicines platform developer

CNBC reports that AllScripts (MDRX) has acquired ZappRx, a start-up that aims to modernize how people access prescription drugs. It was started in 2012 in Boston by a former Wall Streeter after her brother was diagnosed with severe epilepsy and needed access to specialty medicines.

The buyout price is confidential, but informed sources say it was less than the $40M it had raised to date.

https://seekingalpha.com/news/3471218-allscripts-acquires-specialty-medicines-platform-developer

AMA updates recommendations for medical AI usage

Almost exactly one year after issuing its first policy recommendations on the use of artificial intelligence in medicine, the American Medical Association clarified its goals regarding medical AI and expanded its corresponding list of policy recommendations during the AMA House of Delegates annual meeting this week.

While the AMA’s initial recommendations for AI usage primarily addressed challenges in the design, evaluation and implementation of advanced technology, the new report shifts the focus instead to the effects of that implementation on patient outcomes, physician satisfaction and the costs of care.

The AMA pledged to achieve those outcomes by advocating for, among other factors, greater oversight and regulation of healthcare AI systems; payment and coverage for systems that comply with safety and privacy laws and streamline clinical workflows; and clearly aligned liability and incentives for mandatory uses of medical AI.

Read the AMA’s full updated list of policy recommendations regarding AI here.

https://www.beckershospitalreview.com/artificial-intelligence/ama-updates-recommendations-for-medical-ai-usage.html

How to protect your at-home DNA test data

Since at-home, direct-to-consumer DNA testing kits are still relatively new, fall somewhere in the murky area between the commercial and healthcare sectors and are not subject to HIPAA-protected physician approval, they can pose major risks to the privacy of users’ most personal health information.

Until stricter laws are put in place to regulate how consumer genomics companies use and share data, they are largely at will to distribute it to third parties such as insurance companies, law enforcement, pharmaceutical companies and more. Mailing in a cheek swab is registered as consent for 23andMe, Ancestry.com and their competitors to share a customer’s DNA results with a whole host of third parties.

Here, according to The New York Times, are tips for protecting at-home test data both before and after submitting DNA for testing.

1. Choose a major company: James Hazel, PhD, a postdoctoral fellow at the Center for Genetic Privacy and Identity in Community Settings, told NYT that larger, well-known companies like 23andMe, Ancestry.com and MyHeritage are more likely to have comprehensive privacy policies that hold them accountable for users’ data privacy than smaller, newer firms.

2. Read the fine print: Before signing up for a DNA testing service, read the privacy policy and user agreements to learn how and in what form data will be shared. For reference, “de-identified aggregate data” cannot be traced back to an individual, while “de-identified individual-level data” theoretically can. Additionally, the agreements may ask for permission to store DNA samples for future testing or to connect long-lost relatives with matching DNA, two deeply personal options that should be considered before giving consent.

3. Know how to revoke DNA test data: All of the major DNA testing companies offer customers the option to delete their data and test results from the company’s database. Users should familiarize themselves with those processes, but keep in mind that some identifying data may still be kept on record and that deleting data from the testing companies will not necessarily revoke it from the third parties with whom it has already been shared.

https://www.beckershospitalreview.com/healthcare-information-technology/how-to-protect-your-at-home-dna-test-data.html

Noninvasive laser detects, kills melanoma cells in bloodstream

A noninvasive device using laser, ultrasound and phone technologies can detect and destroy circulating tumor cells (CTCs) in a cancer patient’s bloodstream without drawing any blood, according to a studypublished June 12 in Science Translational Medicine.

Scientists at the University of Arkansas for Medical Sciences in Little Rock used the Cytophone device on patients with and without melanoma. The device correctly identified all 19 healthy patients, and detected CTCs in 27 of 28 melanoma patients. Due to its high level of sensitivity, the tool was able to detect CTCs in patients with melanoma tumors not visible on the skin, due to either small size or surgical removal.

The Cytophone uses photoacoustic flow cytometry to scan a patient’s entire blood supply for CTCs, which are often sparse and difficult to detect, with the ability to identify even just one CTC per liter of blood, a detection rate approximately 1,000 times more sensitive than existing methods. Those methods require blood draws, allowing them to search for CTCs in only a small amount of blood.

Once CTCs are detected, the Cytophone also destroys the cancerous cells without harming any surrounding cells. As a result, the device is able to prevent metastasis by stopping the disease from traveling to other parts of the body through the bloodstream.

https://www.beckershospitalreview.com/healthcare-information-technology/noninvasive-laser-detects-kills-melanoma-cells-in-bloodstream.html

FDA OKs Amgen’s Herceptin biosimilar

The FDA approves Amgen’s (AMGN +0.4%) KANJINTI (trastuzumab-anns), its biosimilar to Roche’s (OTCQX:RHHBY +0.4%) Herceptin (trastuzumab).

https://seekingalpha.com/news/3471195-fda-oks-amgens-herceptin-biosimilar

Questions surround Bone Therapeutics’ spine data

The company needed a hit in its spine trial, and it claims to have got one.

The disastrous halting of a trial of Bone Therapeutics’ cell therapy Preob in hip osteonecrosis last autumn left the Belgian group in a precarious position. It is now claiming a hit with its one real remaining hope, the allogeneic osteoblast product Allob, in a phase IIa study in lumbar spinal fusion, and the company’s stock is up 9% so far today.

But with no control group the study does not settle the question of how much of the benefit seen was actually conferred by Allob.

Today’s news appears good. The trial enrolled 30 patients with degenerative spine disorders to whom Allob was administered at the surgical site during the standard fusion procedure for the lumbar vertebrae. This standard treatment involves the surgical implantation of an interbody cage with bioceramic granules into the spine.

Fusion

A year after the procedure successful fusion was seen on CT scans in in 22 out of 30 patients (73.3%). Bone Therapeutics gives a p value for this – less than 0.001 – despite the trial having no control group. It is comparing the one-year outcomes to baseline, in which case it is hardly surprising that there was an improvement.

Indeed, owing to the trial’s design, it is impossible to say whether the improvement was down to the inclusion of Allob or simply the standard spinal fusion procedure.

“How can we be sure the efficacy is coming form Allob? Obviously without a control we will never be sure,” Thomas Lienard, Bone Therapeutics’ chief executive, told Vantage on a conference call to discuss the results. He said that the trial’s objective was not to go head-to-head with another type of treatment but rather to have information on the safety of Allob and indications of its efficacy.

Professor Bronek Boszczyk, head of spinal surgery at Benedictus Hospital, Tutzing, Germany, said the trial was a cohort study, and as such the control group would be historical data from other studies.

“We believe the results are strong compared with the standard procedure alone,” Mr Lienard added.

Fracture trial

In its press release, the company added that the other eight patients showed evidence of bone formation, and said that 13 of the first 15 patients who reached the 24-month follow-up time point (86.7%) showed successful fusion.

It then stated that “treatment with Allob resulted in a clear and statistically significant clinical improvement from the pre-treatment baseline in functional disability” since 63% of the trial patients had improvements on the Oswestry Disability Index. It again gives a p value of less than 0.001. But again the data do not show that this improvement can be definitively attributed to Allob.

The company now plans to push Allob forward in its other indication, delayed-union or non-union fractures, with a phase II/III trial pencilled in for next year. The next steps in spinal fusion are not yet clear.

Perhaps it is not unusual for a phase IIa trial to dispense with a control group. But claiming statistical significance under these circumstances looks disingenuous.

https://www.evaluate.com/vantage/articles/news/trial-results/questions-surround-bone-therapeutics-spine-data