Child ingests antipsychotic drug, leading Novartis to recall packages that don’t meet child safety rules

Novartis and its generics unit Sandoz are voluntarily recalling nearly half a million packages of medications after a child opened a “child-proof” blister pack and ingested a tablet of antipsychotic medication haloperidol.

The recall of 470,000 packages of a variety of drugs was announced Friday by the Consumer Product Safety Commission, which said, “The prescription drug packaging is not child resistant as required by the Poison Prevention Packaging Act, posing a poisoning risk if swallowed by children.”

It didn’t say how, or if, the child was affected. A Novartis logo is pictured on its headquarters building in Mumbai


Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to collaborate with internet stakeholders to stop the illegal sale of opioids online

FDA Director Scott Gottlieb said in a statement that the Internet, although not the only channel for illegal prescription drug sales, has the most profound impact and poses unique challenges for technology companies, law enforcement agencies and the FDA. In the future, FDA will use big data solutions and artificial intelligence technologies to grasp the channels and locations for illegally selling prescription drugs through the Internet.

A crisis of this magnitude requires broad, collaborative and creative approaches. We’re especially aware that as we take more actions to curb the lawful prescribing of prescription opioids, our actions will inevitably push more and more people to obtaining opioids from illicit sources. And we know that digital drug dealers and other criminals are increasingly selling their illicit opioids through the internet, including social media and illegal online pharmacies. This activity is contributing to the public health emergency of opioid-related overdose deaths that have ripped apart families and communities. We (FDA) aim to confront these new threats.

See more details on U.S. Department of Health and Human Services

AbbVie invests in switchable CAR-T therapies for cancer

AbbVie is partnering with Calibr to develop universal CAR T cells directed to different tumors via antibody switches. he partnership shows AbbVie’s excitement about new, controllable versions of cell therapy that are just now beginning to move into clinical studies.

In the partnership with AbbVie, Calibr will receive an up-front payment and will grant AbbVie exclusive access to its switchable CAR-T system for up to four years. AbbVie may acquire an exclusive license for the system during that time. Calibr will also develop multiple switchable CAR-Ts directed at several solid-tumor antigens picked by AbbVie. The duo isn’t disclosing financial details about the partnership, but Calibr Chief Operating Officer Matt Tremblay says, “This is the biggest deal that we’ve done by far.”


French regulators cite contamination, other issues at factory of Indian API maker Dhanuka Labs

The French National Agency for Medicines and Health Products Safety issued a warning letter to Indian API maker Dhanuka Labs after inspectors found a risk for product contamination and other issues at its Gurgaon, Haryana, plant.

In its letter posted on the EudraGMPD website, the French regulatory agency said an inspection conducted in late March found a total of 24 deficiencies at the factory that produces APIs for antibiotics, including cephalosporin.

Of the issues, one was critical in that inspectors found multiple risks of contamination. Other problems listed as major included water-quality control, insufficient maintenance of the plant, material storage issues and validation problems.

In its letter, the agency recommended a recall be issued of batches already released. Additionally, it called for the plant to be prohibited from supplying APIs until the issues at the facility are resolved.

FDA hits CDMO Kolmar Korea with warning letter over manufacturing issues

The FDA issued a warning letter to Korean contract drug manufacturer Kolmar Korea, citing significant GMP issues stemming from an inspection conducted last September.

In a letter posted to the regulatory agency’s website, the FDA said inspectors found that the company failed to investigate out-of-specification results for certain lots of an over-the-counter cream and instead retested and invalidated the OOS results without justification.

Additionally, FDA inspectors said Kolmar Korea didn’t follow its own written procedures for document control, which require quality control unit approval for discarding records. (See more details on fiercepharma)


FDA wants social media giants to help crack down on illegal opioid marketers

The FDA’s latest crackdown targets pharmacies hawking illegal opioids online. The agency issued warning letters this week to nine online pharmacies that run 53 websites selling drugs with suspect monikers like “Roxycodone” and “Tramadol Generic.”

Many of the websites shut down one day later, but at least one——was still operating Thursday morning.

While legitimate FDA-approved pharma opioid makers had long quit marketing to consumers and even doctors, the illegal online pill-pushing remains rampant. And the FDA is trying to enlist the online platforms that host or display ads from the fly-by-night pharmacies.

Johnson & Johnson suffers another cancer-suit loss as talc case count climbs above 9,000

In the second trial loss for Johnson & Johnson’s talc products in as many months, a jury in Los Angeles ordered the company and other defendants to pay $25.75 million in damages to plaintiff Joanne Anderson.

Anderson sued J&J and its co-defendants alleging the company’s Baby Powder contains asbestos and caused her mesothelioma, a type of lung cancer linked with the substance. The jury originally handed down compensatory damages of $21.75 million after trial, and followed that up on Thursday with an award of $4 million in punitive damages, according to Androvett Legal Media. J&J is liable for two-thirds of the verdict amount.

A J&J spokesperson said the company is “disappointed with the verdict and we will begin the appeals process.” The company will “continue to defend the safety of our product because it does not contain asbestos or cause mesothelioma,” she added.

See more details on FiercePharma

Johnson & Johnson