Allergan Archives - Medical Design Sourcing

Teva and Allergan reportedly agree to pay $5B billion to settle opioid allegations

[Prescription pill bottle image courtesy of Pexels]

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and AbbVie unit Allergan Plc (NYSE:ABBV) could pay more than $5 billion in total to settle some 3,500 opioid lawsuits, according to Bloomberg. While the two companies are willing to settle the suits in the consolidated case, the deal has not been finalized.

The consolidated case is titled In Re National Prescription Opioid Litigation, 17-MD-2804, U.S. District Court, Northern District of Ohio (Cleveland).

Teva and Allergan have reportedly been in mediation for more than a year.

In 2016, Teva completed a $40.5 billion acquisition of Allergan’s generic business, including generic opioids.

In 2020, AbbVie acquired Allergan.

Earlier this year, Teva Pharmaceuticals and AbbVie reached a deal with Rhode Island for a total of $28.5 million to settle opioid-related claims.

Teva entered…

FDA approves generic for dry-eye treatment Restasis

Viatris (NSDQ:VTRS) has received FDA approval for the first generic of Restasis (cyclosporine ophthalmic emulsion) eye drops.

FDA first approved the drug, which was developed by Allergan, in 2003.

Now marketed by AbbVie (NYSE:ABBV), Restasis sales are on the order of $1.2 billion annually.

AbbVie recently noted in its projections for 2022 that it expected to maintain U.S. exclusivity of the drug.

Although no longer covered by patent protection, “the complex nature of the product” delayed the launch of a generic, wrote Truist analyst Gregory D. Fraser in a briefing note.

Generic Restasis revenue could be “a material sales contributor for VTRS given the size of the market and potential for limited competition,” Fraser said.

To attempt to discourage generic competition tied to Restasis, Allergan transferred six patents related to the drug to the St. Regis tribe of the Mohawk people in 2017. Allergan made an upfront payment of $13.75 mi…

FDA approves first eye drop for presbyopia

AbbVie (NYSE:ABBV) subsidiary Allergan has received FDA approval for Vuity (pilocarpine HCl ophthalmic solution), a novel eye drop for treating presbyopia. This common age-related condition leads millions of middle-aged people to acquire reading glasses.

Vuity is a once-daily prescription eye drop.

Presbyopia, or age-related blurry near vision, can be diagnosed through a basic eye exam by an eye doctor (optometrist or ophthalmologist) and is a common and progressive eye condition that affects 128 million Americans, or nearly half of the U.S. adult population.

“We are pleased to be able to bring this first-of-its-kind treatment to market sooner than expected for the millions of Americans with presbyopia who may benefit from it,” said Jag Dosanjh, senior vice president of medical therapeutics, Allergan, in a press release.

Vuity uses Allergan’s proprietary pHast technology, which facilitates the eye drop’s ability to adapt to the physiol…

The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news release.

Nominees need to be FDA-approved for the market within the last five years a…

The 18 most innovative medical devices of 2021

[Images from BD, Edwards, Alcon and CVRx]

The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards.

The foundation nominates devices, biotechnology and pharmaceutical products for its annual Prix Galien awards to highlight products designed to improve the human condition.

“The Awards Committee is excited to introduce the nominees for the 2021 Prix Galien USA Awards. These products have been created by scientists who have dedicated their lives to discovering, developing and distributing life-saving answers for patients,” said Sue Desmond-Hellmann, chair of the Prix Galien USA and Prix Galien International Award committees and former CEO of the Bill & Melinda Gates Foundation.

“We appreciate the opportunity to honor these researchers and their tireless efforts,” Desmond-Hellmann said in a news releas…

Allergan must face breast implant class action

A federal judge in New Jersey on Friday shut down part of Allergan’s request to dismiss a multi-district lawsuit over its Biocell textured breast implants, but kept most other parts of the litigation.

Judge Brian Martinotti ruled that some of the plaintiffs’ claims against Allergan (now part of AbbVie) were preempted by federal law while most others could stand — including one alleging that Allergan failed to report adverse events related to Biocell implants to the FDA.

Textured breast implants have been linked to BIA-ALCL, a type of non-Hodgkin’s lymphoma. The FDA asked Allergan to recall its Biocell textured implants in July 2019, saying that “the risk of BIA-ALCL with Allergan BIOCELL textured implants is approximately six times the risk of BIA-ALCL with textured implants from other manufacturers.”

The recall covered 246,831 Biocell implants in the U.S., according to the judge’s order. Allergan refuses to pay the implants’ users for …

FDA: Thousands of new breast-implant-related illnesses reported

The FDA today reported that it has received nearly 2,500 new reports globally of “breast implant illness” or BII. Reports of new breast implant-related cancer were also up.

BII is not cancer, nor is it a term often found in medical literature, the agency said. But it is frequently used by patients and healthcare providers when reporting adverse events related to breast implants.

The new total of 2,497 new BII reports that the FDA collected globally dates from November 2018 to October 2019. That’s in addition to the 1,080 BII case reports received from January 2008 through October 2018. The agency attributed the increase to heightened awareness from press, social media and its General and Plastic Surgery Devices Advisory Committee meeting held in March 2019.

The top 10 most common BII symptoms reported to the agency include fatigue (49%), brain fog (25%), joint pain (25%), anxiety (24%), hair loss (21%), depression (19%), rash (1…

Allergan, Ideal Implant targets of FDA warning letters

The FDA issued warning letters today to two breast implant manufacturers for failure to comply with regulatory requirements.

One letter went to Allergan (now part of AbbVie) for failing to comply with requirements — under two separate premarket approval orders — to conduct post-approval studies to assess the long-term safety and risks of two models of breast implants, both of which were voluntarily recalled from the market last year. The FDA also issued a warning letter to Ideal Implant (Dallas, Texas) for failure to comply with current good manufacturing practice requirements and adverse event reporting requirements following an inspection conducted earlier this year.

Every manufacturer of FDA-approved silicone gel-filled breast implants must conduct post-approval studies to further evaluate the implants’ safety and effectiveness and to answer additional scientific questions about the long-term safety and potential risks of breast implants that their pre…