FDA said it has received reports of 457 unique cancer cases related to breast implants since 2010, including nine patient deaths. The agency identified those unique cases from a total of 660 adverse event reports in the U.S. from 2010 through September 2018, including 246 new adverse event reports since 2017. FDA began reporting on cases […]
Report: Pharma companies kick off new year with price hikes
Major pharmaceutical firms started the new year by hiking the prices of hundreds of drugs, according to a new study published by Rx Savings Solutions. First reported in The Wall Street Journal, the study found that the average price increase taken by more than three dozen companies was roughly 6.3%. Get the full story at our […]
Report: Despite settlement, patient seeks prosecution for off-label Seri scaffold breast surgery
A patient in Southern California who underwent breast reconstruction surgery using an off-label Seri surgical scaffold is pushing for the state to prosecute the operating plastic surgeon, despite having received $1 million in a settlement, over claims that he altered her medical records, according to a Pasadena Star News report. The patient, Wendy Knecht, underwent […]
Allergan pulls textured breast implants from the European market
Allergan (NYSE: AGN) has removed its textured breast implants from the market in Europe following a recall request from French regulators. France’s National Agency for the Safety of Medicines and Health Products said that it hasn’t “identified any immediate risk for the health of women carrying the implants,” and that it plans to convene an expert committee […]
FDA approves five-year hormonal contraceptive
Allergan (NYSE:AGN) and the nonprofit women’s health pharma company Medicines360 said today that the FDA approved an application to extend the duration of use for Liletta for the prevention of pregnancy for up to five years. Medicines360 first won approval for the levonorgestrel-releasing intrauterine device in February of 2015. The system’s latest FDA approval is based on a […]
FDA pushes back on silicone breast implant study
The FDA last week pushed back at a large study showing an association between silicone breast implants and some rare diseases, standing by its record of warning the public about their risks – despite granting approvals to a slew of the implants in recent years. The study, published Sept. 14 in the Annals of Surgery, […]
Oyster Point takes aim at the root of dry eye disease with intranasal drug-delivery technique
Large pharmaceutical companies dominate the dry eye disease space – Allergan (NYSE:AGN) rakes in more than a billion dollars every year for its Restasis eye drops. Eight-person Oyster Point Pharma wants in on that market. But it’s betting on a completely different approach. “What we’ve come up with is a very innovative nasal spray, which when sprayed into the […]
Tribe taking steps to ‘ramp up’ drug patent business
The Native American tribe wrapped up in litigation with generic pharmaceutical companies is trying to prove that its arrangement with Allergan (NYSE:AGN) reflects a legitimate move to boost its economy, according to court documents. The St. Regis Mohawk Tribe of New York found itself it the middle of a controversial deal this year after it agreed to […]
Allergan touts 5-year data for Liletta intrauterine contraceptive
Allergan (NYSE:AGN) and its nonprofit partner, Medicines360, touted five-year data today from an on-going pivotal trial of its intrauterine device, Liletta. The levonorgestrel-releasing contraceptive is approved in the U.S. to be used to prevent pregnancy for up to four years. Get the full story at our sister site, Drug Delivery Business News.
Report: Takeda raises $60B offer for Shire, nears prelim acquisition agreement
Takeda Pharmaceutical (TYO:4502) has sweetened its approximately $60 billion bid for Shire (NSDQ:SHPG) and is approaching a preliminary agreement for acquisition, according to a new report from Bloomberg. The deal could come to a head as early as today, according to the report, as both companies have been working on a tentative agreement and price for the […]
Allergan, Takeda spar for Shire
Allergan (NYSE: AGN) today confirmed that it’s in the running to acquire Shire (NSDQ:SHPGY), which rejected a $63 billion offer from Takeda Pharmaceutical (TYO:4502). Dublin-based Allergan, which is in the process of slashing 1,400 jobs from its payroll and exploring “strategic actions,” said there’s no guarantee it will make an offer for Shire. Get the full story at our sister […]
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