Drugs & Medical Devices Archives - Page 84 of 90

User Groups, Congressman push E-Free Act to Revoke PMA Status for Bayer’s Essure

Staff - October 12, 2015

Congressman Fitzpatrick’s law simply reads: “Not later than 60 days after the date of enactment 8 of this Act, the Commissioner of Food and Drugs shall issue an order under section 515(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(e)) withdrawing approval for Essure System.” Essure Problems is also asking others who have experienced complications from the device to also send their Representatives this letter (which is provided in Word Doc. Format at the bottom of the page).

Behind The Red Tape – By Angie Firmalino, Founder of Essure Problems

Staff - September 28, 2015

We have the answers for you panel members, we have the answers for you FDA, all you have to do is ask us and we will show you. I am not a doctor, I am a metal smith. But that does not make my knowledge of Essure less real, it doesn’t make our knowledge or our information untrue. We can present to you allergy reports, operative notes, toxicology reports, blood work, x-rays, CT scans, MRIs, radiology reports, we have the medical information right in our hands.

Bayer, Essure Take Beating at FDA Risk Panel

Staff - September 26, 2015

After the intense discussion and testimony, the FDA panel recommended that more data be collected regarding skin allergies and other symptoms, as well as demanding that doctors need to be trained more thoroughly on how to implant and remove the device, although stopping short of demanding that Bayer recall the product.

FDA Panel to Review Essure Risks

Staff - September 23, 2015

Although no formal decisions will be made at Thursday’s meeting, the experts will consider whether or not to require a warning label on the product and if more clinical studies are needed to ensure the safety of the device.

Will Industry Ties Hamper Nominee for FDA Commissioner?

Staff - September 20, 2015

Dr. Califf, a cardiologist, has been serving as the FDA’s deputy commissioner for medical products and tobacco since he joined the agency in February, divesting interest in his pre-FDA activity. Although he has donated his proceeds from private industry to nonprofit groups since the mid-2000s, Dr. Califf has taken some form of financial support from over 20 companies according to a disclaimer added to the end of a European Heart Journal article he penned last year. His financial disclosure form for 2014 alone lists consulting fees provided to him from seven companies, and his salary at Duke was funded in part by drugmakers Merck, Novartis and Eli Lilly.

FDA Grants Bristol-Myer’s Kidney Cancer Drug ‘Breakthrough’ Status

Staff - September 17, 2015

Opdivo was first approved in Japan in July 2014 for the treatment of melanoma and nivolumab was approved by the European Commission this past July for the treatment of lung cancer. The FDA also approved Opdivo for the treatment of melanoma in December and lung cancer in March. In addition to being granted breakthrough designation prior to its two FDA approvals, it has also been given the status for the treatment of Hodgkin lymphoma.

FDA Panel Unanimously Recommends Approval for Abuse-Deterrent Painkiller Xtampza

Staff - September 14, 2015

Despite the dosing warning issued by the Food and Drug Administration (FDA) earlier last week amid concerns about the product’s labeling, an independent panel commissioned by the agency recommended approval for a experimental oral painkiller. The panel’s 23-0 vote is a major win for Massachusetts-based Collegium Pharmaceuticals, and its potential breakthrough drug marketed as Xtampza.

FDA Issues Dosing Warning for Collegium’s Experimental Painkiller

Staff - September 10, 2015

Unlike most opioid painkillers, which are either taken on an empty stomach or without regard for food intake, users must take Xtampza after eating to release the maximum effects. The FDA warned that if Xtampza is taken without food, it will lead to inadequate pain control, and contribute to abuse and overdose by users who are seeking to remedy their pain.

Appeals Court Rules for Novartis against Amgen in Biosimilar Cancer Treatment Suit

Staff - September 3, 2015

The U.S. Court of Appeals for the Federal Circuit granted a major victory for Novartis AG, the world’s pharmaceutical market leader. The court’s three-judge panel ruled 2-1 on Wednesday, declining a petition to renew a six-month injunction filed by competitor Amgen involving the marketing of a biosimilar drug comparable to Amgen’s breakthrough cancer treatment Neupogen

Valeant Strikes Collaboration Deal with AstraZeneca over Experimental Psoriasis Drug

Staff - September 1, 2015

The terms of the agreement include Valeant paying AstraZeneca $100 million up front, adding another $170 million depending on pre-launch benchmarks, as well as up to $175 million depending upon sales benchmarks. After the product’s launch, the two companies will share profits. Valeant will handle the regulatory submission processes and the associated costs. In return, Valeant will retain the commercialization rights to brodalumab in all markets except in Japan and some Asian countries, where Amgen, the originator of the drug, had made a pre-existing agreement with Japanese biotech firm Kyowa Hakko Kirin.

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