Search Results for Bayer

Showing 1 – 25  of 28

Reps Question Gottlieb on Bayer's Follow-Up Essure Studies By Zachary Brennan - Published 31 October 2017

Reps. Rosa DeLauro (D-CT), Jan Schakowsky (D-IL) and Louise Slaughter (D-NY) on Monday sent a letter to FDA Commissioner Scott Gottlieb regarding concerns related to Bayer's postmarket study for its permanent birth control device Essure.

Categories: News, US, FDA, Compliance, Medical Devices, Postmarket surveillance

Tags: Essure, Bayer, Gottlieb, medical device safety

Congressmen Investigate 'Shadow Pricing' of MS Drugs By Zachary Brennan - Published 17 August 2017

Democratic Reps. Elijah E. Cummings (MD) and Peter Welch (VT) on Thursday sent letters to seven pharmaceutical companies requesting information about the skyrocketing prices for drugs used to treat multiple sclerosis (MS).

Categories: News, US, Crisis management, Drugs

Tags: MS drug prices, Teva, Bayer, Welch

FDA Approves First Treatment for a Form of Batten Disease By Zachary Brennan - Published 27 April 2017

The US Food and Drug Administration (FDA) on Thursday approved the first-ever treatment for a form of the rare pediatric Batten disease, bringing Biomarin its second lucrative priority review voucher (PRV).

Categories: News, US, FDA, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Batten disease, priority review voucher, PRV, Stivarga, Brineura, Bayer, Biomarin

EMA, Drugmakers Weigh FDA Draft Guidance on Physiologically Based PK Analyses By Zachary Brennan - Published 13 February 2017

With an eye toward more harmonization, the European Medicines Agency (EMA) earlier this month weighed in on the US Food and Drug Administration’s (FDA) draft guidance on physiologically based pharmacokinetic (PK) analyses, alongside pharmaceutical companies including Novartis, Merck and Bayer.

Categories: News, Europe, US, EMA, FDA, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: PBPK modeling and simulation, EMA and FDA harmonization, Bayer, Merck, Novartis

European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017) By Nick Paul Taylor - Published 12 January 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: regulatory harmonization, ICMRA, Bayer, biologic quality standards

Despite Industry Opposition, HHS to Fine Drug Companies for Overcharging Hospitals By Zachary Brennan - Published 05 January 2017

The US Department of Health and Human Services (HHS) on Thursday finalized a rule that would fine pharmaceutical companies for overcharging hospitals and clinics for drugs purchased under the 340B drug pricing program.

Categories: News, US, Crisis management, Drugs, Government affairs

Tags: 340B, CMS, drug pricing, Medicaid, PhRMA, BIO, Bayer, Teva

FDA Signs Off on Bayer Study of Essure Following Numerous Adverse Events, Deaths By Zachary Brennan - Published 02 September 2016

The US Food and Drug Administration (FDA) on Friday approved Bayer’s updated postmarket surveillance study plan for its permanent birth control device Essure, which has been linked to four adult deaths, 15 incidences of pregnancy loss and 631 reports of pregnancies in patients with Essure.

Categories: News, US, FDA, Clinical, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Essure, Bayer, adverse events, medical devices

Health Canada to Develop Better Risk Communications on Essure Contraceptive Devices By Michael Mezher - Published 25 May 2016

Canadian drug and device regulator Health Canada on Monday said it is working with Bayer to develop better risk communication for the permanent birth control device Essure after a safety review of the device found the its risks are not adequately communicated.

Categories: News, Canada, FDA, Health Canada, Communication, Medical Devices, Postmarket surveillance

Tags: Essure, Bayer

European Regulatory Roundup: EMA Offers Draft Proposal on Dissolution of Generics (19 May 2016) By Nick Paul Taylor - Published 19 May 2016

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs

Tags: European Regulatory Roundup, Bayer, PRAC

How a Fax Caused the Federal Circuit to Invalidate a Patent for Two Bayer Oral Contraceptives By Zachary Brennan - Published 16 May 2016

The US Court of Appeals for the Federal Circuit on Friday ruled that a Merck KGaA patent - linked to two of Bayer’s oral contraceptives, Safyral and Beyaz - is invalid because ingredients in the drug were offered for sale before the filing of the patent.

Categories: News, US, FDA, Drugs

Tags: Merck KGaA, Bayer, Beyaz, contraceptives, fax machine, drug patents

[Update] FDA: New Postmarketing Study, Black Box Warning for Essure By Zachary Brennan, Michael Mezher - Published 29 February 2016

This article has been updated with more information presented by FDA in a press call Monday and the release of the draft guidance referenced in FDA's announcement.

Categories: News, FDA, Labeling, Medical Devices, Postmarket surveillance

Tags: Essure, Bayer, Essure Problems, Black box warning

Bayer Refutes Congressman's Claims on Essure Safety By Michael Mezher - Published 18 February 2016

Editor's Note: On Wednesday, Focus reported allegations raised by Rep. Mike Fitzpatrick (R-PA) during a press call that Bayer's permanent birth control device Essure is associated with far more reports of fetal death than previously reported by the US Food and Drug Administration (FDA). After publication we received a statement from Bayer Healthcare refuting those allegations. In this article we discuss Bayer's response and clarify certain aspects of the claims made by Rep. Fitzpatrick and Madris Tomes, a consultant who investigated the claims.

Categories: News, US, FDA, Medical Devices

Tags: Essure, Essure Problems, Bayer

Congressman Says More than 300 Fetal Deaths Related to Essure Ahead of FDA Announcement By Michael Mezher - Published 17 February 2016

Rep. Mike Fitzpatrick (R-PA) on Wednesday presented new information raising questions about the safety of the permanent birth control device Essure, claiming the number of fetal deaths related to the device are far greater than what has been reported by the US Food and Drug Administration (FDA).

Categories: News, US, CDRH, Medical Devices, Postmarket surveillance

Tags: Essure, E-Free Act, Bayer, Conceptus, Rep. Mike Fitzpatrick, Essure Problems

EMA Investigating Validity of Clinical Trial Led by FDA Commissioner Nominee By Zachary Brennan - Published 03 December 2015

The European Medicines Agency (EMA) has told Focus that it’s currently investigating whether a medical device defect may have had an impact on a major clinical trial that was designed and overseen by FDA commissioner nominee Robert Califf and ultimately led to the drug’s FDA and EMA approvals.

Categories: News, Europe, US, EMA, Crisis management, Drugs, Due Diligence, Ethics, Government affairs, Manufacturing, Medical Devices, Postmarket surveillance, Research and development

Tags: EMA, Califf, FDA, FDA commissioner, Xarelto, Bayer

New Bill Directs FDA to Pull Bayer Birth Control Device By Zachary Brennan - Published 04 November 2015

In an unprecedented move, Rep. Michael Fitzpatrick (R-PA) on Wednesday unveiled a new bill that directs the US Food and Drug Administration (FDA) to withdraw from the market Bayer’s birth control implant Essure.

Categories: News, US, FDA, Government affairs, Medical Devices, Postmarket surveillance, Quality

Tags: Essure, E-Free Act, Bayer, birth control, medical device, FDA

DeLauro Calls for FDA to Pull Birth Control Device By Michael Mezher - Published 12 October 2015

Citing safety concerns and a recent citizen's petition, US Rep. Rosa DeLauro (D-CT) is calling for the US Food and Drug Administration (FDA) to pull the birth control implant Essure from the market.

Categories: News, US, CDRH, Government affairs, Medical Devices, Postmarket surveillance

Tags: Essure, Rosa DeLauro, Bayer, Citizen's Petition, Obstetrics and Gynecology Devices Panel

Bayer, Boehringer Latest to be Hit by Indian Patent Office Decisions By Michael Mezher - Published 11 March 2015

In two recent decisions, India’s patent office struck major blows to German drug makers Bayer and Boehringer Ingleheim, saying their respective patents for Nexavar and Spiriva fail to meet the inventiveness requirements under the country’s controversial Patents Act.

Categories: News, India, Drugs, Government affairs, Regulatory strategy

Tags: Intellectual Property, Patents, Nexavar, Spiriva, India Patent Office, Bayer, Boehringer

Bayer's Eylea Gets NICE Recommendation for AMD Indication By Louise Zornoza, RegLink - Published 25 July 2013

Categories: NICE

Tags: Final Guidance, Bayer, UK, guidance, EU

Consumer Advocacy Group Fires Back at FDA Over Transparency of Advisory Committees By Alexander Gaffney, RF News Editor - Published 12 November 2012

Categories: FDA

Tags: Drospirenone, POGO, Yasmin, Yaz, Bayer, AdComm, Latest News, advisory committee

Landmark Ruling Clears Way for Use of Compulsory License in India By Alexander Gaffney - Published 18 September 2012

Categories: India

Tags: Compulsory License, natco, Patents, Bayer, Latest News

UK: Bayer's Blood Clot Drug Gets Draft OK From NICE By Louise Zornoza, RegLink - Published 01 June 2012

Categories: Regulatory Update, NICE

Tags: DVT, PE, VTE, HTA, time, Bayer, Xarelto, CER, UK, approval

Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto By Alexander Gaffney - Published 24 May 2012

Categories: FDA

Tags: Against, Temple, Nissen, ACS, Vote, Janssen, J&J, Bayer, Xarelto, Latest News, cardiovascular, advisory committee

Reviewers Express Doubts in Advance of Xarelto Review By Alexander Gaffney - Published 22 May 2012

Categories: FDA

Tags: Cardiovascular and Renal Drugs Committee, Hicks, ACS, Heart, J&J, Bayer, Xarelto, Latest News, pharmaceutical, data, advisory committee, drug

New Safety Warning Issued For Popular Birth Control Product, Potentially Rekindling Controversy By Alexander Gaffney - Published 10 April 2012

Categories: FDA

Tags: Beyaz, Drospirenone, Yasmin, Yaz, Birth Control, Blood Clots, Bayer, Latest News, Hamburg

In Landmark Ruling, Indian Generics Manufacturer Obtains Compulsory License By Alexander Gaffney - Published 12 March 2012

Categories: India

Tags: Nexavar, natco, Indian Patent Office, Pharmaceuticals, Bayer, Indian, Latest News