Latest news with #REMS
The Hindu
28-05-2025
- Politics
- The Hindu
Approve pending promotions: transport staff union to A.P. govt.
A.P. Public Transport Department (APPTD) Employees' Union state committee leaders on Wednesday (May 28) urged the government to approve the promotion of RTC employees, which, they said, has been pending for the past six years. The union's State president P. Damodar Rao and general secretary G.V. Narsayya, along with Andhra Pradesh JAC-Amaravati chairman Bopparaju Venkateswarlu, submitted a representation in this regard to Principal Secretary to the Chief Minister Muddada Ravichandra. They said nearly 3,000 RTC employees have been awaiting promotions for over six years. Citing nearly 11,000 vacancies in the department, they said the government should permit APSRTC to recruit staff and purchase new buses to improve the public transport infrastructure. Their other demands included payment of arrears for 24 months under the 11th Pay Revision Commission (PRC) and clearance of the pending gratuity and leave encashment of retired employees. They also wanted the government to operationalise the Retired Employees Medical Scheme (REMS) and requested NTR Trust CEO to formalise its procedures and guidelines. Seeking alternative employment to staff declared medically unfit, they wanted the officials to initiate the pending appointments on compassionate grounds without further delay. They also sought job security for the outsourced workers in the department. Insisting on immediate implementation of the 12th PRC, they demanded that the authorities announce an interim relief immediately.
Yahoo
20-05-2025
- Health
- Yahoo
Abortion providers challenge FDA's remaining mifepristone restrictions in federal court
'We just want to ensure that the most popular method for abortion in Virginia and beyond is protected no matter who sits at the White House and who sits in the FDA,' said Whole Woman's Health founder and president Amy Hagstrom Miller outside of the U.S. District Court of the Western District of Virginia in Charlottesville, Virginia, on May 19, 2025. (Photo by Charlotte Rene Woods/Virginia Mercury) CHARLOTTESVILLE, Va. — Abortion pills — and questions over their inherent safety — were back in federal court Monday. Unlike a lawsuit rejected by the U.S. Supreme Court last year, plaintiffs this time are not anti-abortion activists arguing medication abortion should be banned, but abortion providers arguing the remaining restrictions should be lifted to match the drug's 25-year record of safety and efficacy. The suit seeks to make abortion pills more accessible by removing several existing restrictions on the U.S. Food and Drug Administration's mifepristone-misoprostol regimen first approved in 2000. The drug was approved under the FDA's drug safety program called Risk Evaluation and Mitigation Strategy (REMS), provisions of which have been steadily eliminated over time but not fully. On behalf of independent providers in Virginia, Montana, and Kansas, Center for Reproductive Rights senior counsel Linda Goldstein argued the FDA's most recent evaluations did not properly assess whether remaining restrictions are still medically necessary. She argued that the biggest risks the FDA has identified with mifepristone — serious bleeding and infection — are not exclusive to the drug but with all pregnancy terminations, including spontaneous miscarriages, which she said affected about 25% of all pregnancies. Beyond abortion, for which the drug has captured attention, mifepristone is also used to treat miscarriages so that they conclude safely to help prevent infection. 'The FDA has acknowledged that staying pregnant is more dangerous than not staying pregnant,' said Goldstein, arguing that at minimum the FDA should be required to explain why drugs that pose similar risks are not subject to the same restrictions. She noted that of the 20,000 drugs the FDA has approved, only 73 have REMS provisions, and that mifepristone has proven to be a safe drug over time. About 7.5 million U.S. patients have taken it as of the end of last year, Goldstein said. As of December 2024, the FDA has reported 36 patient deaths associated with mifepristone since it was first approved in 2000. Whole Woman's Health Alliance v. FDA is the first time the U.S. Department of Justice is arguing a position on mifepristone in court since the Trump administration took office. Justice Department attorneys said current regulations are necessary for the most common form of pregnancy termination to be considered safe. When asked by the judge, DOJ attorney Noah Katzen did not confirm or deny whether or not the FDA still considers the drug to be safe and effective overall. 'That is what the FDA determined in the past,' Katzen said during the hearing at the U.S. District Court for the Western District of Virginia in Charlottesville, where the case was originally filed in 2023. Katzen, the FDA's former associate chief counsel until 2021 and currently a trial attorney for the Consumer Financial Protection Bureau, said the FDA has found that the evidence was 'not sufficient' to conclude the REMS are no longer necessary. U.S. District Judge Robert S. Ballou, appointed by Democratic President Joe Biden, appeared more sympathetic to plaintiffs' argument that some of the requirements appear arbitrary in that they don't apply to other drugs with equal or greater risk, including drugs his parents have taken. Ballou did not rule at the end of Monday's hearing but said he would as soon as possible. After the hearing, Whole Woman's Health Alliance founder and president Amy Hagstrom Miller told States Newsroom she took note of Katzen's response about whether the FDA considers mifepristone to be safe and effective. 'It was an interesting choice of words,' she said. This lawsuit is among several federal cases involving mifepristone. Earlier this month, the Trump administration filed a brief in the case Missouri v. FDA, requesting the court dismiss three states' lawsuit to restrict mifepristone on procedural grounds, but did not comment on the merits of the case or explicitly defend the FDA's current medication abortion policy. While the Missouri v. FDA lawsuit seeks to reinstate regulations loosened between 2016 and 2021, the Whole Woman's Health v. FDA lawsuit takes aim at restrictions that require: medical professionals who prescribe mifepristone to register with the drug manufacturer; pharmacies to apply for special certification and maintain copious records, and patients to review and sign a counseling form. On behalf of plaintiffs, which include Whole Woman's Health Alliance in Virginia and other states, All Families Healthcare and Blue Mountain Clinic in Montana, and Trust Women in Kansas, Goldstein argued that these existing rules are burdensome and make these medications harder to access by limiting the number of providers and pharmacies who can provide and dispense it and impede access to time-sensitive care. Goldstein noted the 'political climate' surrounding mifepristone and pointed to how abortion opponents seek either rescinding of FDA approval for mifepristone or a return to the in-person dispensing requirements. She added how efforts to make abortion medication more difficult to obtain are outlined in Project 2025 — the conservative Heritage Foundation's playbook. Before and especially since Roe v. Wade was overturned in 2022, anti-abortion groups have tried to convince courts that abortion pills, in addition to ending the lives of embryos and fetuses, harm pregnant people at rates that warrant being pulled from the market or at the very least heavily restricted. During his presidential campaign and since taking office, President Donald Trump and his health appointees have messaged strategically on medication abortion, on the one hand promising to retain its access while also open to examining new evidence suggesting it is unsafe. Just last week, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said he would direct the FDA to review abortion pill safety and potentially change its drug label, following the release of an anti-abortion white paper commissioned by far-right funders, whose analysis has been widely criticized by reproductive health scientists and is outflanked by hundreds of studies showing a very low rate of serious adverse events. Hagstrom Miller called the current restrictions 'politically motivated' and said overturning them would be especially significant for Virginia, which as the least restrictive state in the South, has seen an uptick in people traveling from elsewhere to receive care. 'They're not related to the safety of the medication,' Hagstrom Miller said, of the current restrictions. 'We just want to ensure that the most popular method for abortion in Virginia and beyond is protected no matter who sits at the White House and who sits in the FDA.' Virginia moves to protect reproductive and voting rights, but the fight is far from over Virginia is in the process of amending its state constitution to enshrine abortion and other reproductive health care procedures or medications. The constitutional amendment passed the legislature on party-line votes this year and must pass again next year before appearing on ballots for voters statewide. Its continued success or failure hinges on the outcome of the state's competitive House of Delegates elections — where Democrats hold a slim majority. While governors don't have a say in constitutional amendments, the issue is a divergence between gubernatorial candidates Lt. Gov. Winsome Earle-Sears and Democratic challenger former Congresswoman Abigail Spanberger. This means that should the amendment fail and partisan control of the House shift, whoever is the next governor could advance or block potential future efforts to walk back Virginia's current abortion access laws. 'It's really important that we protect that safe access to medication abortion no matter where people live — Virginia is playing a key role in the South right now,' Hagstrom Miller said. SUPPORT: YOU MAKE OUR WORK POSSIBLE
The South African
18-05-2025
- The South African
Eastern Cape R102 head-on crash claims one life, two Injured
One person has died and two others were seriously injured in a head-on collision on the R102 between Humansdorp and Tsitsikamma in the Eastern Cape. Eastern Cape Transport MEC spokesperson Makhaya Komisa told the SABC that the crash involved a bakkie and a Suzuki seven-seater passenger vehicle. The driver of the bakkie died at the scene. Paramedics took the passenger of the same vehicle to the hospital. The Suzuki driver, who was alone in the vehicle, also sustained serious injuries, and paramedics transported him to the hospital. Emergency medical service, REMS, said they received the call at 19:00, Saturday, 17 May 2025. Upon arrival, they found the severe wreckage, with one patient trapped and pinned by the dashboard and steering wheel. Paramedics stabilised the patient while Kouga Fire and Rescue used the jaws of life to extricate them. REMS noted that the number of fatal accidents in the Kouga region is becoming a concern. Transport and Community Safety MEC Xolile Nqatha extended condolences to the bereaved families and wished a speedy recovery to the injured. Humansdorp police opened a case of culpable homicide. The cause of the crash is under investigation. A head-on collision on the R30 near Dumasi in Mthatha killed one person and left three others seriously injured on Sunday afternoon, 20 April 2025. According to police spokesperson Captain Welile Matyolo, the vehicles collided around 15:40. Police suspect reckless driving contributed to the crash. The 30-year-old driver from Mqwangqweni in Ngqeleni, behind the wheel of one of the vehicles, died on the scene from severe injuries. The second driver, a 33-year-old man from Mxhosa, Ntlaza A/A in Libode, suffered serious injuries. Paramedics rushed him and his two passengers to the hospital after the crash crushed their vehicle. Let us know by leaving a comment below or send a WhatsApp to 060 011 021 1. Subscribe to The South African website's newsletters and follow us on WhatsApp, Facebook, X, and Bluesky for the latest news.
Business Wire
08-05-2025
- Business
- Business Wire
Securities Fraud Investigation Into Cytokinetics, Incorporated (CYTK) Announced – Investors Who Lost Money Urged To Contact Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm
LOS ANGELES--(BUSINESS WIRE)-- Glancy Prongay & Murray LLP, a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Cytokinetics, Incorporated ('Cytokinetics' or the 'Company') (NASDAQ: CYTK) investors concerning the Company's possible violations of the federal securities laws. IF YOU ARE AN INVESTOR WHO LOST MONEY ON CYTOKINETICS, INCORPORATED (CYTK), CLICK HERE TO INQUIRE ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS. What Happened? On May 1, 2025, Cytokinetics disclosed that the FDA has extended the review period for its cardiac myosin inhibitor drug, aficamten, by three months, citing additional time required to review newly submitted Risk Evaluation and Mitigation Strategy (REMS). The Company further revealed that, 'following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS.' On this news, Cytokinetics's stock price fell $5.57, or 12.9%, to close at $37.35 per share on May 2, 2025, thereby injuring investors. Contact Us To Participate or Learn More: If you wish to learn more about this action, or if you have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us. Charles Linehan, Esq. Glancy Prongay & Murray LLP 1925 Century Park East, Suite 2100 Los Angeles California 90067 Email: shareholders@ Telephone: 310-201-9150 (Toll-Free: 888-773-9224) Visit our website at Follow us for updates on LinkedIn, Twitter, or Facebook. Whistleblower Notice Persons with non-public information regarding Cytokinetics should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program. Under the program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Charles H. Linehan at 310-201-9150 or 888-773-9224 or email shareholders@ About Glancy Prongay & Murray LLP Glancy Prongay & Murray LLP ('GPM') is a premier law firm representing investors and consumers in securities litigation and other complex class action litigation. GPM has been consistently ranked in the Top 50 Securities Class Action Settlements by ISS Securities Class Action Services. In 2018, GPM was ranked a top five law firm in number of securities class action settlements, and a top six law firm for total dollar size of settlements. With four offices across the country, GPM's nearly 40 attorneys have won groundbreaking rulings and recovered billions of dollars for investors and consumers in securities, antitrust, consumer, and employment class actions. GPM's lawyers have handled cases covering a wide spectrum of corporate misconduct and relating to nearly all industries and sectors. GPM's past successes have been widely covered by leading news and industry publications such as The Wall Street Journal, The Financial Times, Bloomberg Businessweek, Reuters, the Associated Press, Barron's, Investor's Business Daily, Forbes, and Money. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Business Wire
08-05-2025
- Business
- Business Wire
Cytokinetics, Incorporated (CYTK) Investors Who Lost Money – Contact Law Offices of Howard G. Smith About Securities Fraud Investigation
BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Cytokinetics, Incorporated ('Cytokinetics' or the 'Company') (NASDAQ: CYTK) investors concerning the Company's possible violations of federal securities laws. IF YOU ARE AN INVESTOR WHO SUFFERED A LOSS IN CYTOKINETICS, INCORPORATED (CYTK), CONTACT THE LAW OFFICES OF HOWARD G. SMITH ABOUT POTENTIALLY PURSUING CLAIMS TO RECOVER YOUR LOSS. Contact the Law Offices of Howard G. Smith to discuss your legal rights by email at howardsmith@ by telephone at (215) 638-4847 or visit our website at What Happened? On May 1, 2025, Cytokinetics disclosed that the FDA has extended the review period for its cardiac myosin inhibitor drug, aficamten, by three months, citing additional time required to review newly submitted Risk Evaluation and Mitigation Strategy (REMS). The Company further revealed that, 'following pre-NDA discussions with FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS.' On this news, Cytokinetics's stock price fell $5.57, or 12.9%, to close at $37.35 per share on May 2, 2025, thereby injuring investors. Contact Us To Participate or Learn More: If you purchased Cytokinetics securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact us: Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, Telephone: (215) 638-4847 Email: howardsmith@ Visit our website at: This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
