media – Page 338 – DrugDu- Global Leading Pharmaceutical & Medical Device Platform

FDA says Ipca Labs failed to address quality issues with bad API batches

Tyler Patchen News Reporter Ipca Laboratories, an India-based maker of active pharmaceutical ingredients, was cited for several quality and testing issues during a recent FDA inspection. The FDA inspected an Ipca manufacturing facility in Ratlam, India, between June 5 and June 13, and investigators made a total of 11 observations. The FDA said the company failed to properly investigate root causes for deficient API batches. In April, Ipca had received a complaint saying there were “metal-like particles and magnet particles” in some products. The regulator also said the facility’s quality unit did not issue a recall of an unnamed product that did not meet specific impurity standards. Inspectors found that Ipca did not conduct the correct contamination testing of a drug substance that was redacted from the report and therefore was not aware of potential hazards. Laboratory tests on manufactured APIs were found to be deficient by inspectors, as were ...
- Source: drugdu
- 110
- July 6, 2023
Amgen and Horizon call FTC’s attempt to block $28B merger unconstitutional in counterclaims

Nicole DeFeudis Editor Amgen and Horizon filed counterclaims against the FTC, alleging the agency’s attempt to block their nearly $28 billion merger “runs roughshod” over provisions of the Constitution. The FTC in May filed a lawsuit in federal court trying to scuttle Amgen’s proposed buyout of Horizon. The agency’s claims center around bundling, a scrutinized industry practice that involves offering multi-product discounts that make it difficult for rivals to compete. Amgen and Horizon previously called the case “as misguided as it is unprecedented,” and they argued the proceeding is unconstitutional on Thursday. Amgen and Horizon argue FTC’s suit to block $28B merger is ‘as misguided as it is unprecedented’ Defendants alleged in new counterclaims that the FTC’s effort violates multiple provisions of the Constitution, including the due process clause of the Fifth Amendment “because the FTC will play the role of investigator, prosecutor and judge.” “The FTC’s case is wholly novel ...
- Source: drugdu
- 114
- July 6, 2023
Global efforts to reduce infectious diseases must include older children and adolescents

Global efforts to reduce infectious disease rates must have a greater focus on older children and adolescents after a shift in disease burden onto this demographic, according to a new study. The research, led by Murdoch Children’s Research Institute and the Institute for Health Metrics and Evaluation, has found that infectious disease control has largely focused on children aged under five, with scarce attention on young people between five and 24 years old. Published in The Lancet, the study found three million children and adolescents die from infectious diseases every year, equivalent to one death every 10 seconds. It looked at data across 204 countries between 1990 and 2019 from birth to 24 years of age. Diarrhea, pneumonia and malaria account for two-thirds of infectious diseases and death among children and adolescents. HIV and tuberculosis were the leading causes among older adolescents. The shift in infectious disease burden from young ...
- Source: drugdu
- 102
- July 6, 2023
Omega-3 rich oil can prevent damage to honey bee mitochondria caused by pesticides

New research suggests that the use of an omega-3 rich oil called “ahiflower oil” can prevent damage to honey bee mitochondria caused by neonicotinoid pesticides. This research is part of an ongoing project by PhD student Hichem Menail of the Université de Moncton in New Brunswick, Canada. “Pesticides are a major threat to insect populations and as insects are at the core of ecosystem richness and balance, any loss in insect biodiversity can lead to catastrophic outcome,” says Mr Menail, adding that pesticide-related pollinator declines are also a huge concern for food crops globally. Imidacloprid, a neonicotinoid pesticide, is one of the world’s most commonly used insecticides. Imidacloprid was banned for outdoor use by the EU in 2018, along with two other major neonicotinoids, but their use continues around the world, including the United States of America. Mr. Hichem Menail (PhD student, Université de Moncton in New Brunswick, Canada) said, ...
- Source: drugdu
- 93
- July 6, 2023
FDA approves Skyline Therapeutics’ IND for macular degeneration trial

Chinese gene therapy company Skyline will initiate a global trial investigating a gene therapy to treat neovascular age-related macular degeneration (nAMD), after receiving clearance from the US Food and Drug Administration (FDA). The FDA granted the company’s investigational new drug (IND) application for a Phase I/IIa trial of SKG0106 – a one-time intravitreally delivered adeno-associated virus (AAV) gene therapy. Skyline has not disclosed when it expects to initiate the trial. Skyline Therapeutics’ candidate encompasses a new AAV capsid and unique transgene genome encoding an anti-VEGF protein. Vascular endothelial growth factor (VEGF) is a protein that promotes the growth of new blood vessels and also makes vessels more permeable or leaky. Patients with macular degeneration secrete too much of this protein. The company’s anti-angiogenic treatment is able to suppress neovascular lesions at a low dose with durable effects from a single injection. The prevention of neovascularisation provides relief of vascular leakage ...
- Source: drugdu
- 113
- July 6, 2023
Labcorp forms spin-off of Fortrea

Labcorp, the laboratory service supplier based in the US, has completed the spin-off of Fortrea, to create the newly formed contract research organisation that will give pharmaceutical and biotechnology organisations access to global Phase I-IV clinical trial management, patient access and technology solutions. Fortrea made a cash distribution of around $1.6bn as partial consideration for the assets that Labcorp contributed to Fortrea in connection with the spin-off. Labcorp will use the distribution toward a $1bn accelerated share repurchase program and pay down $300m of debt maturing this year. Whatever is left of the funds will be distributed among shareholders. The spin-off distribution was completed on 30 June 2023 to stockholders of record as of the close of business on 20 June 2023. Labcorp’s stockholders each received one share of Fortrea common stock for every share of Labcorp common stock they held as of the record date. The spin-off will pass ...
- Source: drugdu
- 115
- July 6, 2023
Regeneron’s high-dose Eylea hit with surprise FDA rejection over manufacturing hiccups

The FDA turned down the closely watched eye med because of manufacturing problems the agency spotted at a third-party drug filler, Regeneron said in a release. The FDA didn’t flag any issues with the med’s efficacy and safety or its labeling and drug substance manufacturing and didn’t request additional clinical data, the company said. In a race against Roche’s Vabysmo, Regeneron and its partner Bayer’s application for the 8 mg Eylea (aflibercept) version was accepted in February, hoping for approval in wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy. Despite the hurdle, Regeneron remains “committed to working closely with the FDA and the third-party filler” to introduce the high-dose drug, the company said. A Regeneron spokesperson declined to comment on the identity of the filler or where it’s located. Elsewhere, the FDA recently published a Form 483 against an Eli Lilly plant in Indianapolis after an inspection in ...
- Source: drugdu
- 98
- July 6, 2023
Boehringer’s spesolimab shows promise in generalised pustular psoriasis prevention

Boehringer Ingelheim has shared positive new 48-week data from a phase 2b trial of its anti-interleukin-36 receptor (IL-36R) antibody in patients with generalised pustular psoriasis (GPP). The results from the EFFISAYIL 2 trial, presented by the company at this year’s World Congress of Dermatology, show that spesolimab reduced the risk of GPP flares by 84% over 48 weeks compared to placebo. The trial also demonstrated no flares after week four of spesolimab treatment in the high dose group, Boehringer said. GPP is a rare and chronic neutrophilic skin disease, which is genetically and clinically distinct from plaque psoriasis. GPP is caused by neutrophils – a type of white blood cell – accumulating in the skin, causing painful, sterile pustules all over the body. Despite the varying severity of GPP flares, if left untreated they can be life-threatening due to complications such as sepsis and multisystem organ failure, and the unpredictability ...
- Source: drugdu
- 199
- July 6, 2023
first interchangeable biosimilar to Humira rolls out across US

Boehringer Ingelheim’s new autoinjector pen administering Cyltezo (adalimumab-adbm) is now available to patients living with chronic inflammatory diseases in the US. The Cyltezo pen autoinjector, which is a biosimilar to AbbVie’s blockbuster Humira (adalimumab), received approval from the US Food and Drug Administration (FDA) in May 2023. Boehringer Ingelheim originally received FDA approval for the drug in 2017, and then further approval as an interchangeable biosimilar in 2021. The 40mg/0.8ml pre-filled Cyltezo Pen will be offered in two, four and six-pack options. AbbVie has enjoyed a prosperous monopoly of the adalimumab market with Humira generating $21.2bn in global sales in 2022. With several biosimilars likely to flood the market in 2023 and the company losing exclusivity, AbbVie said it expects its sales of the drug to decline 37% in 2023. Challengers to Humira are now vying for market share. Organon and Samsung Bioepsis launched an autoinjector pen on 1 July, ...
- Source: drugdu
- 135
- July 5, 2023
Zealand Pharma submits NDA for hyperinsulinism drug dasiglucagon

Zealand Pharma has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its treatment dasiglucagon for use in paediatric patients aged seven days or older with congenital hyperinsulinism (CHI). Based on an announcement released on 30 June, the application is based on clinical data from two Phase III studies and interim results from an ongoing long-term extension trial (NCT03941236). This includes results from a Phase III trial (NCT041724412), which tested dasiglucagon’s efficacy and safety in a hospital setting among 12 neonates and infants with CHI aged seven days to 12 months. In the first part of the trial, which took the form of a 48-hour crossover study, dasiglucagon reduced the need for glucose infusions by 55%. The application also features data from a second Phase III study (NCT03777176), which tested subcutaneous dasiglucagon infusions in 32 children with CHI aged three months to 12 years. ...
- Source: drugdu
- 116
- July 5, 2023

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.