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Pfizer’s Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. What’s more, the company’s latest product pulls threaten to intensify the ongoing shortages of several critical hospital drugs. Shortly before the holiday, Pfizer’s Hospira announced two separate recalls over the potential presence of glass particulates in vials and syringes of certain meds. In the case of injectable cancer medication bleomycin—of which Hospira is recalling one lot—a confirmed customer report alerted the company to the presence of glass particulates within a single vial, the company said in a notice posted on the FDA’s website. The second recall, which covers three drugs—two strengths of injectable sodium bicarbonate, plus one lot of atropine sulfate injection—kicked off after the company flagged “the potential presence of glass particulate matter” during routine product inspection. In both cases, Pfizer and Hospira said they hadn’t received ...
- Source: drugdu
- 197
- December 29, 2023
Amgen’s request for full approval of Lumakras in lung cancer denied by FDA

Amgen’s request to gain full approval of Lumakras in non-small cell lung cancer has been rejected by the FDA. The California pharma will now have to conduct an additional confirmatory trial to gain the coveted FDA nod. Lumakras was granted accelerated approval in May 2021 to treat second line KRAS G12C-mutated NSCLC. The company was asked by the FDA to launch a confirmatory trial and a dose optimization study to gain a full approval. The therapy faced an advisory committee meeting in October where a panel was asked to consider whether the primary endpoint for the phase 3 CodeBreak 200 trial could be reliably interpreted in Amgen’s study. The committee voted 10-2 against the measure, suggesting that they were unimpressed with Amgen’s trial design. Despite the negative vote, the agency was not expected to remove Lumakras from the market, but instead request another confirmatory trial. Amgen now says that’s exactly ...
- Source: drugdu
- 135
- December 29, 2023
Fosun Diagnostics’ Fully Automated Chemiluminescence Immunoassay Analyzer F-i1000 Obtains EU IVDR Certification

Recently, Fosun Diagnostics announced that its fully automated chemiluminescence immunoassay analyzer, F-i1000, has received approval for EU IVDR CE registration. The issuance of the registration certificate under the IVDR regulation signifies international recognition of the quality of Fosun Diagnostics’ chemiluminescence products and the ability to meet diverse testing requirements for projects in various levels of medical institutions such as hospitals, core laboratories, and clinics, both domestically and internationally. CE certification is granted based on relevant EU laws, regulations, and standards, serving as a passport for products to freely circulate in the EU market. On May 5, 2017, the EU released the In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746), replacing the original EU In Vitro Diagnostic Medical Devices Directive (IVDD, Directive 98/79/EC). After the transition period following the regulation’s implementation, in vitro diagnostic medical devices without IVDR CE certification will no longer be allowed to enter the EU ...
- Source: drugdu
- 105
- December 29, 2023
FDA Grants Fast Track Designation to Henlius’ EGFR-Targeting ADC HLX42 for NSCLC Patients with Disease Progression on EGFR Targeted Therapies

Shanghai, China, December 27, 2023 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation(FTD) for HLX42, an investigational EGFR-Targeting ADC that developed by the company based on the collaboration with MediLink Therapeutics, for the treatment of patients with advanced or metastatic EGFR-mutated non-small cell lung cancer whose disease has progressed on a 3rd-generation EGFR tyrosine kinase inhibitor. Previously, HLX42 was approved for conducting clinical trial by the National Medical Products Administration (NMPA) and FDA. Yongqiang Shan, general manager of Henlius’ Global Innovation Center, said: “I am glad to see the continuous progress we have made in advancing our ADC portfolio. The grant of FTD represents FDA’s recognition of HLX42’s potential in addressing serious diseases that filled unmet medical needs. In the future, Henlius will maintain our focus on areas of unmet medical needs and accelerate the development and delivery ...
- Source: drugdu
- 263
- December 29, 2023
WHO to progress plans to develop a model for the medical (care) planning of mass gatherings

The World Health Organization (WHO) will move forward with its plans to develop a set of standards and recommendations that can be adopted and adapted for the medical (care) planning of mass gatherings following the conclusion of a successful two-day consultation that was held at the WHO office in Lyon, France, in November 2023, to explore the proposal further. A technical working group will now be set up to develop and discuss an early draft of the model in the first half of 2024, with the Emergency Medical Teams (EMT) methodology of principles, standards and quality domains forming the bedrock of the work. This will then be followed by further consultations and testing of the agreed model with key stakeholders. The workshop, which was organized by the WHO EMT and other Rapid Response Capacities Unit and Border Health and Mass Gatherings Unit, came on the back of work done in ...
- Source: drugdu
- 118
- December 29, 2023
Innovent and SanegeneBio Enter Strategic Collaboration to Develop siRNA Drug for the Treatment of Hypertension

ROCKVILLE, Md. and SUZHOU, China, Dec 20, 2023 — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic, ophthalmology and other major diseases, and Sanegene Bio USA Inc. (SanegeneBio) announce that they have entered into a collaboration agreement to co-develop SGB-3908, an siRNA drug candidate targeting angiotensinogen (AGT) for the treatment of hypertension. Innovent also obtains an exclusive option to license in the future development, manufacturing and commercialization rights of SGB-3908. SGB-3908 is an IND-enabling stage siRNA drug developed based on SanegeneBio’s proprietary LEAD™ (Ligand and Enhancer Assisted Delivery) platform. Under the terms of the agreement, both parties will be jointly responsible for the development of SGB-3908 to certain stage. Innovent will receive an exclusive option to pay different option exercise fees to obtain the exclusive development, manufacturing, and commercialization license of SGB-3908 in ...
- Source: drugdu
- 169
- December 29, 2023
Bayer wins latest Roundup cancer trial, ending losing streak

Dec 23 (Reuters) – Bayer has won a trial in a lawsuit brought by a California man who said he developed cancer from exposure to its Roundup weedkiller, ending what had been a five-trial losing streak for the company in trials over similar claims. The verdict was handed down on Friday by a jury in San Benito County, California Superior Court, Bayer announced. The company said in a statement that the verdict was “consistent with the evidence in this case that Roundup does not cause cancer and is not responsible for the plaintiff’s illness.” Lawyers for plaintiff Bruce Jones did not immediately respond to requests for comment. Like most plaintiffs in Roundup lawsuits, Jones alleged that the product caused him to develop a form of cancer called non-Hodgkin lymphoma. Around 165,000 claims have been made against the company for personal injuries allegedly caused by Roundup, which Bayer acquired as part ...
- Source: drugdu
- 138
- December 28, 2023
US FDA warns about counterfeit versions of Novo’s diabetes drug Ozempic

Dec 21 (Reuters) – The U.S. Food and Drug Administration on Thursday warned consumers not to use counterfeit versions of Novo Nordisk’s (NOVOb.CO) diabetes drug Ozempic that have been found in the country’s drug supply chain. The health regulator said it will continue to investigate counterfeit Ozempic 1 milligram injections and has seized thousands of units, but flagged that some may still be available for purchase. Danish drugmaker Novo Nordisk and the FDA are testing the seized products and do not yet have information about the drugs’ identity, quality or safety, the agency said. Novo said the seizures took place in warehouses outside the company’s authorized supply chain. The agency said the needles from the seized injections are counterfeit and their sterility cannot be confirmed, which presents an additional risk of infection for patients. Other confirmed counterfeit components from the seized products include the pen label and accompanying information about ...
- Source: drugdu
- 118
- December 28, 2023
AstraZeneca to buy China’s Gracell Biotechnologies in $1.2 billion deal

Dec 26 (Reuters) – AstraZeneca (AZN.L) said on Tuesday it will buy Gracell Biotechnologies (GRCL.O) for up to $1.2 billion as the Anglo-Swedish pharma company furthers its cell therapy ambitions and boosts its presence in China, the world’s second-largest pharmaceuticals market. The cash deal, which adds several experimental therapies to AstraZeneca’s portfolio, values Gracell at $2 per ordinary share, or $10 per American Depository Share, of Gracell, representing a premium of 61.6% from its last close on Dec. 22. The shareholders will also receive a non-tradable contingent value right of $0.30 per ordinary share, if certain regulatory milestones are met. Shares of China-headquartered Gracell surged 60% in premarket trading in the United States. Gracell’s CAR-T cell therapy works by extracting disease-fighting white blood cells known as T-cells from a patient, re-engineered to attack cancer and infused back into the body. H.C. Wainwright analyst Emily Bodnar said this could be AstraZeneca’s ...
- Source: drugdu
- 183
- December 28, 2023
BMS agrees to acquire Karuna Therapeutics for $14bn

Bristol Myers Squibb (BMS) has signed a definitive agreement for the acquisition of all outstanding shares of common stock of biopharmaceutical company Karuna Therapeutics for an equity value totalling $14bn in cash. The new strategic merger deal is part of BMS’ strategy to bolster its neuroscience portfolio. Karuna focuses on the discovery and development of therapies for psychiatric and neurological ailments. Through the transaction, BMS will gain access to Karuna’s lead asset KarXT (xanomeline-trospium). It is a potential antipsychotic therapy for patients with schizophrenia and Alzheimer’s disease psychosis. KarXT possesses a new mechanism of action with varied distinguished efficacy and safety profiles. The US Food and Drug Administration (FDA) recently has accepted Karuna’s new drug application (NDA) for KarXT to treat adult patients with an approval decision anticipated on 26 September next year under the Prescription Drug User Fee Act (PDUFA). The antipsychotic is currently being analysed in registrational clinical ...
- Source: drugdu
- 209
- December 28, 2023

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