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 ...
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 ...
Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter referred to as “the Company” or “Tonghua Dongbao”), a wholly-owned subsidiary Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., received the approval notice for the clinical trial of injectable THDBH120 (GLP-1/GIP dual receptor agonist) from the National Medical Products Administration Drug Evaluation Center. The company has initiated the Phase I clinical trial and recently completed the enrollment of the first subject. After the approval for clinical use of injectable THDBH120, the company completed the enrollment of the first subject in the Phase I clinical trial in just around half a month, showcasing the company’s accelerated progress in the research and development of innovative products, as well as its ability and determination to transition into an innovative pharmaceutical enterprise. The company will further explore and uncover the potential of injectable THDBH120 in other indications such as obesity, continually opening up new therapeutic areas to maximize the value ...
Tens of thousands of patients at risk of kidney disease will be able to get tested from the comfort of their own homes as part of a £30 million tech and AI innovation fund this winter. The Healthy.io early detection device will initially be sent to 30,000 patients who are considered most at risk for kidney disease. Analysis suggests the device could help detect 1,300 cases of undiagnosed chronic kidney disease (CKD) over the coming months, as well as stopping some patients from developing end-stage renal disease – improving outcomes for individuals and reducing pressure on the NHS by preventing unplanned hospital admissions. Patients place a small device in a urine sample before scanning the device into an app which gives immediate results on whether a patient may have a kidney condition. The test results are immediately uploaded to the patient’s electronic medical record for clinical review. The National CKD ...
Even with the Federal Trade Commission keeping a watchful eye on the biopharma industry and the economic landscape giving some players pause, mergers and acquisitions are back on the rise. And it is with cautious optimism that industry watchers see the trend continuing in 2024. Wielding plenty of firepower, drugmakers are more likely to make higher-value deals in the new year as they address growth challenges that loom later in the decade because of patent cliffs and the effects of the Inflation Reduction Act. “Executives will continue to deploy cash balances and seek out areas of innovation and clinical differentiation,” PricewaterhouseCoopers wrote in its Pharmaceutical and Life Sciences: U.S. Deals 2024 Outlook. “As regulators’ perspectives on key deal factors become better understood, there may be a return of larger deals, along with continued interest in the $5 billion to $15 billion deals to fill targeted strategic gaps.” Look no further ...
ROCKVILLE, U.S. and SUZHOU, China, Dec 18, 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, metabolic, autoimmune, ophthalmology and other major diseases, announces that results of a Phase 2 clinical trial of mazdutide (Innovent R&D code: IBI362), a glucagon-like peptide-1 receptor (GLP-1R) and glucagon receptor (GCGR) dual agonist, in Chinese patients with overweight or obesity were published in Nature Communications. Professor Linong Ji, the leading principal investigator of the study, Peking University People’s Hospital, stated, “As a chronic disease with complex underlying causes, obesity is one of the leading risk factors of type 2 diabetes, fatty liver, cardiovascular and cerebrovascular diseases, joint diseases, sleep apnea in addition to cancers. Obesity requires increased public awareness of long-term treatment and management with effective and science-backed approaches. China has the largest obese population; however, no safe and efficacious ...
Science has named the development of glucagon like peptide-1 (GLP-1) agonists and this year’s discovery that these drugs can blunt obesity-associated health problems as its 2023 Breakthrough of The Year. Although obesity’s causes span genetic, physiological, environmental, and social factors, as a medical problem, obesity’s risks can be life-threatening – including heart disease, diabetes, arthritis, liver disease, and certain cancers. Drug treatments for obesity have had “a sorry past, one often intertwined with social pressure to lose weight and the widespread belief that excess weight reflects weak willpower,” writes Jennifer Couzin-Frankel in the Breakthrough news feature. However, a new class of drug therapies for weight loss has emerged and is showing promising results. Originally developed to treat diabetes nearly 20 years ago, the excitement surrounding GLP-1 drugs to treat obesity has recently exploded. And this year, two landmark clinical trials that showed in large numbers that GLP-1 agonists produced meaningful ...
A BMJ investigation has shone a spotlight on the marketing of semaglutide in the U.K., raising questions about the effectiveness of regulatory oversight of materials on the weight loss and diabetes treatment. Novo Nordisk is the marketing authorization holder for semaglutide, the active ingredient in diabetes drug Ozempic and obesity therapy Wegovy, but the results of online searches for the molecule include pharmacy websites unrelated to the drugmaker. The BMJ looked into whether any of those pages break the rules on the advertising of prescription drugs and how authorities in the U.K. respond to allegations of illegal promotion. A complaint filed by academics in the U.K. and Sweden forms the centerpiece of the report. Writing to the U.K. drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), the academics said they were “appalled” to find Pharmadoctor, a provider of clinical services to pharmacists, was marketing Wegovy “directly to the ...
Pharmaceutical Executive Editorial Staff Patients with obesity are now able to access Zepbound (tirzepatide) with a prescription at retail and mail-order pharmacies across six dose strengths. Eli Lilly and Company announced today that its obesity treatment Zepbound (tirzepatide) is now commercially available at pharmacies in the United States.1 Last month, the FDA approved Zepbound injection as the first and only approved treatment for obesity that activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) hormone receptors.2 Image credit: Kurhan | stock.adobe.com Patients with obesity are now able to access Zepbound with a prescription at retail and mail-order pharmacies across six dose strengths—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg. “Today opens another chapter for adults living with obesity who have been looking for a new treatment option like Zepbound,” said Rhonda Pacheco, group vice president, Lilly Diabetes and Obesity, US, in a press release.1 The ...
By Tristan Manalac Pictured: Roche’s building in California Roche on Monday announced it has entered into a definitive merger agreement with Berkeley, California-based Carmot Therapeutics, a move that could place it in the thick of the lucrative and increasingly competitive weight-loss market. As per the terms of the acquisition, Roche will make an upfront payment of $2.7 billion at the transaction’s close, which the companies anticipate will occur in the first quarter of 2024, pending regulatory and anti-trust clearance. Carmot’s equity holders will also be eligible for up to $400 million in additional payments, contingent on the achievement of certain milestones. In return, Roche will gain access to Carmot’s portfolio of preclinical and clinical assets, including three GLP-1 receptor agonists, which have “best-in-class potential to treat obesity,” according to Monday’s news release. Carmot’s lead asset is CT-388, a dual agonist of both the GLP-1 and GIP receptors that is ready ...
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