Search Results for “FDA” – Page 102 – media

AstraZeneca’s Lynparza to dominate PARP inhibitors market with $4 bn in sales by 2027

In 2014, the FDA approved the first (adenosine diphosphate-ribose) polymerase (PARP) inhibitor AstraZeneca/Merck’s Lynparza (olaparib) for use in breast cancer gene (BRCA)-mutated metastatic ovarian cancer patients who have received three or more prior lines of chemotherapy. Since then, the PARP inhibitors market has made significant strides, but Lynparza maintains its dominance with projected global sales of $4 billion by 2027, according to an analyst consensus forecast by GlobalData. GlobalData’s analyst consensus reveals that high sales projections underscore Lynparza’s role in treating multiple cancer types, including ovarian, pancreatic, prostate, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Expected revenues in these indications will reach over 68 per cent of the global PARP inhibitors market by 2027. GlaxoSmithKline’s (GSK) Zejula (niraparib) holds the second position with over $1.6 billion in sales and 28 per cent of the market share. Most of Lynparza’s sales come from ovarian and HER2-negative breast cancer treatment. Biswajit Podder, ...
- Source: https://www.expresspharma.in/astrazenecas-lynparza-to-dominate-parp-inhibitors-market-with-4-bn-in-sales-by-2027-globaldata/
- 159
- May 4, 2024
Pioneer Institute study finds IRA discourages non-opioid drug innovation

Astudy from a US-based public policy research firm has highlighted that the US Inflation Reduction Act (IRA) is likely to stifle research efforts into non-opioid pain medications. The ongoing opioid crisis in the US demands alternatives to addictive pain medications. Several pharma companies have been accused of fuelling the opioid crisis by downplaying the addiction risks of their prescription pain drugs, contributing to the out-of-control opioid addiction problem in many American cities. The majority of heroin and fentanyl addictions stem from initial use of prescription drugs. According to a report on GlobalData’s Pharma Intelligence Center, there were 1,038,938 diagnosed cases of opioid use disorder in the US in 2022. This number is expected to increase to 1,062,610 in 2027. Introduced in 2022, the IRA allows Medicare to negotiate prices and rebates for certain drugs from drug makers in a pursuit to curb inflation. Critics have said the IRA may discourage ...
- Source: drugdu
- 126
- May 3, 2024
Ono Pharmaceutical acquires cancer-focused biopharma Deciphera for $2.4bn

Deciphera Pharmaceuticals is set to be acquired in a $2.4bn buyout, as the biopharma announced that it has commenced a definitive merger agreement with Ono Pharmaceutical. Under the terms of the offered transaction, Ono will make a cash purchase of all outstanding shares of Deciphera’s common stock at $25.60 per share and subsequently merge Deciphera with a wholly-owned subsidiary of Ono upon the deal’s completion. The deal has been unanimously approved by both companies’ boards of directors and is expected to close in Q3 2024. Following the announcement of acquisition, Deciphera’s stock has jumped 71.9%. Waltham, Massachusetts-based Deciphera brings to the table an extensive kinase inhibitor pipeline, kinase drug discovery expertise, and a strong commercial and sales platform in the US and European markets that is meant to advance Ono’s capabilities and presence in the oncology space. Upon the successful completion of the acquisition, Ono will gain access to Deciphera’s ...
- Source: drugdu
- 106
- May 3, 2024
Pfizer’s First Gene Therapy Approval Sets Up a Showdown With CSL in Hemophilia B

The FDA has approved Beqvez, a Pfizer gene therapy developed for moderate-to-severe hemophilia B. The one-time treatment carries a $3.5 million price tag, the same as a CSL Behring gene therapy already available for treating the inherited bleeding disorder. By Frank Vinluan Pfizer’s first FDA-approved gene therapy is the second such treatment for the inherited bleeding disorder hemophilia B, introducing some competition to a therapeutic area that now has two of the most expensive medicines in the world. The FDA approval announced Friday covers the treatment of adults with moderate-to-severe hemophilia B. Known in development as fidanacogene elaparvovec, the Pfizer therapy will be marketed under the brand name Beqvez. The company expects this therapy will become available to patients later in the current quarter. Hemophilias stem from genetic mutations that lead to abnormally low levels of clotting proteins. These disorders mainly affect males and make patients susceptible to bleeding events ...
- Source: drugdu
- 69
- May 2, 2024
Technoderma Medicines Advances TDM-180935 Atopic Dermatitis Clinical Program with Phase 2 Trial

CHENGDU, China, April 29, 2024 /PRNewswire/ — Technoderma Medicines, Inc. (“the Company”), a clinical stage biopharmaceutical company, is pleased to report the Company has begun dosing patients in its Phase 2a clinical trial (NCT06363461) of topical TDM-180935 ointment. This clinical trial in the Atopic Dermatitis (AD) program includes 8 weeks dosing of two different active formulation strengths and placebo in a study entitled, “A Randomized, Vehicle-Controlled, Parallel Group Study of Topical TDM-180935 to Evaluate the Preliminary Efficacy, Safety, Tolerability, and Pharmacokinetics in Atopic Dermatitis Patients”. It is a randomized, vehicle-controlled, parallel group comparison study with an open-label PK sub-study. Objectives are to evaluate the safety and efficacy of topical TDM-180935 as well aspharmacokinetics. Seven U.S. clinical sites are currently participating in this study under an open IND with FDA. Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer at Technoderma Medicines commented, “We expect the current study to support ...
- Source: https://en.prnasia.com/releases/global/technoderma-medicines-advances-tdm-180935-atopic-dermatitis-clinical-program-with-phase-2-trial-445242.shtml
- 74
- May 2, 2024
Degu Insulin Liraglutide Injection was approved for clinical application

Tonghua Dongbao Pharmaceutical Co., Ltd (hereinafter referred to as “Tonghua Dongbao”) has recently obtained the clinical trial approval notification of Degu Insulin Liraglutide Injection issued by the Center for Drug Evaluation (CDE) of the State Drug Administration. The clinical approval of Degu Insulin Liraglutide Injection is another significant progress in the research and development of insulin analog GLP-1RA compound preparation, which will further enhance the company’s competitiveness in the field of endocrine therapy. In the future, the Company is expected to accelerate the process of clinical trials and speed up the approval and listing of its products by virtue of its R&D advantages accumulated in the field of diabetes treatment over the years, so as to provide richer and better choices for clinical medication. Degu Insulin Liraglutide Injection has a broad market prospect in the future, and the market scale shows a rapid growth trend. Its original Degu Insulin Liraglutide ...
- Source: drugdu
- 79
- May 1, 2024
A Flawed Measure of Health

It’s time we move beyond BMI and adopt a holistic approach to truly gauge health. By Gretchen Zimmermann Body Mass Index (BMI) has long been regarded as a standard measure for assessing weight-related health risks and, more recently, determining eligibility for anti-obesity medications like GLP-1 receptor agonists semaglutide (Wegovy) and tirzepatide (Zepbound), according to the FDA. BMI, calculated from weight and height, offers a simplistic yet flawed assessment of health. It was initially designed for non-Hispanic white populations and overlooks nuances like muscle mass, fat distribution, and ethnic background, which can influence certain risk factors. It’s an antiquated measure that perpetuates inequities in healthcare and misses the mark for calculating cardiometabolic conditions. The perception that a “normal” BMI is ideal and an “overweight to obese” BMI is not ideal only exacerbates bias within the medical community and complicates our efforts to solve the obesity crisis. Individuals with an overweight to ...
- Source: drugdu
- 81
- May 1, 2024
Gilead writes $2.4B off Trodelvy as CEO underscores ‘time of focused execution’

The flurry of Trodelvy developments accentuates what Gilead CEO Dan O’Day called “a time of focused execution” at the California biotech. (Jim Watson/AFP/Getty Images) After a negative phase 3 readout, Gilead Sciences is taking a $2.4 billion impairment charge on Trodelvy, which serves as the cornerstone of the company’s solid tumor ambition. Gilead has cut the carrying value of Trodelvy to $3.5 billion in its first-quarter report, from $5.9 billion at the end of 2023, CFO Andrew Dickinson told investors during a call Thursday. The move comes after a January report of a phase 3 trial that the TROP2-directed antibody-drug conjugate failed to significantly extend the lives of patients with previously treated non-small cell lung cancer compared with chemotherapy. The bad news at that time caused a 10% slide in Gilead’s stock price. The write-off reflects a “smaller addressable market that Trodelvy could serve among second-line-plus metastatic non-small cell lung ...
- Source: drugdu
- 116
- April 30, 2024
Judge approves settlement of more than $500M from Philips recall

Dive Brief District Judge Joy Flowers Conti approved a settlement on Thursday that will provide more than $500 million to people who purchased, leased or rented recalled Philips devices. Philips must put at least $467.5 million into a settlement fund for users who bought a recalled device and for devices returned to the company. The company must also set aside $34 million into a payer settlement fund. Flowers is a judge for the U.S. District Court for the Western District of Pennsylvania. The agreement does not include personal injury and medical monitoring claims, which the plaintiffs’ attorneys are pursuing separately. Dive Insight The settlement is related to Philips’ ongoing recall of sleep apnea devices and ventilators. Philips started recalling the devices in June 2021 because foam used to soundproof the machines could break down and be inhaled by patients, posing potential health risks. The majority of the funds will go ...
- Source: drugdu
- 82
- April 28, 2024
GLP-1/GIP Dual-Target Receptor Agonist (THDBH120 for Injection) Clinical Trial Approval for Weight Loss Indication Declaration

Tonghua Dongbao Pharmaceutical Co. (hereinafter referred to as the “Company”, “Tonghua Dongbao”), a wholly-owned subsidiary of Tonghua Dongbao Zixing (Hangzhou) Biomedicine Co., Ltd. has recently obtained the clinical trial approval for THDBH120 for weight loss indication from the Center for Drug Evaluation (CDE) of the State Drug Administration. THDBH120 for injection for the indication of weight loss drug clinical trial approval notice. The approval of the clinical application for THDBH120 for weight loss indication for injection signifies that the company’s GLP-1 pipeline in the field of overweight and obesity treatment has also stepped into the phase of clinical trials, which is of milestone significance. In the future, the Company will accelerate the research and development progress of THDBH120 for injection in diabetes indication and weight loss indication, and further explore and tap the potential of other indications to maximize the value of the product. THDBH120 for injection has a huge ...
- Source: drugdu
- 92
- April 26, 2024

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