Search Results for “biosimilar ” – Page 11 – media

BIO-THERA Signs License and Commercialization Agreement with Macter for BAT1706

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that it has entered into a license and commercialization agreement with Macter International Limited (“Macter”) for BAT1706, an Anviva reference product. The Company announced today that it has entered into a license and commercialization agreement with Macter International Limited (“Macter”) for BAT1706, a biosimilar developed with reference to Avastin® bevacizumab. Under the terms of the agreement, Macter will have exclusive distribution and marketing rights for BAT1706 in Pakistan and Afghanistan. BAT1706 has completed global Phase III clinical studies, demonstrating a high degree of safety, efficacy, and immunogenicity similarity to the originator, and BAT1706 (PuperChi®) has been approved for marketing by the National Drug Administration (NMPA) of China in November 2021, and BAT1706 (Avzivi®) has been approved for marketing by the U.S. Food and ...
- Source: drugdu
- 83
- January 5, 2024
As ICER places a spotlight on pharma’s price hikes, J&J, Roche and more hit back

After many years of tracking the pharmaceutical industry’s pricing tactics, the Institute for Clinical and Economic Review (ICER) is once again placing a spotlight on the price increases that end up costing the U.S. healthcare system the most. In an annual report (PDF) on “unsupported price increases” (UPIs), the independent nonprofit has placed scrutiny on hikes that it says aren’t supported by evidence of new clinical benefit, ranking the medicines by their contributions to excess healthcare spending. This year’s edition saw the return of AbbVie’s superstar Humira, which last year enjoyed a break from the annual list after being included in every other report since the series began in 2019. The fifth annual version, released Monday, evaluates the industry’s pricing moves in 2022. For Humira, 2022 was the last year of market exclusivity before the med’s dive off of the patent cliff. Humira captured ICER’s top spot on its UPI ...
- Source: drugdu
- 95
- December 13, 2023
As Stelara cliff looms, J&J expects 25 blockbuster drugs to drive future sales growth

As Johnson & Johnson places a magnifying glass on its pharmaceutical business, the focus for the remainder of the decade rests on the shoulders of some 25 new and upcoming drugs. Together, those meds will help the company deliver pharmaceutical sales growth of 5% to 7% between 2025 and 2030, the company said Tuesday. That phalanx of novel products will be essential as J&J’s longstanding immunology star, Stelara, nears its tumble over the patent cliff. Last year, the drug generated $9.7 billion and was J&J’s top product by sales. During an enterprise business review Tuesday, J&J laid out its expectations across the 2025 to 2030 timeframe. Chief among those, J&J says it will boast 10 or more drugs with peak sales potential of at least $5 billion, including cancer launches Talvey and Tecvayli, plus another 15-plus products with sales potential of at least $1 billion. The latter group of therapeutics ...
- Source: drugdu
- 97
- December 7, 2023
With filing in Sanofi and Mylan insulin lawsuit, FTC amps up scrutiny on pharma’s patent tactics

The U.S. Federal Trade Commission isn’t letting up in its effort to crack down on pharma’s alleged misuse of a patent mechanism in the FDA’s regulatory process. And it’s Sanofi’s turn to land in the crosshairs. The FTC is weighing in on an antitrust lawsuit that Viatris’ Mylan brought against Sanofi in May centered on the French pharma’s popular insulin product Lantus. Although the agency didn’t pick sides in the case, it’s using the lawsuit as an opportunity to criticize the type of behavior accused of Sanofi. Specifically, the FTC argues “improper” listings in the FDA’s “Orange Book” can “cause significant harm to competition, and that harm can extend beyond the delay” in access to a competing drug, the FTC said in an amicus brief filed in the case. In the lawsuit, Mylan accused Sanofi of running a “multifaceted monopolization scheme” to protect Lantus. One of the alleged illegal practices ...
- Source: drugdu
- 102
- November 23, 2023
Orphelia pushes boundaries with regulatory barriers for pediatric indications

Orphelia Pharma is taking action to drive regulatory agencies like the European Commission to adapt pharmaceutical legislations that would facilitate the development of rare disease pediatric drugs, like the company’s Kizfizo (Ped-TMZ). Kizfizo, a temozolomide biosimilar, is the first oral liquid suspension of temozolomide designed to act as a monotherapy or as a Kizfizo/DNA topoisomerase inhibitor combination treatment for the treatment of relapsed or refractory (r/r) neuroblastoma. Originally indicated exclusively for the treatment of glioblastoma in adults in the US, temozolomide has been used off label to treat r/r neuroblastoma patients for years. The drug is approved for treating GBM in adults and children in Europe. Use of temozolomide in this manner, especially in children, has its drawbacks because children end up being underdosed, executive chairman Giles Alberici told Pharmaceutical Technology. “You often open the capsules and put that in your water. And this is something that should not be ...
- Source: drugdu
- 93
- November 16, 2023
HHS Considers Removing J&J’s Stelara from Medicare Drug Price Negotiations

By Tristan Manalac Pictured: Entrance to the Department of Health and Human Services in Washington, DC/iStock The Department of Health and Human Services in a supplemental court filing posted late last week has suggested that Johnson & Johnson’s blockbuster psoriasis therapy Stelara (ustekinumab) might soon be “deselected” from the Inflation Reduction Act’s Drug Price Negotiation Program. The development comes after the FDA last week approved Amgen’s Wezlana (ustekinumab-auub), an interchangeable biosimilar to Stelara. In May 2023, Amgen and J&J settled their patent dispute over the biosimilar challenge to Stelara, allowing the entry of Wezlana “no later than January 1, 2025.” Under the current negotiation guidelines, the Centers for Medicare and Medicaid Services can reconsider a drug product for price negotiations when it is “subject to meaningful competition.” HHS referred to this provision in a separate October 2023 court filing, supporting its prior motion to dismiss a lawsuit filed by various ...
- Source: drugdu
- 114
- November 9, 2023
Novartis Inks Potential $1.3B Contract with Korean Biotech for Small Molecule

By Tristan Manalac Pictured: Novartis’ head office in Canada/iStock, JHVEPhoto Novartis on Monday inked a technology export contract with Korean biotech company Chong Kun Dang Pharmaceutical for an early-stage HDAC6 Inhibitor, according to Korea Biomedical Review. Under the agreement, Novartis will make an upfront payment of $80 million and pledge up to nearly $1.23 billion more in development and regulatory milestones. The Korean biotech will also remain eligible to future sales-based royalties, as well as an ongoing technology fee depending on net sales. In return, Novartis will gain the exclusive global rights—except in Korea—to develop and commercialize the investigational small-molecule HDAC inhibitor CKD-510. The candidate in 2021 cleared a Phase I first-in-human study in 87 healthy volunteers and the Korean company appears to be positioning the drug candidate as a potential treatment for Charcot-Marie-Tooth disease, a rare and heritable disease that afflicts the nerves in the limbs. However, a Chong ...
- Source: drugdu
- 108
- November 9, 2023
More Than 60 Groups Ask Senate Leadership To Pass Legislation To Lower Drug Prices

In a letter to Senate leadership, several organizations asked for the passing of legislation that would reform the patent system and improve competition in the prescription drug space. By MARISSA PLESCIA More than 60 organizations sent a letter Wednesday to Senate Majority Leader Chuck Schumer (D-New York) and Senate Minority Leader Mitch McConnell (R-Kentucky). The letter calls for the passing of legislation that the organizations say would lower drug prices through patent reform and increased competition. The organizations include Patients for Affordable Drugs Now, a nonprofit fighting to lower prescription drug prices, and AARP, a nonprofit focused on Americans aged 50 and older. They call for the Senate leadership to advance the following bills: • S. 142, which would tamp down on pay-for-delay deals. This refers to when brand name drug makers pay potential generic and biosimilar competitors to prevent them from bringing their product to market. • S. 150, ...
- Source: drugdu
- 100
- November 3, 2023
Lilly’s Mirikizumab Shows Long-Term Remission in Phase III Crohn’s Trial

By Kate Goodwin Pictured: Eli Lilly world headquarters/iStock, jetcityimage A 52-week study finds Eli Lilly’s mirikizumab to be effective for long-term remission in over half of patients with Crohn’s disease. The company announced Thursday plans to submit a marketing application to the FDA for approval in 2024, followed by submissions to other global regulatory agencies. In the Phase III trial, moderately to severely active Crohn’s disease patients on mirikizumab demonstrated clinical remission as well as endoscopic response at the one-year mark. Over 54% of the patients in the treatment arm achieved clinical remission at week 52, versus 19.6% of those receiving placebo. The endoscopic response was seen in 38% of those on mirikizumab versus 9% on placebo. Safety was consistent with the known profile of the therapy with the frequency of serious adverse events greater in the placebo arm than the treated group, according to Lilly. The interleukin-23p19 antagonist demonstrated ...
- Source: drugdu
- 110
- October 14, 2023
Takeda to Pull Lung Cancer Drug from Market After Failed Confirmatory Study

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond. By FRANK VINLUAN Accelerated approval offers a way to more quickly bring patients drugs for diseases that have few treatment options. But that speedy path to the market comes with the understanding that the FDA can take its regulatory blessing away—unless the company takes its drug away first. That is what Takeda Pharmaceutical has decided to do with its cancer drug, Exkivity. Following discussions with the FDA, the Japanese pharmaceutical giant is voluntarily withdrawing Exkivity from the market. Exkivity treats non-small cell lung cancer by targeting epidermal growth factor (EGFR). That cancer protein must have exon 20 mutations—the same genetic signature addressed by Johnson & Johnson’s Rybrevant. ...
- Source: drugdu
- 197
- October 10, 2023

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