Search Results for “FDA” – Page 155 – media

Ahead of high-stakes California trial, GSK notches Zantac win in Canada

As GSK’s July court date nears for a key Zantac trial in California, the company can wipe its hands of at least one Canadian class action suit. The company said in a Friday statement that it “welcomes the decision” of the British Columbia Supreme Court to dismiss a proposed class action suit on behalf of Canadian Zantac users. A Vancouver man filed the lawsuit in 2020, alleging that his use of the heartburn med from 2018 to 2019 caused him to develop cancer. His complaint named more than a dozen companies as defendants, including Sandoz Canada and GSK. But the court dismissed the case due to “the uncontroverted evidence that neither ranitidine nor NDMA are reliably associated with increased cancer risk,” GSK said in its statement. Zantac is ranitidine’s brand name and much of the Zantac cases revolve around reports of N-nitrosodimethylamine (NDMA) contamination in the products. Health Canada started investigating the potential impurity in ...
- Source: drugdu
- 120
- May 16, 2023
Sandoz taps Evotec in long-term biosimilar development and manufacturing deal

As Novartis’ Sandoz unit prepares to go it alone, the off-patent medicines specialist is buckling up for the biosimilars long haul. Sandoz on Tuesday struck an accord with Just – Evotec Biologics to develop and manufacture biosimilar candidates over a multiyear stretch. The deal, which includes an “option for expansion,” marks the latest step in Sandoz’s quest to strengthen itself as a standalone company, the generics unit said in a release. The companies did not say how much they are paying for the deal. Last summer, Novartis telegraphed plans to spin off Sandoz. The decision came as part of a wider strategic review at the company that kicked off in October 2021. As of last August, the spinoff was expected to wrap up in the second half of 2023. Under its latest pact, Sandoz will get its hands on Just – Evotec Biologics’ drug substance development platform and manufacturing technology. Sandoz will use that ...
- Source: drugdu
- 205
- May 15, 2023
Sobi to acquire CTI BioPharma for approximately $1.7bn

Swedish Orphan Biovitrum (Sobi) has said it will acquire CTI BioPharma for approximately $1.7bn, marking a notable expansion to the Swedish drugmaker’s rare haematology pipeline. The deal will grant Sobi access to the US biopharma’s recently-approved Vonjo (pacritinib), a novel oral kinase inhibitor for patients with myelofibrosis and severe thrombocytopenia. The drug was granted accelerated approval by the US Food and Drug Administration (FDA) in February last year to treat adults with intermediate or high-risk primary or secondary myelofibrosis with low platelet counts. This was based on positive results from a phase 3 trial of Vonjo in patients with myelofibrosis. Results showed that 29% of patients receiving Vonjo had a reduction in spleen volume of at least 35% compared to 3% of patients receiving best available therapy. Sobi said Vonjo will be ‘highly complementary’ to Doptelet (avatrombopag), its oral thrombopoietin receptor agonist which also addresses rare haematological platelet disorders. Guido ...
- Source: https://www.pmlive.com/pharma_news/sobi_to_acquire_cti_biopharma_for_approximately_$1.7bn_1491454
- 124
- May 14, 2023
Otsuka, Lundbeck’s Rexulti nabs new use in Alzheimer’s disease agitation

After Lundbeck and Otsuka’s Rexulti cleared a key advisory committee hurdle, the FDA has given the drug the go-ahead to treat dementia-associated agitation in Alzheimer’s disease patients With the approval, Rexulti becomes the first drug approved for this use in the United States. The FDA granted the nod based on data from two 12-week studies in which patients showered statistically significant and clinically meaningful improvements on the Cohen-Mansfield Agitation Inventory scale, according to the FDA. The metric looks at the frequency and intensity of dementia-related agitation. In the studies, Rexulti demonstrated a 31% improvement from baseline agitation symptoms compared with placebo. Agitation symptoms cover a wide group of behaviors including pacing, gesturing, profanity, shouting, and physical outbursts, Otsuka said in a release. The symptoms are the leading causes of assisted living or nursing room placement and have been known to be associated with accelerated disease progression, Tiffany Farchione, director ...
- Source: drugdu
- 113
- May 13, 2023
Sobi Emerges as Savior for CTI Biopharma Cash Crunch With $1.7B M&A Deal

CTI Biopharma has something many biotech companies aspire to achieve—revenue. Sales of its approved cancer drug are growing, but commercialization comes with costs as does development of the molecule for additional indications. CTI expects it will need to raise money, but the dismal financial conditions mean fundraising prospects for any biotech company could remain challenging for the foreseeable future. Enter Swedish Orphan Biovitrum (Sobi), the Stockholm-based rare diseases biopharmaceutical company. Sobi has agreed to acquire CTI in a cash deal that values the Seattle-based biotech at $1.7 billion. According to the terms of the deal, Sobi will pay $9.10 for each share of CTI, which represents an 89% premium to the stock’s price before the deal was announced Wednesday. The heart of the acquisition is Vonjo, a drug for myelofibrosis, a rare bone marrow cancer that impairs the production of red blood cells. Last year, the FDA granted accelerated approved ...
- Source: drugdu
- 112
- May 13, 2023
Experiment shows thoughts influence tactile perception

If we sincerely believe that our index finger is five times bigger than it really is, our sense of touch improves. Researchers at Ruhr University Bochum demonstrated that this is the case in an experiment in which the participants were put under professional hypnosis. When the participants signaled that they understood the opposite hypnotic suggestion that their index finger was five times smaller than it actually was, their sense of touch deteriorated accordingly. The study shows that our tactile perception is affected and can be altered by our mental processes. The scientific community has been divided on this issue. Headed by PD Dr. Hubert Dinse, Professor Albert Newen and Professor Martin Tegenthoff, the researchers published their findings in the journal Scientific Reports on April 21, 2023. Two needles feel like one The researchers measured the tactile perception of their 24 test participants using the two-point discrimination method. This involves the ...
- Source: drugdu
- 105
- May 13, 2023
Mirati’s KRAS drug beats estimates in Q1, but Keytruda combo plan remains unclear

Just as Amgen’s KRAS contender Lumakras suffered a sequential sales decline, Mirati Therapeutics’ rival drug Krazati has surprised analysts in its first full quarter on the market. But investors remain more interested in Mirati’s plan for newly diagnosed lung cancer patients. After an FDA approval in KRAS-mutated non-small cell lung cancer (NSCLC) in December, Krazati generated $6.3 million in the first three months of 2023, coming in ahead of Wall Street’s expectation of $3.4 million. Krazati delivered that beat just as Lumakras’ sales in the U.S. slumped by $14 million, or 23% lower than its haul in the fourth quarter of 2022. In a sign of early interest in the therapy, Krazati has captured a third of new patient starts, Mirati’s chief commercial officer Ben Hickey told investors during a call Tuesday. Among the top 50 doctors that Mirati is targeting with its awareness efforts, 80% have prescribed Krazati, he ...
- Source: drugdu
- 370
- May 13, 2023
Cancer drugs among top 5 most affected by shortages in the US

By Deidre McPhillips, CNN CNN — As the US faces a near-record number of drug shortages, cancer treatments are among the hardest hit. There is an active shortage of about two dozen chemotherapy drugs, the fifth most of any drug category, according to data from the end of March from the University of Utah Drug Information Service. “The fact that we have this many chemo drugs in shortage is really concerning,” said Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists. Unlike some other drugs that also rank among the top five categories for shortages, such as antimicrobials, there aren’t often alternatives for chemotherapy drugs, he said. And the shortages are affecting treatment for a broad range of cancers. “One of the key predictors of how well a patient will respond to treatment is getting a full dose on the right schedule,” Ganio said. “So when ...
- Source: drugdu
- 112
- May 13, 2023
Experts call for monitoring of respiratory vaccine after trials suggest possible increase in preterm births

Experts have called for further scrutiny of a new Pfizer vaccine given during pregnancy to prevent respiratory infection in infants, after trials of a similar GSK vaccine were stopped after a rise in preterm birth and infant deaths. Pfizer says its vaccine is safe and effective, but experts contacted as part of an investigation published by The BMJ today, say Pfizer’s trial data should be reviewed in light of the signal for preterm births seen in GSK’s trial. Pfizer’s maternal RSV vaccine aims to protect infants from severe illness caused by the respiratory syncytial virus (RSV). RSV is very common but can be fatal, especially in young children. In 2019, an estimated 3.6% of all deaths worldwide in children aged 1–6 months were due to RSV, with 97% of these deaths occurring in low and middle income countries. The vaccine has not yet been approved for use, but a decision by the U.S. Food and Drug Administration is ...
- Source: drugdu
- 166
- May 12, 2023
Teva CEO Richard Francis, after 4 months at the helm, preps grand strategic reveal

After a little over four months as Teva’s CEO, Richard Francis is getting ready to debut his long-term vision for the drugmaker. In Francis’ first quarter as Teva’s CEO, the Israeli pharma giant pulled down $3.7 billion in sales, a flat number versus the same period last year. In Europe, the company posted a 9% sales gain, Teva said Wednesday. Huntington’s disease and tardive dyskinesia med Austedo delivered a 10% global revenue gain to $170 million during the first quarter, while migraine prevention drug Ajovy posted a 35% increase to $95 million. Overall, first-quarter revenues came in around estimates, Barclays analysts wrote in a note to clients. In an investor presentation (PDF), Francis highlighted key attributes of the company, including its innovative pipeline and a “balanced risk portfolio.” The generics group is “a strong business that generates significant cash,” he added on Teva’s first-quarter earnings conference call. But what has ...
- Source: drugdu
- 128
- May 12, 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.