Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental New Drug Application (sNDA) for the use of TRISENOX® (arsenic trioxide) injection in combination with all-trans retinoic acid (ATRA) for induction of remission and consolidation in patients with newly diagnosed low or intermediate risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced it has entered into a definitive agreement under which CooperSurgical will acquire PARAGARD® (intrauterine copper contraceptive), a product within its global Women’s Health business, in a $1.1 billion cash transaction. PARAGARD® had revenues of approximately $168 million for the trailing twelve month period ending June 30, 2017. This transaction includes Teva’s manufacturing facility in Buffalo, NY, which produces PARAGARD® exclusively.
Teva’s Austedo is now the first and only therapy approved in the US to treat both tardive dyskinesia and chorea associated with Huntington’s disease.
The National Institute for Health and Care Excellence (NICE) is now backing routine NHS commissioning of Teva’s Cinqaero to treat a severe form of asthma after having initially been minded to block the drug’s use.
Davy James Alvotech’s and Teva’s Selarsdi (ustekinumab-aekn), the second FDA-approved biosimilar to Stelara, is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and for patients aged 6 years and above with active psoriatic arthritis. Image credit: Maria | stock.adobe.com Alvotech’s and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) has been approved by the FDA as a biosimilar to Stelara (ustekinumab), which represents the second approval for a Stelara biosimilar.1 Selarsdi is indicated to treat patients aged 6 years and above with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and for patients aged 6 years and above with active psoriatic arthritis. “The approval of Selarsdi—which is our second biosimilar approval this year—underscores Teva’s commitment to expanding the availability, access and uptake of this important treatment option to patients in the US,” Thomas Rainey, ...
Ahandful of UK charities and community pharmacists urged the UK government to find a fix for the ongoing drug shortage issue to prevent further patient suffering. The UK Epilepsy Society, SUDEP Action, Epilepsy Action and Parkinson’s UK, joined forces to call for a meeting with the Health Secretary, Victoria Atkins. The Association of Independent Multiple Pharmacies (AIMp) found that community pharmacists are spending an average of two hours every day to find patients’ medications due to the disruptions. In a 11 April press release, Dr. Leyla Hannbeck, AIMp’s CEO, said, “The system is overly complex and shrouded in secrecy – what we need is openness and transparency. Pharmacists are in the same position as patients – we are at the end of the supply chain but are the last people to find out about medication shortages. Consequently, we are unable to plan in advance and support the people who rely ...
Mirador Therapeutics applies machine learning to human data to discover new immunology and inflammation drugs. The startup’s management includes several from the executive team of Prometheus Biosciences, an immunology biotech bought by Merck last year. By FRANK VINLUAN Nearly a year ago, Merck struck a $10.8 billion deal to acquire Prometheus Biosciences, a clinical-stage company whose technology platform analyzed genetics and biology data to discover new drugs. The executive who led Prometheus to that buyout is now back with a new immunology startup supported by $400 million. Mirador Therapeutics launched Thursday, aiming to take the precision medicine approaches that have led to advances in cancer drugs and apply them to the research of new therapies for immunology and inflammation. It’s a similar strategy to the one taken by Prometheus under the helm of Mark McKenna, now the CEO of San Diego-based Mirador. There’s a plethora of immunology drugs on the ...
Alto Neuroscience will apply the IPO proceeds toward clinical tests of its psychiatric drugs in patients who exhibit certain biomarkers. The company’s two most advanced programs are depression drugs in mid-stage development. By FRANK VINLUAN Matching a drug to a patient’s biology is not a new idea, but it hasn’t caught on in neuropsychiatric disorders, which have high failure rates in drug studies. The technology of Alto Neuroscience brings precision medicine to psychiatric drug research and its IPO has raised $128.6 million to see if this approach can yield better clinical trial results. Alto priced its IPO late Thursday, offering more than 8 million shares for $16 apiece. The Los Altos, California-based company was able to raise more than planned. When Alto set preliminary financial terms earlier this week, it projected offering 6.7 million shares in the range of $14 and $16 each, which would have raised $100.5 million at ...
Lundbeck wants migraine suffers to say “nope” to doing more and “yep” to doing less with their condition as the core message of its new campaign for Vyepti. The “Say Yep” initiative plays on the yep in Vyepti, the pharma’s intravenous migraine prevention therapy that was approved by the FDA exactly four years ago next month. The therapy brought in DKK 1 billion ($145.9 million) in 2022, double what it made in 2021 and driven by what Lundbeck said was “strong demand.” The multi-channel media campaign is trying to reach the 40 million Americans who suffer from the often-debilitating condition. The message is to slow down and not push through the pain of a migraine. The campaign “brings to life the brand’s empathetic understanding that people are doing a lot to manage migraine and deserve to do a little less, if possible,” a spokesperson from Lundbeck said. “Say Yep subtly ...
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 ...
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