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 ...
By Tyler Patchen Pictured: A neurosurgeon analyzes an MRI/iStock, gorodenkoff GSK spinout Autifony Therapeutics has entered into an exclusive global licensing deal potentially worth $770.5 million with Jazz Pharmaceuticals for two different ion channel targets associated with neurological disorders. Under the deal announced on Tuesday, the U.K.-based biotech Autifony will receive an undisclosed upfront payment from Jazz and is eligible to receive development, regulatory and commercial milestone payments as well as royalties on any future net sales. Autifony, which is focused on developing treatments for central nervous system disorders and other brain diseases, will spearhead the drug discovery and the preclinical development of the two ion channel targets. Prior to the completion of preclinical development, Jazz will take over clinical development and assume responsibility for manufacturing, regulatory actions and commercialization. “Jazz has an exceptional track record of rapidly advancing neuroscience development programs and effectively commercializing novel therapies that offer improvements ...
University of Arizona Health Sciences researchers received a $13.1 million grant from the National Institute on Aging to continue studies aimed at rejuvenating the immune system of older people in order to improve health throughout the lifespan. Older adults are disproportionally affected by infection, cancer and certain types of autoimmune disease. This is influenced by the fact that as a person ages, their body produces fewer T cells and gets less proficient at maintaining them. T cells are a type of white blood cell essential to the immune system and defense against infection. Janko Nikolich, MD, PhD, principal investigator, professor and head of the Department of Immunobiology at the University of Arizona College of Medicine – Tucson, said, “It is clear how much our immune system declines with age when you look at all the previous epidemics and pandemics that have hit us, including COVID-19. Older adults die at a ...
Five pharmaceutical companies have been fined €13.4m ($14.1m) by the European Commission as part of an antitrust cartel settlement revolving around a key ingredient for the antispasmodic drug, Buscopan. The European Commission (EC) has confirmed that Alkaloids of Australia, Alkaloids Corporation, Boehringer, Linnea, and Transo-Pharm all admitted involvement in the cartel and agreed to settle the investigation with the fine. A sixth company, C2 Pharma, was also involved in the plot but was not fined as it revealed the cartel to the EC under the leniency programme. The EC investigation revolved around N-butylbromide scopolamine/ hyoscine (SNBB), an important input material used to produce the abdominal antispasmodic drug, Buscopan, as well as its generic versions. The investigation found that the six companies had coordinated and agreed to fix the minimum sales price of SNBB to customers, as well as allocate quotas. Additionally, the six companies exchanged commercially sensitive information. In a ...
In a company press release, Actym Therapeutics announced that it has extended its Series A financing round with an additional close of $25.5 million, bringing the total Series A amount raised to $59.5 million. Co-led by Boehringer Ingelheim Venture Fund and Illumina Ventures, with GKCC LLC as a new investor, the new capital is expected to enable ACTM-838 into first-in-human oncology trial. “We have advanced the STACT platform and defined a value-building clinical pathway that will allow us to translate our deep understanding of the tumor microenvironment into a novel approach to an effective and safe cancer treatment,” said Christopher Thanos, PhD, CEO, co-founder, Actym Therapeutics. “We value the continued commitment from our current investors and welcome GKCC LLC into the syndicate. Through their combined support, we aim to bring innovative therapies to patients across multiple solid tumor indications.” Image Credit: Adobe Stock Images/Carlos Montes Published on: October 19, 2023
AbbVie has shared detailed results from a head-to-head study comparing its IL-23 inhibitor Skyrizi (risankizumab) to Johnson & Johnson’s Stelara (ustekinumab) in Crohn’s disease. The late-stage SEQUENCE study has been evaluating the drugs, both given as a subcutaneous injection every eight weeks after a lead-in period of intravenous infusions, in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. Despite the availability of a range of treatments, not every patient achieves long-lasting remission, and the progressive damage from disease flare-ups can result in some patients requiring surgery. The results from SEQUENCE, which were presented at the United European Gastroenterology Week, showed that Skyrizi was superior to J&J’s IL-12 and IL-23 inhibitor at achieving endoscopic remission after 48 weeks of treatment, with 32% and ...
After the Centers for Medicare & Medicaid Services revealed the list of drugs set to face the first round of price negotiations under the Inflation Reduction Act (IRA), the drugmakers responsible for marketing them are confronting a series of deadlines. First up, the companies need to tell CMS by Sunday whether they’ll participate in the process or exit the Medicare and Medicaid programs entirely. In a statement to Fierce Pharma, an AstraZeneca representative said the company plans to “participate in the process outlined by CMS to communicate the value of Farxiga to people covered by Medicare” as part of its commitment to ensuring access. BMS plans to begrudgingly participate in the process, a spokesperson told Fierce Pharma in an emailed statement. “If we did not sign, we’d be required to pay impossibly high penalties unless we withdraw all of our medicines from Medicare and Medicaid,” the spokesperson said. “That is ...
By Kate Goodwin Pictured: Human lung anatomy concept/iStock, magicmine Oxford-based biotech AlveoGene launched Thursday with plans to leverage a proprietary platform from the U.K.’s Gene Therapy Consortium to develop inhaled gene therapies for rare respiratory disorders. With seed funding from Oxford Science Enterprises, alongside other academia venture capital funds, AlveoGene has exclusively licensed the Gene Therapy Consortium’s next-gen lentiviral delivery platform—called InGenuiTy—for the treatment of respiratory diseases with high unmet need. However, use of the CTFR gene is excluded from the deal as Boehringer Ingelheim exercised its option in 2021 to develop the inhaled formulation, which is in the works for cystic fibrosis. AlveoGene’s first target will be treating Alpha-1 Antitrypsin Deficiency (AATD), one of the most common rare disorders. AATD is inherited and leads to reduced levels of a plasma protein that protects the lungs, leading to increased risk for lung and other diseases. It’s a major genetic risk ...
AbbVie has shared positive top-line results from a head-to-head study of its interleukin-23 inhibitor Skyrizi (risankizumab) in Crohn’s disease. The late-stage study, SEQUENCE, has been evaluating the drug against Johnson & Johnson’s Stelara (ustekinumab) in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents. Skyrizi was shown to match Stelara in terms of clinical remission at week 24, with remission rates of 59% in the Skyrizi group and 40% in the Stelara cohort. On the second primary endpoint of endoscopic remission at week 48, Skyrizi demonstrated superiority to Stelara, with remission rates of 32% and 16%, respectively. All secondary endpoints achieved statistical significance for superiority versus Stelara, AbbVie said, and safety results were consistent with the overall safety profile of Skyrizi. Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. It is ...
Merck & Co. was the first drugmaker to sue over the controversial Medicare price negotiation provisions in last year’s Inflation Reduction Act (IRA). But the New Jersey drug giant “lacks standing” to challenge the law in court, the Biden administration argued in a new filing. Monday, the Department of Health and Human Services (HHS) argued that Merck can’t sue the agency because it isn’t the primary manufacturer for the diabetes med Januvia—one of 10 medications up for the first round of price negotiations in 2026. Simply put, HHS argues a Merck subsidiary is the company set to face the negotiation process, not Merck itself. Merck has argued it stands to suffer harm from the price negotiations because it developed and markets Januvia. But that assertion is “incorrect,” according to HHS, because a “non-party” to the lawsuit, Merck Sharp & Dohme, holds the FDA license to Januvia. “Accordingly, [the Centers for ...
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.